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INTEGRATED MANAGEMENT
SYSTEM
MANUAL ISO 9001:2008, ISO
14001:2004
Designation:
Prepared by
Name:

Signature:
Reviewed by
Name:
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Signature:
Approved by
Name:

C.E.O

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Signature:

Company Nam:
Address:

INTEGRATED MANAGEMENT
SYSTEM MANUAL

Company Logo

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Page 1 of
38

TABLE OF CONTENTS
Section
1

2
3
4

--

--4.1

Company Profile
Scope
Exclusion
Structure of Quality, Health & Safety &
Environmental Management System
Manual
Definitions & Abbreviations
Integrated Management System
General Requirements

4.2

Management of Documents and Records

-5.1
5.2

Management Responsibility
Management Commitment
Customer Focus

5.3
5.4
---5.5

Integrated System Policy

Planning
Environmental Aspects & Significance
IMS Objectives & Targets
Management Program
Responsibility, Authority, Resources and
Communication
Management Representative
Communication (Internal / External)
Management Reviews
Resource Management
Provision of Resources
Human Resources
Competence, awareness and training
Infrastructure
Work Environment
Product Realization
Planning of Product Realization
Customer Related Process
Purchasing Process
Verification of Purchase Product
Production and Service Provision
Control of Service & Production Provision
Validation of Process for Production and
Service
Identification and Traceability
Customer Property
Management of Monitoring and Measuring
Devices
Measurement,
Analysis
and
Improvement
General

--

--5.6
-6.1
6.2
-6.3
6.4
-7.1
7.2
7.4
-7.4
----7.5

Section Title

-8.1

Page No
QMS
1.0
---

EMS
----

5
7
7
7

3.0
4.0
4.1
4.2.3
4.2.4
5.0
5.1
5.2

9
13
13

5.3
5.4
-5.4.1
5.4.2

-4.0
-4.4.5
4.5.4
-4.4.1
4.3.1
4.3.2
4.2
4.3
4.3.1
4.3.3
4.3.3

5.5

4.4.1

19

5.5.2
5.5.3
5.6
6.0
6.1
6.2
6.2.2
6.3
6.4
7.0
7.1
7.2
7.4
7.4.3
7.5
7.5.1
7.5.2

4.4.1
4.4.3
4.6
-4.4.1
-4.4.2
4.4.1
-4.4
4.4.6
--4.4.6
-4.4.6
4.4.6

20
20
21
23
23
23
23
24
24
26
26
26
26
27
27
27
27

7.5.3
7.5.4
7.6

--4.5.1

27
28
28

4.5

30

8.1

--

30

13
16
16
16
16
18
18
18
19

Section
8.2
----8.3
8.4
8.5
----

Section Title

Page No

Monitoring and Measurement

Customer Satisfaction
Internal Audit
Monitoring and Measuring Process

8.2
8.2.1
8.2.2
8.2.3

Monitoring and Measurement of Product

8.2.4

Control of Non-conformance, Accidents and

Incidents
Analysis of Data
Improvement
Continual Improvement
Corrective Action
Preventive Action

8.3
8.4
8.5
8.5.1
8.5.2
8.5.3

--4.5.5
4.5.1
4.5.2
4.5.1
4.5.2
4.4.7
4.5.3
4.5.1
--4.5.3
4.5.3

30
30
30
31
31
32
33
33
33
33
34

SECTION 1
COMPANY PROFILE

COMPANY PROFILE

Combined has is currently structured around major departments, which

are as follows:
1234- .

SECTION 2
SCOPE

2.

SCOPE
The scope of this Integrated Management System manual is to
demonstrate the companys commitment to provide consistently products
that meet customer and regulatory requirements. It applies to all the
activities and functions of company related to Storages, Inspection, and
Packing etc. This manual establishes compliance with the requirements of
Quality and Environmental Management System as well as regulations.

