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Corrective Action Completion dates

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qbot123, Oct 12, 2020.

  1. Qbot123

    Qbot123 Member

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    I'm updating our non-conformance procedure and struggling with the completion date for the corrective action. Should this be the date the action is actually completed, or the date the effectiveness has been verified.

    Its easy to plan a date for completing the action, for example updating a procedure, but planning a date for verifying that change has been effective is harder. Is it enough to say that the verifier is happy that the action will be sufficient to prevent recurrence?
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Qbot123 ;
    If I understand correctly, you are attempting to write a "completion" time (e.g. "...within 30 days from..." [duration/time frame] ) requirement into your organization's procedure for responding to "non-conformances". Is that correct?
     
  3. Qbot123

    Qbot123 Member

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    No, this is the date that the action owner is setting to say they can close out the corrective action. But is it the date of them actually completing the action. Or should they be building in the verification time into their planned close out date.
    The only problem I have with them including the verification time is that once people set a date they tend to put off work until right near that date, so adding in verification time , in practise just ends up with people putting off completing the action rather than completing the action quickly and then leaving time for the action to be checked for effectiveness.
    I hope that makes sense!
     
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Ok...thank you.
    Still not sure I understand exactly what you are trying to accomplish, but I believe I have the gist of it so allow me to offer some council...

    Corrective action
    is not the same as managing the non-conformance.

    A- non-conformance:
    At the time of notification/awareness your organization should...
    a) have a series of steps to locate (lot/product traceability) any suspect product (in order, if necessary, to contain/recall, etc...)...
    and the conditions that may be making MORE suspect product.
    b) stop the production of suspect product (cease production and/or take action to prevent the situation.) ...or (not ideal but sometimes necessary) verify/sort product to prevent outflow of nonconformance.

    The aforementioned action can take place "immediately" (i.e. production can be stopped until an initial "fix" or verification can be established. Product sold/produced/in WIP can be contained until the required verification/scrap/rework/repair can be done).



    B- Corrective action:
    Using the appropriate discipline(s)...
    a) identify the root cause,
    b) correct/remedy the problem,
    c) verify the effectiveness
    d) ensure the "fix" is established systemically in order to prevent recurrence.


    It is impossible to "proceduralize" (i.e. determine ahead of time) a date/time frame for corrective action. Some problems can be easily identified and corrected nearly immediately. Other problems require extensive research (possible re-creation testing, etc..etc..) to identify the root cause and may take even LONGER (order parts, change equipment design, etc..etc..) to correct. While the isolation/containment/verification of product may be needed/possible "immediately" in order to keep good/verified product flowing to the customer, the necessary time for actual root cause analysis and correction is impossible to predict considering the infinite amount of scenarios.

    I would highly recommend your procedures do not attempt to predict or require a specific time frame for corrective actions.

    Hope this helps.

    Be well.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    An effective corrective action plan may have any number of dates associated with it, developed as the task of taking action is developed. Without going through all of the potential dates, there will be 2 key dates: The date the action to correct the situation (not contain an issue) is one and also the date the verification of effectiveness is performed is another. Any action which is effective will result in something measurable (that is tangible) with regard to a product or process. With some thought, that shouldn't be too hard to assign a timeframe to. Then, there's audit to complete the verification, which is a whole other topic!
     
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  6. John C. Abnet

    John C. Abnet Well-Known Member

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    The database/tracking method my organizations/I have used historically, always had TWO "closure" dates listed.

    1- Response to customer completed (actual situation corrected - reply to customer- and verified for effectiveness)
    2- Internal completion (yokoten including other campuses, etc...)

    The reason for this is that it is not uncommon for "yokoten" (feedback/feedforward) to be applicable. In other words...maybe the problem occurred on one of six identical/similar pieces of equipment/processes. Although the corrective action is completed specific to the situation/equipment on which it occurred, we would leave the second date (internal completion), "open" until the same corrective action was successfully implemented on any/all applicable similar equipment/processes. This allowed leadership to see a "report" to let us know if the customer's concern had properly/completely been addressed, while at the same time providing us a prompt and opportunity to confirm if other "behind the scenes" areas are also addressed.

    Hope this helps.

    Be well.
     
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  7. John C. Abnet

    John C. Abnet Well-Known Member

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    "Verification" is intrinsic to corrective action. It cannot be separated from corrective action. For that reason, the date the issue is "closed" should include the verification.

    Hope this helps.

    Be well.
     
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  8. NISHITH NEEMA

    NISHITH NEEMA Member

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    The observation is closed with evidence of corrective action. For this it is evident that for corrective action, date which has to be given is the date on which you have an evidence of what you mention in corrective action.
     
  9. Eric Twiname

    Eric Twiname Well-Known Member

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    If it helps...

    We had three dates:
    - When the work was anticipated to be done ("correction")
    - When the effectiveness would be verified (based on the above date)
    - when the item was closed as completed.

    Since each of the three (in our system anyway) was done by a different person, the three dates were appropriate and functional as "due dates".
    If something went past a due date..."Why?" was asked and reschedule was performed based on most recent data.
     
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  10. Evers

    Evers Member

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    The way I approached this is by having multiple dates as well as CAPA status:

    Closed: Yes, No, Pending (waiting for review results).
    [​IMG]
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Are you using a commonly found methodology, like "8D" or similar?
     
  12. tony s

    tony s Well-Known Member

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    The requirement says "review the effectiveness of any corrective action taken" (clause 10.2.1d). Whenever I encounter the word "effectiveness", I have to go back to its definition i.e. "extent to which planned activities are realized and planned results are achieved". So it has two parts. You may set a target date on when the "planned action" is to be completed and another date on when the "planned result" can be demonstrated with concrete evidence/s that it has been achieved.
     
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