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WELCOMES YOU TO
IATF16949:2016 Awareness Training
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Background Information
1st Published in 1999 (TS 16949:1999)

2nd Published in 2002 (TS 16949: 2002)

3rd Published in 2009 (TS 16949: 2009)

Present - IATF 16949 : 2016 First Edition

Also Called as Automotive QMS Standard.

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Major Changes in IATF16949:2016

Some of the new enhancements to the automotive quality standard to address
recent issues in the automotive industry include:
 Requirements for safety-related parts and processes
 Enhanced product traceability requirements to support
regulatory changes
 Requirements for products with embedded software
 Warranty management process including addressing NTF
(no trouble found) and use of automotive industry guidance
 Clarification of sub-tier supplier management and development
requirements
 Addition of corporate responsibility requirements

0.1 General

To improve overall performance.

To provide a sound basis for sustainable development initiatives.

What is
Sustainable
What is Overall Development
Performance

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Sustainable development is development that meets the needs of the present

without compromising the ability of Future Generations to meet their own
needs .

Sustainability can be defined as the practice of maintaining processes of

productivity indefinitely—natural or human made—by replacing resources used
with resources of equal or greater value without degrading or endangering
natural biotic systems .

Risk based thinking enables an Organization to determine the factors

that could cause its Processes and its QMS to deviate from the planned
results, to put in place preventive controls to minimize negative effects
and to make maximum use of opportunities as they arise.

0.2 Quality Management Principles

ISO 9001:2015 ISO

9001:2008
QMP 2
Leadership QMP 2
Leadership
QMP 8
QMP 7 QMP 3 Mutually QMP 3
Relationship Engagement beneficial Involvement
of People supplier of People
Management
QMP1 relationship
QMP 1
Customer QMP 7
Customer
QMP 6
Evidence
Focus QMP 4
Factual
Approach to
the Focus
QMP 4
Process
Decision Approach
Based Process
Decision Approach Making
Making
QMP 5
QMP 6
QMP 5 System
Continual
Improvement Approach to
Improvement
Management

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0.3 Process
Approach

Schematic representation of the elements of a Single

process
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0.3.2 Plan-Do-Check-Act Cycle

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0.3.3 Risk Based Thinking NEW

Effects of
Uncertainty on
Objectives
What is Risk ?

An effect is a Deviation
from the Expected –
Objectives can have Positive /Negative
different aspects
and can apply at
different levels

Risk Based NEW

Thinking

Risk is often Characterized by reference to potential events and

consequences .
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Risk Based NEW

Thinking
Events:

Occurrence or change of a particular set of Circumstances .

An event can be one or more occurrences and can have several causes.
An event can consist of something not happening .

Consequences:

Outcome of an event affecting Objectives.

An event can lead to a range of consequences .
A consequence can be certain or uncertain and can have positive or negative
effects on objectives.
Consequences can be expressed Qualitatively or quantitatively.

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0.4 – Relationship with other MSS

This International Standard applies the frame work developed by ISO to improve alignment among
its International Standards for management systems (see Cl. A1)
 ISO9000 – QMS – Fundamentals & Vocabulary
 ISO9004 – Managing for the sustained success of an Organisation
 ISO10001 QMS Guidelines for Customer Satisfaction
 ISO10002 QMS Guidelines for Complaints Handling
 ISO10004 QMS Guidelines for Monitoring and Measuring
 ISO10005 QMS Guidelines for Quality Plans
 ISO10012 Measurement System standard
 ISO/TR10013 QMS Guidelines for System documentation
 ISO10014 QMS Guidelines for realising financial & economic benefits
 ISO10015 QMS Guidelines for Training
 ISO10018 QMS Guidelines on People Involvement & Competence
 ISO10019 Guidelines for Selection of QMS consultants
 ISO19011 Guidelines for Auditing Management systems

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Quality Management Systems - Requirements

1. Scope :
Consistency in meeting Customer and statutory requirements

Enhance Customer satisfaction and improvement in the Business

Processes .

Automotive Scope:
Design and Development , Production ,Assembly ,Installation and Services of
Automotive related Products including Products with Embedded Software.

Manufacture of Customer specified Production Parts , Service Parts and Accessory

Parts.

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NEW

Custom Floor Mats

Truck Bed Liners

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NEW

Wheel Covers

Sound System Enhancements

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NEW

Sunroofs

Spoilers

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Superchargers

NEW

Embedded software

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4. Context of the Organization NEW

4.1. Understanding the Organization and its context

- Determine the External and Internal Issues.

- How theses issues positively or negatively affects the organization.
- Monitor and review Information about these issues.

Take a hard look around you and ask these Questions.

What are we especially good at?

What aspects of our Organization Culture are especially help to us?

What do newcomers to our organization think we need to improve?

What emerging technologies could assist us?

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4. Context of the Organization NEW

What legal or regulatory issues have the potential to cripple us ?

What weaknesses do our competitors have that we can exploit ?

Where do we need more knowledge and Training ?

So it is an Organization Environmental Scanning of a strategic

Planning Process.

External context – Like Legal, Market, Cultural,

Technological, Competitive

Internal Context - Values, Culture knowledge and

performance.
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Exercise

Group Exercise 1

Do a SWOT analysis for your present Organization

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4.2 - Understanding the needs and NEW

Expectations of Interested Parties
- Determine interested Parties that are relevant to the organization.
- Determine requirements of these interested Parties that are relevant to the
organization.
- Monitor and review information about the interested parties and their relevant
requirements.
Who are interested party’s,
Who cares about your organization and what do they want from you,
Any one who has an interest in your operation, no matter whether official Business is
transacted or not.
Interested parties are any people or entities that believe they affect ,or affected or
could be affected by your organization,
Customers, Suppliers, Employees, Owners, Community, Schools and Colleges,
Regulatory bodies, Law enforcement, Emergency Responders, News media.

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Needs and Expectations of Interested Parties NEW

A definition for a need is "something that solves an actual or imaginary

problem."
A want is simply something that we’d like to have for whatever rational
or irrational reason.
Expectations are the anticipated circumstances of a purchase. They include all
steps of the customer journey, all interactions with the company, as well as the
effects of the purchase and experience, the practical benefits, and the
emotions. Customers rate a company’s performance by its ability to meet their
expectations.
Needs:What an interested Party has to have?
More focused on the service or Product specifications

Expectations :What an interested party like to have?

More focused on the people dimension or how I get what I need.

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NEW

Interested party Needs Expectations Business Processes

Customers On time delivery Better communication Customer processes

Zero Defects Loyal Logistics
No field Failures Flexibility Sales and Service
Right Price Trust worthy Quality Assurance
Process

Suppliers Timely payment Better Planning Purchasing

Accuracy of the
specifications Finance
On time communication

More SOB

Clear Job instruction

Employees and Training No politics HR Processes
Good Work Trust
Environment
Pay cheque accurate & Job Finance
On time sequrity
Resolution of
Grievances

Owners Return on Investment Consistency in Growth Business Planning

No legal issues Support the society Finance
Provide More Employment

No excessive noise or
Community Pollutions No Excessive truck traffic SHE Process
Logistics Process

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4.3 Determining the Scope of the QMS. NEW

Organization & Interested

its Context Parties

QMS Scope

Products &
Services

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NEW

Shall be made available and maintained as a Documented information.

Provide Justification for Exclusions.

Ensure that if these exclusions are not affecting the organization responsibility
towards Customers.
4.3.1- Support Functions (Onsite or remote) like Design centres ,Warehouses,
Distribution centres and Corporate Headquarters - Shall be included in the
Scope.
Only permitted exclusion – Product design and Development but do not include
Manufacturing Process Design.

4.3.2- Customer Specific requirements- shall be evaluated and included in the

Scope of the QMS.