2.1

Exclusions & Justifications

Following Clauses of ISO 9001:2008 are not applicable to the companys
Integrated Management System:

2.2

Structure
Manual

of

Integrated

Management

System

This integrated system manual follows the integrated format of ISO 9001:
2008 & ISO 14001:2004. It provides direction for the implementation and
maintenance of the Quality, and Environmental Management Systems to
ensure products are of the highest quality and customer satisfaction is
obtained through an environment of continual improvement while
following all the applicable rules and regulations of health, safety and
environment.
This Manual provides an orientation of an effective Quality and
Environmental
Management
System
implemented
at
Harrison
Pharmaceuticals. It aims to enhance customer (internal and external)
satisfaction through the effective implementation of integrated
management system including processes for continual improvement,
assurance of conformity to customer and complying with legal
requirements.

SECTION 3
DEFINITIONS &
ABBREVIATIONS

DEFINITIONS AND ABBREVIATIONS

3.

All applicable standards

-

CPA

Where the term all applicable standards is used

in the Quality and Environmental Management
System Manual, all documents listed in the
Applicable standards and regulations section of
this document apply
Corrective and Preventive Action

Quality
-

Conformance to the requirements of interested

parties or
absence of variation

Quality Management System

Environmental Management System

Occupational Health and Safety Management

System

Integrated Management System

Environmental Management Program

System Management & Development

QMS
EMS
OHSAS

IMS
EPM
SMD
NEQS

National Environment Quality Standard

Accident/Incident

-An undesired event giving rise to death, illness,

injury, damage, or other loss.

Auditor

-A person with the competence to conduct an

audit.

Continual Improvement

-A recurring process of enhancing the IMS in

order to achieve improvements in overall IMS
performance consistent with IMS Policy.

Corrective Actions

-Actions to eliminate the cause of a detected

nonconformance.

Document

-Information and its supporting medium.

Environment

-Surroundings in which CFL operates, including air,

water, land, natural resources, flora, fauna,
humans, and the various interrelationships of the
above.

Environmental Aspects -Elements of CFL activities, products or services

that can interact with the environment.
Environmental Impacts -Any change to the environment, whether adverse
or beneficial, wholly or partially, resulting from CFL
environmental aspects.
Hazard Identification

-A process of recognizing that a hazard exists and

defining its characteristics.

Hazards

-Sources or situations with a potential for harm in

terms of injury or illness, damage to property, or a
combination of these.

Health and Safety

-Conditions and factors that affect the well-being

of employees, temporary workers, contractors,
visitors, and any other person in the workplace.

Interested Party

-A person or group concerned with or affected by

the QHSE performance of CFL

Internal Audits

-A systematic, independent, and documented

process for obtaining audit evidence and
evaluating it objectively to determine the extent
to which the QHSE Management System audit
criteria set by CFL are fulfilled.

Nonconformance

-The non-fulfillment of a requirement.

Preventive Actions

-Actions to eliminate the cause of a potential

nonconformance, prevention of employee injuries,
pollution use of processes, practices, techniques,
materials, products, services, or energy to avoid,
reduce or control the creation, emission, or
discharge of any type of pollutant or waste, in
order to reduce adverse environmental impacts,
quality defects, safety and health hazards.

IMS

-Part of CFL Integrated Management System used

to develop and implement its Integrated System
Policy and manage its quality concerns, customer
requests, health issues and environmental
aspects. The management system is a set of
interrelated elements used to establish policy and
objectives and to achieve those objectives. The
Integrated Management System includes CFL
structure, planning activities, responsibilities,
practices, procedures, processes, and resources.

QHSE Objective

-An overall environmental goal, consistent with

the QHSE Policy that CFL has set itself to achieve.

Quality, Health, Safety & Environmental Performance

-Measurable results of CFL Management of its
environmental aspects, safety hazards, quality
concerns and items. In the context of the
Integrated Management System, that these
results can be measured against CFL QHSE Policy,
objectives, targets, and other IMS performance
requirements.
IMS Policy
-The overall intentions and direction of CFL related
to its IMS performance, as formally expressed by
top management. Our IMS Policy provides a
framework for action and for the setting of IMS
objectives and targets.
Quality, Health, Safety & Environmental Target
-A detailed performance requirement, applicable
to CFL or parts thereof, that arises from the IMS
objectives and that needs to be set and met in
order to achieve those objectives.
Risk

-A combination of the likelihood and consequences

of a specified hazardous event occurring.

