Objectives of the Training

Understanding Goals and Purpose of ISO/TS 16949:2009.

Understanding Process Approach of ISO 9001:2005 and
additional requirements of ISO/TS 16949:2009.
Documentation and Actions required for implementation
Methodology for implementing the standard

Forward
What is difference between normal ISO standards and ISO /
TS standards?
Prepared by
International Automotive Task Force-IATF
Japan Automobile Manufacturers Association Inc.-JAMA
Supported by ISO/TC 176
Base Document is ISO 9001 : 2005

Forward
For This Training:
Requirements of ISO 9001:2005 are in Normal Text

Additional requirements of Automotive Sector are in

Italics

Introduction
Eight Quality Management Principles:
Customer Focused Organization
Leadership
Involvement of People
Process Approach
System Approach to Management
Factual Approach to Decision Making

Continual Improvement
Mutually Beneficial Supplier Relationship
5

Introduction
Goals of Technical Specification
Development of fundamental quality systems that provide for
continual improvement,
emphasizing defect prevention and
the reduction of variation and waste in the supply chain
To avoid multiple certification and provide common approach

2. Normative Reference
ISO 9000:2005
Quality Management System -Fundamentals and vocabulary

3. Terms and Definitions

Organization - Company implementing QMS
Supplier -

Providing product and/or services to organization

Customer -

Customer End User

Product -

Result of a Process. (Means Service also)

Site -

Location at which value added manufacturing process

occurs
7

Understanding the
Process Approach
Process: Set of interrelated or interacting activities which
transforms inputs into outputs
Inputs and outputs may be tangible or intangible
Inputs and outputs can be
Materials
Equipment
Components
Information

Energy
Financial Resources,

Process Approach:
A desired result achieved more efficiently when activities and
related resources are managed as a process
8

Typical Network of
Interacting Processes
A P
C D

Input E

Output E

PROCESS E

Input A
PROCESS A

AA PP
CC DD

AA PP
CC DD

Output A
Input C
PROCESS C

AA PP
CC DD

Input B
PROCESS B

AA PP
CC DD

PROCESS D

Output C AA PP

CC DD

Output B

Input F
Internal
Customer

Output D

Input D

PROCESS F

AA PP
CC DD

Output F
Internal
Customer

Feedback

Process Approach
Continual Improvement of the Quality
Management System

Resource
management

Requirements

Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)

Management
Responsibility

Customers
(ISO 9001)
And other
Interested
Parties
(ISO 9004)

INPUT

Product
realization

Measurement,
analysis and
improvement

Product

Satisfaction

OUTPUT

10

4. Quality Management System

4.1 General Requirements

Establish, document, implement & maintain QMS

Implement QMS by
Identifying QMS processes throughout organization
Determining sequence and interaction between these processes

Determining criteria & methods required to ensure that both

operation and control of these processes are effective
Ensuring the availability of resources & information necessary for
operation & monitoring of processes
11

4. Quality Management
System
monitoring, measuring and analyzing these processes,
implementing actions necessary to achieve planned results and
Continual Improvement of the processes
Identify and control outsource processes

4.1.1 Ensuring control over outsource processes and does not

absolve responsibility of conformity to customer requirements

12

4. Quality Management
System
4.2 Documentation Requirements
4.2.1 General :
QMS documentation to include

Quality Policy & Quality Objectives

Quality Manual

documented procedures required in this standard

documents needed by organization

quality records
13

4. Quality Management
System
4.2.2 Quality Manual
Establish & maintain Quality Manual
the scope of QMS, including details of, and justification for
any exclusions
documented procedures established for QMS or their
reference
a description of the interaction between the processes of QMS
NOTE: The above applies to all requirements of TS
14

4. Quality Management
System
4.2.3 Control of Documents
Establish a procedure defining the controls
4.2.3.1 Engineering Standards/Specifications & Changes
Assure timely review (max. Two Weeks), Distribution & Implementation
Maintain a record of the date each change is implemented in
production
Note1: Update record of customer production part approval when the
specifications change (e.g FMEA / Control Plan etc.)
15

4. Quality Management
System
4.2.4 Control of Quality Records
Establish a Procedure defining Control of Records.

4.2.4.1 Records Retention

Control to satisfy regulatory / statutory & customer requirements

16

5.0 Management Responsibility

MANAGEMENT COMMITMENT - 5.1
Top management to demonstrate commitment to QMS &
continually improving its effectiveness by
Communicating the importance of meeting customer and statutory /
regulatory requirements
Establishing Quality Policy & Quality Objectives
Conducting Management Reviews; &
Ensuring the availability of necessary resources

5.1.1 Process Efficiency

Review Product realization and support processes for
effectiveness and efficiency
17

5.0 Management Responsibility

5.2 CUSTOMER FOCUS

Aim to enhance customer satisfaction

5.3 Quality Policy

Appropriate to purpose of the organization

Commitment to comply with requirements and continually
improve the effectiveness of QMS
Provides a frame-work for establishing and reviewing Quality
Objectives
Communicated and understood
Reviewed for continuing suitability
18

