BRC CP Guideline

For more information visit www.brcglobalstandards.
com
GLOBAL STANDARD FOR CONSUMER PRODUCTS

INTERPRETATION GUIDELINE
SA
M
PL
2010
British Retail Consortium
London: TSO
Page 1 of 153
6660 BRC IG TEXT v0_1.pdf 1
Interpretation Guidelines CP Draft 1
30/4/10 12:44:30
For more information visit www.brcglobalstandards.com
Contents
Section I Overview
1 Introduction
1.1 Why is the guideline needed?
1.2 Status of the guideline
2 General and Background Information
2.1 Summary of the Global Standard
2.2 What is certification?
2.3 The benefits of certification
2.4 The cost of certification
2.5 The value of certification
2.6 Time to achieve certification
2.7 Will it be too difficult?
2.8 Scoring and continuous improvement
2.9 The history and background of the Global Standard
SA
M
PL
Section II Product Groups and Risk Assessment

1 Defining Product Scopes
2 Assigning the Correct Product Group
2.1 The difference between manufacturers and packers
3 Using the Decision Trees
3.1 Product Group 1
3.2 Product Group 2
3.3 Product Group 3
4 Process of Risk Assessment the Basics
5 Product and Process Risk Assessment
5.1 Risk assessment of the product design and materials
5.2 Risk assessment of the manufacturing process
6 Planning a Risk Assessment
6.1 Setting up a team
6.2 Team activities
7 Considerations in a Risk Assessment
7.1 Pre-designed products or components (design)
7.2 Product use
7.3 Vulnerability of users
7.4 Hazards
7.5 Nature of injury
7.6 Probability
7.7 Risk level
8 Risk Assessment Methods
8.1 Hazard Analysis and Critical Control Points
8.2 Risk priority number
8.3 Failure mode and effect analysis
8.4 Fault tree analysis
8.5 Nomographs
Page 2 of 153
30/4/10 12:44:34
SA
M
PL
Section III Explaining the Requirements of the Global Standard

1 Senior Management Commitment and Continual Improvement
1.1 Safety and quality objectives
1.2 Review process and evaluation
1.3 Records, documentation and communication of the review
1.4 Provision of resources
1.5 Staff responsible for the Global Standard shall report regularly to senior
management
1.6 Site shall have a copy of the Global Standard
1.7 Approval by the authorities
2 Risk Management
2.1 Product scope and group determination
2.2 Legislative and safety requirements
2.3 Risk assessment prior to production
2.4 Verification of the product risk assessment
3 Management System
3.1 Policy statement
3.2 General documentation requirements
3.3 Organisational structure, responsibility and management authority
3.4 Internal audit
3.5 Purchasing, supplier approval and performance monitoring
3.6 Customer-supplied property
3.7 Corrective and preventive action
3.8 Traceability
3.9 Management of product withdrawal and product recall
3.10 Management of incidents and business continuity
3.11 Contract review and customer focus
3.12 Complaint handling
4 Site Standards
4.1 Location, perimeter and grounds
4.2 Internal site: factory layout, product flow and segregation
4.3 Building interiors
4.4 Staff facilities
4.5 Cleaning procedures
4.6 Waste/waste disposal
4.7 Pest control
4.8 Product transport, storage and distribution
4.9 Site security
5 Product Control
5.1 Pre-production reference samples
5.2 Chemical formulation control
5.3 Product packaging materials
5.4 Control of non-conforming materials
6 Product Conformity Assessment
6.1 Product analysis/testing
6.2 Inspections
6.3 Product claims
Page 3 of 153
30/4/10 12:44:34
7 Process Control
7.1 Control of operations
7.2 Control of incoming components and raw materials
7.3 Equipment and equipment maintenance
7.4 Foreign-body detection and control
7.5 Calibration and control of measuring and monitoring devices
7.6 Retained production samples
7.7 Final product packing and control
8 Personnel
8.1 Training and competency
8.2 Protective clothing
8.3 Hygiene practices
SA
M
PL
Section IV Guidance for Achieving Certification

1 First Steps
2 Planning
2.1 Commitment
2.2 Team building
2.4 Deciding the product group
2.5 Carry out a self-assessment or gap analysis
3 Preparation
3.1 Documentation
3.2 Evidence and fact
4 Selection of a Certification Body
4.1 Accreditation
4.2 Scope
4.3 Audit teams and other visitors
4.4 Consistency of certification bodies
4.5 Code of conduct
4.6 Customer preferences
4.7 Location
4.8 Resources and service
4.9 Applications
4.10 Contract
4.11 Pre-assessment audits
5 Preparing for the Audit Visit
5.1 Choosing a date
5.2 Availability of staff and information
5.3 Auditor facilities
6 The Audit Visit
6.1 The opening meeting
6.2 Auditor activities and time on site
6.3 Document reviews
6.4 Facility inspection
6.5 After the site visit
6.6 Closing meeting
6.7 Tips for the audit visit
Page 4 of 153
30/4/10 12:44:35
7 After the Audit Visit

7.1 Handling non-conformities and corrective action
7.2 Revisits
7.3 Review of documentary evidence
7.4 Timing
8 The Audit Report
8.1 The report format
8.2 Report ownership
9 Certification
10 Use of the Logo
11 The Directory
12 Feedback
13 Further Support
Summary
Main Differences
SA
M
PL
Appendix: Differences between Issue 3 and Issue 2A

Summary
Main Differences
Page 5 of 153
30/4/10 12:44:35
SA
M
PL
SECTION I
OVERVIEW
Page 6 of 153
30/4/10 12:44:35
Section I
Overview
1 Introduction
This guideline is intended to help you understand and implement the Global Standard for
Consumer Products Issue 3 (henceforward referred to as the Global Standard). It builds
on the information in the Global Standard and provides an expanded explanation of the
certification programme, the requirements and the audit process. It does not repeat
information contained in the Global Standard and you will need a copy of the Global
Standard for reference when studying this guideline.
1.1 Why is the guideline needed?
This interpretation guideline is generally applicable to manufacturing and assemblypacking sites and is not intended for any specific industry sector. In some cases, sectorspecific guidelines are also available. This guideline will also be useful for auditors and
those sites requesting that their suppliers adopt the Global Standard.
SA
M
PL
The requirements of the Global Standard contain clear statements that can be evaluated
by an auditor during an audit visit. The auditor can then make an assessment of whether
the site has met each of the requirements. The clauses of the Global Standard are
generally short statements without explanation. The Global Standard does not define the
means by which a site fulfils the requirements (indeed this may vary from site to site),
nor is it possible to include detailed explanations of the intention or background of the
requirements in the Global Standard.
The Global Standard tells a site what needs to be achieved, but does not explain how it
should be achieved, or why. This guideline helps to fill in the gaps so that sites seeking
certification, auditors and retailers can gain a better practical understanding of what is
required. It gives sites an indication of what an audit visit might entail, and the kind of
information and evidence an auditor will look for.
This guideline contains:
a detailed explanation of the certification programme
guidance on risk assessment
an enhanced explanation of each clause of the Global Standard, with practical
examples
information and guidance about the audit process and audit visits.
1.2 Status of the guideline
This guideline has been produced to help sites meet the requirements of the Global
Standard. It is not essential to have a copy of the guideline or to follow every suggestion
in it in order to obtain certification. Its main purpose is to provide support for sites that
are looking to obtain certification but are unfamiliar with the Global Standard and how to
fulfil its requirements.
Page 7 of 153
30/4/10 12:44:36
Sites are audited against the Global Standard, not the guideline. Therefore, a site is able
to adopt its own approach to tackling the requirements if it so wishes. The British Retail
Consortium (BRC) always welcomes additional suggestions or improvements and may
include interpretations and updates on its website from time to time:
www.brcglobalstandards.com. This interpretation guideline is complemented by a series
of BRC best-practice guidelines, which provide in-depth considerations of issues such as
pest control, complaint handling, foreign-body detection and internal auditing.
2 General and Background Information
2.1 Summary of the Global Standard
What follows is some useful background information on the Global Standard, which will
help those sites considering certification understand more about it. It explains why the
Global Standard exists and has evolved to Issue 3, the advantages of obtaining
certification, the likely level of investment, and the resources and time necessary to bring
a site to the level required for certification. It also helps sites to compare the
requirements of the Global Standard to their current systems for quality and safety.
SA
M
PL
The Global Standard for Consumer Products is, as its title suggests, a standard about
consumer products that can be used globally but it helps to know a little more. Most
importantly, the Global Standard is about the safety, legality and quality of products. In
order to apply the Global Standard, a site must be manufacturing or contract/assembly
packing consumer products.
Examples
A company imports giftware products, which it supplies to a retailer for its private-label range. The
retailer has told the company that it needs to obtain certification to the Global Standard.
The Global Standard is not applicable to importers. The importer can request its manufacturer
meets the Global Standard.
A company imports pens, pencils and erasers in bulk, which it packages into stationery sets for the
consumer.
The company may be considered an assembly packer, and the Global Standard is applicable.
The Global Standard does not cover issues such as worker safety, protection of the
environment, social and ethical issues, or sustainability. These are all important topics
but the Global Standard is completely focused on products and helping to ensure that
they are safe, legal and made to the required quality. The Global Standard has been
produced by experts in these areas.
Those auditing the Global Standard are required to have substantial expertise and
experience in the safety, quality and legality of products within the scope of the auditing
competence.
The Global Standard is a voluntary, private standard produced by technical committees
comprised of retailers, with input from a number of other stakeholders. The Global
Standard is owned by the BRC and Issue 3 has been developed in partnership with the
Retail Industry Leaders Association (RILA) in the USA. It is designed to meet the needs
of retailers and their customers, and help sites ensure that suitable products reach the
marketplace.
Page 8 of 153
30/4/10 12:44:36
The Global Standard does not replace or conflict with product-specific standards
(whether voluntary or mandatory) or any legal requirements. Indeed, the requirements of
the Global Standard include checks to ensure that manufacturers are aware of and meet
their obligations in this respect.
Examples
A company produces toasters for export to Europe and has been testing products for electrical safety
to EN 60335-2-9. It is concerned that the Global Standard does not include this test.
The Global Standard is not a specific test standard. It is an auditing standard, which ensures that
companies can consistently manufacture in accordance with its requirements. The auditor would
expect the company to show that it knew and kept up to date with the product standards relevant to
its products (including EN 60335-2-9).
A company produces cosmetics for the global market and follows an industry guide for good
manufacturing practice (GMP). It is concerned that the Global Standard will create extra work.
The Global Standard is applicable to most types of consumer product and is written in general
terms. It is very unlikely that it will conflict with more specific requirements and, if a company
already has procedures in place, this is likely to make implementation of the Global Standard
easier. The Global Standard covers many aspects, including GMP.
SA
M
PL
A common question concerns the difference between the Global Standard and ISO 9000
(the standards for quality management systems). In simple terms, the difference is
around the Global Standards focus on products. In order to meet the requirements of
the Global Standard, a site has to define the scope of the products for which it wishes to
be certificated and the regions of the world in which it intends to sell those products.
Many of the clauses in the Global Standard are specifically related to products such as
those on product conformity, risk assessment and hygiene. ISO 9000, on the other hand,
is about management systems. The Global Standard includes a number of clauses
about management commitment and management systems, and a site that has
achieved ISO 9000 will be in a good position to meet the requirements on these matters.
Another difference is that the Global Standard is part of a centrally controlled certification
programme with comprehensive checks and balances in place. ISO 9000 certification is
offered by many organisations and there is no single point of control. Many of the
approved certification bodies that carry out audits to the Global Standard also carry out
ISO 9000 audits, and it is possible to combine these visits if required. Further information
on these services can be obtained directly from the certification bodies.
More detail of the similarities and differences between the Global Standard and ISO
9000 can be found on the BRC Global Standards website
(www.brcglobalstandards.com).
Figure 1 illustrates how the Global Standard overlaps with other quality assurance
systems.
Page 9 of 153
30/4/10 12:44:37
PL
SA
M
Figure 1 How the Global Standard for Consumer Products overlaps with other quality
assurance systems
The Global Standard contains a set of requirements, and fulfilment of these
requirements helps to ensure that a site consistently produces products to meet retailers
expectations. It is possible for a site to implement the Global Standard and use it solely
for its own benefit in order to improve its processes and procedures; but this is unusual.
A site generally wishes to gain certification to the Global Standard either because it has
been asked to do so by a customer or because, once it has obtained certification, its
details will be placed on a database of certificated suppliers and it will be able to use the
certification to help generate business.
2.2 What is certification?
Certification is the recognition that a site is operating in compliance with the
requirements of the Global Standard. Once a site feels it has carried out all the
preparation necessary to meet the Global Standard, it contacts a certification body to
arrange an audit visit. After the visit, the site receives a report that details any nonconformities the auditor has witnessed during the visit. These must be corrected within a
given timescale 60 days for the initial visit and 28 days for subsequent audits. No
certificate is awarded until all non-conformities have been satisfactorily addressed. When
this has been done, the site becomes certificated and its details are loaded onto a
secure database. The information is owned by the entity that paid for the audit, which is
usually the site itself although, in some cases, it may be an agent or representative. The
Page 10 of 153
30/4/10 12:44:38
owner can choose who has access to detailed information such as audit reports, and
whether they wish the certificate to be available on the public website. The audit
processes are addressed in more detail in Section IV of this guideline.
The BRC and RILA do not carry out any audits themselves. Audits are carried out by
approved certification bodies that have to sign a contract agreeing to follow certain
requirements. Certification bodies must be independently assessed (known as
accreditation) for their competence by one of the national accreditation agencies
responsible for checking the systems and competence of the auditors. The BRC
maintains a list of the accreditation agencies it works with. Certification bodies have to
be audited every year to ensure that they are performing correctly. Any justified
complaints received by the BRC about certification bodies are investigated by the BRC
and referred to the appropriate accreditation agency for consideration.
2.3 The benefits of certification
SA
M
PL
There are numerous ways to assess whether certification will be of value to your site. As
well as the direct value of being able to trade with a particular client, who may have
insisted you become certificated as a requirement for business, there are many other
advantages of certification:
Implementation of logical processes and procedures leads to a more consistent and
efficient operation with a better use of resources.
Documenting processes and procedures helps to prevent mistakes, rework or recalls
and makes investigations into any problems much easier.
It provides a competitive advantage over sites not yet certificated, especially given
current concerns about product safety, and may lead to increased sales.
It can provide evidence of good practice and a certain level of defence when
problems do occur. It may even reduce insurance premiums.
It enables your site to be benchmarked against industry best practices, and routine
audits assist sites with continuous improvement.
The global nature of the Global Standard may open up trade opportunities in new
countries or regions.
Visibility on the BRC Global Standards website (www.brcglobalstandards.com), is
viewed by many of the worlds leading retailers and other customers.
It ensures that there is a framework in place to keep up to date with safety legislation
and current safety concerns.
There is a high level of prestige for a site that achieves certification to the Global
Standard.
Implementation of the Global Standard provides an excellent training tool for staff.
It is essential, however, that a site becomes familiar with the Global Standard and
studies it in detail before rushing into certification. There are many sources of advice and
information (including certification bodies, retailers, consultants etc.) who can advise on
the best way forward.
Page 11 of 153
30/4/10 12:44:38
Examples
A company produces childrens books. It has a problem with a sound chip detaching from the book
and, as this is a possible choking hazard, needs to carry out a recall. It cannot identify the faulty
batch so has to recall all products from 26 countries. A similar company, but with the Global
Standard in place, needs to recall childrens shoes that have a faulty decoration. Because its
traceability system complied with the requirements of the Global Standard, it is able to trace the
problem to a small batch of product and conduct a limited recall of a small delivery in one country.
This demonstrates how the systems put in place to meet the requirements of the Global Standard
can have direct practical benefits for a company.
A producer is making bicycles for the European market when it is asked to fulfil an order by a new
client in Australia.
Using the system it has put in place to meet the requirements of the Global Standard to keep
updated on product safety standards and legislation, the company is quickly able to identify that,
although the product standards in Australia are different from those in Europe, which was the
region of intended sale, it can adapt to the requirements and is able to meet the order.
2.4 The cost of certification
PL
The cost of certification will vary greatly from site to site and will depend, to a large
extent, on how close a site already is to meeting the requirements of the Global
Standard.
It is likely that much of the cost of achieving certification will be incurred by the work
necessary to fulfil the requirements of the Global Standard, rather than the actual audit
cost.
SA
M
The final cost of certification will comprise:

Purchase of the Global Standard (it is a requirement for a site to be in possession of
a legal copy of the Global Standard in order to achieve certification).
Purchase of any guidelines required (optional).
Upgrading equipment or buildings to meet the requirements, where this is important
for product safety.
Management time to prepare and implement new procedures, or improve existing
ones.
Staff training about the Global Standard and any new procedures required.
External consultancy or advice (as necessary).
A pre-assessment visit (optional).
The audit visit.
Correction of any non-conformities raised.
The BRC registration fee.
2.5 The value of certification
Sites should balance the cost of gaining certification against the benefits of having a
more robust and controlled system in place, and the confidence to produce safe and
legal products. This is likely to lead to an enhanced reputation and the possibility of
greater sales.
The Global Standard is not prescriptive about the format of any documentation or the
way in which sites show compliance so, if a site already has good procedures in place
which cover all aspects of the Global Standard, costs will be largely limited to the
purchase of the Global Standard, the audit visit and the registration fee.
Page 12 of 153
30/4/10 12:44:39
The Global Standard is suitable for a wide range of operations, from small sites making
one simple product type for a local market to large sites making a wide range of products
for international markets. The complexity of the product type, the level of risk the product
might present and the amount of legislation surrounding the product will also affect the
amount of work required to meet the Global Standard. This, in turn, will affect
implementation costs and the length (and therefore cost) of the audit visit.
The BRC or RILA do not control the cost of the audit visit. This is set by the certification
body and is governed by market forces. The certification body will typically ask you for
some information about your site and products (often in the form of an application pack
or questionnaire). It will then provide you with a quotation detailing the length and cost of
the audit, as well as any extras such as expenses for travel and subsistence. Quotations
are affected by a number of factors, including the availability of an auditor with
experience in the relevant product sector, workload, different pricing structures and
location, so it may be worth shopping around.
PL
The BRC registration fee is payable at each certification. The fee is collected by the
certification body on behalf of the BRC. This fee includes registering the site on the BRC
Directory and helps to support other services such as compliance management,
newsletters, updates etc.
Despite the initial outlay, implementation of the Global Standard may result in substantial
savings brought about by improvements in efficiency and management control.
2.6 Time to achieve certification
SA
M
The time needed to gain certification is dependent, like the cost, on how close the site
already is to meeting the requirements of the Global Standard, and how complex the
operations are.
Auditors will expect to see a working system in place and evidence that actions have
been completed and records kept. A template created just before an audit visit, without
any actual data recorded onto it, is not likely to be sufficient to convince an auditor that
the operation is working consistently and well.
For a new site, once the management is confident that the Global Standard has been
implemented, the systems should operate for a minimum of three months before the site
seeks certification. Sites that already have procedures in place and are migrating to the
Global Standard after experience of other programmes may be able to complete the
process within a shorter timescale.
Sites that aspire to become certificated to the Global Standard and are working towards
certification may register on the scheme and undergo an initial audit even though they
may not be ready for certification. This allows sites to establish a gap analysis and work
on the aspects that need improvement. It also means that their customers (retailers or
others) are able to track their progress towards certification.
Page 13 of 153
30/4/10 12:44:39
Most certification bodies offer a pre-assessment audit to help a site gauge where it is
with regards to certification, and enable it to work on any the gaps in its system. In order
to avoid a conflict of interests, certification bodies are not allowed to offer consultancy
and advice unless they have a separate consultancy division. There are, however, a
number of consultants who can help sites meet the requirements of the Global Standard.
2.7 Will it be too difficult?
Many sites have concerns about implementing the Global Standard. A smaller site, for
example, may not be familiar with independent assessment against a standard, or it
may have particular concerns about its products (small runs, seasonal items, speed
from production to market etc.). Then, of course, there are concerns about the
investment needed in both money and time, and whether there are sufficient resources
or expertise available.
Do not be intimidated by the Global Standard. Instead, purchase a copy and study it in
detail. Most of the requirements are normal business practices and a site may find that it
is already doing most of what is required, even if it does not have all the procedures or
documentation in place.
SA
M
PL
If a site requires capital investment or changes to the building layout in order to achieve
certification, it should consider whether this investment may bring other business
benefits. The Global Standard is not generally prescriptive about how sites meet the
requirements and it may be possible to identify less expensive means to achieve the
same objectives. The Global Standard includes requirements to ensure the safety and
quality of products. If products are not being produced using the principles behind the
Global Standard are you confident that you can ensure their safety and legality and that
they will consistently meet your customers demands without costly rejections and
returns? Consumer expectations and product legislation are becoming ever more
demanding, so consider whether working towards the Global Standard now will help you
to adapt to the market in the future.
2.8 Scoring and continuous improvement
When a site is awarded certification it receives a grade which is determined by the

number and severity of the non-conformities discovered during the audit visit. Each site
is also awarded a score. This score is allocated during the audit visit by the auditor
completing the BRC checklist of questions. More information about the checklist is
available on the BRC website (www.brcglobalstandards.com). It is not included in this
guideline as it needs to be updated and modified from time to time.
All sites are scored whether or not they achieve certification. Unlike the audit grade,
the scores are not published on the public website, nor do they affect the frequency of
audit visits.
In addition to the scored questions in the checklist, there are a number of critical failure
questions. These questions relate to critical failure points or substantial failures to meet
fundamental requirements of the Global Standard. Such failures automatically lead to a
failed audit.
Page 14 of 153
30/4/10 12:44:40
Site scores are made available to those retailers and other partners to whom the site has
chosen to reveal its full information. Retailers can use the scores to compare sites and
identify any problem areas.
This system allows sites that are not yet ready for certification to undergo audits and
register on the BRC Directory. It also allows a site working towards BRC certification to
show continuous improvement as its audit scores improve over time.
This approach also gives retailers visibility of the performance of sites that do not yet
meet the full certification requirements so that they can form an opinion about whether or
not to use that supplier.
Un-certificated sites do not appear on the public directory of certificated sites.
2.9 The history and background of the Global Standard
SA
M
PL
The idea for a Global Standard to help ensure the safety and quality of non-food
products originally came from large retailers in the UK. These retailers had become
accustomed to working with the BRCs Global Standard for Food Safety, found it helpful
and wanted something similar for the non-food items on their shelves. One of the drivers
for such a standard was the introduction of the General Product Safety Regulations into
UK law in 1994. This law introduced, for the first time in the UK, a requirement that all
consumer products were reasonably safe and that manufacturers and others in the
supply chain had a duty to make sure that this was the case. When unsafe products
were found to have been sold to consumers, it was a defence against legal action if sites
could show that they had taken all reasonable steps to prevent a problem occurring. This
is commonly referred to as a due diligence defence. Retailers considered that the use of
a standard programme for their suppliers would help them in these cases.
A committee of technical experts began working on the first issue of the Global Standard
but it soon became apparent that it was not easy to cover the whole range of product
types, and that there was little experience in the industry for such a new approach to
non-food product safety which had previously relied almost entirely on pre-shipment
inspections and some testing. Nevertheless, the first issue of the Global Standard was
published in 2003.
In 2006, after valuable experience gained from the first issue, an improved and revised
standard was published. With the second issue it was possible to achieve consistent
results when audits were carried out by various certification bodies. The accreditation
bodies were satisfied (on the basis of an international guideline for product certification,
ISO/IEC Guide 65) that the Global Standard was robust and began to accredit the
certification bodies that performed the audits. This became the basis for the current
scheme.
After two years, Issue 2 was finding wider appeal and being used internationally by both
manufacturing sites and retailers, so a minor revision (Issue 2A) was produced to
remove some UK-specific references. The requirements for the sites did not change
between Issues 2 and 2A. Issue 3, to which this guideline refers, reflects a growing
international aspect, as demonstrated by the partnership between the BRC and the
RILA. The Global Standard can now be considered truly global, with translations in a
number of different languages.
Page 15 of 153
30/4/10 12:44:40
This current Standard addresses the changes that have taken place in consumer
product safety over time and takes account of the fact that there is now more regulation,
the market for products is international, and new, innovative products are being
produced which need to meet increased consumer demands for quality and safety.
Implementation of the Global Standard helps to address these issues in a cost-effective
and efficient way.
2.9.1 Previous issues of the Global Standard
Issue 3 builds on the previous versions of the Global Standard, so sites that have
achieved certification to Issue 2 or 2A should be able to progress to Issue 3 without any
major changes to their systems and procedures although there are several new
requirements and several sections have been rationalised or re-ordered. A table of the
major changes between Issue 2A and 3 is in the Appendix of this guideline.
The certificates of sites that have achieved Issue 2 or 2A of the Global Standard remain
valid until the date of renewal, at which time they must be audited to Issue 3.
SA
M
PL
Sites being audited to Issue 3 of the Global Standard must be in possession of a valid
copy of Issue 3.
Page 16 of 153
30/4/10 12:44:40
SA
M
PL
SECTION II
PRODUCT GROUPS AND RISK
ASSESSMENT
Page 17 of 153
30/4/10 12:44:41
Section II
Product Groups and Risk Assessment
The detailed requirements of the Global Standard differ according to which of the three
groups a product belongs. This ensures that the audits are suitable for the product type
being manufactured. Some requirements, such as a management commitment to
product safety, are essential for all product groups, but others are only required for
products that potentially present a higher risk. The intention of the Global Standard is to
be appropriate for the manufacture of safe and legal products of the desired quality, and
not to put an unnecessary burden on producers. This is why there are fewer
requirements for products in Groups 2 and 3 than for those in Group 1.
Example
PL
A company making lipstick, which will be placed on the skin and in close contact with the mouth,
should pay more attention to hygienic practices than a company making bricks.
The lipstick will be a Group 1 product as this is where most hygiene issues are addressed. The
bricks will be in Group 2 or 3, depending on the exact nature of the products.
SA
M
Sites must first define the scope of the products that they wish to cover within their
certification and then assign those products to a product group. When deciding a product
group, the site must begin by looking at the risk level of its products. This section of the
guideline identifies why risk assessments are important when assigning product groups
and explains in some detail how to assign products to a group. It also explains the
fundamentals of risk assessment and some of the more common approaches to carrying
one out.
1 Defining Product Scopes
Certification is specific to an individual site and if a company has more than one location,
each site must be audited separately. It is frequently the case that a site applies to be
certificated for all the products it produces on the site but, in some cases, it may want to
limit the certification to only part of its range of products. The product scope must reflect
only those product types included in the certification.
There are a number of issues to consider when defining the product scope:
The product scope chosen must be precise enough for the auditor to be able to
determine whether the requirements of the Global Standard can be achieved by the
site for the range of products stated. The definition may include product types, and
the technology used to produce them may also be an important consideration.
Examples
It would not be acceptable to state plastic items as a scope. It would be acceptable to state
injection-moulded plastic handles and furniture fittings.
The term cosmetics would be too broad for an auditor to assess, but describing the products as
shampoo, shower gel and hair conditioner would be acceptable.
Page 18 of 153
30/4/10 12:44:41
The scope should not include brand names or retailer names but be a generic
description of the product. Certification to the Global Standard applies to the systems
and processes on the site. It would not usually be acceptable to request certification
for only one retailers product if other very similar products are being produced using
similar processes. At the very least this would question management commitment,
which is essential to the Global Standard.
The scope should not normally be so specific as to exclude similar products

produced using similar technology, especially if they are produced in the same
production area. This would unnecessarily limit certification and show a lack of
understanding of the aims of the Global Standard.
Examples
It is possible to combine very different operations in one certification and one audit
provided they are produced on the same site and clearly stated.
SA
M
PL
A company has a certificated operation for the production of yellow dusters. A client wants them to
produce green dusters.
Its certificate does not include this product in the scope. The retailer may want to carry out extra
checks to understand whether the dusters are made in a safe manner. This example indicates the
need for a company to think carefully about product scopes. It is probably in a companys best
interests not to limit the scope unnecessarily.
A scope has been defined as injection-moulded toy parts. When an auditor visits the site the
manager shows them a blow-moulding operation, which the site also wants included in the audit.
The certification body will not have allowed for this in the visit plan. It may be that the auditor
does not have expertise in blow moulding. This example shows how careful planning with regard
to product scope and information passed to the certification body is essential.
Example
A toy factory is making plastic toys, soft textile toys and electronic toys.
One certificate can be awarded provided the scope is well defined.
It is necessary to identify the geographical areas in which a product is intended for

sale. This is because safety and/or legal requirements for many products vary from
place to place, either because of different perceptions about safety or because of
different use patterns. Depending on the product type, it may be adequate to specify
a region (such as Europe or the USA) but for some products, requirements may be
specific to individual states or cities and, if necessary, these should be defined or
specifically excluded. The Global Standard requires sites to have a system to show
they are aware of, and meet legislation applicable to, their products in the areas of
intended sale.
Page 19 of 153
30/4/10 12:44:42
Examples
A company is packing bottles of shampoo into a gift pack with a comb and brush set.
Although shampoo as a cosmetic would normally fall within Product Group 1, in this case the
shampoo is in sealed bottles and so it is not appropriate to apply all the requirements of Product
Group 1. Therefore, the operation would be Product Group 2 if extra labelling is required, or
Product Group 3 if all the required labelling is already on interior packages.
Bulk supplies of aspirin tablets are received by a packer who packs them into individual foil wraps.
The bulk product is potentially exposed to contamination and the packaging must contain the
correct information. This site is treated as a manufacturer, and its product would be in Product
Group 1.
2 Assigning the Correct Product Group
PL
The correct product group for the products being produced must be selected. One group
is not better than another; each group is intended to be appropriate for the products
concerned. When products fall into more than one product group, the higher group
should be used for the complete audit unless the operations are so separate that they
can be assessed independently. This can also apply when a company produces a range
of goods at different times of year although it should try and arrange the audit at a time
when higher-group products are in production.
SA
M
With such a wide range of products covered by the Global Standard, it is inevitable that
some items will be difficult to categorise, and there will be some differences of opinion
and borderline cases. The BRC will try to address some of the recurring issues with the
help of technical advisory committees, and post guidance on the website. However, it will
not be possible to take a view on every item. It is for the site applying for certification to
specify and justify the product group to which it wishes to be audited. If the chosen
certification body does not agree with the decision, the procedures in the Global
Standard can be followed.
A site cannot simply choose the product group it would like to use. The product group
has to be justified using the decision tree in the Global Standard and any additional
relevant information pertinent to production.
The selection of the product group should be regularly re-assessed because new
legislation about product safety and the development of more standards means that
products, which in the past were not subject to mandatory requirements, may well be in
the future.
2.1 The difference between manufacturers and packers
In the Global Standard, there is one product group decision tree for manufacturers
(Global Standard for Consumer Products Issue 3, Figure 2) and one for assembly
packers (Global Standard for Consumer Products Issue 3, Figure 3). This is because
packers may be assembling finished and packed goods into larger sets and the
individual items will not be exposed to the same hazards as if they were actually being
produced. The decision trees also allow for when exposed products are packed and, in
this instance, redirect the user back to the appropriate level of the manufacturing
decision tree.
Page 20 of 153
30/4/10 12:44:42
Examples
A company is packing bottles of shampoo into a gift pack with a comb and brush set.
Although shampoo as a cosmetic would normally fall within Product Group 1, in this case the
shampoo is in sealed bottles and so it is not appropriate to apply all the requirements of Product
Group 1. Therefore, the operation would be Product Group 2 if extra labelling is required, or
Product Group 3 if all the required labelling is already on interior packages.
Bulk supplies of aspirin tablets are received by a packer who packs them into individual foil wraps.
The bulk product is potentially exposed to contamination and the packaging must contain the
correct information. This site is treated as a manufacturer, and its product would be in Product
Group 1.
3 Using the Decision Trees
The decision trees are used to help sites decide into which product group their products
belong. Most of the questions are precise and have definite answers, although some
research may be necessary to establish the answer.
PL
The most difficult questions are those relating to whether products can cause death or
serious injury/harm. There could be insufficient data available to make a clear decision
between minor and major injury, and it may depend on what is considered to be
foreseeable use. Risk assessments may help to establish an answer. It is recommended
that the reasons for any decision based on the product causing or not causing serious
injury is documented and justified, and the result of a consultation process.
SA
M
In the case of true borderline decisions, the requirements of the higher product group
should be met.
A few examples of how to work through a decision tree are posted on the website
(www.brcglobalstandards.com). They are not included in this guideline because
requirements for consumer products change quickly and specific details soon become
out of date and in need of revision.
A point of confusion sometimes arises when sites have put measures in place to control
hazards; the analysis using the decision tree should consider the intrinsic hazards
relating to the product and process even if an individual site has methods to prevent
them.
Example
A site is producing clothing for babies. It has a metal detection system in place to prevent any
broken needles or other metal parts reaching the consumer and potentially causing injury.
Although the factory may have a good control system and be confident that it works, when
assessing the product group, it must consider the level of hazard without taking account of the
control. If metal contamination is theoretically possible and can produce a risk to the consumer,
this must be taken into account.
3.1 Product Group 1

The defining characteristic of Product Group 1 is that products in this group need to be
produced in hygienic conditions. This may be because it is a legal requirement or
because microbiological contamination is a potential risk.
Page 21 of 153
30/4/10 12:44:43
Products that need to be clean but that do not themselves support microbiological
growth, or are handled in such a way that hygienic conditions during production are not
relevant to the final product, should not be considered in this group.
Examples
Ceramic tableware for food use.

