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Categories of Nonconformances leading to Corrective Action

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

  1. Dobis

    Dobis Member

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    We are currently having a little argument in our office on the category of nonconformities that should be taken through corrective action process.

    Here is the issue: Machine breakdown (that does not involve total stoppage of the production line or that takes less than 30 minutes downtime) is a nonconformity that does not need any corrective action, meaning that this non conformity does not need to be taken through 5Whys. Is this in accordance with the standard?

    Please help us out.
     
    Dobis, Aug 16, 2018
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "Category of non-conformity"? Not sure why you do this, however, you are allowed, by the requirements to "correct" issues, since full-blown root cause isn't appropriate for everything.
     
    Andy Nichols, Aug 16, 2018
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  3. RoxaneB

    RoxaneB Moderator Staff Member

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    The standard does not dictate or mandate how you classify nonconformities or even that an organization needs to do so. What it does require is that actions taken to address them be appropriate to the situation (e.g., you don't use a sledgehammer to kill a mosquito).

    What we did was analyze our machine downtime - both the duration and the category. From that, we established which downtime occurrence would require root cause analysis and a more detailed action instead of just a correction. Using historical data, we determined that any downtime moments > x minutes or any downtime moments within a specific type of category, a full-blow corrective action approach would be taken. All others were to be logged, fixed, and that was it. Our reasoning for this was to provide us (and our 24 hour, 7 days a week operation) with consistent protocols for when to apply which methodology. It also allowed us to focus on our "bigger" issues. After a year of that, we re-analyzed our downtime data and revised our triggers. Since our average downtime duration had lessened (a good thing), we now focused on downtime moments > y minutes (with y < x from the previous year). This increased our number of full-blown corrective actions for a time - at least until we were more stable and then the number dropped. After that year, we re-analyzed our downtime data and revised our triggers. Now it was downtime moments > z (with z < y < x)...and hopefully, by now, you see a pattern in our approach.

    We didn't not pick an arbitrary number as our decision point to determine corrective action versus correction.

    But to answer Andy's question, we did this type of "cateogorization" to help ensure a consistent and value-added approach to solving nonconformances within our manufacturing process.
     
    RoxaneB, Aug 16, 2018
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe you're unfamiliar with the size of Michigan's mozzies?

    [​IMG]
     
    Andy Nichols, Aug 16, 2018
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  5. Dobis

    Dobis Member

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    thanks
     
    Dobis, Aug 17, 2018
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  6. Artem

    Artem Member

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    sorry if too late...
    The definition of a category may be conducted based on the FMEA. If you have reviewed the impact of 30 min stop and have statistically sound proof that possibility of any internal or external claim is very small and the severity of such a claim may be not that high, you consider the risk low and therefore officially state in the corresponding procedure that based on those (documented) considerations you do not conduct 5whys
     
    Artem, Sep 4, 2018
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  7. tony s

    tony s Well-Known Member

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    I don’t automatically consider machine breakdown as a nonconformity but this can be considered as a “consequence” of the nonconformity. NC is defined as “nonfulfillment of a requirement”. This must be addressed through clause 10.2
     
    tony s, Sep 7, 2018
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