Awareness Session for Transition to IATF 16949:2016

Transcription

1 NAME DEPARTMENT - Awareness Session for Transition to IATF 16949:2016 Faculty Arun Kumar Sharma , arun.rtb@gmail.com 1 Get FREE IATF 16949:2016 Courses from -

2 ISO/TS Overview ISO/TS 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 automotiverelated products. ISO/TS certification is a mandatory industry requirement developed by the International Automotive Task Force (IATF) to align automotive quality systems throughout the world. ISO/TS 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, 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 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. 2

3 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 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 Concept of Risk based thinking throughout the standard A more comprehensive approach to controlling externally provided processes, products and services Improved definition of the context of the organization Improved definition of Interested parties and an increased focus on performance and stakeholders The concept of protecting Organizational knowledge 3

4 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 4

5 - 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 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 certificate expire after 14 Sept

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7 Notable Changes in terminology 7

8 Revival of quality management principles Customer Focus Leadership Engagement of people Process approach Improvement Evidence-based decision making Relationship management Seven quality management principles are described in ISO 9000 Clause wise additions Clause No. Clause Name ISO 9001 Reqmts Introduction Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement Total--> 69 IATF

9 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 9

10 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 10

11 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 11

12 DOCUMENTED PROCESS 22 No s 1.) Management of Product Safety related to Products and manufacturing processes ( ) 2.) Managing Calibration & Verification records ( ) 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.) Design & Development of products and services supplemental ( ) 8.) Special Characteristics ( ) 9.) Supplier Selection Process ( ) 10.) Statutory and regulatory requirements ( ) use of word shall document their process instead of documented process 11.) Identify and select type of control for outsourced process ( ) 12

13 12.) Criteria to Evaluate Supplier Performance ( ) 13.) Identification and Traceability supplemental ( ) use of word developing & documenting instead of documented process 14.) Control of Changes ( ) 15.) Temporary change of process controls ( ) use of words like shall identify, document, and maintain instead of documented process 16.) Control of reworked product ( ) 17.) Control of repaired product ( ) 18.) Non Confirming Product disposition ( ) 19.) Internal Audit Process ( ) 20.) Problem Solving (10.2.3) 21.) Error-Proofing (10.2.4) 22.) Continual Improvement (10.3.1) 13

14 Frequency Requirement/ Recommendation 1.) Contingency Plan review minimum annually ( ) 2.) Quality Objective review with annual targets ( ) 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 ( ) 5.) Engineering specification review within 10 working day of receipt of change ( ) 6.) Acceptance criteria for attribute data sampling is zero defects (8.6.6) 7.) QMS Audit cover all process in 3 year calendar ( ) 8.) Manufacturing Process Audit- cover all process in 3 year calendar ( ) 14

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