5.0 Management Responsibility

5.4 Planning
5.4.1 Quality Objectives
Established at relevant functions and levels
Shall cover customer & product requirements
Shall be measurable and consistent with Quality Policy

5.4.1.1 Quality Objectives-Supplemental

Quality objectives shall be included in Business Plan and
used to deploy Quality Policy
Note: Objectives should address customer expectations and be
achievable in defined time frame.
19

5.0 Management Responsibility

5.5 Responsibility, Authority & Communication
5.5.1 Responsibility & Authority
Top Management to define Responsibilities &
communicate within the organization.
5.5.1.1 Responsibility for Quality
Management personnel responsible for Quality have authority for stop
production untill corrective action completed
Production operation across shifts to have exclusive or delegated a
Shift Quality In-charge
20

5.0 Management Responsibility

5.5.2 Management Representative
Appoint Management Representative (MR).

Customer Representative- 5.5.2.1

Designate person(s) to represent customer to address quality
related requirements
He / She represents customers needs in internal functions

21

5.0 Management Responsibility

5.5.3 Internal Communication
Top Management to ensure that communication processes

5.6 Management Review

Management Review to include all elements
Management Review result to provide evidence of
achievement of Quality Policy, Objectives, Business Plan
and Customer Satisfaction

22

5. Management Responsibility
Review Input

Shall include information

Audit Results;
Customer feedback;
Process performance and product conformity;
Status of preventive and corrective actions;
Follow up actions of previous management reviews;
Planned changes that could affect QMS and
Recommendations for improvement
Input to include Analysis of actual and potential field
failures and their impact on Quality, Safety or Environment
23

5.0 Management Responsibility

5.6.3 Review Output

Include any decisions and actions related to

improvement of the effectiveness of QMS and its
processes;

improvement of product related to customer

requirements and
resource needs

24

6. Resource Management
6.1 Provision of Resources
Determine and provide resources needed :
Resources means :
Human Resources (i.e. Competent Man-power)
Infra-structure
Work Environment

25

6. Resource Management
6.2 Human Resources
6.2.1 General
Personnel to be COMPETENT
on the basis of appropriate education, training, skills and
experience

26

6. Resource Management
6.2 Human Resources
6.2.2 Competence, Awareness and Training
The organization to
Determine necessary competence for personnel performing work
affecting product quality,
Provide training or take any other actions to satisfy these needs,
Evaluate effectiveness of the actions taken.
Ensure that its personnel are aware of
relevance and importance of their activities
how they contribute to the achievement of the Quality Objectives

Maintain records of education, training, skills & experience,

27

6. Resource Management
6.2.2.1 Product Design Skills
Product Design Responsible personnel be
competent to
achieve design requirements and

have skills in applicable tools & techniques as

identified by organization

Examples of skill are : DFMEA, DOE, GD&T ,FEA etc.

28

6. Resource Management
6.2.2.2 Training
Establish Documented Procedure for
identifying training needs & achieving competence
qualification of personnel with specified assigned tasks
attention be given for satisfying customer specific requirements
Note1:Applies to all employees at all levels
Note2 :Customer specific requirements, for example, digitized mathematically based
data.

6.2.2.3 Training on the Job

Provide on Job Training to personnel including contract or agency personnel for
New or Modified jobs
Personnel be aware of consequences to the customer of the non-conformity to
quality requirements
potential consequences of departure from specified procedures.
29

6. Resource Management
6.2.2.4 Employee Motivation & Empowerment
For Employee Motivation, have a Process to :
Motivate employees to achieve objectives
Make continual improvements
Create an environment to promote innovation
(Motivation Methods may be Awards, Trophies, Certificates,
Incentives, Appreciation Letters etc.)

The above process to include throughout the organization :

Promotion of Quality
Technological Awareness
30

6. Resource Management
6.2.2.4 Employee Motivation & Empowerment
For Employee Empowerment, have Process to measure
the extent to :
which personnel are aware of their relevance & importance of their
activities.
how they contribute to the achievement of the quality objectives
(refer 6.2.2 d)
roles and responsibilities in achieving conformance to quality policy
and meeting objectives

31

6. Resource Management
6.3 Infrastructure
Determine, provide and maintain infra-structure needed to
achieve the conformity to product requirements
Infra-structure includes, as applicable :
buildings, workspace and associated utilities
process equipment (both hardware and software)
supporting services (such as transport or communication)

32

6. Resource Management
6.3.1 Plant, Facility & Equipment Planning
Use Multi-disciplinary approach in developing plans for
Plant, Facilities & Equipment
Plant Layout to optimize Materials Travel & Handling;
Optimize Value added use of Floor Space; Facilitate
Synchronous material flow

Develop methods to evaluate & monitor the effectiveness of

existing operations and implement them.
Note : Focus on Lean Manufacturing Systems
33

6. Resource Management
6.3.2 Contingency Plans
Prepare Contingency Plans to satisfy customer requirements
during emergency conditions; such as :

Contingency
Utility Interruptions
facilities
Labour Shortages
Key Equipment failure
Field Returns

Actions to be taken
e.g. Hiring or availability of spare

e.g. Multi-skill Training

e.g. Job work from out-source
e.g. Inventory of items

In Other Words - SHOW MUST GO ON i.e. Supplies should

NOT be stopped.

