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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
5. Management responsibility
6. Resource management
15
7. Product realization
17
27
33
36
37
1. DISTRIBUTION LIST
Copy no.
Issued By
Issued to
Name
Remarks
Approved By
Name
COMPANY LOGO
QUALITY MANUAL
Procedure No.
Review: XX (No.)
Review Date: XX-XX-XXXX
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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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QUALITY MANUAL
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While establishing, implementing and maintaining the Quality Management System, the following
aspects are considered and established:
a)
b)
c)
d)
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QUALITY OBJECTIVES
SL
No
MONITORING
FREQUENCY
QUALITY OBJECTIVES
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QUALITY MANUAL
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Issued By
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COMPANY LOGO
f)
QUALITY MANUAL
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Effectiveness and efficiency of product realization and support processes are reviewed by
Top Management during management reviews.
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QUALITY MANUAL
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Internal communication
Sl No
Topics to be
communicated
Responsibility
for
communication
Communication to
Mode
Time frame
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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.
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QUALITY MANUAL
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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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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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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
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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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QUALITY MANUAL
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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
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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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Procedure No.
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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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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.
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Laboratory requirements
7.6.3.1 Internal Laboratory
A laboratory scope is maintained which includes:
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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.
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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.
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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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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
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P P P P
C C - C
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- C
Annexure-02
Process Map Showing Process Interactions
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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