DO IT RIGHT THE FIRST TIME

1. Cindy Soltis-Stroud Cindy.Soltis@cogentgps.com 210 380 1587 CEO, Cogent Global Performance Solutions, Inc. DO IT RIGHT THE FIRST TIME

2. Goal for Corrective Action IATF Rules 5th Edition (Automotive) Improve responses to your CB Certification Body Responsibility All reference to sections & pages are from Rules 5th Edition 1 November 2016

3. Corrective Action ResponseResponding to your Certification Body AuditorExpertise is in AutomotiveWho is Automotive

4. Response Timing Days = Calendar Days (5.11.1, pg 34) Timing Start = Closing Meeting (5.11.1, pg 34) NC= Major Non-Conformance nc= Minor Non-Conformance

5. Who Is Responsible? The client and the CB are both responsible Client “you” CB “Certification Body”

6. Client: Major Non-Conformance • 20 Days maximum (5.11.1, pg 34) Evidence of: • Implemented Correction • Root Cause including methodology used, analysis & results

7. Client: Major Non-Conformance • 60 Days maximum (5.11.1 pg 34) Evidence of: • Implemented systemic corrective actions to eliminate each non-conformity • Consideration of impact to other similar processes / products

8. Client: Major Non-Conformance • 60 Days maximum (5.11.1, pg 34) Evidence of: • Verification of effectiveness of implemented corrective actions

9. Client: Minor Non-Conformance • 60 Days (maximum) • Implemented Correction • Root Cause (methodology&results) • Systemic Corrective Actions • Impact to other processes / product • Verification of effectiveness

10. Client: Verification of Effectiveness • 60 Days (maximum) • Verification of effectiveness must be included! Besides root cause concerns, this is the biggest miss by clients.

11. Correction: 5.11.1, pg. 34 • Major NC: Initial response due in 20 days maximum • Completed response in 60 days maximum • Definition of Major • pg. 56 Ts & Ds (Terms and Definitions)

12. Correction • Minor NC: Due in 60 days maximum • Definition of Minor NC • pg. 56 Ts & Ds (Terms and Definitions)

13. Correction IS “Action to eliminate a detected nonconformity” Rules 5th Edition 10.0 Terms And Definitions pg 55

14. Correction Is Not • Left Blank • Not Applicable • What failed • An explanation of why it is not an NC No correction = rejection of the response

15. Correction Example: Good NC: Calibration records show micrometer XYZ out of calibration upon receipt with no evidence of actions taken. Correction: Micrometer XYZ investigation information provided, actions taken with results provided.

16. Correction Example: Bad NC: Calibration records show micrometer XYZ out of calibration upon receipt with no evidence of actions taken. Correction: Micrometer taken out of service

17. Root Cause Methodology Used • Ishikawa “fish bone” • 5 Why • IS / IS Not • Brainstorming • Etc..

18. Root Cause Is • Failure of the system • Machine • Method • Materials • Human factors • Management Commitment

19. Root Cause Is Not • Training • Operator Error • Lack of knowledge of the IATF requirements • Repeating the problem statement • Failure to change a procedure • Failure to write a procedure

20. Root Cause • Root cause not addressing system failure =

21. Corrective Action Is Action against the system Action against the process Consideration of other products Consideration of other processes

22. Corrective Action Is Not • Correction • Writing a procedure or work instruction • Training people • Training class on IATF

23. Verification of Effectiveness • Audit • Spot Check • Sampling • Trends

24. Verification of Effectiveness Is Providing to the auditor: Audit results Sampling with quantity, results Trending data with results Spot checks with results

25. Verification of Effectiveness Is Not • Procedure implemented • Corrective action implemented • Training completed

26. Actual Evidence: Good

27. Actual Example: Bad

28. Appeal Process • Per Rules 5th Edition section 2.9 pg 16 • The certification body shall have a process for addressing appeals from the client.

29. Best Practice Response Method Consistent Organized Easy Repeatable Sustainable

30. Audit non-conformance • Add non-conformance statement here.

31. Containment Actions • List Containment Actions here • Remember containment is correction and short term. Correction corrects the immediate concern identified in the audit evidence.

32. Containment Action Evidence • Put pictures of containment actions here. • Use as many slides as required.

33. Containment action evidence of effectiveness • Evidence can be a statement of what was reviewed and the results identified. • If required, state additional actions taken if actions were not effective.

34. Impact • List other products and or processes impacted or potentially impacted by this concern. • If no potential impact state “none” justify your analysis.

35. Root Cause • Add Root cause here. Include 5y statements or pictures of: • Brainstorming session • Fish bone • Etc…

36. Root Cause Evidence • Attach pictures/forms/records of the root cause analysis activities.

37. Systemic Corrective Action • List system corrective actions here

38. Corrective Action Evidence • Attach evidence of implementation of corrective actions. • Use as many slides as necessary

39. Effectiveness of Actions Taken • Identify the method used for verifying the effectiveness. • If actions are necessary to take beyond the 90 days.. How you will verify effectiveness

40. Evidence of Corrective Action Effectiveness • Statement of what was reviewed • Statement of results of the review • Who performed the review • Date of the review • Pictures or attachments of the evidence of what was reviewed if applicable.