1. IATF 16949:2016 Update and Automotive QMS Transition Success
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

2. IATF 16949 Success Panel Bob DeGarmo Cherie Reiche Scott Gray
General Motors BIQS
Cherie Reiche
IAOB Program Manager
Scott Gray
AIAG Director Quality
Cathy Fisher – Panel Moderator
Quistem, LLC
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

3. SCAC/AIAG Supply Chain & Quality Conference August 25, 2017
Session Agenda
IATF 16949:2016 Overview
Customer-specific Requirements and IATF 16949
IATF Transition Audit Update
Top 8 IATF Transition Audit Nonconformities
Common Questions about transitioning your Automotive QMS to IATF 16949
Your Questions Answered
Next Steps
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

4. SCAC/AIAG Supply Chain & Quality Conference August 25, 2017
IATF 16949:2016 Overview
Scott Gray
AIAG Director Quality
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

5. Transitioning to IATF 16949:2016 Scott Gray, AIAG August 25, 2017

6. Background on the Revision Project
Revision work began in December 2014 and was completed in August 2016
The team completed a 5-Phase approach to develop IATF 16949
Pre-plan; Analyze; Build; Validate; and Deploy
Revision Work Team consisted of 17 global partners from 14 organizations (IATF OEMs, National Associations, Oversight Offices)
AIAG
IAOB
ANFIA
IATF France
BMW
Jaguar Land Rover
FCA US LLC (formerly Chrysler)
PSA Group
FCA Italy S.p.A. (formerly Fiat)
SMMT
Ford
VDA QMC GM VW

7. Unprecedented Stakeholder Input
IATF launched a survey (via the National Associations) early June 2015 soliciting feedback from over 2,000 key stakeholders:
OEMs
Suppliers (all Tiers)
Certification Bodies
Witness Auditors
Subject Matter Experts
Oversight Offices
Over 1,700 comments were received for consideration
Additionally, the IATF conducted a face to face review of the draft IATF standard in Rome, Italy in April 2016 with over 100 stakeholder representatives including CBs, suppliers, and witness auditors.
Several hundred more comments were received for consideration

8. Context of organization Performance Evaluation
ISO/TS to IATF 16949
The new automotive standard: IATF 16949:
Follows the high level structure of ISO 9001:2015
Rationale
Better alignment to business strategic direction
PDCA approach
More compatible with other management system standards
ISO is going from 8 clauses to 10 clauses
Plan Do 4
Context of organization 5
Leadership 6
Planning 8
Operation 9
Performance Evaluation 10
Improvement 7
Support
High Level Structure
Check
Act

9. Builds on the new areas of emphasis in ISO 9001:2015
ISO/TS to IATF 16949
The new automotive standard: IATF 16949:
Builds on the new areas of emphasis in ISO 9001:2015
Leadership
Competence
Risk-Based Thinking
Must be used in conjunction with ISO 9001:2015
Two (2) documents must be used to have all requirements
IATF cannot be used as a stand-alone requirements document

10. Changes to Drive Value & Credibility
IATF members focused on the linkage between ISO/TS Certification and Supplier/Client quality performance
Increased focus on operational performance and customer feedback (customer scorecards/metrics)
IATF contains many former OEM Customer Specific Requirements (CSRs)
Most of the changes occurred in areas where IATF OEM’s observed weakness trends and systematic issues

11. IATF Transition Support
IATF 16949:2016 Resource Center
IATF and ISO Standards
Rules 5th
Core Tools and other CQI’s
IATF Training
Auditor Certifications
Gap Analysis Tool

12. IATF16949 Training Courses Understanding IATF 16949:2016
Transitioning to IATF 16949:2016
Transitioning to IATF 16949:2016 for Automotive Auditors
IATF Understanding and Internal Quality Auditing
Exemplar Global Certified ISO9001:2015 Internal Auditor Training with Automotive Emphasis
Exemplar Global Certified ISO9001:2015 Lead Auditor Training with AIAG IATF 16949:2016 Supplier Auditor Certification
New – IATF Executive Understanding
New – Transitioning to IATF eLearning

13. Questions?

14. Customer-specific Requirements and IATF 16949:2016
Bob DeGarmo
General Motors BIQS
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

15. IATF 16949 Roll-Out Meeting Robert DeGarmo GM IATF Representative
SCAC/AIAG Conference Charleston, SC August 25

16. Instructions to Suppliers
The need to transition to IATF has been affirmed by Gary West, General Motors Executive Director of Supplier Quality and Development
The letter was communicated to all GM Tier 1 Suppliers on November of 2016