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4.4.1 QMS and its Processes

Evaluate and implement any changes needed to achieve the intended results

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Manufacturing Process: Example

Risks : Resource needs :
Delivery failure Authority &
Human Resource
Customer complaints Responsibility
Infrastructure
Accidents. Work Environment
Opportunity :
New customers
arrival.
Inputs : Out puts:
Customer Schedule Products shipped as per
CSRs the Schedule
Product
requirements
FMEAs, CPs,
SOPs
KPIs : Interacting Processes: Documents:
Process Map No.
Maintenance
COPQ SOP / WI
Purchase,
OEE
HR ,Tooling, QA
Shop floor PPM
No of
accidents.

1. - Conformance of Products and Processes

Ensure conformance of all Products and Processes including Service and Outsourced
Parts.

NE
2. – Product Safety W
Documented Process - Product Safety related to Products and Manufacturing
Processes.
 Identify product related statutory and regulatory requirements.
 Customer notification
 DFMEA special Approval
 Identify Product Safety related Characteristics
 Specify these Characteristics in SOPs, WI’s, CP’s.
 Special approval of CP & Process FMEAs.

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4.4.1.2 – Product Safety NEW

 Reaction Plans
 Define responsibility and Escalation process – Top Management and
Customer notification.

 Identify the Training by the Organization or Customers for the personnel

involved.
 Change Management for any safety related process or product changes.
 Transfer the Product safety requirements throughout the Supply chain
including Customer Approved sources.
 Product Traceability - Throughout the Supply chain.
 Lesson learned

4.4.2 - Maintain and retain the documented information of these processes.

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5.0 Leadership
 Top management shall demonstrate Leadership and Commitment
 Taking accountability
 Ensure Quality Policy and Objectives are established which are compatible
with Strategic direction and Context.
 Ensure the integration of QMS requirements and Business Processes.
 Promote Process Approach and Risk based Thinking.
 Ensure the availability of resources.
 Communicating the importance of QMS.
 Ensure intended results are achieved .
 Engaging, Directing and Supporting persons.
 Promote Improvement.
 Support Process Owners to demonstrate their Leaderships
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5.1.1.1 - Corporate Responsibility NEW

Define and implement CR Policies
Minimum- Anti Bribery Policy, Employee code of Conduct and Ethics Escalation
Policy ( Whistle Blowing Policy )

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5.1.1.2 - Process Effectiveness and Efficiency

Top Management shall review Business Processes Effectiveness and Efficiency.

Included in management Review input.

5.1.1.3 – Process Owners NEW

 Top Management shall identify Process Owners.

 Process Owners shall understand their roles and be competent.

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5.1.2 - Customer Focus

Top Management shall demonstrate
Customer and legal requirements are determined, Understood and consistently met.
Risks and opportunities to enhance Customer Satisfaction are determined and
addressed .
Focus on Customer satisfaction is maintained.

2. Policy
1. – Establishing Quality Policy
Top Management shall establish, Implement and Maintain
In line with Purpose and Context of the organization and Strategic Direction.
Provide a framework for setting Quality Objectives .
Commitment to satisfy applicable requirements and Continual improvement.

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5.2.1 – Establishing Quality

Policy
Organization Context Needs & Expectations of
Interested Parties

Quality Policy

Quality Objectives

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5.2.2 Communicating the Quality Policy

 To be available and maintained as a Documented Information.

To be communicated, understood and applied with in the

Organization.

 To be made available to the relevant interested Parties as

appropriate.

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5.3 Organizational roles, Responsibilities

and Authorities
5.3.1- Top management Shall ensure that

 Responsibilities and Authorities for relevant roles are Assigned,

Communicated and Understood.

 QMS practices are conforms to this Standard.

 Processes are delivering their intended outputs.

 They receive the Performance of QMS and OFIs.

 Promotion of Customer Focus .

 When changes happened integrity is maintained.

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5.3.2-Responsibility and Authority for Product &

Corrective actions
 Authority to stop Production and Shipment

 In Some special cases the affected batch must be contained and prevent
the shipment.

 Responsible Personnel are informed not to ship nonconforming

Products and identify and contain Potential NC Products.

 All the operational shifts are staffed to ensure conformity with Product
requirements.

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6 Planning NEW

6.1 - Actions to address Risks and Opportunities

6.1.1 -
Risk management has a variety of Benefits.

It increases everybody’s awareness of Risk.

It focuses our efforts on the things that

matter most.

It helps create a culture of prevention and Risk Management.

It helps make us more successful.

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Risks and Opportunities NEW

Risk is anything that can affect our ability to achieve the Organization's Objectives

Risk can be Good or Bad.

Where do the Risk and Opportunities come from?

Is all the Risks and Opportunities to be addressed?

Standard explicitly says “ Determine Risks and Opportunities that need to be

addressed”.

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Interactions of Risks and Opportunities

4.2- Needs and
10.2.1 e -
4.1 – Expectations of
Corrective
Organization Interested
Actions
and its Context Parties

6.1 Actions to address 9.3.2 e –

9.1.3.e –
Risks and Opportunities Management
Analysis and
Review
Evaluation

5.1.2 b –
4.4.1(f)
5.1.1 d –Leadership Customer Focus
QMS
Processes
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Risks and Opportunities NEW

Determine Risks and Opportunities from

 Organization Context and needs and Expectations of the Interested

Parties.
 Give assurance that Organization achieves their intended Results .
 Enhance Desirable Effects.
 Prevent or Reduce undesired Effects.
 Achieve improvement.
Actions to address these risks and Opportunities :

They are Planned

They are integrated into QMS Processes.

They must be Proportional

They are Checked for Effectiveness.

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Risks and Opportunities

Severity Likelihood

1= No potential for harm 1=very unlikely

2=Distraction/Limited Effect 2=Possible, but not likely.

3=Negative Effect on
Sales and Reputation 3=Quite Possible

4=Loss of Major Customers/

Significant drop in Revenue 4=Likely

5=Death to Employees/
Business Closure 5=Very Likely

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Risks and Opportunities

Risks related to this Likelih S x
Training Effect Sever ood O Action Planned
ity
Start Monitor the room
Participants temparature
Hall Temperature High complain 3 2 6 Ahead of time

Participants can't Verify the Projector

System Won't connect to view the make/Model
Projector Slides 4 3 12 with the System.

Partipants
Outside Noise attention
/Distrubtions Distraction 3 2 6Check room noise level

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6.1.2.1 Risk Analysis NEW

Risk Analysis to include Lessons Learned from

 Product recalls

 Product Audits

 Field Returns and Repairs

 Complaints

 Scrap

 Rework

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6.1.2.2 – Preventive Actions

Eliminate the causes of Potential non conformance to Prevent their Occurrence.

Establish a Process to

 Determine Potential NCs and their Causes.

 Evaluate the need for action to prevent Occurrence.

 Determine and implement actions needed .

 Documented information of Actions taken.

 Reviewing effectiveness of the action taken

 Horizontal deployment to similar Processes.

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6.1.2.3 -Contingency Plans

Identify and Evaluate Internal and External Risks to all Manufacturing Processes
and Infrastructure Equipment.
Define Contingency Plans according to Risk and Impact to the Customers.
Prepare Contingency Plans for

 Key Equipment Failure

 Interruption from Supplier Products and Processes and Services.
 Natural disasters
 Fire
 Utility Interruptions
 Labour Shortages
 Infrastructure Disruptions.

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6.1.2.3 -Contingency
Plans
If any such situations arises notify the Customer and other interested
Parties for the extent and Duration.

Periodically test the Contingency Plan for Effectiveness (e.g.; Mock

Drills)

Review Contingency Plan (Minimum Annually) using CFT including Top

Management and Update.

Document the Contingency Plan and retain the Documented Information

for any revisions, including authority

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6.2 – Quality Objectives and Planning to Achieve

them

Establish Quality Objectives at Relevant Functions, Levels and Processes.

