Paradise IATF IA Presentation PDF

Welcome to the
Training on
IATF 16949: 2016 Internal Auditing
Course Overview
 Goal of Organization
 Important information about transition to IATF
16949:2016
 IATF 16949 history
 About IATF
 IATF Approach-Automotive Process Approach
 Risk Based Thinking
 IATF 16949:2016 - key Requirements
 Effective Internal Audit by using Automotive Process
approach
2
Quality Management System
Developed by Published on
IATF 1st October,
2016
An Automotive
Quality Replaces
Management ISO/TS
System Standard 16949:2009
IATF
16949:2016
3
IATF
IATF members includes following vehicle manufacturers and their

respective trade association :
OEM,s : Trade Associations:

1. BMW Group 1. ANFIA ( ITALY
2. Chrysler Group
2. FIEV (FRANCE)
3. Daimler AG
3. SMMT ( UK)
4. Fiat Group automobiles
4. VDA (GERMAY )
5. Ford motor Company
5. AIAG ( US)
6. General Motors
7. PSA Peugeot Citroen
8. Renault
9. Volkswagen AG
4
Approach of IATF
PDCA
Risk
Based
Thinking
Process
Approach
5
Process Approach “Turtle Diagram”
With what?
Resources With Who?
Personnel
Inputs Process Outputs

From (specific value- To whom/
whom/ added activities) where
where
How done? What results?

Methods/ Performance
Documentation indicators
What: What are the Materials, Equipment and Who: Who applies the Resources?
other Resources for the Process?
Process Owner (competence requirements)
Materials (Raw materials, chemicals, sub-assemblies, etc.):
Personnel (competence requirements)
Equipment (Production, test, inspection):
Who is involved in supporting this process?
Buildings (Floor space, office, etc.):
( Skills, qualification, no. of people, responsibilities etc. )
Hardware/Software:
Input: Customer needs? Output : Customer needs fulfilled for

Input Requirements Customer requirements(Internal or
What are the defined characteristics that external customer requirements)
define the product of this process?
Process Name What output criteria are used to
Customer Specifications: determine what should have been
Governmental/ Regulatory: produced has been produced?
Other:
How: How is this process controlled ? Measure: Measurement /analysis of process

effectiveness
Procedures / Control Documents / Timing Charts /Work
Instructions, drawings / display / legislation
Result indicators (Effectiveness & efficiency)- Objectives for
Support Processes measuring the performance
Process Approach - Example
With what? - Resources

Measuring Equip., Hyd. Lifter,
With Who? Personnel
Trolley
Competent Engineer,
Helper
Outputs
Inputs
Material,
Process Confirming
Challan, Test (Inward Insp. ) product to next
process,
Report, MRIR
/Records
What results?
How done? Incoming Quality PPM
Procedure P-QA-01, Supplier Perf. Indicator
Inspection Standard, Good/Worst supplier Data
Check sheet Line Stoppages
Quality Management System (QMS)
• the activities you

perform within your
QMS organization to satisfy
the quality related
refers expectations of
customers
Risk Based Thinking / Mindset
Risks and Opportunities
Risk = Effect of Uncertainty
Effect= Deviation from expected-positive or negative.
There are risks in all systems, processes and functions.

Risk-based thinking ensures these risks are identified,
considered and controlled throughout the design and use of
the quality management system.
One of the purposes of a QMS is to act as a preventive tool

The concept of risk based thinking is explicit; being
incorporated throughout its requirements, especially: Clause
6.1 (actions to address risks and opportunities) which
requires a determination of risks and opportunities
What should I do ?
Analyze and Prioritize the risk and opportunities in

your organization
• What is acceptable
• What is not acceptable
 Plan actions to address the risks
• How can I avoid or eliminate the risk
• How can I mitigate the risk
 Implement the plan-take action
 Check the effectiveness of the actions-does it work ?
 Learn from experience-continual improvement
IATF 16949:2016 requirements
ISO
9001:2015
IATF
16949:2016
Automotive
sector
specific
requirements
+ Core Tools
Goal of IATF 16949: 2016
Dev. Of QMS that provides for
Continual Reduction in Variation &

Improvement waste in Supply chain
GOAL
Emphasizing
Defect prevention
IATF 16949:2016 Requirements
Standard core sections

Chapter No. Description
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement
1.Scope-Added
Automotive Supplemental to ISO 9001:2015
Includes products with embedded software

also
Applicable to production parts, service parts and/or

accessory parts (Sunvisor, wheelcap etc)
2. Normative References
As a normative reference, ISO 9000:2015 helps the user understand the
normal definitions of certain words and concepts
ISO
Annex-A Annex-B
9000:2015
Quality
Management Bibliography
(list of Books
System
Control Plan, referenced)-
Fundamental Automotive
and Supplemental
vocabulary
3. Terms and definitions
3.Terms and definitions: Included /Changed
accessory part
customer-specified additional component(s) that are either mechanically or electronically
connected to the vehicle or powertrain before (of after) delivery to the final customer
(e.g., custom floor mats, truck bed liners, wheel covers, sound system enhancements,
sunroofs, spoilers, super-chargers, etc.)
customer-specific requirements (CSRs)

interpretations of or supplemental requirements linked to a specific clause(s) of this
Automotive QMS Standard
4. Context of the Organization
4.3
4.2
Scope of QMS
Interested Parties
4.1 4.4
Understanding QMS and its
Context Context processes
18
4.1 Understanding the organization and its Context and
Internal & External Issue Identification
Determine external and Monitor and review the

internal issues information
• relevant to purpose and • About internal and external
strategic direction that issues
affect ability to achieve the
intended results(s) of QMS
Context
4.2 Understanding the needs and
expectations of interested parties
Determine Monitor and review

information about
Relevant interested
these interested
parties
parties and
Relevant
their relevant
requirements of
requirements
interested parties
List of Potential Interested Parties
Potential Interested Parties Potential Interested Parties
Management Corporate Share Service Providers

Business partners / investors Statutory Bodies
Staff Income tax department
Workers Judiciary
Union Particular Communities
Distributors Certification Bodies
Channel partners Consultants / Trainers
External Service Providers Mediators
End Users Particular State
Contract Workers Any individual
4.3 Determining the scope of QMS
• The external and internal issues referred

Must to in 4.1
• The requirements referred to in 4.2
Consider • Products and services provided
• All requirements are applicable

• If a requirement can not be applied, it
Applicability must not affect the ability to provide
conforming product and be justified
4.3 Determining the Scope of QMS
Organisation to Consider: Context, req. of interested

parties
Scope to Include
 Supporting functions, whether onsite or remote (such as design
centres, corporate headquarters and distribution centres)
 Customer Specific Requirements(4.3.2)
The only permitted exclusion

 Product design and development requirements
 Permitted exclusion do not include manufacturing process design
4.3.2 Customer specific requirements
Customer • Shall be evaluated

specific and included in
requirements organization QMS
Customer specific requirements
A way to identify if any customer-specific requirements exist is to compare

sections of the IATF 16949 standard where the term « if required by the
customer » exists and verify if the existing customer requirement document
lists any specific requirements that are related to a requirement in the IATF
16949 standard.
4.4 Quality Management System and its Processes
Determination of
• Process inputs and outputs
• Sequence and interaction of processes
• Related Performance Indicators
• Resources for process and ensuring their availability
• Responsibilities and authorities for processes
• Risk and Opportunities

• Evaluation of processes and implementation of changes
4.4.1.2 Product Safety
Documented Process
for the management of product-safety related
products and manufacturing processes
To include the following

a) Identification of statutory and regulatory product-safety requirements
b) Customer notification of requirements in item a)
c) Special approval for Design FMEA
d) Identification of product-safety related characteristics
e) Identification and control of safety-related characteristics of product
and at the point of manufacture
f) Special approval of control plans and process FMEAs
g) Reaction plans
h) Defined responsibilities, definition of escalation process and flow of
information, including top management, and customer notification.
i) Training identified by the organization or customerfor personnel

involved in Product- safety related products and associated
manufacturing processes
j) Changes of product or process shall be approved prior to
implementation
k) Transfer of requirement with regard to product safety throughout
the supply chain
l) Product traceability by manufactured lot throughout the supply
chain
m) lessons learned for new product introduction.
5. Leadership
5.2 Policy
5.3
5.1 Leadership Organizational
and Roles,
commitment responsibilities
and authorities
Leadership
30
5.1 Leadership and Commitment
integration of
QMS communicating that QMS
requirements the importance achieves its
into business of QMS intended results
processes
taking engaging,
accountability directing,
of supporting
effectiveness persons
of QMS
Availability of supporting for