Risk Assessment

-A protocol to estimate the magnitude of risk and

decide whether or not the risk is tolerable.

Safety

-Freedom from unacceptable risk or harm.

Tolerable Risk

-Risk that has been reduced to a level that can be

endured by our company with respect to our legal
obligations and QHSE policy.

SECTION 4
INTEGRATED MANAGEMENT SYSTEM
(ISO: 9001, ISO: 14001)

4.

INTEGRATED MANAGEMENT SYSTEM (IMS)

4.1

General Requirements

Harrison Pharmaceuticals has documented, implemented and

maintained an Integrated Management System based on Quality and
Environmental Management System in accordance with the
requirements of all applicable standards and regulations. continually
improves the effectiveness of its system that:
a) Identifies the processes needed for its operations and their
application throughout the organization
b) Determines the sequence and interaction of these primary
processes
c) Identifies the associated health & safety hazards and
environment aspects and control them after and before the
processes
d) Determines criteria and methods needed to ensure that both the
operation and management of these processes are effective
e) Ensures the availability of resources and information necessary
to support the operation and monitoring of these processes
f) Ensures implementation of actions necessary to achieve planned
results and continual improvement of these processes
g) Evaluate periodically the IMS and update the system whenever
its necessary
4.2

Management of Documents and Records

4.2.1 General
The following controlled documents ensure the effective operation
and control of our processes:
Levels
I
II
III
IV

Documentation Types
Integrated System Policy, Integrated system
Manual, Job Descriptions, Organizational Chart
Integrated System Procedures
Process Flows / Work Instructions/SOPs / Safety
Signs
Forms and Formats / Records

4.2.2 IMS Manual

This manual defines policies and guidelines necessary to ensure that

all actions affecting quality, health & safety and environmental
issues are conducted according to documented procedures; the end
result being the control of processes which affect the quality of
products provided to our customers.
4.2.3 Control of Documents
A system is maintained to control documents required for the
integrated management system. Documented procedures exist to
establish the following levels of control:

d)
e)
f)
g)

a) Approval of documents for adequacy prior to issue

b) Review, update as necessary and re-approval of
documents
c) Identification of the current revision status of
documents
Assurance that relevant versions of applicable documents
are available at points of use
Assurance that documents remains legible, identifiable
and readily retrievable
Assurance that documents of external origin are identified
and their distribution controlled
Preventing the unintended use of obsolete documents,
and to apply suitable identification to them if they are
retained for any purpose

4.2.4 Control of Records

Control all the records required for the Integrated Management
System. Such records are maintained to provide evidence of
conformance to requirements and effective operation of the
integrated management system. A Procedure has been defined to
document the identification, storage, retrieval, protection, retention
time and disposition of records.
4.2.5 Related Documents:
i.

Procedure for Documents and Records Control

SECTION 5
MANAGEMENT
RESPONSIBILITY

5.

MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management of Harrison Pharmaceuticals has defined the overall
strategy and objectives for the Integrated Management System in the
form of the Integrated System (IMS) Policy.
Top management is committed to continue improvement of the
integrated management system is shown through active participation in
the Management Review Meetings & by endorsement and review of the
Integrated System Policy.
5.1.1 Top management identifies and provides adequate resources
to achieve the Integrated System Policy objectives. The need
for required resources is discussed at Management Review
Meetings and documented in the Minutes of Management
Review Meetings.
5.1.2 Top management regularly communicates to the organization
the importance of meeting IMS requirements, customer and
regulatory requirements.
5.1.3 Top management is also committed to minimize pollution and
ensure health & safety rules are followed while ensuring
environmental friendly conditions in all the sites and the
working premises.

5.2

Customer Focus

Each function maintains high customer focus through trainings and

awareness sessions and making the employees realize the importance of
meeting and understanding customer requirements. Top management
ensures that customer requirements are identified and are met with the
aim of improving customer satisfaction and going beyond their
expectations.

