Management Systems

Exercise 1
What does
Quality Mean?

What is Quality?
The ability of a system,
process, or a product to
fulfill the requirements of
customers and other
interested parties.

Exercise 2
What is a
Management
System?

What is a Management
System?
A management system isa
proven framework for
managing and continually
improving your
organization's policies,
procedures and processes.

Manual (Level One)

The scope of the Management System, including
details of, and any justification for any exclusions
Documented Procedures or reference to them
A description of the sequence and interaction of the
processes included in the Management System

Manu
al
Methods of Process
Control/Quality
Plans
Work
Instructions

Support
Documentation

Procedures, Flow Charts (Level Two)

Procedures as required by the Standard and
the Policy , plus other documentation to
control the processes
Procedures and Flow Charts define-Who does
it,? What is done? When it is done?
Operational Instructions (Level
Three)
Instructions to detail how a
particular activity is carried out
Other Support
Documentation (Level
Four)
Records
Test Results
Objective evidence to
prove that the system is
working

Quality Management
1. Management commitment to the customer and the
company
2. Preventive thinking
3. Confidence
4. Suitable systems
5. Defined objectives
a) Defined roles
b) Defined standards of performance
c) Training and regular review

Process Identification

PDCA Cycle

Process Identification
A process is any activity that transforms
inputs into outputs using resources and
being subject to specific controls.
All activities can be considered as a process.
By identifying and controlling the inputs,
providing the correct resources and applying
suitable methods of control we should
achieve the desired output.

Process Identification
INPUTS
Materials
Data
Machines (Resource)
Manpower (Resource)
Measurement (Control)
Methods (Control)
Environment (Control)

Process Identification
Primary or main input to a process will be
data, information or instruction to begin.

Process Identification
Controls

Inputs

Process

Resources

Outputs

Process Identification
Primary
Process

Process Identification
Primary
Process

Secondary
Process

Process Identification
Outputs from a process are the results of
the transformation of the inputs.
These may include:
Product that is acceptable.
Product that is unacceptable.
Waste.

Policy
Objective
s

Sales

Design

Purchasin
g

Productio
n

Stores

Inspection

Dispatch

Exercise 3
Popcorn Exercise

Exercise 4
Objectives of
Standard

Interaction of Processes
Design Process
Calibration
Sales
Contract Review

Delivery
Standards
API
ISO

MEASUREMENT
Process
Product

Product
or
Service

Stores

Purchasing

Competent Operators
DOCUMENTED
PROCEDURES

MANAGEMENT
CONTROLS

Forms
Records

Resources
Leadership

Evolution of Quality Thinking

The Pyramids
Craftsmen
Industrial Revolution
Mechanisation
War Time Requirements
Statisticians/Gurus
Systems
Empowerment/Delegation

Post World War II

Developments
Higher Manufacturing Costs
Profit Erosion
World Wide Competition
New Technologies For Manufacturing
Market Driven Thinking
Survival
= Prevention Not Detection Of Waste

Quality Assurance Objectives

For the client to have the confidence that he
will get:
What he wants
(Quality)
When he wants it
(Delivery)
At an agreed and accepted
(Cost)
price

Together with the right

relationship

FIRE FIGHTING IS MACHO & EXCITING

SYSTEMS ARE BORING

We spend too much time

fighting yesterday's fires
and not enough on winning
tomorrow's battles

How can we change

this situation ?

Continual Improvement of the Management System

4
Management
Responsibility

Customers
8
Measurement,
Analysis &
Improvement

4.3
Organisation
Capability

Customers

5
Product
Realisation

Requirements
Input

Information Flow
Value-adding activities

Satisfaction

Product

Output

Exercise 5
Auditor
Competence

Exercise 6
Auditor Personal
Attributes

Internal AuditsWhat and Why?

