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Corrective Action Effectiveness

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Devesh#89, Aug 7, 2024.

  1. Devesh#89

    Devesh#89 Member

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    I have a question, on checking effectiveness of the CAPA it was found that the CAPA is not effectively implemented so, what are the steps we could take here, what i think is we should have another root cause analysis and a fresh CAPA is to be generated. what do u think?
     
    Last edited by a moderator: Aug 7, 2024
    Devesh#89, Aug 7, 2024
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Interesting question!
    There are a lot of additional questions which really need to be asked/answered before a true and accurate answer can be given. CAPA doesn't work for many reasons, including:

    Is the problem statement clear and compelling?
    Does everyone involved know how to perform root cause using the appropriate tools?
    Is a team working on CAPA and do they have the appropriate approach to problem solving (D.i.S.C)
    Is the problem one which management WANT to have people working on ($$$$)?
     
    Andy Nichols, Aug 7, 2024
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  3. Miner

    Miner Moderator Staff Member

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    I would keep it all in the original CAPA. Keep in mind that if the corrective action was not effective, there are at least 3 possible causes:
    1. The corrective action itself was not effective
    2. The root cause was incorrect
    3. There was more than one root cause
     
    Miner, Aug 7, 2024
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  4. Bev D

    Bev D Moderator Staff Member

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    What do you mean that it wasn’t effectively implemented?
    Was it not implemented at all?
    Was it only partially implemented?
    Was it implemented but employees aren’t following it? Or using it?
    Was it full implemented and being used but the Problem still occurs at the original occurrence rate? Or is it a lower rate?

    Each of these has. Very different path and cause.

    Good root cause analysis starts with good questions and works back towards the cause.
     
    Bev D, Aug 7, 2024
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    Andy Nichols likes this.
  5. Devesh#89

    Devesh#89 Member

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    Hi Bev, The CAPA was effective for the root cause generated but there was an issue that is unexpected and can't be covered in RCA as that was a new issue generated which led to a deviation,

    If i give you precise info, company used to upload cases on the FDA portal related to pharmacovigilance and during upload missed one field to check, the implemented preventive action was to map the process and put a validation on those fields which are critical, but this time a non-critical field showed error and this led to deviation
     
    Devesh#89, Aug 8, 2024
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  6. Bev D

    Bev D Moderator Staff Member

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    Your response is helpful. Without really stating the causal mechanism (other than what I would infer is that someone just forgot to fill out a field?) I would say that your implementation was incomplete. Same cause, same Problem. There is no valid reason to add a validation check only on ‘critical’ fields as anyone can forget to fill out any field; validation should have been added to all fields - this is a common software thing for ‘forms’ that get filled out…
     
    Bev D, Aug 8, 2024
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    Miner likes this.