5.3

Integrated System Policy

Harrison Pharmaceuticals has defined an integrated system policy

according to the requirements of Integrated Management System.
a) Top management communicates the IMS Policy to the
organization and the intent of the policies and ensures that
they are understood at all levels of the organization.
b) The policies and objectives are periodically reviewed for
suitability by top management as part of the Management
Review

Related Documents:
i. Integrated System Policy

Environment

IMS POLICY

While
activities, the impact
aim of Combined
Fabric
is product
to ensure
health
carrying
Minimizeout
theitsenvironmental
of operations
and
through
andsafety
its employees,
contractors,
customers
and local improvement
communities, in
to
the of
adaptions
of sustainable
practices
and continuous
protectenvironmental
theenvironment
and ensure public safety on the basis of the following
performance
guiding principles:
Ensure regular monitoring of Effluent discharge, Air Emissions and other
parameters
associated
with various
processes
andwith
activities
at work
all
activities must
be managed
in strict
compliance
regulations
and
place
buyers terms of engagements;
Managing
wastes
proper
segregation
disposalthat constitute
the
adoption
of through
principles,
standards
andand
solutions
international bestpractices in business for the protection of health, safety,
the environment and public safety;

operational management must be based on defined criteria in terms of

environmental protection and the objective must be pursued ofimproving
health and safety conditions according to practices and procedures;

personnel training and the exchange of experience and information must

be considered fundamental tools in order to achieve QHSE objectives, with
a view to thecontinuous improvement of prevention and protection
standards;

employees, when carrying out their duties, must be use of Personal

Protective Equipment (PPE) like Mask, Apron, Gloves etc. (where
applicable);

employees, authorities and the general public must be informed

periodically about theresults achieved in terms of environmental
protection, health and safety

when requested, cooperation must be ensured with competent authorities

regardingthe preparation of technical regulations and guidelines
concerning HSE issues;

the foregoing principles must be reviewed constantly and their application

monitoredperiodically.

OUR COMMITMENTS
Quality

Ensure quality right from the source

Improve quality by strict quality control and quality assurance.

Continual efforts to maintain superior quality products at most reasonable

prices with prosperous employees and fully satisfied customer.

5.4

Planning

a) Top management ensures that objectives, including those needed

to meet requirements for product, are established at relevant
functions and levels.
The objectives are measurable and
consistent with the policies.
b) Top management ensures that the resources needed to achieve
the Integrated System objectives are identified and planned.
c) Planning is conducted to ensure that changes to the
management systems are conducted in a controlled manner such
that the integrity of the management system is maintained.
5.4.1 Evaluation of Significant Environmental Aspects
Harrison Pharmaceuticals takes into account the following for the
ongoing planning health and safety hazard identification, risk
assessment and risk control, and identification of environmental
aspects that have or can have significant impact(s) on the
environment.
a)
b)
c)
d)
e)
f)

Activities of all personnel having access to the

workplace (including subcontractors and visitors);
Routine and non-routine, i.e. periodic or
emergency activities;
Activities, products or services that can be
controlled or influenced, i.e. purchase;
The environmental concerns of interested
parties;
Existing and changing environmental
legislation and regulations;
All information on occupational health safety
hazards and environmental aspects and impacts
assessments is kept up to date and regularly reviewed;

Related Documents:
i. Procedure for Environmental Aspects Analysis
5.4.2 IMS Objectives & Targets
IMS objectives & targets are set keeping in view the following
parameters:
a) Integrated System Policy
b) Significant environmental aspects and identified health and
safety risks
c) Applicable legal and other requirements
d) View of interested parties
e) Financial, Operational and other requirements

5.4.3 Management Program

Harrison Pharmaceuticals has established a system to ensure its
effectiveness through Management Program which describes the
following:
a) Resource Requirement for each step / target
b) Responsible person(s) for each step
c) Target date
d) Starting date
e) Completion date
f) Remarks for any correspondence reference etc.
Related Documents:
i.

