awareness session for transition to iatf...

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Awareness Session for Transition

to IATF 16949:2016

Faculty – Arun Kumar Sharma

+91 9027715766, [email protected]

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ISO/TS 16949 Overview

ISO/TS 16949 Technical Specification for Automotive Quality

Management Systems, in conjunction with ISO 9001, defines

the quality system requirements for the design/ development,

manufacturing, installation and servicing of automotive-

related products. ISO/TS 16949 certification is a mandatory

industry requirement developed by the International

Automotive Task Force (IATF) to align automotive quality

systems throughout the world.

ISO/TS 16949 was developed in 1999 by the IATF in

conjunction with the ISO quality management technical

committee ISO/TC 176. It is now one of the most widely used

international standards in the automotive industry, aiming to

harmonize the different assessment and certification

systems in the global automotive supply chain.

Changes to the Standard

The IATF released the Automotive Quality Management

System Standard, IATF 16949, on October 1st, 2016. This

new document, along with applicable automotive customer

specific requirements (CSRs) and ISO 9001:2015, defines the

fundamental quality management system requirements for

automotive suppliers.

IATF 16949 is not a stand-alone QMS standard and must

be audited in conjunction with ISO 9001:2015 and the

CSRs.

These separate standards must be used together to

implement the changes as well as to audit the revised QMS.

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The goal of the standard is the development of a QMS that:

- Provides for continual improvement

- Emphasizes defect prevention

- Includes specific requirements and tools from the automotive industry

- Promotes the reduction of variation and waste in the supply chain

Feedback from certification bodies, auditors, suppliers and

original equipment manufacturers (OEMs) was considered

during development of the standard, to make it an

innovative and customer-oriented document. Common

automotive customer-specific requirements were also

incorporated.

Relationship to ISO 9001:2015

ISO 9001:2015 provided the structure and foundation upon

which IATF 16949 expands for the automotive industry.

Some of the key changes provided by the ISO 9001:2015

standard are as follows:

A new 10 clause

structure based on

the Annex SL

model

A more comprehensive

approach to controlling

externally provided

processes, products and

services

Improved definition of

Interested parties and

an increased focus on

performance and

stakeholders

Concept of Risk based

thinking throughout

the standard

Improved definition of

the “context of the

organization”

The concept of

protecting

Organizational

knowledge

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Changes from ISO/TS16949:2009 to IATF16949

IATF16949 requires complete conformance to all ISO

9001:2015 requirements and identifies the supplemental

automotive management system requirements (which are

extensive). The majority of the supplemental requirements

are carry over from ISO/TS 16949:2009. However there have

been significant changes based on the automotive industry

direction

14 Key Changes

- Risk Analysis consideration are expanded beyond ISO 9001

requirements throughout the standards

- Corporate responsibilities Policies such as “whistle blowing” are now

required

- Manufacturing feasibility requirements are enhanced to include

capacity planning and the analysis is now required for any changes to

process or product design

- Internal auditor and second party auditor competencies are more

clearly defined and expanded

- Multiple requirements related throughout the standard related to

managing product with embedded software

- Additional requirements related to an organization supplier selection

process

- Requirement added for second party audit as a part of the supplier

management approach

- Statutory and regulatory conformance evidence requirement added for

all materials/components for country of manufacture and destination

- Significant expansion of the requirements related to identification and

traceability or products

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- Requirements added for “Temporary change of process controls” to

define and approve in advance, alternate process controls

- Enhanced expectations related to Total Productive Maintenance

- Several additional inputs to be considered during management reviews

- Added requirement to have a documented process pertaining to

application of error proofing methodologies

- Requirement to have a warranty management process for No Trouble

Found (NTF)

Transition Timeline

IATF 16949:2016 published on 1st Oct 2016. Rules for IATF recognition published on 1st Nov 16 The earliest auditing can start then would likely be Jan 2017, but more realistically around March 2017 as client will need time to update. After 1 Oct 2017, no more audits to the 2009 version. All next audits must be transition audits to the new IATF 16949:2016. If the client is not ready to transition, the decertification process is initiated. All current TS 16949 certificate expire after 14 Sept 2018.

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Notable Changes in terminology

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Revival of quality management principles

1. Customer Focus 2. Leadership 3. Engagement of people 4. Process approach 5. Improvement 6. Evidence-based decision making 7. Relationship management

Seven quality management principles are described in ISO 9000

Clause wise additions

Clause No.

