Automotive QMS for Meeting Today s Challenges

Transcription

1 Session 22B Automotive QMS for Meeting Today s Challenges Baskar Kotte Quality System Enhancement Phone: baskar@enhancequality.com ASQ NEQC 60th Conference, Springfield, Massachusetts

2 Focus How Many Certifications Involved? Components of TS 16949: 2009 Automotive Tier 2 Supplier Impact US Based Automotive Manufacturers and Non US Based Manufacturers Who is Influencing the TS 1649? ASQ NEQC 60th Conference, Springfield, Massachusetts 2

3 Focus Cont d. Can IATF and IAOB be Successful in Keeping ISO 9001:2008 as Base Standard? How Many of the Tier 2 Suppliers Drop ISO 9001:2008? IAOB/IATF Position on Tier 2 for ISO 9001:2015 QMS Quality Management Principles ISO/DIS 9001:2014 Common Structure Summary ASQ NEQC 60th Conference, Springfield, Massachusetts 3

4 ISO 9001:2015 Impact on TS Entire Present Structure to be Changed to Meet JTCG Developed High Level Structure 10 Element Structure: Only 3 Titles come from ISO 9001:2008 Common Text: For all Management System Standards ASQ NEQC 60th Conference, Springfield, Massachusetts 4

5 ISO 9001:2015 Impact on TS Cont d. Common Terms: 22 Terms Identified as Common to all Standards New Concept Introduced: Risk-Based Thinking Radical Face-lift to ISO/TS 16949:2009 if IAOB Decides to Adapt ISO 9001:2015 ASQ NEQC 60th Conference, Springfield, Massachusetts 5

6 How Many Certifications Involved? There are at Least 50,000 TS Certifications (Tier 1) There are at Least 100,000 Tier 2 with ISO 9001:2008 Certifications There are at Least 1.2 Million ISO 9001:2008 Accredited Certificates in the World Some Portion of this 1.2 Million are Issued to Tier 3 Automotive Suppliers All these Certificate Holders to be Prepared for Upcoming ISO 9001:2015? Or Not? ASQ NEQC 60th Conference, Springfield, Massachusetts 6

7 Components of TS 16949:2009 ISO 9001:2008 Plus International Automotive Requirements Plus Application of Automotive Core Tools Plus Automotive Customer Specific Requirements ASQ NEQC 60th Conference, Springfield, Massachusetts 7

8 Automotive Tier 2 Supplier Impact Must Transition to ISO 9001:2015 by 2018 All Transition Guidelines as Stipulated by International Accreditation Forum (IAF) are to be Followed Documented System is to be Modified Unless Otherwise Directed by IAOB Through their Tier 1 Customers ASQ NEQC 60th Conference, Springfield, Massachusetts 8

9 US Based Automotive Manufacturers and Non US Based Manufacturers GM, Ford and Chrysler Require Tier 1 Suppliers Certified for TS and Play a Critical Role in Managing all Interested Parties Toyota, Nissan, Honda, Hyundai BMW, Mercedes etc. are Not Requiring their Tier 1 Suppliers Certified for TS US Based and Non US Based Automotive Manufacturers Embrace or Not Embrace ISO 9001:2015? What if US Based Automotive Manufacturers who are Active with IAOB Do Not Embrace ISO 9001:2015? ASQ NEQC 60th Conference, Springfield, Massachusetts 9

10 Who is Influencing the TS 16949? International Automotive Oversight Bureau (IAOB) Automotive Industry Action Group (AIAG) What are They Saying about Embracing ISO 9001:2015? ASQ NEQC 60th Conference, Springfield, Massachusetts 10

11 Can IATF and IAOB be Successful in Keeping ISO 9001:2008 as Base Standard? IATF/IAOB Expressed Several Concerns about ISO 9001:2015 and Related Annex SL, JTCG Common Structure, ISO Guide 83 Dropped Requirements Unnecessary Additional Requirements Introduction of Risk Based Thinking in Place of Preventive Action ASQ NEQC 60th Conference, Springfield, Massachusetts 11

12 Can IATF and IAOB Keep ISO 9001:2008 as Base Standard Cont d. Inadequate Process Approach Emphasis and Application in the High Level Common Structure Confusion Related to Documented Information Unnecessary Cost Related to Transition IATF/IAOB Requested ISO for Permission to use ISO 9001:2008 in ISO/TS ASQ NEQC 60th Conference, Springfield, Massachusetts 12

13 How Many of the Tier 2 Suppliers Drop ISO 9001:2008? Can IATF/IAOB Succeed Retaining ISO 9001:2008 in TS Can Tier 2 Retain ISO 9001:2008 and Continue Surveillance Audits from 3rd Party Registrars?... Not Really This Leaves IATF/IAOB to Decide How They Want Tier 2 Supplier Development Section... Now it Requires to Work Toward Achieving ISO 9001 If NO Decision is made, there is a Potential for a Lot of Certificates Dropping ASQ NEQC 60th Conference, Springfield, Massachusetts 13

14 IAOB/IATF Position on Tier 2 for ISO 9001:2015 IATF/IAOB has a Tough Challenge to Face Obtain Special Permission from ISO to use ISO 9001: Possible? Tier 2 Supplier Control will be in a Limbo Many Sanctioned Interpretations Needed from IATF to Clarify this Dramatic Decision of not Supporting or Embracing ISO 9001:2015 ASQ NEQC 60th Conference, Springfield, Massachusetts 14

