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Difference between clause 8.7 and 10.2

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by MCW8888, Apr 2, 2016.

  1. MCW8888

    MCW8888 Well-Known Member

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    My company is now transitioning to ISO9001:2015. As I look at these documented information one question came to my mind: What is the difference between Clause 8.7 Control of Nonconforming outputs and Clause 10.2 Nonconformity and corrective action? Is clause 10.2 the action taken when a non-conforming product/service is identified (internal or external)? Thank you.
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Outputs that have been non-conforming can be thought of as nonconforming product, but now it's recognized that means services too. So the questions are:

    1) How are they controlled to keep them from the final product or service
    2) How they are managed: rework, accept with concession etc.

    Let us note this now includes outputs from upstream: interactive processes that the final product/service depends on.

    Corrective action is still a process all its own and is recognized to be for services also. It can be used for resolving what went wrong to make the nonconforming outputs, customer complaints, internal and external audits, and any time the organization wants to apply discipline problem solving process to address some internal point of their concern.
     
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  3. MCW8888

    MCW8888 Well-Known Member

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    Thank you Jennifer.
     
  4. Marcelo Antunes

    Marcelo Antunes Active Member

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    8.7 is what you do when you found a non-conforming product - you have to take action on that product/service (incidentaly, product has for a long time - t least since ISO 9000 - 2000 - meant services, software,hardware and processed materials).

    10.2 is a little weird in this version of the standard. Past versions of the standard dealt with non conforming product as mentioned, and the corrective action clause was focused only in eliminating the cause and thus begun with reviewing NCs. One of the problem in that case was there were no specific requirement of what to do with NCs which were not related to product (for example, system NCs such as not complying with a process requirement). This new version in clause 10.2 corrected this because it begins with what to do when you find an NC (react to it), then you evaluate the need to corrective action.

    The only problem (well, the worst one) is that 10.2.1 a) may create confusion in the case of non-conforming product requirements in 8.7.
     
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  5. MCW8888

    MCW8888 Well-Known Member

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    Thank you.
     
  6. MCW8888

    MCW8888 Well-Known Member

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    8.7 is what you do when you have nonconforming output. That means products or services- so if the service we get from outsourced processes failed to meet our requirements per SLA we have to issue a Supplier Corrective Action which is 10.2 in order to eliminate the NC. Therefore can I just maintain a CAR log for all the product nonconformities external or external? The car log should have a section for containment, root cause and follow-up for effectiveness. The corrective actions taken from the nonconformity should improve the effectiveness of the process. Quality Alerts that we observe everyday in the LPA or GEMBA walk do not need root cause analysis but needs to be corrected right away. Your comment? Thank you.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Non-conformances don't always need anything else but action to disposition them. I'd be very cautious about doing CARs for every non-conformity because you will sink under the weight of them. Non-conformities need a) to be dispositioned, dealt with and records kept b) they need to be analyzed (real time) and using 80/20 type rules, you can then c) determine which are going to have a corrective action.

    Whatever you do, avoid NC = CAR!
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    It is a good place for risk based thinking, yes?
     
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  9. MCW8888

    MCW8888 Well-Known Member

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    Thank you all for your feedback.
     
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  10. Marcelo Antunes

    Marcelo Antunes Active Member

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    As mentioned by Andy, you do not need to directly escalate for corrective action every NC.

    In ISO 9001:2015, after you find a NC, you need to react to the NC, as mentioned in 10.2.1 a), and then you evaluate the need for a corrective action, in 102.1 b). You need to follow on c)-f) only the ones you determine in b) the need for corrective action (elimine the cause to prevent recurrence or occur elsewhere).
     
  11. MCW8888

    MCW8888 Well-Known Member

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    I understand, thank you.
     
  12. Randy A. Kaczynski

    Randy A. Kaczynski Member

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    Per ISO's "Correlation matrices between ISO 9001:2008 and ISO 9001:2015",
    8.7, Control of nonconforming outputs (2015) <---> 8.3, Control of nonconforming product (2008)
    10.2, Nonconformity and corrective action (2015) <---> 8.3 Control of nonconforming product; 8.5.2 Corrective action (2008)
     
  13. tony s

    tony s Well-Known Member

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    Is this official? Is this from iso.org? TC 176?

    I believe it is not the intent of 8.7, even the 2008's 8.3, to extend the controls to initiate corrective action/s. The entire statements of both clauses mentioned the words "correction" and "corrected" but NOT "corrective action".
     
  14. Quality Renegade

    Quality Renegade Member

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    Looks like it is official, see page 4 of TC 176's correlation matrix. It aligns 8.3 to 8.7 and 8.3 & 8.5.2 to 10.2, an earlier version i had did not relate 8.3 to 10.2.
     

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  15. MCW8888

    MCW8888 Well-Known Member

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    I think Tony's answer make sense to me now. I have that matrix. Thank you.
     
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  16. Randy A. Kaczynski

    Randy A. Kaczynski Member

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  17. MCW8888

    MCW8888 Well-Known Member

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  18. Qualmx

    Qualmx Well-Known Member

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    Marcelo why no?, a nc needs corrective action (correction or corrective action (Fishbone 8d).
    Or both. Ia better to say a nc needs a correction (containment ) or corrective action (full analysis)
    Are you agree?
     
  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Correction isn't synonymous with containment. Correction is correction. This discussion is being held in another thread here, so I'd suggest that to get your best answer, it should be continued in that thread.
     
  20. MCW8888

    MCW8888 Well-Known Member

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    Thank you Jennifer. Correction is needed to stop the problem immediately. It may not need a full Corrective Action plan.
     

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