Top other relevant
resources for
QMS management management
roles
implementation to ensure
promotion of
process promoting
approach and improvement
risk based
thinking ISO 9001:2015
5.1.1.1 Corporate Responsibility
Organization shall define and implement corporate

responsibility policies, including at a minimum
1 an anti-bribery policy
2 an employee code of conduct
3 an ethics escalation policy(whistle-blowing policy)

5.1.1.3 Process Owners
Top management to Process Owners

identify shall
process owners for understand their

managing the roles
organization’s
processes and be competent to
related outputs perform those roles
5.3.1 Organizational roles, responsibilities and
authorities-supplemental
Documented assignments to ensure meeting customer

requirements with responsibility and authority
Selection of special characteristics
Setting quality objectives and related training
Corrective and preventive actions
Product design and development
Capacity analysis
Logistics information
Customer scorecards and customer portals

5.3.2 Responsibilities and authorities for
product requirements and corrective actions
Personnel responsible for conformity to

product requirements have
Authority to stop shipment and stop

production
6. Planning
6.2 Quality
objectives and
planning to
achieve them
6.1 Actions to
address risks 6.3 Planning of
and changes
opportunities
6.
PLANNING
6.1 Action to address Risk and Opportunities
6.1.1 and 6.1.2
When Planning for QMS
Consider issues referred to in 4.1 and the

requirements referred to in 4.2
Determine risks and opportunities that needs to be

address
Give assurance that QMS will achieve its intended result

Enhance desirable effects
6.1.2.1 Risk analysis
The organization • Lessons learned from products recall

shall include in • Product audits
its risk analysis, • field returns and repairs
at a minimum • complaints, scrap and rework
Retain
documented • As a evidence of results of risk analysis
information
6.1.2.2 Preventive Action
• Organization shall establish a process to lessen the impact of negative effects of

risk – potential non conformities and their causes.
6.1.2.3 Contingency Plan
Major Change
a Identify and evaluate internal/external risk to manufacturing process

and infrastructure equipment essential to maintain production
output
Define contingency plan according to risk and impact to the

b customer
Prepare contingency plan continuity of supply in event of key

c equipment failure, interruption from externally provided products,
processes and services, recurring natural disasters, fire, utility
interruptions, labour shortage and infrastructure interruptions
6.1.2.3 Contingency Plan
A notification process to the customer and other interested parties for the
d extent and duration of situation
periodically test the contingency plans for effectiveness (e.g. simulations as

appropriate
e
conduct contingency plan reviews (at a minimum annually) using a multi

disciplinary team including top management, and update as required
f
Document the contingency plans and retain the documented information

g describing any revision(s) including the person who authorized the change(s).
The contingency plans shall include the provisions to validate that the manufactured product
continues to meet customer specifications after the restart of production following an
emergency in which production was stopped and if the regular shutdown processes were
not followed
6.2.2.1 Quality Objective-Supplemental
Interested parties and their relevant requirements shall be

considered when the organization establishes its annual
(at a minimum) quality objectives and related
performance targets (internal and external).
6.3 Planning of Changes - QMS
Any need for change in QMS, the changes shall

be carried out in planned manner. Organization
to consider:
Purpose of change and potential consequences
Integrity of quality management system
Availability of resources
Allocation / reallocation of responsibilities and authority

7. SUPPORT
7.3
AWARENESS
7.2 7.4
COMPETENCE COMMUNICATION
7.5
7.1 7 DOCUMENTED
RESOURCES
SUPPORT INFORMATION
43
7.1 RESOURCES
7.1.1 General :The organization shall provide the

resources for QMS and consider:
Capability and constraints on existing internal resources
What needs to be obtained from external providers
7.1.2 People : Org shall determine and provide the

person necessary for the effective implementation of its
QMS and for the operation and control of its processes.
7.1.3 Infrastructure ( ISO 9001:2015) : No change

7.1.3.1 Plant, Facility and Equipment
Planning
a Methods to evaluate manufacturing feasibility for new

product or new operations including capacity planning
Include risk identification and risk mitigation methods for

b developing and improving plant, facility and equipment
plans
Plant layout to support optimize material flow, material

c handling, value added use of floor space including control of
non-conforming products and facilitate synchronous flow
7.1.4 Environment for the operation
of processes (ISO 9001:2015)
Human and Physical factors also

to be included now
Social (e.g. non-discriminatory, calm, non-

confrontational)
Psychological (e.g. stress reducing, burnout

prevention, emotionally protective)
Physical (e.g. air flow, temperature, heat, humidity,

light, hygiene, noise)
Note : where third party certification to ISO 45001 (or equivalent) is

recognized, it may be used to demonstrate the organization’s
conformity to the personnel safety aspects of this requirement.
7.1.5 Monitoring and measuring
resources
7.1.5.2
Measurement
traceability
7.1.5.1.1
Measurement 7.4
System COMMUNICATIO
Analysis N
7.5
7.1 .5.1 7 DOCUMENTED
General
SUPPORT INFORMATION
47
7.1.5.1.1 Measurement System Analysis
Additional requirements
Records of customer acceptance of alternative
methods shall be retained along with results from
alternative measurement systems analysis)
NOTE: Prioritization of MSA studies should focus on

critical or special product or process characteristics
7.1.5.2.1 Calibration/verification records
Documented Process
for managing calibration/verification records which
includes:
• Onsite supplier owned equipment also
• Evidence of conformity to
legislative/regulatory/customer requirements
7.1.5.2.1 Calibration/verification records
Calibration/verification activities and records shall include :
• Assessment of risk of the intended use of product caused by the out

of specification condition.
• Documented information on the validity of previous measurement
results
• Associated standard's last calibration date and next due date on the
calibration report
• Verification that the software version used for product and process
control is as specified
• Records of calibration and maintenance activities for all
gauging(including employee owned, customer owned and onsite
supplier owned equipment
• Production related software verification used for product and
process control
7.1.5.3.1 Internal laboratory
Earlier it was 7.6.3.1
Internal laboratory shall have a defined scope and implement as

minimum :
• Adequacy of laboratory technical procedures.

• Competency of laboratory personnel
• Testing of the product
• Capability to perform these tests correctly, traceable to relevant
process standards. When no national or international standards
available, the organization to define and implement a
methodology to verify the measurement system capability
• Customer requirements if any
• Review of related records
7.1.5.3.2 External laboratory
ISO/IEC 17025 accredited
Include the relevant inspection, test, calibration

service in the scope of the accreditation (certificate)
Certificate of calibration or test report shall include

the mark of a national accreditation body
Evidence that external laboratory is acceptable to the

customer
7.1.6 Organizational knowledge
Determine the knowledge necessary for the operation of

its processes and to achieve conformity of products and
services
This knowledge shall be maintained and be made

available to the extent necessary
Determine how to acquire or access any necessary

additional knowledge and required updates
7.2.2 Competence- on the job training
on-the-job training (which shall include customer

requirements training) for personnel in any new or
modified responsibilities.
The level of detail required for on-job-training shall

be commensurate with the level of education the
personnel possess and the complexity of task(s)
they are required to perform for their daily work
Consequences of not meeting customer requirements

7.2.3 Internal auditor competency
Documented Process
• To verify that internal auditors are competent, taking into
account any customer specific requirements
• Organization shall maintain a list of qualified internal

auditors
Mandatory competencies required for QMS
Automotive process approach
Risk based thinking
ISO 9001:2015 and IATF 16949:2016
Understanding of automotive core tools
Planning, conducting, reporting and closing out audit

findings
Manufacturing
Product auditors
process auditors
Technical understanding of
Understanding of product
relevant manufacturing
requirements
process(es)
Technical understanding of Competency in use of

process risk analysis(PFMEA) relevant measuring and test
and control plan equipment
Where training is provided to achieve competency, documented information shall

be retained to demonstrate the trainer’s competency with the above requirements
Maintenance of and improvement in the

internal auditor competence shall be
demonstrated through :
Executing a minimum no. of audits per year as

defined by the organization and
Maintaining knowledge of relevant requirements

based on :
- Internal changes(process technology, product
technology)
- External changes(ISO 9001, IATF 16949, core tools
and CSR)
7.2.4 Second - party auditor competency
Second party auditors to meet customer specific

requirements. Minimum core competencies are:
Risk based thinking
Customer and organization specific requirements
ISO 9001:2015 and IATF 16949:2016
Manufacturing process(es) to be audited, including

