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Audit findings

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Kodirl, May 29, 2020.

  1. Kodirl

    Kodirl Member

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    Hey everyone,

    What are people doing when there are observations/recommendations for improvement identified as part of audit findings?

    Do you record observations/recommendations for improvement on a spreadsheet and assign the relevant departmental personnel to action and close out the findings by a particular date.

    James
     
    Kodirl, May 29, 2020
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  2. tony s

    tony s Well-Known Member

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    When I have recommendations, I usually include them in my audit report. It's up to the auditee if they will adopt/address them or not. Recommendations are not binding according to section 6.4.10 of ISO 19011:2018.
     
    tony s, May 29, 2020
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  3. Kodirl

    Kodirl Member

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    Thanks Tony.

    If you were asked the question "Provide the list of audit findings that are tracked for closure" how would you respond?

    Would you provide audit report with its findings?
     
    Kodirl, May 29, 2020
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Firstly, I avoid them, as an internal auditor. The origins started in external audits, as a way of helping audit clients feel they were getting "value for money' and if it was a supplier, they would take note in the hope of winning business. There's little good reason for them internally.

    "Audit findings" are anything observed by an auditor, of any nature. What should be considered is when non-conformity with the QMS is either a) ineffective in achieving results or b) more effective in achieving results than the defined process/requirement.

    Depends whose asking. Those things might be highly sensitive. If it's a customer, I'd deflect them unless there's an NDA in place and even then, I'd need to know what they want them for. If you are certified by a UKAS CB, or similar, there should be zero need to know, frankly.
     
    Andy Nichols, May 29, 2020
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  5. yodon

    yodon Well-Known Member

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    As a receiver of recommendations, OFIs, concerns, etc. (as well as findings) from audits, I review them with the management team and we determine if there are any actions warranted. It never hurts to look at things with a fresh perspective.

    Only the ISO auditors have the right to review internal audit findings. FDA, customers, etc. should not be given access to that information.
     
    yodon, May 29, 2020
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  6. tony s

    tony s Well-Known Member

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    Based on ISO 19011's definition of an "audit finding" which is "results of the evaluation of the collected audit evidence against audit criteria" with a note "Audit findings indicate conformity or nonconformity", consequently, I would focus tracking of closure on nonconformities.
     
    tony s, May 30, 2020
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  7. Qualmx

    Qualmx Well-Known Member

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    What I have implemented is the next:

    I do monthly audits (5 processes each month)
    and opportunities of improvements, when detected
    are included in the audit report.
    Is known that for OFI, Actions are not required, but....

    Is common that even if any OFI it may have benefits to the process,
    the auditee doesn´t do anything.

    Quarterly the QMS responsible gathers the audit reports, organizes
    a meeting, invites the auditees and discuss about the OFI´s
    and if qms coordinator/auditees agree, implement the necessary OFI´s.

    My two cents
     
    Qualmx, Jun 1, 2020
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can I ask why?
     
    Andy Nichols, Jun 1, 2020
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  9. Qualmx

    Qualmx Well-Known Member

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    Because I have 18 processes, some of them are audited internally up to 3 times a year, and some suddenly audits
    in specific problems, additionally surveillance and customers audits.
     
    Qualmx, Jun 1, 2020
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Ok, but why? Having 18 processes doesn't dictate why they need to be audited monthly. Why audit 3 times a year? What's a "sudden" audit? WHat's an "additional surveillance" audit? Do you mean the CB surveillance?
     
    Andy Nichols, Jun 2, 2020
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  11. Qualmx

    Qualmx Well-Known Member

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    I have scheduled the audits throughout the year for all the processes.
    Suddenly means, e.g. if
    a problem is detected in the warehouse Inventory, immediately an audit is performed.
    Yes is a CB audit.
     
    Qualmx, Jun 2, 2020
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I still am not understanding "why", when you say you schedule them throughout the year. Also, when you say a "problem is detected in the warehouse inventory", why would that begin an audit? What would be a "problem?" What's the purpose for the audit? I am really trying to understand why audits are done this way. Not implying it's good/bad, just trying to have a clear picture.
     
    Andy Nichols, Jun 2, 2020
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    We can start a new thread, since this is NOT what the OP is in regard to.
     
    Andy Nichols, Jun 2, 2020
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  14. Qualmx

    Qualmx Well-Known Member

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    I do have A yearly scheduled audits, for that I have a spreadsheet and is the planning of the audits to processes.
    Problems, well, suppose you have had several minor problems in a process, not filled out some formats, it was detected a material list not updated, so, there is a suspicious that this process is not running well, ok, at this time is decided to perform a sudden audit in this process, and not wait til the scheduled audit (2 months ahead).
    The audit , I think is a good tool to revise it's performance.
     
    Qualmx, Jun 5, 2020
    #14