ISO 9001:2015-QMS

Lead Auditor Training Course

Model Company Profile v 1.7a

Pioneer Engineering Company (PEC)

Chennai, India

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Pioneer Engineering Co.,

QMS Apex Manual

This Profile is a confidential and controlled document describing the

QMS policies of Pioneer Engineering Co., Chennai, INDIA.

Released under the authority of MD.

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CHAPTER CONTENTS

1. Introduction, and Terms and Definitions

2. Quality Policy
3. Organisation Structure and Responsibilities
4. Quality Planning
5. Quality Management System Documentation
6. Resources and Support including Training, Awareness and
Competence
7. Pre-Production
8. Production
9. Maintenance
10. Performance Evaluation including measurement and evaluation
11. Non-conformity Management
12. Communication
13. Procedure for Improvement Projects

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TERMS & DEFINITIONS

1. Top management: Person or group of people who directs and controls an

organization at the highest-level Organization.

2. Management system: Management refers to those who direct and control

that part of the organization

3. Organization - Person or group of people that has its own functions with
responsibilities, authorities and relationships to achieve its objectives
4

4. Context of the organization - combination of internal and external issues

that can have an effect on an organization’s approach to developing and
achieving its objectives
5. 1
6. Interested party – stakeholder; Person or organization. Example:
customers, owners, people in an organization, providers, bankers,
regulatory bodies
1

7. Provider – supplier organization that provides a product or a service

8. External provider - external supplier. Provider that is not part of the

organization

9. Metrological function - measurement management system

10. Improvement – status of performance towards development

11. Continual improvement -Sustained success of an activity

4

12. Management - coordinated activities to direct and control an

organization
4

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13. Project management - planning, organizing, monitoring, controlling

and reporting of all aspects of a project
14. Process - set of interrelated or interacting activities that use inputs to
deliver an intended result
15. Project - unique process, dates, undertaken to achieve an objective
requirement, including the constraints of time, cost and resources
16. Competence acquisition-process of attaining competence
17. Outsource (verb): Make an arrangement where an external
organization performs part of an organization’s Function or process
18. Contract -binding agreement
19. Design and development- set of processes that transform
requirements for an object into more detailed can be expressed in a broader,
more general sense than the requirements forming the output of design
20. System -set of interrelated or interacting elements
21. Infrastructure -<organization> system of facilities, equipment and
services needed for the operation of an organization
22. Management system - Set of interrelated or interacting elements of an
organization to establish policies and objectives and processes
23. Work environment - set of conditions under which work is performed
24. Measurement management system - set of operations required to
ensure that measuring equipment conforms to the requirements and control
of measurement processes
25. Policy - <organization> intentions and direction of an organization
26. Vision - <organization> aspiration of what an organization Management
27. Strategy -plan to achieve a long-term or overall objective
28. Nonconformity – deviation from the requirement(s)
29. Conformity – confirming to the requirements
30. Capability- The ability to perform a task

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31. Traceability – the ability to trace a process

32. Objective - result to be achieved
33. Success -<organization> achievement of an objective
34. Sustained success - <organization> success over a period of time
35. Output - result of a process
36. Product - output of an organization In the context of knowledge
37. Service - output of an organization In the context of knowledge
38. Performance - measurable result
39. Risk -information related to, understanding or knowledge of, an event,
its consequence, or likelihood.
40. Effectiveness - extent to which planned activities are realized and
planned results are achieved
41. Data - facts about an object
42. Information- meaningful data
43. Objective evidence- data, statements of fact or other information
which are relevant to the audit
44. Documented information- information organization and the medium
on which it is contained
45. Validation - objective evidence that the requirements for a test or other
form of determination such as performing alternative calculations or reviewing
documents
46. Change Management - Changes and the status of the implementation
of approved changes
47. Dispute - <customer satisfaction> disagreement, arising from a
complaint submitted
48. Characteristic - distinguishing feature
49. Monitoring - determining the status of a system a process a
product a service

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50. Measurement - process to determine a value