Professional

Observant

Ethical

Analytical

Discipline

Positive
Attributes
of Auditor

Objective

Patient

Unbiased

Impartial

Diplomat

Good Listener

Inquisitive

Poor at
preparation
and planning

Afraid of
passing
unpopular
judgments

Poor
timekeeping

Stays in
office

Too rigid

Negative
characterist
ics of
Auditor

Easily
influenced

Opinionated

Jumps to
conclusions

Argumentativ
e

Bad
communicat
or

Knowledge & Skills of Auditor Auditing

To apply audit principles, procedures & techniques.
To plan & organize the work effectively.
To conduct audit within agreed time schedule.

To prioritize & focus on matters of significance.

To collect information through effective interviewing, listening, observing and
reviewing documents, records & data.
To understand appropriateness and consequences of using sampling techniques
for auditing.

Knowledge & Skills of Auditor Auditing

To verify accuracy of collected information.
To confirm sufficiency and appropriateness of audit evidence to support audit
findings & conclusions.
To assess those factors that can affect the reliability of audit findings &
conclusions.
To use work documents to record audit activities.
To prepare audit reports.
To maintain the confidentiality and security of information.
To communicate effectively, either through personal linguistic skills or through an
interpreter.

The Audit
Process

Identify Scope of Audit

Team Procedures

Audit

Flow of Work

Prepare a Plan

Time Available
Complete Review
Complete Report

Preparation of Checklist

Process Based
Time allocated from Plan
Persons to be Interviewed

Undertaking Audit

Opening Meeting
Introduce Yourself
Prepare Legible Notes
Deviate from Plan if you suspect problem
Take notes of all objective evidence seen
Thank Auditee

Review Notes

Team Review Notes

Identify Problems if any
Write NCRs
Write Final Report

Closing Meeting

Thank Auditee
Identify and Read NCRs
Accept Comments
If Requested Discuss ways of Solving NCRs

Report

Submit Report to QMR

Scope of the Audit

The audit scope includes an assessment of the Management
Systems including:
Policy and Management commitment

Leadership and employee involvement

Awareness and legal requirements
Objectives
Organisation and responsibility
Training and education
Communication
Management System documentation
Operational control
Monitoring, assessment and measurement
Review, improvement and recognition

Audit Plans

Audit Objectives and Scope

Audit Criteria
Focus/Risk Areas
Organisational/Functional Units, Processes to
be Audited
Sequence of Events
Key Individuals that may be required for
Interview
Reference Documents
Identity of Audit Team Members
Date of Audit

The Audit Process

Communication
An Audit consists of a number of interviews.
Every interview consists of the transfer of
information between two people.

What?

Who?

Where?

Why?

How?

When?

Show
me

Audit Checklist
To assist in
keeping the
audit on track

To assist with
time
management

Purpose

To provide
evidence of a
full system
audit

To provide a
structured
approach to
the audit

The Audit Checklist

Process Based Audit Checklist
Should follow a logical process
flow
Should identify all inputs into
the process

The Audit Checklist

Can be restrictive
Could miss something if followed rigorously

End of Day One

Exercise 7
Initiating the
Audit

Exercise 8
List of Documents

Exercise 9
Audit Plan

Exercise 10
Preparing a
Checklist

Audit Techniques
Process Documents

Ask for outline of process

Show me

Check Process Records

Collecting & Verifying Information

INTERVIEW
INTERVIEW
PEOPLE
PEOPLE

EXAMINE
EXAMINE
DOCUMENT
DOCUMENT
S
S
OBJECTIVE
OBJECTIVE
EVIDENCE
EVIDENCE

OBSERVE
OBSERVE
ACTIVITIES
ACTIVITIES
&
&
CONDITION
CONDITION
S
S

Opening Interview

Be on time
Introduce yourself
Ensure appropriateness of time
Explain the purpose of the
discussion and how the information
gathered will be used-Explain that
you will be taking notes. Assure
confidentiality
Strive to build the desired sense of
comfort and confidence

Conducting Interview

Request an interview of the interviewees job

and applicable responsibilities
Watch your language-Clarify acronyms
Start with some general questions, then
gather more detailed information
Resolve ambiguities through constructive
probing
Do not run over time without checking
Provide feedback as appropriate