PFMEA and control plan
Planning, conducting, reporting and closing out audit
findings
Automotive Process Approach
Automotive process approach includes
Process selective
Objective selective
CAPA selective
CSR and audit trial

7.3.1 Awareness-supplemental
Maintain documented information to demonstrate that all

employee are aware of :
Their impact on product quality
Importance of their activities in achieving, maintaining and

improving quality including customer requirements and
Risk involved for the customer with non-conforming products

7.4 Communication
Internal and external communications

relevant to QMS which include :
On what it will communicate
When to communicate
With whom to communicate
How to communicate
Who communicates
7.5.1.1 QMS documentation
The Quality manual shall include at a minimum the

following:
The scope of QMS, including details of and justification for any

exclusions
Documented processes established for QMS or reference to them
The organization's processes and their sequence and interactions

(inputs and outputs)
Type and extent of control of any outsourced processes
A document(i.e. matrix) indicating where within the

organization’s QMS their customer specific requirements are
addressed
7.5 Documented information
Creating and updating the

7.5.2 documented information(earlier
4.2.3-control of documents)
Control of documented information

7.5.3 (earlier 4.2.4-control of record)
Now both requirements are denoted

as documented information
7.5.3.2.1 Record retention
• Define, document and implement a record retention policy.
• Production part approvals, tooling records (including maintenance

and ownership ), product and process design records, purchase
orders, contracts and amendments retention period – Product active
life for production and service requirements + 1 calendar year
NOTE : Production part approval documented information may

include product, applicable test equipment records, approved test
data.
7.5.3.2.2 Engineering specifications
Documented Process
To review, distribution and implementation of all customer
engineering standards/specification and related revisions
• Review should be completed within 10 working days of receipt of change
• Date on which each change is implemented in production shall be recorded
• Implementation shall include updated documents
8 Operation
8.3 Design 8.4 Control of

and externally provided 8.5 Production
development processes, and service
of products products and provision
and services services
8.2 8.6 Release of

Requirements products and
for products services
and services
8.1 Operation 8.7 Control of

8. non-conforming
planning and
control Operation outputs
67
8 Operation
8.1.1 Operation planning and control-supplemental
When planning for product realization, the following topics

shall be included:
a) customer product requirements and technical specifications;
b) logistics requirements;
c) manufacturing feasibility;
d) project planning;
e) acceptance criteria.
8.2 Requirements of products and services
8.2 Requirements of
products and services
8.2.2
8.2.3 Review of
Determining 8.2.4 Changes
the
8.2.1 Customer the to requirements
requirements of
communication requirements for products
products and
for products and services
services
and services
8.2.1.1 Customer communication-supplemental
Written or verbal communication shall

be in the language agreed with the
customer
8.2.2.1 Determining the requirements for products

and services-supplemental
8.2.3.1.1 Review of requirements for products and

services-supplemental
8.2.3.1.3 Organization manufacturing feasibility
The Organization shall utilize

multidisciplinary approach for feasibility
analysis to determine
Manufacturing processes capability for producing

products that meets all engineering and capacity
requirements
This feasibility analysis shall be conducted for any

new or changed manufacturing process/product
design
8.2.3.1.3 Organization manufacturing feasibility
Org. to analyze the feasibility of its mfg. processes are capable of consistently producing parts that
meets all Engg. and capacity requirements given by customer for new parts.
Additionally org. to validate their ability to make products to specifications at the required rate through
Production runs
Benchmarking studies or
Other appropriate methods
8.3.3.1 Product design input: Excluded
8.3.2.1 Design and development planning-
supplemental
Design and development planning includes all

affected stakeholders within the organization and its
supply chain. MDA includes :
Project management(for example APQP or VDA-RGA)
Product and manufacturing process design activities (for

example, DFM and DFA), such as consideration of the
use of alternative designs and manufacturing processes.
Development and review of DFMEA, PFMEA, process

flows, control plans and standard work instructions
including actions to reduce potential risks
8.3.2.2 Product Design Skills
The Organization shall ensure that personnel

with product design responsibility are
competent
To achieve design requirements
Are skilled in applicable product design tools and

techniques
Applicable tools and techniques shall be identified by the organization

8.3.2.3 Development of products with embedded
software
Using prioritization
A software
based on risk and
Organization shall use development
potential impact to
a process for quality assessment
customer,
assurance for their methodology shall be
organization shall
products with utilized to assess the
retain documented
internally developed organization’s
information of a
embedded software software development
software development
process
capability assessment
The organization shall include software development within the scope

of their internal audit programme
8 Operation
8.3.3.1 Product design input
Product Design input includes but not limited to:
a) product specifications including but not limited to special

characteristics boundary and interface requirements;
b) identification, traceability, and packaging;
c) consideration of design alternatives;
d) assessment of risks with the input requirements and the
organization’s ability to mitigate/manage the risks, including from
the feasibility analysis;
8.3.3.2 Manufacturing process design input
8 Operation
Manufacturing process design input requirements including
but not limited to the following:
a) product design output data including special characteristics;

b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and
h) design for manufacturing and design for assembly
The manufacturing process design shall include the use of error-

proofing methods
8.3.3.3 Special characteristics
Documented Process
to identify special characteristics including those determined
by the customer and the risk analysis performed by the
organization. Organization shall use a multidisciplinary
approach for establish, document and implement this
process.
8.3.3.3 Special characteristics
8 Operation
This documented process shall include the following:
a) documentation of all special characteristics in the drawings
(as required), risk analysis (such as FMEA), control plans, and
standard work/operator instructions; special characteristics
are identified with specific markings and are cascaded through
each of these documents;
b) development of control and monitoring strategies for special
characteristics of products and production processes;
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or
the organization’s equivalent symbols or notations, as defined
in a symbol conversion table. The symbol conversion table
shall be submitted to the customer, if required.
8.3.5.1 Design & Dev. Output (Product design output): Excluded
8.3.4 Design and development control
This clause includes the requirement of design review,

design verification and design validation
8.3.4.1 Monitoring 8 Operation
Measurement at specified stages Measurements of the product and

during design and development of process development activity shall be
product and process shall be defined, reported to the customer at stages
analyzed and reported with summary specified, or agreed to, by the
results as an input to MRM customer
8 Operation
8.3.4.2 Design and development validation
Design and development validation shall be performed in

accordance with customer requirements, applicable industry
and governmental agency-issued regulatory standards.
timing of design and development validation shall be

planned in alignment with customer-specified timing, as
applicable
Where contractually agreed with the customer, this shall include

evaluation of the interaction of the organization’s product,
including embedded software, within the system of the final
customer’s product
8.3.4.3 Prototype Program,
8.3.4.4 Product approval process
8 Operation
8.3.4.3: When required by customer, organization shall have a
prototype program and control plan. (use of same suppliers,
tooling, and mfg. processes as will be used in production.
8.3.4.4: Establish, implement and maintain a product

and manufacturing approval process conforming to
requirements defined by customer
Organization shall approve externally provided

products and services, prior to submission of
their part approval to customer.
Organization shall obtain documented product

approval prior to shipment, if required by customer.
Records of such approval shall be retained.
8.3.5.2 manufacturing process design output
Manufacturing process design output shall includes but not

limited to:
a) Specifications and drawings
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact
characteristics;
d) tooling and equipment for production and control, including
capability studies of equipment and process(es);
e) Manufacturing process flow charts/layout, including linkage of
product, process, and tooling
f) Capacity analysis
g) Maintenance plans and instructions
8.3.6.1 Design and development changes-
supplemental
8 Operation
Organization will evaluate all design changes after initial product

approval, including those proposed by the organization or its suppliers,
for potential impact on fit, form, function, performance and durability
These changes shall be validated against customer requirements

and approved internally, prior to production implementation.
If required by the customer, organization shall obtain documented

approval, or a documented waiver, from the customer prior to
production implementation
For products with embedded software, the organization shall document

the revision level of software and hardware as part of the change record
8.4 Control of externally provided processes,
products and services
8 Operation
Determine controls to be applied on externally

provided processes, products and services when
Products and services from external providers are

intended for incorporation into the organization’s own
products and services.
Product and services are provided directly to the customer

by external providers on behalf of the organization
Process or part of process is provided by external

provider as a result of a decision by the organization
8.4.1.2 Supplier selection process
Documented Process
Supplier selection process shall include :
• An assessment of the selected supplier’s risk to product conformity and
uninterrupted supply of the organization’s products to their customers
• Relevant quality and delivery performance
• An evaluation of supplier’s QMS
• Multidisciplinary decision making and
• An assessment of software development capabilities, if applicable
8.4.1.3 Customer directed sources(also
known as “Directed –Buy”)
8 Operation
All requirements of Section 8.4 (except requirement of

