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preventive action

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Manish Sawant, May 6, 2016.

  1. Manish Sawant

    Manish Sawant Member

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    Hello friends,

    I read somewhere about the need to determine different tools to detect, analyze and eliminate potential causes of Nonconformities. Can anyone please provide any examples on this?

    Also, For all the NC that are a quick fix and do not require any corrective action, do we consider these are opportunities for improvement and apply preventive actions on them?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not an ISO requirement to do this, however, the use of an "FMEA" (Failure Mode Effects Analysis) is helpful, as are the Control Plans which go with them.
    Call it what it is - a correction. Of you have an NC, you can't apply preventive action. It's too late, isn't it? And you can call it what you like, as long as you're not fooling yourself or anyone else. Dressing up an NC by calling it "Improvement" is a "spin" most will see straight through...
     
  3. meloford

    meloford New Member

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    I've found it easiest to use systems that are already in place. Why reinvent the wheel?! For example, we have a pretty robust employee suggestion program. Whenever there is a suggestion for improving the QMS, it is processed through our Corrective Action/Continual Improvement system (if it is a change that can eliminate a potential NC, it is considered an "improvement"). This is just one of the many ways we identify preventive actions or OFIs.

    I agree with Andy, if the "bad thing" (or NC) has already happened, I wouldn't consider it an OFI or preventive action. This distinction is sometimes difficult for our employees to grasp...
     
  4. MarkMeer

    MarkMeer Well-Known Member

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    The need for preventive action may come from anywhere where a potential NC is identified.
    This usually involves some type of risk assessment, and can be incorporated in to just about all processes.

    For example, equipment control:
    - You're purchasing a new engine.
    - What can go wrong? How can you prevent this from happening? Brainstorm.
    - You might determine that parts wear-and-tear is the most likely failure, and so employ a scheduled replacements and oil-changes. ...this is preventive action.

    Document and establish the above, and you've "detect(ed), analyz(ed) and eliminat(ed) potential causes of Nonconformities".

    It is worth noting that an identified NC may still result in preventive actions if the cause is assessed to potentially affect other things.
    For example, if one piece of equipment breaks down, this may result in an assessment of other equipment to see if perhaps similar break-downs might be prevented...
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Wouldn't it have to be similar? In which case, surely it's still corrective action... The "class" of equipment has had a failure...
     
  6. MarkMeer

    MarkMeer Well-Known Member

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    I'd say it depends on the cause. Some are really general, and can be relevant to a range of functionally unrelated items. For example, maybe the cause was as simple as dust or debris built up. Having identified this, perhaps there is other equipment that could also use a regular cleaning, or spray-out with compressed-air, if this was not previously considered for them.

    We're into the weeds a bit...but hopefully the OP gets the gist...
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    True, but it's in the details where the confusion is cleared.

    A true preventive action would have looked at the atmospheric conditions, in your example, and determined if there was a (risk) situation which could lead to problems and determined controls to be put into place. Everything else then becomes corrective action since the problem occurred - and they are now responding.