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COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
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COMPANY ________
QUALITY MANUAL
COPY NO: ________/____
ISSUED TO: ______________
TABLE OF CONTENTS
ISO/TS
16949:2009
Clause No.
-

Description

Page No.

1. Distribution List

2. Revision Records

3. Organization profile

4. Quality Management System

5. Management responsibility

6. Resource management

15

7. Product realization

17

8. Measurement, Analysis and Improvement

27

Responsibility Matrix (Annexure-01)


Interaction Map of the Process of the Quality
Management System (Annexure-02)
Locations and Activities (Annexure- 03)

33

36
37

1. DISTRIBUTION LIST

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2. REVISION RECORDS
Review
No.

Date

Page No

Nature of Revision

3. ORGANIZATION PROFILE
Background- Company
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
______________________________________________________________________________
Company-India
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
______________________________________________________________________________
Products:
_______________________________________________________________________________
_______________________________________________________________________________
______________________________________________________________________________
Customer profile:
_______________________________________________________________________________
______________________________________________________________________________
4. QUALITY MANAGEMENT SYSTEM
4.1 General requirements
A documented Quality Management System has been established and maintained to meet the
requirements of ISO /TS 16949:2009, in all the activities of Company and the organization is
committed to continually improve the effectiveness of the Quality Management System.

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While establishing, implementing and maintaining the Quality Management System, the following
aspects are considered and established:
a)
b)
c)
d)

Processes are determined and applied throughout the organization,


Sequence and interaction of these processes are determined (see Annexure 1),
Criteria and methods for effective operation and control of these processes are determined,
Resources and information necessary to support the operation are made available and
these processes are monitored,
e) Identified processes are monitored, measured, and analyzed, and
f) Actions are implemented to achieve planned results and continual improvement of the
processes.
The processes established are managed in accordance with the requirements of ISO/TS
16949:2009 and outsourced manufacturing process has been identified and process to be followed
mentioned in XXX-XXX-XXX-XX
During development of Quality Management System, normative reference ISO 9000: 2005, Quality
Management Systems-Fundamentals and Vocabulary has been made use of.
4.1.1 General requirements Supplemental
XXX takes responsibility for conformity to all Customer requirements including those connected with
outsourced processes.
4.2 Documentation requirements
4.2.1 General
The Quality Management System documentation at XXX consists of:
a) Quality Manual and statement of Quality Policy and Quality Objectives,
b) General Management Procedures,
c) Work Instructions/Work Instructions, Job Aid, Drawings, Control Plans, PFMEA,
d) Formats, and
e) Documents of external origin such as applicable Quality Management System Standards,
Customer Drawings, Specifications, Material and Testing Standards.
Records required for the effective functioning of the Quality Management System has been
identified and controlled and detailed in 4.2.4 and XXX-XXX-XXX-XX.
MISSION
_______________________________________________________________________________
______________________________________________________________________________
VISION
______________________________________________________________________________
CORPORATE VALUES
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
__________________________________________________________________________

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QUALITY OBJECTIVES
SL
No

MONITORING
FREQUENCY

QUALITY OBJECTIVES

4.2.2 Quality Manual


a) The Scope of the Quality Management System established and maintained covers:
_______________________________________________________________
The following clauses of the standard are not applicable to the activities of COMPANY:
Clauses 6.2.2.1 (product design skills), 7.3.2.1 (product design inputs) and 7.3.3.1
(product design outputs) are not applicable as product design and development activities
are not involved as products are manufactured as per specifications or
national/international standards such as IS/ASTM/DIN, and
Clause 7.5.4 (Customer property) there are no customer property involved in manufacture
of existing products. Procedure will be established and implemented as and when it
becomes applicable.
b) Reference to applicable documented procedure is given while addressing each requirement
of the standard in the quality manual. List of documented procedures required by the
standard and those needed for effective operation of the Quality Management System is
given in pages 6 & 7
c) Interaction between processes of the Quality Management System is detailed in Annexure 2.
And remote locations and activities detailed in Annexure 3
List of Procedures

4.2.3 Control of documents


XXX-XXX-020-01details the methods of control of documents of internal origin and external origin
The control exercised covers the following:
a) Approval of documents for adequacy prior to issue,

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b) Personnel responsible for review and updating of documents including re-approval,


c) Methods of identification of documents, identification of changes and current revision status
through defined numbering system and maintenance of master list and control of changes,
d) Control regarding ensuring that relevant versions of applicable documents are available at
point of use and maintenance of distribution list,
e) Control towards ensuring that documents remain legible and their replacement when they
become illegible,
f) Documents of external origin, responsibility for maintenance and methods of distribution, and
g) Removal of obsolete documents from points of use and identification of obsolete documents
retained for any purpose.
4.2.3.1 Engineering specification
Process has been established for timely review, distribution and implementation of Customer
engineering standards/specifications. Timely review should be as soon as possible, and shall not
exceed two working weeks. Records of implementation in production and of updated documents are
maintained. Procedure XXX-XXX-002-02, XXX-XXX-015-04, XXX-XXX-020-04, XXX-XX-020-04
details the handling of engineering changes, changes in internal documents towards improvements
and changes at supplier end.
4.2.4 Control of records
Records, which provide evidence of conformity to requirements and of the effective operation of the
Quality Management System have been identified, established and maintained.
Procedure XXX-XXX-020-02 details the records maintained their methods for identification, storage,
protection, retrieval, and disposition. The procedure describes the list of quality records along with
their minimum retention period.
Records are ensured to be readily identifiable to the products/services involved and ensured to be
legible and are stored in areas having adequate protection against deterioration, damage, or loss.
Records include Customer-specific ones and maintained towards regulatory compliance ones.
4.2.4.1 Record retention
Retention time of records is ensured to meet Customer, statutory and regulatory requirements.
5. MANAGEMENT RESPONSIBILITY
5.1 Management commitment
Top Management is committed to the development and implementation of the Quality Management
System and to continually improve its effectiveness.
Towards the above:
a) Importance of meeting Customer requirement, as well as statutory and regulatory
requirements, has been communicated at various levels of the organization.
b) A Quality Policy has been established (Integrated Policy).
c) Quality objectives have been established, targeted, and reviewed periodically in
management review meetings.
d) Management review meeting are being conducted periodically to ensure the continuing
suitability, adequacy, and effectiveness of Quality Management System established and
implemented.
e) Adequate resources have been provided for all the activities of the organization. They are
periodically reviewed and needed resources are identified and provided.