Procedure for Objectives and Targets

5.4.2 Legal and Other Requirements

Harrison Pharmaceuticals has established, documented and
maintained a procedure for identifying the legal and other
requirements that are applicable to the environmental aspects and
impacts and Occupational Health hazards of its operations.
a) Policy requirements
b) Legal requirements
c) Non-regulatory guidelines
d) Company standards
Management Representative maintains a record of legal and other
requirements and monitors amendments or additions.
Related Documents:
i. Procedure for Legal and Other Requirements

5.5

Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Responsibilities and authorities within the organization are defined
in form of organizational charts and job descriptions. Each employee
is issued with his job description.
Related Documents:
i. Job Descriptions
ii.
Organizational Chart

5.5.2 Management Representative

Top management of Harrison Pharmaceuticals has appointed a
Management Representative for integrated management
system. The Management Representative:
a) Ensures that products are produced that satisfy the customer
and QHSE requirements
b) Ensures the prevention of pollution and health & safety
hazards through compliance to regulations, consolidation and
review of environmental impacts.
c) Has the authority and responsibility to ensure that the
requirements of the integrated management system are
established, implemented and maintained
d) Reports on the status of the management system and
continual improvement as inputs to the Management Review
Meetings
e) Promotes awareness of customer and regulatory requirements
throughout the organization
5.5.3 Internal Communication
Top management ensures that appropriate communication
processes are established and communication takes place regarding
the effectiveness of the integrated management system through
meetings, newsletters, and internal postings etc.
The company has selected employees representatives for the
consultation on the behalf of employees for the development review
of policies for managing the risks. The employees are also consulted
where there are any changes that could affect the workplace health
and safety. All the consultation is documented.
The issues that are communicated to the employees are but not
limited to;
a)
b)
c)
d)
e)
f)
g)

Inclusion of new product in the product line

Any change or inclusion in equipment
Change in qualification level of the employees
Change in job description
Regulatory requirements
New information for controlling the identified hazards
Complaints

5.5.4 External Communication

Customer feedback and complaints that affect customer satisfaction
are documented and discussed at Management Review meetings
and necessary action taken for improvement.

Related Documents:
i.

Procedure for Internal and External Communication

ii.

Procedure for Customer Feedback and Complaints

5.6

Management Review

Top management has established a process to review the Integrated

Management System at planned intervals to evaluate its effectiveness
and suitability and verify that IMS policies and objectives are being
satisfied.
At a minimum, the attendees of the Management Review Meeting needs
to be the department managers / heads or designates and
representation from top management.
Related Documents:
i.

Procedure for Management Reviews

SECTION 6
RESOURCSE MANAGEMENT

6.

RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management of Harrison Pharmaceuticals identifies and provides the
resources, including equipment, raw materials, work areas, and trained
personnel for implementing and continually improving the effectiveness
of the integrated management system.
The justification and acquisition of the required resources is discussed at
the Management Review Meeting and documented in Management
Review minutes. Roles and responsibilities to maintain and improve the
integrated management systems are defined in concerned job
descriptions.

6.2 Human Resources

6.2.1 General
Harrison Pharmaceuticals has identified various in-house verification
activities including in-process and final verification of product and
the personnel responsible for carrying out these activities in order to
meet specified requirements. Personnel performing the above
mentioned activities are competent on the basis of appropriate
education, training, skills and experience.
The contract of external experts involved in the development,
implementation, operation or assessment of IMS is kept in records.
6.2.2 Competence, Training and Awareness
a) Competency needs for personnel performing activities that
impact quality, health, safety and environmental compliance are
identified in job descriptions.
b) Training needs for all employees are determined based on job
descriptions and regulatory requirements. The Management
representative establishes a training plan to address these
needs.
c) Training effectiveness is evaluated against predetermined
requirements to determine the employees competency.
d) Management ensures that employees are aware of the relevance
and importance of their work activities and how they contribute
to the achievement of the objectives.
e) General awareness training is conducted for all employees.
Training records are stored and maintained.
Related Documents:

i.

Procedure for Competence, Training and Awareness

6.3

Infrastructure

Management of Harrison Pharmaceuticals is committed to provide the

entire necessary infrastructure to ensure compliance with the
requirements of interested parties (internal customer & external
customer)
a) Infrastructure needs are well identified/defined at planning stage.
These include:
i.

Equipment, hardware and software

ii.

Good Maintenance

iii.

Supporting Services

iv.

