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4.2.3 Control of documents

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by wywy2020, Oct 9, 2015.

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  1. Nikki

    Nikki Well-Known Member

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    I guess we do!! :p
     
    Nikki, Oct 12, 2015
    #21
  2. wywy2020

    wywy2020 Member

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    the document owner could tell u that yes it is over 5 years old but nothing has been changed thats y the document remain valid and current.
    have u facing such feedback before?
     
    wywy2020, Oct 15, 2015
    #22
  3. JCIC49

    JCIC49 Member

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    Agreed they can tell you that an update or no change is required, but the issue as I have said was the QMS was seen as being owned by QA so they didn't do this.

    What was changed was how they brought into and ownership to the QM, the result of this was they presented documents with the updates identified for changes to be made. Part of this was putting a review period into the QMS, but it also involved work in all areas of the QMS, it took time but worked well
     
    JCIC49, Oct 15, 2015
    #23
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Pancho: 9.2.2...

    "the organization shall plan, establish...an audit programme...which shall take into consideration...changes affecting the organization..."
     
    Andy Nichols, Oct 15, 2015
    #24
  5. James

    James Active Member

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    Is that section and language from the 2008 version?
     
    James, Oct 15, 2015
    #25
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Noooooo it's right out of 2015. Hence the 9.2.2 not 8.2.2...
     
    Andy Nichols, Oct 15, 2015
    #26
  7. James

    James Active Member

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    Just making sure.
     
    James, Oct 15, 2015
    #27
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  8. Pancho

    Pancho Active Member

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    Andy, "establish an audit programme taking into consideration the changes affecting the organization" is not quite the same as "requires AUDITS when changes are made". The first one can be met rather easily. The second one would be onerous.
     
    Pancho, Oct 16, 2015
    #28
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In the context of what we're discussing - the need for reviews of documentation, changes to processes etc will trigger internal audits and, therefore the relevant process documentation. Hence negating the need for a forced annual review of just documents. It's true not ALL changes would require an audit, however, if we are Risk Based Thinkers, we know that changes frequently cause problems, hence the need for a) planning for the changes and b) audits to confirm, later the changes have "stuck"...

    Moreover, it goes to show (IMHO) that even TC 176 recognizes that this fascination which implementers of ISO 9001 have with doing anything - calibration, document reviews, audits and management reviews - once per year is not effective...
     
    Last edited: Oct 16, 2015
    Andy Nichols, Oct 16, 2015
    #29
  10. Sidney Vianna

    Sidney Vianna Well-Known Member

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    I have not seen that requirement (yet). I see that changes to the organization, processes, products, etc are supposed to be an input to the audit program, but I have not seen a requirement that mandates audits when changes are made.
     
    Sidney Vianna, Oct 16, 2015
    #30
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Status and importance..."
     
    Andy Nichols, Oct 16, 2015
    #31
  12. RoxaneB

    RoxaneB Moderator Staff Member

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    Yes. And I've encountered processes that haven't changed in five years. But I would ask for evidence of the review for validity...this could be through the history of the document (e.g., e-records showing that the documented had been reviewed and deemed still valid by the document/process owner) or even an audit that checks the actual activities to what is documented.
     
    RoxaneB, Oct 16, 2015
    #32
  13. MCW8888

    MCW8888 Well-Known Member

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    The Document Control Procedure should specify how often are your documents reviewed for applicability. If it is annually, and it does not change, indicate in the revision history that on that year there's no revision. The CB's want to see objective evidence that it's done according to the procedure.
     
    MCW8888, Oct 16, 2015
    #33
  14. Sidney Vianna

    Sidney Vianna Well-Known Member

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    Actually in ISO 9001:2015, we have a NEW requirement in 8.5.6, which requires a "change review" for production and/or service provision processes. While a change review might be performed through an audit, that is not the only way to assess the impact of the change. Outside of product and service realization processes, changes don't TRIGGER an audit, necessarily. While audits could be a method to ensure change effectiveness and effectivity, there are other methods available.
     
    Sidney Vianna, Oct 16, 2015
    #34
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Only if you've written that into your procedure. I'd suggest that CBs want to see what's effective, not simply following procedure...
     
    Andy Nichols, Oct 16, 2015
    #35
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I didn't suggest that a change review is done through an audit at all and didn't imply such either. The fact is that changes CAN trigger an audit - as a CB marketing representative (AS91XX) you will probably know that when a client changes their CB it triggers an audit, for example. In previous versions of the internal audit requirements, the "status" of a process has been cause for a change - although, unhappily, the point is commonly missed by the vast majority of internal audit implementers AND external auditors. It's simply a case that ISO TC 176 have straight out called it what is it instead of using words no-one apparently knows how to apply. Change = risk (to some degree or other) = good reason to audit. End of story.
     
    Andy Nichols, Oct 16, 2015
    #36
  17. PaulJSmith

    PaulJSmith Well-Known Member

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    The one thing I see missing from this conversation is what seems to me to be the obvious question; If you find that your process no longer matches your documentation, which one is wrong?

    How many times have we all encountered someone doing something "the same way they've always done it," only to find that they've deviated over time and are actually doing it wrong? Just because the documentation doesn't match the actual process, doesn't mean that the documentation needs to be changed or updated. It may, in fact, still be right.

    As Pancho alluded to earlier, if people are actually following the documented procedures, they are likely being reviewed on a far more regular basis than any scheduled document review would accomplish.
     
    PaulJSmith, Oct 16, 2015
    #37
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  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Good (great) question, Paul! This where the audit comes in useful - IF - the auditor understands they have to look for the effectiveness of the process too! Too many auditors (of all persuasions) end their investigation at "not following procedure" type of thing, instead of looking for evidence of effectiveness of what's being done. "Doing it wrong" - according to the document - may NOT be a "bad" thing. In fact, from a lot of what I've seen written down as a process/procedure, they are what need fixing...
     
    Andy Nichols, Oct 16, 2015
    #38
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  19. PaulJSmith

    PaulJSmith Well-Known Member

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    Yeah, it seems that way most of the time. The process "evolves" into something new, but the documentation hasn't been updated to reflect the new reality. I have also see the opposite, though, where an operator does the same thing for years not realizing that they've been slowly devolving away from what's required.

    Honestly, both scenarios are examples of not following documented procedures, and potentially not maintaining relevant versions of those documents.
     
    PaulJSmith, Oct 19, 2015
    #39
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  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Exactly, and this is what makes for intelligent audit program management, knowing such things exist, rather than rolling out a schedule over months to some arbitrary calender and then changing it to react... Not clever.
     
    Andy Nichols, Oct 19, 2015
    #40
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