17. Customer Specific Requirements
GM released the new CSR for IATF (80% reduction in content)
ISO/TS CSR has also been updated
Each CSR contain requirements unique to the two standards
Both documents will be maintained in sync during the transition period
Both are available on IATF web site and on GM Supply Power

18. Changes to GM-CSR for IATF 16949
Customer satisfaction – Supplemental.
BIQS Certification
Organizations shall achieve and maintain BIQS or QSB certification. The organization whose BIQS or QSB certification is revoked shall notify its Certification Body within 5 business days after revocation.
Lack of the organization having a BIQS or QSB certification shall result in a major finding by the organization’s Certification Body.
CSII (Controlled Shipping Level 2)
The organization shall notify its Certification Body within 5 business days after being placed in Controlled Shipping – Level 2 (CS II) Status.
NOTE: The GM special status conditions of CS II (Controlled Shipping – Level 2) is a performance indicators of an organization’s product realization problems. Such status should have resolution, or credible resolution and corrective plans in place, which are confirmed by the customer.

19. SUPPLIER CERTIFICATION MANAGEMENT SYSTEM (SCMS)
NEED SLIDE(S)
– ABCD Supplier

20. New GM Sourcing Tool (replacing the old GM Bid-List)

21. Key Points about Customer-specific Requirements (CSRs)
May exist at any level in Automotive supply chain, (OEM, Tier 1, etc.)
Identify CSRs for all your Automotive customers
Determine applicability of CSRs and align with your QMS processes
Include CSRs in Scope of our QMS
Internal auditing of CSRs
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

22. SCAC/AIAG Supply Chain & Quality Conference August 25, 2017
IATF Transition Audit Update including Transition Audit Nonconformities
Cherie Reiche
IAOB Program Manager
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

23. SCAC / AIAG IATF 16949:2016 Transition Audit Update
August 25, 2017
Cherie Reiche, IAOB

24. Current Certificate Distribution (both standards)
Distribution of the 68,654 certified sites as of 31st July 2017
(only countries with more than 500 certified sites listed)

25. IATF 16949 - Progress As of 31st July 2017:
1,939 completed audits to IATF 16949
As of 31st July, total NCs issued = 2,320

26. IATF 16949 - Progress Top 8 non-conformity areas in order of frequency
8.5.1 (ISO) Control of production and service provision
Total productive maintenance
Control plan
Standardized work – operator instructions and visual standards
Special characteristics
Contingency plans
Measurement systems analysis
Manufacturing process design output

27. 8.5.1 Control of Production & Serv…
ISO 9001:2015 requirement
Production and service provision implemented under controlled conditions
Includes documented information for:
characteristics of the products produced, services provided, activities performed;
results to be achieved;
availability and use of suitable monitoring and measuring resources;

28. 8.5.1 Control of Production & Serv…
monitoring and measurement activities at appropriate stages (verify criteria for control of processes or outputs, and acceptance criteria for products and services)
use of suitable infrastructure and environment for the operation of processes;
appointment of competent persons, including any required qualification;

29. 8.5.1 Control of Production & Serv…
Validation of the ability to achieve planned results of the processes for production and service provision
Implementation of actions to prevent human error
Implementation of release, delivery and post-delivery activities
Also see IATF Standardized Work and Verification of Job Set-ups

30. 8.5.1.5 TPM Total productive maintenance
System for maintaining and improving the integrity of production and quality systems through machines, equipment, processes, and employees that adds value to the manufacturing process.
TPM should be fully integrated within the manufacturing processes and any necessary support processes.
Also see Management of production tooling …

31. 8.5.1.1 Control Plan Strengthened control plan requirements
Brought IATF OEM customer-specific requirements into the IATF standard
Elevated NOTE regarding customer approval to a requirement
Strengthened control plan review and updated criteria and linked to the PFMEA updates.
Control plans are needed for the relevant manufacturing site and all product supplied, and not just for the final product or final assembly line

32. Control Plan
Family control plans are acceptable for bulk material and similar parts using a common manufacturing process
Care should be given to identify the degree of difference that is acceptable to apply common control

33. 8.5.1.2 Standardized Work … Operator instructions and visual standards
Communicated / understood by the employees who perform the work (legible, in the language understood by personnel, accessible at the designated work areas)

34. 8.3.3.3 Special characteristics …
Established using multidisciplinary approach to identify special characteristics
Risk analysis performed
Documentation of all special characteristics: drawings, control plans, standard work / operator instructions (identify with specific markings)
Control and monitoring strategies
Customer-specified approvals, as required
Use of symbol conversion table, submitted to customer as required

35. Contingency Plans
Prepare contingency plans along with a notification process to the customer or other interested parties.
Organizations would first take a systematic approach to identifying and evaluating risk for all manufacturing processes, giving particular attention to external risk.