51. Measuring equipment- equipment/tool used measurement process
52. Test -determination according to requirements
53. Preventive action -Action to eliminate the cause of a potential
nonconformity or other potential undesirable situation
54. Corrective action - Action to eliminate the cause of a nonconformity
and to prevent recurrence
55. Correction-Action to eliminate a detected nonconformity
56. Regrade -Alteration of the grade of a nonconforming product or
service in order to make it conform to requirements differing from the initial
requirements
57. Concession -Permission to use or release a product or service
requirements
58. Release -permission to proceed to the next stage of a process or the
next process; Used to refer to a version of the software or the document itself.
59. Rework - action on a nonconforming product or service to make it
conform to the Requirements
60. Repair - action on a nonconforming product or service to make it
acceptable for the intended use on a nonconforming product or service
61. Audit - Systematic, independent and documented process for obtaining
objective evidence and evaluating it objectively to determine the extent to
which the audit criteria are fulfilled
62. Combined audit - audit carried out together at a single auditee on two
or more management systems
63. Audit programme- arrangements for a set of one or more audits
planned for a specific time frame and directed towards a specific purpose
64. Audit scope-extent and boundaries of an audit
65. Audit plan - description of the activities and arrangements for an audit

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66. Audit criteria- set of policies procedures or requirements used as a

reference against which objective evidence is compared
67. Audit evidence -records, statements of fact or other information, which
are relevant to the audit criteria / results of the evaluation of the collected
audit evidence against audit criteria
68. Objective evidence: Data supporting the existence or verity** of
something
69. Audit conclusion - outcome of an audit, after consideration of the audit
objectives and all audit findings
70. Auditee -organization being audited
71. Audit team - one or more persons conducting an audit technical expert
72. Auditor -person who conducts an audit
73. Observer -<audit> person who accompanies the audit team but does
not act as an auditor

74. Attack - is defined as “attempt to destroy, expose, alter, disable, steal

or gain unauthorized access to or make unauthorized use of an asset

75. Attack then becomes “attempt to destroy, expose, alter, disable, steal
or gain unauthorized access to or make Unauthorized use of anything that has
value to the organization”.
76. Access control - means to ensure that access to assets (2.3) is
authorized and restricted based on business and security Requirements
77. Accountability - responsibility of an entity for its actions and decisions
78. Asset - anything that has value to the organization.
There are many types of assets, including
A) information
B) software, such as a computer program

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C) physical, such as computer

D) services
E) people, and their qualifications, skills, and experience; and
F) intangibles, such as reputation and image
79. Authentication - provision of assurance that a claimed characteristic of
an entity is correct
80. Authenticity - property that an entity is what it claims to be
81. Availability - property of being accessible and usable upon demand by
an authorized entity
82. Business continuity - processes and/or procedures for ensuring
continued business operations
83. Confidentiality - property that information is not made available or
disclosed to unauthorized individuals, entities, or processes
84. Control - means of managing risk including policies, procedures,
guidelines practices or organizational structures, which can be administrative,
technical, management, or legal in nature.
85. Note control is also used as a synonym for safeguard or countermeasure.
86. Effectiveness - extent to which planned activities are realized and
planned results achieved
87. Efficiency - relationship between the results achieved and how well the
resources have been used
88. Event -occurrence of a particular set of circumstances
89. Guideline-recommendation of what is expected to be done to achieve
an objective
90. Impact -adverse change to the level of business objectives achieved
91. Information asset-knowledge or data that has value to the
organization

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92. Information security risk-potential that a threat will exploit a

vulnerability of an asset or group of assets and thereby cause harm to the
organization
93. Procedure-specified way to carry out an activity or a process
94. Process-set of interrelated or interacting activities which transforms
inputs into outputs
95. Record-document stating results achieved or providing evidence of
activities performed
96. Reliability-property of consistent intended behaviour and results
97. Risk-combination of the probability of an event and its consequence
98. Risk acceptance-decision to accept a risk
99. Risk analysis-systematic use of information to identify sources and to
estimate risk
100. Risk analysis provides a basis for risk evaluation, risk treatment and
risk acceptance
101. Risk assessment- overall process of risk analysis and risk
evaluation
102. Risk communication-exchange or sharing of information about risk
between the decision-maker and other stakeholders
103. Risk criteria -terms of reference by which the significance of risk is
assessed
104. Risk estimation-activity to assign values to the probability and
consequences of a risk
105. Risk evaluation -process of comparing the estimated risk against
given risk criteria to determine the significance of the risk
106. Risk management - coordinated activities to direct and control an
organization with regard to risk.