8.4.1.2) are applicable to the organization’s control of
customer-directed sources unless specific agreements are
otherwise defined by the contract between the
organization and the customer.
8.4.2 & 8.4.2.1 Type and extent of control-
supplemental 8 Operation
Documented Process
• To identify outsourced processes
• To select the type and extent of controls used to verify conformity of externally provided products,
processes and services to internal and customer requirements
The process shall include the criteria and actions to escalate or reduce the types and extent of
controls and development activities based upon supplier performance and assessment of product,
material or service risks.
Where characteristics or components “pass through” the organization's QMS without validation or
controls, the organization shall ensure that the appropriate controls are in place at the point of
manufacture.
8.4.2.2 Statutory and regulatory requirements
Documented Process
• To ensure that purchased products, processes and services conform to
the current applicable statutory and regulatory requirements in the
country of receipt, the country of shipment and the customer identified
country of destination.
If the customer defines special controls for certain products with statutory and
regulatory requirements, the organization shall ensure they are implemented and
maintained as defined, including at suppliers
8.4.2.3 Supplier QMS development
Ultimate objective of becoming certified to this Automotive QMS Standard.

Following sequence to be applied to achieve this requirement:
• Certification to ISO 9001

1
• Certification to ISO 9001through third part audit, unless otherwise specified by

customer
2 • Certification body shall be accredited from IAF MLA (International Accreditation Forum
Multilateral Recognition Arrangements between accred. Bodies for mutual recognition of accreditations.
• Certification to ISO 9001 with compliance to other customer defined QMS

requirements(such as minimum Automotive QMS Requirements for Sub-
3 Tier Suppliers[MAQMSR] or equivalent) through second party audit
8.4.2.3 Supplier QMS development
• Certification to ISO 9001 with compliance to

IATF 16949 through second party audit
4
• Certification to IATF 16949 through third
party audit by IATF recognized certification
5 body
8.4.2.3.1 Automotive product related software or embedded software:

Implement and maintain a process for software quality assurance for their product. Retain
documented information of a software development capability self Assessment.
8 Operation
8.4.2.4 Supplier monitoring
Documented Process
and criteria to evaluate supplier performance. At a minimum, following indicators
shall be monitored :
• Delivered product conformity to requirements
• Customer disruptions at the receiving plant, including yard holds and stop ship
• Delivery schedule performance
• Number of occurrences of premium freight
• Special status customer notifications related to quality or delivery issue
• Dealer returns, warranty, field actions and recalls
8.4.2.4.1 Second party audits
8 Operation
Include second party audit process in supplier management

approach. Second party audit may be used for the following:
Supplier risk assessment
Supplier monitoring
Supplier QMS development
Product audits
Process audits
8.4.2.4.1 Second party audits
8 Operation
Document the criteria for determining the need, type,

frequency, and scope of second-party audits based on risk
analysis, product safety/regulatory requirements, performance
of the supplier, and QMS certification level
Retain records of the second-party audit reports
If the scope of the second-party audit is to assess the

supplier’s quality management system, then the approach shall
be consistent with the automotive process approach.
8.4.2.5 Supplier development
Determine the priority, type, extent, and timing of

required supplier development actions for its active
suppliers. Inputs shall include:
Performance issues identified through supplier

monitoring(8.4.2.4)
Second party audit findings (8.4.2.4.1)
Third party QMS certification status
Risk analysis
Implement actions necessary to resolve open (unsatisfactory)

performance issues and pursue opportunities for continual improvement
8.4.3 8.4.3.1 Information for external providers-
supplemental
8 Operation
The organization shall pass down the

following requirements to their suppliers:
All applicable statutory and regulatory requirements
Special product and process characteristics
Suppliers to cascade all applicable requirements down the

supply chain to the point of manufacture
8.5.1 Control of production and service provision
Implement production and service provision under controlled

condition. Controlled conditions include:
• The availability of documented information-characteristics of products

to be produced, activities to be performed and result to be achieved
• Availability and use of suitable monitoring and measuring resources
• Implementation of monitoring and measuring activities at appropriate
stages
• Use of suitable infrastructure and environment for the operation of
processes
• Appointment of competent person, including any required
qualification.
• Validation and periodic validation of the processes
• Implementation of actions to prevent human error
• Implementation of release, delivery and post delivery activities.
8.5.1.1 Control Plan
Review control plans and update for any of the following
the organization determines it has shipped nonconforming product to the customer;
when any change occurs affecting product, manufacturing process, measurement,

logistics, supply sources, production volume changes, or risk analysis (FMEA);
after a customer complaint and implementation of the associated corrective action,

when applicable
at a set frequency based on a risk analysis
If required by the customer, the organization shall obtain customer approval after review or
revision of the control plan
8.5.1.2 Standardized work-operator instructions and visual standards
also include rules for operator safety

8.5.1.3 Verification of job set- ups
The organization shall
verify job set-ups when performed, such as an initial run of a job,

material changeover, or job change that requires a new set-up
maintain documented information for set-up personnel
use statistical methods of verification, where applicable;
perform first-off/last-off part validation, as applicable; where

appropriate, first-off part should be retained for comparison with the
last-off parts; where appropriate, last –off parts should be retained for
comparison with first-off parts in subsequent runs
Retain records of process and product approval following setup and

first- off/last-off part validations
8.5.1.4 Verification after shutdown
Organization shall define and implement the necessary

actions to ensure product compliance with requirements after
a planned or unplanned production shutdown period
8.5.1.5 Total productive maintenance
8 Operation
Develop, implement and maintain a documented total

productive maintenance system. The system shall include:
identification of process equipment necessary to

a produce conforming product at the required volume
availability of replacement parts for the equipment

b identified in item a);
provision of resource for machine, equipment, and

c facility maintenance;
8 Operation
d packaging and preservation of equipment, tooling, and

gauging
e applicable customer-specific requirements;
documented maintenance objectives, for example: OEE ,

MTBF , and MTTR and Preventive Maintenance compliance
f metrics. Performance to the maintenance objectives shall
form an input into management review;
regular review of maintenance plan and objectives and
g 8 Operation
a documented action plan to address corrective actions
where objectives are not achieved;
h use of preventive maintenance methods
use of predictive maintenance methods, as

i applicable;
Periodic overhaul
j
8.5.1.6 Management of production tooling and

manufacturing, test, inspection tooling and equipment
Earlier it was 7.5.1.5-management of production tooling-No change
• include identification, handling,

contamination control, packaging,
8.5.4.1 Preservation-supplemental storage, transmission or
transportation, and protection.
8.5.1.7 Production scheduling
8 Operation
Organization shall ensure that
Production is scheduled just in time(JIT)
Production is supported y an information system that

permits access to production information at key stages of
the process and is order driven
Include relevant planning information during

production scheduling e.g. customer orders, supplier
on time delivery performance, capacity, shared
loading( multi-part station), lead time, inventory level,
preventive maintenance and calibration
8.5.2 & 8.5.2.1 Identification and traceability
• Organization shall use suitable means to identify outputs
• Identify status w.r.t monitoring and measurement requirements
• The purpose of traceability is to support identification of clear start and stop

points for product received by the customer or in the field that may contain
quality and/or safety-related nonconformities
• Organization shall implement identification and traceability processes
• conduct an analysis of internal, customer, and regulatory traceability

requirements for all automotive products, including developing and
documenting traceability plans, based on the levels of risk or failure severity
for employees, customers, and consumers.
8.5.3 Property belonging to customer or external providers

