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8.7 Conrtrol of Nonconforming Outputs VS 10.2 Nonconformity and Corrective Action

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Joihn A., Feb 21, 2017.

  1. Joihn A.

    Joihn A. New Member

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    Hi

    So lets assume we have a QMS process related nonconformity. You have performed the correction and also decided that corrective action will apply. Do you consider the correction part should be documented under 8.7 or 10.2.

    In the past I have always documented product nonconformities under 8.7, but correction on QMS related processes has been documented under a corrective action procedure (10.2) along with the corrective action. Does it really matter where you document it?

    I assume with 8.7, when they say 'output' as apposed to product, they are covering products and services. When 10.2 talks about nonconformity and correction they are covering processes here.

    Any input appreciated.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I "think" the issue is that you're stating the thing was both corrected and subject to CA. I'd use one and stick with it. If a QMS NC can be corrected, do it. Don't THEN apply CA. If you have a number of NCs for similar issues (over time) I'd subject that part of the QMS to CA, since to make multiple corrections makes no sense.
     
  3. tony s

    tony s Well-Known Member

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    I agree. But not just limited to products and services. IMHO, unlike with the 2008 version, which is limited to cover only products, Control of Nonconforming Outputs intend to cover "outputs" of processes that can affect the quality of products and services. The reason why 8.7.1 has the following statement:
    "The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services".
     
  4. Joihn A.

    Joihn A. New Member

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    Hi

    OK so lets assume its just correction. Its the correction documented under 8.7 or 10.2?
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Correction is a disposition which is contained in how to process non-conformance. The use of non-conformance within the context of the QMS has long been corrupted by the external audit process when it's expected to give corrective action responses, which then imply (at least in many auditors' heads) some type of root cause etc. Instead, we should always be allowed to simply disposition a QMS non-conformity as "fixed"...
     
  6. RoxaneB

    RoxaneB Moderator Staff Member

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    Why does it matter under which section the QMS process nonconformance is documented? I'm not being sarcastic, I'm genuinely interested. My first though, Joihn, is that the process for addressing a nonconformance has been made too complicated within your organization. If, however, your organization tracks these type of data for possible improvement actions in the future, I understand the approach although, again, I think the more important data to capture would be which process(es) have identified nonconformances. I can appreciate the desire to assign a nonconformance to a section of the standard, but I sometimes think we become too fixated on details that add little value to the sustainability of the QMS.
     
  7. tony s

    tony s Well-Known Member

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    If corrections are taken to deal with nonconforming outputs, I'll retain documented info to satisfy 8.7.2.
    If corrections are taken to react with nonconformities, I'll retain documented info to satisfy 10.2.2.

    For example: If the Purchasing Officer failed to check the completeness of the specifications provided by the requestor prior to placing the order to its supplier which then resulted to receiving of products that do not conform to the requestor's requirements - there are two issues here. One is the nonconforming purchased products which should be addressed as per 8.7. The other is the failure of the Purchasing Officer to check the completeness of the specifications which should be addressed as per 10.2.
     
    herbert mak likes this.
  8. Randy A. Kaczynski

    Randy A. Kaczynski Member

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    Per ISO 9002:2016,

    8.7.1 The intent of this subclause (8.7 Control of nonconforming outputs) is to prevent the unintended delivery or use of non-conforming outputs (at all stages of production and service provision).

    10.2.1 The intent of this subclause (10.2 Nonconformity and corrective action) is to ensure that the organization manages nonconformities, and
    implements corrective action, appropriately.
     
  9. sunrize

    sunrize Member

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    if we have a customer complaint regarding non conforming services

    the NCR initiated based on 8.7 or 10.2.1 ?
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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