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107. Risk management generally includes risk assessment, risk treatment,

risk acceptance
108. Risk communication, risk monitoring and risk review.
109. Risk treatment - process of selection and implementation of measures
to modify risk

110. Threat -potential cause of an unwanted incident, which may result in

harm to a system or organization
111. Vulnerability - weakness of an asset or control that can be exploited
by a threat
112. Availability - ability of a component or service to perform its required
function at a stated instant or over a stated period of time. Availability is
usually expressed as a ratio of the time that the service is actually available
for use by the business to the agreed service hours.
113. Baseline - snapshot of the state of a service or individual configuration
item at a point in time (see
114. Change record - record containing details of which configuration items
are affected and how they are affected by an authorized change
115. Configuration item (CI) - component of an infrastructure or an item
which is, or will be, under the control of configuration management.
Configuration items may vary widely in complexity, size and type, ranging
from an entire system including all hardware, software and documentation, to
a single module or a minor hardware component.
116. Document- information and its supporting medium
117. Incident - any event which is not part of the standard operation of a
service and which causes or may cause an interruption to, or a reduction in,
the quality of that service
118. Problem - unknown underlying cause of one or more incidents

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119. Record - document stating results achieved or providing evidence of

activities performed
120. Release - collection of new and/or changed configuration items which
are tested and introduced into the live environment together
121. Request for change -form or screen used to record details of a request
for a change to any configuration item within a service or infrastructure
122. Service desk -customer facing support group who do a high proportion
of the total support work
123. Service level agreement (SLA)-written agreement between a service
provider and a customer that documents services and agreed service levels
124. Service management -management of services to meet the business
requirements

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Chapter 1
Introduction
Pioneer Engineering Company, Chennai, INDIA, established in 1989, is one of the
leaders in design, development, production and Sales of precision engineering
components specifically for automotive and heavy machinery industries in INDIA. PEC
has an additional production facility in Giza, Egypt.

PEC adopts the regional, national and local regulatory requirements in meeting customer
demands. Turnkey projects are the main stream operation of the company. It employs a
total of 164 personnel including CEO and Corporate Management Team in INDIA &
Egypt.

Certified to ISO 9001 in 2009, PEC has committed itself to ensure and exceed Customer
Satisfaction. Since the requirements of ISO 9001 have improved drastically, PEC now in
2020 is seeking ISO 9001:2015 Certification afresh.

With Mr. Ravikumar KE, CEO setting the Vision, Mission and strategic direction towards
having a dedicated Quality Management system, PEC is looking forward to ensure
continual improvement to become one of the TOP-10 Engineering companies in INDIA by
2030.

Scope for Quality Management system (for Chennai Plant only)

This QMS profile addresses the Scope of QMS as follows:
“Design, development, production and Sales of precision engineering components
of PEC, Chennai, INDIA”
.
Context of the organization
PEC has considered the external and internal issues that has impact on PEC and
ensures that the factors relevant to its Quality strategy at a management review keeping
in business view of political, economic, legal, technological and social factors. PEC
regularly monitors and reviews the validity of determined external and internal issues to
keep it current.

Needs and expectations of interested parties

Since Interested parties, both external and internal, have a major role in company’s
performance, PEC determines the interested parties relevant for QMS, and also
determines needs and expectations of determined interested parties such as Board of

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Directors, Investors, Customers, Suppliers and Sub-Contractors, Competitors,

Neighborhood, legal and statutory bodies.

Risks and Opportunities

PEC as a true pioneer in the industry recognizes the need to manage Risks and
Opportunities effectively by carrying out Risk Assessment and Risk Mitigation with
guidance from ISO 31000, and induct the same into our QMS.

Operational areas of PEC, Chennai for certification to ISO 9001:2015:

1. Office of Managing Director

2. Quality Planning
3. Sales & Marketing
4. Office of QMS Manager (covering ISO 9001 Internal audit programme)
5. Design & Development
6. Procurement
7. Production
8. Maintenance
9. Logistics
10. HR & Admin
11. Finance

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2. Quality Policy and Quality Objectives:

Quality Policy, PEC, Chennai

The management and employees of Pioneer
Engineering Company, Chennai dedicate our
professional competencies to ensure we consistently
delivery products and services to conform to and exceed
the expectations of our stakeholders particularly the
customers by deploying the principles of ‘doing right first
time, and continually improve every time’.
‘Best in Design, Best in Quality’ is our prime motto in
compliance with legal, statutory and regulatory
requirements in line with stipulations of ISO 9001:2015.

ddmmyyyy
(Signed) Ravikumar KE, MD
Quality Objectives
Metric Levels Per Annum
 Improving Design parameters for relevant processes 15%
 Reduction in Procurement costs 7%
 Maintaining Customer Satisfaction Threshold 98 %
 Profitability 4.6%
 Reduction of Customer Complaints, Appeals 5%

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RESPONSIBILITY

It is the responsibility of all PEC personnel to ensure that this policy is adopted at all times
and that of the Quality Manager to ensure that the Quality Policy is effective and
consistently meets the business needs of the company.