Workspace and associated facilities

b) Proper safety arrangements like personal protective equipment; Fire

extinguishers, etc. are provided.
c) Adequate storage areas for spare parts, hardware items and
material are well maintained.
d) Storage areas for raw material are well maintained. All stores have
proper racks/ pallets, identification plates, bins/cartons to keep the
small items.
e) Appropriate communication channels are provided to the Managers
and staff members who have significant role in product conformity.
Fax, e-mail, intercom and Internet facilities are available as lines of
communication.
f) Computers and area networking is provided in all departments.
(Where required).
g) Appropriate software programs are installed in the computers for
routine work and essential product & process analysis.

6.4 Work Environment

Management has identified and provided the work environment
necessary to produce conforming product as per the requirements of
Integrated Management System.
a) Proper Lighting facilities, safety requirements (Signages), aisles
marking, proper ventilation, and enough space is provided for work
that makes the workers comfortable.
b) Management has established comfortable, clean and wellmaintained offices at suitable locations within the facility and on the
different sites. Decision-makers are provided with well-trained and

supporting staff helping them to accomplish their work smoothly.

c) Proper floor marking, passage areas and emergency exits are
marked to walk in case of emergency and to move the
products/items without any obstacle.

SECTION 7
PRODUCT REALIZATION

7.

7.1

PRODUCT REALIZATION
Planning of Product Realization
The organization plans and develops the processes needed for product
realization. Planning of product realization is ensured to be consistent
with the requirements of the other processes of the integrated
management system and should meet the customer requirements.
Records of planning are maintained.
This is achieved through effective development, implementation and
monitoring the planned activities. has developed a comprehensive
system for the monitoring of control measures throughout the
processing and in the events of nonconformities.

7.2

Customer-Related Processes
7.2.1 Determination & Review of Requirements Related to
the Product and Intended Use
Requirements for service are identified and documented. These
requirements include:
a) Requirements specified by the customer / users
b) Requirements not stated by the customer / users but
necessary for specified or intended use, when known
c) Any additional requirements determined by the Combine
Fabric Limited.
7.2.2 Related Documents:
I.

7.3

Procedure for Customer Feedback and Complaint Handling

Design & Development

Note: ISO 9001:2008 Clause 7.3 Design & Development is not
applicable to the CFL

7.4

PurchasingProcess
7.4.1 Purchasing Process
It is the responsibility of purchasingdepartment to ensure that
materials used in a product are procured from approved suppliers
who can comply with the purchase order and regulatory
requirements as specified. An Approved Supplier List is maintained.
Suppliers are selected on the basis of their ability to meet purchase
order requirements, and / or the results of a quality system review,
where applicable. Assessment of suppliers is conducted before any
purchase. Supplier assessment records are maintained.

7.4.2 Purchasing Requirements

Purchasing department ensures that purchase documents clearly
describe the product ordered. The applicable issue of standards and
specifications are specified or referenced on the purchase
documents.
Where appropriate, purchase documents also describe the
requirements for qualification of personnel and quality / health and
safety/environmental management system requirements (if
applicable). Changes to procurement documents require the same
degree of control as the original issue.
7.4.3 Verification of Purchased Product
The amount of inspection required for the purchased products is
determined based on the type of material, the impact of the
material on final product quality, and the historical capability of
suppliers providing the material. Where the company or its
customer intends to perform verification at the supplier's premises,
the organization states the intended verification arrangements and
method of product release in the purchasing documents.
Related Document:
i.

7.5

Procedure for Purchase

Production and Service Provision

7.5.1

Control of Production and Service Provision

Harrison Pharmaceuticals plans and carries out all its production
activities under controlled conditions. All those operations that can
have significant environmental aspects or can be hazardous for
health and safety are identified through evaluation of significant
aspects and risk assessment.
Documented instructions exist for any activity where the absence of
such instructions would adversely affect quality, health & safety or
environment. Manufacturing specifications may be supplemented by
other documents such as Procedures, Work Instructions, Technical
Manuals (TM's), etc. when deemed necessary. Health and Safety and
Environmental instructions are available for processes having
significant Environmental or Health and Safety risk.
Related Document:
i. Procedure for Environmental Aspect Analysis

7.5.2
Validation of Processes for Production and Service
Provision
Excluded from the management system because product
requirements can be validated through production monitoring and
product testing
7.5.3

Identification and Traceability

Materials used in deliverable product are readily identified in
relation to the manufacturing process, raw materials, storage and
dispatched products records. Material which has lost its original
identity cannot be applied to an order until its identity is reestablished.