The surface of ceramic materials does not easily support microbiological growth, products are
commonly washed before use and products are frequently transported in an unwrapped state,
which would negate most of the hygiene controls on site. Such items would be Product Group 2.
However, some countries may have a legal requirement to make such products under good
manufacturing practice and, if so, these products would then move to Group 1.
Tampons.
These products are used invasively and are likely to remain in the body for more than 30 minutes,
so are Product Group 1.
Bubble-blowing liquid.
This is a product for use by children, may support microbiological growth and may be stored for
some time before use. Although normal detergents for adult use would not normally be Group 2,
and toys would usually be Group 2, it is foreseeable that children could ingest the material and so
it is classed as Product Group 1.
3.2 Product Group 2
SA
M
PL
This is probably the group into which most products would be categorised. This is
because many products have the potential to cause harm if the design, materials or
manufacturing process is not well controlled. Additionally, more and more consumer
products now have product-specific legislation concerning safety or quality.
In some countries, the designation of some product standards as mandatory is common
practice. In Europe, some standards are defined as harmonised standards, which have
a quasi-legal status. It has been decided by the European Commission that compliance
with these standards may be used in most circumstances to show that products are
reasonably safe. There is a definition of harmonised standard in the glossary of the
Global Standard.
It should be noted, however, that most product standards are voluntary standards. The
majority of standards published by bodies such as ISO, CEN, ANSI, ASTM, BSI and DIN
are not compulsory. Products covered by these standards do not necessarily fall into
Product Group 2 unless the standards have been awarded a special harmonised or
mandatory status or the product meets other criteria for this group.
Similarly, a product that requires risk or safety labelling is included in Group 2 but
voluntary labelling of a product does not automatically mean the product should be in
Group 2.
Page 22 of 153
30/4/10 12:44:43
Examples
3.3 Product Group 3
PL
Toys.
Almost all countries have (often complex) legislation for the safety of toys. Toys will never be
lower than Group 2 although some may be Group 1.
Outdoor furniture.
A harmonised standard (EN 581) exists for such furniture on the European market and so, in this
case, it would be Group 2. Similar products made for other markets do not have mandatory
standards and so the product group would be judged on whether it could cause death or serious
injury and, depending on this risk assessment, placed in Group 2 or Group 3.
Carpets and rugs.
The USA has a mandatory standard concerned with the flammability of domestic carpets and
rugs, which would mean that such products are Group 2. This may not be the case in other
jurisdictions.
Garden chemicals.
Most countries have legal requirements for labelling toxic chemicals such as pesticides and weed
killers. These products would be in Group 2 for this reason and because they could cause serious
harm.
Ladders.
In many places the standards and warnings on ladders are voluntary. However, well-documented
evidence of injuries to people falling from ladders would suggest this product should be in Group
2. Note that the problem in this case could well be due to the person rather than the product
manufacture but because there is potential for injury due to a product failure it is still in Group 2
SA
M
This group is intended for low-risk products. Previous versions of the Global Standard
used to categorise this group as having no applicable specific safety legislation, and any
such products would still fall into Group 3 unless they had the potential to cause serious
injury or death. With the advent of new chemical legislation in many countries, many
more products have to meet legal requirements concerning the safety of chemicals used
in products. Where chemicals are contained in articles (rather than used in preparations
such as shampoo or liquid detergent) and the right starting materials are used, provided
no further hazards are introduced because of the product process or the product design,
such items may still fall into Group 3, as long as other criteria on the decision tree are
consistent with this category.
Examples
Textile shopping bags.

In Europe, textiles in prolonged contact with the skin, such as bag handles, must be free of banned
azo dyes. Provided azo-free material is sourced to make the bag, and this can be demonstrated, the
bag is likely to fall into Product Group 3 as a low-risk item.
Writing paper.
This is considered to be a low-risk product with no particular requirements. Finger cuts from
paper edges are defined as a minor injury since they are usually completely cured after a few days.
Desk accessories.
Items such as pencil holders, mouse mats and coasters do not have any particular requirements
and would usually fall into Group 3 unless they are specifically intended for children.
4 Process of Risk Assessment the Basics

There are many places in the Global Standard where risk assessment is mentioned.
Users should not be intimidated by this. A risk assessment usually involves applying a
logical thought process to an issue and writing down the outcome. In some (but no
Page 23 of 153
30/4/10 12:44:44
means all) cases, research might be necessary or specific knowledge and expertise may
need to be applied.
The principles of risk assessment are very simple and designed to ensure that care is
taken where it is needed and that issues are addressed proactively (rather than once
they have happened). A risk assessment involves the systematic evaluation of any
hazards that a product could present and an assessment of the likely exposure or
occurrence during use or foreseeable use.
A risk is the hazard multiplied by the exposure. Therefore, some things that are very
hazardous are of low risk because there is almost no chance of them happening.
Risk assessment principles can be applied to many situations. This guideline focuses on
the safety or legality of a product, but risk assessment techniques can also be used to
evaluate financial risk or risk to a brand name. In the context of the Global Standard, risk
assessment is considered in terms of the safety of the initial product design and
materials, the potential for hazards being introduced during or after production, or
individual concerns or problems forming part of the site operation or management.
PL
Examples
SA
M
Tigers are dangerous wild animals, hazardous to humans.

In an office nobody worries about being attacked by a tiger. Such animals are rare and, if they are
in the area at all, they will be in a zoo. Even if one escaped, the chances of it entering a building
and attacking someone are minute. A situation of high hazard but very low risk.
Kittens are small and considered to be no danger.
At first sight this appears a reasonable statement, but pets such as kittens are known to cause
asthma attacks in vulnerable people. The kitten therefore poses a hazard and, depending on the
situation, a risk assessment may show the kitten to be more of a risk than the tiger.
A manufacturer of cots has a new design with a fretwork panel. On review, the holes in the panel may
be of such a size that babies could get their fingers stuck in them.
The manufacturer has to decide whether this is actually the case and, if so, whether children can
really place fingers in the holes or if it is just a perceived problem. If they can get fingers into the
holes, will there be a chance of injury? This is a risk assessment.
A company needs to decide whether to supply workers with protective gloves.
The company considers why gloves are needed is it to protect the worker or the product? Is there
any evidence to suggest that workers may need protection? Is there a likelihood that gloves could
contaminate the product? What is the risk to the product or worker if they do not wear gloves?
Sometimes levels of risk have to be considered. In this case, protecting workers may lead to an
increased product risk and an alternative solution may be required.
In order to fully understand those aspects that are important to a products safe
manufacture and use, it is advisable to carry out a formal risk assessment. The amount
of detail necessary for this will depend on the product type, the amount of data about
risks that is available, and the experience of the site.
It is usually the products that are not well known to the site, and possibly outside the
core range of its production, that require the most effort. Sites should be particularly
vigilant when supplying products to a new customer type (e.g. children) or in a new
marketplace (e.g. the USA when already supplying into Europe).
Risk assessment is not the same as product testing and should not be confused with it,
although test results are likely to be incorporated into the risk assessment.
Page 24 of 153
30/4/10 12:44:44
Just because a product has passed a standard test, a risk assessment may still be
necessary. This is because, for example:
there may be safety issues not covered by testing to the existing product technical
standards
products are usually tested when they are new, and certain problems may only arise
after prolonged use
it is usual that only a very small number of products are tested, so product variability
may need consideration.
Examples
PL
Over the last few years toys have been recalled because they contain potentially dangerous small
magnets.
There was no test for magnets in the Toy Standard and, for a long time, the problem was not
identified. Hospital data led to a re-assessment of the risk. It was found that some toys included
very strong magnets and that children sometimes ingested them.
A producer of a swing frame had to recall products because the supporting cross-bar rusted through
very quickly and there was potential for a child to fall.
The product had passed all the required safety tests. It was found that the design allowed water to
lie in the cross bar which rusted over time, weakening the support.
An iron is tested and found to meet the safety test requirements. The company receives complaints
because the electrical flex is detaching from the body of the product.
The assembly of the products is found to be variable, and some of the cable clamps used were not
tightened sufficiently to support the flex.
SA
M
Different industries have different approaches to risk assessment and use a range of
terms to describe the process, such as HACCP (Hazard Analysis and Critical Control
Points), FMEA (failure mode and effect analysis), RPN (risk priority number) and many
more. There are different ways of conducting risk assessments and there is a variety of
software packages and semi-automatic methods available. A site must decide which
method or combination of methods is most suitable and whether the use of any such
aids will be useful. It should bear in mind, however, that the eventual outcome of the
assessment is only as good as the data provided and the level of understanding about
the product. An international standard, ISO/IEC 31010 Risk management Risk
assessment techniques gives details of a number of approaches. The BRC does not
advocate any particular system but sites should expect auditors to question how they
have determined the risk posed by their products and the steps taken to manage such
risk.
5 Product and Process Risk Assessment

Risk assessments commonly fall into two parts: risk assessment of the product design
and materials, and risk assessment of the manufacturing process.
5.1 Risk assessment of the product design and materials
A risk assessment of the product design and materials is essential to ensure a safe and
legal product. This assessment should address matters such as:
The materials used in the make up to ensure that they have the correct mechanical
properties such as strength and durability.
The chemical composition of materials to ensure that toxic or dangerous
substances are not used.
Page 25 of 153
30/4/10 12:44:45

The assembly of the parts to ensure that the materials work together (for example,
the correct type of adhesive).
The mechanical assembly for example, screwing, gluing etc.
The technical features of the design such as the shape of moulds, the fit of
components etc.
It is likely that the assessment will be carried out over different stages, starting with the
concept drawings and continuing until the first pre-production samples are produced.
Assessment of the product design should then continue based on feedback obtained
from all sources.
Once a site is in routine production, it may not be necessary to carry out a complete
assessment for every variant. However, changes should not be made without an
assessment of the new parts or materials, and the likely effect on the product.
Example
PL
A candle maker has a design of candle which it has made and sold successfully and safely for many
years in a range of colours. It decides to add a dark red colour to the range and assumes it will be
satisfactory because of its record.
The company receives several complaints about candles flaring up, and is informed of one fire
incident. On investigation, it is found that the red pigment affects the burning characteristics of
the wax, giving rise to high, smoky flames and unstable burning. A check of the pigment
characteristics or a test burn following a risk assessment of the change to the original product
may have avoided these problems.
SA
M
5.1.1 Manufacturing sites with no responsibility for product design

It may be the case that the product design is supplied to a site and that the site has no
input into the risk assessment of the product. In these situations a site sometimes thinks
that the risk assessment process is not relevant, and that all it needs to do is produce
items to the specification it has been given. This has been the cause of a number of
unsafe products getting into the marketplace.
Examples
A battery powered bubble-blowing machine is found to overheat and pose a burn hazard. This is
because the batteries have been wired up in a parallel arrangement rather than a series arrangement,
which allows a dangerous condition to occur.
On investigation, it is found that the manufacturer knew the problem could occur but had made
the products in accordance with the wiring diagram supplied by the customer. The customer had
expected the manufacturer to check and finalise the wiring layout and had provided the plans as
an indication of what they wanted. The problem would not have occurred if the risk assessment
had been checked.
A buyer takes a sample of a childs dress to a factory and asks for it to be produced. A ribbon has
been tied around the dress in order to carry it more easily. The factory produces and ships several
thousand of the items.
On receipt, the retailers quality assurance department realises that the ribbon, which was not
supposed to be there, posed a strangulation hazard to small children and an expensive re-packing
operation was required. The manufacturer had followed exactly the clients instructions.
When the product design is supplied to the site it is essential that the site:
Has a formal written specification.
Is provided with a validated copy of the risk assessment, if this exists.
Page 26 of 153
30/4/10 12:44:46

Is able to carry out an assessment or commission an assessment if one does not

exist. If an assessment is commissioned the site must validate the capability of the
external party to conduct the risk assessment.
Has formally agreed to abide by the content.
Has a system in place for communicating key information to the workforce and back
to the specifier, if necessary.
Has a procedure for taking the design risk assessment and producing a process risk
assessment, establishing any key control points in the process.
It is not acceptable for a site to produce an unsafe or illegal product because it was
supplied with a faulty design brief.
5.2 Risk assessment of the manufacturing process
SA
M
Example
PL
This part of the risk assessment establishes any hazards that may be introduced as part
of the manufacturing process, and define the points at which control is necessary. When
the control is critical to the safety of the product, this is termed a critical control point.
The following should be considered:
manufacturing parameters such as pressure, time and temperature
process specifications and tolerances
wear of equipment, moulds and machinery
policies on contamination (e.g. needle policy)
calibration of equipment
quality control sampling, charts and procedures
procedures for dealing with non-conforming products.
Glass containers are being produced for cafetires (coffee pots with plungers). The retailer receives
complaints that some of the pots are shattering in use.
The producing company has a specification, and a risk assessment has been carried out on the
design. Suitable materials are being used but it is found that the factory has not been correctly
controlling the temperature of the annealing oven or the time the glass is in the oven, resulting in
a weak container. Had a proper risk assessment been made on the procedure, the temperature of
the oven would have been identified as critical and adequate control measures put in place.
Both parts of the risk assessment (product design and manufacturing process) are
essential for the reliable production of safe and legal products of the desired quality and
they should be reviewed and validated at regular intervals and when any major changes
occur.
6 Planning a Risk Assessment

For most products, there are no legislative requirements about who should carry out a
risk assessment but, for an increasing number of products, there is a requirement that a
risk assessment is completed and recorded. For a few product types, such as cosmetics
or pharmaceuticals, it is a legal necessity that the suitability and safety of the formulation
is assessed by a person qualified to the requirements defined by the region of sale.
Page 27 of 153
30/4/10 12:44:46
A site can determine how it wishes to conduct the assessment and whether it is
incorporated into wider product or process control measures. For both product and
process risk assessments the required steps are similar.
6.1 Setting up a team
It is very unusual for one person to be able to carry out the entire assessment and it is
likely that a team of people will be required. For example, an engineer who can evaluate
the strength of a moulding may not be able to evaluate the toxicity of the materials used
to make the product.
A suitable team should be assembled to cover all aspects with a designated responsible
person of sufficient authority to approve the outcomes. The team must have the
commitment of senior management.
PL
This does not mean that a whole range of staff has to be employed for the purpose.
While this may be appropriate for very large, complex operations, it is more likely that the
duties will form just a part of someones job, or external resources will be used. There
are numerous third parties that provide risk assessment services, but they must be
correctly briefed about the sites products and processes, and which of the
considerations listed in part 7 of this section, Considerations in a Risk Assessment, they
take into account as part of their brief. The final responsibility for the risk assessment will
rest with the site producing the items and, at the very least, a staff member there should
coordinate and be responsible for the assessment.
SA
M
For a product risk assessment the team is likely to comprise some of (but not limited to)
the following:
designers
chemists
materials scientists
human factors specialists, such as ergonomics experts or child psychologists
engineers
quality assurance staff
legal staff.
For a process risk assessment, the team may be made up of:
an operations manager
quality assurance staff
engineers
chemists
production team leaders.
6.2 Team activities
The team should systematically evaluate and record the assessment for each product
and process. It may need to incorporate specialist advice and carry out research into
possible hazards.
When sufficient data clearly establishing risk levels is not available, it may be helpful for
the team to act as (or set up) a panel to evaluate the products and, from the different
Page 28 of 153
30/4/10 12:44:47
opinions, obtain a balanced view of the issue, which can be recorded as part of the risk
assessment.
The team should also review any accident, complaint or injury data that is received.
The site should have a clear and documented process flow evaluated by the risk
assessment team, and this should allow the product to move around the site in a logical
fashion and minimise any confusion between batches and products.
The team should establish where control points are necessary and whether these are
critical to the safety and legality of the product. They should define what control is
required and have fully documented and approved procedures.
The same team will probably be responsible for managing adverse incidents and
traceability systems for products and materials, and defining measures to handle these
aspects.
A copy of a validated risk assessment should be kept with the product technical file.
PL
7 Considerations in a Risk Assessment
SA
M
A risk assessment involves the evaluation of all the features that affect the safety of a
product. It should include details of:
product information about the actual product, its construction and packaging
product use information about the intended or foreseeable use of the product
user types categories of those using or likely to use the product
hazards property of the product or use that may give rise to harm
injury medical injury types classified by severity
probability numerical classification of risk terms
risk combination of the above factors.
Each and every aspect needs to be assessed before combining the information into an
overall risk rating and deciding the acceptability, or otherwise, of the product.
The risk factors in the end product comprise those resulting from the design of the
product and the materials chosen for its fabrication, and those which may be introduced
during the production, packaging or delivery process. Sites may want to include other
factors such as financial exposure and perceived risk but these are not part of the
requirements of the Global Standard.
7.1 Pre-designed products or components (design)
Specified designs and requirements are often submitted to sites, which then produce the
item to meet the specification. In this case, the manufacturer is not in a position to carry
out a full risk assessment of the product. Nevertheless, the manufacturer has a
responsibility to ensure that the requested product is not obviously unsafe and that it can
produce the item without introducing unacceptable risks. It should make an assessment
of the important risk factors during the production process and control the process at
those points. The site should be in possession of the risk assessment of the design and
should record the process and outcomes of assessing the risk factors during production.
Page 29 of 153
30/4/10 12:44:47
In practice, the site may not be able to obtain this from its customer and, in this case,
should document the absence. It should still perform the risk assessment for in-process
hazards, as indicated in 5.2 Risk assessment of the manufacturing process.
When a site is assembling pre-fabricated components into a final product it must also
assure itself that a risk assessment has been carried out on the components, and that
the information is available to the factory and, at least as much as legally necessary, to
the purchaser.
Example
PL
7.2 Product use
A site has been asked to produce childrens cutlery to match a supplied sample. The customer has
not produced a risk assessment and the site does not have the authority to change the design or
appearance of the product. The site documents the lack of a risk assessment, assures itself that
production meets the requirements of the product standard for the region of sale and assesses the
production risks of supply or raw materials, possible contamination and controlling the moulding
process. It sets control points on the settings of the moulding machine and requires the supply of
raw materials to be accompanied by satisfactory test certificates.
The auditor would find this to be satisfactory. Any shortcomings in the design of the cutlery would
be the responsibility of the customer.
The following aspects of a products use should be considered.
SA
M
7.2.1 Behaviour
The way in which a product is used will significantly influence the likelihood of injury.
Many injuries are caused when products are used in an inappropriate way, or when
people have not fully read or understood instructions. For childrens products, this
usually means that the items are given to children of an unsuitable age or that carers do
not follow advice on the supervision of the child.
It is useful to define or consider what the intended use is and what reasonable
foreseeable use may occur.
Examples
Yo-yo balls are childrens toys comprising a weighted ball with an integral cord made from highly
stretchy plastic material. The intended use is to bounce the product up and down in a similar fashion
to a yo-yo. In practice, children found that it was more fun to use the product like a lasso and there
were several near-strangulation incidents when the product became entangled around the neck.
It is difficult, in such cases, to decide whether this was foreseeable but for anyone making similar
items in the future such a consideration would be important. This case also shows the need to keep
up to date with changes and to be aware of product recall information as required by the Global
Standard. An auditor will look to see how this is achieved on site.
A customer complains that there is a problem with their new kitchen. The cooker extractor hood has
melted and dripped onto the gas hob. The cooker hood is replaced but the problem recurs.
It is found that the cooker hood is only suitable for use with electrically powered hobs and not
with gas hobs, which give out more heat. The information was available in the instructions for the
hood but only in small text, mixed with other information. This was either not seen or disregarded.
Sites must consider the affect of their products on others where relevant, and supply suitable
information. If an auditor discovered a case such as this it would lead to a non-conformity as the
risk had not been properly addressed.
Page 30 of 153
30/4/10 12:44:48
7.2.2 Durability
The frequency and duration of use may also affect the safety of a product. Sites should
try and establish the likely use of the product. This may be difficult when trying to
understand how a product is used in a culture very different from the one in which it is
manufactured.
Examples
A company in Southern China is manufacturing sledges for a retailer in Norway.

The factory does not understand snow and is unaware of the frequency of use of a sledge by
Norwegian families or the roughness of the terrain. The sledge fails because the plastic becomes
brittle at low temperatures and cannot withstand the forces applied over a period of time.
Although this is understandable, and shows the difficulty of manufacturing products that are not
clearly understood, it would not be acceptable and would result in a non-conformity unless the
customer had been asked for a risk assessment and failed to provide one.
Electric blankets are assumed to have an in-use lifetime of three years. However, a market survey
shows that many blankets more than 10 years old are still in routine use. Unfortunately, the plastic
wiring sheath degrades over time and some of the blankets become an electrical/fire risk.
If a product is likely to become unsafe over time, a clear instruction to check the item or dispose of
it may be required.
SA
M
PL
7.2.3 User awareness

An important part of the risk assessment process is deciding what level of awareness a
user is likely to have about a hazard. Children do not generally exercise the same level
of thought and care when using products and may not consider the risks in the same
way as an adult. Older people may not see as clearly and not realise a hazard exists. If
the product is new and innovative, users may not have a clear idea of how to use it.
Examples
Cigarette lighters are widely used, without major problems, by adults throughout the world.
Recently there has been a trend towards novelty lighters representing different objects such as guns,
sharks, fruit and figurines.
These items are attractive to children who think of them as toys and do not understand the fire
risk. They have recently been banned in a number of countries.
A customer receives a new set of cooking utensils. They are unaware that the new items do not
withstand heat as well as metal utensils and leave them near a flame on the stove top where they
present a fire hazard.
It is foreseeable that this might happen and so the company should consider providing suitable
warnings to alert the user.
7.2.4 Information and advice

Some products do have inherent risks that are accepted because of the perceived
benefits of the product. In some cases, it is possible to anticipate how the consumer may
react if an accident occurs and provide information to mitigate the results. The need for
such measures, and how best to provide them, would be part of the risk assessment.
Example
A site is producing bleach. It sells the item in a bottle with a child-proof opening but it considers
that there is still a small risk of someone ingesting the bleach.
It has labelled the bottle with instructions on what to do if someone does swallow the bleach and
provided an emergency helpline. The bottle also has raised labelling in Braille so visually
impaired people know its contents.
Page 31 of 153
30/4/10 12:44:49
7.2.5 Cultural differences

Cultural differences may affect the way products are used, and this is a particularly
important consideration when dealing with the global marketplace. Manufacturers
sometimes try to innovate by introducing traditional products from one market to another,
unfamiliar with their use. This can mean that products may be used in an unsafe way,
unless the user is provided with more information than that which would be considered
necessary in the home market.
Example
Articulated pull-along metal carts for children are widely available in America, where generations
have grown up playing with them and understanding their use. These products do not have brakes.
W hen introduced to the European market, which is much less familiar with such products, there
was concern about the lack of braking as this was expected by purchasers.
7.3 Vulnerability of users
SA
M
Older children
Vulnerable people
Definition
Older than 36 months and younger than 8
years
8 to 14 years
People with reduced physical, sensory or
mental capabilities (e.g. partially disabled or
elderly people with some reduction in their
physical and mental capabilities). Those who
lack experience and knowledge (e.g. older
children)
PL
Vulnerable consumers
Young children
Users may be divided into intended and non-intended users. Particular attention should
be paid to the use of the product by vulnerable consumers.
Very vulnerable consumers

Very young children
Very vulnerable people
0 to 36 months
Persons having very extensive and severe
disabilities
It is not the purpose of the risk assessment to ensure that all products are safe and
suitable for all users. If this were the case, it would not be possible to sell many of the
products that are in daily use such as motorcycles, sharp knives and weed killers.
However, it is important that consideration is given as to who the product is intended for
and whether anyone else is likely to use it. Products must be correctly presented to be
suitable for the target market for example, bottles of weed killer must not be easily
mistaken for soft-drink containers. If products are not specifically designed for vulnerable
users then care must be taken not to present the items as appropriate.
Examples
Cookware can be decorated with characters from childrens TV series.
This might encourage children to reach for hot pans and pull them over.
Packaging on the outside of an inflatable boat might show a small child alone in the boat.
The product itself may be safe and fit for purpose but it is not safe to leave a small child alone in
the boat.
Page 32 of 153
30/4/10 12:44:49
7.4 Hazards
The potential hazards of each product should be analysed. This may be done in a
number of ways, but it is generally advisable to take a systematic approach to the
possible hazards and the scenarios that are likely to produce injuries. Depending on the
product type, and the amount of information a site has about the product range it makes,
it will probably not be necessary to consider every aspect with every product. It is
necessary to consider aspects affected by changes in design, formulation or
construction.
Examples
PL
A factory only makes shampoo. It produces numerous different formulations for different customers.
The products are all packed into plastic bottles of the same basic construction, but in different sizes.
Its customer wishes to introduce a new fragrance to one of the lines.
There would be no need to consider physical injuries, flammability etc. as these would have been
part of a previous assessment. The factory would just need to consider whether the change has any
impact on chemical safety, or allergic reaction.
Sofas are produced in the same style and same basic construction but with a range of outer fabric
choices for upholstery.
There is no need to repeat the assessment of the sofa itself but the properties of the cover should
be reviewed with regard to flammability and chemical safety. Quality aspects may also need to be
considered as these would affect the product being fit for purpose, and issues such as
colourfastness and abrasion resistance would also be relevant.
SA
M
Table 1 lists some of the main hazard and injury types. This list can be used as a
template and customised to reflect the product types manufactured by a site. Sites may
also wish to add quality criteria. Quality matters do not present a health risk but can still
be important as they may affect the fitness for purpose of the product or the producers
ability to meet its customers specification.
Table 1 Main hazard and injury types
Hazard group
Hazard
Typical injury scenario
Typical injury
Example
Size, shape and

surface
Sharp corner or
point
Person hits sharp corner or

is hit by moving sharp
object; this causes a
puncture or penetration
injury
Puncture, blinding
foreign body in eye,
hearing foreign body
in ear
Darts
Table edges
Sharp edge
Person touches sharp

edge, this lacerates skin or
cuts through tissues
Laceration, cut,
amputation
Broken glass or ceramic

Knives
Burrs on metal edges
Gap or opening
between
elements
Person puts a limb or body

part in the opening and
finger, arm, neck, hand,
body or clothing is trapped.
Injury occurs due to gravity
or movement
Crushing, fracture,
amputation,
strangulation
Outdoor equipment with

potential traps such as
climbing frames
Children becoming trapped
between cot bars
Toes trapped in taps
Page 33 of 153
30/4/10 12:44:50
Product tips, person near

product is hit by the
product; electrical product
tips, breaks and gives
access to live parts, or
continues to work heating
nearby surfaces
Bruising, dislocation,
sprain, fracture,
crushing, electric
shock, burn
TVs falling from wall

mounts
Unstable wardrobes
Badly weighted saucepans
Low mechanical
strength
Product collapses by
overloading; electrical
product tips, breaks and
gives access to live parts,
or continues to work
heating nearby surfaces
fracture, crushing,
electric shock, burn
Chairs collapsing
Ladder rungs too weak
Pressurised
liquid or gas or
vacuum
Liquid or gas under

pressure is suddenly
released, person in the
vicinity is hit; or implosion
of the product produces
flying objects
Dislocation, fracture,
crushing, cuts (see
also Fire and
explosion hazard)
Toy rockets
Aerosols
Steam cleaners
Gas canisters
Parts moving
against one
another
Person puts a body part

between the moving parts
while they move together,
the body part gets trapped
and put under pressure
(crushed)
fracture, crushing
Power tools
Folding ironing boards
Door hinges
Noise
Person is exposed to noise

from the product, tinnitus
and hearing loss may occur
depending on the sound
level and distance.
Hearing injury.
Telephones.
Music players.
Power equipment.
problems from
products falling
or tipping
Kinetic energy:
problems from
moving products
or parts
SA
M
Noise energy
Low mechanical
stability
PL
Potential energy:
Electricity
Extreme
temperatures
Page 34 of 153
High/low voltage
Person can touch part of

the product that is at high
voltage; the person
receives an electric shock
and may be electrocuted
Electric shock
Potentially most electrical

products
Could also consider socket
covers and similar items
Heat production
Product becomes hot, a

person touching it may
sustain burns; or the
product may emit, for
example, molten particles
or steam, which comes into
contact with a person
Burn, scald
Overheating due to
incorrect wiring of batteries
(e.g. in torches)
Computer batteries
Live parts too

close
Electric arc or sparks occur

between the live parts, this
may cause a fire and
intense radiation
Eye injury, burn, scald
Some lighting and

electrical equipment
Hot surfaces
Person does not recognise

the hot surface and touches
it, the person sustains
burns
Burn
Products to be heated,
such as bed warmers
heated in a microwave
Pan handles
Hot liquids
Person handling a
container of liquid spills
some of it, the liquid falls on
the skin and causes
scalding
Scald
Kettles with faulty spouts
30/4/10 12:44:51
Person does not recognise

the cold surface and
touches it, the person
sustains frostbite
Burn
Teethers which are cooled

in the fridge
Radiation
Radiation illness,
burns
Person unknowingly comes

into contact with radioactive
substance
Poisoning (acute or
chronic), burn
Some luminous dials

Use of waste containing
radioactive elements in
building products
Fire and
explosion
Flammable
substances
Person is near the

flammable substance; an
ignition source sets the
substance on fire; this
causes injuries to the
person
Burn
Flammable fabrics
Aerosols
Mattresses
Overheating
Product overheats, fire

and/or explosion occurs
Burn, scald, eye injury

foreign body in eye,
hearing foreign body
in ear
Candle holders
Toxic solid or
fluid
Person ingests substance

from product; and/or
substance gets onto skin
Toxic gas
Person inhales substance

from product; and/or
substance gets onto skin
Acute poisoning in
lungs, irritation,
dermatitis.
Fumes from incorrect

solvents trapped in
packaging
Sensitising
substance

from product, e.g. by
mouthing and/or substance
gets onto skin
Sensitisation, allergic
reaction
Latex on toys, balloons etc.

Use of fragrances
Formaldehyde as a
preservative
Nickel-coated metal belts
Use of DMF on furniture
CMR substance

from product, e.g. by
mouthing; and/or substance
gets onto skin.
Cancer, mutation,
reproductive toxicity
Use of unsuitable
materials, such as primary
aromatic amines in dyes,
wood preservatives, flame
retardants and others
Microbiological
contamination
Microbiological
contamination
Person gets into contact

with contaminated product
by ingestion, inhalation or
skin contact
Infection, local or
systemic.
Natural materials
susceptible to mould
growth.
Feathers
Toys containing unclean
water
Cosmetics/
pharmaceuticals
Product
operating
hazards
Overexertion
Design requires use of

considerable force when
operating the product
Sprain or strain;
musculoskeletal
disorder
Tools too heavy for

sustained use
Page 35 of 153
Acute poisoning,
irritation, dermatitis
PL
SA
M
Toxicity
issues with
chemicals
Cold surfaces
Use of inappropriate
materials (for example,
lead jewellery)
Lead chromate in paint
Household chemicals
Bleach
Pest killers
Incorrect formulation of
cosmetics
30/4/10 12:44:52
Design is not adapted to

human anatomy, which
makes it difficult or
impossible to operate
Sprain or strain
Shape makes product hard

to lift or handle
Ignoring
personal
protection
Design makes it difficult for

a person wearing protection
to handle or operate the
product
Various injuries
Products may not advise

the need for protection
People may feel the
information implies they
are not competent
Equipment may not
provide the protection it
states
Inadequately
fitting parts
Person tries to fit a part,

needs too much force to fit
it and the product breaks;
or part is too loosely fitted
and becomes loose during
use.
Sprain or strain,
laceration, cut,
bruising, entrapment
Many plastic fittings
Missing or
incorrectly fitted
protection
Hazardous parts are

reachable for a person
Various injuries such

as burns, crushing,
laceration or electric
shock.
Accessible motors or
electrical parts
Insufficient
warning texts
and symbols
User does not notice

warning texts and/or does
not understand symbols
A wide range of injuries

depending on the
product type
Unclear instructions for use

Not clear whether
information is for child or
parent
Too many inappropriate
warnings
Wrong language
Information hidden in small
print
SA
M
PL
Anatomical
unsuitability
7.5 Nature of injury
Injuries are classified by both type and seriousness. The Global Standard for Consumer
Products defines injuries as minor (slight) or major (serious or very serious), depending
on the degree of incapacity caused.
Immediate injuries such as cuts, falls etc. are usually easily characterised, but longerterm injuries (particularly those resulting from chemicals) are much more difficult to
quantify. There are a number of procedures in place that use various exposure scenarios
and take account of external factors that might influence the seriousness of any injury.
Assessment of chemical risk requires detailed technical knowledge and will be beyond
the scope of many sites. A site producing articles should meet the legal requirements
concerning the use of materials and ensure that it is aware of any restrictions. This is
usually sufficient.
Sites formulating products from agreed and accepted positive lists, such as those for
cosmetics or food-contact items, would not be expected to further justify the chemical
safety of such materials. Those sites using chemicals in other ways would be expected
to carry out an assessment or obtain this from a third party.
Page 36 of 153
30/4/10 12:44:53
Examples
A site is making polycarbonate and melamine food containers for Europe. The starting materials for
the products are listed on the published list for food-contact materials. The site has satisfied itself
and has evidence to show that the raw materials are the appropriate grade. It has tested the final
products to show that the level of monomers is within the allowed limits, and has done other
product testing as required by legislation.
There is no need for the site to seek further evidence of the safety of the products, but it would need
to carefully follow changing opinions on the presence of bisphenol A, as this is found in some
polycarbonates and is the subject of current concern.
A research department has developed a new coating for textiles with anti-microbial properties.
Additionally, the coating makes use of nanotechnology in order for the effect to work.
The site would need to carry out detailed research on the safety of the chemical before placing it
on the market. It would need to check whether any registration or authorisation is necessary and
follow guidance on the use of nanomaterials in the countries of sale.
7.6 Probability
PL
In order to decide whether a product is likely to cause injury it is helpful to review past
injury data. Finding information and data about injuries that have occurred can be
difficult. Sites may have their own information resulting from customer complaints (or
lack of complaints), and information may be available from the authorities. Details
provided with product recalls may also highlight injuries that are known to have occurred.
The USA has a website which gives detailed injury reports:
www.cpsc.gov/LIBRARY/neiss.html. The European injury database also gives some
information on types of injury: https://webgate.ec.europa.eu/idb.
SA
M
It is important to consider the circumstances or scenarios in which injury may occur

including chemical exposure or possible activities and interactions (for example, climbing
on a chair when holding an electric drill). Once the scenarios and injury types have been
considered, the likelihood of any such injury occurring has to be estimated. Ideally this
should be based on available data but, because this is frequently not available, the
likelihood has to be judged on a more subjective basis. This can be undertaken by the
risk assessment team. It is often advisable to seek independent opinions before distilling
the consensus view for example, by the use of questionnaires.
Table 2 shows one way in which probabilities can be expressed, and is an ideal solution
given the data available. In practice, it is likely that any such assessment will be very
approximate.
Table 2 Example probability calculations
Probability of damage during the foreseeable lifetime of the
product
Almost certain, might well be expected
> 50 %
Quite possible
> 1/10
Unusual, but possible
> 1/100
Only remotely possible
> 1/1,000
Conceivable, but highly unlikely
> 1/10,000
Practically impossible
> 1/100,000
Impossible unless aided
> 1/1,000,000
(Virtually) Impossible
< 1/1,000,000
Page 37 of 153
30/4/10 12:44:55
Examples
A company has produced 10,000 chairs. The engineering department has advised that there is a 1%
chance of the leg of the chair breaking under a load of 100 kg or more.
If this is correct and all chairs were subject to 100 kg or more then 100 chairs would break.
In practice, many chairs would not be subjected to 100 kg load but it is best to take a worst-case
scenario at this stage.
It is now necessary to estimate what would happen if the chair leg broke. Tests are carried out and it
is found that the leg cracks first and gradually breaks over a period of a few minutes. It is considered
that most people would notice this and get off the chair. It is estimated that 10% of users may not do
this because they didnt notice the problem or were infirm and had difficulty moving easily.
Accepting this as true, this means that 10 people would fall off the chair.
The next stage is to consider whether the people would be injured and if this would be severe. It is
considered that the 10% who did not get off the chair before it collapsed may be largely from a
vulnerable group and it is estimated that 80% may sustain an injury. There is no data for the
proportion of people falling from chairs who sustain serious injuries but there is data to suggest that
some people who fall off chairs suffer serious injuries, such as fractures.
It is assumed that 50 % of those falling from the chair receive a serious injury. This figure is
subjective but a team has agreed it to be reasonable This results in the risk of five people receiving
a serious injury from the sub-standard chair.
7.7 Risk level
PL
This equates to 1 in 2000 and is described in Table 2 as only remotely possible.
SA
M
Following the assessment of the product, the data is combined to evaluate the overall
risk level and so the acceptability of the product on the marketplace.
It may be necessary to carry out an additional risk assessment following a report of an
incident. In this case, the same approach is applied and the outcome of the assessment
is used to decide on the appropriate level of action that will be required.
A product is deemed acceptable or not depending on the seriousness of the injury and
the likelihood of occurrence. Whether or not a producer or its customer decides the risk
is acceptable also depends on the other factors, such as:
user type
awareness of risk
the culture of the site (producer or retailer) and its attitude to risk
legal requirements.
Some sites will be willing to sell products provided they reliably meet the legal minimum
requirements, whilst others will be more cautious and take account of brand protection,
perceived rather than actual risk, commercial risk, emerging information or possible
future problems.
Page 38 of 153
30/4/10 12:44:56
Table 3 Example of an overall risk evaluation