Identify, Verify, Protect and safe guard, report in case of unsuitable or lost or
damaged (Intellectual Property)
8.5.4 & 8.5.4.18 Preservation-supplemental
Operation
• Organization to preserve outputs during production and service provision
• Include identification, handling, contamination control, packaging, storage,

transmission or transportation, and protection.
• shall apply to materials and components from external and/or internal
providers from receipt through processing, including shipment and until
delivery to/acceptance by the customer.
• In order to detect deterioration, the organization shall assess at appropriate
planned intervals the condition of product in stock, the place/type of storage
container, and the storage environment.
• Inventory management system to optimize inventory turns over time and
ensure stock rotation, such as FIFO.
• obsolete product is controlled in a manner similar to nonconforming
product.
• comply with preservation, packaging, shipping, and labeling requirements
as provided by their customers.
8.5.5 Post Delivery Activities
Post-delivery activities can include actions under warranty provisions, contractual
obligations such as maintenance services, and supplementary services such as recycling
or final disposal.
8.5.5.1 Feedback of information from service
Communication process is established between Manufacturing plant , Material

Handling , Logistics , Engineering and Design to ensure that service related
concerns are properly communicated .
Note 1: service concerns - ensure org is aware of NC products and materials may be
identified at customer location or in the field
Note 2: Service concerns includes results of field failure test analysis (10.2.6) where
applicable
8.5.5.2 Service Agreement with customer
Service agreement with customer, the org shall:
a) Verify the relevant service centres comply with applicable requirements
b) Verify the effectiveness of any special purpose tools or measurement equipment
c) Ensure that all service personnel are trained in applicable
requirements
8.5.6 & 8.5.6.1 Control of changes
Documented Process: to control and react to changes that

impact product realization
The organization shall
Define verification and validation activities to ensure compliance

with customer requirements
Validate changes before implementation
Document the evidence of related risk analysis
Retain records of verification and validation.
Changes, including those made at suppliers, should require a

production trial run for verification of changes(such as changes to part
design, manufacturing location or manufacturing process) to validate
the impact of any change on the manufacturing process.
8.5.6.1 Control of changes-supplemental
When required by the customer, The organization shall
Notify the customer of any planned product realization changes after

the most recent product approval
Obtain documented approval, prior to implementation of changes
Complete additional verification or identification requirements, such

as production trail run and new product validation
8.5.6.1.1 Temporary change of process
controls
Documented Process
to manage the use of alternate control methods
8.5.6.1.1 Temporary changes of process controls
Documented Process
to manage the use of alternate control methods
identify, document, and maintain a list of the process

controls that includes the primary process control and
the approved back-up or alternate methods.
document the process that manages the use of

alternate control methods
include in this process, based on risk analysis (such as

FMEA), severity, and the internal approvals to be
obtained prior to production implementation of the
alternate control method. ;
Before shipping product that was inspected or tested

using the alternate method, if required, the organization
shall obtain approval from the customer(s).
maintain and periodically review a list of approved

alternate process control methods that are
referenced in the control plan
standard work instructions shall be available for each

alternate process control method
Review the operation of alternate process controls

on a daily basis, at a minimum, to verify
implementation of standard work with the goal to
return to the standard process as defined by the
control plan as soon as possible.
Example methods include but are not limited to the

following:
-daily quality focused audits (e.g., layered process audits,
as applicable);
-daily leadership meetings.
Restart verification is documented for a defined

period based on severity and confirmation that all
features of error-proofing device or process are
effectively reinstated
implement traceability of all product produced while

any alternate process control devices or processes
are being used (e.g., verification and retention of
first piece and last piece from every shift).
8 Operation
8.6 Release of products and services
Implement planned arrangements, at appropriate stages, to verify that the

product and service requirements have been met.
The release of products and services to the customer shall not proceed until
the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority and, as applicable, by the
customer.
- retain documented information on the release of products and
services.
The documented information shall include:
a) evidence of conformity with the acceptance criteria;
b) traceability to the person(s) authorizing the release.
8.6.1 Release of products and services-supplemental

The organization shall ensure that the planned arrangements to verify that the
product and service requirements have been met encompass (completely) the
control plan and are documented as specified in the control plan
8 Operation
8.6.2 Layout inspection and functional testing
A layout inspection and a functional verification to applicable

customer engineering material and performance standards shall
be performed for each product as specified in the control plans.
Results shall be available for customer review.
NOTE 1 Layout inspection is the complete measurement of all
product dimensions shown on the design record(s).
NOTE 2 The frequency of layout inspection is determined by the
customer.
8.6.3 Appearance items

Use of haptic technology, (Sense of touch) a vibrating seat to inform driver of
a pedestrian about to cross the street, By adding haptics, your finger will , get the
impression that you are pressing an actual button.
8.6.4 Verification and acceptance of conformity of externally provided products and services
8.6.5 Statutory and regulatory
conformity
New
requirement
• Prior to release of externally provided products into its production flow,

the organization shall confirm and be able to provide evidence that
externally provided processes, products, and services conform to the
latest applicable statutory, regulatory, and other requirements in the
countries where they are manufactured and in the customer-identified
countries of destination
8.6.6 Acceptance Criteria: No Change

Acceptance criteria shall be defined by the organization and, where appropriate or required, approved by the
customer. For attribute data sampling, the acceptance level shall be zero defects.
8.7.1.1 Customer authorization for concession
Earlier it was 8.3.4 (customer waiver) -requirements

added
obtain customer authorization prior to further

processing for “use as is” and for repair of
nonconforming product
If sub-components are reused in the

manufacturing process, that sub-component
reuse shall be clearly communicated to the
customer in the concession or deviation permit. ;
8.7.1 & 8.7.1.2 Control of non-conforming product-customer
specified process
• The organization shall comply with applicable customer-specified

controls for nonconforming product(s).
8.7.1.3 Control of suspect product
The organization shall ensure that product with unidentified

or suspect status is classified and controlled as
nonconforming product
The organization shall ensure that all appropriate

manufacturing personnel receive training for containment of
suspect and nonconforming product.
8.7.1.4 Control of reworked product
Documented Process
For rework confirmation in accordance with the control plan or
other relevant documented information to verify compliance to
original specification.
8.7.1.4 Control of reworked product
utilize risk analysis (such as FMEA) methodology to assess risks

in the rework process prior to a decision to rework the product.
If required by the customer, the organization shall obtain

approval from the customer prior to commencing rework of
the product.
Instructions for disassembly or rework, including re-

inspection and traceability requirements, shall be
accessible to and utilized by the appropriate personnel
retain documented information on the disposition of reworked

product including quantity, disposition, disposition date, and
applicable traceability information
8.7.1.5 Control of repaired product
Documented Process
For repair confirmation in accordance with the control plan or other relevant
documented information.
8.7.1.5 Control of repaired product
utilize risk analysis (such as FMEA) methodology to assess risks

in the repair process prior to a decision to repair the product.
the organization shall obtain approval from the customer

before commencing repair of the product.
Instructions for disassembly or repair, including re-

inspection and traceability requirements, shall be
accessible to and utilized by the appropriate personnel
retain documented information on the disposition of repaired

product including quantity, disposition, disposition date, and
applicable traceability information
8.7.1.6 Customer notification
Notify customer in the event of non

conforming product has been shipped
• Initial communication shall be followed with detailed documentation of

the event
8.7.1.7 nonconforming product disposition
Documented Process
-For disposition of nonconforming product not subject to rework or
repair
For product not meeting the requirements, the organization shall

verify that the product to be scrapped is rendered unusable prior
to disposal
The organization shall not divert nonconforming product to

service or other use without prior customer approval
8.7.2 • Org. shall retain documentation of nonconformity, actions taken,

concessions obtained, authority deciding action etc.
9. Performance Evaluation
9.2 Internal
audit
9.1 Monitoring ,
measurement, 9.3
analysis and management
evaluation review
9.
PERFORMANCE
EVALUATION
127
9.1 Monitoring, measurement, analysis and
evaluation
What needs to be monitored and measured
The methods of monitoring, measurement, analysis and evaluation

needed to ensure valid result
When the monitoring and measurement shall be performed
When the results of monitoring and measurement shall be analysed

and evaluated
Retain appropriate documented information as evidence of the results