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Effectiveness and efficiency of product realization and support processes are reviewed by
Top Management during management reviews.

5.1.1 Process efficiency


Efficiency and effectiveness of product realization and support processes are reviewed by top
management in management review meetings.
5.2 Customer focus
Processes have been established by Top Management to determine Customer requirements and to
effectively meet those requirements with the aim of enhancing Customer satisfaction.
5.3 Quality policy
Statement of Integrated Policy (covering Health & Safety, Environment and Quality) is given
defined by Chief Executive Officer and adopted by all Company companies.
The Integrated Policy statement;
a) Is ensured to be appropriate for the organization.
b) Includes a statement to comply with the requirements and to continually improve the
effectiveness of the Quality Management System.
c) Provides a framework for establishing and reviewing the quality objectives.
d) Is ensured to be communicated and understood within the organization by:
Suitable awareness programs at all levels of the organization.
Display of Integrated policy boards.
Issue of Integrated policy cards.
Establishment of Quality objectives processes for control and review at all
functional areas.
e) Is reviewed during Management Review Meetings for continuing suitability.
5.4 Planning
5.4.1 Quality objectives
Overall quality objectives of the organization are stated
The quality objectives are ensured to be consistent with the Integrated Policy and
measurable. Quality objectives and targets are established and monitored for all the areas
where ISO/TS16949:2009 scope covers.
Quality objectives established include those needed to meet the expectations of Customer
and achievable within a defined time period.
5.4.1.1 Quality objectives-Supplemental
Quality objectives and Measurements are defined by Top Management and included in Plan
of Business ( ).
5.4.2 Quality Management System planning
a) Planning of the Quality Management System is carried out by Top Management to meet the
general requirements of the Quality Management System (4.1) and the stated quality
objectives.
b) These processes are reviewed periodically and whenever changes are envisaged for
improvement, these changed processes are ensured to be integral with the Quality
Management System established to meet the Integrated Policy and objectives.

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5.5 Responsibility and authority and communication


To ensure effective implementation of the established Quality System, the responsibility and
authorities of individuals and their interrelationships are defined through:
o Responsibility and authority
o Organization chart
o Responsibility Matrix (Annexure 1)
5.5.1 Responsibility and Authority
In addition to control of applicable documents and records in their activity, the following specific
responsibilities and authorities are defined for identified personnel.

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Position Wise Responsibilities to be specified here along with Organizational structure


5.5.1.1 Responsibility for Quality
Managers responsible for quality are informed promptly when products or processes do not
conform to requirements.
Personnel responsible for quality are authorized to stop production to correct quality problems.
Personnel in charge for product quality are identified in all production shifts.
5.5.2 Management representative
Management Representative is nominated by Top Management.
Management Representative is responsible and authorized for:
a) Ensuring that the processes for the Quality Management System are established
implemented and maintained.
b) Reporting to Top Management on the performance of the Quality Management System and
improvement action needed.
Arranging periodic Internal Audits towards effectiveness of the Quality Management
System.
Follow up for timely corrective and preventive actions identified during Internal Audit and
verification for the effectiveness of the actions taken.
c) Taking necessary actions for the promotion of awareness of Customer requirements and
expectations throughout the organization.
d) Liaison with external parties on matters relating to the Quality Management System.
5.5.2.1 Customer Representative
Customer Representatives are nominated by Top Management with Authority and Responsibility to
address Customer requirements. Requirements includes selection of special characteristics,
training, setting Quality objectives, corrective & preventive actions and product development
5.5.3

Internal communication

Sl No

Topics to be
communicated

Responsibility
for
communication

Communication to

Mode

Time frame

5.6 Management review


5.6.1 General
Management reviews of the Quality Management System are conducted at planned
intervals to ensure its continuing suitability, adequacy, and effectiveness. The review

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includes assessing opportunities for improvement and need for changes to the Quality
Management System, including Quality Policy and Objectives.
Top Management carries out the reviews. Management Representative facilitates the
management review activity.
Reviews are planned and conducted once in 6 months. Participants for review include
those responsible for carrying out processes of the Quality Management System.
Records of management review are maintained including decisions taken,
responsibilities and target dates.
Management Representative follows up actions decided in the management review.
Procedure XXX-XXX-020-03 details the management review process.

5.6.1.1 Quality Management System performance


Management Review includes all requirements of Quality Management System and its
performance trends.
Monitoring Quality Objectives and cost of poor quality is a part of the agenda for review.
Achievement of Quality Objectives specified in Plan of Business ( ) and Customer
satisfaction with products supplied are reviewed and recorded.
5.6.2 Review Input
Inputs to management review include information on:
a) Results of audits (Internal, Process & Product and by regulatory bodies).
b) Review of Customer feedback, trends of Customer satisfaction index and trends of
Customer complaints.
c) Review Process conformance and product conformity.
d) Status preventive and corrective actions.
e) Follow-up actions from previous management reviews.
f) Changes that could affect the Quality Management System.
g) Recommendations for improvement.
5.6.2.1 Review input-supplemental
Analysis of actual field failures and their impact on quality, safety or the environment is
provided as input to management review.
5.6.3 Review Output
Outputs of management review include any decisions and actions related to;
a) Improvements in the effectiveness of the Quality Management System and processes,
b) Improvement in product/ service related to Customer requirements and
c) Resource needs.
6. RESOURCE MANAGEMENT
6.1 Provision of resources
Resources needed to implement, maintain and to continually improve the effectiveness of
the Quality Management System has been determined and provided. Resource include
human resources, specialized skills, technology and/or financial are reviewed in
management review meetings and strategic planning meetings. These resources are
reviewed in the light of enhancing the Customer satisfaction by meeting the Customer
requirements and expectations.
6.2 Human Resources