Maintain Documented Information on Quality Objectives.

Quality Objectives shall be

Consistent with Quality Policy.

Monitored and Measurable.

Relevant to Conformity of Products and Services.

Communicated and updated.

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Quality Objectives

6.2.2 -
The Organization shall determine

 What will be done

 What Resources will be required

 Who will be responsible

 When it will be completed

 How the results will be evaluated.

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Quality Objectives

Example :

Quality Objectives: Achieve Zero defects at Customer End.

What will be done: Introduce Prevention /Detection type Error Proofing.

Resource needed: CFT meeting once in 10 days for 30 minutes at Gemba.

Who will be Responsible: Process Engineering -Owner.

When it will be Completed: Before Part approval Process .

How the results will be evaluated: On monthly monitoring the Customer

score card.

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6.2.2.1 – Quality Objectives –

Supplemental
Throughout the Organization.

Consider interested parties and their requirements.

Including Internal & External.

Establish Quality Objectives and related Performance Targets review minimum

Once in a year

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6.3 –Planning of Changes

Changes shall be carried out in a Planned manner

Consider

a) The Purpose of the Changes and their potential Consequences.

b) The integrity of the QMS.

c) Availability of Resources.

d) Allocation or reallocation of Responsibilities and Authorities.

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7 Support
7.1- Resources
7.1.1 General
The Organization shall consider
Capabilities and constraints of Existing Internal Resources.
What needs to be obtained from External Providers.

Example includes Resources needed for

o Internal Auditing
o Training
o Communication
o Calibration
o Maintenance
o Software used with QMS.

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7.1.2 People

Determine and Provide People for effective Implementation and for the Operation
and Control.

7.1.3 - Infrastructure
Determine, Provide and Maintain the Infrastructure
Building, Machines, Software, Transport Vehicles, IT Services, Utilities etc.,

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7.1.3.1 - Plant, Facility and Equipment Planning

Use CFT including Risk identification and Mitigation methods for developing and
improving Plant ,Facility and Equipment Plans.

 Plant Layouts to ensure

 Optimise material flow and Handling
 Value added use of Floor Space
 Control of non conforming Products.
 Facilitate synchronous material Flow.
 Evaluate Manufacturing Feasibility for New Products or New processes.
 Capacity assessment to be included in Manufacturing Feasibility study.
 The above to cover also for Proposed changes to existing operation.

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7.1.3.1 - Plant, Facility and Equipment Planning

Maintain Process effectiveness by

 Periodic re evaluation related to risk

 Incorporate all the changes
 Control plan maintenance
 Verification of Job set ups.
 Management review inputs to include :
 Manufacturing Feasibility assessment and Capacity Planning
evaluation.
 These requirements may include Lean Principles
 May be applied to On site supplier activities

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7.1.4 - Environment for Operation of Processes

Determine, Provide and Maintain .

Temperature and Humidity, Safety hazards, Lighting, Noise,Vibration,
House Keeping, Personal Hygiene and Behaviour .
(Third Party Certification to ISO 45001 may be used )

7.1.4.1 Environment for the operation of processes-Supplemental

The organization shall maintain its premises in a state of order,

cleanliness and repair that is consistent with the product and
manufacturing process needs

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7.1.5- Monitoring and Measuring Resources

7.1.5.1 –General
The resources provided have to conform
Suitability - Selecting the correct Monitoring or Measuring resource for the Job at
hand.
Fitness for their Purpose - Preserves its ability to make measurements.
This can be achieved by ;

 Calibration
 Verification
 Preventive Maintenance
Repair
 Visual inspection
 Automatic replacement
after a defined time
frame.
 Statistical Analysis of
Measurement variation.

Retain Documented
information as an
evidence of Fitness for
Purpose.
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7.1.5.1.1 – Measurement System Analysis

Statistical Studies to be conducted to analyse the Variation present in the EACH

type of Inspection, Measurement and Test Equipment as identified in the Control
Plan.

Default level use MSA AIAG Manual.

If Customer approved other analytical methods are acceptable.

Records of Customer accepted alternative methods shall be retained along with

their MSA results.

Critical or Special product or Process Characteristics should be given Priority.

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7.1.5.2- Measurement Traceability

Measuring Equipment shall be

Calibrated or Verified or both at regular intervals.

When no National or international standard available, the basis used for

calibration shall be retained as a Documented information.

Identified for their status of calibration

Safeguarded from adjustments, Damage or Deterioration.

If the validity of the previous Measurements results found to be unfit for its
intended Purpose appropriate actions are to be taken

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7.1.5.2.1 – Calibration / Verification Records

Documented Process required for Calibration / Verification Records .

Employee Owned, Customer Owned and On site Supplier Owned Equipment to be
covered,
Retention Period - Consider Legislative and Regulatory and Customer defined
period

Calibration/ Verification records shall have

Revisions following Engineering changes that impact Measurement System.

Any out of Specification readings.

Risk assessment for out of Specification condition.

During calibration if it is found out of calibration or defective, validity of previous

measurement results shall be retained as a Documented information.
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7.1.5.2.1 – Calibration / Verification Records

Customer notification if suspect product is shipped.

Statements of conformity.

Software version verification.

Calibration records of all Gauges including Employee, Customer and On site Supplier
Owned.

Software verification including Employee, Customer and On site Supplier Owned

Equipment.

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7.5.1.3- Laboratory Requirements

7.1.5.3.1 – Internal Laboratory

Lab facility shall have a defined Scope for Inspection,Test or Calibration Services.

Scope shall be included in the QMS documentation.

Lab Shall specify and implement

 Lab technical Procedure.

 Competency of Lab Personnel.

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7.1.5.3.1 – Internal Laboratory

 Testing of the Product

 Traceable to international standard .

 When no such standard available – Organization shall define a

methodology to verify Measurement system capability.

 Include customer requirements if any.

 Review of related Records.

 Third Party accreditation to ISO/IEC 17025 (NABL) may be used for the
compliance.

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7.1.5.3.2 - External Laboratory

Shall have a defined Lab Scope.

Either Accredited to ISO/IEC 17025 or National Equivalent or Acceptable to

Customer.

If it is Acceptable to Customers- Customer assessment or by Customer approved

Second party assessment or Second Party assessment performed by the organization
may be acceptable.

Calibration Services performed by the Equipment manufacturer shall meet Internal

Laboratory ( 7.5.1.3.1 ) Requirements.

Calibration performed by Labs other than Qualified or Customer acceptable source

may be subject to Government regulatory confirmation.

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7.1.6- Organizational Knowledge

1) Determine the necessary Knowledge .

2) Maintain the Knowledge and Made available.
3) When changing needs and Trends consider the Current Knowledge
4) Determine how to acquire additional Knowledge.

Internal Sources of Knowledge:

TGW/TGR, Root causes of the Customer Complaints ,Shop floor rejections, Delivery
failures, Field Failures ,Accidents , Differences in perceptions .
Results of Kaizens, Out come of FMEAs , Outcome of the meetings and Teams
learning .
External Sources of Knowledge:
New Technology, Bench marking, Knowledge gained from Customers and External
Service Providers.
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7.2 –
Competence
1) Determine the necessary competence.
2) Ensure persons are competent on the basis of Education ,Training or Experience.
3) Evaluate the Effectiveness of the action taken.
4) Retain as a Documented Information.

7.2.1 –Competence - Supplemental

Identification of Training needs and Awareness - Establish and Maintain a Documented
Process.

All personnel engaged in Product and Process requirements to be covered.

Personnel performing specific assigned tasks shall be Qualified.

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7.2.2 - Competence – On the Job Training.

OJT to be included for Customer Requirements, Internal requirements, Regulatory or

Legislative requirements.

 New or modified jobs.