34

6. Resource Management
6.4 Work Environment
Determine and manage work environment needed to
achieve the conformity to product requirements
Based on Human Factors & Physical Factors
These may include :
safety, rules and guidance, use of PPE
Ergonomics (a science of space requirement)
special facilities for employees
noise, light, temperature, humidity, vibration
hygiene, pollution, cleanliness

35

6. Resource Management
6.4.1 Personnel Safety to Achieve Product Quality
Address Product Safety & Means for minimizing
potential risks to employees, especially during
Design & Development Process
Manufacturing Process Activities

6.4.2 Cleanliness of Premises

Maintain the premises in state of order; Cleanliness &
repair (during & after) consistent with requirements of
product & process needs
36

7. Product Realization
7.1 Planning of Product Realization
Plan and develop product realization processes
Product realization process must be compatible with QMS
Determine the following as appropriate
Product specific Quality Objective and system requirements;
Product specific processes, documents and resources;
Product specific verification, validation, monitoring, inspection testing
and acceptance criteria;
Records required to demonstrate the compliance of product and
processes to the requirements
Use suitable form(s) for documenting / recording planning output
37

7. Product Realization
7.1 Planning of Product Realization
NOTE 1: A document covering QMS process (including product
realization processes & resources required can be referred as
Quality Plan
NOTE 2: Requirements given in 7.3 may be applied for
development of product realization processes
NOTE: Some customers refer to Project Management or APQP for
product realization. APQP emphasizes for defect prevention and
continual improvement instead of defect detection and based on
multi-disciplinary approach
38

7. Product Realization
7.1.1 Planning of Product Realization - Supplemental
Include customer requirements and references of its technical
specifications in the product realization as a part of quality plan

7.1.2 Acceptance Criteria

Define acceptance criteria for each process (e.g. process

capability)
Have approval from customer, if required
Use Zero Defect as acceptance level for attribute data sampling

7.1.3 Confidentiality

Ensure confidentiality by customer contracted product & project

under development and related product information
39

7. Product Realization
7.1.4 Change Control
Establish process to control and react to changes
Define system for assessment, verification and validation of
change.
Perform validation before implementation to the extent possible
For proprietary designs, review the effect of change(s) on fit, form
and function with customer
Ensure the compliance for additional verification / approval
identification requirements
NOTE 1: Any product realization change affecting customer requirements
requires notification to and agreement from the customer
NOTE 2: This applies to product and manufacturing changes
40

7.2 Customer Related Processes

7.2.1 Determination of Requirements Related to the Product
Determine requirements

specified by customer including delivery and post delivery activities (Inspection

testing & servicing)
Not specified by customer but are necessary for intended use
Statutory and regulatory related to product (Safety, Environment etc.)
Any additional determined by the organization
NOTE 1: Post delivery activities include any after sales product servicing provided as
part of customer contract or purchase order
NOTE 2: This requirement include recycling, environmental impact and
characteristics identified as a result of the organizations knowledge of product and
manufacturing processes (7.3.2.3 - Special Characteristics)
NOTE 3: Compliance to Govt. regulations include all applicable safety and
environmental regulations applied to acquisition, storage, handling, recycling and
elimination or disposal of materials
41

7.2 Customer Related Processes

7.2.1.1 Customer Designated Special Characteristics
Demonstrate conformity to customer requirements for designation,
documentation and control of special characteristics
7.2.2 Review of Requirements Related to Product
Review the requirements before giving commitment for supply to ensure
Product requirements are completely defined
Differing requirements of contract / order are resolved
Organization have the ability to meet the requirements

Maintain the records of review and subsequent action planned and taken
When customer does not provide documented requirements confirm the
requirements before acceptance
42

7.2 Customer Related Processes

When the product requirements change ensure
Updating the affected documents
Providing information about the change to the concerned
personnel
NOTE 1: In some situations such as internet sales, a formal review
is impractical for each order. Instead, the review can cover relevant
product information such as catalogues or advertising material

7.2.2.1 Review of Requirements Related to Product - Sup.

Waiving the requirements of contract review in the above note
requires customer authorization.