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6.2.1 General
Personnel performing work affecting conformity to product requirements are ensured to be
competent on the basis of appropriate education, training, skill, and experience.
6.2.2 Competence, training and awareness
a) Competency levels required for each work area affecting conformity to product
requirements has been analyzed and determined. Job descriptions are maintained for
each position in the Organization.
b) Training needs are continually assessed and identified. Training is planned and provided
to enhance the competencies of personnel.
c) Training plans are reviewed and their effectiveness is evaluated periodically.
d) Awareness programs are conducted at various functions and levels to highlight the
relevance and importance of their activities and how they can contribute to the
achievement of quality objectives.
e) Appropriate records of education, training, skills and experience of personnel are
maintained.
Training activities are detailed in procedure XXX-XXX-013-02.
6.2.2.1 Product Design skills
Not applicable
6.2.2.2 Training
A documented procedure has been established and maintained to identify training needs to achieve
competence of all personnel performing activities affecting Quality. Personnel performing specified
tasks are ensured to be qualified including requirements of Customers.
6.2.2.3 Training on the Job
On the job training is provided to all the personnel whose activities affect product Quality.
Appropriate training is given to contract workers also.
6.2.2.4 Employee motivation and empowerment
Activities to motivate employees to achieve quality objectives and to make continual improvements
are in place. This includes training programs, awareness programs, suggestion schemes,
Participation Scheme activities and small group activities.
Measurement of extent to which personnel are aware of relevance and importance of
their
activities and their contribution to achievement of quality objectives is undertaken as per Procedure
XXX-XXX-013-01.
6.3 Infrastructure
Infrastructures needed to achieve product conformity have been determined, provided, and
maintained. These include:
a) Buildings and workspace,
b) Process Equipments and utilities, and
c) Supporting services for communication and computing.
Buildings are maintained in good state of repair and Workspaces are kept neat and
tidy.

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Procedure for maintenance of Infrastructure is detailed in XXX-XXX-011-01. This


includes process equipments, utilities, communication, and computing equipments
Resource requirements are reviewed during management reviews.

6.3.1 Plant, facility and equipment planning


A Multi-disciplinary approach is used to develop plant, facility and equipment plans. Plant layouts
are reviewed to optimize material travel, handling and value-added use of floor space and
synchronous material flow. Methods are developed to evaluate and monitor the effectiveness of
existing operations. Records of evaluation and of any plans for improvements are maintained.
6.3.2 Contingency plans
Contingency plans are prepared to satisfy Customer requirements in the event of emergencies
like utility interruptions, labor shortages, key equipment failures and field returns
(Procedure:XXX-XXX-020-17).
6.4. Work Environment
Work environment is determined, managed, and ensured to be safe and conducive to achieve
conformity with product requirements. There are no environmental conditions like noise, ambient
temperature, humidity, illumination etc which affects meeting the requirements of the product.
6.4.1 Personnel safety to achieve Product Quality
Appropriate Personnel protective equipments and work instructions are provided to ensure potential
risks to employees are minimized (Safety Hand Book: GBS; Environment Health & Safety Hand
Book)
6.4.2 Cleanliness of premises
Work Premises is kept in good state of order, cleanliness and repair. 5S activities are carried out to
maintain state of cleanliness.

7. PRODUCT REALIZATION
7.1 Planning for product realization
When new products are envisaged for introduction the following aspects are reviewed:
a) Quality Objectives and requirements of the product,
b) Establishment of processes including tooling requirements,
c) Documentation required (eg. Process datasheets, work instructions)
Provision of resources (human resources with necessary skills and Infrastructure),
d) Verification, monitoring and measurement stages (at receiving, in process and final stages)
and methods. Validation requirements of processes and
e) Records to be maintained as evidence that the activities to meet requirements.
Product and manufacturing design and development (Advanced Product Quality Planning (APQP))
process is followed for all new products and applicable documentation is maintained. This includes
Customer requirements, technical specifications, and acceptance criteria.
Out puts of APQP process include Material Specifications, FMEAs, Control Plan and Work
Instructions (Work instructions).
Design reviews, verification and validation conducted at appropriate stages.

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PPAP process is followed as recognized by Customer. Process approval procedure is also


applied to identify Suppliers.
Manufacturing process design and development is detailed in XXX-XXX-020-18.
A process for change control arising out of XXX or from suppliers is established to ensure
compliance with Customer requirements. Changes are validated before implementation. XXXXXX-002-02, XXX-XXX-015-04, XXX-XXX-020-04, XXX-XX-020-04 details the process.
7.1.1 Planning for product realization
Customer requirements and reference to technical specifications are included in planning for
product realization as a component of Control Plan.
7.1.2 Acceptance criteria
Acceptance criteria is defined and approved by Customer, if required. For attribute data sampling,
the acceptance level is Zero.
7.1.3 Confidentiality
Confidentiality of Customercontracted products, projects under development and product
information are maintained.
7.1.4 Change control
Process has been established for control that impact product realization. This includes changes
made in-house towards improvements and changes caused by suppliers. Changes are validated
before implementation.
For proprietary designs, impact of form, fit and function are reviewed with Customer after
evaluation.
When required by Customer, additional verification/identification requirements similar to new
products are met. These activities are handled as per XXX-XXX-002-02, XXX-XXX-015-04, and
XXX-XXX-020-04, XXX-XX-020-04.
7.2 Customer related process
7.2.1 Determination of requirements related to the product.
During handling of enquires, the following are determined:
a) Specified requirements of the Customer including requirements for delivery. These may
include specifications and applicable standards.
b) Known requirements of the product necessary for intended use. These include
applicable standards,
c) Statutory & Regulatory requirements related to product(documentation, packing and
marking requirements), and
d) Additional requirements deemed necessary (e.g. documentation, packing, marking,
traceability).
7.2.2.1 Customer designated special characteristics
Conformity to Customer requirements for designation, documentation and control of special
characteristics are demonstrated.
7.2.2

Review of requirements related to the product.