Severity of injury
Probability of damage during the foreseeable
lifetime of the product
Very serious
Almost certain, might well be expected > 50 %

Quite possible > 1/10
Unusual, but possible > 1/100
Only remotely possible > 1/1,000
Conceivable, but highly unlikely > 1/10,000
Practically impossible > 1/100,000
Serious
Moderate
Slight
NOT ACCEPTABLE
REVIEW
Impossible unless aided > 1/1,000,000

(Virtually) Impossible < 1/1,000,000
AND IMPROVE
ACCEPTABLE
PL
Table 3 shows what an overall risk evaluation may look like. Once the overall risk
evaluation has been made and the legal requirements of the country of sale achieved,
the product may be sold. In addition, matters such as meeting customer requirements
with regard to quality, aesthetic properties, functionality and durability will also need to
be considered.
8 Risk Assessment Methods
SA
M
The type of risk assessment used, and the terminology employed, will vary depending on
the industry sector, the experience of site personnel and individual preference. This
guideline does not address the various methods in detail and there are many
publications and training courses on the different risk assessment models. Auditors to
the Global Standard will be looking to see that the principles of logical assessment of risk
and control of critical measures have been applied, rather than any particular system.
Overviews of some of the more widely used methods are given below.
8.1 Hazard Analysis and Critical Control Points
Hazard Analysis and Critical Control Points (HACCP) is mainly used in the food industry,
where it is often mandatory. It is based on the World Health Organisations Food and
Agriculture Office Codex Alimentarius. It is only intended to cover health risks. Its use
has been taken up by other producers of formulated products and producers of products
close to the food chain, such as some packaging suppliers.
The HACCP system uses a decision tree to identify the critical control points (see Figure
2). These are defined as steps at which control can be applied and are essential in
preventing or eliminating a safety hazard or reducing it to an acceptable level. The
HACCP system assumes that certain prerequisite programmes such as personal
hygiene, pest control, cleaning and disinfection are already in place and only works if
this is the case.
Page 39 of 153
30/4/10 12:44:57
PL
Figure 2 An HACCP decision tree
SA
M
In order to prepare for HACCP:

assemble an HACCP team of people with relevant expertise
describe the product in detail
identify the intended or likely use
construct a process flow diagram
obtain on-site confirmation that the flow diagram is correct in practice.
The HACCP system then follows seven basic steps:
1. Conduct a hazard analysis (note this is not a risk analysis, it is an identification of
hazards that may be present).
2. Determine the critical control points (CCPs).
3. Establish critical limits for the parameters being controlled.
4. Establish a scheme to measure and monitor control of the CCPs.
5. Establish actions to be taken if a CCP is out of control.
6. Establish procedures to verify a system is working correctly.
7. Establish documentation and records.
8.2 Risk priority number
Risk priority number (RPN) is a technique used for the evaluation of identified risks. The
RPN is used to prioritise all potential failures in order to decide upon risk-reducing
actions usually by reducing the likelihood of occurrence and improving controls for
detecting the failure. It is most commonly used in engineering-related industries.
With this tool, there are three criteria for the consequences of failure:
severity (S)
likelihood of occurrence/probability (P)
inability to detect it (D).
Page 40 of 153
30/4/10 12:44:59
Each criterion is indexed with a number, from lowest risk to highest risk. Various scales
can be used for example, 1 to 3 or 1 to 10 depending on the discrimination required.
The overall risk of each failure is called the risk priority number, and is the product of
severity (S), occurrence (P), and detection (D) rankings:
RPN = S x P x D
The site also has to decide what the acceptance level should be. A graphical/pictorial
representation is often used (see Figure 3).

No risk
Acceptable risk

Justifiable risk

Unacceptable
PL
Probability
of hazard

SA
M
Severity of impact
Figure 3 RPN analysis
8.3 Failure mode and effect analysis
Failure mode and effect analysis (FMEA) is used in many formal quality systems, such
as some of the industry-specific ISO standards.
The basic process involves:
taking a full description of the parts of a system
listing the consequences occurring for each part if it fails
evaluating the consequences (usually by using RPN).
Table 4 is an example FMEA table. FMEA is a useful method to identify major failures. It
is not able to discover complex failures (involving multiple failures) or discover expected
failure intervals of particular failures. For these, a different method called fault tree
analysis is used.
Page 41 of 153
30/4/10 12:45:00
Table 4 Example of an FMEA table
Wrong raw
material
Wrong
process
temperature
Too much
re-grind
Batch control
Random
testing
Thermocouple
Automatic
reading
Factory
procedure
12
No use of
re-grind
Action taken
User
falls
RPN
Responsibilities
and timeline
Plastic
breaks
Recommended
actions
Potential
effects of
failure
Mould
seat
Installed
controls
Potential
failure
Potential cause
Process
description
Step #
Screw
legs on
Screw
breaks
User
falls
Screw
falls
out
Wrong
screws
Batch control
None
Pre-set
drivers
None
PL
Insufficient
torque
Product
ion of a
stool
8.4 Fault tree analysis
etc
SA
M
A fault tree is useful to structure and display the source of risks. As in the previous
method, it requires a description of the parts of a system and a list of the consequences
if each part fails. This method is often used in connection with a cause-and-effect
fishbone or Ishikawa diagram to identify the root causes.
Fault tree analysis looks at the influence of various factors contributing to a failure.
These are often the four Ms (manpower, methods, materials, machinery) but may
include other factors such as measurements, money or the environment. Figure 4 is an
example of a fishbone diagram.
Machinery
Human
re
as
o
ca for n
us
e
Major Cause
Environment
PROBLEM
Method
Page 42 of 153
Material
30/4/10 12:45:01
Figure 4 Example of a fishbone diagram

8.5 Nomographs
TIE LINE
certain
likely
probable
CONSEQUENCE
very rare
certain
rare
multiple
fatality
infrequent
fatality
occasional
serious
injury
frequent
medical
injury
continuous
first aid
SA
M
possible
EXPOSURE
RISK SCORE
PL
PROBABILITY
Some organisations have produced nomographs as a means of combining the various

risk factors into an overall assessment. A nomograph can be a useful graphical way of
comparing the risk evaluations carried out and whether produced by a team or an
individual, the results can be very useful. As the points chosen on the scales are
somewhat subjective, care has to be taken when comparing assessments done by
different people or groups. An example of a typical nomograph is shown in Figure 5. An
assessment is made as to where to place the point on each of the lines. By joining the
points and extrapolating the line, an overall result is achieved. Such an approach is
appropriate to many types of product and the points on the scales can be changed to be
relevant to a particular situation.
unlikely
High
risk
Medium
high
Medium
low
Low
risk
Figure 5 An example of a typical nomograph
Page 43 of 153
30/4/10 12:45:01
SA
M
PL
Section III
EXPLAINING THE REQUIREMENTS OF THE
GLOBAL STANDARD
Page 44 of 153
30/4/10 12:45:02
Section III
Explaining the Requirements of the Global
Standard
The headings in this section have the same numbers as the clauses in the Global
Standard which they describe. It is essential to have a copy of the Global Standard
to hand when reading this section of the guideline as the text is not repeated.
This section explains the requirements of each clause in detail, gives examples and
gives the reader an idea of the kinds of thing auditors will look for. Each auditor is
individual and has their own way of gathering information. The audit will reflect the actual
site situations and what the auditor sees on the day, so there is no guarantee that your
audit will follow these examples, but they should help you understand the requirements.
PL
There are eight main clauses of the Global Standard, listed in Table 5. Each clause
begins with a statement of intent. These statements set out the general principles of
what the clause is about and the basis for the more specific requirements that follow.
The statements of intent are requirements of the Global Standard themselves and must
be observed.
For reference, Table 5 lists the number of clauses applicable to each product group.
SA
M
Table 5 The eight main clauses of the Global Standard

Clause
Fundamentals followed
by the number of
subclauses for each group
Other clauses followed by

number of subclauses in brackets
Product group
1 Senior management
commitment and continual
improvement
2 Risk management
3 Management system
4 Site standards
5 Product control
6 Product conformity
assessment
7 Process control
8 Personnel
TOTAL
1
1 (0)
2
1 (0)
3
1 (0)
1
7 (0)
2
7 (0)
3
6 (0)
1 (0)
2 (17)
2 (13)
0
1 (10)
1 (0)
2 (17)
2 (9)
1 (0)
2 (15)
2 (6)
1 (10)
1 (9)
4 (16)
12 (41)
7 (43)
6 (24)
2 (13)
4 (16)
12 (41)
7 (32)
6 (23)
2 (13)
4 (12)
12 (32)
7 (28)
6 (18)
2 (12)
2 (9)
1 (3)
10 (52)
2 (9)
1 (3)
10 (48)
2 (7)
1 (3)
10 (40)
5 (28)
2 (14)
45 (179)
5 (25)
2 (6)
44 (156)
5 (22)
2 (1)
43 (125)
The Global Standard designates 10 fundamental requirements. The clauses dealing

with these requirements are marked with the word FUNDAMENTAL and denoted with
the symbol . Fundamental requirements are critical to the sites ability to meet the
requirements of the Global Standard. They collectively form the core of an effective
Page 45 of 153
30/4/10 12:45:02
quality system and provide evidence that the systems operating at a site are well
managed, fully established and embedded into the everyday activities.
If a site receives a critical or major non-conformity against one of these requirements it
will not be certificated and will receive a fail grade D. Because these clauses are so
important, the site is not allowed the normal period of time to correct the non-conformity
and still achieve certification. For these clauses, it must be right on the day otherwise a
complete re-audit will be needed once the issues have been addressed.
The text of the fundamental clauses is repeated in this guideline before the requirements
for that clause are explained.
Example
Traceability (clause 3.8) is a fundamental requirement. A company is found to have no clear means of
tracing any of its products or raw materials. The manager says that there is a system but that they
took all the documents home to work on and forgot to bring them back. The manager promises to
send them to the auditor.
The company cannot be certificated. This is observed as a major, or probably critical, nonconformity on the day of the audit and cannot be corrected later. A complete re-audit will be
required.
PL
As Table 5 shows, products in the higher-risk groups are subject to more clauses and
have more requirements, which will probably result in a more complex audit. For a
product in Group 1 there are more than 250 individual requirements to consider.
SA
M
Statements of intent summarise the overall clause requirements and allow auditors to
raise non-conformities if the overall principles of the clauses are not being followed. They
also enable an auditor to raise the level on non-conformity from minor to major if
numerous small non-conformities are identified within the same section of the Global
Standard.
One further point to note is the use of the word shall. In the Global Standard shall
should be taken to mean must. This is common with the terminology in many standards
and auditing schemes.
1 Senior Management Commitment and Continual Improvement

FUNDAMENTAL
The company's senior management shall demonstrate that they are fully
committed to the implementation of the requirements of the Global Standard for
Consumer Products. This shall include provision of adequate resources, effective
communication, systems of review and actions taken to identify and effect
opportunities for improvement.
The statement of intent for this clause is a fundamental requirement. Without
commitment from the senior management, that has the authority to allocate budget and
resources and set site policies, it is not possible to properly implement the Global
Standard. A department manager or quality manager may think it is a good idea to adopt
the Global Standard and try to address matters on their own initiative but many of the
requirements need support from different parts of the site and demand commitment at
Page 46 of 153
30/4/10 12:45:03
the highest level. The requirement encompasses a need to effect continuous

improvement consumer quality and safety expectations rise steadily and legal
requirements become more complex. Site standards from 20 years ago would not be
acceptable today.
Example
1.1 Safety and quality objectives
At the opening meeting, no senior management representatives are available. The quality manager
informs the auditor that senior management is dealing with an important client and has authorised
the quality manager to deputise. The auditor also notices that no senior managers have been present
at the audit review meetings for the past year. The auditor asks the quality manager to ensure that the
senior site manager is available, but this is not possible.
Senior management does not understand the importance of its commitment. If the senior
management was unavailable due to exceptional circumstances then the audit visit should have
been postponed. The auditor will decide whether to continue with the audit after consultation with
the certification body, if necessary, and depending on the conditions of business between the
certification body and the site.
SA
M
PL
Senior management needs to set objectives concerning safety and quality so that the
workforce understands what is required from them. Setting such objectives also enables
the allocation of suitable budgets and resources. Auditors will be looking for evidence
that this has been done and communicated to the appropriate staff. Objectives may
include, for example:
reducing customer complaints
fewer non-conforming products
better customer satisfaction scores
fewer lots rejected by customers.
There are many other objectives that could be included here. In each case, the objective
should be measurable and documented. It is then possible to review success or failure.
Examples
A detergent company has set objectives for the level of customer complaints each year and can
demonstrate that it has diligently monitored the complaint levels for the past five years. There is no
evidence that actions have been taken to address the failure to meet objectives.
This would result in a non-conformity. Effort is being made to collect data but it is not being used
effectively.
The quality manager of a plastic-bag company shows the auditor a document stating that there are
documented key performance indicators (KPIs) set for the level of customer rejects. When the auditor
visits the site none of the operators are aware of this document and there is no evidence that the
rejects are being monitored. The auditor is told this is done by George who is away on holiday.
A non-conformity, since there is no evidence that the KPIs are monitored.
A company has set an objective to reduce the amount of rework to less than 1% of production within
two years and has set KPIs for various departments in order to achieve this objective.
The auditor is shown monitoring charts and the results of the KPIs to support this objective. An
auditor would consider this acceptable.
1.2 Review process and evaluation

The management review process is an important part of the system. It usually takes
place annually although other, shorter time periods are acceptable. The review should
Page 47 of 153
30/4/10 12:45:04
be a specific meeting with a defined agenda. Topics discussed during other events, such
as a short mention of safety matters in a weekly management meeting, do not constitute
a review.
Note that this clause gives a list of aspects to be covered. All the bulleted points should
be addressed. It is acceptable to consider additional points relevant to the review, but
not to omit any of the points listed in the Global Standard.
Second- and third-party audits are audits done by, or on behalf of, customers, or audits
carried out by independent bodies (such as a BRC audit)
Example
A company has not discussed resource requirements at a meeting because the senior manager does
not think that financial and staff information should be disclosed to the technical team.
It is a requirement to discuss resource needs. There is nothing in the Global Standard to say that
detailed financial information has to be revealed and the manager could have withheld sensitive
information while still addressing the topic. A non-conformity would result.
PL
1.3 Records, documentation and communication of the review
This is usually achieved by producing and circulating to relevant members of staff the
minutes of the meeting, updated with any required actions. If a schedule is set for review
meetings then it should be adhered to.
SA
M
Example
A shoe company maintains a quality manual which covers the procedures for the Global Standard
and also its ISO 9000 system. In the manual it states that management review meetings occur
monthly and include both standards.
The auditor finds that ISO 9000 is reviewed monthly but that the Global Standard is only
addressed on a six-monthly basis. The auditor is told that this is a mistake in the manual. A nonconformity is raised pending correction.
1.4 Provision of resources
This clause will be judged by the auditor on a number of aspects witnessed during the
visit. Things that might raise questions about available resources include:
audits, tests etc. always behind schedule
lack of availability of necessary information, such as subscription to information
sources
lack of budget for training on quality or safety issues
risk assessments not done because there is no expertise available
equipment essential for safety not adequately repaired, serviced or calibrated.
Page 48 of 153
30/4/10 12:45:05
Example
A factory has a number of balances with which it check weighs products to ensure that they are to
specification. It also operates within temperature- and humidity-controlled environments, which are
monitored. None of the equipment has been calibrated over the last year. The auditor is told that the
calibration lab has increased its prices and the site cannot afford to maintain calibration. The site is
sure that the equipment will still be OK, because it was in calibration when last checked.
This would not only raise a non-conformity about the calibrations but would highlight a lack of
provision of resources for a key task.
1.5 Staff responsible for the Global Standard shall report regularly to senior
management
The Global Standard does not define how frequently the reporting shall occur or exactly
what information needs to be transmitted. It will be judged on a case-by-case basis. The
auditor will look for evidence of communication about important issues and whether
there is a record of any improvement suggestions, and assess the awareness of the
management about the level of compliance with the scheme.
PL
1.6 Site shall have a copy of the Global Standard
SA
M
It is impossible to operate the site in accordance with the Global Standard without having
a copy (either paper or electronic) to refer to. The Global Standard is the base document
that should be consulted for confirmation of all details regarding certification. The Global
Standard is copyrighted and the BRC/RILA do not support the unauthorised copying of
either paper or electronic versions.
1.7 Approval by the authorities
This is the first clause of the Global Standard which does not apply equally to all product
groups. It is for Group 1 and 2 products only. It refers to the requirement for some sites
to be registered concerning the safe production of their products. Auditors will expect to
see evidence of up-to-date registration for the correct range of products.
Example
A toy company is producing soft-filled plush toys. It has recently started exporting products to the
USA. The company is unaware of the Pennsylvania stuffing requirements and has not registered its
factory or products.
The company could get two non-conformities on the basis of this, one for the lack of registration
and one for failing to be aware of requirements in the country of sale (clause 2.2).
Page 49 of 153
30/4/10 12:45:06
2 Risk Management
FUNDAMENTAL
The company shall have a management process in place to assure product safety,
legality and quality, based on risk assessment principles. Sites must be aware of
and refer to up-to-date legislation, product standards, codes of practice and
developments in science or technology that may impact the risk concerning their
products and packaging where these exist in the regions of intended sale.
PL
Section II of this guideline gives detailed information about risk assessments. This
clause is about the management of the scheme and ensuring that information is
available to support full risk assessments. It stresses that the management must be
comprehensive and systematic, so the availability of a few isolated risk reports on a
small proportion of products would not be deemed sufficient. The concept of risk should
be integral to the whole operation. This is a fundamental clause because an
understanding of risk and management of the procedures and processes using a riskbased approach is essential to the implementation of the Global Standard. Auditors will
look for systematic product and process risk assessments, and decisions made on the
basis of risk.
The whole clause has been deemed fundamental, rather than individual subclauses,
because each part is important to the operation of a site in conformity with the Global
Standard.
SA
M
2.1 Product scope and group determination
2.1.1 Scope
Product scopes (including the need to define the region of intended sale) were described
in Section II. Auditors may be interested in why products have been excluded from the
scope or why certain products in production are not adequately described by the scope.
Example
A site lists its scope as the production of batteries for the North American market. An auditor notices
cases of batteries with European shipping addresses. All batteries are made on the same production
lines. The company has excluded European batteries from its scope because of the requirements
concerning restricted substances and different product labelling.
W hilst this is not prohibited, it would raise questions in the auditors mind about the companys
commitment to product safety and quality. The auditor would probably investigate in more depth
to see if this was an indication of poor practice or a lack of commitment to the requirements of the
Global Standard.
2.1.2 Product groups

The three different product groups were described in Section II of this guideline.
The site actually needs to document the way in which it has arrived at its decision for
assigning the product group. The auditor would normally expect this to be by
answers to the questions in the decision tree.
If a distinction has to be made about whether a product has the potential for slight or
serious harm, the justification for the choice should be documented.
Page 50 of 153
30/4/10 12:45:06

It is possible for a product to fall outside its normal group and into a higher or lower
group based on a particular factor. If this is the case, the reasoning should be fully
explained.
If a site wants to use a higher product group, it still needs to have been through the
decision-making process and identified the product group to which its product should
belong.
It is also very important to understand that it is the potential of the product to cause
harm that is being evaluated. Sometimes this is misunderstood. A site may think that
because it is confident it can make its product with low risks, the product can be moved
into a lower group. This is not correct. The main purpose of the Global Standard is to
help ensure that all products are safe, but some types of product need a more
sophisticated management system than others to achieve this goal.
Examples
SA
M
PL
A toy company has developed good systems to ensure that its products do not use toxic raw
materials and the design of the toys is such that they do not include small parts, which could be a
choking hazard. Its toys are of simple design; it considers the operation to be low risk and wants
to use Product Group 3.
Although the factory has done a good job, this is not correct. Toys are Group 2 by their nature
because of the legal requirements and the vulnerable user group. The site needs to have good
systems and processes in place to ensure that its products continue to be made safely, and
certification to Product Group 2 demonstrates this.
A small family firm has been producing household lighting for many years. It has kept records that
demonstrate it has had very few complaints and no injuries have been reported. The company wants
to apply for certification. It thinks it should be in Product Group 3, because its products are safe, and
it will be cheaper to implement the requirements for Product Group 3 than for Group 2.
Electrical products are Group 2 because of legislation and because there is always the risk of
injury through fire or electric shock if such a product fails. A company that has been making such
products with no problems probably has many controls in place and may not find implementation
as difficult as they fear. The cost of the audit is more dependent on the size and complexity of the
operation than the product group.
A company making food containers has established that its product falls into Group 2. It feels that it
would help with marketing if it could pass a Group 1 audit, since many of its customers feel that such
products have to be clean.
The company applies for and achieves Group 1 certification. Its decision tree answers show that
the products fall into Group 2, as microbiological contamination is not a concern, but that the
company had applied for the higher grade anyway.
2.2 Legislative and safety requirements
This section is about knowing the legal and appropriate industry requirements for your
products.
2.2.1 Information system
This clause emphasises the necessity of a system for obtaining and deploying
information concerning legal requirements, product safety and industry practices for the
regions of intended sale. The auditor will be looking for some evidence of systematic
checking and what the process is for, ensuring the information is transferred into action
as necessary. Where they exist, the BRC sector-specific guidelines will give an overview
of the information needed and provide sources of further information. Some industries
have little legislation and no formal product safety standards but, even so, a site should
have a system in place to ensure that it is aware of any developments or industry issues.
Page 51 of 153
30/4/10 12:45:06
There are many ways in which sites (including small producers) can source information
for the local market without it becoming too burdensome, including:
trade association newsletters
free updates from testing and quality organisations
help from local enforcement offices
routine web searches of, for example, selected legislative and standards
websites.
Examples
PL
A specialist maker of picture frames has assumed that there are no legal requirements for its products
as a quick check some years ago showed there to be no legislation or standards about these items. It
has not reviewed the information for many years, but notes that there are no requirements.
This would result in a non-conformity, partly because no checks or systems are in place and partly
because the company has not appreciated that it needs to look more widely. There is probably
legislation concerning the paint it is using and the species of wood from which the frames are
made. There may be industry standards about the size and thickness of glass used in furniture. The
company should also routinely check recall websites to see if there are any issues with similar
products.
A US company has a successful business making childrens strollers; it has a system for monitoring
US requirements, belongs to the industry trade association and is well aware of Consumer Product
Safety Commission (CPSC) recall information. It also works closely with a test house. The company
wants to export to France and assumes that its current high level of control will be adequate.
Another non-conformity since companies are required to have a system to demonstrate
knowledge in their regions of sale, not assume it. In this case the company may initially need
specialist help since requirements in France may be specific and will be in an unfamiliar
language.
SA
M
2.2.2 Reliance on customer information

On large sites there may be a team who has the sole responsibility of following safety
information. Small sites, on the other hand, may have no such specialist team and may
just view it as something that gets in the way of production.
In many cases, sites rely on information supplied by their customers. This may take the
form of a customer quality or safety manual, or may be more specific to an order such
as we need a test report showing compliance with . standard before we will accept
this order. Such information is helpful and forms a good basis, but the following should
also be considered:
Customer information should be systematically stored and acted upon. It builds into a
knowledge system about product requirements.
Customer manuals must be the current versions and checked frequently for updates.
Customers are not always right. They may ask for the wrong tests or miss something
important. Dont assume they are right and check from another source whenever
possible.
When sites wish to sell their products in diverse geographical markets, often working in
languages that they dont understand, this becomes more difficult. Whatever the system,
it is vital to update it frequently as new issues emerge, and changes in legislation and
standard updates regularly occur.
Page 52 of 153
30/4/10 12:45:07
Examples
PL
A toy manufacturer relies on its customer who has told it that the product must be tested to the
European Standard for Toys EN71. The manufacturer does this, but the product is a battery-operated
toy and it does not meet the requirements of the electrical toy safety standard EN 62115.
The supplier says that it wasnt an expert and that the producer should have known. An auditor
finding this problem would issue a non-conformity because the producer did not have a
systematic check in place and relied on third-party information.
A large retailer has a comprehensive manual stating its requirements for the production of apparel,
which includes legal, quality and safety parameters. The manual is used by its main shirt supplier
and it forms the cornerstone of the companys safety information system. There is a problem with
some metal studs used as closures on a range of mens shirts.
Investigation shows that the studs did not meet the requirements concerning nickel. Although it
was topical information in the industry, it was not in the supplier manual, which the retailer had
not updated for some time. An auditor would raise a non-conformity because no validation or
cross-checking of information was in place.
A small giftware company has little expertise on product safety so it has signed up for safety updates
from two independent test houses and also to receive notification of all product recalls in its sector.
The administrator is tasked with routinely checking this information. The administrator has been on
a short training course to help them understand the issues and has a contact at the test house to
consult for more information. The administrator is also responsible for logging any client requests
concerning safety.
The auditor should find this satisfactory. A system appropriate to the level of the operation is in
place and as information is from various sources, cross-checking is also evident.
SA
M
2.2.3 Incorporation of changes

The best system of information gathering is of no use if the information is not acted
upon. This clause ensures that any changes are adopted in a timely manner. Most
changes allow a reasonable time for implementation before they are enforced, and they
may require:
additional cost
redesign of product
sourcing of new materials
training of staff
new packaging or labelling.
Procedures should be in place to ensure adequate consideration in an appropriate
timescale.
Example
A factory producing CD and DVD players for the European market has problems. The soldering
machines it uses do not operate at the higher temperatures required for the new lead-free solder,
which has recently become a requirement. The factory knew that new solder was required but did not
consider the problem in advance of the implementation date, and did not realise it would need to
upgrade machinery.
A lack of forward planning has had a direct effect on the companys ability to supply. This clause
aims to prevent such occurrences. Using its existing equipment for the European market would
result in a non-conformity.
2.3 Risk assessment prior to production

This clause ensures that proposed designs and materials allow for the production of safe
and legal products.
Page 53 of 153
30/4/10 12:45:07
Sites may be concerned about sharing confidential information, formulations and design
details with the auditor. Auditors must be able to view sufficient information to ensure
that the site has made a complete risk assessment. All audits are confidential between
the site and the auditor. No proprietary or design/ formulation information is released on
the audit report and the site can decide whether it allows its report to be viewed by third
parties.
2.3.1 Product specification
The list in this clause only contains suggestions for the type of information that could be
included and does not specify exactly what is required. The site can determine what is
needed to properly specify its products, but it should expect the auditor to use the list as
a basis for their investigation and be prepared to justify omissions.
Example
PL
A producer of plastic combs and brushes has a specification file with information on composition,
size, colour, materials and origin of materials. The producer has not included other parameters, as it
says these are not relevant.
An auditor will understand that such items do not need a shelf-life indication or special storage
conditions, but they may ask why there is no information on packaging and whether any advice on
cleaning the products is included or has been considered.
SA
M
2.3.2 List of legal requirements

This is a straightforward clause. The list serves as a reference for the site and enables it
to demonstrate that the relevant legal requirements and product standards are known.
Sites should pay particular attention to regional requirements. For example, some US
states have requirements in addition to the federal laws. This clause only refers to laws
and standards relevant to product safety or quality. It does not address other matters
such as tax issues or environmental requirements. There are, however, some matters
which blur the boundaries between safety and the environment. In doubt, it is
recommended that the measures are listed.
Example
A producer of electrical products for Europe must meet the Restriction of Hazardous Substances
(ROHS) requirements concerning the restricted use of toxic metals in the production of electrical
items.
Although this requirement is intended to reduce the amount of toxic waste produced by electrical
products at the end of their life, it also addresses the safety of the product and consideration of
the requirements is necessary at the production stage. An auditor would expect the company to be
aware of and list this directive.
2.3.3 Availability of a risk assessment

Changes in design and specification become more difficult and expensive as a project
progresses. To change a shape when a product is a paper or computer concept is easy
but to change the shape of a mould is more difficult and to change the shape of plasticmoulded products after production, almost impossible. For this reason the risk
assessment has to be done before production starts so that any issues can be corrected.
Page 54 of 153
30/4/10 12:45:08
It should be noted that risk assessments can include reference to previous or generic
assessments when these are applicable. It is not necessary to repeat everything every
time.
Although risk assessments are likely to be the result of a team effort, the Global
Standard requires one person to have overall responsibility. If the assessment is
provided by external sources a designated staff member must still take responsibility for
it.
Example
PL
A company makes adult nightwear. It has carried out a general risk assessment on its products and
identified some key issues, such as fabric composition, flammability, not using toxic dyes,
colourfastness of fabric to washing and rubbing (customer quality requirement), only using buttons
that do not break under certain forces, packaging type, and so on. This is recorded as the basic risk
assessment. A template has been designed that covers key points of difference to be evaluated such
as whether new fibre type has been used, size and shape of garment, type of closures used, copy for
the garment label, packaging etc. and is filled in for each new product type. This template is
reviewed by the technical manager and considered against risk criteria. The technical manager signs
and dates it when complete, having added any comments or reviewed any issues of concern.
This system is in line with the requirements of the Global Standard. A short practical review of
each garment is all that is needed, provided the basic assessment has been done and is reviewed at
suitable intervals.
SA
M
It is not only the product itself that is important. The safe use may also be affected by a
range of other factors, which need to be considered even if they are later discounted. If
any changes are made because of a risk assessment, the product may need to be reassessed to ensure that such changes do not adversely impact the product in another
way.
Examples
A skateboard company has assessed its product and ensured that it meets the requirements of the
national standard. It has also carried out endurance testing to ensure that it remains safe and fit for
purpose. The risk assessment reveals detailed assessments of the instructions for use, warnings about
protective equipment, and so on. The product is packaged in a box with a photograph on the outside
showing a child riding the board on what appears to be a public road and not wearing any safety
equipment. The packaging was not considered in the assessment.
The auditor would probably raise a minor non-conformity in this case. The company has done
a good job and assessed most of the issues well but has failed to consider all aspects, which has
meant its product is presented in an unsafe situation.
A company has redesigned a climbing frame after a risk assessment revealed that some of the holes
could be potential head traps. The holes are made larger to remove the problem. Unfortunately, this
solution weakens the frame so that it does not have sufficient mechanical strength.
This is an example of how solving one problem can trigger another problem. It demonstrates why
it is necessary to revisit the risk assessment after making changes.
2.3.4 Use of products deemed unacceptable

This clause clearly states that any products deemed unacceptable by the risk
assessment should not be produced. This does not mean that all products need to be
risk-free, but only that the risks have been assessed and are acceptable with regard to
legality and the safety of consumers.
Page 55 of 153
30/4/10 12:45:08
Example
A company producing kitchen knives will need to take account of the risk of consumers cutting
themselves on the blade.
This does not mean that it cannot sell sharp knives but is likely to mean that it needs to produce
appropriate packaging and have the correct labelling.
2.4 Verification of the product risk assessment

This clause ensures that the risk assessments carried out are appropriate, adequate and
used.
2.4.1 Carried out and documented by competent staff

Assessments must be done by those who understand the products and processes.
Auditors will look for staff training, qualifications and experience. When assessments are
done externally, auditors will look for the basis on which the assessment company has
been chosen and approved.
PL
Auditors will expect to see a documented procedure of how the site assures the
competence of its staff.
It is a requirement of all BRC auditors to have successfully completed a course on risk
assessment.
SA
M
Example
A small operation producing cleaning solutions for spectacles has outsourced the assessment as it
does not have any expertise in house. It has a procedure for checking suppliers in general, which it
has used to assess the external company, adding additional criteria concerning risk assessment
expertise and product knowledge.
The site has chosen to use a local service with many years experience in chemical formulations. It has
verified that the company is part of a local trade association, that the operation is accredited for labtesting activities, has ISO 9000, and that the person doing the review is a qualified chemist
experienced in risk assessment. The site has shown a sample assessment to its main customers
technologist and received their opinion that it is satisfactory.
This is a reasonable approach for a small company and would be deemed satisfactory. The
company should also make sure that the timeliness of delivery of the assessments is covered in the
procedures.
2.4.2 Annual review of assessments