36. Contingency Plans
Contingency plans would be developed for any of the outlined disruption conditions -- interruption of externally provided products, processes, and services, recurring natural disasters, fire, or infrastructure-related disruptions.
Customer notification is a mandatory step in any contingency plan, unless there is no risk to deliver nonconforming product or affect on-time delivery.

37. MSA
Conducted to analyse variation in results of each type of inspection, measurement, and test equipment system (per control plan)
Analytical methods and acceptance criteria; alternative methods may be approved by customer (records of customer acceptance retained along with results of alternative MSA)
MSA study prioritization should focus on critical or special product / process characteristics.
Also see Section

38. Mfg Proc. Design Output
Shall be verifiable against mfg process design inputs
This includes specs/drawings; special characteristics for product/mfg process; id of input variables; tooling and equipment for production and control, including capability studies of equipment and processes; mfg process flowcharts/layouts; capacity analysis;

39. Mfg Proc. Design Output
mfg process FMEA; maintenance plans/instructions; control plan; std wk/wk instructions; acceptance criteria approval; quality/reliability data; results of error proofing; rapid detection and correction of nonconformities

40. IATF 16949 - Progress Top 8 non-conformity areas in order of frequency
8.5.1 (ISO) Control of production and service provision
Total productive maintenance
Control plan
Standardized work – operator instructions and visual standards
Special characteristics
Contingency plans
Measurement systems analysis
Manufacturing process design output

41. Common questions …
Must we use both ISO 9001:2015 and IATF 16949:2016 when conducting audits?
ANSWER: Yes, as it states in the IATF Foreword – Automotive QMS Standard, IATF is not a stand-alone standard, it must be used in conjunction with ISO 9001:2015

42. Common questions …
Will the IATF be granting waivers for those organizations who cannot meet the Transition Plan timing?
ANSWER: No, from 1st October 2017 onward, all audits are required to be conducted to IATF 16949
There are no plans to approve/grant waivers
ISO/TS certificates are not valid past their expiry or 14th September 2018, whichever occurs first.

43. Common questions …
What about competency for internal auditors and second-party auditors? Do they have to all take an IATF-sanctioned lead auditor training course?
ANSWER: No. Organizations are responsible for ensuring key personnel, including their auditors, are properly trained and competent. The IATF supports the use of IATF-recognized training providers; however, the IATF does NOT mandate the use of a lead auditor training course for all auditors in the organization.
Organizations are still allowed to have key personnel trained and certified as lead auditors, and then using those key personnel to T3 (train-the-trainer) to disseminate the information throughout the organization.

44. Common questions …
What is the goal of ? Do all organizations supplying automotive product have to be IATF certified?
ANSWER: As stated in , the ultimate objective is to have IATF certification; however, the IATF recognizes that for various reasons, that is not feasible for all organizations.
At a minimum, the expectation is for organizations to be certified to ISO 9001:2015, unless otherwise authorized by the organization’s customer(s)
This cadence is applicable to the entire automotive supply base

45. 8.4.2.3 Supplier Quality Management System Development
IATF rd party certification
Supplier’s QMS
IATF nd party conformity
ISO 9001 registration + customer-defined QMS
ISO rd party registration
ISO nd party conformity
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

46. Common questions …
Do all of my support locations need to be audited to IATF before the mfg locations can transition to IATF 16949?
ANSWER: No. Please see the IATF Transition Strategy document. The Transition Strategy supplements Rules 5th Edition (and any SIs or FAQs related to Rules):

47. SCAC/AIAG Supply Chain & Quality Conference August 25, 2017
Your Questions
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017

48. Standards and Rules available at: www.aiag.org
Next steps …
You need to have these critical documents:
ISO 9001:2015
IATF 16949:2016
Rules 5th edition
Transition Strategy
Applicable Customer-Specific Requirements – confirm with your customer
Standards and Rules available at:

49. IATF 16949 Power Breakfast Stakeholder Feedback
Thursday, August 31, :30-11AM
Center for Manufacturing Innovation, Greenville, SC
SCAC/AIAG Supply Chain & Quality Conference August 25, 2017