43

7.2 Customer Related Processes

7.2.2.2 Organizations Manufacturing Feasibility
Investigate, confirm and document the manufacturing feasibility
including risk analysis during the contract review
7.2.3 Customer Communication
Determine and implement effective arrangements for communicating
about,
Product information
Enquiry, contract / order handling including amendments
Customer feedback and customer complaints

7.2.3.1 Customer Communication Supplemental

Have ability (resources & competence) to communicate necessary
information / data in customer prescribed language and format (e.g.
CAD, Electronic Data Exchange)
44

7.3 Design & Development

7.3 Design and Development
NOTE: This requirement includes product and manufacturing process design &
development and focus on error prevention than detection

7.3.1 Design and Development Planning

Plan and control design and development by determining
Design and development stages
Review, verification and validation of design & development activities required
at different stages
Responsibility and authority for design and development

Manage interfaces between different groups involved in design and

development activities to ensure
Effective communication
Clear assignment of responsibility

Update planning output as design and development activities progress

45

7.3 Design & Development

7.3.1.1 Multidisciplinary Approach
Use multidisciplinary approach to prepare for product
realization including
Development / Finalization and monitoring of special characteristics
Development and review of FMEA including actions to reduce
potential risks
Development and review of control plans
NOTE: A multidisciplinary approach typically includes the organizations design,
manufacturing, engineering, quality, production and other appropriate
personnel

46

7.3 Design & Development

7.3.2 Design and Development Inputs
Determine the following inputs related to product and maintain records
Functional and performance requirements
Applicable statutory and regulatory requirements
Informations derived from previous similar design (where required)
Other requirements necessary for design and development

Review the inputs for adequacy

Ensure the requirements are complete, unambiguous and do not
conflict with each other
NOTE: Special characteristics (see 7.2.1.1)are included in this
requirements
47

7.3 Design & Development

7.3.2.1 Product Design Input
Identify, document and review product design input requirements including
Customer requirements given in contract such as
Special characteristics
Identification and traceability
Packaging
Establishing a process to use Informations gained from previous design
projects, for current and future projects of similar nature. The information
includes
Competitor analysis
Internal inputs
Field data
Other relevant sources
Target for product quality, life, reliability, durability, maintainability, timing and
cost
48

7.3 Design & Development

7.3.2.2 Manufacturing Process Design Input
Identify, document and review the manufacturing process
design input requirements
Product design and output data
Target for productivity, process capability and cost
Customer requirement, if any
Experience from previous developments
NOTE: The manufacturing process design includes the use of errorproofing methods to degree appropriate to the magnitude of
problems and commensurate with the risk encountered

49

7.3 Design & Development

7.3.2.3 Special Characteristics
Identify special characteristics and
Include all special characteristics in the control plan
Comply with customer specified definitions and symbols
Identify in the process control documents including
Drawings, FMEAs, Control Plans, Operator Instructions
Use customer prescribed symbols / notation or equivalent to identify
special characteristics

NOTE: Special characteristics can include product characteristics and

process parameters

50

7.3 Design & Development

7.3.3 Design and Development Output
Define design and development output using units or measurables
which can be verified and validated to meet design input
requirements
Ensure Design and Development output
Meets the input requirements
Provide appropriate informations for purchasing, production and service
provision
Contain or reference product acceptance criteria
Specify the characteristics of product that are essential for its safe and
proper use
51

7.3 Design & Development

7.3.3.1 Product Design Output Supplemental
Express the product design output in terms that can be verified and
validated against product design input requirements. Include the
following in product design output,
Design FMEA, reliability results
Product special characteristics, specifications
Product error- proofing, as appropriate
Product definitions (Drawings, Math data)
Product design reviews results

Diagnostics guidelines (maintenance and operation manual),

where applicable
52

7.3 Design & Development

7.3.3.2 Manufacturing Process Design Output
Express in terms that can be verified and validated against
manufacturing process design inputs requirements. Include the
following in manufacturing process design outputs
Specifications and drawings
Manufacturing process flow chart / layout
Manufacturing process FMEA
Control Plans
Work instructions
Process approval acceptance criteria
Data for quality, reliability, maintainability and measurability
Results of error - proofing activities and
Methods of rapid detection and feedback of product / manufacturing
process non-conformities
53

7.3 Design & Development

7.3.4 Design and Development Review
Plan & perform systematic review of design and development at
different of stages,
To evaluate the ability of the results of design and development to
meet requirements
To identify any problem and propose necessary actions
Include representatives from the relevant stages of design and
development in review
Prepare and maintain records of review and subsequent actions

54

7.3 Design & Development

7.3.4 .1 Monitoring

Define and analyze the measurements at different stages of design

and development.
Report summary results as input to Management review
NOTE: These measurements include quality risks, costs, lead times,
critical paths and others as appropriate

7.3.5 Design and Development Verification

Plan and perform design and development verification

To ensure design and development output meets the input
requirements
Maintain the records of verification and subsequent actions

55

7.3 Design & Development

7.3.6 Design and Development Validation

Plan & perform design and development validation to ensure

Resulting product is capable of meeting the requirements for application
or intended use where known
Whenever practicable, complete validation before delivery or implementation
of product
Prepare and maintain records of validation and subsequent actions
NOTE 1: The validation process should include an analysis of field results
NOTE 2: The requirements of verification and validation apply to both product
and manufacturing processes

7.3.6.1 Design and Development Validation Supplemental

Perform design and development validation in line with customer
requirements including program timing.
56

7.3 Design & Development

(Contd.)