A regular review is necessary because new safety information may have been
published, there may have been recalls of similar products or the legislation may have
changed. In general, consumers expectations of safety increase over time. A good
example is passenger cars, which originally did not have seat belts and, until recently,
did not have air bags.
Reviews can be carried out more frequently if required. Where products are made for
less than a year and the risk assessment is no longer relevant to production, there is no
need to conduct a full review but any complaints or incidents relating to products no
Page 56 of 153
30/4/10 12:45:09
longer in production should still be part of a review process. The review should be
carried out by those responsible for risk assessments and a summary reported to senior
management as part of the overall system review.
2.4.3 Assessments done prior to production and verified
This applies to products in Groups 1 and 2, where there is a higher risk to the consumer
from unsafe goods. Risk assessments must have been completed and authorised prior
to manufacture.
Examples
SA
M
PL
A company has a good system and most of the documentation is in order. The auditor finds one case
where a risk assessment has not been signed and one case when it is dated the day after production
started.
The auditor is likely to raise a minor non-conformity. The company needs to take care that the
system is operated correctly but there are no real concerns that there is a breakdown of the system
or that product safety is compromised.
A company has some risk assessments documented but they are not signed or dated. It is not
completely clear whether assessments exist for all products. The product is household cleaning
cloths and is in Group 3
This would warrant a major non-conformity as the Global Standard is systematically not being
adhered to properly. It is not a critical non-conformity as there are some aspects of the Global
Standard in place and the auditor does not consider that the lapse will result in an unsafe or
illegal product.
A factory has a team responsible for carrying out a risk assessment of product design. There are
representatives from the design, production, quality assurance and management teams and all team
members have had training in risk assessment. Each product idea is passed to the team at each stage
of development and a full report produced and signed by the team leader. Any additional external
resources or information are included in the documented risk assessment pack along with the team
findings.
Procedures have been followed correctly and an auditor would be satisfied by this approach.
2.4.4 Product testing as part of the verification

This concerns Product Groups 1 and 2 only, and addresses the specific cases when
testing of a product representative of overall production must be carried out because of
legislation. It will often be the case that the allowed test organisations are also specified.
The general requirements concerning product testing are detailed in clause 6 of the
Global Standard.
Example
Production of gas barbecues and other gas appliances for Germany requires that a type test be done
by a designated European notified body. The product must pass this test and subsequent production
must be in conformity with the approved model, prior to placing the product on the market.
This test result forms part of the product verification procedure. The company must ensure that
production models are made to the same specification as the product approved after testing. An
auditor would wish to understand how the factory incorporates the findings from the type test,
and ensure that all production is to the same standard as the approved example.
2.4.5 Transfer to production

Products may be designed to meet a variety of specifications such as strength, flexibility,
hardness etc. The risk assessment of the product will have investigated whether the
specifications are suitable and can be achieved, but such parameters have to be
Page 57 of 153
30/4/10 12:45:09
SA
M
PL
transferred into the production process. The person responsible for the risk assessment,
together with other competent people as required, must establish these key factors and
set limits, which have to be monitored and achieved.
Page 58 of 153
30/4/10 12:45:10
Example
A teddy-bear company is attaching plastic eyes to the bears. There is a legal requirement for the eye
to withstand a vertical force of 90 N for 10 seconds, but the customer has a requirement for a 10%
increase on the force. Internal design engineers are confident that the eyes can withstand 120 N
without failure.
This is transferred to production by defining the settings on the sonic welding machines and then
testing the eye assembly with a calibrated force gauge at statistically defined intervals. The eyes
are tested to 120 N. Action limits are set for eyes withstanding less than 110 N. A result of less
than 100 N requires the machine to be stopped and a full investigation to be carried out.
2.4.6 Assessment by a qualified person

This only applies to those Group 1 and Group 2 products for which there is a specific
requirement for assessments to be carried out by legally qualified people. This is
particularly relevant to formulated products such as cosmetics, which require a safety
assessment to be done by a person qualified in the region of sale.
Example
PL
Sites should consider that, although this assessment is a requirement, it may only cover
some of the aspects set out in the Global Standard and that supplementary work may be
necessary.
SA
M
A qualified, board-registered toxicologist has assessed a cosmetic for safety and produced a
favourable report. The American company produces the material and ships it to another state. En
route, many of the bottles explode, contaminating products and leaving sharp plastic parts in the
boxes.
The toxicologists review is concerned with chemical safety. They did not consider the physical
problems of overfilling bottles, or the build-up of pressure due to volatile components. Auditors
will expect to see that all aspects have been addressed by the risk assessment.
Page 59 of 153
30/4/10 12:45:10
3 Management System
A well-controlled, systematic and documented management system forms the basis for
the product and process controls necessary to manufacture safe products that meet
customer specifications, and ensures that the staff are well trained and informed. The
management system requirements are very similar to a number of other quality
management systems standards.
This part of the Global Standard overlaps the most with generic quality management
systems, such as ISO 9000. Most sector-specific schemes also contain a section about
management systems. This is because good systems allow for well-controlled
management which, in turn, helps to deliver consistent, controlled performance in any
field. It also enables problems to be properly investigated and improvements to be made.
PL
A site that already has a well functioning, documented quality management system
should be able to meet these requirements without a much extra effort or resource. This
is because the Global Standard is not generally prescriptive about how requirements are
fulfilled and, as long as the requirements are met, it will not be necessary to replace any
existing programme or have a different system in place. Sites should compare their
system against the requirements of the Global Standard and address any gaps that
exist.
Some of the terminology in the Global Standard is not quite the same as that used in
ISO 9000, although it has been harmonised where possible.
SA
M
If the system used has not been set up specifically to meet the requirements of the
Global Standard it may be helpful to the auditor, and make the audit quicker and more
efficient (more cost effective!), if the site is able to provide a short summary table of how
the schemes interact. A cross-reference table of the Global Standard and ISO 9000 is
provided in Appendix 9 of the Global Standard for Consumer Products.
It is often possible for certification bodies to carry out joint audits of the Global Standard
and other quality management systems. Sites should contact their certification body
directly for more information.
3.1 Policy statement
A policy statement should clearly state the aims of the site, establish the commitment of
the senior management and enable all staff to work together towards the common goal
of producing legal and safe products that meet customer requirements.
The statement needs to be reviewed, although not necessarily changed, regularly to
ensure that it is still applicable. It should be signed by a senior manager, such as the
CEO, managing director or site manager, and dated to establish its relevance.
The Global Standard does not define the frequency of review but this would ideally take
place as part of an annual review. An auditor could be concerned by statements that are
reviewed less than annually, and may ask for justification of the interval chosen.
Page 60 of 153
30/4/10 12:45:11
3.1.1 Content of policy

This clause is straightforward and defines what must be included in the policy statement.
Auditors will check that all aspects are included.
Example
The policy statement of a manufacturer of sunglasses states that the company will make products
that meet or exceed European standards, strive to continually improve the production and carefully
review the operation each year.
This statement does not specifically address safety, quality or legality although these are implied
in the reference to European standards. There is no mention of customer requirements. This is an
unacceptable policy and the auditor would raise a non-conformity. The policy could be improved
by including the key requirements, for example:
The companys products will meet European regulatory requirements and meet or exceed the criteria
set in the European standards for sunglasses. The company will pay attention to its customers
quality requirements, strive to continually improve the production, act quickly to address
complaints and carefully review the operation each year.
PL
3.1.2 Communication of policy

The policy can be communicated in many ways, including posting it on notice boards,
uploading it to the site intranet, and including it in the employee induction/orientation
process. Sites must ensure that the policy also reaches temporary or contracted staff, as
well as those who may work off site, when these staff are concerned with activities
affecting quality, safety and legality. All staff can have an affect on, for example,
products and packaging not just technical and quality assurance staff.
SA
M
Auditors will review the means of communication and expect staff to be able to state the
site policy, not necessarily in the exact words of the text, but at least to be clear about
the overall intention.
Example
A company has an adequate signed and dated policy, which is displayed on notice boards. When
talking to staff, the auditor finds that several people are unaware of the policy. Further investigation
reveals two issues: some staff have been brought in on temporary short contracts to fulfil a big order;
and many of the staff do not read English (the language of the policy).
The company is given a non-conformity. It needs to improve communication and find ways of
reaching all necessary staff.
3.2 General documentation requirements

Documentation may be produced and stored in several different ways, including
electronic copies, databases, intranet systems, photographs, diagrams etc. Records
must be permanent (or at least have a defined lifetime) and therefore adequate storage
or back-up systems will be necessary.
This Standard (unlike some previous versions) does not specifically demand a quality
manual, although there are many instances where documentation is required and many
sites will find it easiest to collect this into some kind of manual.
Page 61 of 153
30/4/10 12:45:11
3.2.1 Documentation control

In order to be useful, documents must be available where and when they are needed,
and controlled so that there is no confusion between different versions of the same
document, out-of-date requirements, alterations made by writing unauthorised notes on
the margins of specifications, and other similar issues.
The method the site uses to control documents should, itself, be documented as a
procedure, so that any member of staff producing documents understands the system
and operates in the same way.
Documents need to be identified by, for example, an identification number, issue date,
version number or author. Documents should be numbered with page numbers and the
total number of pages (for example, page 4 of 7). A method for rescinding previous
versions, in part or in whole, should also be in place.
The reason for, and nature of, any changes and amendments must also be recorded as
part of the document control process so that the history can be investigated if necessary.
Example
PL
An auditor notices a print worker adding thinner to an ink and consulting a piece of paper that
appears to give mixing proportions. The paper has no identification or date. When consulted, the
print worker says that they had been given the piece of paper by the person who ran the machine
previously, and that this was always used to make sure the press ran smoothly.
A document that is important to the correct functioning of the process should be controlled and
authorised. A non-conformity would be raised.
SA
M
It is important that documents are accessible to those who need them and in an
appropriate format. They should be sufficiently detailed so that a reasonably trained and
competent person using the document will arrive at the desired outcome. A full set of
detailed documents that only exist in the quality assurance managers office, or a clean
set of books provided especially for the auditor are not what is required.
Checks should be made as part of the regular internal audits or by other means to
ensure that the workforce actually understands the requirements. It may be necessary to
write in non-technical terms, provide diagrams or flow charts, and produce information in
a number of languages.
Example
An auditor notices that, throughout the factory, all documents appear suspiciously clean and new.
Because they are in such good condition, the auditor is unconvinced that people are actually using
the documents. However, when the staff are consulted, the auditor finds that they use the documents
and are well informed, and that the quality assurance manager produced new copies of everything the
day before to create a good impression.
This is acceptable and would not result in a non-conformity, although the extra work was
unnecessary. The auditor expects to see a working site and not a showcase. As long as the system is
operating well, a little wear and tear is to be expected.
Note that the system for document control extends to the issuing of external documents,
such as copies of standards (including the Global Standard), customer specifications
and legal information.
Examples of documents that need to be controlled include:
Page 62 of 153
30/4/10 12:45:11
product specifications
procedures, such as those for supplier approval, or for selecting reference
samples
work instructions
forms
records
other similar documents.
3.2.2 Record completion and maintenance

Records are documents that contain evidence about past effects. They provide
information to act upon and data to help with continuous improvement. There should be
a clear understanding of why records are to be kept and what purpose the information
will serve. In order to be useful, they must be legible and genuine. It is also essential that
they are signed, dated and authorised so that the person making the record can be
identified and consulted as necessary.
PL
Records relating to the safety, legality or quality of the products must be kept securely
and in good condition so that they can be consulted if necessary. There is no point
recording every detail if, when needed, the records are found to have been lost,
destroyed or damaged.
SA
M
The retention period (i.e. the length of time for which a record needs to be kept) depends
on a number of criteria:
Legal requirements in the country/regions of sale. Some countries have minimum
periods, especially related to product liability laws.
Customer requirements some customers demand a minimum period.
Product lifetime this is a reasonable approach but may be difficult to determine in
practice. An estimation of the lifespan of a product should be part of a risk
assessment.
Time for any effects to have been realised. For some products, this is simple. For
example, once a piece of kitchen paper has been used, there is not likely to be any
further effect, but for some products, particularly chemical products with potential, or
even unknown, long-term effects this can be very difficult. For example, some of the
chemical previously used in hair dyes are no longer acceptable. In such situations, it
is recommended that industry best practice is consulted, or records are kept for as
long as possible.
Example
Loss of records often occurs as a result of wider changes in a company. A textile company moves to a
new premises and the managing director decides to have a clean out. Many old record boxes are sent
for disposal by the site services manager, without considering their content. The company installs a
new computer system in its new premises. Unfortunately, some of the record files use old software no
longer compatible with the new system. Important records are lost by both actions.
This would result in a non-conformity. It highlights the importance of management commitment
to, and understanding of, the requirements of the Global Standard.
Records are documented information about measurements or events such as:

a signed check to show each time pest control stations have been checked
a control chart of tests done to check the strength of a seam
Page 63 of 153
30/4/10 12:45:12
the product release form from a goods-in department showing each product
signed for release
documented evidence of employee training.
There will always be occasions when mistakes are made and records need to be
amended. Such amendments must be clear and identified for example, by simply
crossing out a result, recording the correct one and initialling the change. If appropriate,
a brief reason for the change can also be included. The use of pencil for records (which
can be erased) and correction fluid (which obscures the original) are not acceptable.
Records which store results electronically, whether by manual or automatic processes,
should have suitable security systems to prevent unauthorised changes. Auditors will
ask for a demonstration of this.
Records must be true observations of the event at the time and should not be completed
later, or even before, the event.
Examples
SA
M
PL
An operator on a line producing fabric conditioner has a record sheet on which to enter the results of
half-hourly pH checks. The auditor notes that the operator has pre-initialled the column used to
authorise results for the whole day, even though only two readings have been taken.
This is a non-conformity and also may encourage the auditor to investigate whether similar
methods are used by others.
An auditor is shown a data logger attached to a viscosity gauge in the same factory. The auditor asks
the operator about an unusual result. The operator says that it must have been a rogue result, and
deletes it.
Another non-conformity as the record could be changed with no evidence or authorisation.
A factory has a record of all needles, who they have been distributed to, and when. The records also
include evidence that all broken parts of a needle are returned before a new one is issued. The record
is signed by the distributor and receiver of the needles.
This is a satisfactory record and acceptable to the auditor.
Senior management is responsible for the procedures relating to overall control of

records. It must ensure that the data is properly collected, used, stored, reviewed and
maintained.
3.2.3 Specifications and technical information dossiers
This clause covers two important but different aspects:
the need to have information about the materials and components used to make the
product
the need to keep all the technical information about the product itself.
It requires such information to be accurate and accessible to those employees who need
to use it.
The Global Standard refers to the collection of product information as the technical
dossier.
In some product sectors there is a formal legal requirement to maintain a technical file.
This clause would also apply to such files. This does not mean that all the information
has to be physically available on one file at all times, but that it does have to be available
for a product and can be assembled together if necessary.
Page 64 of 153
30/4/10 12:45:12
In some countries and for some products (for example, electrical products in the
European Union) there is a legal requirement to produce such a file for the authorities
within a defined timescale and in a language which they can understand. It is therefore
advisable to ensure and test that a technical dossier can be assembled from the
available information, if it is stored in a variety of locations.
Some industry sectors call these collections of data product information packages or
job bags. It doesnt matter what the information is called, as long as the content is
correct. The site must be aware of what comprises its technical dossier, even if it is not
in one place. This can be achieved, for example, by keeping a list of those documents
considered to form the dossier and their location.
The correct materials and components are essential to the safety and quality of the
product. If items are not clearly specified or bought on well-defined specifications, it is
likely that they may be unsuitable for the purpose. The supplier cannot be responsible for
supplying the wrong grade of material if it has not been correctly specified. The use of
inadequate components and raw materials is the cause of many product failures and
safety issues.
Examples
PL
The specification must relate to the safety and quality and not just the performance or
physical characteristics.
SA
M
A company is sourcing materials to produce nylon kitchen implements. It is known that there have
been incidents where black colouring material used in such items has contained a banned chemical
(an amine) and this has lead to a number of recalls. The company must include in the specification of
the colouring material that it is free from the chemical, and not just define the bulk chemical, particle
size etc.
A producer of electric toasters for the UK market is buying in the electric plugs which it will
assemble onto the product. It is not sufficient to define the plug as a UK plug or even by reference
to the relevant British Standard. UK plugs have integral fuses of various ratings and unless the
correctly rated fuse is specified, the product may be unsafe.
Note that although the issue is not specifically addressed by this clause in the Global
Standard, the need for vigilance against counterfeit parts and materials is also important
and the setting of good specifications and validation of the specification can help to
prevent this problem.
The technical dossier should be the source of all technical information about the product.
The list provided in the Global Standard is only given to suggest the type of information
required and is not exhaustive or compulsory. The actual information will depend on the
type of product being produced and specific requirements in the regions of intended
sale. It should be treated as a living document and information added as it becomes
available. It is not something to set up at the beginning of production and then forget
about! The auditor will expect to see evidence that the technical dossier is being used.
Page 65 of 153
30/4/10 12:45:13
Example
An auditor asks to see the technical file at a sewing-machine manufacturer. This does not exist as a
stand-alone document, but the auditor is shown a list of the documents considered to comprise a
technical file. The list includes test reports for EMC testing. The manufacturer cannot produce any
EMC reports for the model in production.
The file is not complete and a non-conformity is raised.
For products in Groups 1 and 2, a site must ensure that the specification meets
customer requirements. The site is obliged to ask the customer to confirm that the
specification for the product is what it wishes to purchase and that it is satisfied with any
safety or legal requirements. If possible, both the customer and the producer should sign
the specification. Customers may not wish to do this but, for Group 1 and 2 products, the
onus is on the manufacturer to attempt to get agreement and to be able to show that the
attempt has been made.
Example
PL
A producer of electric saws has prepared a detailed specification for manufacture based on a sample it
has been given and the supplier brief concerning colours etc. The producer sends it to the customer
requesting that the customer signs and returns it to confirm acceptance, or lets the producer know
within 20 days if any changes are required. The producer receives nothing in return but is instructed
by email to start production.
The producer has attempted to get confirmation and has informed the client about the intended
product. This is sufficient to meet the requirements of the Global Standard.
SA
M
For Product Groups 1 and 2, there is a formal requirement to have a procedure for
amending specifications and regularly reviewing them. This is good practice for all
product groups.
3.3 Organisational structure, responsibility and management authority
If an organisation is well structured with clear roles, reporting lines and responsibilities it
is much simpler to communicate with staff and manage the site. This requirement
applies to any type of site, whether small or large, and whether making simple low-risk
products or more complex items. In all cases the same principle applies, even though
the actual structures needed may be more complex in some cases.
3.3.1 Organisation chart
There is a requirement for an organisation chart. The Global Standard specifies a chart,
so text describing the organisation will not be sufficient.
3.3.2 Defined responsibilities
This requirement is usually addressed by job descriptions or may actually be part of the
employment contracts. Other ways of documenting and communicating the
responsibilities are acceptable, as long as key staff can demonstrate that they have the
information.
Page 66 of 153
30/4/10 12:45:13
3.3.3 Someone responsible for product safety, legality and quality

This clause specifies that a named person is responsible for the aspects covered by the
Global Standard and that this must not conflict with other roles. It does not necessarily
specify a full-time post, although this would normally be appropriate. The auditor will
need to be assured that the reporting line of the quality assurance manager or
representative does not conflict with the achievement of the sites stated objectives on
quality and safety.
Example
A small company only has 15 members of staff but wants to apply for certification. Its operation does
not warrant a staff member to be responsible for the Global Standard. It is considered that the
operations manager should not take on the role because of the possible conflict with getting
products out quickly and the sales manager would be more concerned with maximising sales rather
than quality. The managing director decides to take direct responsibility for the role.
A reasonable compromise in a small company. The auditor will wish to see that the managing
director is carrying out their role and not abdicating responsibility.
SA
M
PL
3.3.4 Absence of key staff

Production, and any associated problems, will continue when people are off sick or on
holiday. It is unacceptable to produce unsafe products because someone was absent,
and action on withdrawals or recalls will not usually wait for someone to return to work.
Even on a small site, written procedures that make arrangements to cover absence are
required to remove any doubt as to who is responsible for what for example, by
appointing deputies. It is particularly important that the site provides cover for the
individual with nominated responsibility for safety and quality. This is another indication
of management commitment.
3.3.5 General work instructions
This clause requires that there are instructions for general work duties, which are
documented and communicated in addition to information concerning particular product
productions or individual items of equipment. Many general procedures such as those
for methods of work, housekeeping and site systems can contribute to the assurance
of safe products and should, therefore, be detailed. These general requirements may
sometimes be part of a job description or contained in a general site manual.
The detailed instructions on how to carry out specific tasks are recorded in work
instructions. These documents contain the practical details of how to carry out tasks, in a
form easily understood by the employee. They can be pictorial, diagrammatic or in text
format.
Page 67 of 153
30/4/10 12:45:14
Examples
3.4 Internal audit
PL
A company cleaner is provided with detailed instructions about cleaning duties. The site has a
cleaning procedure covering general requirements but the work instructions include:
details of the area to be cleaned
schedule to be followed
how to clean what materials to use
how to dispose of waste materials
how to fill in a log book to show that work has been completed.
The instructions are provided in simple text and in a language that the cleaner understands.
This would be satisfactory.
Production-line workers in a cosmetics factory have work instructions, in the form of flow charts and
diagrams, provided at each station. These clearly show how to mix ingredients together, and include:
how to check the formulation being made
the order of adding chemicals
how to transfer chemicals to the vat and control quantity
mixing time
mixing temperature and how to record it
what to do when batch mixing is complete, and how to sign-off
how to record the batch production.

The instructions provided are referenced, approved and dated. The individual formulations are also
recorded and approved and have to be checked by a supervisor before production begins.
The auditor would check that all aspects of the batch-mixing production are properly included
and can be understood by the employees.
SA
M
In any system, it is important to periodically check that it is functioning and working as

expected. This is why internal audits are necessary and crucial in providing evidence
that the site is committed to its safety and quality goals.
The BRC has a separate guideline, Internal Auditing, that may be useful for those
requiring more information.
3.4.1 Scheduling
The Global Standard requires departmental audits to be scheduled and the scope
defined. This ensures that aspects of the Global Standard do not get missed or glossed
over and that, over a 12-month period, all departments are covered.
Example
A new quality manager is appointed in a shoe factory and enthusiastically sets up an ambitious and
frequent internal audit programme. Several months into the job, the quality manager realises that it is
unrealistic and because some of the audits are not necessary cuts back. Unfortunately, this is not
documented nor is a new schedule devised. When the auditor reviews the audits they discover that
some aspects have many audits but that others have not been covered at all.
This results in a two non-conformities: one because the documented audit procedure has not been
followed, and two because aspects of the Global Standard have not been audited.
Blades on a cutting machine have to be checked and cleaned or replaced weekly. An internal audit is
scheduled at six-monthly intervals to confirm that the records have been correctly completed and that
the operative follows the procedure. At the same time, the operatives training records are examined
to demonstrate competence.
The auditor records that the operative had the correct version of the procedure, followed it and
was adequately trained. The auditor also notes that the records of machine maintenance had been
completed correctly since the last audit. This is satisfactory.
Page 68 of 153
30/4/10 12:45:14
3.4.2 Competency of internal auditors

Auditors are expected to have received training (internal or external) on how to audit and
what the process entails. They will also need to know how to report findings.
Many skills of internal auditing do not depend on technical knowledge of the process, but
sometimes this will be required. It can be difficult to source such knowledge from
someone independent of the operation being audited. Someone should never audit their
own work, since it will not be possible to remain objective, or will not be viewed as
objective. If this situation arises, then the person responsible for internal auditing may
need to seek external independent resources to assist with the audit.
Example
PL
A small company produces household cleaning materials and needs to carry out an internal audit
covering clause 5.2 and the use of dangerous chemicals. An internal audit is carried out by the
company engineer who finds that assessments have been made and a procedure is in place but still
feels unable to evaluate whether the justifications for using dangerous chemicals are adequate.
There are several ways to handle this situation. The internal auditor should first check whether
the evaluation has been validated by another competent person. If not, the auditor could contact
the trade association for further information, seek help from another staff member or possibly
employ an external resource for this matter. The company engineer should not just accept the
findings and hope that they are correct.
A company has a documented procedure for how to calibrate a balance before use. An internal auditor
can check that an employee is following the requirements even if they do not actually know how to
use the balance themselves.
SA
M
3.4.3 Agreement of corrective actions

Agreement of the actions required and the timescale for implementation ensures that
corrections actually get done and it is clear who is responsible. It sets an expectation
and can be reviewed against the actual result achieved.
Example
The site supervisor of a cosmetics factory has agreed to improve cleaning in the packing area. They
revise the cleaning schedule for walls and windows and document a new procedure within a month.
The internal audit subsequently contains an update note that the action has been delayed by a week
due to illness. The action was implemented a week late but found to be satisfactory.
This would be acceptable. Although the deadline was missed, it was carried through in a
reasonable period and the reason for delay was clear.
3.4.4 Recording and verification of actions

This section simply requires that there is a record of audits and that actions said to have
been completed are verified to see that they have been done and that they successfully
address the non-conformity. It is essential that audits and follow-up actions are clearly
and completely recorded. If matters are not recorded, it is not possible for an auditor to
verify that the work has been done and it is not possible for the site to refer back to
issues at a later date.
Page 69 of 153
30/4/10 12:45:15
Example
A company has an audit schedule which it keeps to. Audit reports are available but they only list
the non-conformities found.
This results in a non-conformity and the need for better training or procedures for audit
reporting. It is not possible to judge from the reports whether all aspects have been considered
during the audits since positive aspects are not included in the report
3.5 Purchasing, supplier approval and performance monitoring

This clause sets out the requirement for sites to control their purchasing of anything that
affects product safety, legality and quality. This includes not only raw materials but
components, subcontracted work, packaging materials, instruments, machinery and
possibly processing aids if they can result in unsafe products being produced. It is
essential that potential suppliers are evaluated.
PL
3.5.1 Performance monitoring

It is essential that sites work with reliable suppliers and that they know the basis on
which they have chosen their suppliers. It is increasingly necessary in some product
sectors to be assured that suppliers cannot only supply to specification but also maintain
adequate traceability systems.
SA
M
The precise methods of approval are not prescribed and may well vary depending on the
items to be purchased and the level of risk, as well as the experience of working with the
site. Whichever method is used, a documented procedure is required. This should set
out the procedures to be used, whether a risk assessment has been conducted, the
records to be kept, the criteria for approval or non-approval and how, if there are
exceptions, these are handled.
Examples
A company is purchasing paint to decorate baby cots with. It has approved the supplier based on the
fact that the supplier has current ISO 9000 certification.
The auditor would not accept this without further research. Unless the factory is carrying out its
own testing on each batch of paint supplied, the approval process is unlikely to be sufficient. It
would be more usual to insist that batches of paint are delivered with certificates of analysis.
A small company is making cleaning cloths. It has used the same supplier of thread for many years
and the supplier has proved to be reliable. The supplier has no formal quality system or certification
but the material is a low-risk component and each delivery is inspected before use.
An auditor would find it satisfactory that such a supplier is accepted as an approved supplier.
3.5.2 Supplier approval

Every new supplier of goods (or services) that could affect the safety and quality of the
final product needs to be formally evaluated to ensure that it is able to reliably deliver the
specified products. Sites may wish to have a formal supplier-approval system and
checklist or they may wish to adopt a case-by case-approach. Either is satisfactory
provided the key issues are addressed and suppliers are reviewed at intervals to ensure
that their products actually do meet requirements and they continue to meet the criteria
used for their initial approval. This performance review is recommended to include an
Page 70 of 153
30/4/10 12:45:15
assessment of how any complaints are handled, the customer service in case of
problems and the actual supply record.
3.5.3 Use of unapproved suppliers
Ideally, only approved suppliers should be used but a site may find that it requires
unusual supplies at short notice, or is not in a position to wait for supplies if an approved
supplier has unexpected problems with delivery. If a site foresees that such a situation
might occur then it should have a procedure in place determining how to the handle the
situation and when an unapproved supplier can be used. Any instances when an
unapproved supplier is used must be documented.
Examples
SA
M
PL
A shirt company has been asked by a customer to produce a childs shirt with sequined decoration
at short notice. This is an important order but none of the companys approved suppliers produce
sequins. It sources some from a well-known accessories supplier and makes the shirts.
This is the kind of situation where problems are likely to happen. The company had no procedure
in place for using an unapproved supplier and had no requirement to check the component
specification, as sequins were not normally used. In fact, the sequins were only suitable for use on
adult clothing and when the customer requested final product testing, the shirts were found to be
unsafe. The company would not only receive a non-conformity for this approach but, more
importantly, may need to initiate a recall.
A pottery company sources most of its pigments from two approved suppliers but finds that both are
having trouble supplying a particular colour. Rather than stop production it sources from a third
company, following its procedure for unapproved suppliers, which required the supplying company
to fill in a self assessment evaluation and for the batch of material to be tested before use and a small
trial run to be carried out.
An auditor would find this approach satisfactory.
3.6 Customer-supplied property
No further explanation is really needed for this clause, which requires sites to take
adequate care of any materials supplied to them by their customers. Materials include
things such as artwork, instructions, models and computer software, as well as actual
physical products, components or materials.
Examples
A company lists that it has its customers design template as part of its own technical file. When
audited, the template is missing.
The customer property has not been properly cared for and the company would receive a nonconformity for such an incident.
A company receives artwork files by CD. It has a written procedure for logging and labelling the CD
and ensuring it is stored in the correct place.
The auditor would consider this to be satisfactory, but would check that the procedure had been
followed.
Page 71 of 153
30/4/10 12:45:16
3.7 Corrective and preventive action

FUNDAMENTAL
The company's senior management shall ensure that procedures exist to record,
investigate, analyse and correct the cause of non-conforming products or failure
to meet standards, specifications and procedures which are critical to product
safety, legality and quality.
It is essential that sites have good systems in place to discover, record and investigate
cases where their products or procedures fall short of requirements. Sites failing to
demonstrate that they have a robust system will not be certified because they will not be
able to give the auditor confidence in their ability to reliably place safe and legal products
onto the market.
PL
3.7.1 Capture and investigation of non-conformities

There are many different ways in which non-conformities are discovered, both internal
and external for example:
problems may be noticed internally by inspection, or quality assurance staff or
operators working at the packing lines
evidence may come via internal audits or routine reviews
externally, non-conformities may be found during customer or third-party audits,
customer complaints, or actions of enforcement agencies.
SA
M
A site needs to have an efficient means of recording and investigating non-conformities

or potential non-conformities and reporting the findings. Even if, on investigation, there is
no actual non-conformity, the investigation should still be recorded and it may help if the
problem recurs.
The Global Standard requires issues to be investigated in a timely way. It does not
define timely but auditors would expect the site to have some requirements or
guidelines in place that specify the timescales appropriate to the level of risk to the
consumer.
Page 72 of 153
30/4/10 12:45:16
Example
PL
A company quality assurance manager keeps a log of all non-conformities discovered by the quality
assurance department or during internal audits, and has an effective system for investigating and
addressing the issues. During an audit, an auditor notices a product being packed into an incorrect
box. The auditor queries this with the line supervisor and is told that often happens, I try and watch
all the lines but it is impossible. Further questioning reveals that the supervisor has never reported
this and doesnt know how to go about doing it.
The company would receive a non-conformity. Although the quality assurance manager has a
good system in place, they have not considered other sources of problem identification.
A company is informed by its customer that products have been received without a batch-code
marking on the package. The auditor discovers this issue when looking through the non-conformity
records of the company and checks that the correct procedures and actions have been completed
satisfactorily. The auditor finds that an ink-jet printer had been malfunctioning and that the affected
stock had been identified and treated appropriately. The problem had been investigated and action
taken to prevent future issues.
The auditor would consider this approach to be satisfactory.
The auditor reviews a company policy for recording non-conformities and finds it to be a
comprehensive system including the whole factory, from goods in to dispatch, as well as customer
issues, transport company reports, internal audits and quality assurance checks. The auditor finds
that the recorded issues have been systematically addressed.
The auditor would consider this to meet requirements.
SA
M
3.7.2 Customer complaints

This clause of the Global Standard covers customer complaints about safety, quality or
legal issues. The system for recording complaints may be much wider and include
issues such as delivery, value, customer service etc. In this case, it must be possible to
extract the complaints relevant to the scope of the Global Standard.
Customer complaints, especially for larger producers, are likely to be received from a
wide range of sources and a defined system, as well as staff training, is likely to be
required to ensure that an effective capture system exists and that complaints are well
managed.
For sites needing more guidance on complaint handling, the BRC produces a bestpractice guideline, Complaint Handling.
3.7.3 Responsible staff member
The Global Standard requires that a named individual is responsible for each identified
corrective action. This has been found to be one of the most reliable ways of ensuring
that actions are completed, and avoids any confusion. It does not mean that one person
has to do all the work to correct the non-conformity; in many cases this is likely to be a
team effort. The responsible person must, however, be documented and held
accountable for the successful completion of the corrective action.
3.7.4 Ensure effective corrective actions and prevent recurrence
The Global Standard requires sites to investigate non-conformities in order to
understand the root cause of the problem and to put in place a sustainable solution that
will prevent recurrence. This clause of the Global Standard also requires the completed
action to be carried out within an appropriate timescale, and to be recorded.
Page 73 of 153
30/4/10 12:45:16
Example
An assembly company has found a non-conformity during an internal audit. At one station, the
torque applied when inserting screws into the casings is insufficient, not to specification and means
that there is a risk that the product will come apart. The problem is investigated and it is found that
the machine setting has been altered. The setting is corrected, checked and the non-compliance is
signed off.
The company is surprised to receive a non-conformity for this even though everything has been
properly documented. However, it did not address the part that prevents recurrence. The company
did not try to find out why the setting had been changed and how this could be prevented, and
therefore did not try to discover the root cause of the issue.
3.7.5 Annual review

This clause is self-explanatory and requires an annual review to ensure that appropriate
measures are adopted and new ideas taken up when appropriate.
3.8 Traceability
PL
FUNDAMENTAL
The company shall have a system to identify and trace product lots/batches
including raw materials, components and packaging materials and follow this
from the source of the incoming material through all stages of processing to
supply of the product to the primary customer and vice versa in a timely manner.
SA
M
This is a fundamental requirement because it is vital that stock can be traced in order to
take appropriate action. There are two aspects to consider:
Tracing back to suppliers raw materials and components used within the site to
produce the products.
Tracing forward-finished products to the initial customers (i.e. retailers or
wholesalers who have purchased the items). In some cases, it will be a legal or
customer requirement that products (for example motor cars) can be further
traced, perhaps even to the final consumer.
It is worth remembering that a good traceability system usually makes sound business
sense and prevents or limits the scope of unnecessary recalls or withdrawals of product.
If it can be demonstrated that materials are low risk with respect to the final product, then
traceability is not required by the Global Standard. The auditor may, however, want to
see the justification for this decision.
Example
A company sources buttons from three suppliers and places them all in a storage bin. It is informed
by one supplier that a batch of colorant used in the buttons was contaminated with lead. The
company has to withdraw all the production as it cannot identify which buttons have been used on
which products.
The company will receive a non-conformity because it did not have a system in place. The company
will have also wasted time and money recalling good products because it cannot distinguish them
from bad ones.
Page 74 of 153
30/4/10 12:45:17
The BRC publishes a best-practice guideline, Traceability, which gives more detail for
those requiring further information. It includes examples of methods to be used and case
studies. Therefore, this guideline does not address each subclause of 3.8 in detail but
offers further clarification on subclauses 3.8.2 and 3.8.4.
3.8.2 Definition of a lot/batch