Before the contract is accepted for execution or acceptance of changed requirements, review
is carried out to ensure whether:
a) Product requirements or changed requirements are defined,

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b) Differences between proposal and contract have been resolved, and


c) Organization has the ability to meet the defined requirements.
Procedure XXX-XXX-002-01 for Handling of enquiries, details the activities, responsibilities
and check lists used for these activities till submission of quotation.
Procedure XXX-XXX-002-02 for Handling of orders and amendments details the activities,
responsibilities and check lists used for these activities and communication internally for further
action. Records of review and actions arising thereon are maintained.
In the absence of documented requirements from Customer, the requirements are documented
by and communicated to Customer.
When product requirements are changed, they are reviewed differences are resolved, applicable
documentation is amended and communicated to relevant personnel for implementation.
Change control process XXX-XXX-002-02 details the same.
7.2.2.1 Review of requirements related to product- supplemental
Whenever formal review is not required by Customer, an authorization is obtained from Customer
towards the waiver.
7.2.2.2 Organization manufacturing feasibility
Manufacturing feasibility is investigated, confirmed and documented for all proposed products. This
includes risk analysis.
7.2.3

Customer communication

Procedure for effective Customer communication has been determined and implemented.
a) A www.Company.in is maintained for information about company and products. This is
periodically reviewed and updated when found necessary.
b) Enquires are handled as per procedure XXX-XXX-002-01 for effective communication till
submission of proposal. Review of orders and review of changed requirements are handled
as per XXX-XXX-002-01.
c) Periodically feedback from Customer is obtained and acted upon to improve Customer
satisfaction. Procedure XXX-XXX-002-03 details same.
Customer complaints are received registered necessary corrective actions planned and
implemented in a timely manner to improve Customer satisfaction. Procedure XXX-XXX002-18 details the handling of Customer complaints. Records of communication with
Customer and prompt resolution of the same are maintained.
7.2.3.1 Customer communication- Supplemental
Relevant ability to communicate necessary information, including data, in Customer
specified language and format is established.
7.3

Design and development


Requirements of design and development are applied to manufacturing process design and
development.
Manufacturing process design and development is detailed in XXX-XXX-020-18.

7.3.1 Design and development planning


Design and development activities are planned and controlled. A design and development
plan is prepared for each project and includes:
a) Design and development stages,
b) Review, verification and validation requirement at each stage of design and development
and

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c) Responsibilities and authorities for design and development.


Interfaces between different groups involved in design and development effectively managed
with clear assignment of responsibilities.
Planning outputs are appropriately updated as the design and development is progressed.
7.3.1.1 Multi-disciplinary approach
A multi-disciplinary approach, with representatives from design, engineering, production, quality
and servicing is used.
They are involved in preparation for product realization, including;
- Development / finalization and monitoring of special characteristics,
- Development and review of FMEAs, including actions to reduce potential risks and
- Development and review of control plans.
7.3.2 Design and development inputs
Inputs for product requirements are determined and recorded. Inputs include:
a) functional and performance requirements,
b) applicable statutory requirements,
c) Information derived from previous similar designs, and
d) other requirements essential for design and development.
Inputs are reviewed for adequacy. Requirements are ensured to be complete, unambiguous
and not in conflict with each other.
7.3.2.1 Product design inputs
Not applicable.
7.3.2.2 Manufacturing process design input
Manufacturing process design inputs are identified, documented and reviewed. These include:
-Product design output data,
-Targets for productivity, process capability and cost,
-Customer requirements, if any and
-Experience from previous developments.
7.3.2.3 Special characteristics
Special characteristics of product and processes are identified and:
- Included in Control Plan,
- Complied with Customer specified definitions and symbols and
- Identified in drawings, FMEAs, control plans and work instructions with Customer symbol.
7.3.3. Design and development outputs
Outputs of design and development are provided in a form that enables verification against
design and development input and are approved before release.
Design and development outputs are ensured to:
a) Meet the design and development inputs,
b) Provide appropriate information for purchasing, production and service provision,
c) Contain or reference to acceptance criteria and
d) Specify the characteristics of the product that are essential for safe and proper use.
7.3.3.1 Product design output-supplemental
Not applicable.
7.3.3.2 Manufacturing process design output

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Manufacturing process design and development outputs are expressed in terms that can be
verified against manufacturing design input requirements and validated. Outputs include:
- specification and drawings,
- manufacturing process flow chart,
- manufacturing process FMEAs,
- control plan,
- process approval acceptance criteria,
- data for quality, reliability, maintainability and measurability,
- results of error-proofing activities, as appropriate, and
- method of rapid detection and feedback of production/manufacturing
process nonconformities.
7.3.4 Design and development review
At suitable stages, as defined in design and development plan, systematic reviews of design
and development are performed:
a) to evaluate the ability of results of design and development to meet requirements,
b) to identify any problems and propose necessary actions.
Participants for design reviews include those functional representatives concerned with
design and development stage reviewed. Records of results of review and necessary actions
are maintained.
7.3.4.1 Monitoring
Measurements at specified stages of design and development are defined, analyzed and
reported as input for management review
7.3.5 Design and development verification
Verifications are performed as per design and development plan to ensure that design and
development outputs meet design and development input requirements. Records of results
of verifications and of necessary actions are maintained.
7.3.6 Design and development Validation
Design and development validation is performed as per design and development plan to
ensure that resulting product meets the requirements for specified application or intended
use. Validation is performed before delivery of product, where applicable. Records of results
of validation and any necessary actions are maintained.
7.3.6.1 Design and development validation-supplemental
Design and development validation is performed in accordance with Customer
requirements and programme timing.
7.3.6.2 Prototype program
When required by Customer, XXX maintains a prototype program and control plan. In
such cases, XXX will use the same suppliers, tooling and manufacturing processes in
production, wherever possible.
All performance testing activities are monitored for timely completion and conformity to
requirements.
If services are outsourced, XXX takes the responsibility for outsourced services and
technical leadership.
7.3.6.3 Product approval process
XXX conforms to a product and manufacturing process approval procedure as recognized
by Customer.