7.5.4

Customer Property
The customer provides drawings/pictures and specification
according to which the products are to be made. All these
specifications and drawings/pictures are properly identified and
stored.

7.6

Management of Monitoring and Measuring Devices

To ensure QHSE compliance, the organization has determined the
measurements to be made, required accuracy, instrument
capability, equipment to be calibrated, frequency of calibration, and
the validity of previous measurement results when instruments are
found to be out of calibration.
7.6.1 Identified equipment is calibrated or verified prior to use
under normal environmental conditions and against standards
traceable to international or national standards. Where no
such standards exist, the basis used for calibration or
verification is documented.
7.6.2 The calibration status of equipment is identifiable through the
use of labels, tags, color-coding, engraving and records, etc.
and is safeguarded against adjustments that would invalidate
measurement results.
7.6.3 Equipment is protected
maintenance and storage.

from

damage

during

handling

7.6.4 If required Consultant-administered audits will be used for the

evaluation of legal compliance. These audits are conducted a

minimum of every three years.
Related Document
i.

Procedure for Equipment Management

SECTION 8
MEASUREMENT, ANALYSIS
AND
IMPROVEMENT

8.

MEASUREMENT,
IMPROVEMENT

ANALYSIS

AND

8.1 General
Measurement and monitoring activities needed to assure conformity
and continually improve the effectiveness of the Integrated
Management System as defined, planned, and implemented.
This includes the determination of the need for, and use of,
applicable methodologies including statistical techniques.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction
Information relating to customer perception as to whether the
company has met customer requirements is monitored.
Methods of analysis are determined and documented. Results
of customer satisfaction measurements are part of the
Management Review and are used to identify and prioritize
continual improvement projects.
Related Document
i.

Procedure for Customer Feedback and Complaints

8.2.2 Internal Audit

Internal audits are scheduled on the basis of the results of
previous audits and importance of the activity being audited
and are performed by personnel independent from the activity
being audited. Audits are performed in accordance with a
documented procedure.
Audit findings are documented by the auditor and reported to
the area Supervisor / Manager of the activity audited,
corrective action is taken by the responsible personnel, and
follow-up activity is performed and recorded to verify that the
corrective action taken has been implemented without undue
delay and is effective.
Audit results are maintained as records and are a part of the
management review of the management system
Related Document
i.

Procedure for Internal Auditing

8.2.3 Monitoring and Measurement of Processes

Monitoring and measurement of integrated management
system processes are performed and discussed as part of
Management Review.
8.2.4 Monitoring and Measurement of Product
Identification of inspection and test status is maintained
throughout production and delivery of the product to ensure
that only product that has passed all required inspections is
delivered to the customer.
Incoming inspections are conducted on materials used in
deliverable product and documented as detailed in quality
procedures.
In-process inspections and tests are performed as indicated on
the manufacturing specification and/or inspection procedures.
Final products are inspected to ensure that it is complete and
required operations have been performed.
Each unit lot or batch of product is verified to a final test
specification
generated
or
referenced
within
the
manufacturing specification.
8.2.5 Monitoring and Measurement of
and Environmental Performance

Health, Safety

Harrison Pharmaceuticals has established procedures for

monitoring and measuring the Integrated Management
System performance on a regular basis. These procedures
provide for both qualitative and quantitative measures,
proactive measures that monitor compliance, reactive
measures of performance to monitor accidents, near misses,
and other evidence of substandard IMS performance. The
recording of such data and the ensuing results are used to
facilitate subsequent corrective and preventive action
analysis.
has established appropriate IMSPIs (Integrated
Management System Performance Indicators) to measure
these indicators.
a)
b)
c)
d)
e)

Electricity consumption
Water consumption
Waste generation /disposal
Paper Waste / Usage
Fuel Consumption

f) Employee Injuries
g) Customer complaints
h) Supplier evaluation

Related Document
i.