Lots or batches are easier to define in some industries than others. For example, a
curtain manufacturer making curtains from one roll of fabric might easily define that as a
batch. On the other hand, a computer manufacturer assembling thousands of different
parts, themselves all from different batches or even different suppliers, may need a more
sophisticated process. If each product has a serial number that uniquely identifies it, then
it may become a batch of one. When products are made by a continuous production
technique, the site may need to adopt an empirical approach and define the batch in
such a way as to limit the damage from any issues that occur for example, by using a
date or hour code. The auditor may ask the site to explain the rationale behind the
selection of a batch.
SA
M
PL
3.8.4 Marking of outer packaging

Outer packaging is defined in the glossary of the Global Standard as the packaging
visible when the product is released from the site. It is likely to be a cardboard box,
multipack etc. rather than an individual consumer product unit. The Global Standard
does not require individual products to be marked unless this is a legal or customer
requirement.
3.9 Management of product withdrawal and product recall
This part of the Global Standard ensures that there are adequate procedures in place
should the situation arise where unsafe or illegal products are distributed beyond the
site. The term product recall applies to products that have reached the end consumer,
but it has a slightly different meaning in North America. In North America, product recall
encompasses various actions, including informing a consumer not to use a product or
supplying replacement parts. In Europe, the term usually means a physical return of the
product either for replacement or repair. The systems a site has in place to deal with the
issue should reflect the regions in which its products are available for sale.
Product withdrawal refers to actions taken for products that have not reached the
consumer, such as those in retailer stores, storage depots, distribution points etc.
The BRC produces a best-practice guideline, Product Recalls, which may help those
requiring more detail. Authorities such as the CPSC (in the USA) and the European
Commission (DG Sanco) also produce information and guidance.
The reason for the requirement in clause 3.9.3 to inform the certification body of any
recalls is so that it can investigate whether there is any need for a re-audit and whether
the recall casts doubt on the certification. The BRC does not require any definite action
to be triggered on its behalf and the certification body may feel that actions have been
carried out in accordance with defined procedures and no further work is needed.
Page 75 of 153
30/4/10 12:45:17
It is also courteous to inform the certification body in case its audit is called into question
following the recall.
Example
A company discovers that one of its toy products contains a small part that can become detached and
present a choking hazard. It has immediately informed the US and European authorities and recall
notices have been posted. It has also informed its certification body, which seeks information as to
the cause of the problem and how it has been addressed. The company has established that bought-in
plastic parts did not meet the strength test, even though it had been supplied with a certificate of
conformity. The company has reviewed and improved its supplier-approval policies and instigated
additional test procedures.
The certification body decides that the incident has been dealt with correctly and that there is no
need to revisit or suspend the certification.
3.10 Management of incidents and business continuity
This requirement is in place to ensure that business processes continue should

unexpected events occur. The Global Standard is only concerned that guidance is in
place concerning product safety and legality, although a full business continuity plan is
likely to cover a much wider scope of activities.
PL
For products in Group 3 some simple guidance is required. For products in Groups 1 and
2 more specific requirements are laid down, which are likely to cover the most important
issues.
SA
M
3.11 Contract review and customer focus
In order for customers to be satisfied with the products and services they receive, their
suppliers need to have a well-defined understanding of their requirements and
expectations. The Global Standard requires the senior management of the site to take
responsibility for this and make sure that there is an appropriate system in place. The
management must also ensure that customer requirements have actually been carried
out. This would typically be done by reviewing a sample of orders and deliveries against
the customer requirements and by monitoring performance.
For sites carrying out product design activities, there are likely to be a series of
development meetings for new products, as well as ongoing pre-production meetings to
ensure that the customer requirements are being met.
Once products are in production, periodic reviews that the product continues to meet
specification and that the specification is still in line with customer requirements may be
required.
3.11.1 Documentation and review
Problems often arise when there has been a misunderstanding or lack of communication
between the producer and the customer. In order to prevent this, the Global Standard
requires that customer requirements are clearly documented. The Global Standard does
not define the means of doing this. Safety and quality requirements are frequently
included as part of a signed specification and incorporated into other customer
Page 76 of 153
30/4/10 12:45:17
information such as quantities, delivery dates etc., which together form the purchase
order for the products.
Example
A company produces a detailed specification for its products, together with a list of the product
standards it will be produced in conformity with, and the regulations that will be taken into
account. This document is referenced, signed and dated and sent to the customer. Once an order has
been agreed, the company sends the customer a purchase order which references the specification and
requires the customer to sign and date the order before any work is started.
The customer places several repeat orders. For each one, the same process is followed. After six
months, the specification is reviewed and modified because a new product standard has been
published. A new reference specification is produced and the customer is informed; subsequent
orders reference this new specification.
An auditor would find this procedure satisfactory.
PL
3.11.2 Customer-set performance requirements

It is not unusual for customers to set some key performance indicators for their suppliers.
Many of these will be concerned with matters that are not requirements of the Global
Standard, such as delivery performance, reliability and cost but may also cover product
quality, adherence to specification and similar factors.
SA
M
It is a requirement of the Global Standard that any such indicators are appropriately
monitored and reviewed by the site management at least annually to determine how well
customer needs are being met. For products in the higher-risk groups (Product Groups 1
and 2), clause 3.11.4 requires that sites set their own performance indicators, monitor
and review their performance, even if their customers have not set any performance
indicators.
Relevant staff should be informed of the targets and their performance against them, as
this will help to maintain standards and drive improvement.
Auditors sometimes find that the quality manager or sales executive will have a set of
performance indicators that they review once a year, either internally or with their
customers, but that the production staff are not aware of this and so have not adjusted
their performance to meet the customers needs. It is therefore essential that key
performance indicators are well communicated and acted upon by all staff.
3.11.3 Customer communication
For sites of all sizes, it is important that a customer is made aware of information
relevant to their products, whether the information is positive or because of a problem or
issue. For higher-risk products, where such information could relate to safety or legal
matters, the Global Standard requires that individuals are responsible for customer
communication. This does not mean that a person has to be employed solely for this
task, or that the same person has to be responsible for all communication, but it does
mean that a system has to be in place, people have to be aware of their responsibilities
and any communication is found to be effective.
Page 77 of 153
30/4/10 12:45:18
The effectiveness of this system should be checked and reviewed. There are a number
of ways to do this for example, follow-up calls or visits, customer surveys, reviewing
complaints, logging customer contact and feedback but the Global Standard is not
prescriptive.
3.12 Complaint handling
In some ways complaint handling is very similar to dealing with non-conformities (see
clause 3.7.1). The site needs to ensure that complaints are effectively captured and
recorded. Depending on the nature of the business, it is likely that complaints are
received from a wide range of sources and delivered to a number of people for
example, individual consumers calling customer service lines, comments made to sales
people during business development meetings, letters sent to the chief executive, and
product returns from unsatisfactory deliveries. Whatever the source, the site needs a
system to capture and collate the information.
Example
PL
Many sites will record product safety and quality complaints along with a much wider
range of issues. This is quite acceptable provided that quality and safety issues can be
identified and are routed to an appropriate person for investigation in a timely manner.
SA
M
A company has a procedure for logging complaints and a simple form on the companys intranet site
where all employees can record information. The system is explained to an employee as part of their
initial training. Each section manager is responsible for reviewing the input to the system on a
monthly basis and a customer services manager has overall responsibility to review the complaints
and follow up on any necessary actions. When complaints concern safety, quality or legality, they
are coded so that the quality manager also receives the complaint immediately and can review the
urgency of any action to be taken.
An auditor reviews the complaints on the intranet system and selects one example. They follow the
trail of the complaint to ensure that all parties have carried out the required actions and that the
correct information has been logged. During this investigation, the auditor takes the opportunity
to question staff about the system and finds it to be well understood and used. The auditor is
satisfied with the process.
Complaints are an important source of information concerning business performance

and customer satisfaction. It is important that this information can be recorded accurately
and that it is not hidden or lost because people are worried about the implications of
reporting negative comments. Complaints should be seen as opportunities for
improvement.
3.12.2 External investigations of complaints
In complex supply chains, customer complaints may be delegated to third parties, e.g.
agents or importers. In such cases, the allocation of responsibilities must be clear and
documented in advance. It is important that problems do not arise because of the
unclear division of responsibility, or because people think that someone else is handling
the issue. It is also important that the third party knows the extent of their authority when
offering remedial actions, refunds etc. In these circumstances, clear communication with
the provider of this service is essential to ensure an appropriate capture and
management system is in place.
Page 78 of 153
30/4/10 12:45:18
3.12.3 Actions following complaints

This clause simply requires that appropriate actions are carried out by suitably trained
staff. It should be noted that the frequency of problems identified is mentioned, and sites
would be expected to review the recurrence of similar issues and take action to
investigate the causes (and not just deal with issues on an ad hoc basis, as they occur).
Corrective action plans must be clearly documented, giving details of the investigation
and actions taken to prevent a recurrence.
SA
M
PL
3.12.4 Analysis of data

It is a requirement of the Global Standard that the complaint data from products in
Groups 1 and 2 is analysed and used to drive continuous improvement. This is good
practice for all product groups. A summary of this data, any obvious trends and the
effectiveness of corrective actions taken as a result of it, should be part of the annual
management review.
Page 79 of 153
30/4/10 12:45:18
4 Site Standards
This part of the Global Standard is one of the most straightforward. It requires that
products are fit for purpose, both externally and internally, and requires that operations
are conducted in an orderly fashion so as not to jeopardise the safety or quality of the
product.
4.1 Location, perimeter and grounds
For many products, the external conditions around a site will have no effect, but there
are some situations when the external conditions can have a substantial impact on the
products being manufactured.
Example
PL
A company stores cardboard boxes in an outbuilding, in an area of high rodent population. This
could have an impact on the products, but the company keeps the area around the outbuilding as
clear as possible and has good pest control. There is no evidence of rats entering the building.
The auditor considers that this is satisfactory and that practical steps have been taken. It is not
necessary or cost-effective to move the store but the site should continue to monitor the situation.
In all cases, it is important to ensure that the site is of adequate size and construction to
produce the stated products safely.
SA
M
4.1.1 Location and definition of site

The site needs to be well defined with boundaries clearly marked partly so that the
auditor is clear about the premises to be audited, and partly so that proper consideration
can be given to the state and suitability of the location. As part of the audit visit, the
auditor will look around the exterior site to establish the suitability of the location, the
possibility of contamination and any other potential problems that may be caused by a
lack of clarity about the responsibility for shared or communal areas. Auditors
understand that conditions are not always ideal and that sites and their surroundings
often develop over time. They will understand that some buildings may be old or that
new methods have had to be accommodated in buildings for which they were not
intended. The auditor will need to be satisfied that any shortcomings in this regard do not
pose a risk to the safety and quality of the product.
Example
A company is producing bath and shower gel products in a purpose-built unit. The auditor observes
that part of the site is not named on the factory plan, and establishes that this area has been sub-let to
a separate chemical formulation research company.
Because the area is not clearly separate from the main operation, the auditor would want to
determine that there is no risk to the production site from the use or disposal of chemicals from
the sub-let unit. The auditor would investigate how the company controlled the sub-let area, any
areas of overlap, common services etc., and ask to see copies of documented procedures, as well as
observing the activities on the factory floor.
Since it is probable that the company would not be able to sufficiently control the activity of the
sub-let operation, it is likely that the auditor would issue a non-conformity.
Page 80 of 153
30/4/10 12:45:19
4.1.2 Local activities and measures to prevent contamination

This clause requires a site to consider its external environment. In most cases, there will
be no concerns but if measures have to be taken, the site must demonstrate that it
checks these measures and ensures that they are still adequate.
Example
A company making CDs has to operate in a dust-free, clean-room environment. The area outside the
factory is quite industrial and so the factory has installed dust filters to the main production areas, as
well as additional filters for the clean-room area. It monitors the performance of the inner filters and
finds that they need replacing more frequently. The company finds out that a new factory nearby
produces stone and creates a lot of dust. It establishes that a more robust primary air filtration system
is needed and has budgeted this for the following year.
An auditor should find this satisfactory since the company has a reasonable plan of action and
the risk of contamination to the products has been addressed by more frequent replacement of
filters to the inner rooms.
PL
4.1.3 External areas maintained in good order

This clause is rather subjective, but its purpose is to ensure that the products are not
subjected to risk of contamination, made unsafely or not to the quality required.
Some issues to think about when considering this part of the requirement include:
piles of rubbish or disused equipment that could harbour pests
stagnant water, which may be a breeding ground for insects, or create an
unpleasant odour
good practice would be to have a clear zone, free of vegetation around the base
of the walls.
SA
M
It is worth considering that appearances, even for auditors, can be important and an
untidy, unkempt exterior may lead the auditor to question the sites commitment to
quality and safety even if such matters do not directly affect the products.
4.1.4 Traffic routes
Roadways under the control of the site should be maintained so as to minimise the risk
of product contamination for example, by mud or dust. Roads may have a variety of
surfaces and no particular requirements are defined in the Global Standard. It is
recognised that other factors (such as the weather) can affect the situation and that
similar problems could arise from roads outside the sites control. It may be necessary to
have additional measures, such as cleaning grates on vehicle entrances or wash down
facilities for trucks.
The state of the road may have no bearing on the products. In this case, there is no
need for any action but the site should have assessed the situation and confirmed that
no action is required.
Page 81 of 153
30/4/10 12:45:19
Example
A furniture company is situated in a rural area and the roads can become very dusty at some times of
year. The factory itself produces a lot of dust from wood-working operations and has systems in place
for dust extraction and for cleaning the final products before packing. It has assessed that external
problems from the roads do not impact production.
The auditor would be satisfied that the issue had been considered and that the outcome was
reasonable in this case.
4.1.5 Drainage
When likely to be relevant to the safety or quality of the product, drainage should be
adequate to deal with normal quantities of rainfall without long-term pooling of water. Any
site with a history of flooding should take measures to rectify this or to ensure an action
plan exists to protect products if the situation occurs. If natural drainage is inadequate
supplementary drains should be installed.
4.2 Internal site: factory layout, product flow and segregation
PL
FUNDAMENTAL
Premises and plant shall be suitably designed, constructed and maintained so as

to control the risk of product contamination and to comply with all relevant
legislation.
SA
M
The layout of a plant is fundamental to an efficient production process. The state of the
interior of a building is important to the production of most product types. Where any
major issues are unlikely to be solved in a brief time period (because, for example, they
may require plant redesign or capital investment) a revisit and re-audit would be
appropriate. The auditor may review actions that have been put into place temporarily to
overcome an issue that may require capital expenditure, and accept them if they are
suitable. Such temporary solutions would be expected to have been permanently fixed
by the time of the next scheduled audit.
4.2.1 Building maintenance
The building should be maintained sufficiently so as not to increase the risk of unsafe
products. Items such as broken windows and peeling paint can pose a risk of physical
contamination. The use of unsuitable materials may make cleaning or product handling
difficult. Damage to roofs or doors can allow products to deteriorate on storage or allow
the entry of pests. There are many other examples where a badly maintained building
may be indicative of poorly controlled production.
This clause is one where several minor instances of non-compliance of the same type,
but occurring across the site, may escalate to produce a major non-conformity. For
example, one broken or cracked window is likely to be considered as a minor issue but if
a number of windows are damaged and broken this shows a more systemic failure to
address the issue and a major non-conformity would result.
Page 82 of 153
30/4/10 12:45:19
4.2.2 Product flow, equipment positioning

This clause is far more important in some industries than others. It is especially relevant
when the product is likely to become contaminated or damaged by being placed in
contact with other stages of production. It is particularly likely to be relevant to
continuous flow sites where dead space in pipes or potential mixing with the wrong
components may give rise to non-compliant products.
Example
A company is producing liquid laundry detergents. The product has to be adjusted to the right pH at
the end of the line. Any cross-contamination with earlier stages of mixing will result in a potentially
contaminated product. The factory is arranged so that the final stage of mixing is at the end of the
production line and has an automatic check immediately prior to bottling, removing any possibility
of cross contamination.
The auditor would find this satisfactory provided the automatic check is adequately calibrated
and tested at suitable intervals.
Example
PL
4.2.3 Process flow diagrams

Any site should be able to produce a plan of its process. The auditor can, to some
extent, use this as a site guide. Care should be taken to include all relevant processes.
This should not only cover the main production area but ancillary storage or mixing
facilities, and their relationship with the main process.
SA
M
A shoe factory has provided a plan that shows cutting, stitching, assembly, soling and finishing.
The auditor observes a dye vat in the corner of the factory.
The process flow diagram is incomplete. The factory has not included the dyeing operation as it
thought it was separate from the main production. A non-conformity is raised.
4.2.4 Work space

It is self-evident that if a site is too cramped, the quality of the operation is likely to suffer.
Auditors will wish to evaluate the work pattern and discuss how peaks in demand are
dealt with. It is essential that equipment is located with sufficient space to allow easy
access for operating, cleaning and maintenance.
4.2.5 Segregation
The requirements for clause 4.2.2 are also relevant here. It may be necessary to
segregate a product for many different reasons for example, to prevent microbial
contamination or to ensure that products for different geographical locations do not mix.
Example
Radio-controlled model aircraft are being produced. The radio control functions are set to different
frequency bands to reflect the regulatory requirements in the country of sale. The factory runs two
separate lines to avoid confusion and products are stored in different designated and clearly marked
parts of the warehouse, as well as being packed in differently coloured cartons.
Segregation is deemed to be adequate by the auditor.
Page 83 of 153
30/4/10 12:45:20
4.2.6 Location of facilities

This only applies to Group 1 and 2 products where it is important not to risk the product
integrity by possible microbiological or chemical contamination caused by workers or
their food and personal effects.
Example
An auditor observes staff eating their lunch on a table situated adjacent to a production line. There is
the potential for staff members to spill food into the product being assembled.
This is unsatisfactory and would result in a non-conformity. All staff facilities should be located
so that product contamination is not possible.
4.3 Building interiors
PL
Buildings should be adequate to allow products to be made safely and of the quality
required. The exact requirements will change depending on product type. For example,
in a textiles site the exact quality and intensity of light may be specified and important for
colour and pattern matching; at a site making plumbing fittings, on the other hand, as
long as it is well lit and operatives can see clearly to work, no further requirements would
be necessary. As a guide, the auditor will want to understand the importance the site
places on lighting crucial to the product and, at the very least, be reassured that
eyestrain is avoided.
SA
M
Particular industries will have their own detailed requirements and the clauses in this
section reflect the more stringent needs for sites making products with potential
cleanliness issues or within particular environmental settings.
A site needs to consider which factors may affect its products and whether it has taken
reasonable steps to avoid or control the risks from these factors, particularly with regard
to appropriate cleaning measures.
4.3.1 Condition of the site
Judging whether a site is sufficiently clean, tidy and in good repair is subjective, but
auditors will be considering the condition of the site with regard to the potential for any
adverse effects on production. Auditors will expect to see a working environment rather
than showcase conditions, but will raise non-conformities for unnecessarily dirty or untidy
sites as well as for unreasonably cramped or congested locations. A generally clean and
tidy site, relative to the product group, may be seen as a reflection of management
commitment and worker safety.
4.3.2 Building inspections
This clause requires that documented inspections are undertaken to investigate any
contamination risk from the building structure, and takes account of areas such as
overhead beams, ceiling fittings, void areas etc. where dirt might accumulate and could
easily be missed from routine cleaning cycles. The Global Standard does not specify a
frequency for such inspections, which would depend on the site structure as well as the
types of product being produced. The auditor is likely to ask for a justification of the
frequency chosen if they have doubts as to the effectiveness of the inspections.
Page 84 of 153
30/4/10 12:45:20
4.3.3 Ambient conditions

An assessment should be made to first establish whether any control is needed. Many
products are made satisfactorily in the ambient conditions of the location and do not
need further control. Some products, however, are susceptible to variations in conditions
and need to be produced in conditions where temperature and humidity are controlled. If
so, the requirements must be met and compliance with these requirements monitored.
The site should have contingency plans for any failures to meet the required conditions.
Example
A factory is producing bamboo bowls and food steamers. If the humidity becomes too high, then it is
difficult to prevent mould growth. The site has installed dehumidifiers in the storage areas and the
area is checked daily to confirm that a humidity of less than 60% is achieved.
Provided the company can show that the level of control is suitable to prevent mould growth, this
action would be satisfactory.
4.3.4, 4.3.5, 4.3.6 Cleanliness of water and ease of cleaning

These requirements only apply to sites producing goods that need to avoid
microbiological contamination that is products in Group 1.
SA
M
PL
A site would be expected to demonstrate how it controls the quality of water used on
site, and its knowledge of the requirements for water quality specified for the product in
the country of sale. Auditors would normally expect to see evidence of water sampling
and testing for chemical and/or microbiological contamination done at appropriate
frequencies.
4.4 Staff facilities
This clause focuses on staff facilities, from the perspective of eliminating product
contamination. There may be other requirements relating to the health, safety and
wellbeing of employees but these are not part of the scope of the Global Standard.
Most of the clauses in this section relate only to the higher product groups, because it is
in these groups that potential contamination issues are most likely to cause a problem.
4.4.1 Design and operation of facilities
The requirement is not for any specific design or type of facility but to ensure that
product contamination is minimised. This generally means that break activities, eating
etc. should be physically removed from any production or packing area.
This clause applies to all product groups and basic hygiene levels would be expected in
all washroom facilities.
Page 85 of 153
30/4/10 12:45:21
Example
A customer complaint shows that a customer has received a part of a sandwich inside a package they
have purchased containing a light fitting.
An investigation reveals that an operator on the packing line had been eating lunch in the area and
mistakenly placed the food into the box.
The auditor would look to see that procedures are now in place that do not allow for the eating of
food near production, and that these procedures are effectively monitored otherwise a nonconformity would result.
4.4.2 Smoking
Smokers waste, such as cigarette ends, matches, ash etc., can become a source of
product contamination and so, for Product Groups 1 and 2, must be controlled. External
waste should also be controlled to prevent it being transferred inside the site.
PL
4.4.3 Storage facilities

If staff are not able to bring their possessions with them into production areas, because
of possible product contamination, then they must be provided with adequate and safe
storage for their items. This is required so that staff do not try and carry items with them
for fear of them being lost, damaged or stolen. The Global Standard is not prescriptive
on this matter and solutions suitable to the size and complexity of the site are
acceptable.
SA
M
4.4.4 Changing facilities

This requirement is only for Product Group 1 and is intended to prevent microbiological
contamination. Once staff have changed into their work wear, they should be able to
enter the production site without the risk of re-contaminating it on their journey from the
changing facilities. This is equally important for others (e.g. maintenance staff or visitors)
entering the site.
In some cases, the design of the site may not allow direct access to the production area
from the changing facilities. If so, the person responsible for the quality, safety and
legality of the product must carry out an assessment to gauge the risk of contamination.
It may be necessary to define a specific procedure (or route) to reach the production
area. If the assessment reveals that it is not possible to reach the production area
without a risk of contamination, then the facilities will need to be redesigned.
Page 86 of 153
30/4/10 12:45:21
Example
A small cosmetic factory has changing facilities near to the front entrance. In order to reach the
production area, employees have either to exit the building and walk around to the side door or walk
through the office area.
A risk assessment has been carried out and it has been found that there is a low risk of contamination
if the staff walk though the central corridor of the office to the production area but that there is a high
risk if they go outdoors. A procedure is in place to ensure staff take the office route and that they pass
directly though the office without stopping.
The auditor observes that the procedure is in place and that workers appear to be taking the
correct route. The auditor has some reservations about the risk assessment and how rigorously
the procedure is enforced, and is concerned about office staff directly entering the factory. The
auditor raises a minor non-conformity as some potential hazards have not been considered.
After a further review to close out the non-conformity, the company decides to construct a
separate corridor to avoid possible contamination.
PL
4.4.5 Storage of clothing

It is essential that clean work wear is not contaminated by being placed next to outdoor
clothing and other personal effects. Auditors may ask to view storage areas.
SA
M
4.4.6 Hand cleaning and instructions

For Group 1 products, hand cleaning is essential. Facilities must be provided in
washrooms and other appropriate points, such as entrances. It is also a requirement that
signs or notices are placed near the washing points. These act as a reminder and should
also contain information about how the cleaning shall be done. It is often appropriate to
include pictures or diagrams rather than a lot of text.
4.4.7 Food storage
This applies to Group 1 products only and requires suitable food storage away from
production. The requirements are self-explanatory.
4.5 Cleaning procedures
FUNDAMENTAL
Housekeeping and cleaning systems shall be in place which ensure that adequate
standards of cleanliness and tidiness are maintained at all times and the risk of
contamination is minimised.
No matter what types of products are being made, a clean, tidy site prevents
unnecessary contamination and ensures that the work is carried out in an orderly
fashion.
4.5.1 Cleaning to minimise contamination
The cleaning carried out shall be effective and not cause any product contamination.
There is no requirement to have a defined procedure for Group 3 products (see clause
Page 87 of 153
30/4/10 12:45:21
4.5.5 for Groups 1 and 2) but this is good practice and helps to define exactly what is to
be done.
Both routine and exceptional cleaning (such as that needed for new equipment, after a
closedown or after maintenance) should be appropriate and of adequate frequency. The
use of suitable tools, which do not in themselves cause contamination, should be
considered for example, not using cloths or mops that are prone to leave threads, or
employing colour-coded materials and equipment for use in different areas.
4.5.2 Validation of procedures
Changes in buildings, equipment or the products being made may require adjustments to
the cleaning regime. Whenever changes are made, cleaning provision should be
considered to make sure that it is still sufficient and suitable.
Example
PL
A site has installed a new paint storage section in a previously disused area. The cleaning protocol
is modified to include more frequent cleaning, removal of any paint spillages using a proprietary
specialist cleaner, and checking drain filters to ensure there are no blockages.
The auditor observes the paint store, which appears clean and well organised, and is satisfied the
procedure is operating.
SA
M
4.5.3 Chemical storage and labelling

Cleaning materials often contain potentially dangerous chemicals. Sometimes the
chemicals they contain may become hazardous if mixed with other materials. All
chemicals used on site should be adequately labelled and securely stored. This clause is
included here because the primary use of chemicals on many sites is for cleaning, but
the requirements also apply to any other chemicals used, such as pest control
chemicals, weed killers, machine lubricants and the like.
It is not good practice to decant chemicals into other containers, especially if the shapes
are associated with other liquids (for example, decanting a colourless solvent into a soft
drink bottle). If liquids have to be decanted then they must be clearly labelled with as
much of the original information as possible, in particular any safety or warning
information and any instructions for use.
Example
A small unlabelled plastic spray bottle is on top of a printing press. The bottle contains solvent to
thin the ink on the press if it becomes sticky.
The auditor will raise a minor non-conformity. The bottle should be labelled with the contents,
warnings and instructions for use.
4.5.4 Outsourced cleaning

It is recognised that the cleaning of sites is often carried out by a third-party company.
This clause ensures that the responsibility for a clean, tidy site is not abdicated by the
site management and that the cleaning company used is committed to following suitable
methods at a defined frequency.
Page 88 of 153
30/4/10 12:45:22
The clause contains a requirement for a log book to be maintained. This can be done in
any format (for example, signed-off work sheets or computer entries) as long as the
information is recorded, signed and dated.
4.5.5 Documented procedures
For Product Groups 1 and 2, specified cleaning procedures are needed; the Global
Standard outlines the minimum details to be covered. Additional information should be
added as necessary in order to adequately define the cleaning.
4.5.6 Trained personnel

For Product Groups 1 and 2, cleaning personnel must be trained with regard to the
procedures outlined in clause 4.5.5. It is good practice for all cleaning staff to be trained
in accordance with a set procedure. Training is likely to take the form of practical
demonstrations as well as checks to ensure that the protocols and procedures are
understood. This requirement also applies to any temporary or third-party staff that may
be used.
SA
M
PL
4.5.7 Validation of cleaning

In areas where cleanliness is important, the actual success of the cleaning should be
confirmed. There are a number of ways to achieve this and the site would need to
assess the appropriate means for its own operation. Examples of controls might include:
swabbing to check microbiological cleanliness
confirmation of times and temperature used during steam cleaning
audit of the full cleaning procedure.
4.6 Waste/waste disposal
Waste material allowed to accumulate in a site may be a source of product
contamination, become confused with satisfactory products or materials, and present a
risk of materials being misused.
Example
A company has left a number of drums of rejected plastic stabilising solution outside the factory for
disposal. An employee has been on holiday for a week and doesnt know they have been rejected.
Thinking they can be used, the employee takes the drums to the production area, without first
checking with the supervisor.
The site should have procedures in place to identify this error before the material is used.
Normally the drums would be expected to be clearly labelled as rejected product. If no such
procedures are in place, the company will receive a non-conformity as there is the possibility of an
out-of-specification product being produced.
4.6.1 Waste system

This clause is a general requirement for a system to be in place. It does not define the
type of system but does require it to prevent the use of unfit or defective materials.
Auditors will observe the production or packaging site to identify any possible areas
where waste may be misused or is poorly controlled.
Page 89 of 153
30/4/10 12:45:22
4.6.2 Categorisation and segregation of waste

There are a number of reasons why waste may need to be categorised and segregated.
Examples include:
disposal of toxic waste
disposal of highly flammable waste
segregation for recycling purposes, e.g. plastic, paper etc.
measurement of weight or volume of some waste, e.g. batteries.
Some countries have legal requirements covering the waste measures indicated above,
as well as others.
PL
In some cases, particularly those concerning toxic waste, disposal may only be carried
out by registered and licensed operators. If so, the site must demonstrate that
appropriate contractors were identified and evaluated through the sites supplierapproval scheme, and that appropriate records are maintained and include information
such as:
identification of material disposed
quantity (volume, weight, number as appropriate)
type and number of containers
date and time of disposal
signature of waste contractor (or responsible staff member if in house).
SA
M
4.6.3 Product disposed on safety grounds

If unsafe or illegal products have been indentified, they must be disposed of securely to
ensure that they cannot re-enter the supply chain. The site may also have specific
customer requirements for products that do not meet their specifications. In such cases,
disposal must be carried out securely and the disposal/destruction validated and
recorded. This work is often subcontracted to specialists. These specialists must have
been evaluated under the supplier-approval procedure.
Any evidence that destroyed product has re-entered the supply chain shall be rigorously
investigated.
Example
A company has sent a lot of T-shirts for disposal as the finish does not meet the customer
requirements and the customer has requested that they are destroyed. A batch of T-shirts is for sale on
the internet, which appears to match the description of the destroyed samples. An investigation
reveals that an employee took a carton from the premises, because they thought it was wasteful to
destroy them.
A site would be expected to deal with this on a number of levels, and to review:
waste disposal procedures
employee training
employee contracts and disciplinary procedures (including theft)
understanding of customer requirements.

