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What criteria to follow to write down this NC?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, May 31, 2019.

  1. Qualmx

    Qualmx Well-Known Member

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    Hello everyone

    Please help to clarify what is the best method to write down a NC into a process.

    I´ll explain, When auditing the Purchasing process, and asked the auditee to show the identified
    process where he is considered, the result, it was not possible to access the document, because a network failure caused because server was down caused by an electric shutdown.
    From Here, I have several clauses on Where I can support the NC.

    4.4.1
    The organization shall determine the processes needed for the quality management system and their
    application throughout the organization, and shall:

    Control of documents
    7.5.3.1 a) it is available and suitable for use, where and when it is needed;

    Network for computers and electric issue
    7.1.3
    a) buildings and associated utilities;
    b) equipment, including hardware and software;
    d) information and communication technology.

    In your opinion, which clause or clauses should I mention as a source of the NC?


    Thanks
     
  2. tony s

    tony s Well-Known Member

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    In writing an NC, you have to establish first a requirement/criteria. You don't need to quote all the ISO 9001 clauses that you deem relevant to the evidence you have observed. You can also raise the issue against an internal or external requirement without the need to quote a clause of ISO 9001. From your explanation, it seems that you're just seeing symptoms and you will need to dig deeper to determine whether there is a nonconformity behind the symptoms.
     
  3. Qualmx

    Qualmx Well-Known Member

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    Thanks Tony s
    Without going deeper, it may be simple in my opinion ,not mentioning possible causes, Id consider it like this .
    I'm asking a document, if for any reason it can't be shown.
    I think it may be 7.5.3 (document is not available) as simple as that, don't you think like this?
    Thanks
     
  4. tony s

    tony s Well-Known Member

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    On your initial explanation, apparently, the document is existing but only inaccessible due to electric shutdown. I don't see yet an NC on this UNLESS it is a critical document that must be made available all the time, anytime at any place. If there's a requirement that such document must be made available anytime, all the time, every time, anywhere, any place at any situation to anyone who ask for it and the auditee failed to present it to an auditor, then I would definitely agree that there's an NC against that requirement - not necessarily against 7.5.3.
     
  5. Qualmx

    Qualmx Well-Known Member

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    To
    Tonys , im asking the file, I don’t know if exist, by the way, I have to disagree in someway, is it really complex to do an audit?, do really exist into a system a control of all what you say, to use as a criteria the availability of some files? Audits takes very little time for processes , and there are other more important issues to audit , compared to the criteria you mention , unless you have one complete day to audit a process.
    I have witnessed several cb audits, and never have seen an audit following your complex criteria, please explain a little bit more.
    I thought it was more simple to audit.
    Thanks
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You shouldn't be a) writing any NCs and b) should have accessed the documentation beforehand, so you had a copy to refer to. Postpone the audit to another time. Consider what you will be doing here. There was a network outage? What are they supposed to do? Your audit just happened to be badly timed. Move on. Do the audit another time and go in better prepared.
     
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  7. Qualmx

    Qualmx Well-Known Member

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    thanks Andy
    I didn't explain the case completely, here goes.
    It was a three days Audit, audited 12 processes, when auditing one process, everything was running fine , auditee showed several all documents, suddenly, it couldn't show a pair of documents, because a network failure.
    If so stop the audit, and continue when network is ok, then in what moment could I report infraestructure nonconformities?.
    But in this case, I may report both , document availability 7.5 and 7.1.3 network problems, why no?
    Please explain
    Thanks
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Never. What was the systemic issue here? I believe, once again, you are overthinking this. To be able to write a non-conformity - and certainly NOT document control - did you look into how many times the network goes down? If not then shrug and move on.
     
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  9. Qualmx

    Qualmx Well-Known Member

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    Thabks
    thanks
    Yes in fact ,I'm Overthinking this issue because only happened three times and only in one process
     
  10. tony s

    tony s Well-Known Member

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    Not really, unless you want every issue raised to every clause you deem relevant.
    My approach is simple. A NC can only be raised against a requirement. What is/are the requirement in your example?
    Yes, unless your overthinking every issue and grasping at any relevant clauses to raise an NC.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You have to bring this information to us earlier in the discussion, please. When did these happen? 3 times in what? An hour, day, week, month, year?
     
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  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    When writing a statement of nonconformity, choose the clause that represents the failure. The process would need to be that which could prevent the failure. I have never seen a document control process that controls the uptime of networks.

    Was this electric shutdown a failure due to storm or power outage? If so, you can investigate what has been put in place to address the risk of network failure due to storm or power outage. It may be that persons need to also have hard copy documents; this is often the case for emergency response.

    If your organization has done that, and your procedure requires these persons to have a paper copy in case of power loss and they did not, 7.5.3 applies. Otherwise this looks like an opportunity for improvement in planning actions to address risks of network downtime due to storm/power outage. Many of my clients have backup systems that can at least shut down the network in an orderly manner in event of sudden power loss. Again, this is not within the document control process. It is infrastructure.
     
  13. Qualmx

    Qualmx Well-Known Member

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    Tony
    Tony's
    "My approach is simple. A NC can only be raised against a requirement. What is/are the requirement in your example?
    To have some clearer input for me
    In the example, one iso requirement is 7.5.3.1 a.
    To have available the document, additional into an internal procedure of control of documents , only mention the process of revisions and approvals, nothing regarding availability.if you ask the auditee to show you the document, and for whatever reason he can't, I think you simply raise the NC, don't have to worry to investigate the reason., The support, would be" document was not available" if going deep, it could be competency, network failure, computer failure, etc.in this situation, what would you do?
    Once in an audit training, I was told that we have to raise the NC in front of you, back to that nC, it could Fit network, people, compu ter, etc.
    Thanks
     
  14. Qualmx

    Qualmx Well-Known Member

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    T
    thanks Jenny
    Could You share your Point of View of my last message?
    Thanks
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, if you want to bring little or no value when auditing! Did you establish if this network failure was systemic? You are supposed to be auditing a system, not finding "gotcha" issues that make everyone shrug and look at you like you caught a kid with their hand in the cookie jar.

    Please tell us what you hope to have management get excited about and corrected, in this example, which would have them saying "Well, that audit was worthwhile"...
     
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  16. Golfman25

    Golfman25 Well-Known Member

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    Stuff happens. There is no NC here. Electrical power goes out and computers go down. Unless there is some requirement for backup move on to important things.
     
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  17. tony s

    tony s Well-Known Member

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    Auditors should be able to understand not every negative issues in front of them are NCs. They could be symptoms or consequences of NCs or risks that need to be dealt with. NCs can lead to nonconforming outputs, nonconforming products/services, complaints, undesirable effects, non-achievement of objectives, unavailability of documents, network failure, server failure, electric shutdown, etc.
     
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    First, determine if it is a broken process or a true gap, in order to determine if it is a true nonconformity.

    How is the document owner supposed to control network outage? It is not sensible to raise a conformity to someone who does not control the issue.

    I also not convinced this is a true nonconformity. You need to identify the requirement, the true issue and not just the symptom.
     
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