Procedure for Monitoring and Measurement

8.2.6 Emergency Preparedness and Response

Harrison Pharmaceuticals has established and maintained the
Emergency Preparedness and Response Plan which is used
to identify potential for, and response to, incidents and
emergency situations, and for preventing and mitigating the
likely illness, injury or environmental impacts that may be
associated with them. Reviews and revises, where necessary,
its emergency preparedness and response procedures, in
particular, after the occurrence of accidents or emergency
situations. Harrison Pharmaceuticals periodically tests these
procedures where practicable
Related Document
i.

Procedure for Emergency Preparedness & Response

Control of
Incidents

8.3

Non-conformances,Accidents

and

The incharge of each section is primarily responsible for controlling

and segregating nonconforming product in accordance with a
documented procedure. Nonconforming product is properly
identified to prevent its inadvertent use.
Records of nonconformities and any actions taken, including release
authority of acceptance by concession, are maintained.
If a nonconformance is found after delivery of product, the
organization takes actions appropriate to the magnitude and
consequences of the defect.
Any incident or accident related to Occupational Safety and
Environment will investigated according to Procedure for Incident
Investigation.
Related Document
i.
ii.

Procedure
for
Non-Conformities,
Preventive Action
Procedure for Incident Investigation

Corrective

and

8.3.1 Evaluation of Compliance

Management Representative will carry out annual evaluation
of compliance with legal and other requirements, as part of
the internal audit. The audit report will identify and describe
the compliance status and non-conformances. It will also make
recommendations on actions required within given timescales
to address these issues.
Related Document
i.

Procedure for Compliance Evaluation of Compliance

8.4 Analysis of Data

The organization determines, collects and analyses appropriate data
to demonstrate the suitability and effectiveness of the integrated
management system and to evaluate where continual improvement
of the effectiveness of the quality management system can be
made. This includes data generated as a result of monitoring and
measurement and from other relevant sources.
The analysis of data provides information relating to
a) Customer satisfaction Manager Production regularly takes
the feedback from the customers and analyses them.
b) Conformity to Product Requirements
c) Characteristics and trends of processes and products,
including opportunities for preventive action
d) Suppliers Manager Production performs the supplier
evaluation and keeps the supplier performance records.
8.5 Improvement
8.5.1 Continual Improvement
The effectiveness of the Integrated Management System is
continually improved through the use of
a)
b)
c)
d)
e)

IMS Policy and Objectives

Communication
Management review
Internal audit
Corrective and preventive action

8.5.2 Corrective Action

The intent of corrective action is to identify and eliminate the
root cause of nonconformance to prevent recurrence. The
need for corrective action is based on assignable non

conformances found by reviewing processes, work operations,

concessions, records, customer complaints, negative trends,
environmental, health & safety issues and audit findings.
MR evaluates the data related to quality, health & safety,
environmental issues and initiates the corrective action when
non-conformity is found. Harrison Pharmaceuticals
has
established a documented procedure that specify appropriate
actions to identify and eliminate the cause of detected
nonconformities, to prevent recurrence, and to bring the
process or system back into control after nonconformity is
encountered. These actions include
a) Reviewing
nonconformities
(including
customer
complaints),
b) Reviewing trends in monitoring results that may indicate
development towards loss of control,
c) Determining the cause(s) of nonconformities,
d) Evaluating the need for action to ensure that
nonconformities do not recur,
e) Determining and implementing the actions needed,
f) Recording the results of corrective actions taken, and
g) Reviewing corrective actions taken to ensure that they
are effective.
Record of these corrective actions is kept.
8.5.3 Preventive Action
The intent of preventive action is to identify and eliminate
potential nonconformances to prevent occurrence.
The need for preventive action is based on the review and
analysis of processes, work operations, concessions, quality
records, customer complaints, trends, health, safety &
environmental issues and audit results.
Procedures for initiation, control, and follow-up of preventive
actions are established at each facility. Records of the results
of preventive actions taken are maintained.
Related Document
I.

Procedure for Non-Conformities, Corrective and

Preventive Action