If an auditor had discovered this issue then a number of non-conformities might arise.
Page 90 of 153
30/4/10 12:45:22
4.6.4 Quarantine of waste

If waste material is not separated from good stock it is likely to become confused. A
variety of quarantine methods, appropriate to the site, can be used and may include:
separate storage areas
defined and colour-coded/fenced-floor areas
separate bins or containers.
4.6.5 Waste containers
This clause is self explanatory and requires that the containers are managed so as not to
present a risk to the product.
4.7 Pest control

Most sites need some form of pest control to ensure that products are not damaged or
contaminated. Even when the product itself is unlikely to be damaged by pests,
customers may still have pest control requirements so as to avoid the problem of
infestation in the warehouses or transport.
PL
There are many publications providing further detail on pest control, including the BRC
best-practice guideline Pest Control.
SA
M
4.7.1 Absence of pest control

In the rare cases where a site considers that no pest control is required, it must justify its
reason for the decision and review it every year.
Note that a site is responsible for managing the risk from pests even if it subcontracts the
activity.
4.7.2 External contract or trained staff
Pest control is often subcontracted to external sites, which may need to be licensed or
approved by the authorities. Where contractors are used, the signed contract must
clearly define the scope and level of activity to be provided. If is handled in house,
responsible employees must have undergone formal training and have demonstrated
their competence.
4.7.3 Written procedures
The requirements of this clause are self-explanatory.
4.7.4 Action after infestation
This clause is intended to ensure that the appropriate actions are taken if any infestation
is discovered. The pests should immediately be controlled and eradicated, and the
cause investigated. It is likely that additional cleaning may be required.
Page 91 of 153
30/4/10 12:45:22
If a product has actually or potentially been contaminated the site must evaluate the
situation with regard to:
Safety could contamination pose a health risk?
Customer specification are there any customer requirements?
Cross-contamination could other products be affected?
A responsible person is required to authorise the release of any such products.
4.7.5 Material safety data sheets
These sheets (commonly called MSDS) must be available for all pest control chemicals.
They must be kept in a designated place so they can be easily found and are available
to appropriate staff at all times (as incidents could potentially occur out of working
hours).
Some sites provide an on-demand fax service for datasheets or have them available
online. If a site relies on such a service, it must be able to prove to the auditor that the
service is easily accessible, robust and reliable.
PL
Although pest control is the most likely reason dangerous chemicals will be on a
production site, MSDS sheets are required for all dangerous chemicals on site not just
those used in pest control.
SA
M
4.7.6 and 4.7.10 Bait stations

These clauses are self-explanatory. Note that clause 4.7.10 only applies to Product
Group 1 and requires that the stations are tamper evident this means that they cannot
be opened or modified without it being detected. This is important for high-risk product
groups, where any pest contamination could seriously affect consumer safety. This is
good practice for all bait stations, but is not a requirement of the Global Standard for
other product groups.
4.7.7 Fumigation
Fumigation requirements apply to both products and packaging as necessary.
Fumigation is often necessary when products are packed onto wooden pallets.
Fumigation records must be maintained detailing all appropriate parameters including:
mandatory markings in place (if required)
time and temperature of treatment
chemicals used
storage conditions after fumigation
clearance procedures
who authorised the release
results of any post-treatment inspections.
Products which would normally have required fumigation but have undergone alternative
treatment (for example, kiln-dried wood) should have documentation to clarify why
fumigation has not been required.
Page 92 of 153
30/4/10 12:45:23
Products made from natural materials prone to infestation, such as wood, bamboo,
raffia, straw etc., would normally be expected to be fumigated unless justification is
given.
4.7.8 to 4.7.10 Drains traps and bait stations
These requirements are specific to Group 1 products and are self-explanatory
4.8 Product transport, storage and distribution
Products are at risk from contamination during storage and when they are being moved
around a site or transported off site. Off-site transport is often outside the control of the
production site but, where it has responsibility for such transport, it must not introduce
hazards.
PL
The individual requirements listed in this clause are self-explanatory. Concerns to be

considered include:
storage temperature
protection from rain or dust
stacking limitations
handling procedures manual and via pallet truck etc.
cross-contamination of materials.
SA
M
4.9 Site security

Access to sites should be controlled in order to prevent any accidental or malicious
damage to the product or materials.
Contractors should be suitably qualified and supervised, when appropriate. Whether or
not continual supervision is appropriate, a nominated staff member should be designated
as responsible for any contractors on site and ensure that appropriate procedures are
respected.
Care should be taken that the system for site security is maintained during shift work and
any shutdown periods
Page 93 of 153
30/4/10 12:45:23
5 Product Control
These clauses are intended to ensure that sites have properly defined the products that
they are making, the materials and components used, and the packaging. They require
that records and samples are kept so that, in the event of any problems, the matter can
be properly investigated.
5.1 Pre-production reference samples
It is helpful if a site keeps a sample of the product it intends to make. It may also be
useful to keep subassemblies or components if there are a number of variations to the
same model.
Example
PL
A company makes a number of slight variations on a basically similar model of computer. It decides
to keep one complete model and samples of various components to cover the entire range. For each
style of computer a full parts list is generated.
The auditor will be satisfied with the approach provided that the company can demonstrate all
issues of assembly and manufacture are covered.
A site will often operate a final approved sample system with its customers. If so, a
documented procedure, in which samples are matched with first examples from the
production line, should be in place to ensure compliance with customer requirements.
SA
M
5.1.1 Process of selection and identification

Sites must have a written procedure to explain how samples are selected, which takes
into account whether samples are kept at various stages before production e.g. first
model, looks like, works like model, final pre-production sample. The procedure should
include how samples are identified and selected, and who approves the sample. Any
known differences between the sample and production should be noted.
Customers often have their own requirements concerning samples. If so, a copy of their
requirements should be available and the site procedure should detail how these
requirements are implemented and reviewed.
5.1.2 Keeping samples
If customers require a sample to be kept, then their instructions should be followed. If
there is no customer requirement, at least one representative sample shall be kept. Note
that clause 5.1.6 allows for exceptions to be made when storage is impractical. This is
likely to be the case with very large items, high-value items or when sites essentially
make individual customised products.
Page 94 of 153
30/4/10 12:45:23
Example
A garden furniture company makes tables and chairs from recycled wood. Although it has a few basic
designs, each product is hand-crafted and unique. The company keeps examples, which show the
basic construction techniques, as well as design drawings and details of materials.
The auditor will be satisfied with this approach provided that the company can demonstrate that
all issues of assembly and manufacture are covered.
5.1.3 Storage conditions

Samples must be stored correctly where an investigation of a production issue is
necessary, it will be unhelpful to find the reference sample rotten, faded or otherwise
deteriorated.
Requirements usually concern keeping products at the right temperature and/or

humidity, but other aspects such as light, freedom from magnetism etc. can be important
in some cases. If the site does not know what storage conditions are suitable for its
products, it should examine the samples at suitable intervals to determine whether any
deterioration is noticeable.
Example
PL
The site would be expected to understand the impact of storage conditions on the quality
of stored product, and apply suitable controls.
SA
M
A company makes plastic bottles. There are complaints about the security of the stoppers and bottles
leaking. When the sample is retrieved, it has been stored in bright sunlight and the plastic has
become very brittle from the decomposition of antioxidants. The sample cannot be used for any
investigation.
The auditor would issue a non-conformity in this instance as the storage conditions were not
suitable.
5.1.4 Tamper-evident system

Storage must be secure. If samples are not controlled it is not possible to say whether
they have been substituted, left in unsuitable conditions, modified or otherwise changed.
Samples may also be removed or lost without secure storage. The level of such a
system, and whether each product needs to be controlled or if it is sufficient to keep
products in a locked room or cupboard with controlled entry, will depend on the type of
product, the site and any customer requirements. The auditor will be looking for a system
which gives confidence that the samples are reliable reflections of the pre-production
model.
This requirement is not intended to prevent samples being used or examined but to
ensure that such events take place in a controlled way and with an appropriate
procedure in operation.
Page 95 of 153
30/4/10 12:45:24
Examples
A small company is making shoe laces. It labels an example of each type with a numbered paper label
and stores it in a locked cupboard.
This is appropriate for the activity and an auditor would find it an acceptable approach.
A large textile factory produces ladies shirts for the high street. The customer requires that each
design is sealed in a bag with a tamper-proof seal and a log signed by the responsible person. If the
bag is opened or the seal broken the factory has to contact the customer.
The auditor would check that the process had been followed and look for evidence of missing
samples or samples with damaged seals. If any evidence is found and the customer has not been
informed, then a non-conformity will be raised.
5.2 Chemical formulation control
PL
It is increasingly important that the materials used to produce products are fully
documented. This is because of heightened concern about the use of dangerous or
polluting chemicals and the speed at which legislation is increasing so that materials
that were once acceptable may no longer be suitable. Sites will need to identify which
chemicals are in which products. In some situations manufacturers may need to register
that they are using certain chemicals and the purpose for which they are being used, or
they may need authorisation from the designated authority. It may also be necessary to
keep track of the amount of a chemical being used across a range of products.
SA
M
Manufacturers are advised to check the REACH (Registration, Evaluation and

Authorisation of Chemicals) requirements if making or exporting products in Europe, and
similar legislation in California and some other US States.
Example
A company makes a wide range of articles from PVC some for adults and some for children. It uses
phthalate plasticiser in the adult items. It must track which items have phthalate plasticiser and
which phthalates are used. There is a yearly limit on the amount that can be used or imported into
Europe without registration.
An auditor will wish to view the records of phthalate use and how the company monitors its use.
They will also ask to see how the company keeps informed of the latest requirements for
phthalates. Failure to properly monitor or keep up to date with the requirements would lead to
non-conformities. The auditor may also continue the investigation in the production area to check
if the actual use of phthalate matches the documentation.
5.2.1 Confidential formulations

Suppliers of formulated products may wish to keep the formulation confidential.
However, the formulation still has to be known and evaluated in order to confirm that the
product is safe, that no illegal substances have been used, and that any requirements for
registration have been met. This can often be achieved by sending the formulation to be
reviewed by an external expert, who then issues a certificate of safety and includes the
minimum necessary information.
Sites must ensure that the full information is recorded safely and can be produced if
legally required. Although audits are always confidential and auditors do not disclose
information to third parties, they only need to view sufficient information to be sure that a
controlled system is in place.
Page 96 of 153
30/4/10 12:45:24
Example
A cosmetics company is supplying product to another company making gifts and does not want to
release a formulation. It has submitted the formulation to a qualified toxicologist who has issued a
report saying that it meets current regulations in the country of sale and that it contains an allergen
that must appear on the label. The gift company has received a copy of the report and a written
assurance that the cosmetic company has a record of the full formulation if needed by the authorities.
This is satisfactory provided the company is informed of any updates or changes to legislation
that occur during its manufacture of the products containing this material.
5.2.2 Dangerous substances

It may be necessary to use chemicals classified as dangerous in some products, either
because they are needed for functionality or because, in the way they are used, the
exposure to the consumer is such that they will not cause harm. This clause requires
that the use of such chemicals is justified and recorded.
It is important that these chemicals are securely stored in the appropriate environmental
conditions. Access to the chemicals should be to authorised staff only.
Examples
PL
It is not within the scope of the Global Standard to consider the health and safety of staff,
but controls on such chemicals would also be necessary for this reason.
SA
M
A company is making car batteries. These contain concentrated acid, classified as dangerous. The use
is justified on the basis of functionality and the lack of a suitable alternative.
An auditor would consider this to be satisfactory and would probably continue to investigate the
issue to see how the materials were stored and handled.
A building company is using antimony trioxide as a flame retardant in some of the plastic coatings of
pipes. Although this is a toxic chemical it presents no danger at the levels used, since the compound
is not easily extractable from the plastic and the exposure to the consumer is negligible.
This would be considered acceptable as long as the use of the material is legal in the country of
intended sale.
5.2.3 Handling procedures

Handling procedures for dangerous chemicals are required both to protect the operators
and to ensure that the chemicals are not misused and, as a result, final product safety
compromised. It is essential that work instructions are produced that can be easily
understood by all employees using the chemicals, and that they are available at point of
use. Work instructions can take any format text, diagrams or photographs.
Any personal protective equipment (PPE) provided for staff should not, itself, present
any hazard to the products, and be suitably cleaned and maintained as necessary.
Page 97 of 153
30/4/10 12:45:24
Example
A company is using a cyanide plating process, which requires employees to work with vats of
highly toxic cyanide solution. Pictorial explanations of the handling are posted at each work
station. Additional detailed information is contained in authorised work instructions permanently
attached to the bench at the side of the area. These instructions are available in two languages and all
employees present were found to understand the information.
The auditor is satisfied with the arrangements and notes the reference from the pictures and text
to check that these match those listed as being used in the companys central procedures.
5.3 Product packaging materials
5.2.4 Nanomaterials
Because of uncertainty about the effects of nanoparticles and possible future legislation,
sites are required to document their use. The Global Standard does not require any
particular handling or labelling requirements at this stage but legal requirements should
be respected.
PL
Because consumers usually receive products in some type of packaging, the

specification of the packing can be as important as the product itself. There are often
regulatory requirements about the amount of packaging that can be used, the
composition of such packaging, and labelling or marking requirements. The site should
assess and document its packaging in this respect.
SA
M
Additionally, the packaging must be suitable for its purpose in protecting the product
from damage or contamination and itself being safe when handled by consumers. The
packing process must not add to the risk of producing an unsafe product.
Auditors will look for evidence of rejected packaging materials and how the rejected
material is treated. Such material should be subject to the process for non-conforming
products and suitably recorded, segregated, disposed and reworked as necessary.
Examples
A company producing wine glasses packs the items four to a box. The interior corrugated card liner is
loose and a large percentage of the glasses arrive at the shops broken. It is thought that, in many cases,
customers have taken broken glasses home. Complaints are received and the company needs to review
and redesign the packaging. There is no evidence that this has occurred.
The auditor will raise a non-conformity about the packing materials. They may, however, consider
that the non-conformity could be raised against the clause concerning customer complaints clause
3.7.2.
A company includes sachets of silica gel in its packing in order to keep products dry. The silica gel is
contaminated with an irritant chemical that causes injury to customers. The company is made aware of
this through a product safety information sheet and takes action to use a different material. It has
documented the actions and removed the contaminated packets from stock items.
The auditor is satisfied that the company has taken appropriate action on packaging once the
information became available.
A lawn mower company packs its products in heavy duty cardboard cartons closed with large metal
staples. The auditor observes that the stapling operation is not functioning correctly and that the
staples are not closed down, leaving sharp spikes which could injure a customer when opening the
box.
The auditor raises a non-conformity and reviews the companys procedures concerning the design
and operation of the packing operation to see if it is an unusual occurrence or an ongoing problem.
Page 98 of 153
30/4/10 12:45:25
Mislabelling is a common problem. Labels should be stored appropriately and separated

to prevent confusion. This is particularly important when different language versions of a
similar label are being used. Care should also be taken to use labels in order of
production so as to prevent old, out-of-date stock remaining and being inadvertently
used. Likewise, products and labelling need to be carefully monitored during changeover
periods to ensure that the correct labels are applied.
Sites should ensure that the responsibility for all language versions of label copy is
clearly defined. It is expected that this information would be part of the technical dossier.
5.4 Control of non-conforming materials
It is vital that non-conforming products or materials cannot be mixed up with good

items. All non-conforming raw materials, components, products and packaging must be
identified, segregated and investigated. Non-conforming materials include any items that
do not meet the stated specification and not just those that are considered to give rise to
a safety or legal problem.
PL
5.4.1 Procedures
Procedures are required so that employees know what to do when a non-conforming
material is discovered. If the actions required are not clearly stated, there may be a
tendency to ignore the problem.
SA
M
In some cases, a non-conforming material may be suitable for an alternative use for
example, a plasticiser unsuitable for childrens toys may be satisfactory for adult
products. In other cases, a material that falls slightly outside the agreed tolerance may
still be usable without a major problem for example, a plastic master batch for a bucket
manufacturer that is the wrong colour.
If concessions are made to allow use, there must be a written procedure for this and all
concessions documented and authorised. The reason for the existence of all nonconforming materials must be investigated, ideally to prevent recurrence. Reduction in
rework should inform a sites KPIs and be reviewed as part of an internal audit.
Procedures are also required to ensure that the subsequent use, return or disposal of
non-conforming materials is handled and documented correctly. The product to be
reworked must be subject to the methods and inspection or testing requirements that are
in place for production.
Example
A company has rejected some plastic mouldings because the shape is incorrect. The items are
segregated and sent to be ground up. The material is to be used as re-grind and added in to the mix
for another product at 8% of the total. Before the material is used, it is subjected to testing to ensure
that the content of toxic elements is within the allowed limits and pre-production samples of the
product are prepared to ensure that the physical performance is appropriate. The material is also
checked for homogeneity. All the procedures are documented.
The auditor finds this to be acceptable. The auditor also reviews the records and test results for
the products made with this material to ensure that they conform to specification.
Page 99 of 153
30/4/10 12:45:25
5.4.2 Disposal
A procedure for the disposal of unsafe or non-conforming material must be available and
fully implemented.
If unsafe or non-conforming products are allowed to be removed from a site without
proper disposal, there is a risk of them getting to the consumer or getting confused with
good products. It is possible to use products as seconds provided there is no safety or
legal issue and that it is not a breach of customer requirements. Any such products
must, however, be identified separately from good products.
In cases where it is warranted, auditors would expect to see that disposal had been
observed and signed off by a site representative or suitable independent third party, or
carried out by an approved professional contractor.
6 Product Conformity Assessment
6.1 Product analysis/testing
PL
FUNDAMENTAL
A suitable, sufficient and validated testing regime shall be in place to ensure the
safe, legal production of products to the required conformance of safety, legality
and quality. Results from the programme shall be recorded, reviewed and stored
securely.
SA
M
Although this is a fundamental requirement, if a site is making simple, low-risk products,

testing may not be necessary. The site is required to consider the matter, document why
no testing is needed and relate this to the product risk, if any. Once this has been done,
the remaining clauses of the section are not applicable. Sites should expect an auditor to
challenge their decision, and be able to justify it.
Example
A small company is producing textile floor-cleaning cloths. It has checked regulations and found
that the only requirement is for the fibre composition. It purchases the material with test certificates
confirming the material to be cotton. As the product is low risk, the company has decided that no
testing is necessary.
The auditor may challenge the decision and question whether any other chemicals such as azo
dyes or formaldehyde should be checked. The company will have to justify why it was not
considered important.
This clause requires a site to justify why it has done the testing it has, how samples were
chosen and how the results have been used.
6.1.1 Testing programme
The testing programme must be established, taking account of the range of factors listed
in the Global Standard. Usually the programme should be determined before production
starts, although there may be occasions where the need for additional testing is
determined at a later date for example, as a result of complaints, in order to improve
features, or to take account of the need to substitute one or more raw materials.
Page 100 of 153
30/4/10 12:45:26
It is good practice to ensure that products meet the requirements of defined product
standards in the countries or regions of intended sale. For some products this will be a
mandatory requirement but, even when the standards are voluntary, compliance is
usually the most straightforward way to show that the product meets the requirements of
the intended market.
Sites should note that some specifiers have their own product standards, which may
contain additional requirements. A site is advised to check if this is the case and, if it is,
to make sure that it or their testing organisation has copies of the most up-to-date
requirements.
The test programme must relate to all parts of in-process production and product where
testing is required. It includes tests on raw materials, component parts and products
during production as well as final products. The programme may include testing carried
out by third-party labs as well as in-house testing, if this is necessary. When raw
materials are specified to be supplied with test reports, this should also be documented
as part of the programme.
Example
PL
A test programme is not complete unless it details how and when samples are selected
and by what criteria the results should be assessed, and who is responsible for checking
and accepting the results.
SA
M
A company produces pepper mills made with plastic and metal parts. Its test programme comprises
the following:
Polycarbonate bodies are purchased with requirement for a test certificate on each batch to
show the product meets the safety of materials in contact with food requirements. The actual
tests and test methods are defined and all tests must be carried out in a laboratory
accredited to ISO 17025 for the defined methods. There is a procedure for checking
certificates before accepting goods.
The company has decided that it is foreseeable that these items will be placed in a
dishwasher so it has conducted dishwashing tests to a defined product standard to check
suitability. This test has been carried out by a company experienced in the testing but not
accredited.
The company carries out stress-cracking tests on initial samples to confirm that the
design does not have inherent weaknesses, and on a random but defined basis. Quality
assurance is responsible for testing and analysing results.
In-process testing is carried out to ensure that the screws are assembled to the correct
torque. An internal procedure exists defining the method and equipment to be used for this
check. Each operator checks a sample hourly and records the result on a production control
chart. The chart has clearly defined action and warning limits and there is an established
procedure for the operator.
The final product is subject to a performance test to grind 50 g of pepper. The conditions
and procedure for this test are defined. The test is carried out by the quality assurance
department.
Every six months a sample of final production is sent to an independent third-party

accredited lab to check for compliance with legislation. The precise legislation is defined.
The factory has a procedure for use testing of the mills at home by volunteers, and records of
the performance are kept on a defined chart. The quality assurance manager reviews this
information.
An auditor would accept this as an appropriate test programme. Auditors are experienced in the
product categories and may have specific comments to make about any tests that are missing or
inappropriate. Note that the test programme covers quality and performance issues as well as
safety and legality.
Page 101 of 153
30/4/10 12:45:26
6.1.2 Stages of testing

The stages at which a product is tested depends on the product type, legal and customer
requirements. It is usually more cost-effective to carry out tests relating to design issues
as early on in the process as possible, so that errors may be corrected before high costs
are incurred.
For many higher-risk products, a type test needs to be carried out by an approved thirdparty lab. This is a test to ensure that the model is made in conformity with the
appropriate legal requirements. Once the product passes this test, it is the sites
responsibility to ensure that the ongoing production continues to match the tested
sample. Even if there is no legal requirement for a type test, sites should ensure that the
general production samples meet the same standards as tested products.
PL
Example
Note that a site needs to be cautious when accepting testing of raw materials and
components as an alternative to final-product testing. It may be that all individual
components and materials are satisfactory, but that there is an interaction between them
or the way they in which they are used, which means that the final product is unsafe. It is
advisable to randomly test the final product to ensure that the product going to the
consumer is satisfactory.
SA
M
A company uses a solvent-based glue to assemble a product. The glue and the plastic materials being
assembled have both been tested and comply with legal requirements and the specification. When
assembled, the solvent from the glue affects another component adjacent to the glued area, causing it
to weaken and break under some conditions.
Testing of the final product would have revealed this issue.
6.1.3 Sampling plans

The sampling plan and test criteria must be defined. It is not uncommon for sites to have
their best products tested. Although this produces the desired result, it does not
represent the true situation and is only likely to lead to problems or customer complaints
later. Sampling should be done on a rational basis.
Full product testing cannot usually be carried out on a sound statistical basis because of
the costs involved and the destructive nature of the tests. Nevertheless samples can be
chosen to reflect the actual situation and must, as far as possible, be representative of
production. A site can:
sample at the beginning, middle and end of a production cycle
sample based on the number of products produced, at reasonable intervals
sample when there has been a substantial change for example in components,
equipment, work force etc.
take account of and address known process variables.
Tests which are undertaken as part of production (e.g. checking the pH of a chemical,
the seam bite on a textile or the strength of a glued joint) can be carried out on a
statistical basis see clause 6.2.
Page 102 of 153
30/4/10 12:45:26
6.1.4 Testing bodies

There are many things to consider when deciding where testing is to be performed and
who will carry it out.
Some sites have the expertise and the resources to carry out all required testing in
house while, at the other extreme, some will have no resources and will have to contract
all the test work.
PL
The Global Standard is not prescriptive about this, as long as testing is competently
carried out and meets customer or legal requirements. The following should be
considered when planning testing:
Customers may have preferred or required test labs
Testing the final product in the country of origin may give faster response times
and make it easier to discuss results, but testing in the country of sale may be
more acceptable to the customer.
Some type tests must be carried out by laboratories approved by the authorities.
Even if capabilities exist in house, it is sometimes useful to have independent
verification of key results both as a benchmark and to reassure clients.
Some test results are subject to interpretation and differing opinions. It can be
useful to get more than one view on tests for important projects.
Sites should always be satisfied that testing is carried out by competent and trained staff.
SA
M
6.1.5 Accredited laboratories

It is only essential to use accredited labs for tests critical to safety or legality that are not
also validated by additional tests. For example, a strength test carried out on the site
does not need to be accredited if some random samples are also sent to a third-party lab
for verification of the results.
An accredited laboratory is one which has been audited by the appropriate national
accreditation service to check that it operates in accordance with ISO 17025. There are
other accreditation schemes in some countries but these generally follow the same
principles. If a laboratory is working to an alternative scheme, this can be accepted
provided it has been audited by a competent and independent third party and can show
that it follows the requirements of ISO 17025.
Sites should note the following important points about accreditation:
Each accredited laboratory has a scope of accreditation, which is publicly
available. Only those tests listed on the scope are accredited.
A laboratory is unlikely to be accredited for all the tests it performs. This does not
mean that it is performing other test work to a lower standard but it may indicate
that it performs the testing less frequently, does not have exactly the right
equipment or has not found accreditation to be cost-effective. If in doubt, a site
should ask the lab why it is not accredited for a particular test.
When an accredited lab is not available for some tests, the site wishing to test
products should confirm that its chosen lab is working to the principles of ISO
17025. An auditor would ask for justification of the use of such a lab if the test
was key to safety or legality.
Page 103 of 153
30/4/10 12:45:27
6.1.6 Security of samples

This is particularly important when problems arise. Sites may need to rely on test results
to justify that their products were produced to the required specification. If the sample
could have been tampered with between leaving the manufacturing site and getting to
the test site, the results may be in question. Similarly, any test results should be stored
safely and checked for accuracy immediately on receipt. Any perceived errors or
omissions in the reports should be queried as soon as possible.
It is therefore essential that the site has a clearly documented procedure to identify the
sample (e.g. by reference number) and secure the sample during transit.
Example
PL
A company relies on third-party testing for its products. Test reports are returned to the
administrator and filed away. A problem arises with a product and the test report is consulted.
It is found that description of the product and the reference number are incorrect. The laboratory has
made a typing mistake on the report and entered the details of another product.
The mistake was found internally and corrective action taken. The auditor is satisfied with the
actions taken to improve the system. It demonstrates, however, the need for a responsible person to
carefully review test reports.
6.1.7 Test submissions

A test programme should be defined as precisely as possible to remove ambiguities. For
example, if the tests required are referenced by a product standard then the edition and
section of that standard should be clearly stated.
SA
M
Example
The European Standard for the safety of toys is EN 71. This standard is in numerous parts and has
been amended several times. A company should list testing as EN 71 Part x year y and not just as EN
71. It may be necessary to further define the testing to indicate which clauses of the standard are
required.
Auditors will check the test protocols to satisfy themselves that testing procedures are sufficient
and up-to-date methods are being used.
Sites often rely on their test houses to advise on the appropriate requirements, as test
houses have more expertise in this area. This is quite acceptable but the site must
ensure that the lab receives a written brief as to the requirements. Examples of this
would be:
Defining the countries of intended sale.
Clarifying any testing which is not required for example, chemical testing of
components is not required.
Indicating any user or usage information for example, the intended age range
for childrens products.
Explaining any limitations to the sample for example, the final product will be in
a different colour.
The availability or not of more samples so that the lab knows whether it has to
do all tests on the product provided.
The individual responsible for the testing programme and follow up must be clearly
identified.
Page 104 of 153
30/4/10 12:45:27
6.1.8 Validity of test results

It is essential that inaccurate results are not relied on. It is also important that the test
methods used are precise, accurate and can meet the required detection limits for the
substance being measured. Likewise, the correct level of discrimination must be
possible.
Example
A company uses a spring-loaded micrometer gauge to measure the thickness of bags. The results are
quoted to an accuracy of 0.001 mm but when checked the instrument is only accurate and calibrated
to 0.01 mm.
Auditors will check the validity of results. In this case a non-conformity would result as the bag
thickness has not been correctly checked.
PL
Part of the assessment to ISO 17025 is that the laboratory uses suitably validated test
methods and has the right quality assurance procedures in place. Even when tests are
being carried out by non-accredited entities, it is still important that test results are
accurate and robust. The Global Standard suggests a number of possible ways to do
this but the list is not exhaustive. For straightforward tests and measurements, very
simple means may be available (for example, cross-checking a measurement with two
different makes of measuring rule), but in other cases more complex work will be
required.
SA
M
The advantage of using recognised test methods, published in national or international

Standards or similar documents, is that the methods have already been validated and
checked so sites can use them with confidence and just have a procedure in place for
ensuring the quality of their own performance. If a site wishes to use a method which is
not recognised or is an in-house method, it will need to record and document the data
justifying its validity.
6.1.9 Review of results
The Global Standard requires that all results falling outside the defined specification are
reviewed and actioned by the responsible person. It is essential that such results are not
ignored until the annual review. It may be appropriate, depending on the risk, to define a
maximum length of time before reviewing the relevant procedures.
It is also possible that a nominated deputy will need to be assigned to this task. Although
not a specific requirement of the Global Standard, it is good practice for the responsible
person to also review a selection of results that are in specification since errors can be
made with false pass results as well as failures. This review should form a part of the
internal audit for the department responsible.
6.1.10 Location and operation of testing laboratories
This clause requires on-site test facilities to be located so that they cannot contaminate
products. Each site will need to make an assessment of the requirements appropriate to
its products and document the result. Any controls that are deemed necessary shall be
monitored and respected.
Page 105 of 153
30/4/10 12:45:27
6.2 Inspections
Inspections, as referred to in the Global Standard, are visual checks of the product.
Sometimes they incorporate other aspects, such as simple tests that can be performed
on site for example, checking the operation of control buttons, the functionality of
battery-operated items, the security of sewn features etc. It is not unusual to also include
some measurements, such as the size of garments.
SA
M
PL
Inspections may be carried out at various stages of production. The most common
inspections are:
Start-up inspections:
o Carried out during the first batch of production to make sure the product
production is as expected.
DUPRO (during production inspection):
o Usually carried out at the production site when a proportion of goods has
been made. Several DUPRO inspections can be carried out in the course
of a long production run.
FRI (final random inspection, also known as PSI (pre-shipment inspection)):
o Usually carried out at the production site once production is complete but
before goods are loaded into a container for shipping to the customer
o Sometimes combined with container stuffing inspection where goods are
checked as they are loaded into the container.
Confirmation or check inspections:
o Usually carried out by the receiver of the goods, if there is concern about
the product meeting specification. These may take place in the
warehouse, at the customer premises or at a third-party location.
The most common inspection is an FRI. This is carried out after production when it is
often too late to correct errors without expensive rework. These inspections are,
however, a necessary part of the process and ensure that customers receive safe goods
to the quality expected (this is especially important for fabricated goods where the quality
may vary between individual pieces).
Sites themselves may carry out internal product inspections at various points in
production and may have an inspection programme for incoming components,
subcontracted work or home work.
The requirements of the Global Standard mean that inspections are carried out on a
defined and rational basis and that, in any subsequent investigation, it can be seen
whether the inspection checked the parameter in question and whether the sampling
programme was sufficient to highlight the levels of defects subsequently detected.
Those unfamiliar with the requirements and technical details of inspection and sampling
procedures should refer to the international standard ISO 2859 Sampling Procedures for
Inspections by Attributes. Other similar, commonly used standards include Mil Standard
105, ANSI Z1.4 and BS 6001.
Page 106 of 153
30/4/10 12:45:28
Example
A company finds that a batch of calculators it has shipped to Europe do not work, even though they
have been inspected. The inspection criteria did not include a test to see whether all the buttons
functioned. The inspectors checked that the calculators turned on, but the problem was that the 9
key did not work.
The importer rejects the goods, the manufacturer tries to blame the inspection company who says
it was unreasonable to check all functions in the time allowed. The criteria were not defined. An
auditor would check that the inspection was carried out as defined by the criteria. If criteria were
not available, a non-conformity would be raised.
6.2.1 Need for product inspections

Product inspections are necessary when there is doubt about the consistency of final
production. Inspections are also frequently required as a condition of trade, and payment
of the goods may be linked to a satisfactory final inspection carried out by a recognised
third-party organisation, which might be chosen by the customer.
PL
It is essential that the scope of the inspection is defined. This is commonly referred to as
a defect list or a defect classification. The document lists all aspects that must be
examined by the inspector and how any defects shall be classified.
Defects are usually classified as critical, major and minor. The number of defects that
are accepted depends on the severity of the defect and the acceptable quality limit
(AQL) required by the inspection (see clause 6.2.3).
SA
M
Example
An inspection is being carried out on toasters. One of the defects to be considered is damage to the
plastic casing. The defect is described as critical if the casing is broken and the interior parts are
accessible; major if the casing is broken but no parts are exposed, there are cracks though the plastic,
or surface marks longer than 5 cm; and minor if there are surface markings of less than 5cm in length.
An inspector must record the type of defect (critical, major or minor) and describe the fault (e.g.
damage to corner).
6.2.2 Sampling procedures

Sampling procedures are required in order for the inspectors to select appropriate
products for inspection. A random sampling process is usually the most acceptable,
where samples are selected based on random number tables. However, it is important to
define the random sampling process for example, are cartons, inner packs or individual
items from packs selected? Sometimes, random sampling may not be the best method
for example, when a problem is suspected and the site wishes to focus on a particular
part of the production.
It may be necessary to document practical information, such as the tools that will be
needed by inspectors and whether any particular handling is necessary. It will also be
necessary to define the frequency of inspections and the amount of time allotted to an
inspection task, unless this is at the discretion of the inspection site.
A documented procedure should be produced and formally agreed by the body carrying
out the inspection. In practice, it may be the inspection body that produces the plan but
Page 107 of 153
30/4/10 12:45:28
the site should review and formally accept the proposals before the inspection goes
ahead.
6.2.3 Sampling plans
The sampling plan should be defined and documented. Different product types may
warrant different plans and, although a site may have a default AQL that it or its
suppliers normally use, it should review it to make sure that it is appropriate for
example, the number of defects acceptable for a batch of plastic buckets may be higher
than the acceptable number for a piece of medical monitoring equipment.
The number of samples to be taken depends on the statistical plan being used and the
purpose of the inspection. Some inspection procedures favour the supplier risk over the
purchaser (or consumer), or vice versa.
PL
In all cases a detailed defect classification shall be available together with the final
acceptance or rejection criteria the information on how many samples found with
defects cause the lot to be accepted or rejected. Note that many sampling plans have a
grey zone, when it is not clear whether lots are to be rejected, accepted or if more
samples should be selected. The action to be taken should be clearly stated in the
sampling plan.
SA
M
6.2.4 Customer acceptance

An inspection is often part of an agreement between a buyer and seller. The sampling
procedure and plan may be agreed between parties, or it may be imposed by the buyer.
Before conducting an inspection, the site should ensure that the other party will find the
plan and the criteria for accepting the product acceptable and document this agreement.
6.2.5 Policy on handling goods
Sampling procedures should include information on the handling of the actual products
sampled, for example:
Do they need to be repacked?
What happens to inspected products
o are they labelled?
o are they returned to production?
o are they segregated or destroyed?
Should the inspection site retain any samples or collect any extra samples to
return for testing?
Should any rejects be photographed?
Additionally, if inspected products are to be disposed of, the disposal procedure shall be
defined. It is also useful to make sure that the conduct of inspectors has been clarified
and that they are not allowed to remove any inspected goods except under defined
conditions, such as returning samples for evidence or testing.
Page 108 of 153
30/4/10 12:45:28
6.2.6 Inspection conditions

If inspections are to be carried out on site, a suitable area must be provided for the
inspectors. If inspections are routine, sites would be expected to have a dedicated and
suitable area, with the appropriate equipment available to carry out measurement or any
empirical checks required. Such an area should be well lit.
6.2.7 Qualified personnel
If a site carries out inspections for its own purposes, it shall ensure that the staff are
suitably trained and competent. The actual inspectors need to be aware of how to look at
the goods and check defects while a responsible person shall be trained to understand
how to select sampling plans and procedures and carry out the statistical evaluations
required.
PL
6.2.8 External inspectors

External inspectors are treated as any other suppliers. Where the inspectors are
mandated by another party, they shall still be subject to the normal supplier process as
far as possible, and any matters of concern should be recorded.
SA
M
6.2.9 Results
This clause is self-explanatory; results of failing inspections must be reviewed in a timely
manner by a designated individual, and appropriate action taken.
6.3 Product claims
The most frequent claims made for a product are about size, weight, volume or quantity.
Sites need documented procedures to monitor that any claims made are accurate.
6.3.1 and 6.3.2 Quantity control
For many product types, and in many countries, product quantity labelling is a legal
requirement and the accuracy of information on this labelling is defined. The method and
frequency of validating the information may also be legally set. Sites should be aware of
and abide by any such requirements.
Example
A company producing shampoo labels the bottles with the net weight. The weight is described
using the European average weight system. The company is obliged to check a defined number of
products and to record that the average weights are within the defined acceptable tolerances.
The auditor is likely to ask to see an example of the records and, if they are not available, a nonconformity would be raised.
6.3.3 Claims
Sometimes sites make particular claims about products for example, washable-ink
pens, suitable for children 3 to 6 years, sun protection factor 10 etc. Whenever a claim
Page 109 of 153
30/4/10 12:45:29
is made there should be evidence to substantiate that it is correct and justified. This
evidence must be documented and reviewed at intervals, and the methods determined.
Examples
A suntan lotion company has rated a product as factor 10. It has done this on the basis of copying
a competitors formulation and has no evidence to show that the factor is correct.
The auditor would find this to be a non-conformity and, depending on the technical information
about the formulation, could decide that the product was unsafe.
A company claims that its washing machine is the quietest on the market. Although this was true
several years ago, the company has not kept up to date with research. Several models are now
available that are quieter; the claim is no longer valid and should be removed.
An expert auditor may be aware of the situation and challenge the claim.
6.3.4 In-use or lifetime trials
PL
Products that claim certain performance need to validate that they actually meet such
claims. Products such as cosmetics usually have a sell by or use by date on them and
stability trails must be conducted to ensure that the product is usable within these time
periods.
For fabricated products, tests are usually necessary to establish that a product is fit for
purpose and likely to endure for a suitable (or guaranteed) use period for example,
light bulbs are tested to establish their minimum life.
SA
M
It is expected that a site would provide documentary evidence to substantiate any

statement regarding shelf life or minimum durability, taking into account environmental
conditions or usage that the product would need to withstand during the stated period.
Page 110 of 153
30/4/10 12:45:29
7 Process Control
7.1 Control of operations
FUNDAMENTAL
The company shall be able to demonstrate effective control of all operations
undertaken, to ensure product safety, legality and quality and ensure that the
processes and equipment employed are capable of producing consistently safe
and legal product with the desired quality characteristics.
This is a fundamental requirement because, without proper control of the manufacturing

process, safe products that are fit for purpose cannot be consistently achieved. There
are various aspects to product safety designing a product, selecting materials that are
capable of resulting in a safe, quality product, and ensuring that the manufacturing
process is controlled so that this is achieved on a consistent basis. Products must also
be packaged appropriately and contain suitable warnings and adequate instructions.
SA
M
PL
7.1.1 Process risk assessment

