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The effectiveness of the CAPA process.

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by ndumiso, Aug 24, 2020.

  1. ndumiso

    ndumiso New Member

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    Hi all,

    I was wondering, what do you think it the best way to measure the effectiveness of the CAPA process?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Easy! No repeat issues of the kind the CAPA was applied to.
     
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  3. tony s

    tony s Well-Known Member

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    To complicate it a bit. Whenever I am confronted with the word "effectiveness", I go back to its definition. Effectiveness is the "extent to which planned results are achieved and planned activities are realized. So, it has two parts.

    Going to back to your question. If I will measure effectiveness of CAPA, I will need to obtain concrete answers to these two questions:
    1. Have all of the planned results been met?
    2. Have all planned activities been completed?
     
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  4. Bev D

    Bev D Moderator Staff Member

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    Despite the persistent misuse of the term, there really is no CAPA process. Per the definitions, there is a Corrective Action Process (which includes actions taken to prevent recurrence of a nonconformity that has actually occurred) and a Preventive Action process (that involves action taken to prevent nonconformities that haven't yet occurred). The confusion set out by the standards was 'rectified' by dropping the use of the term Preventive Action and replacing it with "Risk Based Thinking". Ironically - and tragically - the standards have really only increased the confusion and haven't really increased the amount of risk based thinking and the preventive actions that are intended to come from such an approach.

    Effectiveness per the dictionary definition: "the degree to which something is successful in producing a desired result". In the case of Corrective Action the desired result (by definition of the standard: "corrective action to prevent recurrence") is NOT that planned actions are implemented. The desired action is that the nonconformity is prevented from recurring. That is effectiveness as Andy so succinctly stated.
     
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  5. NISHITH NEEMA

    NISHITH NEEMA Member

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    The clause 10.2 of ISO 9001: 2015 talks about Non conformity and corrective action. A documented procedure for nonconformity occurrence in-house or arising from customer complaints , also to avoid the unintended use of nonconforming parts/products (parts/products )which do not meet quality acceptance criteria).
    This includes the following :
    1) React to the non conformity by Identification of nonconforming parts/product and notification to the function concerned.
    2) Taking actions for controlling ,Disposition and/or segregation of nonconforming parts
    3) Dealing with the consequences .
    4) Documentation and analysis of the details of non conformity The nonconforming parts/products are controlled as follows :
    5) The section which finds a nonconforming parts/product is suitably identify and in order to prevent it from unintended use isolates it from the conforming parts/products until it is disposed .
    6) The section where the nonconformity is noticed, document the non conformity and conduct a primary analysis, and judgment for final disposition.
    So it includes all the effort so that the problem does not repeat any where else.
     

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