7.3.6.2 Prototype Programme

Develop a prototype programme and control plan when

required by the customer
To the extent possible

Use same supplier, tooling, manufacturing processes for prototype

as will be used for regular production
Monitor the timely completion and conformance of all performance
testing activities
when design services are outsourced,
provide technical leadership and
compliance of outsourced processes / services lies with the organization

57

7.3 Design & Development

7.3.6.3 Product Approval Process
Ensure conformance to product and process approval system
as specified / recognized by the customer
NOTE: Product approval should be subsequent to the
verification of manufacturing process

Apply system of product and process approval to suppliers

also

58

7.3 Design & Development

7.3.7 Control of Design and Development Changes
Identify and maintain records of design and development changes
Review, verify, validate and approve changes before implementation
Evaluate the effects of changes on
Constituent parts
Already delivered product
Prepare and maintain records of review of changes and subsequent
actions
NOTE: Design and Development changes include all changes during product
programme life (7.1.4)
59

7.4 Purchasing
7.4 Purchasing

7.4.1 Purchasing Process

Ensure purchased product conforms to specified purchase

requirements
Apply controls on suppliers considering the
effect of purchased product on the subsequent products realization processes
or finished products

Establish criteria for selection, evaluation and re-evaluation of

suppliers
Evaluate and select suppliers based on their ability to meet the
requirements
Maintain records of suppliers evaluation and actions arising from
evaluation

60

7.4 Purchasing
7.4 Purchasing
7.4.1.1 Regulatory Compliance
Ensure all purchased products or materials used in product comply
with applicable regulatory requirements

7.4.1.2 Supplier Quality Management System Development

As a first step all supplier must be ISO 9001:2000 certified by a third
party certification body.
Develop Quality Management Systems complying to the
requirements of ISO / TS 16949:2002
NOTE : The prioritization of supplier for development depends upon
suppliers quality performance and importance of product,
material or services supplied
61

7.4 Purchasing
7.4.1.3 Customer Approved Sources
Purchase products, materials or services from approved sources when
specified in the contract
Responsibility for ensuring quality of purchased product bought from
customer approved sources lies with the organization

7.4.2 Purchasing Information

Describe clearly all the purchasing informations / requirements
including
Requirements for approval of product, procedure, processes and equipment
Requirement for qualification of personnel
Quality Management System requirements

Ensure adequacy of specified purchase requirements before

communication to the suppliers
62

7.4 Purchasing
7.4.3 Verification of Purchased Product
Establish and implement inspection or other similar activity
to ensure the conformance specified purchasing
requirements
When verification is desired at suppliers premises (by the
organization or customer) define in purchase information
The intended verification arrangements
Method of product release

63

7.4 Purchasing
7.4.3.1 Incoming Product Quality
Establish a process to assure the quality of purchased
product
Utilize one or more of the following methods
Receipt of and evaluating statistical data
Receiving inspection and testing
Second or third party audits of suppliers site when coupled with the
records of acceptable quality performance
Part evaluation by a designated laboratory
Any other method agreed with the customer
64

7.4 Purchasing
7.4.3.2 Supplier Monitoring
Monitor the performance of supplier using
Delivered part quality performance;
Customer disruption (problems) including field failure;
Delivery schedule performance (including incidents of premium
freight);
Special status - customer notifications related to quality or delivery
issues
Promote suppliers own monitoring of their manufacturing
processes
65

7.5 Production & Service Provision

7.5.1 Control of Production and Service Provision
Plan and carry out production & service provisions under
controlled conditions which include, as applicable
availability of information that describes product characteristics
availability of work instructions , as necessary
use of suitable equipment
availability and use of monitoring and measuring devices
implementation of monitoring and measurement
implementation of release, delivery and post-delivery activities

66

7.5 Production & Service Provision

7.5.1.1 Control Plan
Develop control plans for products supplied covering
System (Assemblies)
Sub system (Sub-assemblies)
Parts
Material (including bulk material)

Prepare control plan for pre-launch and production

Use Design FMEA and Process FMEA as inputs

67

7.5 Production & Service Provision

Define the following in the control plan
Controls used for manufacturing process control
Methods for monitoring of controls exercised over special
characteristics
Customer required information (if any)
Reaction Plan when the process becomes unstable or statistically
non-capable

68

7.5 Production & Service Provision

Review and update control plan when change occurs which affect
Product, Manufacturing Process; Measurement; Logistics; Supply
sources; FMEA
Note: Customer approval may be required after review or update of
the control plan

7.5.1.2 Work Instructions

Prepare Work Instructions for all personnel having responsibility
for operation of processes ensuring accessibility at work station
Derived work instructions from sources such as Quality Plan /
Control Plan; Product Realization Processes
69

7.5 Production & Service Provision

7.5.1.3 Verification of Job Setups

Verify whenever setup is performed

For Example: Initial run of a job, material changeover,

job change
Ensure availability of work instructions for setup
personnel
Use statistical methods of verification where applicable
Note: Last-off comparisons recommended