 Contract or Agency personnel also to be included.

 Level of depth- Based on the tasks and level of Education of the Person.

 If their work can affect Quality – Shall be informed about consequences

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7.2.3 - Internal Auditor Competency NEW

Shall have a Documented Process

Shall maintain a list of Qualified Internal Auditors.

QMS Auditors, MFG Process Auditors and Product Auditors - Minimum Competency

Knowledge on CSR.

Risk Based Thinking and Automotive Process Approach Auditing .

ISO 9001 & IATF 16949 – Knowledge with respect to Scope of the Audit.

Knowledge on Core Tools.

Knowledge on Planning, Conducting, Reporting and Closing of Audit

Findings.
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7.2.3 - Internal Auditor Competency

Manufacturing Process Auditors :

Technical understanding of the MFG Process (Like Equipment, Measurement System,
Tooling, Fixtures, PFMEA, CP, SOPS, Error Proofing devices, Mfg process Technology
used)
Product Auditors :
Technical understanding of the Product related requirements (Like Customer
Drawings , GD&T Symbols,Test requirements, Packaging requirements, Measurement
Knowledge)
Retain the documented information of the Trainer’s Competency.
Maintenance & Improvement:
Minimum no of Audits per year .
Update knowledge when internal and External Changes.

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7.2.4 Second Party Auditor Competency NEW

 Knowledge on CSR

 Risk Based thinking and Automotive Process Approach

 Knowledge on ISO 9001 & IATF 16949

 MFG Process knowledge including PFMEA & CP

 Knowledge on Core Tools

 Knowledge on Planning, Conducting, Reporting and Closing of Audit Findings

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7.3
Awareness
Ensure that all the employees of aware of

 Quality Policy & Objectives.

 Their contribution including the benefits of the contribution.

Implications of non conformance.

7.3.1 - Awareness - Supplemental

Maintain Documented Information.

Achieving, Maintaining and Improving Quality including Customer Requirements.

Aware of the Risk involved with Nonconforming Product.

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7.3.2 – Employee Motivation & Empowerment

Maintain a documented Process for

 Achieving Quality Objectives

 Making Continual Improvement.

 Creating an Environment to promote Innovation.

 Promotion of Quality and Technological awareness throughout the

Organization.
7.4 Communication
Internal & External :
Determine What,When,With Whom, How and Who
5 Whys & 2 How’s - Preferable

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7.5 Documented Information

7.5.1 - General
 Documented information required by the standard.
 Documented information determined by the Organization.

7.5.1.1 - QMS Documentation:

QMS shall be documented including Quality Manual .
Series of Documents- Retain the list of documents.
 Scope and Justification for Exclusions.
 Documented Processes or their reference.
 Sequence and Interaction of the Processes
 Type of Control of Outsourced Processes.
 A matrix of Organization Processes and Customer
Specific Requirements.
 A Matrix of Requirements of IATF 16949 &
Organization Processes.
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7.5.2 - Creating & Updating

When creating and updating ensure that

 Identification and Description

 Format and Media

 Review and Approval

7.5.3.1 - Control of Documented Information:

Documented information shall be controlled to ensure

 Availability and Suitability for use

 Adequately protected

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7.5.3.2
Distribution, access, Retrieval and use.

Storage, preservation and Legibility.

Control of Changes

Retention and disposition.

External Origin of Documented
information to be identified and
Controlled.

Retained Documented information-

to be protected from unintended
alterations.
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Note: Either permission to view only or permission and authority with edit and
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7.5.3.2.1 – Record Retention

Define, Document and implement a Record Retention Policy.

Control of Records to satisfy Statutory, Regulatory, Organizational and Customer

requirements.

 PAP approvals,
 Tooling records,
 product and Process design records,
 POs or Contract amendments - Retained for length of the Product life plus one
Calendar year or as specified by the Customer or Regulatory agency.

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7.5.3.2.2 Engineering Specifications

Documented Process required for Review ,Distribution and Implementation for the
Customer initiated Changes.
When an Engineering Change resulting in Product Design Change

Retain the Documented information on

Design and Development Changes, Results of Reviews,
Authorization and action taken to prevent adverse Impacts .
When an Engineering Change resulting in Process Change
Refer 8.5.6.1 Control of Changes.
Review Should be Completed with in 10 Working days.
These changes may resulting in Update of PAP documents.

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8.
Operation
8.1- Operational Planning and Control: Typically APQP .
Plan ,Implement and Control to ensure Product requirements are met.

Determine the requirements for the Products and Services .

Establish Criteria for the

 Processes - (Speed, Pressure,Temp,Time, Force)

 Acceptance of the Products- Fit, Functional and Performance
 Determine the resources - (Machines,Tools, Moulds, Fixtures,
Measurement Systems, Outsourced Processes, Competency, Utilities)
 Implementing Control of the Processes- PFMEA, CPs, SOPs,WIs .

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8.1- Operational Planning and Control

Determine, Maintain and retain the Documented information for

 Processes have been carried out as Planned.
 Demonstrate the conformity of Products and Services.
 Have Control on Planned Changes.
 Review the consequences of unintended Changes.
 Take actions to mitigate any adverse effects.
 Ensure that Outsourced Processes are Controlled.

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8.1.1- Operational Planning and Control –

Supplemental
When Planning Product Realization include the following:

 Customer Product requirements and Technical Specifications

 Logistics Requirements
 Manufacturing Feasibility
 Project Planning
 Acceptance Criteria

8.1.2- Confidentiality :
Ensure confidentiality for the Customer Products and Projects under development
and Product related information.

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8.2- Requirements for Products and Services

8.2.1- Customer Communication

 Ensure effective Communication for Providing Product related information.
 Handling Enquiries, Contracts or Orders including amendments .
 Obtain Customer feed back including complaints.
 Handling Customer Property
 Managing contingency

8.2.1.1- Written or Verbal to be acceptable with the Customers

Have the ability to provide Customer specified Format and Language .

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8.2.2- Determining the requirements for the

Products and Services
Organization to Ensure applicable statutory and Regulatory requirements , Safety and
Environmental regulations related to Acquisition, Storage, Handling, Recycling ,
Elimination or Disposal of Material are defined .

Considered necessary by the Organization are defined.

The Organization can meet the claims for the products and Services it Offers.

8.2.2.1-
Include result of the Organizations knowledge on the Product and MFG Processes.

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8.2.3- Review of the Requirements for Products

and Services
Conduct a review before committing to Supply for the following :

Customer specified Delivery and Post Delivery activities.

Not stated by the Customer but necessary .

Organization specified Requirements.

Statutory and regulatory requirements.

Resolve the Discrepancies with Enquiry

and Order.

Even if the customer does not provide conformation, Organization to conform

Customer requirements.

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8.2.3.2-
Retain the Documented information for

Review Results

Any new requirements for the Products and Services.

8.2.4 - Changes to Requirements for the Products and Services :

When there is change in requirements amend the relevant documented information.

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8.2.3.1.1 – Retain documented evidence of a Customer authorized Waiver

8.2.3.1.2- Conform to Customer requirements for Designation, Approval

Documentation and Control of Special characteristics.

8.2.3.1.3- Organization Manufacturing Feasibility

CFT Approach required.

Perform feasibility study to conform Manufacturing Processes are consistently

meeting Customer requirements.
Conduct Feasibility studies for New Manufacturing OR Product Technology or any
changed Product or Process Design.
Run at rate to be validated through production runs, Benchmarking studies or other
methods.

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A Feasibility study may contain several Key elements like:

a) Basic Raw material for the Products.
b) Stages of Manufacturing including Process Flow/VSM.
c) Space and Location
d) Utilities and Internal Transportation
e) Machinery and Equipment
f) Manufacturing Methods
g) People skills Requirements.
h) Process capability
i) Safety considerations.
j) Productivity
k) Quality
l) Expectations.
m) Packaging
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8.2.4 - Changes to Requirements for Products and Services.

