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What outcomes are expected from the consideration?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Leonid, Jan 13, 2020.

  1. Leonid

    Leonid Well-Known Member

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    According to 9.2.2 b) an audit programme(s) shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits. What outcomes are expected from this consideration? Aligning the audit frequency with the above issues? Assigning particular auditors to particular processes?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That will depend on the purpose of the audit, won't it? And audit programme is defined as one or more audits. Outcomes are based on the objective(s) of internal audit(s). Is your question another way of asking "what are the objectives of internal audits"?
     
  3. Leonid

    Leonid Well-Known Member

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    Objectives of the IA are stated in 9.2.1.

    Let's consider CB auditor conducts the surveillance audit and sees that significant changes occurred in the production process and that almost all NC from the last IA are issued for this process. Nonetheless, no evidence of consideration of these issues are made available to the auditor and the audit programme for the current year did not change. What outcomes from the consideration would you expect to see as the CB auditor?
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Is this a hypothetical situation? If so, what is the hypothesis?
     
  5. tony s

    tony s Well-Known Member

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    What changes on the audit programme do you expect to convince that "considerations" were made?
     
  6. Leonid

    Leonid Well-Known Member

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    ISO 9001:2000/2008 included a similar requirement in 8.2.2. The situation I named hypothetical occurred in my practice. Also this has been an exercise of the LA training course. I used to issue a non-conformity report if no proof was provided that the audit programme takes into consideration the importance of the processes, affecting changes in the organization, results of the previous audit. I would accept such outcome as a review of the of audit frequency/duration, audit scope, sampling, audit team, reporting - all aimed to help increase the QMS effectiveness.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sounds like you have the answer to your own question. Are you unsure that you have the correct answer and seek validation?
     
  8. tony s

    tony s Well-Known Member

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    Any specific proof you need to see?
     
  9. Leonid

    Leonid Well-Known Member

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    Here and there changes in the audit programme.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Changes, per se, don't equate to the considerations defined in the standard for audit program planning. As Tony asked, what evidence should an auditor consider? To be frank, simply making changes to a calendar - which of course, isn't actually required - doesn't satisfy the requirement for an effective audit program which supports and effective quality management system.
     
  11. Leonid

    Leonid Well-Known Member

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    I already listed possible outcomes from considerations: changed audit frequency, duration, scope, sampling, team, reporting.
     
  12. Leonid

    Leonid Well-Known Member

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    Changes to audit frequency, duration, scope, sampling, team, reporting.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You answered your own question. What are you seeking from us?
     
  14. tony s

    tony s Well-Known Member

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    From the scenario you have provided, I was expecting specific changes you would like to see as proof of consideration. Should the organization increase the frequency or time allotment to processes that incur a lot of NCs from the previous audit cycle? Or decrease the frequency/time so they can have more time in addressing the previous negative findings? What should be the acceptable evidences of consideration? Do changing the frequency, duration, scope, sampling, team and reporting already acceptable? What if they considered the importance, changes and results but decided to maintain the frequency, duration, scope, etc. to compare the current audit cycle performance with the previous cycle?
     
  15. Leonid

    Leonid Well-Known Member

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    They considered every issue but decided to maintain the programme unchanged. Formally no nonconformity. I would be interested in being informed about their approach to consideration.
     
  16. Leonid

    Leonid Well-Known Member

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    Someone proposes a thread and takes, together with others, active participation in addressing the issue. I think this is a normal practice of any Forum to consider a matter by comparing and eventually aligning points of views.
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What's the issue to discuss? Are you seeking validation that your ideas are the most appropriate? I don't see a direct question to provide discussion points...
     
  18. tony s

    tony s Well-Known Member

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    If no changes to the audit program, frequency, etc., what specific evidence of consideration would you expect from an organization?
     
  19. Leonid

    Leonid Well-Known Member

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    Audit results indicated worsening the effectiveness of processes. Root causes were considered and a combined corrective action plan was approved. The organization was about to plan additional audits with the purpose to assess the effectiveness of the plan. However, top management decided to charge process managers to report about the issue in quarterly management reports.
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Audits are not for this reason. Process measurement and monitoring does. Audits validate that compliance with the process was as planned and the results can be "trusted" to be because the planned process was followed. Audits check to see if the QMS processes were being utilized. When auditors take a role in determining the effectiveness of a process, it's opinion and objectivity is lost. Audit is for confirmation - or not - that results were as planned.
     
    Last edited: Jan 24, 2020

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