70

7.5 Production & Service Provision

7.5.1.4 Preventive & Predictive Maintenance
Identify key process equipment
Provide appropriate resources for machine/ equipment
maintenance
Develop an effective, planned total maintenance system. As a
minimum this system to include :
Planned maintenance activities
Packaging & Preservation of equipment, tooling and gauging
Availability of replacement parts for key manufacturing equipment
Documenting, evaluating and improving maintenance objectives

Utilize predictive maintenance methods to continually improve the

effectiveness and efficiency of production equipment
71

7.5 Production & Service Provision

7.5.1.5 Management of Production Tooling
Shall provide resources for:

Tool and gauge design

Fabrication and verification activities
Establish & implement a system for production tooling management
including:
Maintenance and repair facilities and personnel
Storage and recovery
Set-up
Tool change programmes for perishable tools
Tool design, modification, documentation (including engineering
change level)
Tool identification, defining the status such as production, repair or
disposal
Implement a system to monitor these activities, if any work is outsourced

Note: This requirement also applies to availability of tools for vehicle service parts
72

7.5 Production & Service Provision

7.5.1.6 Production Scheduling
Plan / Schedule production to meet customer requirements (e.g.
JIT); Develop information system to access production
information at key stages of the process; Plan / Schedule
production to be order driven

7.5.1.7 Feedback of Information from Service

Establish and maintain a process for communication of

information on service concerns to Manufacturing; Engineering
and Design activity
Note: The intent of addition of service concerns to this element is to ensure
that the organization is aware of non-conformities that occur external to its
organization
73

7.5 Production & Service Provision

7.5.1.8 Servicing Agreement with Customer
Verify the effectiveness of following
Organization service centre
Special purpose tool for measurement equipment
Training of service personnel

74

7.5 Production & Service Provision

7.5.2 Validation of Processes for Production and Service
Provision
Validate any processes for production and service provision where
resulting output can not be verified by subsequent monitoring /
measurement.
Include any process where deficiencies become apparent only after the
product is in use or service has been delivered
Validate the ability of process to demonstrate achievement of planned
results

75

7.5 Production & Service Provision

Establish arrangements as applicable :
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
Revalidation

7.5.2.1 Validation of Processes for Production and Service

Provision Supplemental
The requirements of 7.5.2 apply to all processes for production and
service provision

76

7.5 Production & Service Provision

7.5.3 Identification and Traceability
Identify the product by suitable means throughout product realization
Identify the product status w.r.t. Monitoring and measurement
requirements
Where traceability is a requirement, control and record the unique
identification of the product

77

7.5 Production & Service Provision

7.5.4 Customer Property
Exercise care with customer property
Identify, verify, protect and safeguard
Record and report the details in the event of loss; damage and any other
unsuitability
Note: customer property can include intellectual property
NOTE: Customer owned returnable packaging is included in this
element

7.5.4.1 Customer Owned Production Tooling

Provide permanent marking on customer owned tooling

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7.5 Production & Service Provision

7.5.5 Preservation of product
Ensure product conformity is preserved during internal processing;
delivery to the intended destination
This include identification; handling; packaging; storage; protection

7.5.5.1 Storage and Inventory

Assess the condition of stored material at appropriate planned

intervals
Establish the inventory management system to
Optimize inventory turns over time
Assure stock rotation (e.g. First in first out)
Control obsolete products as non-conforming product

79

7.6 Control of Monitoring &

Measuring Devices
Determine
The monitoring & measurements to be undertaken
Monitoring & measuring devices needed to provide evidence of
conformity of product
Establish processes to ensure that monitoring & measurement
Can be carried out
Are carried out
in a manner that is consistent with the monitoring & measurement requirements

80

7.6 Control of Monitoring &

Measuring Devices
Where necessary measuring equipment be
Calibrated or verified at specified interval or prior to use with a reference
traceable to national / international standards
Where no such standards exists, basis used for calibration or verification to
be recorded

Adjusted or re-adjusted as necessary

Identified to enable calibration status
Safeguarded from adjustments that would invalidate measurement
results
Protected from damage and deterioration during handling,
maintenance and storage

81

7.6 Control of Monitoring &

Measuring Devices
Assess and record the validity of previous measurement results
If equipment is found not conforming to the requirements
Take appropriate actions on equipment and products affected

Maintain records of the results of calibration and verification

Validate the ability of computer when used for monitoring or
measurement
To be undertaken prior to initial use and re-confirmed as necessary
82

7.6 Control of Monitoring &

Measuring Devices
7.6.1 Measurement System Analysis
Conduct statistical studies to analyze the variation present
in the results of each type of measuring and test equipment
system
Cover all types of measurement system mentioned in
control plan
Use customer reference manual
For analytical methods and acceptance criteria

