Slide 4 v6

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ISO/TS16949 Supplement Training

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Slide 4 v6

  1. 1. Post-Audit Activities “The Job’s not done until the paperwork is done”… 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 1
  2. 2. Day 4 – Post-Audit Activities 1. Review of previous day 2. Recording the audit Did I Pass? 3. Grading NCR’s 4. Closing Meeting 5. Corrective Action & follow-up 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 2
  3. 3. REVIEW OF DAY-THREE: 10 minutes review It is important that we begin each day with a review of the previous day’s activities. Each day lays the foundation for the upcoming subject topics. 1. Review Homework 2. What are the areas that were unclear? 3. Identify topic areas that you want reviewed from yesterday’s activities. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 3
  4. 4. Stage Four: Report The Audit • Recording the Audit • Grading NCR’s • Closing Meeting 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 4
  5. 5. RECORDING THE AUDIT 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 5
  6. 6. Positive Reporting • Say what was done • Say what was seen • Say what was good: • use of well designed methods • well run production team • advanced manufacturing techniques • ownership of quality 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 6
  7. 7. Report ‘Who, What and Where’ • Report reference • Auditee/location/dates • Purpose/scope • Reference documents • Audit team 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 7
  8. 8. Key Items • Non-conformities • Summary statement/Recommendations • Signature of Audit Team Leader • Signature of the Auditee • Further action required 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 8
  9. 9. Other important details • Distribution list • Attendees at opening and closing meetings • Auditee representatives • Audit program 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 9
  10. 10. Audit Report • Communication tool – It stays with the Auditee long after the audit team have gone home – Should be legible – Contain information appropriate to the audit (Relevant to the activity) 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 10
  11. 11. Audit Records – Audit Plan – Audit Schedule – Audit Report – Correct Action Program – Non-Conformance Analysis – Auditor Notes 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 11
  12. 12. END 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 12
  13. 13. Team Exercise: D4-E01: Recording Non-conformities 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 13
  14. 14. GRADING NCR’s 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 14
  15. 15. Non-conformity: A Definition “The non-fulfillment of a requirement” (ISO 9000 : 2000 – 3.6.2) 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 15
  16. 16. Non-conformity: Other Terms • Non-conformance • Deficiency • Discrepancy • Finding • Non-Conformity • Corrective Action Request (CAR) • Deviation 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 16
  17. 17. Categories of Nonconformities MAJOR nonconformity:  The absence of a required procedure or total breakdown of a procedure or process.  Significant failure to conform with requirement  Breakdown of a key aspect of the quality management system  A number of minor nonconformities listed against the same requirement 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 17
  18. 18. Categories of Non-conformities • MINOR non-conformity:  A single observed lapse in a procedure  isolated non-fulfillment of specified requirement  negligible effect on quality 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 18
  19. 19. Observations In some circumstances it may add value to also include ‘Observations’ which: “relate to existing conditions and which, in an assessor’s judgement, warrant clarification or investigation so as to improve the overall status and effectiveness of the quality system” 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 19
  20. 20. Reasons for Nonconformities • Process not in conformance with quality manual • Written procedures not implemented in the process • Process is ineffective 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 20
  21. 21. Always Remember Auditing is looking for conformance BUT…… you should not shy away if there is something to find! 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 21
  22. 22. Non-conformity Statements • The facts: • where • what • why - nature of the non-conformity • ISO 9001 clause • Documented Quality Management System reference 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 22
  23. 23. Recording Non-conformities • The findings: • the facts • acknowledged by auditee • at the time they are found • Non-conformity statements must be: • accurate • complete • helpful • brief 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 23
  24. 24. Handling Possible MAJOR Non- conformities• Major non-conformities - always: – inform the Lead Auditor at the earliest opportunity – do not alarm the auditee or interviewee – follow the certification body’s procedures Remember: a MAJOR is defined as the absence of or breakdown of a required Quality Management System Element 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 24
  25. 25. Example Non-conformity Form ROBERE QUALITY AUDIT NONCONFORMITY REPORT Company under Audit: XYZ plc Nonconformity Number ................... Area under review: ISO 9001 Clause Number ............... .............................................................................. Category MAJOR* MINOR* * delete one Nonconformity Auditor 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 25
  26. 26. Summary • The Audit Report is the formal record of the audit and: • contains all information about the audit • will be read by people not involved in the audit • Non-conformity statements must: • cover the facts, clearly and specifically • be acknowledged by auditee at the time they are found and be: » accurate » complete » helpful » brief 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 26
  27. 27. END 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 27
  28. 28. Team Exercise D4-E02: Grading NCR’s 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 28
  29. 29. CLOSING MEETING 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 29
  30. 30. Pre-Closing Meeting • Review findings • Agree non-conformities • Write non-conformity statements • Write summary statement • Prepare agenda • Team form an agreement on assessment outcome©Robere & Associates (Thailand) 2000 9K2K-LAD-E-IG-D4 Ver 6 30
  31. 31. Closing Meeting : Agenda • Thank you • Purpose • Confirmation of scope • Sample • Findings • Summary • Follow-up activity • Clarify • Report availability • Go 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 31
  32. 32. Closing Meeting Conduct • Lead Auditors meeting • Keep to the agenda • Keep it short • Keep a record (attendees) • End on a positive note 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 32
  33. 33. Summary Statement– Version 1 This Company has a Quality Management System which is well documented and generally in conformance with the requirements of ISO 9001:2000. However,the systems and procedures have not been fully implemented in the contract, project management and product shipment areas. The audit found 33 non-conformities and particular concern is felt for: • Lack of application of the system for review of the quality requirements of contracts. • Evidence of a lack of disciplined control toward customer complaints and related follow-up actions. • Lack of quality awareness on the part of project and senior management personnel. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 33