15 Customer Focus Quality Management Principles Quote from ISO/DIS 9001:2014 Annex B a. Statement: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. b. Rationale: Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the customer. Understanding current and future needs of customers and other interested parties contributes to sustained success of an organization. ASQ NEQC 60th Conference, Springfield, Massachusetts 15

16 Quality Management Principles Cont d. Leadership a. Statement: Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization. b. Rationale: Creation of unity of purpose, direction and engagement enable an organization to align its strategies, policies, processes and resources to achieve its objectives. ASQ NEQC 60th Conference, Springfield, Massachusetts 16

17 Quality Management Principles Cont d. Engagement of People a. Statement: It is essential for the organization that all people are competent, empowered and engaged in delivering value. Competent, empowered and engaged people throughout the organization enhance its capability to create value. b. Rationale: To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as individuals. Recognition, empowerment and enhancement of skills and knowledge facilitate the engagement of people in achieving the objectives of the organization. ASQ NEQC 60th Conference, Springfield, Massachusetts 17

18 Quality Management Principles Cont d. Process Approach a. Statement: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. b. Rationale: The quality management system is composed of interrelated processes. Understanding how results are produced by this system, including all its processes, resources, controls and interactions, allows the organization to optimize its performance. ASQ NEQC 60th Conference, Springfield, Massachusetts 18

19 Quality Management Principles Cont d. Improvement a. Statement: Successful organizations have an ongoing focus on improvement. b. Rationale: Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal and external conditions and to create new opportunities. ASQ NEQC 60th Conference, Springfield, Massachusetts 19

20 Quality Management Principles Cont d. Evidence-based Decision Making a. Statement: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. b. Rationale: Decision-making can be a complex process, and it always involves some uncertainty. It often involves multiple types and sources of inputs, as well as their interpretation, which can be subjective. It is important to understand cause and effect relationships and potential unintended consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made. ASQ NEQC 60th Conference, Springfield, Massachusetts 20

21 Quality Management Principles Cont d. Relationship Management a. Statement: For sustained success, organizations manage their relationships with interested parties, such as suppliers. b. Rationale: Interested parties influence the performance of an organization. Sustained success is more likely to be achieved when an organization manages relationships with its interested parties to optimize their impact on its performance. Relationship management with its supplier and partner network is often of particular importance. ASQ NEQC 60th Conference, Springfield, Massachusetts 21

22 ISO/DIS 9001:2014 Common Structure 1. Scope 2. Normative References 3.Terms and Definitions ASQ NEQC 60th Conference, Springfield, Massachusetts 3

23 ISO/DIS 9001:2014 Common Structure Cont d. 4. Context of the Organization a. Understanding the Organization and its Context b. Understanding the Needs and Expectations of Interested Parties c. Determining the Scope of the Quality Management System d. Quality Management System and its Processes ASQ NEQC 60th Conference, Springfield, Massachusetts 3

24 ISO/DIS 9001:2014 Common Structure Cont d. 5. Leadership a. Leadership and Commitment b. Quality Policy c. Organizational Roles, Responsibilities and Authorities ASQ NEQC 60th Conference, Springfield, Massachusetts 3

25 ISO/DIS 9001:2014 Common Structure Cont d. 6. Planning for the Quality Management System a. Actions to Address Risks and Opportunities b. Quality Objectives and Planning to Achieve Them c. Planning of Changes ASQ NEQC 60th Conference, Springfield, Massachusetts 3

26 ISO/DIS 9001:2014 Common Structure Cont d. 7.Support a. Resources b. Competence c. Awareness d. Communication e. Documented Information ASQ NEQC 60th Conference, Springfield, Massachusetts 3

27 ISO/DIS 9001:2014 Common Structure Cont d. 8. Operation a. Operational Planning and Control b. Determination of Requirements for Products and Services c. Design and Development of Products and Services d. Control of Externally Provided Products and Services e. Production and Service provision f. Release of Products and Services g. Control of Nonconforming Process Outputs, Products and Services ASQ NEQC 60th Conference, Springfield, Massachusetts 3

28 ISO/DIS 9001:2014 Common Structure Cont d. 9. Performance Evaluation a. Monitoring, Measurement, Analysis and Evaluation b. Internal Audit c. Management Review ASQ NEQC 60th Conference, Springfield, Massachusetts 3

29 ISO/DIS 9001:2014 Common Structure Cont d. 9. Improvement a. General b. Nonconformity and Corrective Action c. Continual Improvement ASQ NEQC 60th Conference, Springfield, Massachusetts 3

30 Summary Radical Structural Changes to TS if IATF/IAOB Decides to Adapt ISO 9001:2015 IATF/IAOB Expressed Concerns of Unnecessary Cost in Training/Consulting/Auditing IATF Submitted for Special Permission to use ISO 9001:2008 as a Part of TS If Allowed, IATF has a Challenge to direct the Tier 2 Supplier Development Process for Meeting QMS Requirements Potential Drop of ISO 9001:2008 Certificates ISO/DIS 9001:2015 QMPs and Structure ASQ NEQC 60th Conference, Springfield, Massachusetts 30

31 Thank You Questions? ASQ NEQC 60th Conference, Springfield, Massachusetts 31

32 Baskar Kotte President and CEO Quality Systems Enhancement 1790 Woodstock Road Roswell, GA Phone: Fax: ASQ NEQC 60th Conference, Springfield, Massachusetts 32