The site needs to identify the hazards that might be introduced if production is not
adequately controlled. Hazards may be introduced in a number of ways, including:
contamination from machinery, buildings, other products etc.
poor control of equipment settings
use of incorrect parameters, such as time or temperature
malfunctioning equipment
use of unsuitable raw materials.
A site should carry out and document the assessment even if, subsequently, no
additional hazards or control points are required.
Examples
A toy company is applying eyes to teddy bears. It has carried out a risk assessment and knows that
the eyes have to withstand a tension test or small parts may be released that would be hazardous. In
order to achieve this it has to set the controls on the insertion machine to a certain force and
monitors the tolerance. The company may also do an online check of the force needed for failure.
By establishing the force needed for failure, the company knows whether the products easily
satisfy requirements or are close to the limit. This may determine the amount of checking required
or result in a readjustment of the insertion machine
A company is producing skin lotion; it has carried out an assessment and established that if the
water quality is not controlled, there is a risk of product contamination. A further assessment shows
that both the incoming quality of the water and the cleanliness of interior pipes are important and
monitoring is required.
An auditor would look for the actions that have been put in place as a result of this evaluation.
7.1.2 Process control plan and critical control points

Critical control points (CCP) are those points at which a parameter must be controlled
and monitored in order to prevent critical problems occurring in the process. There would
not normally be many of these points, since there are usually only a few really critical
Page 111 of 153
30/4/10 12:45:30
steps. Other points that need to be controlled, but are not critical to the product integrity,
are called control points.
The monitoring at a CCP should be something that can be done and recorded in order to
detect problems. The control points should have defined monitoring and set limits
outside of which action must be taken.
A common misperception is that the complete product safety test represents a CCP. A
full product safety test is unlikely to be a CCP. This is because it reflects many different
aspects of assembly, usually takes several days, and the result is only known when
production is complete.
Examples
PL
A company is making childrens strollers. It is important that the product meets all safety
requirements so the company has set a CCP that it has to pass the product standard EN 1888. It has
one product a year tested to this standard by an external lab, from a production of 200,000.
The test is important but is not a CCP. It is not a test that gives an indication of where a critical
production issue has to be controlled. A more realistic CCP might be an online check to ensure
that the braking force is sufficient to hold the stroller. This can be checked, recorded and action
taken if it is outside the allowed tolerance.
A company is monitoring the temperature of glass annealing ovens as a CCP. Records show that the
temperature was outside of the action limits on several occasions but no actions were documented
and it did not appear that any action had been taken.
This would result in a major non-conformity since control at this point has been designated as
critical to the process, but has not been taken.
SA
M
7.1.3 Pre-production meetings

Pre-production meetings are necessary to make sure that all relevant staff are aware of,
and briefed about, the products to be produced, changes to products and customer
expectations, and the controls that need to be applied. Pre-production meetings should
be attended by quality assurance and production staff. The meetings should be
documented but there are no particular requirements about format or formality. An
auditor will not be satisfied by the response yes we talked about the new product or
change of specification if nothing is recorded.
7.1.4 Process monitoring
Which parts of the process (if any) need to be monitored is established following the
assessment of potential hazards and required process control. Monitoring may be
needed on the product itself (for example, strength or thickness measurements) or the
environmental conditions. In all cases the parameter to be measured should be clearly
defined as well as the acceptable tolerance, frequency of measurement, measuring
equipment and means of recording results.
It is likely that auditors will ask to view some of these records, such as control charts
filled in by operators, or automated electronic records.
Page 112 of 153
30/4/10 12:45:30
Examples
Glass coffee jugs are being produced and have to be annealed for a certain time at a controlled
temperature. The company has installed an automatic temperature probe connected to a chart recorder,
which is checked every hour. Warning and action limits are set on the readings and operators are
trained to carry out appropriate actions.
An auditor would find this procedure satisfactory.
An electrical company has to control the temperature settings on the automatic soldering machines
to ensure a consistent joint is achieved. The process is monitored by automatic temperature checks,
visual examination and electrical conductivity testing on site. All results are plotted on control
charts with defined process limits. Photographs are available to compare good joints and to show
examples of rejected ones.
This is a good example of the appropriate action being taken.
7.1.5 Corrective actions

This clause requires that action is taken when necessary and documented. It can then
be reviewed for its effectiveness and suitability. Actions should be taken when a process
deviates from the specified parameters, even if there is no evidence that a nonconforming product has been produced.
PL
Whether actions are simple adjustments (such as slight changes to temperature) or

complex changes, they should always be recorded.
SA
M
7.1.6 Formalised process risk assessment

For products in the highest-risk categories, the Global Standard requires that a formal
approach is taken based on one of the well-established systems (usually HACCP). Each
step of the chosen process should be defined, validated and documented.
7.1.7 In-line monitoring
Automatic systems can be very useful but, if they are to be relied upon, checks should
be in place to ensure that they function correctly.
This clause calls for routine testing. The auditor will wish to understand how the interval
between checking was established and that it is appropriate for the products in
production.
Example
A company making hair conditioner checks the pH of the final product by means of an automatic pH
probe, which is set to produce an audible alarm and divert production if the products fall outside
allowed tolerances. A system is in place to introduce check samples in order to ensure that the probe
and divert are working correctly.
The auditor may wish to look at some of the results for the quality assurance samples, if
satisfactory they would find the system acceptable.
Page 113 of 153
30/4/10 12:45:30
7.2 Control of incoming components and raw materials

FUNDAMENTAL
The company shall have procedures to specify, validate and approve incoming
materials, which shall include any testing, inspection or review of certificates of
analysis.
It is vital that the correct raw materials and components are used for products. If the
wrong materials are used, it is very unlikely that products can be corrected at a later
stage of production. This clause is therefore a fundamental requirement for all sites.
Incoming materials and components can be controlled in a number of ways, depending

on the situation. They may require testing, checking of certificates of analysis or
conformity, visual inspection or other checks, which should be described in a
documented procedure. The procedure should also include the means of release of
acceptable raw materials and components and any labelling or recording requirements.
Example
PL
It is usual that accepted product can be identified in some way to help traceability, and to
prove that it has been through an acceptance procedure. Items and materials which are
stored pending acceptance should be segregated so there is no possibility of confusion
with accepted products. Similarly, any rejected goods must be labelled and segregated.
SA
M
A company receives paint from a number of suppliers. It is a requirement that each can is accompanied
by a certificate of analysis of the lead content for a sample from the same batch.
A goods-in employee follows a procedure that requires them to record the batch code, and confirm
that the test results are received, are for the correct batch, and are within specification. The employee
labels the paint can with a reference code, and date stamps and releases it to production after signing
and dating the record.
An auditor is likely to cross-check an actual can of paint against the record to make sure that the
system is operating correctly. They will also observe whether any unlabelled cans of paint are in
use at the site.
7.2.1 Approval procedures

Any materials likely to affect the safety, quality and legality of a product must have
written approval procedures.
It is a requirement that a positive release system is in place i.e. someone has to check
the delivery and approve it. The rationale on which they make that decision should be
clear. It may be that they need to check it is accompanied by a test report or that they
need to physically inspect it for size, colour or another parameter.
Page 114 of 153
30/4/10 12:45:31
Examples
A company manufactures calculators and buys in batteries on a specification for size, type, levels of
toxic metals and absence of mercury. Each batch is required to be coded and supplied with a test
certificate for toxic metal content relating to the batch. An operator would be expected to check the
test report against the batch code and to sample batteries to ensure that they had the right code and
were the right size.
A company has been using a paint supplier for a long time with no problems. The supplier is
supposed to supply paint with certificates of analysis but this is no longer checked, as there have
never been any problems in the past.
This is not acceptable. If the approval procedure states this should be checked, then that should be
done and documented. If this is inappropriate, the procedure should be reviewed, and a new
approach documented and validated before changes are allowed. This would result in a nonconformity.
7.2.2 Subcontracted work

Sites often have problems with subcontracted work as they do not submit it to the same
rigorous control as work produced on site. This clause ensures that any subcontracted
work is subject to the same level of control as work produced on site.
SA
M
PL
There shall be a defined and documented procedure for the selection and instruction of
subcontractors and for the acceptance of products received from subcontractors, which
may include documentation checks, inspection, testing or a combination of these. The
products shall be subject to an authorised positive release system. Subcontractors may
be subject to the same KPIs as the site of major manufacture.
7.2.3 Home working
As for the previous clause, work produced by home workers and the material they use
must be controlled in the same way as work produced on site, because the same safety
or quality problems may occur. Home workers should have documented work
instructions and any equipment they use must be subjected to maintenance procedures
and calibration as necessary. Home workers shall be made aware of any issues
concerning product safety that are pertinent to their work for example, avoiding foreignbody contamination, control of sewing needles etc.
Example
A company outsources the sewing of footballs. Home workers have a specification for thread but
provide their own. It is discovered that many are using cheap cotton, which breaks easily and does
not have sufficient strength to hold the seams, because it is cheaper than the specified materials.
Materials must be purchased to specification. In this case, supplying the materials for the job is
probably the most appropriate action as well as auditing the home workers.
7.3 Equipment and equipment maintenance

This clause is about ensuring that equipment is properly specified, installed and
maintained, and that machinery that is unfit for purpose does not continue to be used.
The Global Standard details the levels of control necessary, and these depend on the
type of production being carried out.
Page 115 of 153
30/4/10 12:45:31
It is also important that any on-site workshops understand the need to follow the same
requirements with regard to product safety and conformity. The auditor will review the
equipment during the site tour and may ask to see more details of the specifications or
maintenance schedules.
An auditor might also examine production control records to establish whether the
equipment is capable of consistently producing products which meets specification.
7.4 Foreign-body detection and control
The site must identify the level of control that is required. There are various kinds of
foreign-body detection but this most usually applies to metal detectors. The BRC bestpractice guideline, Foreign Body Detection, gives guidance for those seeking further
information.
7.5 Calibration and control of measuring and monitoring devices
PL
This section requires equipment to be properly identified, listed and calibrated at an

appropriate frequency by suitably qualified staff. It is easy to believe test results but if the
equipment being used to take the measurements is incorrect this can lead to a false
sense of security and unsafe products being produced.
SA
M
The clauses detail that equipment must not be adjusted by untrained operators and that
each piece is suitably labelled with the calibration status. Auditors may wish to see
calibration certificates.
It is important to note that calibration range and discrimination is important for
example, if a thermometer has been calibrated as accurate between 10 and 100C, it
cannot be reliably used for measurements of 150C; if a balance has been confirmed
accurate for weighing between 10 g and 100 g at an accuracy of 0.1 g, it cannot be used
to record weights to the nearest 0.001 g.
7.6 Retained production samples
Most of the requirements in this section have been covered in the discussion of clause
5.1.
7.7 Final product packing and control
Even if a product has been made successfully, it can be unsafe or not of the right quality
if it is not packaged correctly or placed in the wrong box. The site needs to have a
procedure in place to ensure that this cannot happen. In the case of quantities, it may
well be a legal requirement that suitable checks are in place.
Page 116 of 153
30/4/10 12:45:31
Examples
SA
M
PL
A company making hair dye does not have an appropriate final pack procedure. It packs the wrong
colour dye into the wrong boxes. Many consumer complaints are received.
The same company corrects the error but packs the wrong language edition of the instruction sheet
into the boxes. Customers cannot understand the instructions and are at risk of damaging their hair
or even injuring themselves through incorrect application.
Both these actions would result in a non-conformity, and highlight the importance of proper
control at the packing stages.
Page 117 of 153
30/4/10 12:45:32
8 Personnel
People can be the most important component in ensuring the production of safe and
legal products. They are also of major importance to the success or failure of an audit.
8.1 Training and competency
FUNDA ME N T AL
T he c o m p a n y s h a l l e n s u re that pers o n n el perform i n g w ork t hat
affects p r o d u ct safety , le g a lity a n d q ua lity are de m o n s tra bly
c o m pet e n t t o carry o u t t h e ir a ctiv ity , t h rou g h trai ni n g, w ork
ex perie n c e o r q u a l ifi cat i o n .
In order to successfully produce anything, it is important that employees are competent,

well trained and understand their duties. Auditors will expect sites to be able to show that
staff meet these requirements, and they will probably interview and observe staff to
judge the extent to which this requirement has been met.
Example
PL
Auditors are likely to focus mainly on production, quality and technical staff but others
who could influence the products should also be considered for example, dispatchers,
cleaners and administrators taking orders.
SA
M
An auditor is visiting a paper-carton factory and asks an operative what their duties are with regard
to packing the cartons into outer boxes. The operative does not appear to understand and is not
packing the same way as operatives on other lines. The auditor seeks clarification from the
supervisor and is told that the operative, whose first language is not used on the site, is new and has
been sent by an agency as temporary staff to help with a backlog of work.
The auditor raises a non-conformity. The site must have a way of ensuring that all staff are
competent and clearly understand their job. In this case, some hands-on training, followed by
sign-off after the operative had demonstrated competence, would be appropriate.
8.1.1 Training and records

The auditor will judge the competency of staff. They will look for job descriptions and
ensure that they correspond with staff views of their roles, and for evidence that any
necessary training has been carried out its success evaluated. The need for training and
records does not mean that experienced personnel with no formal qualifications are not
acceptable. Their experience can be evaluated and documented and grandfather rights
may be an acceptable assessment in some cases.
The auditor may be able to review training procedures and records on part of their site
tour for example, observing how staff have been trained to use a new piece of
equipment, or how they are made aware of the requirements of a new customer.
Page 118 of 153
30/4/10 12:45:32
Examples
A factory operative is asked by the auditor about methods of adjusting computer-controlled cutting
machine. The operative doesnt appear to know. When asked, the supervisor produces evidence that
the operative was sent on an external course to learn about the machine. On further questioning it
appears that the operative did not understand the course, didnt go back for the second day of
instruction and no evaluation or questionnaire about the course had been completed.
The operator could not demonstrate competence or adequate training and so a non-conformity
would be raised.
The test lab in a factory has just bought a new piece of equipment to test its products for toxic metals.
The lab supervisor used a similar machine several years ago but others are not familiar with it. An inhouse training session has been arranged with the supplier, and all staff will complete the training
before commissioning the new equipment. The lab has also signed up to a correlation trial to ensure
that its results are reliable.
A satisfactory way of addressing an issue when no one on site has the required competence to
carry out training.
PL
Note that the requirements of this section apply to general duties as well as to specific
job training. Basic understanding of a sites procedures is as important as specialist
knowledge. Misunderstanding the site procedures (relating, for example, to storing
products in the wrong places, not using the correct tools, or not understanding the site
requirements for hand washing) may have a deleterious effect on safety.
SA
M
8.1.2 Risk assessment training

It is a requirement that those carrying out the risk assessment (to ensure products are
safe and legal) have some formal training. The training types and methods are not
specified because different levels and types of training will be appropriate in different
industries. However, it is likely that the auditor will challenge staffs understanding of risk
methods. If the auditor is in any doubt as to the staffs understanding of a process or is
unconvinced by the results of risk assessments, they will evaluate the training.
8.1.3 Records
A training record should be traceable to an individual, and should cover all their relevant
responsibilities, taking account of any privacy laws that apply. The site should give due
attention to refresher training.
Example
A qualified supervisor has carried out some basic hygiene training for shift workers. Unfortunately,
although the training has been minuted and dated, it is not possible to check which operators were
present at the time.
The problem could easily have been solved if each operative had signed an attendance sheet, which
was then filed with the record of the training.
8.2 Protective clothing

Any clothing provided as protection shall not, itself, present a contamination risk to the
products. In many industries, no particular requirements are necessary but, even so,
appropriate controls should be in place.
Page 119 of 153
30/4/10 12:45:33
If, for example, clothing is required, the laundering methods (including frequency and
suitability) shall be documented and assessed. When staff are responsible for their own
laundry, the site should have clear procedures on the process that should be used, to
ensure that product safety and quality is maintained.
8.3 Hygiene practices
This clause encompasses good manufacturing practices (GMP) and prerequisites for
HACCP. It is very important in high-risk product areas such as cosmetics and
pharmaceuticals and may be a legal requirement.
SA
M
PL
The requirements in this clause mostly apply to Group 1 products and are clearly defined
in the Global Standard itself. It is necessary not only to meet the requirements but also to
monitor their implementation and take action on any lapses. The auditor will observe
compliance with this requirement throughout the course of the audit.
Page 120 of 153
30/4/10 12:45:33
SA
M
PL
Section IV
GUIDANCE FOR ACHIEVING CERTIFICATION
Page 121 of 153
30/4/10 12:45:33
Section IV
Guidance for Achieving Certification
The true value of the Global Standard is having in place a system that helps to
consistently supply safe and legal products of the desired quality. A site receives BRC
certification once it has successfully passed an audit conducted by one of the approved
certification bodies, but its systems should be in operation all year around, and a site
must work within the requirements of the Global Standard at all times. Certification
bodies have the right to visit a site outside of the normal scheduled audit if they need to
investigate issues (such as a recall incident), referrals or complaints, and can suspend
sites that are not found to be operating to the Global Standard.
PL
1 First Steps
The key to successful certification is adequate preparation and planning, together with a
clear understanding of the requirements and a commitment at all levels to implementing
the Global Standard. Sites will fail to gain certification if they are unable to demonstrate
that they meet the requirements during the audit visit or fail to carry out adequate
corrective actions in the allotted time scale.
Obtain a copy of the Global Standard and study it. In order to implement it successfully,
the detail of every clause needs to be understood and acted upon. It is important that
sites do what the Global Standard says and not what they think it says.
SA
M
Example
A company has a detailed description of its organisational structure and its personnel, their roles
and responsibilities.
The Global Standard clearly requires an organisational chart. An avoidable and unnecessary
non-conformity is raised because someone did not read the detail and produced a description
rather than a chart.
Becoming familiar with the layout and format of the Global Standard will make
implementation easier and ensure it is approached in a logical manner.
It is vital to read and understand all parts of the Global Standard and not jump straight to
the requirements section. The introductory sections (Sections I and II) provide
background information and aid understanding of the concepts, and the later sections
(Sections IV and V) contain important information about the audit process itself. Failure
to properly understand the audit may lead to difficulties which, in turn, will result in failure
to become certificated.
Example
A textile company has worked hard to meet the requirements of the Global Standard and it is
confident that it will succeed. Unfortunately, the company has not paid attention to the protocol and
there is no senior manager on site on the day of the audit.
The company cannot be certificated and a new audit will have to be arranged.
Page 122 of 153
30/4/10 12:45:33
This guideline should help to explain the Global Standard in more detail. However, if
there are still aspects that are not clear then further information can be sought from
sources such as the BRC Global Standards website, certification bodies or by contacting
the Global Standards office directly by telephone or email. There are also a number of
training courses available, see www.brcglobalstandards.com for details.
2 Planning
Once the principles are understood, the next stage is to start planning. This is likely to be
quite a long process not only is it a lot of work to make sure all the requirements are
implemented but the auditor will also expect to see a reasonable amount of history that
proves the system is operating in accordance with requirements. The auditor will want to
see completed record sheets, evidence of some internal audits, completed risk
assessments for products in production etc. It is difficult to estimate how long the
planning stage will take but, as stated in Section I of this guideline, sites should allow at
least three months, and many sites will need much longer.
2.1 Commitment
Example
PL
Before any detailed planning about the practical side of implementation takes place, the
level of commitment of the senior management must be in place.
SA
M
A sales manager has been promised a large order with a major retailer, which could lead to a major
partnership between the companies, on condition that the company is certificated to the Global
Standard. The sales manager gets a copy of the Global Standard, takes it to the technical manager and
asks them to implement it. The technical manager reads it, thinks it is a good idea, and starts work.
Unfortunately, senior management is not interested in the programme it thinks it is too costly, is
unconvinced by the technical managers implementation plan, and believes its product is so good
that retailers will buy it even without certification.
This is not the right time to implement the Global Standard. The commitment of the technical
manager alone is not sufficient. The technical manager needs to work with colleagues to convince
senior management of the value of the Global Standard before trying to implement it.
Once management commitment is obtained, a budget, resources and a timescale for

implementation can be confirmed.
2.2 Team building
The first stage of the planning process is to decide on the key players:
Who will be responsible for the system? Is there a clear brief for the role?
Will anyone need to be hired? Does someone have to fit it around existing work?
Who will be on the team? It is almost always necessary to establish a team. Various
members will add different skills and contribute to the running of the scheme. Even in
a small site it helps to have more than one person involved.
Is external help needed? If a consultant is required, how are they chosen and what is
their remit?
The following should be considered when establishing a team:
Are team members experienced in site audits and/or certification schemes?
Page 123 of 153
30/4/10 12:45:34

Have they already prepared the site for quality management systems or customerspecific audits?
Are they well versed in product safety, quality matters and, importantly, risk
assessment?
It makes life easier if team members have experience, but they will still need to study the
Global Standard, make sure that they understand differences in requirements, style or
terminology with the programmes they are used to, and become familiar with the layout.
If team members lack experience, then training will be required. This could include:
An awareness course on the basics of the Global Standard
auditor training
risk assessment training
training on product safety or legislation
individual coaching to help with confidence.
The team leader should work out what is needed to establish a solid foundation for their
team.
SA
M
PL
Once they are adequately trained, the team then needs to carefully consider the task
ahead. All members should be clear about:
the range of products to be included
how the scope will be defined
which countries/regions/cities are to be included as locations of sale
what products are being excluded, and why.
the need to understand safety legislation for the products and countries of intended
sale.
2.4 Deciding the product group
This may or may not be obvious. In any case the team should work through the decision
tree, decide on their answers and document the process and reasoning, before deciding
on a product group.
Example
The manager of a factory has not really understood the product group concept, and works hard to
implement all the requirements of the Global Standard so the factory is as good as possible. The
manager will apply for Product Group 1 because they think that this is the best grade and the
company directors will be impressed. The factory makes plastic buckets.
The manager will have incurred extra effort, difficulty and expense without doing anything to
improve the quality or safety of the products. Group 1 is not necessary for buckets. The manager
should have worked out the product group first, and then put in place appropriate requirements.
The factory can still be certificated provided it has made an assessment of the product group into
which its products should be categorised.
Sometimes it is difficult to define the product group as a product may fall into a grey
area between groups (most commonly between Groups 2 and 3). Sites should first
consult the BRC website to check if there is any guidance on the product concerned. If
there is doubt, the site can ask its certification body for advice. There is a procedure
whereby certification bodies can raise issues with the BRC technical committee for
discussion at its next meeting if necessary.
Page 124 of 153
30/4/10 12:45:34
Generally speaking, if a site is in doubt as to which of two groups its products fit in to, the
recommendation would be to use the higher group.
2.5 Carry out a self-assessment or gap analysis
This is the most practical way to start. By assessing against the requirements in a logical
way it is then easier to systematically plan and prioritise what needs to be done. It may
be helpful to prepare a checklist (such as the example posted on the BRC website)
although this will need to be customised to suit a specific operation.
At this stage it is worth considering carefully the relative importance and urgency of the
required measures. Some measures will require:
capital investment and time for example, if building work or new equipment is
necessary.
management effort and time for example, the preparation of procedures, creating
record sheets, authorising and reviewing material.
motivation and training for example, getting staff to work to new procedures,
understanding a safety and quality culture, improving communication channels.
PL
Other aspects will also need to be considered. It may be necessary to coincide key
milestones with other activities for example, matching building work with site closures
or including training within a planned staff conference.
SA
M
It is also important to remember the constraints of the Global Standard:

fundamental clauses have to be right on the day of the audit
a critical non-conformity is awarded if product safety or legal compliance is at risk or
if there is a failure to meet a statement of intent
major non-conformities are awarded where there is evidence raising significant
doubts about a products conformity with stated requirements.
If these issues are addressed at the planning stage, the site is more likely to be
successful.
3 Preparation
Work through the requirements and make sure that they can be met. Operations have to
be part of the routine work practices all day every day, and not just carried out under
ideal circumstances. Make sure that the system which is put into place is one that is
understood by all parties and works well in practice. Introducing new systems always
requires some effort at the start. There may be initial problems, and modification may be
necessary.
Consultants can be very helpful and a good consultant brings a great deal of experience
and knowledge to the task. However, be careful that they do not try to fit the site around
a ready prepared system rather than producing a system to suit the practical working
conditions of an individual site.
Consider the system from an outsiders point of view. An auditor will have to find their
way around your site, systems and documentation and only has a short time in which to
do this. Presenting things clearly and logically will help to achieve an efficient audit. Sites
Page 125 of 153
30/4/10 12:45:34
may have in place systems that have operated for many years and with which they are
familiar, but how easy are they for an outsider to understand?
3.1 Documentation
Documentation is mentioned throughout the Global Standard. If the Global Standard
specifically requires documents then they must be available and a non-conformity will be
raised if they are not. Prior to the audit, read the Global Standard carefully and check
that all the required documents are available.
3.2 Evidence and fact
The auditor will be looking for factual evidence that the site is complying with the Global
Standard. They will not be able to take account of opinions, promises that absent
paperwork really does exist, or assurance that something will be done next week.
Ensure that everything is in place and ready before the audit visit.
Example
PL
A company states that it keeps product technical files for five years. This means an auditor may ask
for a record which is five years old. The factory should be prepared for this and able to retrieve such a
document.
This would apply whether paper or electronic systems are used. If documents are stored off site,
this should be documented and the company should make sure it has a retrieval process available.
SA
M
4 Selection of a Certification Body
Once a site has its preparations underway, it will need to think about selecting a
certification body. All the approved certification bodies are listed on the BRC Global
Standards website. A site is not obliged to use the same certification body every time it
needs to be re-certificated and may choose to change certification bodies, should it wish
to.
There are several aspects to consider when choosing a certification body.
4.1 Accreditation
Certification bodies are externally assessed (known as accreditation) by an independent

national body against ISO/IEC Guide 65. Part of the accreditation requires an auditor
from the certification body to undergo a witnessed audit and its systems for auditing to
be examined. Just as a site needs to have a track record before it can achieve
certification to the Global Standard, so a certification body needs to provide an adequate
history before it can gain accreditation.
If certification bodies were not allowed to audit until they were accredited, then it would
be impossible for any to get started. For this reason, the BRC accepts unaccredited
certification bodies onto its system, provided they have submitted proof that they have
applied for accreditation and are aiming to achieve it within a reasonable timescale.
Certification bodies are listed as accredited or non-accredited on the BRC Global
Page 126 of 153
30/4/10 12:45:35
Standards website. A site can choose either type; its certification will have the same
validity.
4.2 Scope
It is important to find a certification body that has auditors competent in the relevant field
of business. There are 21 categories of product listed in Appendix 3 of the Global
Standard and auditors can only carry out audits for product types in which they have
expertise, and for which they have demonstrated their competence. A site may need to
contact more than one certification body in order to find one with the right match for its
products. If the certification body is accredited, its scope of accreditation (which is
usually available on the accreditation body website as a schedule) will also confirm its
range of competency.
4.3 Audit teams and other visitors
PL
Sometimes more than one auditor will attend an audit. This may be because of the size
of the site or because expertise in more than one product category is required. When
there is more than one auditor, one of the auditors will be identified as the lead auditor.
SA
M
The certification body may send a technical expert along with the auditor. This person is
not an expert auditor but does have in-depth knowledge of the products being audited.
They act as a source of advice to the auditor on technical details, but do not directly
conduct any of the audit themselves. This process often takes place where the
certification body does not have an auditor with sufficient product knowledge. It is most
likely to happen in countries less familiar with the Global Standard, or for very
specialised product types.
The auditor may sometimes be accompanied by someone witnessing the audit as part of
their own audit training, or by a more experienced colleague who is observing the auditor
as part of his/her ongoing assessment of competence. The BRC requires a number of
witnessed audits to be conducted on all of its approved auditors.
It is also possible that auditors will be accompanied by a member of the accreditation
service. Most accreditation bodies carry out audits on the auditors as part of the approval
process.
Additional visitors witnessing the audit, whether from the accreditation body, certification
body or the BRC are not additional site auditors. They should not participate in, or affect,
the audit of the site except when providing technical knowledge as a technical expert.
They are there to evaluate or learn from the auditor and not to check on the site. If the
auditor will be accompanied by someone other than another auditor or technical expert
on their visit, the certification body must ask the sites permission before the audit.
4.4 Consistency of certification bodies
All certification bodies have to agree the same contract with the BRC and meet the same
requirements on auditor qualifications and training, reporting procedures etc. They are all
subject to the compliance programme operated by the BRC and work to the same key
performance indicators. There is a variety of communication channels with the BRC
Page 127 of 153
30/4/10 12:45:36
such as certification body cooperation groups, newsletters and certification body

conferences all intended to maintain the consistency and high standards of the
certification bodies.
Complaints are investigated and there is a process for suspension or withdrawal for
poorly performing certification bodies.
With more than 100 approved certification bodies there are certainly variations in style
and approach. Some are very large international companies and others much smaller,
more localised or more specialised. Take time to find an appropriate one for the
individual needs of the site.
4.5 Code of conduct
Unfortunately, in any business, there are sites or individuals that do not always behave
in an ethical manner. The BRC has a number of procedures in place to help ensure that
audits and certification decisions are based solely on merit. Any bribery or corruption that
is discovered and validated results in withdrawal of the certification as well as action
against the certification body.
4.6 Customer preferences
PL
Many certification bodies have codes of conduct or ethical trading statements, and sites
are advised to satisfy themselves of the integrity of their chosen certification body.
SA
M
If the site is supplying one particular retailer, it may be worth finding out if they have a
preference for a particular certification body. They may even have arrangements for
discounted fees or programmes to merge the customers own audits into the Global
Standard over a period of time. A few customers have lists of which certification bodies
they accept.
4.7 Location
It will be an advantage with regard to cost, understanding the culture and the language if
a local certification body is chosen, but it is also possible to use a certification body from
further afield. This may be necessary if the Global Standard is new to a particular area or
the product is particularly specialised. Several of the larger certification bodies have
offices in many countries and can arrange for audits to be performed almost anywhere.
The offices of certification bodies are only listed on the database if the site actually has
auditor(s) resident in those countries, although it may be that auditors in neighbouring
countries are able to travel to conduct audits.
4.8 Resources and service
Certification bodies have differing resources. Some may have a number of auditors in a
particular field and be able to schedule audits quickly, whilst others may not be able to
conduct an audit for a long period or need to send someone from a distant location. The
level of general resource may be important when it comes to renewal audits.
Page 128 of 153
30/4/10 12:45:36
All certification bodies have a time limit with which to post the certification decision and
audit report onto the database, but a site will also want to establish whether their
certification body is quick and responsive to general enquiries.
The fee levels and structures will vary between certification bodies, as will the structure
for the travel and subsistence costs.
4.9 Applications
4.10 Contract
PL
Once an initial shortlist of potential certification bodies has been made, and those
certification bodies contacted, it is likely that a site will be asked to complete an
application form or general questionnaire. This enables the certification body to
determine the resources for the audit, the likely duration of the visit and the time needed
for writing the report. The certification body may want to know:
product scope and countries of sale
product group
site location, size and number of staff
main technologies/equipment used
number of production lines
if the site is new to the Global Standard or renewing certification
site plans, management structures and organisation charts.
SA
M
A site has a contractual agreement with the certification body. The site management
should read the terms and conditions carefully as the detail may vary for each
certification body. The contract will be a binding document and may contain important
requirements that have an impact on site behaviour, including:
a requirement to inform the certification body of any recalls
a need to inform the certification body of changes to product scope
disclosure of the retail clients of the site
penalties and procedures for postponed or cancelled audits (for both parties)
procedures in case of complaints against the certification body or site.
Once the contract has been signed, the site will be registered onto the BRC database
and the audit process begins.
4.11 Pre-assessment audits
As stated in Section I, 2.6 Time to achieve certification, some certification bodies offer a
pre-assessment service. Many sites find this useful and most certification bodies report a
much greater success rate from sites that have had a pre-assessment visit.
A pre-assessment visit cannot be converted into an audit if things are going well, but
some certification bodies may be prepared to convert an actual audit that is going badly
into a pre-assessment. This may be worth enquiring about when choosing the
certification body.
Page 129 of 153
30/4/10 12:45:36
A pre-assessment visit is not a consultancy exercise. It is a very important principle that

the certification body is not allowed to offer consultancy. This is to avoid a site auditing
its own work (which is unlikely to be impartial).
Some larger organisations may have separate consultancy divisions but checks and
balances will be in place to ensure that the two operations are separate and that there is
no overlap or exchange of information between them.
5 Preparing for the Audit Visit

A site should give careful thought to the audit visit in order to maximise the chance of
success and make the experience as stress free as possible. If the site presents itself
well it will help to make a favourable impression on the auditor.
5.1 Choosing a date
SA
M
PL
It may be tempting to select the first date available, but there are some important issues
to consider:
Suitable products should be in production on the chosen date. An auditor will need to
see the operation as fully as possible. It is important to avoid times of very low
production.
The availability of key staff.
If successful, the certification will need to be renewed at an interval between six
months and two years (a site is allowed a 28-day window before the audit due date).
A visit will be required at least annually. Is the time of year chosen likely to be
appropriate for future years? (Remember that if a grade C is achieved for Product
Groups 1 or 2, a re-audit will be required in six months).
Length of the audit. The certification body will have based its proposal on the
information that has been supplied but, once on site, the auditor may find that things
take longer than expected. It is not a good idea to select an audit date which does
not permit an overrun of the audit schedule.