Clause Name

ISO 9001 Reqmts

IATF 16949

Introduction 6 0

1 Scope 1 1

2 Normative references 1 1

3 Terms and definitions 1 1

4 Context of the organization

5 4

5 Leadership 5 5

6 Planning 5 4

7 Support 14 15

8 Operation 25 58

9 Performance evaluation

2 12

10 Improvement 4 5

Total--> 69 106

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Clause Wise Explanation

4 - Context of the Organization

4.1 – Understanding the Organization & its context - SWOT

4.2 – Understanding the needs & expectations of the

interested parties

4.3 – Determine the scope of the Quality Management

System – Scope, Customer Specific Requirements

4.4 – Quality Management System & it’s processes –product

safety,

5 - Leadership

5.1 – Leadership and Commitment – Corporate

responsibility, employee code of conduct, anti-bribery

policy, whistle blowing policy, process efficiency &

effectiveness, customer focus

5.2 – Policy – Communications

5.3 – Organizational Roles, responsibilities and authorities

6 - Planning

6.1 – Action to address risk and opportunities – Risk Analysis,

Preventive Action, Contingency Plan

6.2 – Quality Objectives and planning to achieve them

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6.3 – Planning of Changes

7 - Support

7.1 – Resources – Infrastructure, Plant facility and

equipment planning, Environment, MSA, Calibration,

Laboratory requirement, organization knowledge

7.2 – Competence – On the job training, Internal Auditor

competency, second party auditor competency

7.3 – Awareness – Employee motivation & empowerment

7.4 – Communication

7.5 – Documented Information – QMS, Record retention,

Engineering Specification

8 - Operation

8.1 – Operational Planning & Control – confidentiality,

8.2 – Requirements for product and services – customer

communication, special characteristics, manufacturing

feasibility,

8.3 – Design & development of products and services – product design skills, embedded software, validation, APQP,

PPAP

8.4 – Control of externally provided processes, product and

services – supplier selection, monitoring, development,

second party audits, regulatory requirements, embedded

software

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8.5 – Production & service provision – Control Plan, Work

Instruction, Job set-up verification, Total Productive

Maintenance, tooling management, Identification and

traceability, Preservation, temporary change of process

control

8.6 – Release of product and services – layout inspection,

acceptance criteria

8.7 – Control of Non Confirming Outputs – customer

concession, rework & repair product,

9 – Performance Evaluation

9.1 – Monitoring, measurement, analysis and evaluation – SPC, Customer Satisfaction

9.2 – Internal Audit – Programme, Process & Product Audit

9.3 – Management Review

10 – Improvement

10.1 – General

10.2 – Non conformity & corrective action – Problem Solving,

Error-proofing, warranty management

10.3 – Continual Improvement

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DOCUMENTED PROCESS – 22 No’s

1.) Management of Product Safety related to

Products and manufacturing processes (4.4.1.2)

2.) Managing Calibration & Verification records

(7.1.5.2.1)

3.) Identification of training needs including

awareness (7.2.1)

4.) Verify Internal Auditors Competency (7.2.3)

5.) Employee Motivation and Empowerment (7.3.2)

6.) Engineering Specification (7.5.3.2.2)

7.) Design & Development of products and services – supplemental (8.3.1.1)

8.) Special Characteristics (8.3.3.3)

9.) Supplier Selection Process (8.4.1.2)

10.) Statutory and regulatory requirements (8.4.2.2)

– use of word ‘shall document their process’ instead of documented process

11.) Identify and select type of control for

outsourced process (8.4.2.1)

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12.) Criteria to Evaluate Supplier Performance

(8.4.2.4)

13.) Identification and Traceability – supplemental

(8.5.2.1) – use of word developing &

documenting instead of documented process

14.) Control of Changes (8.5.6.1)

15.) Temporary change of process controls

(8.5.6.1.1) – use of words like ‘shall identify,

document, and maintain’ instead of

documented process

16.) Control of reworked product (8.7.1.4)

17.) Control of repaired product (8.7.1.5)

18.) Non Confirming Product disposition (8.7.1.7)

19.) Internal Audit Process (9.2.2.1)

20.) Problem Solving (10.2.3)

21.) Error-Proofing (10.2.4)

22.) Continual Improvement (10.3.1)

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Frequency Requirement/ Recommendation

1.) Contingency Plan review minimum annually

(6.1.2.3)

2.) Quality Objective review with annual targets

(6.2.2.1)

3.) Internal auditor competency – minimum number

of audits per year (7.2.3)

4.) PPAP record retention – till product active + one

calendar year if not specified by customer

(7.5.3.2)

5.) Engineering specification review within 10

working day of receipt of change (7.5.3.2.2)

6.) Acceptance criteria for attribute data sampling

is zero defects (8.6.6)

7.) QMS Audit – cover all process in 3 year calendar

(9.2.2.2)

8.) Manufacturing Process Audit- cover all process in

3 year calendar (9.2.2.3)

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NOTES

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NOTES

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