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Approved/Initiated by same person?

Discussion in 'Other Quality and Business Related Topics' started by QA Bee, Jul 12, 2021.

  1. QA Bee

    QA Bee Member

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    What GMP standard/clause/s would you consider a NC against if, during an internal audit, and example of of CAPA that were found that were signed off by the initiator as well as 4 other area approvers?
    We were written up for this that the initiator couldn't sign off his own work although, she was the only area QA but as long as other 4 approvers also approved it, I didn't see it as a NC.

    What do you all think? Thanks so much in advance.
     
  2. RoxaneB

    RoxaneB Moderator Staff Member

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    Who did this write up and what standard/clause/requirement are they citing?
     
  3. QA Bee

    QA Bee Member

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    This was in an internal audit without any reference to the standard and when I disagreed, I was asked for the standard/clause that allows this:)
    I have done this many times in smaller startups as the only Quality personnel, have initiated and approved as QA but of course with other approvers as well and have not been ever questioned before.
     
  4. yodon

    yodon Well-Known Member

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    Could there be internal procedures that is driving this?
     
  5. QA Bee

    QA Bee Member

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    No, I have already looked at our GDP SOP and there is no mention of it.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The internal auditor is incompetent. Pure and simple. It is they who needs to provide the criteria.
     
    QA Bee likes this.

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