Understanding IATF 16949

INTRODUCTION TO IATF
16949:2016

Familiarization to IATF 16949:2016 Quality Management

System

2
 Standards Line of Certification
Members of IATF

International
Organization for
Standard ISO
Standardization Any organization Accreditation Board
No. 1 9001:2015
(International
Standard)
CB to be
decided and
sourced for
Certifying Body MGI

International
For Automotive direct
Automotive Task
Standard IATF 16949 : material supplier to OEM/
Force
No. 2 2016 automotive supplier, or
(Proprietary Company
OEM itself
standard)

In 2016, ISO TS 16949 got revised to IATF 16949:2016

3
 Top Management

Senior management who can take strategic decisions.

High Level Structure (HLS)

In the year 2015, ISO released a document called as Higher level

structure (HLS) for Management system series.
To commonize structure of various standards

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 ESTABLISHING QMS – PROCESS APPROACH (TURTLE DIAGRAM)
Topic # 10
A process approach means an organization manages its business as a system of
processes – not departments or people or products.

3 types of Business processes encompasses all

activities within an organization

Process Customer
Input Output Management Support
Approach Oriented
Oriented Process
Process
Process

PDCA Methodology

Key Success Factor: All business processes MUST have one PROCESS OWNER each 5
 10 Clause Model

HIGH LEVEL
PDCA Methodology
STRUCTURE

What is the 10 Clause Model

or Higher Level Structure?
6
High Level Structure – 10 Clauses of IATF 16949:2016
Clause No. Clause Name Description

Non-Auditable
1 Scope Applicability of the standard

Clauses
INFORMATORY ▪ For ISO 9001:2015, base reference is 9000:2015
2 Normative references
CLAUSES ▪ For IATF 16949:2016, base reference is ISO 9001:2015

3 Terms and definitions

▪ Scope of the Organization
Context of the
4 organization
▪ Issues and Interested Parties Identification related to QMS, IP expectations
▪ QMS processes and systems for organization's QMS

PLAN ▪ Take accountability for Organization's QMS

5 Leadership ▪ Quality Policy

Auditable Clauses
▪ Identify Process owners (roles/ Responsibility)

6 Planning Action Planning based on Risk assessment approach

7 Support Setting up the manufacturing facility and execution of

DO Plant Operations
8 Operation
Performance
9 evaluation
CHECK

10 Improvement ACT
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 Clause 4
Sub-Clauses:
1. Understanding the Context
of the Organization
CONTEXT OF THE 2. Needs of Interested Parties
ORGANIZATION 3. Scope of IATF
4. Establishing QMS & its
Processes
4. Context of
2. Normative 3.Terms and
1. Scope the 5. Leadership
references definitions
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
8
 Clause 4 CONTEXT OF THE ORGANIZATION
Clause 4 Clause Requirement / Action Required Remarks IATF Specific
QMS should be operational and used as BMS
Understanding the Define corporate strategy (short term and long term) - documentation of
4.1 organization and its organizations long term goals (minimum 5 years) as a part of business plan. Organizational SWOT analysis to identify positive and
context Business Plan : customer current and future intended expectations negative issues.
Strategic direction example: n% market share by 20XX
Understanding the needs Prepare list of expectations of interested parties – customers, management,
4.2
of interested parties employees, suppliers, legal authorities through surveys/ workshops
MG Motor sells vehicles as a standalone brand, hence is a
Scope: Design, manufacturing and supply of passenger vehicles (multi fuel) design responsible organization. Design cannot be
Determining the scope of across the Indian market. excluded from the scope of IATF 16949:2016. Design
4.3
IATF Manufacturing site, Remote Location: Warehouse, design centers, homeroom must be considered as a remote location. We
corporate offices etc. will take reference of home room IATF certification for
MGI.
Quality Management Define process owner for each process (should take end to end
4.4 Proposal prepared, to be circulated
System and its processes responsibility)
Conformance of products
4.4.1.1 Includes service parts and all outsourced products and processes. IATF
and processes