When there is Change in Product requirements ensure

Relevant Documented information is amended.

Relevant Persons are made aware of the Changed

Requirements.

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8.3- Design and Development of Products and Services

8.3.1- General- Establish ,Implement and Maintain a Design & Development Process.
8.3.2 – Design & development Planning . ( AOPQ Timing Plan ).
Documented Information needed for demonstration.
While determining Stages & Control consider :
 Nature , Duration and Complexity.
 Process stages and no of reviews .
 Required Verification & Validation activities.
 Responsibility & Authority
 Internal & External Resources requirement
 Interfaces between persons involved.
 Need for Improvement of Customers and users.
 Next Processes requirements
 Level of Control by the Customers and Interested Parties.

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8.3.2.1 - Design & Development Planning -Supplemental.

 Include all the affected stake Holders and Supply Chain

 Use Multidisciplinary approach

 Project Management

 Design for Manufacturing, Design for Assembly

 Consider use of alternate design and Manufacturing Processes

 Development and review of FMEAs - Actions to reduce the risks

 Development and Review of FMEAs, CPs ,Process flows, SOPs & WI’s

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8.3.2.2 - Product Design Skills

Ensure personnel with Product Design responsibility are competent.

Applicable tools and Techniques to be identified .

8.3.2.3 - Development of Products with Embedded

software
Internally developed software - use a process for Quality assurance.
Software development assessment methodology to be used.
Retain Documented information of Software development self assessment.
Include Software development with in the Scope of Internal Audit.

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8.3.3 - Design and Development Inputs :

Consider
 Functional and Performance requirements.
 Information derived from Previous similar designs.
 Statutory and Regulatory requirements.
 Internal requirements .
 Potential Consequences of Failure .
 If any Conflicts in Design inputs to be resolved.
 Retain the Documented information on D& D Inputs

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8.3.3.1 - Product Design Inputs

Identify, Document & Review the following as a minimum

a) Product Specifications including Special Characteristics.
b) Boundary and Interface requirements.
c) Identification,Traceability and Packaging .
d) Consider Design alternative (Like Trade off Curves).
e) Risk assessment and Feasibility Analysis.
f) Target for Preservation, Reliability , Durability, Serviceability , Health ,Safety ,
Environmental, Timing and Cost .
g) Deploy Lessons learned , Benchmarking, Supplier Feed back, Internal inputs, Field
data.

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8.3.3.2- Manufacturing Process Design Inputs

Identify, Document and Review the following as a minimum :

 Product Design out put data including Special Characteristics .

Target for Productivity, Process Capability,Timing and Cost .
 Manufacturing Technology alternatives.
 Customer Requirements.
 Lessons Leaned.
 New Materials
 Handling and Ergonomic requirements.
 DFM & DFA.
 Use of Error Proofing Methods.

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8.3.3.3 - Special Characteristics

CFT Approach required.

 Organization identified and Customer identified.
 Incorporate in the drawing, FMEAs, CPS,SOPs and with the symbol.
 Develop Control and Monitoring for products and MFG Processes.
 Customer approvals if any.
 Compliance with Customer Specified Symbol or Organization equivalent
Symbols or notations - as defined in the Symbol Conversion Table.
 This table to be submitted to the Customers if required.

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8.3.4 –Design & Development Control

Apply Control to Ensure

 The results are defined

 Reviews are conducted

Verification activities are conducted

 Validation activities are Conducted

 Necessary actions are taken on Problems

 Retain the Documented information

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8.3.4.1 Monitoring

Measurement at Specified stages to be defined , Analysed and Reported

Summary results -Input to Management Review.

Report the status at each stages to Customers - If Required.

8.3.4.2 - Validation
To be done inline with Customer and Regulatory ( ARAI ) Standards.

Timings to be aligned with Customer timings .

This includes interaction of the Product with Vehicle upstream Systems including
Validation of the embedded software.

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3. - Prototype Programme
When required by the Customer - Have Prototype Program and Control Plan.
Use the same Suppliers,Tooling and Manufacturing Processes.
All performance Testing- Monitor for timely Completion.
For the Outsourced Services - Have Control on such services.

4. - Product Approval Process

Establish, Implement and Maintain a Process
Perform As per the Customer requirements.
Supplier PAP to be completed prior to
Organization PAP .
Obtain documented Product Approval ( Like PSW ) prior to shipment.
Retain the Records.
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8.3.5 –Design and Development Outputs

Ensure the following :

 Meet the input requirements.

 Adequate for the subsequent Processes .

 Monitoring and Measuring requirements and Acceptance Criteria .

 Specify Characteristics for Safe and proper Use. (User Manual with Safety
requirements).

 Retain the Documented information.

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8.3.5.1- Design and Development Outputs –

Supplemental
Out put shall include minimum the following;
 DFMEA
 Reliability Study Results.
 Special Characteristics.
 Results of Error Proofing - DFSS, DFMA, FTA.
 Product information including 3D Models, GD&T ,Technical data packages and
 Product Manufacturing Information.
 Product Design Review Results.
 Service diagnostic Guidelines, Repair and Serviceability Manuals.
 Service Parts requirements.
 Packaging and Labelling Requirements.

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8.3.5.2 – Manufacturing Process Design Outputs

Out put shall include minimum the following;
 Specifications & Drawings
 Special Characteristics.
 Identification of Process inputs variables.
 Tooling and Equipment for Production Control.
 Capability Studies for Equipment and Processes.
 Process Flow charts, Process FMEAs, CPs and WI’s.
 Maintenance Plan and Instructions.
 Process Approval acceptance criteria .
 Data for Quality, Reliability, Maintainability and Measurability.
 Results of Error Proofing.
 Methods of Rapid detection ,Feed back and Correction of product or process NCs

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8.3.6- Design and Development Changes

Identify , Review and Control Changes :
 Design and Development Changes.
 Results of Reviews
 Authorization of Changes.
 Action taken to prevent adverse impacts.

8.3.6.1 - Design and Development Changes - Supplemental

Evaluate design changes proposed by Organization or Suppliers.

Changes to be validated and approved internally prior to Production.

For the Products with embedded Software – Document the revision level of
the software and Hardware as a part of Change Records .

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8.4- Control of Externally Provided Processes,

Products and Services
8.4.1- General
Determine the Control to be applier for

Raw Materials

Products and Services are provided directly to the Customers.

Processes provided by the subcontractors ( Painting, Plating ) .

Determine and Apply Criteria for Evaluation, Selection, Monitoring of Performance

and Re evaluation.

Retain documented information of these activities .

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8.4.1.1 - General- Supplemental

Include
Sub assembly, Sequencing, Sorting, Rework, calibration and similar Service Providers.

8.4.1.2- Supplier Selection Process

Shall have a documented Supplier Selection Process . This to include
Supplier related Risk assessment.
Quality and Delivery Performance .
Evaluation of Supplier QMS.
Multidisciplinary Decision making .
Assessment of Software development
Capabilities.

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8.4.1.2- Supplier Selection Process

These Criteria may be considered – Not mandatory

 Volume of Automotive Business

 Financial Stability

Technology consideration

 Design and Development Capabilities

 Manufacturing Capabilities

 Business Continuity Planning

 Customer Service

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8.4.1.3- Customer Directed Sources

All the requirements are applicable as per Clause 8.4 Except- 8.4.1.2

8.4.2- Type and Extend of Control :

Ensure Control with in the QMS.

Define the Controls applied to Suppliers and Resulting output.

Consider the effect on Customers and Statutory and Regulatory Requirements .

Consider the Effectiveness of External Providers Controls .

Determine verification or other activities.

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1. Type and Extent of Control -

Supplemental
Shall have a Documented Process for

Type and Extent of Controls.