9.1.1.1 Monitoring and measurement of
Perform process studies on all new manufacturing(including

assembly or sequencing) processes to verify process capability
Process studiers to include those for special characteristics
Maintain manufacturing process capability or performance

results as specified by the customer’s part approval
process requirements
Shall verify that PFD, PFMEA and control plan are

implemented
Records of actual measurement values and/or test results for

variable data
9.1.1.1 Monitoring and measurement of
Implement reaction plan and escalation process when acceptance

criteria are not met
Significant process events, such as tool change or machine repair

shall be recorded and retained as documented information
initiate a reaction plan indicated on the control plan and

evaluated for impact on compliance to specifications
Corrective action shall be developed indicating specific actions,

timings and responsibilities
Organization shall maintain records of effective dates of process

changes
9.1.1.2 Identification of statistical tools
Organization shall determine the

appropriate use of statistical tools
Included as a part of APQP process

and included in DFMEA, PFMEA and
control plan.
9.1.1.3 Application of statistical concepts
Statistical concepts such as variation,

control(stability), process capability and
consequences of over-adjustment shall be
understood.
Used by employees involved in the collection,

analysis and management of statistical data.
9.1.2.1 Customer satisfaction-supplemental
Customer satisfaction shall be monitored through evaluation of

internal and external performance indicators. Performance
indicators shall include the following
Delivered part quality performance
Customer disruptions
Field returns, recalls, and warranty(where applicable)
Delivery schedule performance(including incidents of premium

freight)
Customer notifications related to quality and delivery issues,
including special status
Include the review of customer performance data including online
customer portals and customer scorecards, where provided.
9.1.3.1 Prioritization
Trends in quality and operational

performance shall be compared
with progress toward objectives
and lead to action to support
prioritization of actions for
improving customer satisfaction.
9.2.2.1 Internal audit programme
Documented Process
For internal audit. Process shall include :
development and implementation of an internal audit programme that
covers the entire QMS including QMS audits, manufacturing process
audits, and product audits
9.2.2.1 Internal audit programme
audit programme shall be prioritized based upon risk, internal and

external performance trends, and criticality of the process(es).
Where applicable, the organization shall include software

development capability assessments in their internal audit
programme
The frequency of audits shall be reviewed and, where appropriate,

adjusted based on occurrence of process changes, internal and
external nonconformities, and/or customer complaints
effectiveness of the audit programme shall be reviewed as a part of

management review.
9.2.2.2 Quality management system audit
audit all quality management system processes

over each three-year calendar period, according to
an annual programme, using the process approach
to verify compliance with this Automotive QMS
Standard
Integrated with these audits, the organization shall

sample customer-specific quality management
system requirements for effective implementation
9.2.2.3 manufacturing process audit
audit all manufacturing processes over each three-year calendar

period to determine their effectiveness and efficiency using customer-
specific required approaches for process audits
Where not defined by the customer, the organization shall define

the approach to be used
each manufacturing process shall be audited on all shifts where it

occurs, including the appropriate sampling of the shift handover
manufacturing process audit shall include an audit of the effective

implementation of the process risk analysis (such as PFMEA), control
plan, and associated documents
9.2.2.4 Product audit
audit products using customer-specific required

approaches at appropriate stages of production
and delivery to verify conformity to specified
requirements
Where not defined by the customer, the

organization shall define the approach to be
used
9.3.1 & 9.3.1.1 Management review-supplement
Management review shall be conducted at least annually
frequency shall be increased based on risk to

compliance with customer requirements resulting from
internal or external changes impacting the quality
management system and performance-related issues
9.3.2 Management review input-
9.3.2.1 management review input-supplemental
Review to include:
Changes in external and internal issues
Feedback from relevant interested parties
Extent to which quality objectives have been met
Non-conformities and Monitoring & measurement results
The performance of external providers
The adequacy of resources
The effectiveness of actions taken to address risks and opportunities

9.3.2.1 management review input-supplemental
Management review shall include:

a) COPQ-cost (internal and external)
b) Measures of process effectiveness
c) Measures of process efficiency
d) Product conformance
e) Assessments of manufacturing feasibility made for changes to existing
operations and for new facilities or new product
f) Customer satisfaction
g) Review of performance against maintenance objectives
h) Warranty performance(where applicable)
i) Review of customer scorecards(where applicable)
j) Identification of potential field failures identified through risk
analysis(such as FMEA)
k) Actual field failures and their impact on safety or the environment
9.3.3.1 Management review output-supplemental
8 Operation
Top management shall

document and implement
an action plan when
customer performance
targets are not met
10. Improvement
10.2
Non-conformity
and corrective
action
10.1
General 10.3
Continual
improvement
10
IMPROVEMENT
144
10.1 General
Determine and select opportunity for improvement and

implement actions to meet customer requirements and
enhance customer satisfaction. These shall include
Improving product and services as well as to address

future needs and expectations
Correcting, preventing or reducing the undesired effects
Improving the performance and effectiveness of QMS
NOTE: Examples of improvement can include correction, corrective action,

continual improvement, breakthrough change, innovation and re-
organization
8 Operation
10.2 Non conformity and corrective action
10.2.1
When a nonconformity occurs, including any arising from complaints, the
organization shall:
a) react to the nonconformity and, as applicable:
b) evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere, by:
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if
necessary;
f) make changes to the quality management system, if necessary. Corrective
actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:

a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
10.2.3 Problem Solving
Documented process: Problem solving process includes:
defined approaches for various types and scale of problems (e.g., new product
development, current manufacturing issues, field failures, audit findings);
containment, interim actions, and related activities necessary for control of

nonconforming outputs
root cause analysis, methodology used, analysis, and results;
implementation of systemic corrective actions, including consideration of the

impact on similar processes and products
verification of the effectiveness of implemented corrective actions
reviewing and, where necessary, updating the appropriate documented

information (e.g., PFMEA, control plan).
Use customer specific prescribed process, tools or systems

10.2.4 Error proofing
Documented process
Details of the method used to be documented in the process risk analysis (such as
PFMEA) and test frequencies to be documented in the control plan
The process shall include the testing of error-proofing devices for

failure or simulated failure
Records shall be maintained
Challenge parts, when used, shall be identified, controlled, verified,

and calibrated where feasible
Error-proofing device failures shall have a reaction plan

8 Operation
10.2.5 Warranty management process
When organization is required to provide warranty for their

product(s), the organization shall implement a warranty
management process
the process shall include a method for warranty part analysis,

including NTF (no trouble found).
When specified by the customer, the organization shall implement

the required warranty management process
10.2.6 Customer complaints and field failure test
analysis
Perform analysis on customer complaints and field failures

including any returned parts, and initiate problem solving and
corrective action to prevent recurrence.
Where requested by the customer, this shall include

analysis of the interaction of embedded software of the
organization’s product within the system of the final
customer’s product.
communicate the results of testing/analysis to the customer and

also within the organization
10.3 & 10.3.1 Continual Improvement- supplemental
Documented Process
For continual improvement and include the following:
a) Identification of the methodology used, objectives,
measurement, effectiveness and documented information
b) Manufacturing process improvement
c) Reduction of process variation and waste
d) Risk analysis (such as FMEA)
NOTE: Continual improvement is implemented once manufacturing

processes are statistically capable and stable or when product
characteristics are predictable and meet customer requirements.
Internal Auditing Process
Audit
Systematic, independent and documented process for

obtaining audit evidence and evaluating it objectively to
determine the extent to which the audit criteria are fulfilled
Terms and Definitions
AUDIT CRITERIA
Set of Policies, Procedures or Requirements.

 Customer requirements
 Quality Management System requirements
 Manuals, Procedures/Work Instructions
 Internal specifications/standards
 Control plans, FMEAs, checklists, formats,
etc.
 Automotive core tools
 ISO 9001:2015 and IATF 16949:2016 requirements
 Statutory & Regulatory requirements applicable to product
 Certification body requirements
AUDIT EVIDENCE
Records, statement of facts or other information, which are
relevant to the Audit Criteria and verifiable.
OBJECTIVE EVIDENCE
Data supporting the existence or verify of something
 Be obtained through observation, measurement, test,
interviews or other means.
 Preferably documented
 Shall be verifiable
AUDIT FINDINGS
Results of evaluation of the collected Audit Evidence
against Audit Criteria.
AUDIT CONCLUSION
Outcome of an Audit, provided by Audit Team after
consideration of the audit objectives and all Audit Findings.
Quality Audit Types
Types of Audits
1st Party – WE auditing our own system (Internal)
2nd Party – WE auditing our supplier (External)
3rd Party – WE being audited by a registration body

(External)
Internal Quality Audit
• The
health of QMS of an organization to some extent
depends on effectiveness of Internal Audit
• Quality of Internal Quality Audit to large extent

depends on the competence of Auditors
Internal Quality Audit-Phases
ACT PLAN
Corrective Actions & Audit Planning
Follow-up Audit & preparation
Audit Reporting Audit Execution
CHECK
DO
Audit Planning
Audit Planning and scheduling
• Audit plan shall cover audit of all working shifts

• Process audit shall cover all manufacturing processes
identified in PFD/CP
• Product audit shall cover all products supplied to
customers and shall cover all appropriate stages of
production and delivery
Audit Planning
•Preparation of audit plan
- Area / processes to be audited

- Select audit teams
- Auditor independence
- Auditor qualification
- Decide frequency and scope
- Procedural requirement
- Status and importance of activity
• Distribution of audit plan

Audit Frequency or Prioritization of audit activities
considering :
 Defined in internal audit procedure normally –

 Special audits depending on status and importance of
activity
 Significant changes in the organization, policies or
technology
 Significant changes in system itself
 Results of previous audits
 Performance of the processes
 Risk to the customer / risk to the organization
 Customer complaints / Hold / Warnings
 Customer requirements , including customer specific quality
management system
Process Owner ( IA process ) has to ensure that:
• Finalization of audit plan with audittee.