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3. Organization Structure and Responsibilities:

Roles and Responsibilities:

V 1.2 Organization Structure

PEC, Chennai

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The MD:

 has overall responsibility for ensuring that the customer needs are met
 is responsible for the quality policy and objectives
 is responsible for provision of resources to the quality management system
 has overall responsibility for ensuring that the legal obligations are met
 is responsible for the management review and determining resulting actions
 is responsible for recruitment and human resource improvement

Quality Manager (designated Quality Management Appointee)

 is responsible for the maintenance quality management system

 is delegated responsibility for ensuring the implementation of the system
 is responsible for ensuring the continued suitability and effectiveness of the system
and identifying and reporting of any needs for improvement
 is responsible for quality checking operations and quality department staff
 is responsible for audit of the system and reporting the results to the CEO.
 is responsible for promoting awareness of customer requirements.
 is responsible for all communications on quality matters.

Executive Director

 Is responsible for all communications with the customers regarding contracts and all
communications both in and out of the organization regarding contracts are through
him or his designated staff
 Is responsible for promoting company services via advertising, trade fairs and
mailing
 Is responsible for training of customers
 Is responsible for the management of company Website
 Is responsible for all purchasing activities

Planning Director

 Is responsible for the identification and planning of the development of new and
existing products in line with the organizations quality policies and objectives.

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
responsible for evaluating the quality effects of new products or changes and for
minimizing these impacts.
o Is responsible for design, enhancement and agreement of product designs with the
customers

Finance Director

While the main functions of the Finance Director are outside the coverage of the quality
system, the Finance Director is responsible for holding the originals of contracts with the
customers securely.

All Departmental Managers

are responsible for

 supporting and deputizing for the Directors to whom they report.
 ensuring the implementation of the quality management system in their process
areas.
 the provision of adequate resources in their departments and for ensuring that the
working environment is suitable to ensure quality requirements are satisfied.
 ensuring that reporting staff are aware of the risks to quality that their actions could
possibly cause.
 ensuring that plans and programmes for improvement within their areas where they
exist are implemented effectively and are recorded as appropriate.
 ensuring that all quality issues within their areas are fully documented recorded and
controlled.

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 Are responsible for the review and identification of training needs of their
departments and retention of records.

All Staff

 are responsible for conformity to the requirements of the management system at all
times.
 are responsible for reporting any incident or action s that could lead to a quality
incident to the appropriate manager.
 are responsible for supporting the directors and managers to whom they report.

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Chapter 4
Quality Planning
The means of ensuring that PEC, Chennai. meets customers requirement has been
planned for design, development, material control, procurement, logistics, HR, Finance
and other processes under the scope of ISO 9001:2015 implementation.

Operation Director is responsible for effective Quality Planning.

Marketing Division is responsible for Deals, promotions and contacts with the
customers. On receipt of enquiry, they shall determine the customer’s needs.

Customers’ previously approved designs used for an order/contract, shall be validated by

the customer if the same design is to be used for subsequent order/contract for the same
customer.

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Chapter 5

QUALITY MANAGEMENT SYSTEM DOCUMENTATION:

The management system of PEC, Chennai is clearly documented in the Network/
computer system as follows-

1. Apex Quality Manual: Although the requirement of Quality Manual is not specified
exclusively by ISO 9001:2015, this document addresses the policies of the organisation
with regards to planning and operations that leads to customer satisfaction. It identifies
the responsibilities of personnel and the procedures by which the policies are
implemented.

2. Procedures: These documents support the manual by describing the system

elements by which the policies of the company are carried out and describe the activities
involved, the responsibilities of persons involved and any documentation or records
required.

Responsibilities:

1. It is the responsibility of the Quality Manager to co-ordinate the production and

check of the quality system documentation.

2. It is the responsibility of the managers of each process area to approve procedures

in operation in their areas and ensure that staff understand and implement them.

3. It is the responsibility of all staff to follow the documented system at all times and
notify the manager concerned any shortcomings or if changes are needed.

DOCUMENT CONTROL
Documents pertaining to the quality management system shall be controlled by means of
procedures to ensure that -

1. They can be located and referenced

2. They are reviewed for current validity, and suitability
3. Outdated documents are removed from the point of use
4. Any obsolete documents retained for any reason is identified and labeled

Documentation shall be legible, clear, unambiguous, dated, and identifiable by revision

/version number where applicable, readily identifiable, and maintained as current.