All safety and functional products - CRITICAL TO SAFETY (CTS) (similar to CTQ)
- Statutory and regulatory product-safety requirements；
- Product safety-related characteristics；
- Identification and controls of safety-related characteristics on line (CTS) CRITICAL TO SAFETY
4.4.1.2 Product Safety - Special approval of control plans and process FMEAs; IATF
- Special Mention in alarm escalation Example: PS1, PS2 fasteners, seat belts etc.
- Operator awareness of CTS - product characteristic and process parameters
- Product traceability (at least mfg. lot wise)
- Lessons learned for new product introduction.
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 Clause 5
Sub-Clauses:
1. Corporate Responsibility
and Customer Focus
LEADERSHIP 2. Quality Policy
3. Organization's roles &
responsibilities
4. Context of
2. Normative 3.Terms and
1. Scope the 5. Leadership
references definitions
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
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 Clause 5 LEADERSHIP
Clause 5 Clause Requirement / Action Required Remarks IATF Specific
Track, monitor, review Last quarter performance as per customer
5.1.1 General
requirements.
3 mandatory policies
1. Anti bribery policy
5.1.1.1 Corporate responsibility 2. Employee Code of Conduct IATF
3. Ethics escalation policy - whistle blowing policy - define what is bribe and
what is not
Each process to have 2 KPIs - Example: Customer complaint handling process
Process effectiveness and
5.1.1.2 Efficiency - How fast/ economical 1. Actions open in time frame IATF
efficiency
Effectiveness - Do it right 2. # complaints repeating
1. Top management identifies Single owner for each process
5.1.1.3 Process owners 2. Roles/ Responsibility/ Competency mapping to be done for each process Risk Based Thinking: Prepare QMS FMEA for all KPIs IATF
owner
Current + Future Customer needs/expectations to be addressed:
5.1.2 Customer Focus
How are you looking for business in Indian Market 2025?
Elements of policy vs department wise goals to achieve
5.2 Quality Policy Policy Deployment Matrix to be made.
that
For all employees
Organizational Roles,
>> Role (designation), Responsibility (ownership), Authority
5.3 Responsibilities &
(empowerment)
authorities
>> KRA (activity/individual goal); KPI (process outcome)
Customer Representative
5.3.1 Aftersales department IATF
(CR) As per IATF Min two designations are compulsory: CR,
Quality Representative QR
5.3.2 Quality Operations IATF
(QR )

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 Sub-Clauses:
Clause 6
1. Risk Management
2. Quality Objectives &
Planning
PLANNING 3. Change Management

RISK BASED THINKING mantra

2. Normative 3.Terms and

4. Context of When ever the word "PLAN" occurs next word has to
1. Scope the 5. Leadership
references definitions be "RISK MANAGEMENT“
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
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 Clause 6 PLANNING
Clause 6 Clause Requirement / Action Required Remarks IATF Specific

Actions to address risk From issue register and expectations list, +ve issue >> opportunity, -ve
6.1
and opportunity issue>> risk. Prioritize top issues from above list.
Minimum QMS FMEA required:
1. Organization Quality Objectives
6.1.1 General 2. Prioritized issues QMS FMEA - Source Context of the organization
3. Prioritized expectations of IPs
4. KPIs for all processes
Should include:
1. Lessons learnt from product recalls (self or competitors)
EVIDENCE OF RISK ANALYSIS (FMEA) COMPULSORY.
6.1.2.1 Risk analysis 2. Product audits IATF
For System: OC, IPR and RA
3. Field returns, repairs, complaints
4. Scrap, Rework
6.1.2.2 Preventive Action Need for action based on Priority - ex. RPN IATF
3 Steps
CONTINGENCY PLANNING CONDITIONS:
1. Contingency Planning conditions >>
1. Utility interruption
2. Resource Plan >>
2. Key equipment failure
3. Evaluation and Testing (Mock drills to be conducted for each
3. Labor shortage
contingency as per defined frequency.)
6.1.2.3 Contingency Plan 4. Field return IATF
EXAMPLE:
5. Fire
Contingency planning condition >> Compressor down
6. Recurring natural calamities
Response Plan >> Rental compressor
7. External supply failure
How to test and evaluate >> Bring rental compressor, test on line, test,
8. Cyber attack
record, demonstrate
Quality Objectives and
6.2 Define and document RASIC and resources for all processes.
Planning to achieve them
Quality Objectives-
6.2.2.1 Quality / Cost / Delivery >> Process targets (BPD) IATF
Supplemental
Assess impact of change and define all impacted functions/ processes.
6.3 Planning of changes
Evidence of Change management and linkage to QMS system changes.
Change Management Process 13
 Clause 7
Sub-Clauses:
1. Resources
2. Competence
SUPPORT 3. Awareness
4. Communication
5. Documentation
4. Context of
2. Normative 3.Terms and
1. Scope the 5. Leadership
references definitions
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
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 Clause 7 SUPPORT Sub-clause 1
Clause 7 Clause Requirement / Action Required Remarks IATF Specific
7.1 Resources
If any physical asset required to meet the customer expectation is not
7.1.1 General
available, it is a non conformity.
Person not available (7.1)
7.1.2 People 1. Human Resources - availability of person for the job
Skilled Person not available (7.2)
Work place or operational environment - Associated utilities (Boiler
7.1.3 Infrastructure Compressor etc.), equipment (Printing machine , MSNR) , Space , transport
resource (Truck Spec.)