• Presence of process owner.
• that relevant personnel associated with that process are
available and related records available.
• that all the QMS processes, activities and shifts are
covered.
• that the internal audits are schedule according to annual
plan.
• Increase in audit frequency appropriately when there is
internal / external nonconformities.
Auditor's Competence
Criteria for selection of auditor
 Education
 Work experience
 Auditor training
 Personnel attributes
 Quality specific knowledge and skills
 Core tools knowledge
Competency of the auditors must be evaluated on continuous
basis.
Auditor’s competency
Mandatory competencies required for

QMS auditors
Risk based thinking
ISO 9001:2015 and IATF 16949:2016
Planning, conducting, reporting and closing
out audit findings
Auditor’s competency
Manufacturing
Product auditors
process auditors
Technical understanding of
Understanding of product
relevant manufacturing
requirements
process(es)
Technical understanding of Competency in use of relevant

process risk analysis(PFMEA) measuring and test
and control plan equipment
Audit Preparation
Activities of Auditor :
• Establish communication with auditee & finalize the audit
programme
• Identify Processes to be audited
• Look for previous audit reports & issues
• Performing document review and analyze the process
(Inputs/Outputs/Interaction/links/applicable legal
requirements on products)
• Preparation of Turtle Diagram
• Preparation of checklist
Audit Preparation
Audit checklist
 Convert clauses into questions
 Cover all areas identified in turtle diagram
 Allocate time depending upon the sample size
 Helps in keeping the audit objective clear
 Maintains pace and continuity
 Maintains time management
 Should be used as aids-memoir
 Should not be tick list
 Auditor should not be driven by checklist
Audit Execution
Audit Execution
•Opening meeting
•Audit process
- Information gathering
- Its validation
- Its evaluation
•Writing non-conformity statements
•Closing meeting
-Where possible, the auditor shall audit the processes

where they occur including shift coverage.
-Objective evidence of both the conformance and non-
conformance shall be recorded
Conducting audit
 Ask for overview of the process

 Based upon turtle diagram and audit checklist, seek
information by interviewing the personnel at appropriate
locations/levels
 Investigate to the depth necessary
 No problem found.. Move on
 Don’t keep on auditing until problems are found
Conducting audit
Interviewing Techniques
• Interview the right people
• Interview those who are responsible
• Interview those who are doing
• Use clear open questions
• Allow the auditee time to answer
• Show your interest
• Keep notes
Conducting audit
Questioning Technique
Ask Open questions-These will compel auditee to
describe activities in detail :
• Who (does it?/is doing it?/should be doing?/else can do it?)

• What (is done?/ else can be done?/ what should be done?)
• When ( is it done?/else can be done?/ to do it?)
• Why ( is it done?/he is doing?/ to do there?/ to do that way?)
• When ( to do it?/is it done?/ should it be done?)
• How (is it done?/often is it done?/ should it be done?)
• Show me
Conducting audit
 Do not ask
• Closed ended questions
• Unrelated questions
 Use checklist as reference
 Avoid unnecessary discussions or confrontation
 Adhere to the time schedule
 Cover the total scope
 Select appropriate sample size
 Remain within the boundary of audit scope
 Do not over react on auditee’s reaction
Conducting audit
Avoid asking close ended questions
“HAVE YOU BEEN TRAINED IN CALIBRATION?”
This is a close-ended question since the answer to this is either

“YES” or “NO”
Better to ask :
“HOW HAVE YOU BEEN TRAINED FOR CONDUCTING CALIBRATION?”
OR
“ WHAT TRAINING IN CALIBRATION HAVE YOU RECEIVED?”
Conducting audit
Ask questions to get maximum information
1.“WHERE DO YOU KEEP A COPY OF INSPECTION REPORTS ?”
The answer is “IN THE BOX FILE” gives information that

the audittee knows there is one and also its location.
2. “WHAT DO YOU DO ONCE INSPECTION IS COMPLETE ?”
Such question shall encourage an answer which provides information

on the flow of documentation and sequence of activities.
Attributes of a good auditor
• Disciplined • Decisive (Vital)
• Open minded • Time Management
• Logical/ Analytical
• Polite • Confident
• Knowledgeable • Positive Approach
• Good Listener • Prepared
• Motivated
• Patience
• Unbiased
A good auditor should not
• Jump to conclusion • Be Over Confident
• Assume • Be Harsh
• Act like Policeman
• Be Talkative
• Reactive
• Be Biased • Carry Preconceived notions
• Ask more close- • Have Rigid Mindset
ended Questions
Conducting audit
Methodology for auditing- Process audit approach
Start with a questions about performance, what is expected
from the process, what are the objectives/ measures, what
is the actual performance?
How is performance of the process being improved?
How was the process planned, what systems are in place to

ensure the process is controlled. Does the process address
relevant customer requirements?
Is the process being carried out as planned? Are the

systems understood by all involved in the process?
Conducting audit
Focus on performance:
Purpose of the audit is to verify the effectiveness and efficiency of
QMS processes.
Effectiveness = Extent of Implementation of planned activities +

Extent to which the desired results are achieved
Efficiency = Relationship between out put and resources used

( Monitoring of wastages)
With WHO?
With WHAT?
(TRAINING,
(EQUIPMENT/ KNOWLEDGE,
INSTALLATIONS) SKILLS)
INPUT OUTPUT
REQUIREMENTS
SATISFACTION
Customer Who Customer Who
has a Need PROCESS has a Need Met
HOW ?
(INSTRUCTIONS,
PROCEDURES
METHODS
Start With
INCLUDING
SUPPORT
Performanc
PROCESSES e
Conducting audit
Seek information on :
 Whether process
• Has a owner
• Is defined / documented
• Linkages are established
• Is monitored
• Has records maintained.
 Support process
• With what (Materials and equipment)
• With who ( skills and trainings)
• How (Methods and techniques)
• How many key criteria( Measurement and assessment)
Conducting audit
Analyze and Synthesize (Combine) Data

 Auditor shall be able to collect and analyze data and draw
conclusion based on the same.
 Auditor shall be able to categorize between relevant and

irrelevant information.
 Focus on the area of significance

Conducting audit
Analyze and Synthesize Data
 Should be able to link the various data {( e.g. company level and
individual process level data, correlating organization data with any
customer supplied performance data ( delivery performance, ppm
level)}
 Question the effectiveness of organization process for collection ,

analysis and review of data during the audit , without taking for
granted the integrity of the data presented.
 Should be able to see the big picture based on the various data from
multiple source.
 Draw conclusion form the total data presented and not conclude on
isolated or individual data presented.
Audit Process
Remember one thing very clearly during the Audit........
Only believe on objective evidences

Information gathering
Audit evidence can be obtained through :
Observation of activities:
- Looking at the processes as they are being carried out e.g. Machining,
Testing , Inspection, actual storage, orderliness, identification, test
status, up keep of facility etc.
Condition in the area of concern :

Feeling ( Temperature, Humidity, smell etc)
Review of records, trends, documents :
Interviews:
Asking question and listening to the answer and correlating to what was
observed, felt and reviewed.
Clues requiring further research should be noted for investigation later

Conducting audit
Note taking
Recording Objective Evidence :
• Name and position of person interviewed

• Statement made by person interviewed
• Document No. and their issue/revision level
• Serial number of equipment or components
• Range of sample examined
• Location
• Time and place of an event
Note taking
Notes could be used as reference for:
• Immediate investigation
• Investigation later
• Use by a colleague
• Subsequent audits
Notes must therefore be:

• Legible
• Retrievable
Notes taken during an audit are a record of:

