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To use preventive action procedure/format to mitigate risks?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Aug 11, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everybody. I have a question regarding preventive actions.

    As we know, Preventive action clause was removed in 2015 version, supposed to be covered
    by using RBT.

    So, in the case of detecting a risk, and we want to mitigate it, some actions maybe would be for example:
    lets say the risk is to receive bad raw material from suppliers.

    Ok, for me is critical and not acceptable, the current controls we have are very weak, then I could
    implement a double checking in my process, for that I will modify my procedures and inspection formats
    and will lower the risk at an acceptable level.

    Additionaly I have to say that I have my old procedure which covered both (corrective and preventive actions) which I dont think I have to change it, since the preventive actions still will continue.

    But my question is my mitigation plan could it be documented in the current preventive format?
    Or should I use just modify the procedures?

    Is there a problem in continue using the preventive action format?
    I know that prevention practice continue, but I doubt if I can use my old format or actions focused to prevention should be documented apart.

    Please help.
    Thanks
     
  2. tony s

    tony s Well-Known Member

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    When you satisfy the requirements in Clause 6.1.2, you don't need to use a preventive action form for this. The controls specified in your documented procedures are intended to serve as "the preventive actions" to prevent undesired consequences and to ensure achievement of the planned results. These "preventive actions" in your documented procedure can be determined through the use of tools like FMEA, Risk Register, etc.
     
  3. Qualmx

    Qualmx Well-Known Member

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    Thanks Tonys
    Would you recommend me to modify my current document "corrective and preventive procedure?
    I mean, remove all , what is related to preventive actions ? as well as the format?
    The format is named " Corrective and preventive actions"
    I think is not cause of a Nonconformity, but I think it will cause confusion.

    Please advise on this
    Thanks again
     

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