Reference: PECC/PROCD/01 Procedure for Control of Documented Information

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Chapter 6

Resources and Support including Training, Awareness and

Competence:

Policy

The company operates an annual review system by means of reviewing the training
needs for the forthcoming year. Also when new technology or equipment or processes
are introduced a review of training prior to starting is made by the manager with
responsibility for that area. All personnel whose work may affect quality shall be trained-

1. Awareness of the operating systems of control of the process. (Including

responsibilities).

2. Awareness of the significant impacts of both the company and their individual
activities have and can have on the quality of the product.

3. Competency in the activity (Through training, education or experience).

Records of such training shall be retained and be available.

Responsibilities

1. The managers of each area are responsible for ensuring that all reporting personnel
are trained for the tasks that they perform. Internal training is their responsibility.

2. The managers of each department are responsible for reviewing the training needs
of all reporting personnel and informing the CEO.

3. The CEO is responsible for formally reviewing and evaluating training needs and
effectiveness and for provision of training by outside organizations and for keeping
training records relating to personnel operating in that area

Reference: PECC/PROCD/02 Procedure for resources and Support including Training,

Awareness and Competence

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Chapter 7

Pre-Production:
Planning, Design and Development activities, Material Control process, Stock Acquisition
to Production Shops will include ‘Pre-Production processes.

Planning: One of the prime focuses is towards Risk Management in terms of Risk
Identification, Risk Analysis, Risk Evaluation, and Risk Mitigation of business risks.

Responsibility: Operations Director

The Risk Manager, reporting into Operations Director, has the responsibility to plan
a) actions to address business risks and opportunities
b) the methodology to
1) integrate and implement the actions into our quality management system processes
2) evaluate the effectiveness of Risk Management actions.

Actions taken to address risks and opportunities must be in proportion to the possible
impact on the conformity of products and services.

PEC, Chennai realizes that the Options to address risks can include avoiding risk, taking
risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood
or consequences, sharing the risk, or retaining risk by informed business conclusions.

Operations Director, PEC, Chennai will ensure that opportunities may lead to the
adoption of new business practices, launching new services/products, opening new
customer base or geographies, addressing new customers, building association, opting
new technology and other favorable and feasible possibilities to address the needs of
PEC and/or the organization’s or its customers.

Appropriate procedures exist to ensure Pre-Planning process, Design and Development

activities, Material Control process, Stock Acquisition to Production Shops to meet the
QMS requirements as per ISO 9001:2015.

Reference: PECC/PROCD/03 Procedure for Pre-Production

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Chapter 8

Production:
Responsibility: Operations Director

Manager/Planning and Control is responsible to facilitate coordination with other

divisions, plan, implement and control the QMS processes needed to meet the
requirements for the provision of products and/or services, and to implement the actions
determined in by
1. determining the requirements for the products and/or services;
2. establishing criteria for
a) the processes, product lines, and service provisioning
b) the acceptance criteria of products and services based on customer needs
c) determining the resources needed to achieve conformity to the product and service
requirements
d) implementing control of the processes in accordance with the criteria
e) determining, maintaining and retaining documented information to the extent
necessary:
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.

The result of such planning needs to be suitable for the business enablement of PEC,
Chennai.

Manager/Planning and Control to control planned changes and review the consequences
of unintended changes, taking action to mitigate any adverse effects, as deemed fit.

Manager/Planning and Control is responsible to ensure that all outsourced processes,

including procurement, sub-contracting for all types of engineering works, cafeteria, and
administrative requirements are controlled and monitored.

Communication with Customer:

Manager/Planning & Control is responsible to ensure a robust process for customer

communication across PEC to cover
a) providing information relating to products and/or services
b) handling enquiries, contracts or orders, including changes
c) obtaining customer feedback/complaints relating to products and services complaints
d) handling or controlling property of customers as appropriate
e) establishing specific requirements for contingency actions, as warranted

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Determining and reviewing the requirements for products and

services:

Towards determining and reviewing the requirements for the products and services to be
offered to customers, Manager/Planning & Control to ensure that

1. the requirements for the products and services are defined and determined,
including

I. applicable legal, statutory and regulatory requirements

II. PEC’s requirements

2. PEC can fulfil the claims for the products and services that we offer and propose to
the market.

Design and development of products and services:

Responsibility: Operations Director

Manager/Design and Development is responsible for overall process of Design and

Development of products and services of OEC, Chennai.