83

7.6 Control of Monitoring &

Measuring Devices
7.6.2 Calibration / Verification Records
Prepare & maintain the following calibration / verification records
Equipment identification including the measurement standard against
which equipment is calibrated
Revisions following engineering changes
Any out of specification readings as received for calibration / verification
An assessment of the impact of out of calibration conditions
Statement of conformance to specification
Notification to the customer if suspect product or material has been
shipped

84

7.6 Control of Monitoring &

Measuring Devices
7.6.3 Laboratory Requirements
7.6.3.1 Internal Laboratory
Establish a defined scope
Include capability to perform the required inspection, test or calibration
services
Ensure the lab complies with technical requirement
adequacy of laboratory procedure;
Qualification of laboratory personnel
capability to perform tests correctly, traceable to the relevant process standard (e.g.
ASTM, EN);
Review of related quality records

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7.6 Control of Monitoring &

Measuring Devices
7.6.3.2 External Laboratory

Have accreditation to ISO / IEC 17025 or national equivalent or

acceptable to the customer
Ensure external laboratory have defined scope

Cover capability to perform the intended tests / calibration

Note: acceptance to the customer may be demonstrated by customer
assessment or by customer approved second party assessment
Note: when a qualified laboratory is not available calibration services may be
performed by the equipment manufacturer. In such cases, ensure that the
requirements listed for internal laboratory have been met

86

8. Measurement Analysis &

Improvement
8.1 General
Plan and implement
Monitoring, measurement, analysis improvement processes
To demonstrate conformity of the product
To ensure conformity of the quality management system
To continually improve the effectiveness of QMS

Include determination of applicable methods

including statistical

techniques, and the extent of their use

87

8. Measurement, Analysis &

Improvement
8.1.1 Identification of Statistical Tools
Identify statistical tools during apqp. Include in the control plan

8.1.2 Knowledge of Basic Statistical Concepts

Develop understanding of basic statistical tools through out the
organization (variation; control (stability); process capability;

over-adjustment)

Utilize appropriate tool

8.2.1 Customer Satisfaction

One of the measure of the performance of QMS

Monitor information relating to customer perception (satisfaction /
dissatisfaction) as to organization has fulfilled customer requirements
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8. Measurement, Analysis &

Improvement
Establish methods for obtaining and using the information

Monitor information relating to customer perception (satisfaction /

dissatisfaction)
One of the measure of the performance of QMS
Establish methods for obtaining and using the
information

89

8. Measurement, Analysis &

Improvement
8.2.1 Customer Satisfaction Supplemental
Monitor customer satisfaction. Use

Quality performance of delivered parts

Customer line & field failures
Delivery performance (including premium freight paid)
Customer notifications related to issues of
Quality & delivery

Monitor manufacturing process performance to

Demonstrate compliance to customer requirements related to
Product quality
Process efficiency

90

8. Measurement Analysis &

Improvement
8.2.2 Internal Audit
Conduct internal audit at planned intervals to determine
whether QMS
Conforms to the planned arrangements
Requirements of this standard and QMS established by the
organization
Has been effectively implemented and maintained

Plan the audit programme considering

Status & importance of the processes and area being audited
Results of previous audits
91

8. Measurement Analysis &

Improvement
Define audit criteria, scope, frequency and methodology

Ensure objectivity and impartiality of audit selection of

auditors and conduct of audits
Auditor not to audit their own work

92

8. Measurement Analysis &

Improvement
Document procedure covering

Responsibilities and requirements for

Planning and conducting audits

Reporting results and maintaining records

Auditee to take corrective actions without undue delay

Follow up activities to include

Verification of the actions taken
Reporting of verification results

93

8. Measurement, Analysis &

Improvement
8.2.2.1 QMS AUDIT
Audit QMS to verify compliance to this standard and additional qms
requirements
8.2.2.2 Manufacturing Process Audit
Audit each manufacturing process and determine its effectiveness
8.2.2.3 Product Audit
Carry out product audit at defined frequency at appropriate
production stages and delivery
Product audit to include verification of specified requirements viz
Product dimensions; functionality; packaging; labeling

94

8. Measurement, Analysis &

Improvement
8.2.2.4 Internal Audit Plans
Prepare annual audit plan
Internal audits to include all
Quality management related processes
Activities
Shifts

Increase audit frequency when

Internal / external non-conformities
Customer complaints occur

Internal auditor
Use qualified internal auditor to conduct audit
95

8. Measurement Analysis &

Improvement
8.2.3 Monitoring And Measurement Of Processes
Apply suitable methods for monitoring & where applicable for
measurement of QMS processes
To demonstrate ability of processes to achieve planned results

If planned results not achieved, correction and corrective actions to

be taken

96

8. Measurement, Analysis &

Improvement
8.2.3.1 Monitoring & Measurement Of Manufacturing
Processes
Carryout process studies on all new processes

to verify process capability

Provide additional inputs for process control
Document results of process studies with specification for use in
instructions related to
Production
Measurement & test
Maintenance
Maintain Cpk and performance as specified in customer part approval
process requirements
97