• The audit sample taken
• What was reported
• What was observed
Audit Trail
• Series of correlated audit evidences that should be sought during
audit process.
• Audit Trail is forward/ backward fact finding related to a single
evidence (probing root causes/ consequences of an evidence.)
• Actual or potential non-compliance because of other interfacing

process / department e.g.
- non-availability of supplier delivery schedule in the store( to be

received from purchase)
- Un-calibrated instruments being used on shop floor (

responsibility is of QA department)
Audit Trail Example
There is a ‘New machine installed’

__ Ask for Pre launch control plan for validation of new
machine
__ Ask for process capability study
____ Ask for 100% inspection plan if it is not capable.
____ Ask for Corrective action plan if it is not capable.
__ Ask for changes in PFMEA if applicable
__ Ask for change in control plan if applicable
Audit Trail Example
There is a ‘Change in supplier’

__ Ask for Reason of change
__ Ask for new supplier monitoring records
__Ask for Development status of new supplier.
__ Ask for Part approval process of new supplier.
There is a ‘Change in QC inspector’

__ Ask for updated MSA records
__ Ask for training records / on the job training record.
Audit Trail Example
There is a ‘Change in process parameters’

__ Ask for engineering change records
__ Ask for re-validation records for changed parameters.
__ Ask for updated Part Approval Process
There is a ‘Change in Measurement System’

__ Ask for Calibration records
__ Ask for MSA records.
__ Ask for updated Part Approval Process
Audit Reporting
Non-conformities
‘Non fulfillment of requirements’
Requirement maybe
specified by IATF 16949 or
Customer Specific Requirements or
specified by organization itself

Major Non-conformity
•Absence of a requirement throughout Organization.
•No. of minor NCs against one requirement
•Potential of NC product shipment to customer
•May result in failure / reduce usage of product
•May result in failure of QMS / Reduce ability to control

processes
Minor Non-conformity
• Non-compliance of Documentation requirement
• Single observed lapse against TS requirement
• Not likely to result in failure of QMS

Opportunities for improvement (OFI)
 An opportunity for improvement is a situation where the evidence

presented indicates a requirement has been effectively implemented
but, based on auditor experience and knowledge, additional
effectiveness or robustness might be possible with a modified
approach
 Improvement is after the conformance to the requirement.
 Scope exists for reduction in rejection.
 Scope exists for reduction of variation in parameter ( e.g.

temperature variation during H.T based on the cost effective
technology available).
Audit reporting process
 Evaluate the audit observations / evidence
 Prepare non-conformity reports where objective evidence

available
 Give benefit of doubt to auditee
 Explain the non-conformities to auditee
 Obtain consensus from auditee
 Hand over the non-conformities to the auditee for

determining and implement corrective actions
Audit reporting
• Audit reports will be used long after the auditor is forgotten
• People who read audit reports are many and varied:

• The Management Representative
• The Managing Director / Chief Executive
• The Manager of the area under audit
• The person given responsibility to carry
out corrective action
• An internal auditor
• The next external Auditor
Non-conformity report must be accurate,

legible, brief and complete
Writing non-conformity report
Non- conformities shall be written in a clear manner. It
should
State:
• The statement of non-conformity.
•The requirement or specific reference to the
requirements
•The objective evidence that supports the statement of
nonconformity
Objective evidence only identifies symptoms of a problem with

in QMS not the entire problem that needs to be solved.
Example of a Non-conformity
There are no records of part approval for Bolt part no. AX0023415
supplied by supplier
Is this a good example of writing a non-conformity
If not why ?
Test your Non-conformity statement
Ask yourself : if the opposite were true, would the problem not
occurred
Does my statement address the system issue ?
Does it help the organization to understand why the non-conformity

occurred ?
If the answer to the above is YES, then your statement is good

If the answer to the above is NO, then you have probably confused
your statement with objective evidence.
Non-conformity statement
• Often the statement of non-conformity is confused with

objective evidence
• Statement of non-conformity must be expressed as an
issue with the system
• If the statement of non-conformity is expressed in
terms of a person of incident, it is a objective evidence.
It is important to write non-conformities defining the

system problem, otherwise problem solving with in
organization may not be effective.
Non-conformity statement
Non-conformity : The process of part approval for the

supplier is not fully effective
Requirement : ISO/TS 16949. clause no. 7.3.6.3 states

that….This product and manufacturing process approval
procedure shall also be applied to suppliers….”
Objective evidence: Record of part approval for the

supplied bolt for part no. AX0023415 are not available.
Non-conformity Presentation
Area NCR Description Clause

Ref
Calibration 1 Gage R&R studies were not undertake on instrument # 123456 7.6
Shown on control plan 3456
Is this statement of non-conformity is correct?

Non-conformity Presentation
.
Area NCR Description Clause
Ref
Measurement 1 Description of Nonconformity:- 7.6
System The process for performing Measurement systems analysis
Analysis was not effective.
Evidence observed:- Final Inspection process - Equipment #

123456 a Vernier caliper referenced on control plan GM 55,
observed in use has no records of measurement systems
analysis being completed.
Requirement:- Statistical studies shall be conducted to

analyse the variation present in the results of each type of
measuring and test equipment system. This requirement shall
apply to measurement systems referenced in the control plans.
Corrective actions & follow up
Non-conformity management
Activity Responsibility
Preparation of nonconformity report Auditor
Carryout corrections Auditee

Perform root cause analysis and identify corrective actions Auditee
Submit corrective actions to auditor Auditee
Evaluate corrective action plan and provide feedback Auditor
Revision to corrective action plan if required Auditee
Corrective action plan implementation Auditee
Evaluation of effectiveness of actions taken Auditor
Documents changes to QMA, if required. Auditee
Verify corrective action taken Auditor
Records all action taken. Auditor
Any Question Please ?
Questions/Final Thoughts
211

Paradise IATF IA Presentation PDF

Încărcat de

Informații document

Titlu original

Drepturi de autor

Formate disponibile

Partajați acest document

Partajați sau inserați document

Opțiuni de partajare

Vi se pare util acest document?

Este necorespunzător acest conținut?

Drepturi de autor:

Formate disponibile

Paradise IATF IA Presentation PDF

Încărcat de

Drepturi de autor:

Formate disponibile

Welcome to the

IATF members includes following vehicle manufacturers and their

OEM,s : Trade Associations:

Inputs Process Outputs

How done? What results?

Input: Customer needs? Output : Customer needs fulfilled for

How: How is this process controlled ? Measure: Measurement /analysis of process

With what? - Resources

• the activities you

Risks and Opportunities

Risk = Effect of Uncertainty

Effect= Deviation from expected-positive or negative.

There are risks in all systems, processes and functions.

One of the purposes of a QMS is to act as a preventive tool

Analyze and Prioritize the risk and opportunities in

Continual Reduction in Variation &

Standard core sections

Automotive Supplemental to ISO 9001:2015

Includes products with embedded software

Applicable to production parts, service parts and/or

3.Terms and definitions: Included /Changed

customer-specific requirements (CSRs)

Determine external and Monitor and review the

Determine Monitor and review

Potential Interested Parties Potential Interested Parties

Management Corporate Share Service Providers

• The external and internal issues referred

• All requirements are applicable

Organisation to Consider: Context, req. of interested

 Customer Specific Requirements(4.3.2)

The only permitted exclusion

Customer • Shall be evaluated

A way to identify if any customer-specific requirements exist is to compare

• Risk and Opportunities

To include the following

i) Training identified by the organization or customerfor personnel

Availability of supporting for

Organization shall define and implement corporate

2 an employee code of conduct

3 an ethics escalation policy(whistle-blowing policy)

Top management to Process Owners

process owners for understand their

Documented assignments to ensure meeting customer

Setting quality objectives and related training

Corrective and preventive actions

Product design and development

Customer scorecards and customer portals

Personnel responsible for conformity to

Authority to stop shipment and stop

6.1.1 and 6.1.2

When Planning for QMS

Consider issues referred to in 4.1 and the

Determine risks and opportunities that needs to be

Give assurance that QMS will achieve its intended result

The organization • Lessons learned from products recall

6.1.2.2 Preventive Action

• Organization shall establish a process to lessen the impact of negative effects of

a Identify and evaluate internal/external risk to manufacturing process

Define contingency plan according to risk and impact to the

Prepare contingency plan continuity of supply in event of key

periodically test the contingency plans for effectiveness (e.g. simulations as

conduct contingency plan reviews (at a minimum annually) using a multi

Document the contingency plans and retain the documented information