1. DO IT RIGHT THE FIRST TIME
Cindy Soltis-Stroud
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 Response Responding to your Certification Body Auditor Expertise is in Automotive Who 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 ( 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. Major NC: Initial response due in 20 days maximum
Correction: , 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. Minor NC: Due in 60 days maximum
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. 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. If no potential impact state “none” justify your analysis.
List other products and or processes impacted or potentially impacted by this concern.
If no potential impact state “none” justify your analysis.

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

36. Attach pictures/forms/records of the root cause analysis activities.
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.