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Query on major NC for Manual

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by marni, Sep 13, 2016.

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  1. marni

    marni Member

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    Hi
    I have recently started working in a new company, day 2 to be precise. I have read the last annual audit report and found a major nc for the manual. The next audit is due in December is it acceptable to start the new manual as a work in progress or would it have to be fully completed by this time to be compliant?
     
    marni, Sep 13, 2016
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  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Hi, Marni...Welcome to QFO and congratulations on your first post!

    Is it safe to say that this was an internal audit finding? Would it be possible for you to share the wording/nature of the finding with us so that we have more information to work with?

    Presuming your answer is 'yes' and without knowing all of the details surrounding the finding, I'd recommend that a revised manual - if your organization insists on keeping one - be up and running before your next audit. I don't know how complex your manual is, but if it is simply a repetition of the standard, it's an easy thing to update.

    That said, you've posted in the ISO 9001:2008 forum. There is no requirement for a quality manual in ISO 9001:2015, I believe. If it is not required and if it is not adding value, why keep it around? Perhaps your organization will wish to keep it around to satisfy Customers who would like your organization to be registered and insist on seeing more than just the certificate. However, with ISO 9001:2015 out and organizations starting the transition to the new standard, you could potentially develop an action plan showing that it is currently a work-in-progress to meeting the new requirements. Not my preferred route for your organization as this finding is about 9 months old and that is usually sufficient time to (re)write a quality manual (depending on resources, organizational changes, etc.).

    When is your management review? You could also discuss the state of the manual and the associated finding at management review so that there is evidence of the discussion and the plan to move forward.
     
    RoxaneB, Sep 13, 2016
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    ^^^^ what RCB said
     
    Andy Nichols, Sep 13, 2016
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  4. marni

    marni Member

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    Hi
    This was an external audit and on a brief look at the manual today I think it maybe that business examples have been used against each criteria. As I am new to the company I'm hoping to book a management review within the next couple of weeks after I have collected further information on other weaknesses in the report. Would it be of benefit to take out examples that are currently and simplify the document?
    At this stage we are not ready for the 2015 version but I aim to get us there so I feel for now the document should be kept in place
     
    marni, Sep 13, 2016
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I find it hard to believe that anything to do with a quality manual was a major! Could you repeat the content of the nc here (scrub any company references) and let us know what the audit criterion and the actual evidence is?
     
    Andy Nichols, Sep 13, 2016
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  6. RoxaneB

    RoxaneB Moderator Staff Member

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    I find it hard to believe that a major finding on an external audit has been allowed to remain open this long! In my experience, we had maybe a couple of months to respond and address and provide evidence of closure.
     
    RoxaneB, Sep 14, 2016
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  7. tony s

    tony s Well-Known Member

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    I'm interested to see the statement of the NC.
     
    tony s, Sep 14, 2016
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  8. RoxaneB

    RoxaneB Moderator Staff Member

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    I asked that yesterday, Tony, but Marni is new to her organization and may be hesitant to share that with us. Understandable.
     
    RoxaneB, Sep 14, 2016
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  9. marni

    marni Member

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    It states the manual requires revision that's fine I agree with that part but the main points in the report says it should have hyperlinks in the electronic version to relevant procedures within operation manuals. That the manual does not reflect procedures.
    Now looking over older external audits the manual had on previously had an observation or passed. So i can't see how it jumped to a major nc
     
    marni, Sep 14, 2016
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Well, your auditor is telling you how to fix things, not what is non-conforming and, therefore, not doing their job - and escalating this to a major is a further example. If we were to frame the situation in the context of ISO 9001:2015, the auditor would be even more off base! Some auditors do this once in a while - they want you to do something but instead of recording a proper nc and allowing you to decide how to correct things, the short circuit the whole process and tell you HOW to fix it - not their job!
     
    Andy Nichols, Sep 14, 2016
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  11. RoxaneB

    RoxaneB Moderator Staff Member

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    I'd counter with "Show me where the standard requires that hyperlinks be used." Even the actual referencing to the procedures, beyond saying "A procedure exists for...", isn't a requirement, is it? Sure, it makes things nice and easy for the auditor, but your organization's quality management system was not created for him/her. It was created to add value to your organization and hopefully for your clients.
     
