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Risk plans were not effective, CA is needed?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Feb 16, 2018.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all
    In a QMS system, when things go wrong, we have to raise CA's.
    I wonder if we are having not success in the treatment of risks , would be convenient to raise CA's, as well?
    Thanks for your ideas .
     
  2. Golfman25

    Golfman25 Well-Known Member

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    Risks are managed, not treated. With a corrective action you are looking to eliminate reoccurrences. You can't eliminate true risks.

    So if your risk is loosing key people to retirement, you develop a program to replace them. You manage their replacement. But you still may have gaps.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    Thanks
    but dont you think that, maybe we are failing in applying the right plans to minimize risks?

    You are right, its difficult to eliminate risks, but....

    For example: why are we failing ?, maybe the way we anaiyze the risks, the plans we define, maybe
    people analyzing dont have competency.

    Would this issue apply a CA?

    Thanks
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Issue a CA if you want to. It leaves a trail to refer to later and you noticed risk treatment did not work, correct? Does that mean you have a nonconforming output of some kind?

    Risk is not just for customer product, and corrective action is not just for internal audits and customer complaints.

    Competency for analyzing risk is worth addressing. I have seen many well-crafted FMEAs and also many poor ones. The fact that risk can be addressed with many approaches other than FMEA can cause confusion and leave people in doubt.

    There is no shame in not eliminating risk, though. Factors can include (but may not be limited to) those of man, material, machine, method, and mother nature. Very often risk is addressed without consideration of all these factors, and indeed if all factors are considered it may be difficult to know if the intervention succeeded or failed based on all, or one, or which one of the factors.

    It may be practical to use a fishbone diagram to help analyze risk.

    I am not affiliated with LabCE.
     
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  5. Qualmx

    Qualmx Well-Known Member

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    Thanks Jenny
    Well, I started to use fishbone as a first practice.
    Actions to take to solve ineffectives actions are new for me , I'm starting to manage risks.
    maybe having some experiences, I'll have more information to fix these weaknesses.
    Maybe other members, with experiences in risks could share opinions.
    Thanks
     
  6. Qualmx

    Qualmx Well-Known Member

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    Summarizing, I use fishbone to find root causes for which the risk exist.
    The fishbone you and me are referring to, would be done to find causes why we are not evaluating risk values or defining the correct actions.
    Thanks
     

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