Multi-disciplinary approach for (mandatory)

1. Implementation of LEAN MFG
Plant, Facility, Equipment
7.1.3.1 2. CFT approval for CAPEX LAYOUT PLANNING IATF
Planning
3. Capacity Evaluation
4. Manufacturing feasibility

Ex: lux level, Temperature, Humidity, What type of chair/table, Height of

Environment for
7.1.4 person, Odo monitoring system
operation of process
5S implementation - 1S and 2S - sort and set in order (mandatory)

Related to calibration AND Verification

Monitoring and 1. Equipment damage / continued fitness for purpose
7.1.5 Focus area for Quality IATF
measuring resources 2. Equipment must be identified with sticker
3. Usage condition: Vernier kept in back pocket.
Documented procedure for retaining Organization Knowledge:
Organizational 1. Knowledge transition when employee leaves
7.1.6
Knowledge 2. Lessons learnt from people/projects
3. Knowledge sharing records - training, seminar, context backup etc.
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 Clause 7 SUPPORT Sub-clause 2, 3, 4, 5
Clause 7 Clause Requirement / Action Required Remarks IATF Specific

Competence mapping:
Education, experience, training, skills for every
7.2 Competence
employee
DESIRED>> CURRENT>> ACTIONS>> EFFECTIVENESS
7.2.2 Competence Contract employees OJT required IATF
All employees including Contractors - Q policy objective/their role in
7.3 Awareness
QMS/ Impact of not following QMS

Evidence requirement
7.3.1 General 1. Effect of Defect IATF
2. Effect of Lapses

Employee motivation and

7.3.2 Promote innovation and kaizens IATF
empowerment
7.4 Communication Make Communication matrix
7.5 Documented Information
7.5.1 General Quality manual - mandatory in IATF16949:2016
7.5.1.1 QMS Documentation Make compliance Matrix IATF
All docs must have doc number, doc date, control number/control stamp,
7.5.2 Creating and updating
revision no., revision date, prepared, reviewed, approved, software version

Control of documented Retention period of all documents, where/how to store, how to dispose.
7.5.3
information All BPDs must be archived as a part of document retention.

Documented process for review distribution and implementation of

7.5.3.2 Engg. Specifications specification on product Example: PQS / IPQS, other product standards IATF
Actual Implementation controls
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 Sub-Clauses:
Clause 8 1. Operational planning & Control
2. Facility & Process Set Up
Requirements
3. Product/ Process design &
development
OPERATION 4. Control of Externally provided
Products/ Services (Raw material
control)
5. Production & Service Provision
6. Release of Product & Services
4. Context of
2. Normative 3.Terms and
1. Scope
references definitions
the
organization
5. Leadership
7. NC material handling
9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
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 Clause 8 OPERATION Sub-clauses 1, 2
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Documented procedure for New product development - Global

