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ISO 9001: Write a CAPA for each of the 11 OFIs in internal audits ?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Randy Westover, Oct 22, 2021.

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  1. Randy Westover

    Randy Westover New Member

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    Hello,
    i am new at being a Quality Manager. I have a audit coming up and the old QA Manager just walked out one day and took all the manager meeting notes etc... with him. i have nothing to really go off of. i did internal audits of each clause and have found 11 OFI's. My question on this is, do i have to write a CAPA on each one? or a PAR?
    I wrote a CAPA already about the vast turnover and previous QA taking all info needed.

    Any help on this is appreciated.

    Thank you

    Randy
     
    Randy Westover, Oct 22, 2021
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Randy - welcome and we feel your pain...

    You know that surveillance visits by your CB can be postponed? You can buy yourself some time and delay the audit until you feel ready. Only the very first surveillance, after certification needs to be done on the anniversary. Call your Client support person and explain you want to reschedule. It will gain you a couple of weeks to get set.

    When you say "clauses", you are really supposed to audit processes. Do you have the previous internal audit reports and a procedure to see what was done? If you do, don't make any changes to the audit process, at this point. If you can post (sanitized) the previous schedule and procedure, we can give some guidance.

    As far as "OFI", it's not about grading - what is the content of the findings? That will dictate if anything needs to be actioned. Not all audit non-conformities need a "CAPA". In the ISO 9001 world, we typically don't use "CAPA". You can simply fix the issue - correct it. Root cause actions are only required where the nature of the issue dictates it. I'm not sure how you can write a CAPA against turn-over or the QM taking stuff - unless they are internal requirements of the QMS.

    Have you had some internal auditor training?
     
    Last edited: Oct 22, 2021
    Andy Nichols, Oct 22, 2021
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Welcome @Randy Westover ;
    There are numerous individuals on this site that can provide you wise council. Continue to exploit the knowledge and experience of the likes of @Andy Nichols . He is providing you sound advice and asking the right questions.


    Be well.
     
    John C. Abnet, Oct 22, 2021
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome Randy!

    What does it mean he "took all the manager meeting notes etc... with him"? How does this work: how does an individual make off with all these records ad leave nothing behind? This is the primary concern at this point.

    You are fine to have found issues in audits after this individual left. Log them as CAPAs or whatever your system prescribes. At this point it is important to establish your QMS is functional without your old QA Manager.
     
    Jennifer Kirley, Oct 24, 2021
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  5. RonR Quality Pro

    RonR Quality Pro Active Member

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    I feel your pain - been in the same position once, and it was NOT any fun.

    However, to answer your question - no, you do NOT need to do a CAPA for OFI's.......they are OPPORTUNITIES, not something that is nonconforming. It is up to you (and the company) if you want to act on them, but whether you do or not, it does not require a formal response.
     
    RonR Quality Pro, Oct 25, 2021
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  6. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Randy, I am not aware of how you archived your records or how much effort this individual went through to make off with them, but I have to wonder: Was record retention part of the audit? If so, I wonder if there were at least one fewer OFIs and one more NC.
     
    Jennifer Kirley, Oct 25, 2021
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  7. tony s

    tony s Well-Known Member

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    Using the ISO 19011:2018 as a reference, my answer is NO. You don't need to initiate corrective actions on OFIs. Here's the statement from Section 6.4.10 of ISO 19011:
    "If specified by the audit objectives, opportunities for improvement recommendations may be presented. It should be emphasized that recommendations are not binding".​
     
    tony s, Nov 2, 2021
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  8. Randy Westover

    Randy Westover New Member

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    Thank you for your response. Pretty much what i thought.
     
    Randy Westover, Nov 3, 2021
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  9. junior1505

    junior1505 New Member

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    Greetings of the day.
    Well, your predecessor cannot take all the documents and needs to be saved, if this is not adhered, then this is a serious breach in the organisation about the control of documents and controls of records.
    Secondly, OFI are generally not to be take for RCA and CAPA. They are some potential information that would be helpful so that you dont end up with potential NC or observations. However, you can eventually for your benefit tabulate the Correction and Corrective action taken. Please note that you are improving your system and not documenting for the sake of the system.
    Regards.
     
    junior1505, Dec 9, 2021
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  10. BradM

    BradM Moderator Staff Member

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    Hello Randy! Welcome to the group!

    As far as the number of CAPA's, I would say draft one for each of the non-conforming processes. Each, may have different steps and activities that are required. Also, some may take longer to complete than others.

    What I would do is, draft your proposal for CAPA's then meet with management to determine who is going to own them (not you...). You need to make sure management is going to support and assist with these activities.
     
    BradM, Dec 9, 2021
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  11. John C. Abnet

    John C. Abnet Well-Known Member

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    Welcome to the site @junior1505
     
    John C. Abnet, Dec 10, 2021
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