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This product and manufacturing process approval is applied to suppliers also.


7.3.7

Control of Design and Development Changes


Design and development changes are identified and recorded. Changes are reviewed,
verified and validated and approved before implementation. Review of Design and
development changes also includes effect of changes on constituent parts and products
already delivered.

7.4 Purchasing
7.4.1 Purchasing process
Purchased products and services have been identified and established. Purchase specifications for
these have been determined.
Suppliers for purchased products and services are evaluated and selected on the basis of their
ability to supply product/ service to meet Specified requirements including applicable regulatory
requirements. When specified by Customer, products are purchased from Customer approved
sources.
Procedure for evaluation and selection and reevaluation of supplier including criteria, responsibility,
and records maintained are detailed in procedure XXX-XXX-015-01.
The suppliers are periodically assessed based on performance criteria, established. Procedure for
assessment of suppliers XXX-XXX-015-02 details the criteria, responsibility, Frequency, method of
assessment and actions taken when the performance is not satisfactory.
7.4.1.1 Regulatory conformity
All purchased products or materials are ensured to conform to applicable regulatory requirements
7.4.1.2 Supplier Quality System development
XXX performs supplier Quality System development with the goal of supplier conformity
with TS16949: 2009 requirements. XXX ensures that suppliers are in conformity with ISO
9001:2008 as a first step towards the goal.
Supplier quality management system development activities are performed based on
suppliers quality performance and importance of product.
Suppliers Registration to ISO 9001:2008 by an accredited third-party is ensured, unless
waived by Customer.
Suppliers Quality System development activities are performed as per Procedure XXXXXX-015-03
7.4.1.3 Customerapproved sources
Where specified by contract, XXX purchases products, materials and services from
approved sources, and
XXX assumes responsibility for ensuring quality of such purchases.
7.4.2 Purchasing information
Purchase orders are placed on suppliers and the purchasing information includes, as appropriate:
a) Requirements of approval of product, procedures, and equipment,
b) Requirement for qualification of personal, and
c) Requirements of Quality Management System.
Purchase orders are prepared and released as per procedure XXX-XXX-015-04.
7.4.3

Verification of purchased products

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 17 of 29

Verification methods for purchased products have been established and detailed in XXX-XXX-00301to ensure purchased products meet purchasing specifications.
Wherever Customer or XXX intends to carry out the verification activities at supplier premises, such
information is provided in the purchase order along with method of product release.
7.4.3.1 Incoming product quality
Incoming product quality is assured by one or more of following methods:
receipt and evaluation of statistical data,
receiving inspection/testing with sampling based on performance,
second or third party assessments or audits of supplier sites along with records of
acceptable delivered product quality
part evaluation by a designated laboratory, and
any other method agreed by Customer.
7.4.3.2 Supplier monitoring
Suppliers are monitored through the following indicators:
delivered product quality,
Customer disruptions including field returns,
delivery schedule performance ( including premium freight) and
special status Customer notifications related to quality and delivery issues.
XXX promotes monitoring of the performance of their manufacturing processes by suppliers.
7.5 Production and service provision
7.5.1 Control of production and service provision
Procedures have been established for planning and carrying out of production under controlled
conditions.
Production control activities are carried out as per procedure XXX-XXX-020-04
For adequate control the following are ensured:
a) Availability of information including applicable drawings, specifications, process sheet
and delivery specifications,
b) Availability of applicable control plans, Procedure,
c) Use of suitable equipments and tooling,
d) Availability and use of appropriate monitoring and measurement equipment,
e) Implementation of monitoring and measurement during carrying out of process and
Verification and
f) Implementation of applicable procedures for release and delivery of products.
7.5.1.1 Control plan
XXX has:
developed control plans at component levels for products supplied and
control plans for pre-launch and production that takes into account the manufacturing
FMEA outputs.
The control plan contains;
list of controls used for manufacturing process control,

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 18 of 29

methods for monitoring of controls exercised over special characteristics defined by


XXX and Customer,
Customer required information, if any and
specified reaction plan when process becomes unstable or not statistically capable.

Control plans are reviewed and updated when changes occur affecting product, manufacturing
process, measurement, logistics, supply sources or FMEA.
Customer approval is obtained for updated control plans, if specified in contract.
7.5.1.2 Work Instructions
XXX has documented work instructions for all employees performing activities that impact product
quality. These instructions are made available at work stations.
Work instructions are derived from quality plan, control plan and product realization processes.
7.5.1.3 Verification of Job set-ups
Job set-ups are verified during initial run of job, material change over or job change. Work
instructions are made available for set-up personnel. XXX uses statistical methods for verification,
where applicable.
7.5.1.4 Preventive and predictive maintenance
XXX has identified key process equipments and has provided resources for machine/ equipment
maintenance. An effective planned total preventive maintenance system has been established that
includes:
- planned maintenance activities,
- packaging and preservation of equipment, tooling and gauging,
- availability of replacement parts and
- documenting, evaluating and improving maintenance objectives.
XXX utilizes predictive maintenance methods to continually improve the effectiveness and efficiency
of production equipment. These include vibration monitoring, temperature monitoring, and analysis
of oil samples.
Procedure XXX-XXX-011-01 details the maintenance of infrastructure including preventive and
predictive maintenance of production equipments.
7.5.1.5 Management of production tooling
XXX has provided resources for tool & gauge design, fabrication and verification activities.
XXX has established and implemented a tool management system for production tooling
which includes;
- maintenance and repair facilities and personnel,
- Storage and recovery methods,
- set-up methods and instructions,
- tool-change programs for perishable tools,
- tool design modification documentation with revision control,
- Tool modification and revision control and
- tool identification and status (for production, for repair, for disposal).
If tooling work is outsourced, they are effectively monitored.
Tooling management system is detailed in XXX-XXX-020-05.
7.5.1.6 Production scheduling
Production is scheduled as per Customer requirements such as JIT system and supported
by adequate information and review system.