launch plan (GLP), Review mechanism for deliverables (PQRR)
Operational Planning and Important areas/ considerations : Most related function: Launch
8.1
Control • Risks related to NPD Clause Defines how NPD process should be.
• Acceptance criteria for products and services
• Product conformity
8.1.2 Confidentiality NDA , Product masking , NDA with Employee post employment IATF
Requirements related to
8.2 Establish Interface with Customer
products and services
Communication in the form of:
Strong communication -Product catalogue / product portfolio
How do we communicate to customer about our
8.2.1 system for customers / -Customer complaints
products?
customer requirements -Online feedback to customers
-Service feedback; -Dealership rating
Adequacy review for customer requirements; Feasibility of delivery / post
• Unidentified needs are organization's responsibility.
Determining the delivery
Benefit of doubt is given to customer
8.2.2 requirements for • For orders obtained - delivery must match requirements
• Cannot tell the customer "Pehle nahi bataya" - NOT
products and services • If orders are not finalized - lost opportunity gap analysis to be conducted
ALLOWED
How to recycle / environmental Impact of product
Review of requirements
8.2.3 Similar to MQRR Verbal deviations not allowed IATF
for products and services
Define and validate 6M
8.2.3.1 Org. Mfg. Feasibility Practically validate motion and analysis IATF
Production trial run for line design
Changes of requirements Enquiry changes to be catered to as good as a new enquiry and all
8.2.4
for products and services requirements to be evaluated 18
 Clause 8 OPERATION Sub-clauses 3
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Design and
8.3 IATF includes both product and process design
development
Product design and Mfg. Error proofing, CFT approach, APQP/ VDA project management and review; PFMEA DFMEA
8.3.1.1 IATF
process design review 4 Docs. Skill matrix of product/ process designer
QAP/ CTF / All Vehicle tests prior to
Design and development
8.3.2
planning
Verification and Validation launch / In process tests like destructive
test etc.
Development of products IT management system for automotive software
8.3.2.3 IATF
with embedded software Software development assessment methodology
How the following are addressed and captured? Product Designer specific actions
1. Functional and performance inputs
2. Information derived from previous similar design / development activities
Design and development 3. Statutory and regulatory requirements
8.3.3
inputs Example: Green Batteries - ensure zero
4. Standard or codes of practice that organization has committed to implement
lead usage, zero emission car
5. Potential consequences of failure due to nature of product and services
Trade of curve for different design parameters
Launch Related Clause
Define results, review of design, verification, validation, corrective actions, documented
Design and development
8.3.4 information IATF
controls
Control Plan for all proto builds (Conditional)
PPAP should be done as per AIAG 4th edition
1. Is requirement met?
2. Is output adequate for the subsequent process? Example: in main product design, child Outcome of PE design activities
Design and development
8.3.5 part also to be considered.
outputs
3. Include monitoring and measuring requirements (not methods) For use in manufacturing
4. Acceptance criteria / KCC
Design and development 19
8.3.6 NOTE: without verification and validation - no design change can be implemented. EWO / PTR relevance
changes
 Clause 8 OPERATION Sub-clauses 4
Clause 8 Clause Requirement / Action Required Remarks IATF Specific
Control of Externally
Applicable for direct material/ services ONLY, not for indirect material/
8.4 provided products and Raw Material/ Service Management
services.
services
Define supplier controls based on supplier criticality.
8.4.1 Supplier Management Supplier criticality can be mapped based on 3x3 matrix of Part criticality and SQE: Supplier controls based on supplier criticality
supplier performance (High/Medium/Low)

Supplier development is NOT what purchase does for initiating supplies Controls on supplier can be:
from a vendor. 1. QMS certification
2. Second Party Audit (MGI going to supplier and
8.4.2 Supplier Development IATF here talks about performance-based supplier activities through auditing)
improved through additional controls/ systems. 3. Incoming Inspection
4. Third party inspection (Ex. For GP12)
We should periodically audit supplier's QMS. 5. Layered Audits

How to track:
- No. of IATF certified
Tracker for supplier QMS
- No. of ISO 9001 Certified
8.4.2.3 Development and SQE IATF
- No. supplier upgraded in a yr.
performance
- Yearly plan of supplier upgrade
- Management of software supplier