Consider Organization and end Customers.

Criteria and actions to escalate or Reduce the type and Extent of Controls.

2. – Statutory and Regulatory requirements

 Applicable to the Country of Receipts,

 Country of Shipment and
 Customer identified Country of Destination .

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8.4.2.3 - Supplier Quality Management System

Development
Follow the Sequence; Not mandatory.

Unless specified by the Customer;

 Compliance to ISO 9001 through second Part Audit.

 Certification to ISO 9001 through Third Part Audits.
 IAF MLA – (International Accreditation Forum Multilateral Recognition
Arrangements) Accreditation must .
 Certification to ISO with compliance to other Customer defined QMS
(MAQMSR- Minimum Automotive Quality Management System
requirements for Sub Tier Suppliers.
 Certification to ISO with compliance to IATF 16949 through second party
Audits.
 Certification to IATF 16949 through a third party audits.
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8.4.2.3.1 – Automotive Product related software or

Automotive Products with Embedded Software.

Such suppliers to maintain a Process for Software Quality Assurance for their
Products.

Software development Assessment methodology shall be used.

The Supplier to retain documented information of a Software development

Capability self assessment.

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8.4.2.4 Supplier Monitoring

Monitor the following as a Minimum :

 Quality Performance
 Delivery Performance
 Customer disruptions at the receiving Plant including yard Hold and Stop ships.
 No of Occurrences of Premium Freight.
 If the data Provided by the Customer , Monitor
 Special status Customer notification related to Quality or delivery.
 Dealer returns,Warranty, Field Actions and Recalls.

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8.4.2.4.1 - Second Party NEW

Audits
 Shall include a Second Party Audit Process.

 Based on the Risk decide the need ,Type ,Frequency and Scope.

 Retain the records of second party Audit reports.

 If the scope is to access Supplier QMS – Follow Automotive Process Approach.

 Second Party audit may be used for the following :

 Supplier Risk Assessment, Supplier Monitoring, Supplier QMS

 development, Product Audits and Process Audits.

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8.4.2.5 - Supplier Development

Determine the Priority,Type, Extend and Timing of required Supplier

Development actions. The following to be used as an Inputs Minimum :

 Performance issues related to Quality and Delivery.

 Second Party Audit findings

 Third Party QMS status.

 Risk Analysis.

 Resolve Open issues and Pursue Continual Improvement.

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8.4.3 Information for External Providers

Ensure adequacy of Requirements prior to communication.
Communicate the

 Processes , Products and Services to be Provided.

 Approval of Products, Services, Methods ,Processes and
Equipment.
 Qualification of Personnel.
 Interaction with the Organization.
 Control and Monitor their Performance.
 Permission for performing verification or Validation activities at the
supplier site by the Organization or their Customers.
 Pass down all the Statutory requirements and Special Process and
 Product Characteristics to Suppliers and ask the suppliers to pass down further in
the Entire Supply Chain.
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8.5 Production and Service Provision

8.5.1- Control of Production and Service Provision

Produce the parts under Controlled Conditions which includes :
Availability of
 Documented Information : Drawings, PFMEA, CP, SOPs,
WI etc .
 Suitable Monitoring & Measuring resources .
 Measure the results as per the control plan.
 Use of suitable Infrastructure & Work Environment .
 Competent persons including required Qualification.
 Validation and revalidation of the Manufacturing Processes.
 Error proofing
 Release, Delivery and Post Delivery activities.

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8.5.1.1 Control Plan

Develop Control Plan for System, Subsystem , Component and Material level.

 Including bulk Materials

 Family Control Plans are acceptable for Bulk Material and Similar Parts.

 Control plan required for Prelaunch and Production .

 Control plans to demonstrate Linkages between DFMEA, PFC, PFMEA.

 If required by the Customer , provide Measurement and Conformity data

collected during prelaunch or Production Control Plan.

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8.5.1.1 Control Plan

Control Plan shall have

 Process Control including job set up verification.

First off /Last off part validation.
 Control of Special Characteristics – Organization
& Customer identified.
 Any Customer required information .
 Reaction plan for the unstable and non Capable
processes.

Review and update for the following :

 After a Customer complaint .

 Any changes in the Process, Measurement, Logistics, Supply source ,
Volume changes and Change in FMEA.
 At a set frequency based on a Risk analysis.

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8.5.1.2 – Standardised Work - Operator Instructions

and Visual Standards

Ensure

 Communicated and Understood by the Employees.

 Operator to understand on his Language.
 Accessible for use at the work station.
 Shall include rules for Operator Safety.

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8.5.1.3 -Verification of Job Set ups

Job Set ups to be done for
 Initial, Material Change over or Job Change.
 Maintain Documented information for set up personnel.
 Use statistical methods- if applicable.
 Perform first off/Last off part validation – If applicable .
 Retain first off parts with last off parts for comparison and Last off
Parts with First off of next run (Where appropriate)
 Retain records of set up and First off / Last off part validation.

8.5.1.4- Verification after shutdown NEW

Define and implement necessary actions after a Planned and Unplanned Shutdown.

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2/7/2017

8.5.1.5- Total Productive Maintenance

Documented Total Productive maintenance System required.
 Identification of Process Equipment (Quality & Volume)
 Availability of replacement Parts
 Provision of required resources
 Packaging and Preservation
 Applicable Customer Specific Requirements.
 Documented Maintenance objectives (OEE ,MTBF, MTTR , PM Compliance % )
 Input to Management Review
 Regular review of Objectives - Documented CA for the Gaps
 Use Preventive and Predictive Maintenance methods
 Periodic Overhaul

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8.5.1.6- Management of Production Tooling and

Manufacturing ,Test , Inspection Tooling and Equipment

Provide Resources for Tool and Gauge Design, Fabrication and

Verification. For Production, Service and Bulk Materials.
For Organization or Customer Owned, Have a System for
 Maintenance and Repair Facilities and Personnel.
 Storage and Recovery & Set up.
 Tool Change Program for Perishable Tools.
 Tool Modification: Design records including Change level.
 Tool Identification, Status, Ownership and Location.
 Customer Owned: Permanently Marked
 Include the above to if it is outsourced – For Monitoring.

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8.5.1.7 - Production Scheduling

Order Driven - Pull System .

Have an information System to monitor the status.

During scheduling Consider these for Effective Planning :

Customer Orders, Supplier On time delivery, Capacity, Shared Loading,

Lead Time, Inventory, Preventive Maintenance and Calibration.

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8.5.2 - Identification and Traceability

Use suitable means to identify the Product.

 Identify with Status,

 Throughout Production,

 Unique identification (Bar coding) - Retain the Documented information,

 Note : For the Automated lines (Single piece flow) – Alternatives are permitted.

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8.5.2.1 Identification and Traceability -Supplemental

Conduct an analysis of Internal, Customer and Regulatory traceability requirements.

Develop and document Traceability Plan.
Based on the risk to Employees, Customers and Consumers.

The Plan has to help to

 Identify and Segregate nonconforming or suspect products.

 Consumers or Regulatory time ( Date of Expiry ) requirements as a Documented
information and retain.
 Serialized identification (Bar-coding)
 Extend the above to suppliers

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8.5.3 - Property belongs to Customers or External

Providers
Identify,Verify, Protect and Safeguard.

Provided for use or Incorporation.

When it is lost , Damaged or unusable report to them.

Retain Documented information on what has Occurred.

8.5.4 - Preservation
Preserve the outputs during Production and Service
Provision.

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8.5.4.1 - Preservation -Supplemental

Shall include Identification, Handling, Contamination Control, Packaging

Storage, Transmission, or Transportation and Protection.

To Cover from Receipt to acceptance by the Customers.

Verify periodically for the Storage Container and Environment.

Use Inventory Management System.

