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Corrective action treatment if problems currently dont exist

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Qualmx, Apr 24, 2017.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi all
    Could you explain how to treat this nonconformity.
    we are trying to solve them out of due date (allowed time is 20 days) however this CA is three months old.
    The nc was risen because the kpi was not in compliance,but this kpi already was eliminated in the last management review.
    If I carry out the cause analysis, will define that it was incorrectly set and for that, an action a plan is needed, which is to delete the kpi, but this already was done in the past.
    Is it practical to do the CA now even it was corrected previously and was not documented?

    How to treat them, if are being solved very late?
    Thanks
     
    Qualmx, Apr 24, 2017
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  2. Bev D

    Bev D Moderator Staff Member

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    Is this an internal or externally generated NC?
    That said, there is an issue with the difference between correction and corrective action to prevent recurrence. As you said, eliminating the KPI is correction. Are you required to determine the cause?
     
    Bev D, Apr 25, 2017
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  3. Qualmx

    Qualmx Well-Known Member

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    It was detected in a management review session.

    Well, the responsible just changed it because, determined it was incorrectly set.
    now the new kpi is in compliance, the goal is reached.

    But at revising delayed CAs, I found that one, problem is " not compliance with goal".

    But this change already was done by the user (he left the company) without doing a cause analysis.

    New user could do the CA lying with dates, and the root cause will be "incorrectly KPI" ending up to change KPI (what now is done)

    Hey, but now I have two problems
    one nc for not reaching the goal and attend it very late and with one correction done in advance
    the other NC it is for not follwing the CA procedure.

    What is your thought?
    Thanks
     
    Qualmx, Apr 26, 2017
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  4. Bev D

    Bev D Moderator Staff Member

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    I can appreciate your questions and concerns, they are appropriate. I would urge you to think deeper. A few things to think about as this situation has many good lessons if we really think about it and challenge things.

    Is there a good reason why a single incident of an event that had little to no negative effect on the quality system or the quality of the product worthy of a CA and 'root cause preventive action'? or is the correction sufficient given the severity?
    Why can't you just void the CA? Why can't you just record the action taken and when then close the CA if you feel like you need to document what actually happened this will do that.
    If the person who corrected the KPI didn't follow the CA system - is it more productive to revise the CA system? When people don't follow the system sometimes it's the system that is wrong...

    It seems to me that the KPI weakness was detected by the people who should control them and it was appropriately corrected - isn'y that what the behavior we want to promote?
     
    Bev D, Apr 26, 2017
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm wondering about the nature/content of the CAs which have been issued. It seems to me that a perennial issue with CA is that some arbitrary timeframe is set (30, 60, 90 days) which has little/no relevance to the content of the CA - let me put it this way: if management saw value in correcting something or taking corrective action, they'd be on it, and it might be 5 days!

    So, I'd commend that the content of the CA is the first place to look at fixing this issue, then who is setting the deadline for implementation. As far as the existing situation - review them and, as Bev suggests, void out the less significant ones - just fix them.
     
    Andy Nichols, Apr 26, 2017
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  6. Qualmx

    Qualmx Well-Known Member

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    Thanks Bev D and Andy

    In this case, how recommended is to define a timeframe to attend the CA´s, (30,60,90) because a lot of times, users dont comply with this.

    The could attend or close the CA 2 or 4 days later, so the didnt comply with timeframe.

    How do auditors consider this, would it be an NC?

    Thanks
     
    Qualmx, Apr 27, 2017
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So, you must put a timeframe on the action. However, before you even do that (and it doesn't have to be 30. 60, 90 days) you must find out why people are not responding to what you have as CAs at the moment. And yes, one way or another, not closing corrective actions in a timely manner (it says so in the standard) will result in an NC.

    QualMX - you MUST find out why people are not responding to the CARs which are being written. Your problem really lies there, not in the timeliness of closure.
     
    Andy Nichols, Apr 27, 2017
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  8. Bev D

    Bev D Moderator Staff Member

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    ...in addition remember that a "timely manner" doesn't equate to a set time frame. It is dependent on the situation.

    I have never seen a system that had a set max time frame for closure result in effective corrective actions. They do however result in ineffective corrective actions and disrespect for the system. Andy is correct - find out why. And don't settle for pat answers. Really dig to understand the true situation.
     
    Bev D, Apr 27, 2017
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