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Area of Concern - Closing effectiveness

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Padym, Nov 23, 2015.

  1. Padym

    Padym Active Member

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    Hi All,
    In our last external Audit 9001:2008 auditor noticed one area of concern. Internally we are discussing, on same and tracking via internal ticket. I want to ask how the auditor will assess the effectiveness of the corrective action as still there are discussion around it.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can you give us some details? I'm uncertain what the subject is. What corrective action subject are you discussing?
     
  3. Qualmx

    Qualmx Well-Known Member

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    If you mean a nc ,then,from here a ca is needed.
    In order to determine if the effectiveness of the action was successful, it is needed the evidence.
    And the criteria for the closeout, normally is defined by the responsible of the nc.
    Hope this help
     
  4. Chris Glover

    Chris Glover Active Member

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    We do two audits on non-conformances. The first to assure the Counter-measure determined during the Corrective Action process was implemented. This audit is done 30 days after the CA is closed. The second audit is done at 60 days; this audit is to determine if the counter-measure was effective (also checks to assure C/M is STILL in place.
    We also do, as part of our process audit program, follow-up audits 120-180 days later.
     
  5. MCW8888

    MCW8888 Well-Known Member

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    Even if there is no need for a procedure for CA, perhaps you can specify in your CA form that second audit done in 60 days is the audit of effectiveness.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No need for a procedure? I don't understand your comment. Also, isn't the point of CA that it's specific to the circumstance reported? Why would 60 days be appropriate every time? For an internal audit it should be planned with management, not force to fit some arbitrary number of days...
     
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  7. MCW8888

    MCW8888 Well-Known Member

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    I understand. I was just following the person's note. We have a CAR form that specifies 30 days for first verification of effectiveness, then there is a second verification, etc.. I guess these are no longer necessary.
     
  8. Chris Glover

    Chris Glover Active Member

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    60 days has been determined by management...even if it is arbitrary..that is what we have been directed to do...
    We also do other follow-up audits based on other criteria
     
  9. Qualmx

    Qualmx Well-Known Member

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    Really there is not a rule,it depends on the nc.
    I dont consider a fixed frame to do a follow-up of Ca.
    instead Define the criteria for the closeout ,once I have evaluated the efectiveness.
    For example one nc found in an equipment.my criteria for the closeout it is to work at full capacity for one month,or one nc in control of documents found in an internal audit,well, for me ,I define that efectiveness is ok if in two consecutive internal audits the problem is solved,then I close the ca.
    Regards.
     
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  10. Padym

    Padym Active Member

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    Thanks of all you for your inputs. This is not a NC but an Area of Concern, which may lead to NC in next surveillance audit if no proper action taken to analyze, closeout. The concern is registered in our internal tracking system and still in the discussion.
     

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