    RoxaneB, Sep 14, 2016
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  12. marni

    marni Member

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    Yes I am new to the company this is my first week so I can only move forward not question how things were managed beforehand. I was employed because of this type of issue. If I had been here at the time of the audit there is no way I would have accepted the decision to give a major. So my thoughts are that I do revise the current manuals and make them as simple and clear as possible as they are at the moment more complex than I feel is required. I'm just concerned that due to the work load leading up to this next audit will I have time to close out all the nc's given and if not can get can I argue the original findings and show a work-in-progress.
     
    marni, Sep 14, 2016
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  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Marni - based on what this auditor wrote there is no work to be done! Unless that auditor returns, you should simply explain that you're new, can't find any requirements actually referenced in the nc and, don't know what happened previously (you could add you'll be rejecting the nc back to the CB as a poor report)
     
    Andy Nichols, Sep 14, 2016
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  14. marni

    marni Member

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    Many thanks to you both for your input it is very helpful and much appreciated
     
    marni, Sep 14, 2016
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  15. BradM

    BradM Moderator Staff Member

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    The only thing I might add here...
    you mentioned that the quality manual was mentioned/cited in previous audits. It could be that the most recent external auditor felt the most recent finding of the quality manual is a repeat/systemic issue, and thus felt it needed to be escalated in severity. I'm not sure; and in no way would I suggest that is warranted or that it is a repeat/systemic issue. Just adding that as a possibility.
     
    BradM, Sep 14, 2016
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  16. marni

    marni Member

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    There really is very little in the report to explain the reason behind being given a major for the manual.
    The other 2 are self explanatory to me and I can get them up to speed with those.
     
    marni, Sep 14, 2016
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  17. MCW8888

    MCW8888 Well-Known Member

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    Welcome aboard QFO!

    "It states the manual requires revision that's fine I agree with that part but the main points in the report says it should have hyperlinks in the electronic version to relevant procedures within operation manuals. That the manual does not reflect procedures"

    Perhaps the manual did not include or reference to the documented procedures. But why should it be a major? The suggestion to hyperlink..... is already a solution to the nonconformance which the auditor should never do. This is only my opinion.
     
    MCW8888, Sep 15, 2016
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  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I do not know how extensive or detailed your manual is. I would support a revision. Although I agree it should cite applicable procedures in appropriate places by subject - or even provide a table - but hyperlinks are NOT required - your auditor broke the rules by issuing such a specific suggestion, and by saying "should."

    A quality manual is used for what purpose? Do you send it to customers? It should describe what goes on in a high level manner - avoid complexity or long-winded explanations. Leave those details to the procedures, work instructions etc.
     
    Jennifer Kirley, Sep 15, 2016
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  19. tony s

    tony s Well-Known Member

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    If a major NC is going to be issued to me or my organization, I would ask the auditor the reason for elevating the issue to that level and ask him/her the exact definition of a major NC. I will also ask the auditor to document his/her justification on the report.
     
    tony s, Sep 15, 2016
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  20. Pancho

    Pancho Active Member

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    I'm a bit surprised about how the discussion focuses on the details of whether the NC should be major or minor, or only a recommendation, and whether or not the standard requires that the procedures be only referenced or hyperlinked.

    In my view, the external audit is a way to get some knowledge from outside the organization and improve from that knowledge. That's it. The technicality of the process helps in having folks take it seriously, but shouldn't absorb our attention.

    From the OP's posts, it is not entirely clear whether the manual references the procedures at all. Also, it is not clear whether the audit is to the 2008 or 2015 standard, and therefore whether a manual is required at all. Nevertheless, NC or not, if there is a manual (or any other top level document in the QMS, such as a "home", "index", "landing page", etc., whether called a manual or not), it is a good idea for it to have references to the main procedures. That's the essence of it being the top-level document. Further, it is a good idea to hyperlink those references, if the system is in a computer. Implementing those two things shouldn't take more than an hour or two: Add an addendum (say "index to QMS") to the manual with a list of the main procedures for each process and where to find them. If these procedures are electronic, hyperlink them. These two easy steps help make your system more accessible for the users. Satisfying an auditor is just a side benefit.

    One other thing to point out. No document is perfect. Documents in any system subject to continuous improvement are always "work in process". But I prefer to call them "live". So add the two things the auditor recommends and let your document live to see the next improvement that comes up, from whoever's another observation, minor or humongous spot. December is too far away.
     
    Pancho, Sep 15, 2016
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