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How to address 4.2.3 b

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Qualmx, Aug 19, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all

    Please share your comments regarding 4.2.3 b "b) to review and update as necessary and re-approve documents,"

    I have around 400 documents, and I have revise them according to the standard


    I have scheduled to revise documents every 12 months for adequacy
    The idea it is to identify those who have not been changed into 12 months, what would
    make me think, if it has not changed, maybe is unnecessary.

    But this is very time consuming, so I want to workaround this issue but trying to comply to this clause
    Imagine, to ask the owner of documents, to check every document and it is found something, then
    modify the document, to change the revision number, saying " revision changed from 0 to 1 because of scheduled review" even if it was not changed anything.

    This is a tremendous wasting of time

    Do you have any idea ?

    Thanks
     
  2. tony s

    tony s Well-Known Member

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    Indeed.

    Since the standard already mentions "as necessary", thus any revision should be made "if deemed necessary" - not "every 12 months".
     
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  3. Qualmx

    Qualmx Well-Known Member

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    thanks, maybe other idea would be to say that in every internal audit, they are revised for adequacy, could this be a good choice?
     
  4. yodon

    yodon Well-Known Member

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    What tony s said is spot on but one thing caught my eye: 400 documents sounds like a lot... are they all used / needed?
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think you're missing the point. Documents should be "adequate" in the first place. They should have been part of the internal audit process by now to confirm that they are adequate in providing the necessary control(s) for their associated process(s).

    I'm with Yodon. 400 documents is a lot...

    Another worrying thing is when you imply YOU are doing all this work. Why? I see a lot of your posts and you seem to be doing ALL the QMS work. I'd suggest that, if this is accurate, then you are doing EXACTLY the opposite of what the standard requires. You might want to rethink why YOU are doing all this work.
     
  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    The standard does not require a 12 month document review frequency. The standard says as necessary. Having to do a 12-month review for adequacy hints there is inadequate control of change, which 6.3 is asking for. Why not change the documents as the processes change? Let the process owner initiate the change.

    If a review is done and changes are not deemed necessary, I see no reason to change the revision at all. Revision is the same thing as change. I instead suggest the revision history notes the date the review was done, the outcome "Periodic review. No change necessary" and the authorized person who did it.
     
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  7. RoxaneB

    RoxaneB Moderator Staff Member

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    I do not consider 400 a lot of documents...depending on the organization and how these documents are used. 400 documents could include work instructions that are used as part of training and included within the organization's document management system. 400 documents should be spread out amongst the subject matter experts - I am not responsible for reviewing Human Resources' documents.

    The 12-month review cycle is probably the most common frequency selected, but that doesn't mean you need to subscribe to. Where I am, policies are on a 3-year review cycle, procedures and lower are every 12 months from the last revision date.

    Like Jennifer, i consider review and update as two separate and distinct activities.

    If I review "How to Make Widgets (Rev. 01)" on 1-June-2017, and no changes are needed, the document control software my organization uses allows me to say "Reviewed and no changes needed" The document stays at Rev. 01 and the clock resets so that the next review will due by 1-June-2018.

    If I review "How to Make Widgets (Rev.01)" on 1-Jun-2017 and changes are needed, I update the document. If it is approved on 23-June-2017, the next review will be due by 23-June-2018.
     
    Last edited: Sep 7, 2017
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  8. Flavio Degani

    Flavio Degani New Member

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    If we consider that the document review has the main goal to ensure PDCA cicle is running properly, then it makes sense to review every once in a while and not only "when necessary", as the changes will be done if necessary, but the review must be done regardless.

    If you have a good internal audit program, effective outputs from critical analysis of the QMS and robust action plans you would already be demonstrating that the processes are ok and improvements are happening. There won`t be any reason for the external auditor to worry about document`s reviews.

    If anything, change the 12 month`s frequency to 24. Or demand from each process a review of the documents when presenting the critical analysis of the system. The review itself don`t need to be registered, only if you have a change. So you can just say that the documents go through the heads of departments every single year during the QMS critical analysis.
     
  9. RoxaneB

    RoxaneB Moderator Staff Member

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    "once in a while" is not a set frequency and could lead to documents not being reviewed for adequacy. What I consider 'once in a while' may be different from someone else considers to be 'once in a while' - this means we have a lack of consistency in our review of the document and we could opening the organization up to some potential risk(s).

    I'm not sure I quite understand this. Do you mean processes are consisitent and improving? How does this relate to document management? Or do you mean the document management process? While I agree that an internal audit is one way to identify if documents reflect the actual process, I would rather have a robust, mature document management process in place which includes activities such as document review at defined intervals.

    I disagree that the document review doesn't need to be registered. If there is no record of the review, how is anyone to know whether or not the review occurred and that the document has been verified as being reflective of the current process?

    I don't know what your organization considers within its annual "QMS critical analysis", however, in my opinion, there are other processes that could impact document revisions and thus reset the review frequency. What if a process to make widgets changes? Does your organizationhold off on reviewing the documentation associated with widget production until its annual QMS critical analysis? To me, this is risky - what if someone new starts? Are they trained on an document that is technically incorrect? I would expect to see process changes to include a review of existing and applicable documentation - ensuring it is reviewed for adequacy to the new process. Once this is done, the review cycle on the document would reset and the document is good until the next process change or the next review date.

    This approach also keeps document review as an activity spread out over the course of a year (or longer) instead of reviewing all documents at the same time. If an organization has a lot of documents, having a set time once a year to review all of them can be more of a burden and more stressful on the individual(s) reviewing them.
     
  10. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day all;
    Please allow me to weigh in on this topic/discussion. I applaud Qualmx for noting a potential inefficiency in that organizations's QMS/document review process.

    While most of the stated approaches are worthwhile, and not "wrong", the concern I have is the prescribed review approach.

    As noted correctly by Jennifer Kirley ...
    ...changes initiated by a need for change would be reviewed via a well instituted change point control system (4.2.3-a; ["prior to use" includes use after a revision has been made] , 4.2.3-c [changes are identified] ) In addition, clause 8 (specifically sub-clauses 8.2.2; 8.2.3; 8.2.4) requires organization to review the performance of the QMS (generally inclusive of numerous hard or digital "documents"), the processes themselves, and the resultant product.

    I would, therefore, suggest that organizations allow the QMS to function as prescribed and take care not to burden the organization(s), with additional (redundant?) prescriptive requirements. If it assists Qualmx/others from a link/audit standpoint, then may I suggest that any procedure that may exist specific to 4.2.3-b, simply "point" to these other required activities that I have referenced above as the means for showing how the 4.2.3-b requirement is met. Evidence is then provided via change point control document reviews/approvals, process and internal audit evidence and results, etc..etc...

    Hope this helps.
     
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  11. Brend

    Brend New Member

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    Yeahh, I totally agree with you. That's my opinion
     

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