8. Measurement, Analysis &

Improvement
Ensure implementation of process flow diagram and control plan
Adhere to specified
Measurement techniques
Sampling plan
Acceptance criteria
Reaction plans when acceptance criteria not met
Record significant process events tool change, machine repair
Initiate reaction plan for unstable or non-capable characteristics
Reaction plan to include,as appropriate
Containment of product
100% inspection

98

8. Measurement, Analysis &

Improvement
Prepare corrective action plan to assure that process become
stable and capable, detailing
Target dates
Responsibilities

When desired by customer, get corrective action plan reviewed

and approved from customer
Maintain record of effective dates of changes

99

8. Measurement Analysis &

Improvement
8.2.4 Monitoring and Measurement of Product
Monitor and measure product
appropriate stages of
product realization processes
Maintain evidence of conformity with acceptance criteria
Product or service not released until all monitoring / measurement
completed unless otherwise approved by a relevant authority &
where applicable by the customer
Maintain records to indicate person(s) authorizing release of
product

100

8. Measurement, Analysis &

Improvement
8.2.4.1 Layout Inspection and Functional Testing

Applicable to all customer engineering material & performance standard

Perform on all products at frequent intervals
Maintain results for customer review
Note: layout inspection is a complete measurement of all part dimensions
shown on the design records

101

8. Measurement, Analysis &

Improvement
8.2.4.2 Appearance Items
For parts designated by customers as appearance items,
provide:
Appropriate sources including lighting for evaluation
Masters for color, grain, texture, metallic brilliance distinctness
of image
Maintenance and control of appearance masters and
evaluation equipment
Verification that personnel evaluating are qualified

102

8. Measurement Analysis &

Improvement
8.3 Control of Non-conforming Product
Establish documented procedure to
Identify and control non-conforming product
Deal with non-conforming product by
Taking actions to eliminate the detected non-conformity
Authorizing its use, release or acceptance under concession
taking action to preclude its original intended use or application
Rejecting / scrapping

103

8. Measurement Analysis &

Improvement
Maintain records Of nature Of non-conformities & subsequent
actions taken
Perform re-verification On reworked product
Take appropriate actions when non-conformity is detected
after delivery or use has started

104

8. Measurement, Analysis &

Improvement
8.3.1. Control of Non-conforming Products-supplemental
Classify suspect products as non-conforming

8.3.2. Control of Reworked Products

Instructions for rework and re-inspection shall be accessible to and
utilized by all appropriate personnel

8.3.3. Customer Information

If non-conforming product is shipped, intimate customer promptly

105

8. Measurement, Analysis &

Improvement
8.3.4. Customer Waiver
Obtain prior concession or deviation when
Product or manufacturing process differs from currently approved

Maintain record of expiration date or quantity

Ensure compliance with original or superseding specification
after expiration
Provide identification on each shipping container
This applies equally to purchased products
Concur with suppliers requests before submission to customer

106

8. Measurement Analysis &

Improvement
8.4 Analysis of Data
Determine, collect and analyze data to
Demonstrate suitability and effectiveness of qms
Identify areas of continual improvement
Customer satisfaction
Conformance to product requirements
Characteristics and trends of processes & products
Suppliers

107

8. Measurement Analysis &

Improvement
8.4.1 Analysis And Use of Data
Compare Trends In Quality And Operational Performance With
Progress Towards Objectives And Lead For Actions To Support:
Development Of Priorities For Prompt Solution To Customer Related
Problems
Determination Of Key Customer Related Trends And Co-relation To:
Support Status Review
Decision Making
Long Term Planning

Timely Reporting Of Product Information Arising From Usage

Note: Data Should Be Compared With Those Of Competitors And/or

Benchmarks

108

8. Measurement Analysis &

Improvement
8.5 Improvement
8.5.1 Continual Improvement
Continually improve the effectiveness of qms
Facilitate continual improvement through use of
Quality policy
Quality objectives
Audit (internal & external) results
Analysis of data
Corrective and preventive action and
Management review
109

8. Measurement, Analysis &

Improvement
8.5.1 Continual Improvement of the Organization
Define a process for continual improvement

8.5.1.2 Manufacturing Process Improvement

Focus on Control and Reduction of Variation in
Products Characteristics
Manufacturing Process Parameters
Note 2: Continual Improvement Is Implemented Once Manufacturing
Processes are Capable & Stable

110

8. Measurement Analysis &

Improvement
8.5.2 Corrective Action
Establish documented procedure To
Review Of non-conformities (including customer complaints)
Determine the causes
Evaluate the need for action
Determine and implement action
Record the results

Review corrective action taken

111

8. Measurement, Analysis &

Improvement
8.5.2.1 Problem Solving
Establish defined process for problem solving

Use customer prescribed format when provided

8.5.2.2 Error Proofing

Use Error-proofing Method In Corrective Action Process

112

8. Measurement Analysis &

Improvement
8.5.3 Preventive Action

Establish documented procedure to

Identify potential non-conformities and their causes
Evaluate the need for action to prevent occurrence
Determine and implementing the actions needed
Records of results of action taken
Review preventive action taken
113