Design and Development: Planning and Inputs: PEC, Chennai’s. requirements relating
to the design will be managed considering any legal/statutory/regulatory requirements,
and applicable industry information. The design inputs will suitably be reviewed by the
design Team aiming at providing the best design of products and services.

Any change/s to the design will be identified and controlled including an evaluation of
changes of parts and impact on the product and other related functions. All changes shall
be verified and validated, as appropriate and approved before implementation. The
results of such reviews and changes made and retained as documented information.

Changes requested by the customer/s are initially analyzed by Marketing Department

who will review the type of change requested. Such changes will be then forwarded to
Design and Development Division for final technical review, analysis, evaluation, approval
and sharing the same with Production Division.

Reference: PECC/PROCD/04 Procedure for Production

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Chapter 9

Maintenance:

1. SCOPE

This procedure of PEC defines the actions and responsibilities of the Maintenance
Manager in maintaining the Machinery & equipment in good working condition. This
covers activities from receiving maintenance request up to a turnover of machine &
equipment to the concerned unit

2. PURPOSE

To ensure sustenance of machine and equipment capability by periodic preventive

maintenance.

3. REFERENCE DOCUMENTS

3.1 Quality Manual

3.2 Procedure for Production

3.3 Work instructions for Maintenance (Preventive, Breakdown, Preventative, and

Scheduled)

3.4 Procedure for Equipment Calibration and Maintenance

4. TERMS & DEFINITIONS

4.1 Preventive Maintenance: Preventive maintenance is maintenance that is regularly

performed on a piece of Machinery or equipment to lessen the likelihood of it failing. It is
performed while the equipment is still working so that it does not break down
unexpectedly.

4.2 Breakdown Maintenance: Breakdown maintenance is maintenance performed on a

piece of Machinery or equipment that has broken down and is unusable. It is based on a
breakdown maintenance trigger. It may be either planned or unplanned.

5. RESPONSIBILITY AND AUTHORITY

Maintenance Manager is responsible to plan and carry out periodic preventive

maintenance and ensure continued process capability, and also for responsible for
prevention of oil spillage, vibration, emission and noise level.

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6. DETAILS OF PROCEDURE

6.1 Based on conditions of use and experience, periodic maintenance work on machines
is planned by maintenance dept. it is identified in relevant preventive maintenance work

instruction.

6.2 Maintenance is done based on the maintenance schedule.

6.3 Work instruction for daily maintenance like checking, filling of oil/grease of production
machine is given to PROD for execution.

6.4 Scheduled and other maintenance plans are executed by maintenance dept
personnel

and records are maintained in the respective machine file.

6.5 When breakdown occurs necessary repair/rectification work is carried out and records
are maintained. Maintenance manager reviews the record and classifies the machine
break down as either ‘Minor’ or ‘Major’ and maintains records of downtime hours, spares
consumed and the approximate cost of spares/repair. Root cause analysis and
corrective/preventive action records shall be maintained for all the major machine
breakdowns, The records shall include details of breakdown experienced/attended, the
effectiveness of action taken and preventive action if any.

6.6 If the root cause of machine break-down is due to normal wear and tear of the
repaired/rectified parts then same shall be considered as ‘Minor’, but in case ‘Minor’ is
repeated then it shall be considered as ‘Major’.

6.7 Machine Details like make, capacity, location and spares parts of the machine shall
be maintained in the respective machine file.

6.8 Maintenance Manager plans to procure and stock essential spare parts to ensure
maintenance with minimal downtime. List of critical spares and existing stock is
maintained.

6.9 All the spares/accessories with shelf life shall be identified with the label containing
details like Name, the location of use/application and date of receipt etc.

6.10 Breakdown hours reported in the machine breakdown report shall be analyzed for all
production machines on a regular basis.

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6.11 Maintenance of production draw dies, rolls & edge rollers are verified to ensure
proper working condition. Records are maintained in respectively.