Auditors should be treated in the same way as any other site visitor.
5.2 Availability of staff and information
Auditors will need to see many different records and documents and the site should be
prepared for this. If an auditor has to wait for long periods between requests and is
unable to continue with other work, the audit will be delayed and the auditor will probably
become frustrated. Taking a long time to find paperwork will not reduce the number of
documents an auditor requests, or make the audit easier.
It helps if a number of staff are available to work with the auditor so that, on occasions
when it does take some time to find something, the auditor can progress with another
aspect of the visit.
Many certification bodies will indicate in advance the types of documents they are likely
to require, and it will help if some of these are prepared in advance of the visit.
Page 130 of 153
30/4/10 12:45:37
5.3 Auditor facilities

Ideally, the auditor should be provided with a quiet room, free from too many
interruptions and equipped with basic facilities such as a desk, chair and power socket. If
possible it should be located near to the storage point of records so that time is not
wasted walking to and fro. On small sites, this may not be possible, and the auditor will
understand that. However, some attempt should be made to provide an area where the
auditor can view documents and compile notes.
Since certification to the Global Standard is a technical audit, the auditor will spend quite
some time in the production and related areas (such as packaging or dispatch). The site
should make sure that any necessary protective clothing or equipment (hard hat, ear
defenders etc.) is available in a good, clean condition and that the auditor is informed
about the site health and safety policy. Some auditors may bring their own items.
Auditors should comply with the site rules about clothing or equipment and will not be
surprised when asked to adhere to these procedures.
Example
PL
A cosmetics company has a strict policy about jewellery and hair covering, which all staff adhere to.
The auditor is not asked to remove their jewellery or cover their hair before entering the production
area.
The auditor raises a non-conformity as the site is not following its own procedures and the safety
of the product may have been compromised.
SA
M
The safety of the auditor should also be the concern of the site and the auditor should be
made aware of any health and safety policies or any potentially hazardous areas on site.
6 The Audit Visit
The stages of the visit are set out in Section IV, 9 The On-site Audit of the Global
Standard.
The auditor will have made arrangements to arrive at a specified time and will expect
proceedings to progress swiftly. The duration of the audit will have been confirmed and
the auditor will have planned the visit around the time available.
6.1 The opening meeting
At the opening meeting, the auditor will formally confirm the scope of the audit and the
relevant product groups. This is to ensure that there have been no misunderstandings.
This is not the time to introduce changes, add products or change product groups. Any
such changes should have been communicated well in advance of the visit.
The opening meeting is also when the timings of the visit will be confirmed. It gives the
auditor an opportunity to set out the proposed structure and allows the site being audited
to confirm the presence of key staff and any restrictions on timing that have to be taken
into account (such as staff lunch breaks, any breaks in production, unavailability of key
people for portions of the day etc.). The auditor can establish which products are in
production at the time of the visit. The original visit plan can then be amended as
required and confirmed by all parties. To some extent, the order of the audit visit
depends on auditor preference. Most auditors will explain a little about their way of
Page 131 of 153
30/4/10 12:45:37
working during the opening meeting for example whether any interim meetings are
required at the end of each audit day, whether they prefer to discuss non-conformities as
they are noted or save the discussions for the closing meeting.
The opening meeting also allows introductions to be made and the site staff to ask any
questions they may have. It is essential that the senior management representative
attends this meeting.
6.2 Auditor activities and time on site
An auditor should be treated like any site visitor. They should be subjected to the usual
security procedures (for example, signing in to the site). Similarly, any other aspects,
such as visitor questionnaires, clothing policy, hand washing etc. should also be applied.
The auditor will need to be provided with access to refreshments and have time set
aside for meals. The auditor should not be expected to attend a long or elaborate lunch,
which will take up valuable audit time and could be considered unethical. A simple lunch
on site is usually considered acceptable, although in some countries auditors will provide
their own food. This issue may be addressed by the certification bodys code of conduct.
SA
M
PL
The auditor has to review and check a wide range of documents and procedures. They
are also expected to conduct an in-depth audit of the production site and observe
activities through the whole process flow. The proportion of time spent on each of the
two types of activity will vary depending on a number of factors, including:
site layout
complexity of operations
level of documentation
preparedness of site in having materials organised.
The auditor would be expected to spend a substantial proportion of the time on the
production site, observing the actual operation. On average, its expected that this would
be around 50% of the total visit time.
Auditors are obliged to record on the audit report the proportion of time spent on the site,
as opposed to carrying out document review.
6.3 Document reviews
Some certification bodies and auditors will have already requested information prior to
the visit and will have carried out a preliminary desk study to gain a basic understanding
of the system. Other auditors may want to begin the audit by getting an overview of the
site, its systems and the main risk assessment procedures. Most auditors will wish to
spend at least a short time with the documented system before beginning the site tour.
It is very likely that an auditor will ask for some kind of traceability exercise to be carried
out. This is usually requested at an early stage so that the site can get the process
underway and have results available for the later stages of the audit.
Page 132 of 153
30/4/10 12:45:37
6.4 Facility inspection

Certification to the Global Standard is not a paperwork exercise and the site inspection is
likely to take a considerable proportion of the audit visit. Auditors should be
accompanied by an appropriate and knowledgeable staff member. The auditor will need
to:
see all appropriate production areas
ask staff questions about the operation
view associated areas such as goods in, packaging, staff facilities etc.
follow-up issues
make notes.
Example
An auditor is talking to an operative about floor cleaning. The operative tells the auditor that they
use a vacuum cleaner daily. The auditor may follow this up by asking to be shown where the vacuum
cleaner is kept.
6.5 After the site visit
PL
The auditor should be the person who runs the audit. It is, of course, good to be helpful
and explain areas of operation that may not be obvious but the site representative
should avoid trying to confine the auditor to those areas that the site wishes to display or
distracting the auditor with side issues. Experienced auditors will ask questions if they
need more information or do not understand what is happening on the site at any point.
SA
M
The auditor will have made notes during the visit, and will wish to check documents and
records concerning the things they have seen. This means there will be another
paperwork session.
The auditor will also need to investigate the outcome of the traceability exercise. They
may want to look at various other records and documents so they are satisfied that
requirements are being met. The auditor will almost certainly ask to see minutes of
management review meetings and internal audit reports, if this has not already been
done. The auditor will need some quiet time alone to write up the findings.
6.6 Closing meeting
The auditor, once again, confirms the scope and goes through the audit findings and any
non-conformities that have been discovered. It is helpful to have relevant staff present at
this meeting so that they have a first-hand account of the issues. It is essential that the
senior management representative is present this would usually be the most senior
operations manager.
The auditor will explain the non-conformities found and the level (critical, major or minor).
The auditor will provide a written summary of the visit and ask for it to be signed by a site
representative to indicate their understanding.
The meeting is an opportunity to clarify any points and also to challenge any findings that
may be factually incorrect. The auditors cannot, however, offer advice on how to correct
the non-conformities that have been raised.
Page 133 of 153
30/4/10 12:45:37
The site representatives should take time to ensure that their understanding is clear
because, once the auditor leaves, the site will have to get to work on its corrective action
plan to clear non-conformities.
Sometimes non-conformities are such that they can be put right immediately and sites
produce their corrected non-conformities with evidence at the closing meeting. This is
fine; it saves time and the auditor is able to confirm that the action has been satisfactorily
corrected. However, the non-conformity will still stand, be recorded and count towards
the total number of non-conformities raised.
Remember that the auditor does not make the certification decision. The auditor has to
complete a full report which is reviewed by a certification panel at the certification body,
which may revise some of the auditors findings. The site will receive confirmation of the
certification decision and the grade shortly after the audit visit. The closing meeting will
give a very good indication of how the visit has gone.
6.7 Tips for the audit visit
PL
Auditors are trained to investigate issues and look for objective evidence. They are
skilled in asking the right questions to establish the facts. They are also trained to deal
with aggressive, defensive or obstructive behaviour. They understand that an audit visit
can be stressful and many empathise as they have also undergone similar audits. The
auditors are not there to find fault or criticise, but to establish the extent to which the site
meets the requirements of the Global Standard. Auditors are not expressing personal
views but checking against a defined set of requirements.
SA
M
Site representatives should try to be polite and helpful and remember that the auditor is
providing a service to help them achieve certification and, if necessary, improve their
operations.
It is vital to listen carefully to the auditors questions and answer them as clearly as
possible. Do not add a lot of unnecessary information or try to deflect the auditor by
answering a different question.
Example
An auditor can ask questions in a number of ways and will be doing so for a reason. The auditor may
ask: do you have a pest control procedure?
The answer to the question is yes and the auditor may be checking so that they can investigate in
more detail later. The auditor does not expect a major presentation about pest control
procedures.
On the other hand, the auditor may also ask: how do you control bait stations?
The auditor is looking for more information about how the pest control system is operating and
may follow up with additional questions.
Allow the person who has been asked the question to answer it. Operatives are
sometimes understandably nervous but the auditor has asked them something to check
their understanding. The site representative accompanying the auditor may want to put
the employee at ease, but they must not answer the question for them. The site
representative may answer the question posed to someone else because they are trying
Page 134 of 153
30/4/10 12:45:38
to be helpful, or because they do not have sufficient confidence in the operative. If the
site is well prepared, then all staff members should be confident of their roles.
It can be helpful to brief staff before the audit and clearly explain what the auditors role
is and that the auditor will be asking questions. Staff should also understand that they
cannot give a wrong answer. If their reply leads to a non-conformity, correcting the
matter will help to improve the site.
7 After the Audit Visit

All non-conformities raised have to be satisfactorily corrected within the stated time
frame before a certificate is awarded. Evidence of corrective action has to be supplied.
The grade of certificate awarded (A, B or C) depends upon the number and severity of
non-conformities. Although the site has to correct the non-conformities in order to
achieve certification, the grade cannot be altered or improved once the visit is completed
and will stand until the next audit visit and certification.
PL
Where the combination of non-conformities identified results in the awarding of a D

grade, no certificate is issued. A further full audit will be required, and verification that
appropriate corrective action has taken place to close out these non-conformities will
need to be assessed at this subsequent audit. The site will choose when the re-audit
takes place, depending on the action that needs to be taken to rectify identified issues.
SA
M
Where certification is withdrawn from a site that has already been certificated, the site
must inform their customers of their un-certificated status, together with the proposed
corrective action plan.
7.1 Handling non-conformities and corrective action
The auditor will have identified issues and documented these as non-conformities. It is a
feature of certification to the Global Standard that all non-conformities need to be
corrected before a certificate can be issued.
Evidence must be provided to demonstrate that corrective action has been implemented.
If this is the first audit, the site has 60 days to supply this evidence; or 28 days for
subsequent audits these are working days and do not include non-working days or
public holidays.
Evidence can be in many forms, including documents, photographs, invoices etc. All
types of evidence are acceptable provided the certification body is satisfied that they
show the appropriate action has been taken.
Page 135 of 153
30/4/10 12:45:38
Examples
A company has received a non-conformity because it does not have an adequate policy statement.
Evidence to support close out or rectification of the non-conformity includes a signed, dated copy of
the new statement, a copy of the internal memo to inform staff of the statement and a copy of the
document given to new starters, which includes the statement.
The non-conformity will be closed out.
A factory has received a non-conformity because of poor housekeeping and a dirty, untidy area in the
packaging area. The approved and authorised new cleaning procedure and schedule is submitted,
together with photographs to show that the area has been cleaned.
The non-conformity is closed out.
A factory has received non-conformities relating to the document control procedures and to the poor
completion of records in a number of areas. The factory sends a few new forms to the certification body
on the last day before close out should be completed. The forms do not contain any actual data and
many documents are missing.
The certification body will not grant certification and a re-audit will be required unless the site
can show that there were exceptional and genuine reasons for failure to supply the required
information.
PL
The certification body has to satisfy itself with the evidence provided, and therefore has
the option to revisit the site to view the action taken or accept the submission of
documentary evidence. The site will be informed of the requirement prior to the
submission of evidence.
SA
M
It is at the discretion of the certification body whether a revisit is carried out. One may be
required where:
there are a relatively large number of minor non-conformities
documentary evidence of compliance would be difficult to demonstrate effectively
e.g. where there are several incidents of poor cleaning
there is a history of non-conformities closed through documentary evidence that
are found to be recurring at subsequent audits.
7.2 Revisits
Where revisits are required, these shall be scheduled to occur within the 28/60-day
window allowed for the closure of non-conformities for certified sites. Revisits should
ideally be undertaken by the original auditor, but this may not be possible due to
resource limitations, holidays, sickness etc.
The revisit shall be focused on establishing that the original non-conformities have been
effectively corrected. However, at any stage of the audit process, further nonconformities may be identified that need to be satisfactorily actioned before certification
is awarded although any such discoveries will not influence the grade awarded.
7.3 Review of documentary evidence
Where a revisit is not required, satisfactory documentary evidence may be accepted
to demonstrate that the non-conformities identified at the audit have been corrected.
It is important that the evidence provided clearly demonstrates compliance and also
shows that any underlying issues have been addressed. For example, there is often a
training issue that needs to be addressed, as well as the immediate correction of the
non-conformity.
Page 136 of 153
30/4/10 12:45:38
If a site has doubts about the acceptability of the form in which evidence is being
submitted, it should ask its certification body ahead of the deadline for submission.
Documentary evidence usually includes:
Procedures where evidence is in the form of a new or changed procedure,
supplementary evidence to show that the changes have been put into operation may
also be required (e.g. training record/recording form).
Records where new forms or recording sheets have been introduced to correct an
issue, the submitted evidence must include a completed record to show that these
are in use and a training record may also be required. Make sure these records are
correctly completed. Ideally, a series of completed records shall be included (e.g.
over several consecutive days).
Photographic evidence ideally, photographs should be taken before and after

corrective action to demonstrate the change. Photographs need to show clearly that
the particular non-conformity has been corrected. For instance, it may be necessary
to have a series of photographs zooming in on a particular piece of equipment that
has been modified or cleaned to enable the auditor to identify that it is the correct
item.
Invoices/receipts invoices or receipts for new equipment shall be sufficiently

detailed to ensure that the non-conformity has been addressed.
Increased availability of electronic media means that sites can also use more
innovative ways of producing evidence for example, scans of handwritten
documents, video recordings and electronic access to third-party test data.
SA
M
PL
In cases where major capital expenditure is required, temporary work can be accepted
until expenditure is approved. The temporary solution must still ensure that the safety,
quality and legality of the product is not compromised
7.4 Timing
In order to achieve or maintain certification, the site must have understood the
requirements of the Global Standard and have well-established systems and processes.
It is therefore expected that sites that go on to be certificated will not have significant
issues identified at the audit that will take a long time to solve. Accordingly, 28 days are
allowed for either the submission of documentary evidence or a revisit to occur to
demonstrate compliance.
Where evidence provided is inconclusive, a period of 23 days may be accepted to
provide the additional information. However, this would normally be expected to be
included within the 28-day period, and sites should submit evidence sufficiently in
advance of the deadline. Where satisfactory evidence of corrective action is not provided
within this timescale, certification may not be granted.
Page 137 of 153
30/4/10 12:45:39
8 The Audit Report

The report produced as a result of an audit against the Global Standard is one of the key
outputs from the process and is used to provide information about the companys site for
its customers. This reduces the need for customers own audits, and sites are
encouraged to share details of the audit reports on request with customers and potential
customers. An example of an audit report format is provided on the BRC Global
Standards website to give an indication of the report a site might expect to receive.
The reports are detailed and take considerable time to prepare. Most certification bodies
will identify this time separately on a quotation for certification.
8.1 The report format
There is a set format for the reporting of audits to ensure that consistent information is
provided, and to make it easier for users of reports to find information within the report.
Reports shall be provided in a typed format.
SA
M
PL
The report is in three parts:

Audit details details of the site and certification body etc.
Non-conformity summary sheets giving details of the non-conformities identified
and the action taken.
Detailed audit report this needs to give enough information to any reader to
understand the control processes in place and what evidence was seen during the
audit.
8.2 Report ownership
The audit report belongs to the entity which pays for the audit (usually the audited site).
The owner of the report can decide on the visibility to potential third parties such as
retailers.
Audit reports remain the property of the site commissioning the audit and shall not be
released in whole or in part to a third party unless prior consent has been given by the
owner. Sites are encouraged, however, to release the report to customers on request.
The certification body will keep a copy of the audit report as well as uploading a copy to
the Global Standards directory database, which is visible to BRC staff.
9 Certification
Once all documentation has been reviewed by the certification body, the certificate shall
be issued in the specified format. Note that the certificate remains the property of the
certification body. The certification body may carry out further visits or question activities
to validate continued certification at any time, whether announced or unannounced. This
may be the result of a product recall, or because of information from another source,
such as a customer contacting the BRC. The aim is to safeguard certification, ensuring
that it is operated by the site as a year-round scheme.
Page 138 of 153
30/4/10 12:45:39
Example
A shoe company has had to recall several batches of shoes because it has been found that DMF (a
toxic irritant) has been used as a preservative. The certification body learns about this from a recall
website and is concerned that the company has not informed them, as required, and that there may be
an ongoing problem with the control of incoming materials. The certification body contacts the
company and schedules an audit visit. An examination of records at this visit confirms that
procedures including the control of incoming materials, product recalls and risk assessments have
not been followed on several occasions.
The certification body withdraws certification and informs the BRC. The company is required to
tell its customers of this event. This action is likely to cause severe problems for the company,
especially when combined with the effect of the recall.
The site must ensure that ongoing certification is maintained. Under no circumstances
can the dates of validity of a certificate be extended. The site should liaise with
customers and inform them as necessary if it lapses from certification for any reason.
10 Use of the Logo
PL
The BRC certificated-site logo can be used by sites that have achieved certification
against the Global Standard and agreed with the guidelines for use.
SA
M
The logo can be used on all site communication tools, such as vehicles, letterheads,
compliment slips, business cards, marketing collateral, advertising, exhibition graphics
and electronic media, subject to the usage terms (including specified sizes and colours).
It may not be used on products or product packaging.
Once a site has become certificated, it can obtain details of the terms and conditions for
the logo from the BRC Global Standards website.
11 The Directory
The Directory (www.brcdirectory.com) lists all sites that have achieved certification and
are officially recognised. This should therefore be used as a central point to confirm the
validity of a sites certification. The Directory also lists BRC-approved certification bodies.
This helps to ensure consistency throughout the certification process and adherence to
BRC requirements.
The Directory is a fully interactive web-based system available 24/7, which includes
specific customer access to audit reports when specified by the site. Each certificated
site is provided with their own secure log-in facilities. Certification and audit reports are
the property of the entity paying for the audit (usually the site) and it has complete
control over its visibility on the Directory, as well as the access to its audit reports by
selected retailers.
The Directory offers detailed customer support and a variety of training materials for
companies registered on the site. Any questions regarding the Directory can be
submitted by email to submissions@brcglobalstandards.com.
Page 139 of 153
30/4/10 12:45:39
The system provides management information to all stakeholders and is also used to
monitor the performance of certification bodies and auditors. The provision of a database
helps to reduce the administrative burden for all users. This is achieved through the
automation of the audit reporting system and includes automatic upload by certification
bodies of the resultant audit report and certification status. The database also carries out
a number of automatic checks concerning the validity of reports and sends any reports
or certifications which do not match the defined criteria to a holding area for further
investigation by the BRC compliance manager.
12 Feedback
PL
13 Further Support
Many certification bodies provide feedback forms and the BRC encourages sites to use
these. A site has the right to appeal against the certification decision or grade and, in the
first instance, should contact the certification body in writing within seven days of the
certification decision. However, the site may contact the BRC with details of any specific
concerns either by telephone, email or thorough the website,
www.brcglobalstandards.com.
SA
M
The BRC website, www.brcglobalstandards.com, contains much useful information

about the Global Standard and how to become certificated, including a selection of
FAQs. If sites have other questions, concerns or comments, all correspondence via the
contact us section will be dealt with as soon as possible.
Page 140 of 153
30/4/10 12:45:40
APPENDIX
SA
M
PL
DIFFERENCES BETWEEN ISSUE 3 AND

ISSUE 2A
Page 141 of 153
30/4/10 12:45:40
Appendix
Differences between Issue 3 and Issue 2A
Summary
Issue 3 of the Global Standard has been comprehensively revised and re-structured to
provide a Standard for consumer products that is suitable for the global market and
takes account of developing industry needs, such as product conformity assessment and
traceability. The protocol for certification to the Global Standard has also been
substantially changed to adopt best-practice techniques.
Addition of a section on preparation and planning for certification.

Change of definition of the product groups and reduction from four to three
groups
Introduction of two new sections in the requirements:
o senior management commitment
o product conformity assessment.
Definition of 10 fundamental requirements, key to certification.
Use of a grading scheme for certification based on the number and level of nonconformities.
Maximum number of non-conformities specified before a complete re-audit is
required.
Frequency of auditing modified for some product groups; the maximum interval is
now two years, with an interim surveillance visit.
Clarification and strengthening of auditor competence and experience
requirements.
SA
M
PL
Main Differences
The wide ranging nature of the revision means that it is not possible to highlight every
change between Issue 2A and 3 of the Global Standard on a clause-by-clause basis, but
this Appendix highlights the main differences. Although the table cross-references the
clauses between the Global Standards, users should understand that this does not imply
that the text or the requirements are identical between the issues.
Table of differences: note that the comparison is made between Issue 3 and the
requirements for Product Group 1 of Issue 2A. The shaded rows only apply to some
product groups in Issue 3 (light grey for Product Group 1 and dark grey for Product Group
2).
Issue 3
Clause
Issue 2A
Senior management commitment and continual

improvement
2.5
1.1
2.7
1.2
Not in 2A
1.3
2.7.4
1.4
Not in 2A
Page 142 of 153
30/4/10 12:45:40
1.5
Partly in 2.1.5
1.6
Partly in 2.10.3
1.7
Not in 2A
Risk management
1.1
2.1
Product scope and group determination
1.1
2.1.1
Partly in 1.1.1
2.1.2
1.1.1
2.2
Legislative and safety requirements
1.3
2.2.1
Partly in 1.2.1 and 1.3
2.2.2
Partly in 1.3
2.2.3
Partly in 1.2.1
2.2.4
Partly in 1.3
Risk assessment prior to production
2.3.1
Partly in 2.10.1.1
2.3.2
PL
1.2.1 and 1.3
2.3.3
Partly in 1.2 and 2.10
2.3.4
Not in 2A
2.4
2.4.2
2.4.3
2.4.4
2.4.5
2.4.6
3.1
3.1.1
Verification of product risk assessment
SA
M
2.4.1
Not completely covered

in 2A
2.3
Policy statement

in 2A
Partly 6.2
Partly in 1.2.6, 2.13 and

2.10
1.2.4
Partly in 2.2, 2.5 and 2.10
Partly in 2.1, 2.2.2 and
2.2.3
2.2.1
3.1.2
3.2
General documentation requirements
2.3
3.2.1
Documentation control
Partly in 2.10
3.2.1.1
2.10.3 and 2.10.5
3.2.1.2
Partly in 2.10
3.2.1.3
Partly in 2.10.4
3.2.2
Record completion and maintenance
2.11
3.2.2.1
Partly in 2.10.2
3.2.2.2
2.5, 2.7 and 2.10
Page 143 of 153
30/4/10 12:45:40
3.2.2.3
3.2.3
Not in 2A
Specifications and technical information dossiers

in 2A, partly in 2.10
3.2.3.1
Partly in 2.10.1
3.2.3.2
3.2.3.3
Partly in 2.10, test report

section in 4.3
Party in 2.10.2
3.2.3.4
3.3
Organisational structure, responsibility and

management authority
2.4.1
3.3.1
2.4.1
3.3.2
Partly in 2.4.1
3.3.3
Partly in 2.4.1
3.3.4
Partly in 2.4.1, 2.4.4 and

2.10
Partly in 2.3
3.4
3.3.5
Internal audit
2.8
Partly 2.7 and 2.8
PL
3.4.1
3.4.2
2.8.3
3.4.3
Partly in 2.8.4 and 2.8.5
3.4.4
2.8.2, 2.8.4, 2.10 and 2.11
3.5.1
3.5.2
3.5.3
3.6
3.6.1
3.7
3.7.1
3.7.2
Purchasing, supplier approval and performance

monitoring
SA
M
3.5
Customer-supplied property
Corrective and preventive action
2.9 and 2.9.1

Not in 2A
Not in 2A
2.9.1.1
Partly in 2.9.1.2
Partly in 2.11
3.7.3
2.11
3.7.4
Partly in 2.11
3.7.5
Partly in 2.7
3.8
Traceability

3.8.1
Not in 2A
3.8.2
Not in 2A
3.8.3
Not in 2A
3.8.4
Partly in 4.5.3
3.8.5
Partly in 2.12
Page 144 of 153
30/4/10 12:45:41
3.8.6
2.12.2
3.8.7
Partly in 2.12.3
3.8.8
Not in 2A
3.8.9
Partly in 2.12.1
3.8.10
Partly in 2.9.2
3.8.11
Not in 2A
3.8.12
Not in 2A
3.9
Management of product withdrawal and product recall
2.14.1
3.9.2
Not in 2A
3.9.3
Partly in 2.14.5
3.9.4
3.9.5
Partly in 2.7
3.9.1
3.10
Management of incidents and business continuity
Not in 2A
PL
3.10.1
3.10.2
Not in 2A
3.10.3
3.11
Partly in 2.4
Contract review and customer focus
3.11.3
3.11.4
3.12
3.12.1
3.12.2
3.12.3
3.12.4
2.6.1
Not in 2A
SA
M
3.11.1
3.11.2

4.1
Complaint handling
Partly in 2.4
Partly in 2.6.2
2.15.1
Partly in 2.10.2
Not in 2A
Not in 2A
Partly in 2.15.3
4.1.1
3.1, partly in 3.1.1 and

3.1.2
Partly in 3.1.1
4.1.2
Partly in 3.1.2
4.1.3
3.1.3
4.1.4
Partly in 3.1.3
4.1.5
Partly in 3.1.5
4.2
Location, perimeter and grounds
Partly in 2.6.2
Internal site: factory layout, product flow and

segregation
4.2.1
4.2.2
Page 145 of 153
3.3 and 4.6.9

Partly in 3.3.2 , 3.3.4 and
3.4.1
3.3.2
30/4/10 12:45:41
4.2.3
Partly in 1.2.4
4.2.4
Partly in 3.1.4
4.2.5
4.2.6

3.4.1
3.4 and 5.1
4.3
Building interiors
4.3.1
4.3.3
Partly in 3.4.1, 3.4.6, 3.4.7

and 3.4.8
2.11.2
4.3.4
3.4.2
4.3.5
3.4.12
4.3.6
Partly in 3.4.14
4.3.2
Staff facilities
Partly in 3.7.1
4.4
4.4.1
4.4.2
Partly in 6.1.5
Not in 2A
PL
4.4.3
4.4.4
4.4.5
3.7.5
4.4.7
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
4.5.6
SA
M
4.4.6
Cleaning procedures
4.5.7
4.6
Partly in 6.1.5
Partly in 3.8
3.8.2
Partly in 3.8.4
Partly in 3.8.5
Partly in 3.8.3
Partly in 6.2
Partly in 3.8.4
Waste/waste disposal

in 2A, mainly in 3.9
4.6.1
4.6.2
Not in 2A
4.6.3
4.6.4

4.8.3
Partly in 4.4.1
4.6.5
Partly in 4.8
4.7
Pest control
4.7.1
Page 146 of 153
3.10
Partly in 3.10.1
30/4/10 12:45:41
4.7.2
3.10.2
4.7.3
Partly in 3.10.4
4.7.4
4.7.5
Partly in 3.10.8
4.7.6
4.7.7
3.10.7
4.7.8
3.10.9
4.7.9
4.7.10
Not in 2A
4.8
Product transport, storage and distribution

3.1.1
4.8.2
3.1.2
4.8.3
Partly in 3.11.6
4.8.1
4.8.4
3.11.4
3.11.5
4.8.6
Not in 2A
4.8.7
Partly in 2.9.2
4.9
Site security
4.9.3
5.1
5.1.1
5.1.2
5.1.3
5.1.4
5.1.5
3.2
Partly by 3.2.2 and 3.2.3
SA
M
4.9.1
4.9.2
PL
4.8.5
Pre-production reference samples
5.1.6
5.2
Partly in 2.9.2
Not in 2A
5.3
5.4
5.3.3
Not in 2A
Not in 2A
Not in 2A
Chemical formulation control
Not in 2A
5.2.1
Not in 2A
5.2.2
Not in 2A
5.2.3
Not in 2A
5.2.4
Not in 2A
5.3
Product packaging materials
4.2
5.3.1
Partly in 4.2.3
5.3.2
Partly in 4.2.2
Page 147 of 153
30/4/10 12:45:41
5.3.3
4.2.5
5.3.4
Partly in 4.2.6
5.3.5
Partly in 4.2.4
5.4
Control of non-conforming materials
4.8
5.4.1
4.8.2
5.4.2
5.5
Handling requirements for specific materials
Partly in 4.4
5.5.1
Partly in 4.4.1
5.5.2
Partly in 4.4.2
5.5.3
Partly in 2.3, 2.10 and 4.2.3
5.6
Stock control and product release
Partly in 4.7
5.6.2
Partly in 5.1.1
5.6.1
5.6.3
Partly in 4.5 and 5.1.3

6.1
Product analysis/testing
6.1.1
Not in 2A
6.1.6
6.1.7
6.1.8
6.1.9
6.1.10
6.2
Not in 2A
SA
M
6.1.3
6.1.5
Partly 4.3.1
Not in 2A
6.1.2
6.1.4
PL
5.6.4
Inspections
Partly 4.3.2
Partly 4.3.3
Not in 2A
Not in 2A
4.3.4
Not in 2A
Not in 2A
Not in 2A
6.2.1
Not in 2A
6.2.2
Not in 2A
6.2.3
Not in 2A
6.2.4
Not in 2A
6.2.5
Not in 2A
6.2.6
Not in 2A
6.2.7
Not in 2A
6.2.8
Not in 2A
6.2.9
Not in 2A
6.3
Product claims
Page 148 of 153
Not in 2A
30/4/10 12:45:42
6.3.1
5.2
6.3.2
5.2.2
6.3.3
Not in 2A
6.3.4
Not in 2A
7.1
Control of operations
5.1.1
7.1.1
Partly 5.1.2
7.1.2
Partly in 5.1.3
7.1.3
Not in 2A
7.1.4
Partly in 5.1.6
7.1.5
Not in 2A
7.1.6
Partly in 5.1.2
7.1.7
Partly in 5.1.6
Control of incoming components and raw materials
7.2.1
Partly in 5.1.3
Not in 2A
PL
7.2.2
7.2.3
Not in 2A
7.3
Equipment and equipment maintenance
7.3.1
7.3.5
7.3.6
7.3.7
7.3.8
7.3.9
7.4
5.5.3
SA
M
7.3.4
Partly 5.5.1
5.5.1
7.3.2
7.3.3
Partly in 5.1.3
7.2
Foreign-body detection and control
Partly in 3.6
Not in 2A
Not in 2A
3.5
Not in 2A
Not in 2A
Not in 2A
4.6.1
7.4.1
4.6.1
7.4.2
Partly in 4.6.6
7.4.3
4.6.7
7.4.4
Partly in 4.6.5
7.4.5
4.6.5
7.4.6
4.6.12
7.5
Calibration and control of measuring and monitoring

devices
5.6
7.5.1
5.6.1
7.5.2
Not in 2A
Page 149 of 153
30/4/10 12:45:42
7.5.3
5.6.3
7.5.4
5.6.4
7.5.5
Partly in 5.6.7
7.5.6
Partly in 4.6.8
7.5.7
5.6.8
7.6
Retained production samples
Partly in 5.4
7.6.1
5.4.1, 5.4.2, 5.4.3
7.6.2
5.4.4
7.6.3
Partly in 5.4.5
7.7
Final product packing and control
Not in 2A
Not in 2A
7.7.2
Partly in 5.2
7.7.3
Not in 2A
8.1
7.7.1
Training and competency
6.2
6.2.1, 6.2.2, 6.2.3, 6.2.4
8.1.2
Not in 2A
8.1.3
Not in 2A
8.2
Protective clothing
8.2.3
8.2.4
8.3
8.3.1
8.3.2
8.3.3
8.3.4
6.1.2
6.1.2
SA
M
8.2.1
8.2.2
PL
8.1.1
Hygiene practices
6.1.14
6.1.3
6.1.4
6.1
6.1.7
6.1.8
6.1.6
6.1.9
8.3.5
6.1.5
8.3.6
6.1.10
8.3.7
Partly in 6.1.11
8.3.8
6.1.12
8.3.9
6.1.13
8.3.10
6.1.16
Page 150 of 153
30/4/10 12:45:43
SA
M
PL
Page 151 of 153
30/4/10 12:45:43
SA
M
PL
Page 152 of 153
30/4/10 12:45:43
SA
M
PL
Page 153 of 153
30/4/10 12:45:43

BRC CP Guideline

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

BRC CP Guideline

Uploaded by

Copyright:

Available Formats

For more information visit www.brcglobalstandards.

GLOBAL STANDARD FOR CONSUMER PRODUCTS

6660 BRC IG TEXT v0_1.pdf 1

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

Section II Product Groups and Risk Assessment

6660 BRC IG TEXT v0_1.pdf 2

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

Section III Explaining the Requirements of the Global Standard

6660 BRC IG TEXT v0_1.pdf 3

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

Section IV Guidance for Achieving Certification

6660 BRC IG TEXT v0_1.pdf 4

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

7 After the Audit Visit

Appendix: Differences between Issue 3 and Issue 2A

6660 BRC IG TEXT v0_1.pdf 5

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 6

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

1.1 Why is the guideline needed?

6660 BRC IG TEXT v0_1.pdf 7

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

2 General and Background Information

2.1 Summary of the Global Standard

6660 BRC IG TEXT v0_1.pdf 8

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 9

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 10

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 11

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

2.4 The cost of certification

The final cost of certification will comprise:

6660 BRC IG TEXT v0_1.pdf 12

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 13

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

When a site is awarded certification it receives a grade which is determined by the

6660 BRC IG TEXT v0_1.pdf 14

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 15

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 16

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com

6660 BRC IG TEXT v0_1.pdf 17

Interpretation Guidelines CP Draft 1

For more information visit www.brcglobalstandards.com