  34. 34. Summary Statement– Version 1 • No significant problems were found in the activities of either the Design or pre-sales teams. • There is a need for more frequent review of the Quality Manual and project management procedures. • It will therefore be necessary for the company to undertake corrective action on the deficiencies raised and for a further audit to be carried out to verify that it has been taken before the company can be awarded a certificate. Corrective action should be effected within three months from today. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 34
  35. 35. Summary Statement– Version 2 There are important omissions in the Quality Management System operated by the company, although what exists is mostly in line with the requirements of ISO 9001:2000. It has also been found that the systems and procedures, which do exist, have not been universally implemented, particularly related To the review of contracts, project planning and customer-relations areas. The audit found 33 deficiencies of which 4 were considered to be major. Particular concern is felt for: • Lack of a system for reviewing the requirements of contracts. •The absence of planning and progress control on work not directly related to customer contracts. •The effect that the current lack of control of customer complaints and follow-up actions may cause. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 35
  36. 36. Summary Statement– Version 2 No significant problems were found in the activities of either the Design or Pre-sales teams. There is a need for more frequent review of the Quality Manual and software development procedures. The most important conclusion is that there is a need for more senior management involvement in and support for implementation of the documented system. Until this is established and the declared Quality System is applied consistently and effectively throughout the company, it will not be possible to grant certification. It is recommended that the company takes appropriate corrective action and re-applies for assessment when all of the above concerns and deficiencies have been addressed. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 36
  37. 37. Summary • Be prepared before meeting • Ensure there are NO surprises for the auditee • Stick to the prepared agenda • Don’t be drawn into discussion • Ensure the auditee is clear as to the next step 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 37
  38. 38. END 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 38
  39. 39. Team Exercise: D4-E03: Role-Play: Closing Meeting 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 39
  40. 40. Stage Five: CORRECTIVE ACTIONS & FOLLOW UP 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 40
  41. 41. Corrective Actions Process Stage 1 Initiation of Non-conformity Auditor Stage 2 Provide Programme of CA Auditee Stage 3 Submit CA Programme to Auditor Auditee Stage 4 Analysis of CA Programme Auditor Stage 5 Monitoring,Reviewing,Auditing Auditee Stage 6 Verify and closing Auditor ACCEPT 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 41
  42. 42. Stage 1–Initiation of Non-conformity • The Auditor raises the problem: • the facts • the non-conformity • the department responsible 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 42
  43. 43. Stage 2–Provide Program of Corrective Action • The Auditee Response – Root cause analysis – Corrective action – Preventive action – Approval – The organizations Quality Assurance function provides advice to the responsible manager 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 43
  44. 44. Stage 3 – Submit Corrective Action Program to Auditor • The auditee responds: – with proposed corrective action – and identifies root cause of non- conformity – and initiates action to prevent recurrence – with target date for completion 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 44
  45. 45. Stage 4 – Analysis of Corrective Action Program • The auditor responds: – analysis of the Corrective Action Program against the original NC Statement 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 45
  46. 46. Stage 5 - Monitoring, Reviewing, Auditing • The auditee responds: – Procedures required – Use of status log – Corrective action review meetings – The auditee notifies the auditor when the actions are complete 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 46
  47. 47. Stage 6 - Verify and Closing • The auditor responds: – Verify the implementation of some actions prior to the report close – If Corrective Action is satisfactory, close out the report 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 47
  48. 48. Example: Corrective Action Status Log CAR Date Subject Initiator CAR Response Approval of Verified Closed Nos. Issued of Report Sent To Due Date Response by (Name) (Date) (Name & Date) 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 48
  49. 49. Example Corrective Action Form Auditee Representative Auditor Date: Report Nos. Standard ref.: Doc. Ref. Details of Non-conformance Non conformance Accepted By Immediate Action Preventive Action Corrective Action Verified by Name Date 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 49
  50. 50. Additional Key Point The Auditee role: – Look across the organization to identify the other possible area where the same problem may occur but was not necessarily identified during the audit. – May provide opportunity to prevent problems before they arise. – Using a structured problem solving technique to correct the problem. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 50
  51. 51. Summary: Auditor Role • Communicating/explaining the audit report to the auditee • Eliciting a response from the auditee as to corrective action • Evaluating the auditees response • Agreeing the corrective action proposed • Verifying that corrective action has been taken • Closing out the follow-up 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 51
  52. 52. Summary: Auditee Role • Examines the evidence • Identifies immediate action needs and act • Check corrective action effectiveness • Establish root cause • Identify action to prevent recurrence • Implement action to prevent recurrence 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 52
  53. 53. END 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 53
  54. 54. Team Exercise:D4-E04: Corrective Action 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 54
  55. 55. Day-Four Summary: We reviewed yesterdays activities We discussed how to record the results of the audit by using an exercise based on previous evaluations We continued with our discussion about the audit and about the follow-up activities that we are to perform. We discussed how to grade NCR: Major and Minor We discussed how to report the non-conformances to that our auditee can understand what type of corrective action needs to be taken. We discussed the format and agenda of the closing meeting. We reviewed examples of summary statements that would give us an idea of how to structure our report. We discussed Corrective Actions and what we should expect from our auditee if corrective action was necessary. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 55
  56. 56. End of Day Four Only one-day left.. 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 56
  57. 57. END Team Homework 9K2K-LAD-E-IG-D4 Ver 6©Robere & Associates (Thailand) 2000 57

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