Treat Obsolete products as NC Products.

Comply the Customer requirements.

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8.5.5 -Post Delivery Activities NEW

Consider :

 Statutory and Regulatory Requirements .

 Potential undesired Consequences .

 Nature, use and Intended Life time.

 Customer Requirements.

 Customer Feedback.

PD Activities : Warranty, Maintenance, Recycling, Final Disposal.

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8.5.5.1 - Feedback of Information from Service

NEW

Service concerns to

Manufacturing, Material Handling, Logistics, Engineering and Design activities.

Should include Field Failure test Analysis.

8.5.5.5 Service Agreement with Customer

Verify the Service Centres Capability.

Effectiveness of Special Purpose Tools and Measuring Equipment.

Competency of Service Personnel.

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8.5.6 - Control of Changes NEW

Retain documented information for the

 Results of Review of Changes .

 Persons Authorizing the change
 Any actions arising from the review.

8.5.6.1 – Control of Changes – Supplemental

Shall have a Documented Process
Assess the Effects of any change - By the Organization, Customers or Suppliers.
Define Verification or Validation Activities.
Validate the Change before implementation .
Document the evidence of Risk analysis.
Retain the records.
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8.5.6.1 – Control of Changes – Supplemental

If it is at Supplier End Production Trail Run should be done.
When required by the Customers :
Notify the Customers.
Obtain documented Approval prior to implementation.
Complete identification requirements and Production Trial Run.
NEW
8.5.6.1.1- Temporary Change of Process Controls
Have a List of Process Controls ( Measurement Method in the CP )including Primary and
alternate methods.
 Include this in the FMEA.
 Get the internal approval prior to Production.
 If the products are inspected in an alternate method , if required get Customer
Approval.
 Work Instructions required .
 Review on daily basis ( Error Proofing verification ) like Validation of Measuring devices,
Daily Audits, Daily Leadership meeting.
 Restart verification shall be documented.
 Traceability ( For alternate batches ) shall be made.
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8.6 Release of Products and Services

 On going stage inspection/ Verification.

 Don’t release unless approved by Relevant Authority and Customer.
 Retain the Documented information as a minimum below :
 Acceptance Criteria and Evidence of Conformity
 Who has Authorized?

8.6.1- Release of Products and Services –Supplemental

Include in the Control Plan as a documented information.

Ensure initial release of Product approvals are included in the Product approval.

For ECN/ECR lots follow Change Management Process.

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8.6.2 - Lay out inspection and Functional Testing

 Performed for each product as specified in the Control Plan.

 Retain the Results for Customer Review.
 Frequency is determined by the Customer.

8.6.3- Appearance Items

Provide the following :

 Appropriate Resources including Lighting.

 Master samples for Colour, Gloss,Texture , DOIs .
 Maintenance and Control of Masters.
 Personnel Evaluations.

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8.6.4- Verification and Acceptance of Conformity of

Externally Provided products and Services.
Evaluate statistical data provided by the Supplier -
 Receiving inspection.
 Second and Third Party Audits.
 Evaluation by approved Lab.
 Any other methods approved by the Customers.

8.6.5 - Statutory and Regulatory conformity

Before realising ensure the products are conforming to Legal requirements of
Produced Country and Release Country.

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8.6.6 - Acceptance Criteria

Attribute data sampling Acceptance level shall be Zero Defects.

8.7 - Control of nonconforming Outputs

Scope includes:
Supplier, In house, detected after delivery, During and after
service.

• Correction.
• Containment action.
• Communicating the Customers.
• If any concession - Obtain Authorization.

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8.7.1.1 - Customer Authorization for Concession :

When the Product or Manufacturing Process is different from approved one

Get Customer Concession or Deviation including “use as is “ or Rework Products

and sub component reuse.
Maintain a record for expiration date or Quantity Authorized .
Ensure compliance when the date expire or Quantity reached.
Concession lot - Identification on each container.
Deviation form Suppliers - Approve before submitting to the
Customers.

8.7.1.2- Control of Nonconforming Product – Customer

Comply
Specifiedapplicable
processCSR. NEW

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8.7.1.3 - Control of Suspect Product NEW

Unidentified or Suspect status- Consider as a NC Product.

Competency of personnel -Handling Containment of suspect and NC Products.

8.7.1.4- Control of Reworked Products

 Include Rework in FMEA
 If required Get Customer Approval before starting the rework.
 Have a documented Process.
 Rework instructions including re inspection and Traceability shall be
accessible.
 Retain documented information for Quantity, Disposition & date and
Traceability information.

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8.7.1.5- Control of Repaired Product NEW

Include repair in FMEA.

Get Customer Approval before commencing the repair.

Have a Documented Process .

Repair instructions including re inspection and Traceability shall be accessible.

Obtain Documented Customer Authorization for concession .

Retain documented information for Quantity, Disposition & date and Traceability
information.

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8.7.1.6 - Customer notification NEW

Notify the Customer immediately - if NC Product has been shipped.

Document the initial communication of the event.

8.7.1.7- Non conforming Product Disposition

Have a documented Process for Disposition.
Ensure that the Product to be is scrapped is rendered
unusable.
Shall not divert the Product to service or other use ( After Market ) with out
customer approval.
8.7.2 -
Retain documented information .
Describe the Nonconformity, Action taken and any concessions Obtained.
Authorised persons who Approved or decision taken
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9. Performance Evaluation

Determine

What needs to be Monitored and Measured.

 Methods of Monitoring and Measurement.

 When to Measure and Monitor.

When to analyse the results.

 Retain the documented Information.

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9.1.1.1 - Monitoring and Measurement of

Manufacturing Processes
Perform Process Capability studies for all New Manufacturing Processes.
Use alternative methods if the process capability studies are not possible.
Maintain Process Capability as per PAP.
Ensure PFC, PFMEA and CP are implemented ensure:
Measurement Technique, Sampling Plans, Acceptance Criteria, Actual Measurement
values for variable data.
Have reaction Plans and Escalation Process .
Significant Process Events to be recorded and retained as a documented information.
Reaction plan required If the Process is unstable or not capable.
Corrective action plan required including timing and Responsibility.
If required the same shall be reviewed and Approved.

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9.1.1.2 - Identification of Statistical Tools

Determine Appropriate use of Statistical Tools.

Include in APQP, DFMEA,PFMEA and Control Plan.

9.1.1.3 – Application of Statistical Concepts

Employees involved in Collection, Analysis and Management of Statistical data shall
be aware of Variation, Process capability and over adjustment.

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9.1.2 Customer
Satisfaction
Monitor Customer Perception for the Customer needs and Expectation fulfilment .

Determine the Method.

9.1.2.1 - Customer Satisfaction- Supplemental

Evaluate based on Objective evidence on the following Minimum.
 Quality and Delivery Performance.
 Customer Disruptions.
 Field Returns, Recalls, and Warranty.
 Customer notification related to Quality, Delivery including Special status.
 Monitoring includes: Review of performance data and Customer Scorecards

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9.1.3- Analysis and Evaluation

Results of Analysis to include :

 Conformity of Products.
 Customer Satisfaction.
 Effectiveness of the QMS.
 Effectiveness of Planning implementation.
 Effectiveness of the action taken to address Risks and Opportunities.
 Supplier Performance.
 Need for improvements.

9.1.3.1 – Prioritization
Compare the trends with Business Objectives. Prioritize the action to improve
Customer satisfaction.

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9.2 - Internal Audit

9.2.1- Conduct Internal Audits at Planned Intervals.
Criteria : Organization’s Own Requirements
requirements of this Standard.

Ensure that it is effectively implemented and

Maintained.

9.2.2- Inputs for Audit Schedule

 Results of Previous audits , Importance of the Processes , Changes in the
organization.
 Auditors impartiality.
 Results to be reported to relevant Management .
 Take Correction and CA with out delay.
 Retain Documented Information.
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9.2.2.1 : Internal Audit Programme

Shall have a Documented Internal Audit Process .