6.12 Maintenance department should check and maintain the record for Oil spillage,
vibration, emission and noise in work area

6.13 Maintenance Manager will carry out fortnightly meeting with managers of Design and
Development, Production, and Procurement/Stores Divisions, and retain Minutes of
Maintenance Review

7. RETAINED DOCUMENTED INFORMATION:

7.1 Preventive Maintenance Schedule – (PECCMAINT/F/01)

7.2 Maintenance History Card – (PECCMAINT/F/02)

7.3 Corrective/Preventive action-for Major Breakdown – (PECCMAINT/F/03)

7.4 Critical Spare Parts – (PECCMAINT/F/04)

7.5 Maintenance Work Order – (PECCMAINT/F/05)

7.6 Breakdown Analysis – (PECCMAINT/F/05)

7.7 Oil spillage/Vibration/emission/Noise level – (PECCMAINT/F/05)

7.8 Non-conformity Report (PECC/QC / QF/01)

7.9 Minutes of fortnightly Maintenance Review (PECC/MAINT/REVW/07)

Reference: PECCHENNAI/PROCD/05 Procedure for Maintenance

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Chapter 10

Performance Evaluation including measurement and evaluation

Performance in every process of PEC is measured in a variety of scientific methods, by

customer satisfaction surveys, by calculating the number of site visits and analyzing
growth trends and by complaint analysis.

Responsibilities

Operation Director, who is responsible for Performance Evaluation of PEC, Chennai, will
ensure that the organization first need to shall determine

a) which process/product/service level needs to be monitored and measured

b) the methodology for each segment for monitoring, measurement, analysis and
evaluation needed to ensure valid results
c) the frequency of performing monitoring and measuring activities
d) the schedule when the results of monitoring and measurement to be analysed and
evaluated.

Performance Evaluation process in PEC, Chennai will cover the following major business
needs with suitable metrics:

a) Customer Satisfaction levels

b) QMS Internal Audits
c) QMS 2nd party audits and 3rd party audits, and
d) QMS Management Review

Operations Director will arrange to maintain & retain documented information for all the
proceedings related to Performance Evaluation.

All QMS audits of PEC, Chennai be scheduled and executed at defined regular intervals
in accordance with procedures in order to ensure that the system conforms to the planned
arrangements and has been properly implemented and maintained. The essential aspect
of the audit is to bring about improvement in the system and so improvement in
performance of the company. The results of audits shall be used for this purpose only and
all staff is encouraged to indicate and identify any areas where they might conceive non-
conformance may arise. It should be recognized that the auditees are the beneficiaries of
an audit as they are able to improve their system as a result of the audit.

An audit programme shall be produced annually to ensure that all the site and associated
activities are covered. The frequency of audits shall be in accordance to

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a) The nature of the operation and the status and importance the activity may have
with regards to quality.

b) The results of previous audits,

c) The quality performance.

Auditors shall be selected to be as independent as possible from the activity and be given
the technical support to conduct the audit. All auditors shall be trained in quality auditing
techniques and methodologies. The results of audits shall be reported to the management
responsible for the area or activities and corrective actions shall be initiated and followed
up in accordance with procedures. Results of audits shall be reported to the Directors at
the Management Review Meeting.

Responsibilities

1. It is the responsibility of the Quality Manager to produce an audit programme

annually and to monitor improvement of the system.
2. It is the responsibility of all Managers to implement corrective actions to any non-
conformances or potential non-conformances identified in their areas.
3. It is the responsibility of all auditors to act impartially and in accordance with
procedures clearly recording all observations.
4. It is the responsibility of all auditees to assist the auditors in the conduct of audits
and managers with corrective actions.

MANAGEMENT REVIEW

It is the policy of PEC, Chennai for Top Management to review the quality management
system at defined intervals to ensure its continued suitability, adequacy and
effectiveness.

The Management Review is conducted by the Directors and will consider complaints,
customer feedback, customer surveys, Performance evaluation, audit results, non-
conformances and corrective actions, preventive actions, improvement projects
programmes and progress. The review meeting shall consider possible changes in
market requirements, technology, legislation and policies or other possible needs to
change the quality management system.

Improvement actions and assignment of responsibilities shall be decided at this meeting

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with detailed plans drawn up by the person responsible where required.

They will review projects and consider setting new objectives and the continued suitability
of the quality policy.

Management Review headed by Managing Director is held twice a year once in 6 months.

The next meeting shall be scheduled at the conclusion of the review meeting.

Responsibilities

1. The MD is responsible for the conduct of this meeting

2. The Quality Manager is responsible for scheduling the meeting, acting as secretary
and recording the minutes of the meeting.

Reference:
PECCHENNAI/PROCD/06 Procedure for Performance Evaluation including measurement and
evaluation

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Chapter 11

Non-conformity Management

Nonconformities, also known and recognized in PEC as Incidents, Defects, Problems,

Negative Issues, Hazards, Ill effects, undesirable practices and attitudes, will be
addressed and mitigated ASAP.