Purchase Order for suppliers or external providers should be complete with

Key information provided to the supply chain. Captured in RFQ/SOR/PO.
Information for External
8.4.3 Supporting literatures like: PURCHASE
Providers
For Headlamp - Define what validation or verification test reports to be
shared along with the parts.
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 Clause 8 OPERATION Sub-clauses 5
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Production and service

8.5
provision
To be audited on shop floor - 6 M - Man, machine, material, method,
measurement method, mother nature/ environment
1. Documented information
2. Availability and use of suitable monitoring and measuring resources
Clause gives details what all is required for setting up
3. Measurement activities at appropriate stages to verify specified
Control of Production acceptance criteria/PQS is met
8.5.1 Process Audit and Layered Audit
and service provision 4. Use of suitable infrastructure and work environment
5. Competent people
6. The validation and periodic revalidation of special processes
7. Error proofing - process / part / system
8. Implementation of product & service release, delivery and post delivery
activities
AKA In-process quality plan. Focus on planning information and integration
of lessons learnt
8.5.1.1 Control Plan Important
Measurement and conformity data collected during 1) pre-launch, 2) regular
production control plans must be available

8.5.1.2 Standardized work includes operator safety and addresses language needs of operator Covered in SOS JES, STS TIS

Set-up approval (process parameters)

Verification of Job Set- Example: In Body shop - current/ voltage checks, Chisel test, Poka-yoke
8.5.1.3
ups verification, torque audits, pneumatic checks for pneumatic torque
application
First Piece Inspection (Product parameters)
First-off or Last-off part as applicable
In-process approval (Product parameters)
Monitoring control over special characteristics 21
 Clause 8 OPERATION Sub-clauses 5
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Production and service

8.5
provision

Verification After Shut- Verify product conformance after planned / unplanned shutdown (no
8.5.1.4
down matter how small the duration of shut down)

List of critical equipment and List of critical spares based

Mandatory documented TPM process on
TPM OEE, MTTR, MTBF - tracking and analysis a) quantity
Total Productive OEE improvement strategy based on availability, quality, speed b) function
8.5.1.5
Maintenance c) breakdown history
- Breakdown maintenance to be linked with preventive and predictive
Préventive maintenance - TBM
maintenance.
Prédictive maintenance - CBM
- Analysis reports - prove that breakdown is not recurring.

For All tooling, production/service materials and bulk materials - inhouse/

Management of external provider owned
production tooling and 1. Strengthen identification/marking and tracking requirements for
8.5.1.6 manufacturing; Test self/supplier owned tooling
inspection tooling and 2. Marking of ownership and application in a visible area
equipment 3. Include tool design modification information and engineering changes
4. System to track activities in any out-sourced work

Linkage of production scheduling with feasibility review and capacity

ME Line planning / shift planning etc.
planning.
8.5.1.7 Production scheduling For non-moving FGY inventory stock reverification policy for quality is
required.
Aftersales IATF
CPIT feedback of information from service. 22
Service agreement with customer technical support to dealers.
 Clause 8 OPERATION Sub-clauses 5
Clause 8 Clause Requirement / Action Required Remarks IATF Specific
Production and service
8.5
provision
All material and part labelling - for identification and traceability for
Traceability = Only barcode stickers??? NO
Identification and product conformity
8.5.2
traceability Permanent traceability - VIN, Engine Number
Dynamic traceability - Part barcodes (at least batch wise)
1. Reconciliation of external property to ensure no damage Example: Customer containers/ bins, RSRs from
Property belonging to
2. Stock and status of external property suppliers etc.
8.5.3 customers or external
3. is there any loss / damage Example: Inspection gauge of supplier/ customer - org is
providers
4. How is it communicated responsible for its calibration
FIFO enables preservation. Identification, MSDS, Storage conditions, shelf
life, contamination control, transmission or transportation, protection, place
8.5.4 Preservation and type of storage (ex. Type stacking)
Integrity of product
Treat obsolete product/ part like non-conformity product
Comply to org post delivery product / service requirements
- legal requirements
- potential undesired consequences
- nature/use/intended life (ex. 15 yrs. spare parts availability) EXTERNAL CUSTOMER REQUIREMENTS --- MGI
8.5.5 Post Delivery activities
- customer requirements OBLIGATIONS
- customer feedback
- Feedback from service, material handing and logistics, service concerns,
field failure test analysis
How to switch to back-up process and resume to regular
8.5.6 Control of changes Process change management
process?
All backup processes to be included in PFD and FMEA /CP to be made.
Temporary Changes of Inspection freq. of backup plan to be higher than usual.
8.5.6.1.1 IATF
Process Controls Traceability is required for parts made through backup process.
Revamp strategy is required. 23
 Clause 8 OPERATION Sub-clause 6
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Release of Products and Important: Control Plan audits to be conducted