Cover System, Process and Product Audits.

Prioritized based upon risks.

If software development involved - Include Software Development Capability

assessment in the Audit.

Frequency shall be reviewed .

The Effectiveness of the Audit Programme shall be reviewed as a Part of

Management Review.

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9.2.2.2 - QMS Audit

Plan for Three Years including Annual Plan.

Ensure Automotive Process Approach Auditing and Incorporation of CSR in each

audit.

9.2.2.3 – Manufacturing Process Audit

Audit all Manufacturing Processes over three Year Duration.

Use Customer Specified Approach ( Like VDA 6.3 ) .

If not defined by the Customer- Define your Own Approach.
As defined in the Plan- Each Manufacturing Process shall be Audited in all shifts.
Audit Where it occurs including shift hand over.
Include PFMEA, CP, SOPs ,WIs in the audit.

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9.2.2.4 - Product Audit

 Use Customer Specified Approach.

 Appropriate stages .

 If the Customer not defined define your own Approach.

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9.3- Management Review

Review at Planned Intervals.
Ensure the Effectiveness with Strategic Direction.

9.3.2 - Inputs
 Actions from Previous review.
 Changes in External and Internal issues.
 Effectiveness of the Performance of QMS
 Customer satisfaction and Feed back from interested Parties.
 Quality Objectives.
 Process Performance and Conformity of Products.
 Nonconformities and Corrective Actions.
 Monitoring and Measurement results.
 Audit results.
 Supplier Performance.
 Adequacy of Resources .
Effectiveness of the action taken to address risks and Opportunities.
 Opportunities for Improvement.
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9.3.1.1 – Management Review –Supplemental

 Shall be conducted at least annually.

 Based on the risks frequency shall be increased.

9.3.2.1- Management Review Inputs- Supplemental

 COPQ
 Measure of Process Effectiveness and Efficiency.
 Product Conformance.
 Changes to Existing Operations , New Facilities and New Products.
 Customer Satisfaction.
 Maintenance Objectives Performance.
 Warranty Performance.
 Review of Customer Scorecards.
 Identification of Potential Field Failure ( FMEA Review).
 Actual Field Failures and their impact on Safety or the Environment

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9.3.3.1- Management Review –Outputs

Decisions and Actions related to;

 Opportunities for Improvement.

 Any need for Changes.
 Resource needs.

9.3.3.1 - Management Review –Outputs -Supplemental

Top Management shall document an action plan when Customer Performance targets
are not met.

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10. Improvement -General

Actions to include

 Improving Products and Services

 Future needs and Expectations.

 Correcting ,Preventing or reducing any undesired Effects.

 Improving the performance and Effectiveness of QMS.

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10.2- Non conformity and Corrective Actions

10.2.1 -
 Take actions to control and correct it.
 Deal with Consequences .
 Reviewing and Analysing the nonconformity.
 Determining the Causes of nonconformity.
 Horizontal deployment .
 Implement the actions.
 Review the effectiveness of the action taken.
 Update the risks and Opportunities determined during Planning.
 Changes to the QMS.

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10.2.2
Retain the Documented Information for
 Nature of nonconformity and actions taken.
 Results of any Corrective actions.
10.2.3 Problem Solving
Shall have a Documented process for
 Defined Approaches for Various types and Scale of Problems.
 ( NPD, Current Mfg. issues, Field Failures, Audit findings )
 Containment actions.
 Root Cause analysis, Methodology used Analysis and Results.
 Corrective Actions and Horizontal Deployment .
 Verification of the Effectiveness of the Actions taken.
 Update the necessary documents like PFMEA ,CP .
 When required use Customer Specified method.
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10.2.4 – Error Proofing

Shall have a Documented Process for Error Proofing.

Method used shall be included in PFMEA and Test Frequencies to be included in
Control Plan.
Validate the devices periodically.
Records shall be maintained.
Challenge Parts (Master samples)
shall be calibrated or verified.

Reaction Plan required for Error

Proofing Failures.

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10.2.5- Warranty Management Systems NEW

When required
 Implement a Warranty Management Process.
 Method for Warranty Part Analysis including (NTF) No Trouble Found.
 If Customer specified methodology is to used follow the same.

10.2.6 -Customer Complaints and Field Failure Test Analysis

Initiate problem solving to prevent recurrence.

When required by the Customer – include the analysis of the interaction of Embedded
software.

Results of the analysis – Communicate to Customers and with in Organization

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10.3 Continual Improvement

 Results of Analysis and Evaluation.

 Management Review Outputs.

10.3.1- Continual Improvement - Supplemental

Shall have a documented Process
Includes

 Methodology used, Objectives, Measurement, Effectiveness and

Documented information.

 Manufacturing Process improvement plan to reduce variation

and Waste.

 Risk analysis (like FMEA)

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IATF 16949:2016 Major Documentation

1. -Product design and development requirement –exclusion and
justification maintain documented information
2. – CSRs shall be evaluated and included in the Scope of QMS
4.4.1.2 - product safety - documented processes for management of product safety
related product and manufacturing processes
5.3.1 - Organisation roles, responsibility and authorities -Shall be documented
6.1.2.1 –Risk analysis –retained documented information
6.1.2.3 –Contingency plan –document and retain documented information
7.1.5.1.1 – measurement system analysis -records of customer acceptance of
alternative methods
7.1.5.2.1 -Documented process –for managing calibration and verification
records
7.1.5.3.1. –Lab scope in the QMS documentation
7.2.1 - maintain documented processes for identifying training needs
7.2.3. – internal auditor competency –Documented processes
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IATF 16949:2016 Major Documentation

1. – maintain Documented information -Awareness -
2. – maintain documented information -Employee motivation and empowerment
7.5.1.1 – Quality management system documentation -Quality manual. Document
indicating – organisation QMS and Customer specific requirements matrix
1. – record retention policy. Production part approval documented
information
2. –Engineering specification –Documented process
8.2.3.1.1 –retain documented evidence -of a customer authorized wavier
8.3.1.1 –Document Design and development process
8.3.2.3 - retain documented information -Software development capability self-
assessment
1. - product design input –Document and review
2. - Mfg. process design input -document and review
3. - Document, review and implement -Special characteristics
8.3.4.4 - product approval process -Records for approval

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IATF 16949:2016 Major Documentation

8.3.5.2 – manufacturing process design output -Document
8.3.6.1 - documented approval or documented wavier from the customer. Software
revision level shall be documented
8.4.1.2 – Documented supplier selection process
1. – documented process for identifying outsources process and controls
2. - Statutory and regulatory requirements –documentation
4. – Documented process –Supplier monitoring process
1. – Second party audits -Document process and records of audit.
5. – Standardized work –operator instructions and visual standards
6. – maintain documented information for set up personnel -verification of
job setups and retain documented information
8.5.1.5 - Documented total productive maintenance system
8.5.6.1.1 – temporary change of process controls -identify document and maintain
process controls, including inspection, measuring, test, and error proofing
activities. Document the process for alternate control methods
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IATF 16949:2016 Major Documentation

8.7.1.1 – customer authorization for concession -maintain record of the expiration
date or quantity authorized under concession
4. – control of reworked product –documented process and retain
documented information
5. - Documented process for control of repaired product
8.7.1.7 – Documented process for Nonconforming product disposition
9.1.1.1 –monitoring and measurement of manufacturing processes -Maintain records
of effective dates of process changes
9.2.2.1 – Documented internal audit process.
9.3.3.1 – Document and implement action plan for customer performance targets are
not met
3. – Documented process for problem solving
4. – Error proofing -Documented process
5. – Warranty management process
10.3.1 – Documented process -continual improvement

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Any
Questions

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