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Deviation Procedure

Discussion in 'Documentation Control, Procedures, Templates,...' started by Gavin, Aug 12, 2021.

  1. Gavin

    Gavin New Member

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    All i have a process flow for raising a deviation but it lacks a lot of key information.
    Does anyone have a decent process flow for raising a deviation.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome.

    If you share yours Gavin (sanitize as needed) we could point out what's needed?
     
  3. Gavin

    Gavin New Member

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    All

    I have placed a copy of the procedure below, Like i said this is very brief and feel there is more needed any help is appreciated
     

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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Thanks for this. At first sight I'd offer this:

    Take away metrics. They have nothing to do with a deviation process which is simply an extension of the control of non-conforming product.

    This isn't a process. It has no defined input. It might (maybe) describe someone's logic, but that's all (and, tbh, that's dubious). A deviation is the way in which you wish to manage a situation of non-conformance and how it is a) approved and b) controlled. It has 3 purposes? Engineering releases? Changes? Probably not. Deviations is deviations, nothing else.

    The steps for issuing a deviation are linked to your control of non-conformance. What does that process state?
     
  5. RoxaneB

    RoxaneB Moderator Staff Member

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    My first question when reviewing the document was the scope. It appears to focus on engineering deviations and not the traditional nonconformance one would expect in a quality management standard such as ISO 9001. With that mindset, my initial thoughts are:

    • Reads more as a process flow (or what a former workplace of mine called a 'management standard') than a procedure, but if this is what your organization calls a procedure, so be it.
    • I like the inclusion of measures/metrics on a document such as this, however, I'm not sure these are the best ones for the process flow - take a step back and ask yourself what the purpose of the document is...your measures should support the purpose (i.e., show whether the purpose was achieved or not)
    • The process flow lacks accountability - it says what needs to be done but not by whom and by when
    • The first step presumes that an Initiator knows what constitutes a deviation that would then require a deviation request - that flow (i.e., defining/determining if something is a deviation or not) could help this process a bit more robust
    • If a required deviation is rejected (Judgement decision), I'm not sure if the most correct path is back to the beginning - is (END) not a possibility?
     
  6. tony s

    tony s Well-Known Member

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    The metric and KPI should be aligned with the expected outputs of the process and should be measurable.