8.6
Services periodically to ensure conformance.

In-process and Final inspection (both are compulsory). Must keep record of 2 items:
Release of Products and
8.6.1 1. PDI CARE report - done in MES
Services
CARE BUY-OFF 2. Traceability of person authorizing the release

For tool dominated parts, once in a year. For every dimension mentioned in
Layout inspection and
8.6.2 drawing. Layout insp. plan must be part of control plan. Requirements and scope - QO/ QE / Others
functional testing
After aggregate assy., check Overall dimensions.
• AAR, Lux Level, Color Harmony,
8.6.3 Appearance items IATF
• Eye test for inspector etc., Periodic medical test (1 in 6 month)
Incoming verification is compulsory, incoming inspection is not.
Exam.:- Capability data
Inspection reports
TPI (Third Party Inspection)
Verification and
Part test by designated lab
Acceptance of conformity
8.6.4 Deviation can be time based or quality based IATF
of Externally provided
Control of reworked product
Products and Services
Control of repaired product
(Rework for manufactured product and Repair for assy.)

Non conforming product disposition

Statutory and Regulatory
8.6.5
Conformity
For attribute data sampling the acceptance level shall be zero defects
8.6.6 Acceptance Criteria How to identify OK and NOT OK? 24
DRR is a linked metric
 Clause 8 OPERATION Sub-clause 7
Clause 8 Clause Requirement / Action Required Remarks IATF Specific

Control of Non- Non-conforming product: Not meeting customer requirement or any

8.7 MANDATORY
Conformity outputs unidentified product

Approach to handle NC material: Initiate any one

of the following:

1. Use it as it is IF found conforming

2. Rework followed by re-verification (compulsory) Who does what?

3. Scrap followed by disposal approval from authorized

person

4. Deviation to be taken designer/ customer - based on

time and quantity

8.7.1.7 NC part shipped to SPD is nonconformity under this clause. How MGI controls? IATF

25
 Clause 9

Sub-Clauses:
PERFORMANCE 1. Performance Evaluation

EVALUATION 2. Internal Audit

3. Management Review

4. Context of
2. Normative 3.Terms and
1. Scope the 5. Leadership
references definitions
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
26
 Clause 9 PERFORMANCE EVALUATION Sub-clause 1
Clause 9 Clause Requirement / Action Required Remarks IATF Specific
Monitoring,
9.1 measurement, analysis, Objectives > KPIs + BPD
evaluation
Evaluate performance and effectiveness of QMS. Retain evidence of results
9.1.1 General
and its review.
Short term capability study for new projects - check / record consecutive
samples
Long term - process capability for regular product - as per frequency
Monitoring and
defined in control plan Through builds; Through program reviews, Project build
9.1.1.1 measuring of mfg. IATF
Reaction plan and escalation when acceptance criteria not met. wise scorecard tracking
processes
Control chart >> Special cause >> Reaction plan required
Action on special cause - to make process stable
Action on common cause - to make process capable
Identification of - Tools should be defined in PFMEA and control plan
9.1.1.2 Example: RUN CHARTS FOR TORQUE IATF
Statistical Tool - Correct tool usage is important
All people involved in production must have knowledge of
Application of Statistical
9.1.1.3 - Variation , Stability, Capability, Over adjustment / tampering IATF
Concepts
Problem prioritization based on pareto principle
Can be measured through:
- Repeat Business Orders
9.1.2 Customer Satisfaction
- Warranty and recalls
- Pulse Hub
Various parameters to be checked and evaluated:
- Product / Service conformance, CSAT
- QMS effectiveness
9.1.3 Analysis and Evaluation - Planning effectiveness Covered in various management reviews
- Risks - action effectiveness
- Supplier performance
- QMS improvements 27
 Clause 9 PERFORMANCE EVALUATION Sub-clause 2, 3
Clause 9 Clause Requirement / Action Required Remarks IATF Specific