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 19 of 29

7.5.1.7 Feedback of information from service


Not applicable
7.5.1.8 Service agreements with Customer
Not applicable
7.5.2 Validation of processes for production and service provision (Includes 7.5.2.1)

All production processes covered under control plan is validated. Procedure XXX-XXX-02006 details the process.
The following production processes are validated;
Validation Includes:
defined criteria for review and approval of the processes,
approval of equipment and qualification of personnel,
use of specific methods and procedures,
requirements for records, and
revalidation.

7.5.3 Identification and traceability


Products/items of production are identified during all stages of production storage and delivery by
applicable product codes, drawings, and specifications.
Methods of identification may be identified locations, tags, stickers, display boards, and marking.
Identification provided is ensured to be durable, legible and at an appropriate place.
Traceability requirements have been established.
XXX-XXX-020-07 details the identification methods and Traceability records maintained.
At all stages of monitoring and measurement product status (inspection and test status) is provided
to ensure only confirming products are used for further processing.
The product status may be:
Waiting for Inspection
Accepted
Non-Conforming
Rejected
XXX-XXX-020-08 details the Product status provided during verification products at receiving and all
stages of production.
7.5.3.1 Identification and traceability- supplemental
Products are identified at all stages of production by established methods as in XXX-XXX-020-07.
7.5.4 Customer property
There are no customer property involved in manufacture of existing products. Procedure will be
established and implemented as and when it becomes applicable.
7.5.5 Preservation of product
Identification, Handling, Storage, Packaging, and Protection of products at all stages of
manufacturing and delivery to intended use is detailed in procedure XXX-XXX-020-09
The handling, storage, packaging, and protection methods are ensured to prevent damage, loss
and deterioration of product.
Adequate areas are provided to ensure safety and security of product during storage.
Appropriate method for authorizing and dispatch of materials from such areas are established.

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COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 20 of 29

Shelf-Life products are identified and appropriate controls are exercised.


7.5.5.1 Storage and inventory
Conditions of products, which are stored for more than a year, are checked and revalidated
before use. An Inventory management system is used to optimize Inventory turns and ensure
stock rotation. FIFO method is employed. Obsolete products are treated as Non-conforming
products and handled as such.
7.6 Control of monitoring and measuring equipment
Procedures have been established for control of monitoring and measuring devices to ensure
evidence of conformity of product to determine requirements.
Based on measurements, to be made during monitoring of process and verification of products,
appropriate monitoring and measuring devices are used.
It is ensured that the monitoring and measuring devices are capable of measuring to the
accuracy and precision necessary.
To ensure valid results the following are ensured:
a) The monitoring and measuring devices are calibrated at specified intervals against certified
standards traceable to national standards. XXX-XXX-011-02 details the devices, calibration
frequency, calibrating agency, and calibration method and acceptance criteria. In the
absence of traceability standards, appropriate procedure is established and the basis of
calibration is documented.
b) The devices are adjusted and readjusted as necessary,
c) Monitoring and measuring devices are suitably identified with an indicator as to the
calibration status,
d) Monitoring and measuring devices are safeguarded against unauthorized adjustments that
would invalidate the measurement results and
e) Monitoring and measuring devices are suitably protected from damage and deterioration
during handling, maintenance, and storage.
Validity of previous inspection and test results are assessed when calibration results do not
conform to requirements. Suitable actions are taken on the equipment and any product that is
affected and actions taken are recorded.
Calibration records of monitoring and measuring device are maintained.
Test hardware and test software, wherever used, are verified periodically against defined
acceptance criteria to ensure suitability for use and applicable records are maintained.
7.6.1 Measurement system analysis
Statistical studies are conducted to analyze variation present in each type of measuring
equipment referenced in control plan. Methods and acceptance criteria conform to those
relevant reference manuals.
7.6.2 Calibration/ verification records
The records of calibration / verification of all gauges, measuring and test equipments are
maintained. Records include:
Equipment Identification and measuring standards for calibration,
Out of specification readings, if any, as received for calibration,
statement of conformity to specification after calibration and
Notification to Customer if suspect products have been shipped.
7.6.3

Laboratory requirements
7.6.3.1 Internal Laboratory
A laboratory scope is maintained which includes:

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 21 of 29

List of inspection, test and calibration activities carried out,


Laboratory procedures,
Competency of laboratory personnel,
References to Inspection and test standards,
Review of laboratory and related records and
QA/Laboratory Manual.

7.6.3.2 External Laboratory


When inspection, test and calibration services are obtained from external sources, it
is ensured that:
The facility has a defined scope to carry the activities and
The laboratory is accredited to ISO/IEC 17025 or documented
acceptance of the facility by the Customer
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General
Process for monitoring, measurement, analysis and improvement have been planned and
implemented in the following areas:
a) Demonstration of conformity to requirements of products and services
b) Conformity of the Quality Management System.
c) Continual improvement in the effectiveness of quality management system.
Applicable methods, including statistical techniques and their extent of use have been determined.
8.1.1 Identification of statistical tools
Statistical tools required for each process is determined and included in Control Plan
8.1.2 Knowledge of statistical tools
Appropriate training in concepts of variation, control, process capability and over-adjustment is
provided and utilized.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction

Process for monitoring and measurement of Customer satisfaction has been established
towards performance of QMS and Customer perception of service provided against
expectation.
The feedback is obtained in prescribed formats and analyzed periodically.
Preventive actions are planned, implemented, reviewed to effect continual improvements.
Customer satisfaction levels and trends are reviewed in management review meetings.

