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Delayed corrective action - what to do

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Devesh#89, Jan 7, 2025.

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  1. Bev D

    Bev D Moderator Staff Member

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    IF - and that’s a BIG IF - this is an internal audit AND the archival data storage and retrieval are deemed essential by your organization then the ‘finding’ or Problem statement is wholly inadequate. Teh word “inappropriate” is vague and not actionable at all. What exactly is ‘defect’ of the filing structure? What exactly is ‘wrong’ with it? NC or ‘finding’ statements must be specific as to what is actually wrong…it has to be more than “I don’t like it”….

    *This is NOT a requirement of any standard - as Andy has said.
     
    Bev D, Mar 10, 2025
    #21
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  2. Devesh#89

    Devesh#89 Member

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    Thanks both of you for providing your extensive expertise but i think this is not what I am pushing you for, I am not an expert in ISO 9001 and still i am learning from peoples like you and as i mentioned, i need resources to learn more about these clauses and their appropriate application against non conformities.
     
    Devesh#89, Mar 11, 2025
    #22
  3. Devesh#89

    Devesh#89 Member

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    Hi Bev, Thanks for the reply but what if an internal auditor marked this as a minor non-conformity with one of the ISO clauses that i mentioned above. to your question, yes the filing structure was not as per written procedures.
     
    Devesh#89, Mar 11, 2025
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  4. MonsterEnergy22

    MonsterEnergy22 Active Member

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    First of all, consider obtaining a copy of "ISO 19011:2018 - Guidelines for auditing Management Systems". This gives some clarity regarding the grading system auditors use. This can be quantitative or qualitative (in your case, minor (Qualitative)).

    The fact that the auditor has identified a single instance of a process not being followed would most likely warrant a minor non conformity. It just sounds like the auditor has identified a deviation from the requirements of your orgs documented information procedure?

    The auditor SHOULD discuss these findings with the relevant stakeholders in a closing meeting of sorts - The auditee decides on the best course of action to take dependent on the context of the finding; A Correction or Corrective action. (Unless your internal procedures mandate corrective action in the case of every NCR finding)

    Just fix it & move on.
     
    Last edited: Mar 11, 2025
    MonsterEnergy22, Mar 11, 2025
    #24
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Then, based on this reported statement, the internal auditor isn't competent to be auditing! It's just as simple as that Devesh! As for grading a single instance as "minor" that's ridiculous.

    Internal auditors need to be able to demonstrate characteristics defined in ISO 19011. What was reported, using the words you posted is simply an opinion. "Adequate" is an opinion. How would you feel if someone said "Devesh, your ability to understand ISO 9001 is inadequate". What would you fix? What are you being measured against? It's simply not objective.

    If you want good resources to learn ISO 9001 etc, then I suggest there are many adequate books, including my own, which are available to read.
     
    Andy Nichols, Mar 11, 2025
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  6. tony s

    tony s Well-Known Member

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    Ask the internal auditor: "Where is the SHALL?"

    No requirement, no nonconformity.

    Nonconformity is defined as "non-fulfilment of a requirement". Where is the specific requirement in 7.5.2c or 7.5.3.2b that was violated by inappropriate folder structure for archival data? Auditors are not allowed to create their own requirements out of the standard's requirements.

    If Devesh#89 accepts the audit finding of the internal auditor, they deserve each other.
     
    tony s, Mar 12, 2025
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  7. Bev D

    Bev D Moderator Staff Member

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    . So it is a non-conformance to an internal requirement. What we have said is that the use of the word inadequate is inadequate…it is far too vague and ineffective in conveying the non-conformance. The auditor must state the exact noon-conformance: example: “Manufacturing document 123 was filed in the Equipment Maintenance folder not in the Manufacturing documents folder as required by procedure 987.”.

    However, if the auditor cited an ISO requirement then they are WRONG as there is NO such requirement; it is only your internal requirement…

    If you are truly looking to learn here you need to listen (read) and take the time to understand what we are saying.
     
    Bev D, Mar 12, 2025
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In addition to Bev's comments ^^^ I'd offer that you don't (effectively) learn about a subject like ISO 9001 from understanding audit findings! This approach makes an assumption - always a dangerous thing - that the auditor is correct. Time and again, we find that just like others, they are human and make errors, based on many influences.
     
    Andy Nichols, Mar 12, 2025
    #28
  9. Devesh#89

    Devesh#89 Member

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    Hi andy, Great to hear from you can i know the name of books to understand it better
     
    Devesh#89, Mar 13, 2025
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Andy Nichols, Mar 13, 2025
    #30
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