Responsibility:

Quality Manager

Non-conformities in PEC can rise in a number of ways such as complaints, audits and
reviews, and accidents. It is the policy of PEC to take identify and immediate mitigating
actions and to then establish the root cause of the problem taking action to prevent any
re-occurrence.

The system will follow the opportunities for improvement system whereby corrective
actions are identified and the responsibility for action and completion designated within
agreed timescales.

The Process Manager responsible for the activities where problems have arisen shall
take correction first as deemed fit, and then take corrective action to identify and eliminate
the causes of nonconformities in order to prevent reoccurrence. Corrective action shall be
appropriate to the impact of problems encountered.

Documented procedures shall include –

1. Identifying nonconformities, nonconforming products/services (including complaints)
2. Determining the causes.
3. Evaluating the need for actions to prevent recurrence.
4. Determining and implementing the actions needed.
5. Recording the results of actions taken.
6. Reviewing of actions taken.
7. Getting the NCs followed-up by auditor for timely closure of NCs
8. Updating QMS system through its processes, procedures, and records

The effectiveness of the actions then being checked, Records of incidents and the
corrective actions shall be recorded including communications external to the company.

Responsibilities

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1. The Quality Manager is responsible for the co-ordination of these activities and for
advising Managers on corrective actions required.

2. All Managers are responsible for the compliance of the Quality management
system in their areas and must rectify any non-conformities as quickly as is reasonably
possible.

3. All staff is responsible for informing management whenever they come across a
non- conformity may occur or has occurred.

4. The Directors and Managers are responsible for monitoring non-conformities and
for the initiation of improvement projects in their areas.

5.

Reference:

CHENNAI/PROCD/06 Procedure for Nonconformities Management

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Chapter 12

COMMUNICATIONS
Documented information will be maintained and operated for the control of company
communications both internally and externally. External procedures shall be for
communications with legislator bodies and for with local interested parties and for with the
customer. Internal communications shall ensure that communications arriving from
external sources and developed through internal decisions are disseminated as
appropriate. Communications links between management and staff shall be established
by each department and weekly briefing meetings must be held. (Minutes of these
meetings need not be made to encourage free discussion by all staff.)

Responsibilities

1, The Marketing Director is solely responsible for entire CHENNAI, Chennai for all
communications with all the stakeholders both internal and external, the customers and
all communications both in and out of the organisation are through him or marketing staff.

2. External enquiries on technical matters whether from the customer or the public
must be directed to the Marketing Director who is responsible for replying.

3. The Quality Manager is responsible for enquiries and complaints on quality. He is

responsible for ensuring communications within the company on quality related matters.

4. All managers are responsible for communications within their areas and must
ensure that information is directed to all personnel in their department on a need to know
basis.

4. All staff have a duty to be aware of communications and must indicate whether or
not they understand the communication at the time to the Manager.

References

CHENNAI/PROCD/08 Procedure for Communications

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Chapter 13

Continual Improvement Programmes

The Quality Manager shall collect and analyze appropriate data to determine the
suitability and effectiveness of the QMS and determining where quality management
system improvements can be made. This includes data generated by measuring and
monitoring activities and other relevant sources.

Quality Manager to ensure that all business-critical process areas impacting Customer
Satisfaction shall have mandatory Quality Objectives of developing Continual
Programmes of atleast 5 (Five) continual improvement projects (CIP) per annum.

He/she shall analyze this data to provide information on:

1. customer satisfaction, and dissatisfaction
2. conformance to customer requirements
3. Characteristics of processes, products and their trends;
4. Suppliers

The Marketing Director with the assistance of the Quality Manager shall plan and manage
the processes for the continual improvement of the quality management system. They
shall use the quality policy, objectives, internal audit results, analysis of data, corrective
and preventive action and management review to facilitate continual improvement.
.
The Quality Manager shall identify preventive action to eliminate the causes of potential
nonconformities to prevent occurrence. Preventive actions should be appropriate to the
impacts of the potential problem.

Documented information maintained shall define requirements and processes for

1. Identifying potential nonconformities and their causes.
2. Determining and ensuring the implementation of actions needed.
3. Recording the results of actions taken and reviewing actions taken.

Reference –
CHENNAI/PROCD/09 Procedure for Improvement Projects

<<<<<<<<END OF PEC, CHENNAI QUALITY MANUAL >>>>>>>>>

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