8.2.1.1 Customer satisfaction - Supplemental


Customer satisfaction is monitored through objective data which includes delivered product
quality performance, Customer disruptions including field returns, delivery performance,
premium freight and Customer notifications related to Quality and delivery issues.

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 22 of 29

Performance of manufacturing processes are monitored to demonstrate compliance with


Customer requirements
XXX-XXX-002-03 details the activities, responsibilities, format used, computation of
Customer satisfaction levels and records maintained.

8.2.2 Internal audit


Internal audits are conducted to ensure monitoring and measurement towards:
a) Conformance to planned arrangements towards implementation of ISO/ TS 16949: 2009
and established Quality Management System requirements and
b) Effectiveness of implementation and maintenance of Quality Management System.

Internal audits are conducted at once in 6 months covering all activities.


Internal audits are planned and scheduled by Management Representative and audits
are conducted by trained internal auditors to ensure objectivity and impartiality of the
audit process.
It is ensured that auditors do not audit their own work.
Additional audits in specific areas are also planned, where necessary, considering the
status and importance of processes and results of previous audits.
The audit criteria, scope, frequency, and methods are defined.
Results of the audit are recorded; results reported to head of function and audit records
are maintained.
Head of audited function takes timely actions to eliminate the detected nonconformances and their causes.
Management Representative Initiates follow up actions.
Management Representative arranges for verification of action taken to ensure
effectiveness and verification results are reported.
Results of audit and status of actions taken are reviewed in the management review
meetings.

8.2.2.1 Quality Management System audit


Audits of the Quality Management System are conducted as per procedure XXX-XXX-020-11 to
verify compliance with TS 16949:2009 requirements.
8.2.2.2 Manufacturing process audit
Manufacturing process audit is conducted as per procedure XXX-XXX-020-12 to determine
effectiveness of processes
8.2.2.3 Product audit
Product audit is conducted as per procedure XXX-XXX-020-13 to verify conformity to all
specified requirements
8.2.2.4 Internal audit plans
An annual plan is prepared for conduction of internal audits of processes, activities and covers
all shifts.
8.2.3 Monitoring and measurement of processes
Quality System processes, required to be monitored, are identified,
Methods of monitoring and measuring are defined including the characteristics monitored,

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COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 23 of 29

Methods adopted are ensured to demonstrate the ability of process to achieve planned
results,
Performance of the process is reviewed periodically to gauge effectiveness,
When planned results are not achieved, correction and corrective actions are taken
wherever practicable, and
Applicable process maps details the processes and characteristics monitored.

8.2.3.1 Monitoring and measurement of manufacturing processes


Process studies are carried out to verify process capabilities and to meet Customer
requirements,
Control plans and Process flow diagrams are adhered to during production. A reaction
plan is established to take care of characteristics which are out of control or unstable,
Corrective action plans are initiated till processes are stable and capable and
Process changes are recorded including dates of implementation.
8.2.4 Monitoring and measurement of product
Monitoring and measurement are carried at the following stages of manufacture.
At receiving stage (purchased products),
At identified in-process stages,
At final stage.
Verification of purchased products is defined in XXX-XXX-003-01
Verification at in process and final stages are defined in procedure XXX-XXX-020-04 and detailed
in Control Plans.
Control Plans are established for each product/product family. These define the monitoring and
measurement stages, characteristics checked, sampling plan and acceptance criteria.
Monitoring & Measurement are carried out as per Control Plans to ensure that product conforms
to defined acceptance criteria. Records of monitoring and measurements are maintained as
evidence of conformity to requirements. Records of verification indicate the personnel authorized
release of the product.
No product is released for use or delivery unless verification is carried out as per applicable
verification procedures are satisfactorily completed. Any deviation or nonconformance, is
approved by relevant authority and, where applicable, by Customer.
8.2.4.1 Layout inspection and Functional testing
A layout inspection and functional testing is carried out as per Customer requirements. Results
are made available for Customer review.
8.2.4.2 Appearance items
Not Applicable
8.3 Control of non- conforming products
Products, which do not conform to specified requirements, are identified and controlled to ensure
that they are not used or delivered.
Procedure XXX-XXX-020-10 details the procedure for control of non-conforming products.
Non -Conformance product is identified during verification stages.
Authorized personnel review non-Conforming products and decision are taken.

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Name

COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 24 of 29

Non-Conforming products may be dealt with as below:


By taking actions to eliminate the defected non-conformity either through rework or repair,
Acceptance under concession by identified authority or by Customers, and
Preventing the intended use by rejection.
When non-conforming process are detected after delivery or use has started, analysis of effects of
non-conformance are carried out and appropriate actions are taken keeping in view of the
immediate effects and potential effects of the non-conformity.
Records of non-conformities and actions taken including concessions are maintained.
Reworked or repaired are re-verified as per applicable procedures to ensure conformance to
requirements. Rework instructions are provided to appropriate personnel.
8.3.1 Control of nonconforming product-Supplemental
Products which are unidentified or suspect are treated as nonconforming products.
8.3.2 Control of reworked products
Instructions for rework and re-inspection are ensured to be accessible and used by
personnel.
8.3.3 Customer information
Customers are promptly informed when nonconforming products has been shipped.
8.3.4 Customer waiver
Customer Waiver is obtained when manufacturing process is different from that which is
currently approved. Similarly requests from suppliers are agreed with suppliers before
submission to Customer. Records of quantities and expiry dates are maintained.
Specifications are complied with when the authorization expires. Materials shipped under
authorization are properly identified.
8.4 Analysis of data
Data required demonstrating the suitability and effectiveness of QMS has been determined.
They are collected and analyzed using appropriate statistical tools.
Opportunities for continuous improvement of the QMS is identified and evaluated as a result of
analyzing data.
Sources of data collected for analysis include results of monitoring measurement are,
Used for Customer satisfaction,
Product and service nonconformities, and
Other Quality Management System processes.
Applicable System Procedure details the type of data collected, frequency of collection,
methods of review and analysis, statistical tools used.
It is ensured that Analysis of data provides information on:
a) Customer satisfaction,
b) Conformity to product and service requirements,
c) Characteristics & trends of processes against identified parameters and
identification of opportunities for preventive action and
d) Performance of suppliers.
8.4.1 Analysis and use of data