9.2 Internal Audit Only trained qualified auditors can audit. 3 types of audit - QMS, Process and Product Audit
Make 3-year audit plan.
9.2.2.2 QMS audit Cover all processes; critical process and more NC to be audited frequently
After every audit - revise frequency of audit
Control plan audit >> Process family wise or station wise audit
Manufacturing process
9.2.2.3 All shifts have to be covered.
audit
All change over points to be covered
Quality Plan audit - Any audit / checking not specified in control plan will
9.2.2.4 Product audit Example: PQA. Discuss How?
be counted as product audit.
9.3 Management review MRM can be split up into multiple meetings.
Top management reviews at planned intervals.
Frequency: MINIMUM ONCE A YEAR.
9.3.1 General
1. Suitability; 2. Adequacy; 3. Effectiveness; 4. Alignment to strategic
direction
Provides the MRM agenda:
• COPQ; assessments of manufacturing feasibility made for changes to
existing operations and for new facilities or new product
• measures of process effectiveness and process efficiency
• product conformance
Management review
9.3.2 • review of performance against maintenance objectives; •
inputs
• customer satisfaction; warranty performance; review of customer
scorecards
• identification of potential field failures identified through risk analysis
such as FMEA
actual field failures and their impact on safety or the environment
Opportunities for improvement, changes to QMS, resource needs
Management review
9.3.3 Document and implement action plan when customer performance targets Sufficiency Plans IATF
outputs
are not met.
28
 Clause 10

Sub-Clauses:
1. CAPA
IMPROVEMENT 2. Nonconformity and
corrective action
3. Continual improvement

4. Context of
2. Normative 3.Terms and
1. Scope the 5. Leadership
references definitions
organization

9.
10.
6. Planning 7. Support 8. Operation Performance
Improvement
evaluation
29
 Clause 10 IMPROVEMENT
Clause 10 Clause Requirement / Action Required Remarks IATF Specific
Determine and select opportunities for improvement and implement any How:
necessary actions to meet customer requirements and enhance customer a) improving products and services to meet requirements
satisfaction. as well as to address future needs and expectations;
10.1 General
Examples of improvement can include correction, corrective action, b) correcting, preventing or reducing undesired effects;
continual improvement, breakthrough change, innovation and re- c) improving the performance and effectiveness of the
organization. quality management system.
10.2 NC and corrective action
Problem definition>> containment>> correction>> ICA>> PCA>> System
Address the NC through
10.2.1 review
Problem solving approach
10.2.2 Documented Information Evidences of all problem solving PSR as a tool
10.2.3 Problem solving Triggers for problem solving to be defined Problem Solving procedure
Documented process required
10.2.4 Error Proofing IATF
Golden part / challenged part check -- Poka-yoke verification
Create documented procedure for Warranty Management and method for
Warranty Management warranty part analysis
10.2.5
System Create documented procedure for NTF
Part Specific diagnostic check sheets
Perform analysis on customer complaints and field failures including For any NOK part >> conduct functional test
Customer complaints and returned parts and initiate problem solving and CAPA Result >> OK/ NOK
10.2.6
field failure test analysis Include analysis of the interaction of embedded software of the product NOK >> problem solving
Communicate the results of testing/analysis to the customer OK >> NTF
Documented process for continual improvement
• Identification of the methodology used, objectives,
Continually improve the suitability, adequacy and effectiveness of the measurement, effectiveness, and documented
quality management system information
10.3 Continual improvement IATF
• A manufacturing process improvement action plan with
emphasis on the reduction of process variation and
waste
• Risk analysis such as FMEA 30