Conducting Interview
Dont get
into debates

Dont amplify
criticism
given

Dont jump to
conclusions

Dont force
a meeting

Dont rush
the
interview

Dont use a
tape
recorder

Be wary of
using
sarcasm/humo
ur

Dont
communicate
incomplete or
unsubstantial
findings/conclusio
ns

Dont show
your
reactions

The Audit Process

Communication

Body Language
Facial Expression
Look of Horror
Sharp intake of breath

The Audit Process

DO NOT GIVE OPINIONS
You cannot tell an
organisation how to run
their business

Collecting Information
Interviewing techniques and active listening

Techniques of further enquiry

Active listening

Handling Resistance

Forms of resistance (some examples)

Digression from topic, monosyllable answers or none at all, lack of

concentration, shortage of time, verbal attacks and aggressiveness

Documenting Interview
A Two Step Process

Take Notes
Review immediately
afterwards

Techniques for Recording Information

Write while conducting the audit

Start each new topic on a new page
Clearly label each working paper page
Keep entries factual and legible
Write clearly in an understandable style
Include photocopies of selected documents
Maintain an exhibit list
Highlight to do items and findings
Develop and use standard tick marks

Tips for Effective Note Taking

Never hide the fact you are taking notes

Offer the interviewee the opportunity to view
notes (if necessary)
Keep notepad within easy reach
Take notes about facts that are relevant to the
audit scope
Put the interviewees words into quotation
marks to distinguish them

Gathering Audit Evidence

There are several tasks in formulating a sound
verification
strategy
Evaluate what needs to be done
Determine the depth and rigor of review
Select the types of evidence needed and the methods to
gather them
Compare practices against requirements
Document results

Gathering Evidence
In general there are 4 types of evidence that
can
be gathered during an audit
Physical Evidence

Testimonial
Evidence

Documentary
Evidence

Circumstantial
Evidence

End of Day 2

Exercise 11
Internal Audit

Report Writing
When writing a nonconformity report it
must be:
Factual
Value adding

It should not be:

Trivial
Of no benefit

Report Writing
Who is going to read the
report?
The management of the auditee
The auditorss management
Colleagues who may have to verify the
corrective action at the next surveillance
visit

Gathering Evidence
Upon gathering the information, auditors must
compare facility practices against applicable
Requirements
Is the facility in compliance with the
requirements?
Is there enough data to evaluate whether
systems are being implemented as designed?
Are there underlying causes?

Report Writing
A Nonconformity Report should
contain

Company name and site

Department or area where the non-conformity was found
Date
Standard and clause number that the non-conformity has
been raised against
Unique reference number
Category of the non-conformance
The Audit evidence
Requirement that the company failed to comply with
Name/signature of Auditor
Name/signature of Auditee

Closing Meeting
Closing Meeting
Thanks for the hospitality
Confirm confidentiality
Present findings
Announce result (Recommendation)
Issue documentation
Conclusion

Closing Meeting
Typically the closing meeting consists of 4 principal
phases
Opening the
meeting

Discuss
recommendations

Presenting Audit
findings

Closing the meeting

The Audit Process

Verification of Corrective Action

must include an evaluation of the
EFFECTIVENESS of the corrective
action.
HAS THE ROOT CAUSE BEEN
IDENTIFIED AND CORRECTED

Audit Findings
Non Conformity Categorisation
IAF Guidance for the application of ISO
17021 define a non- conformity as:
The absence of, or the failure to implement
and maintain, one or more Management
System requirements, or a situation which
would, on the basis of available objective
evidence, raise significant doubt as to the
quality of what the organization is
supplying.

Audit Findings
Non Conformity Categorisation
.

Major Non Conformity

Absence of mandatory documentation
Specified standard requirement not
implemented
Product not meeting customer or legal
requirements (CE Marking, Food Safety
Management system,(HACCP))
High number of minor NC against one clause

Audit Findings
Non Conformity Categorisation
.

Minor Non Conformity

A single lapse against the requirements of the

standard or the companys documented
system.

Audit Findings
Observations/Opportunity for
Improvement

A process for adding value to the

management system.
Identifying potential weaknesses in the
system.

Exercise 12
Preparation of
Report Findings

Exercise 13
Presentation of
Auditor Findings