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COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 25 of 29

Results of analysis is used to develop priorities for prompt solutions to Customer-oriented


problems, determination of key Customer related trends and information system for timely
reporting of product information.
8.5 Improvement
8.5.1 Continual Improvement
Opportunity for continual improvement of the Quality Management System is identified through the
use of Quality Policy, Quality Objectives, audit results, analysis of data, corrective & preventive
actions, and management review.
Continual improvement areas it includes,
Enhancement of Customer satisfaction
Reduction in delays and non-conformities in products.
Productivity improvement
Improvement in process capabilities in manufacturing processes
Continual improvement activities are reviewed in management review meetings.
Continual improvement areas are identified & documented including the current performance &
targeted performance.
8.5.1.1 Continual improvement of the organization
Process for continual improvement process is detailed in XXX-XXX-020-14
8.5.1.2 Manufacturing process improvement
Manufacturing process improvements are focused upon control and reduction of variation in
product characteristics and manufacturing process parameters.
8.5.2 Corrective action
Corrective actions are taken on the following activities in order to prevent recurrence:
Customer Complaints,
Non conformities in the product supplied by suppliers,
Non conformities detected during at in process stages and
Non conformities at final stage & verification.
Corrective actions are ensured to be appropriate to the effects of non-conformities / deficiencies
encountered.
Documented procedures have been established to define the requirements for taking corrective
action including:
a) Review of non-conformities (including Customer complaints).
b) Determination of causes of non-conformities / deficiencies.
c) Evaluation of need for action to ensure that non-conformity / deficiency do not recur.
d) Determination and implementation of needed actions.
e) Recording of results of action taken.
f) Review of effectiveness of corrective action taken.
Procedure XXX-XXX-020-15 details the requirements for taking corrective actions.
8.5.2.1 Problem solving
Procedure established defines process for root cause identification and elimination.

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COMPANY LOGO

QUALITY MANUAL

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 26 of 29

8.5.2.2 Error-proofing
Wherever possible, error proofing methods are applied towards corrective actions.
8.5.2.3 Corrective action impact
Corrective actions taken are applied to similar processes and products and controls implemented
to eliminate causes of nonconformity.
8.5.2.4 Rejected product analysis
Rejected products are analyzed to determine the causes and results of analysis are maintained.
Inputs are used for taking corrective actions. Records are maintained for Customer on request.
Time taken for analysis is kept to a minimum.
8.5.3 Preventive Action
Preventive actions are determined to eliminate the causes of potential nonconformance in order
to prevent their occurrence.
Preventive actions are ensured to be appropriate to be effects of the potential problems.
Documented procedure has been established to define requirements for taking preventive
actions including:
a) Review of non-conformities (including Customer complaints),
b) Determination of potential non-conformities / deficiencies and their causes,
c) Evaluation of need for action to prevent occurrence of non-conformities,
d) Determination and implantation of needed actions,
e) Recording of results of actions taken and
f) Review of effectiveness of preventive actions taken.
Procedure XXX-XXX-020-016 details the requirements for taking preventive actions on
potential nonconformance and identification of continual improvement activities.

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COMPANY LOGO

Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
Page 27 of 29

QUALITY MANUAL

5.5.2.1
5.5.3
5.6
6.1
6.2.2
6.2.2.3
6.3.2.4
6.3
6.3.1

P C C C C

P
P
P

P
C
P

C C
C C
P P

C
C
P

C C C C C C C C C C C C C C C
C C C C C C C C C C C C C C C
P P P P P P P P P P P P P P P

P C

P P

P P P P P P P P P P P P P P P

C C

C C C C C C C C C C C C C C C

P
C
P

P
C
P

P P
P P
C C

P
C
C

P P P P P P P P P P P P P P P
P C C P P P P P P C P P P C C C C C C C C C C C C C C C C

P
P
P

P
P
P

P C C
C C
C C

C
C
C

- - - - - - - - - - - - - - C C C C C C C C C C C C C C C
C C C C C C C C C C C C C C C
C C C C C C C C C C C C C C C

C C

C C C C P C C C C C C C C C C

P P P C

C C

C C C C P C C C C C C C C C -

P P

P -

C P

C C C C

C C

- P
P P P - -

P P P

C C C C

P P P P

C C - C
P
P P P P

P P P P

P P P P

- C

Annexure-02
Process Map Showing Process Interactions

Issued By

Name

Approved By

Name

Department 20
Department 21

Department19

Department 18

Department 17

Department 16

Department 15

Department 14

Department 13

Department 12

Department 5

Department 11

5.5.2

Department 10

5.2
5.4.1
5.5.1

Department 9

5.1

Department 8

4.2.4

Department 7

Cleanliness of premises

4.2.3.1

Department 6

6.4.2

4.2.1
4.2.1
4.2.3

Department 4

6.3.2
6.4
6.4.1

General requirements
(Out sourced processes)
Quality policy
Quality Objectives
Control of Documents
Engineering
specifications
Control of Records
Management
commitment
Customer Focus
Functional Objectives
Responsibility & Authority
Management
Representative
Customer representative
Internal communication
Management Review
Provision of Resources
Competence, Awareness
& Training
On job training
Employee motivation and
empowerment
Maintenance of
infrastructure
Plant , facility and
equipment planning
Contingency plans
Work environment
Personnel safety

4.1

Department 3

Description
(P-Primary
responsibilities,
C-Contributory
responsibilities)

Department 2

ISO/TS
16949
Clause
No

Department 1

Annexure-01
Applicability Matrix

P -

QUALITY MANUAL

XXX-QM-01
Review: 03
Review Date: 20.03.15
Page 28 of 38

Annexure- 03
Locations & Activities
Location
No.

Category
of
Location

Address

Processes

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