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Control of Nonconforming Output vs Nonconforming Product

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Oct 22, 2015.

  1. tony s

    tony s Well-Known Member

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    I'm trying to differentiate the 2015 requirement for controlling the nonconforming output from 2008's control of nonconforming product. Here's my take on this:

    In 2008 clause 1.1 General - Note 1, "product" only pertains to "product intended for, or required by, a customer" and "any intended output resulting from the product realization processes". Thus, IMHO, controls required are limited to those nonconforming products that will be delivered to the customer of the organization. See the image below with particular attention to the output of the Product Realization box.

    upload_2015-10-22_21-1-6.png

    In 2015, controls are now required to be present on all types of processes (i.e core or support or management) with nonconforming outputs - not just those that resulted from the product realization processes as depicted above. I arrive on this understanding due to the schematic representation of the elements of a single process in Figure 1 of the 2015 version. See image below:

    upload_2015-10-22_21-23-59.png

    This is my humble interpretation of the difference between ISO 9001:2008 clause 8.3 and ISO 9001:2015 clause 8.7. I would like to invite the other forum members to share their thoughts on this.:)
     

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    Last edited: Oct 22, 2015
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    A good item for discussion, Tony. Indeed, why wouldn't you WANT to treat it like 2015 infers? If the output from Purchasing is a non-conforming Purchase Order (I encountered a situation where the rev of the spec was stripped out by the computer) then you would WANT to ensure it was fixed or a corrective action taken...
     
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  3. tony s

    tony s Well-Known Member

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    What does ISO 9001:2015 clause 8.7 infer? Honestly, my take in the new requirement is that "all nonconforming outputs must be controlled" and shall be dealt with in accordance with clause 8.7.1 a to d. This is what I understand (at the present time) that 2015 infers. ISO 9000:2015 defines "output" as "result of a process" that is why I relate it to the schematic representation of the elements of a single process in Fig.1 of ISO 9001:2015. Since there are many types of processes making up a quality management system, hence my take that "all nonconforming outputs must be controlled".

    Yes, of course. Nonconforming PO resulting from the Purchasing process must be corrected. However, taking corrective action, IMHO, would be asking more than what clause 8.7 infers. I've read the entire clause of 8.7 and haven't encountered the words "corrective action".
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    But if you look at non-conformance controls, they allow for (simple) correction, (or other disposition) not corrective action - which you might take on clear trends etc.
     
  5. tony s

    tony s Well-Known Member

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    It is also my understanding that corrective action is not required by 2015's clause 8.7. That is why I mentioned "taking corrective action, IMHO, would be asking more than what clause 8.7 infers".

    Going back to my original post, I believe that the intent of 2015's clause 8.7 is larger in scope than the intent of 2008's clause 8.3. The old clause 8.3 only requires controls to deal with the "output" of the organization (i.e. product realization processes) while the new clause 8.7 requires controls to deal with the "output" of all types of processes.

    I based this interpretation on the definition of an "output" as the "result of a process" by ISO 9000:2015 clause 3.7.5. Also, in this new version of the standard's vocabulary, "product" is now defined as "output of an organization that can be produced without any transaction taking place between the organization and the customer".
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I believe that the 2000/2008 versions would have inferred this too, however, the main focus was taken to mean just the product. If you take a careful look at the requirements of the 4.1 (I think it is) requirements, it becomes clear (to me at least). It's common in many businesses that the processing of paperwork is ineffective because there's a lack of information - in addition to the PO example, take a look at another Purchasing function - that of receiving purchase requisitions. Many are incomplete, with the result that they get set aside for follow up action by the buyer, before they can be processed. These errant requisitions don't get processed for some time, although the requisitioner thinks they are. The buyer may not get to follow up until later that week, or maybe not...

    It's such processing which is frequently overlooked when considering non-conformance, but never-the-less indicate an ineffective process of the QMS.
     
  7. tony s

    tony s Well-Known Member

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    If 2015's intent is exactly what 2000/2008 are trying to infer, then 8.7 should have been appropriately titled as: "Control of Nonconforming Products and Services". This would also be consistent with the Table A.1 of ISO 9001:2015 where 2008's "product" is expounded into 2015's "products and services". There should be a profound reason why the framers of ISO 9001:2015 change it to "Control of Nonconforming Outputs".
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not exactly, IMHO. "Products and services" refers to the fact that, over time, the standard has had to address not just the (hard) product, but that a) product also includes services with it in some cases and b) that some organizations provide services and not a (hard) product
     
  9. tony s

    tony s Well-Known Member

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    Yes Andy, I think I get it when 2015 expounded the term "products" into "products and services" What concerns me is the change in the 2008's requirement for "Control of Nonconforming Product" into 2015's "Control of Nonconforming Outputs".

    If I have to ask: Does the intent of ISO 9001:2015 clause 8.7 exactly the same as the intent of ISO 9001:2008 clause 8.3?

    I would very much appreciate if our co-forum members will answer this (whether Yes or No) and provide us their reason.
     
  10. Bev D

    Bev D Moderator Staff Member

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    At first blush, I would interpet 'outputs' to mean the output of any process not just the product or service that the organiztion provides. But I wouold ask for 'official' interpretation - what did the authors intend? What is the guidance being given Auditors?

    If this really is going beyond product/service I forsee a lot of additional documented controls, more so than risk managment...
     
    Last edited: Oct 26, 2015
  11. tony s

    tony s Well-Known Member

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    Just to add other information relevant to this topic:
    • ISO 9000:2005 clause 3.4.2 defines "product" as a "result of a process"
    • ISO 9000:2015 clause 3.7.5 defines "output" as a "result of a process"
    • ISO 9000:2015 clause 3.7.6 defines "product" as an "output of an organization that can be produced without any transaction taking place between the organization and the customer"
    • ISO 9000:2015 clause 3.7.7 defines "service" as an "output of an organization with at least one activity necessarily performed between the organization and the customer"
     
  12. Sidney Vianna

    Sidney Vianna Well-Known Member

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    The intent, in my view has expanded. In addition to deliverable product/service, this section of ISO 9001:2015 also addresses non-deliverable outputs. As the example already offered by Andy (nonconforming PO), I would offer a nonconforming assembly drawing (design and development output) which could lead to a nonconforming product. The assembly drawing could be used only internally and, therefore is a non-deliverable item. However, it should be treated as per 8.7.

    So, the way I read it, the new 8.7 goes beyond the old 8.3 because it also address non-deliverable outputs.
     
  13. Randy

    Randy Member

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    Yep, as Sidney said....Just passed my 9001:2015 test;)
     
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  14. askartsolutions

    askartsolutions Member

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    A most interesting discussion! Here is my take on it:
    1. Clause 8.7.2 deals with the symptoms of n/c output whether it is a product, service, process, procedure or other document or activity. Once it has been identified it must be dealt with as required by clause 8.7.1.
    2. Not all n/c's require c/a; but if a c/a is required then clause 10.2 kicks in to address the root cause of the n/c.
    For more insight into this topic, please see the attachment which is an extract from "Understanding ISO 9001:2015" eBook
     

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  15. francis

    francis New Member

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    Can some help me with checklist for internal auditing in my organisation (welding and fabrication industries)
     
  16. oghall

    oghall New Member

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    I know this thread has been idle for a while but I'd like to pose another question regarding this subject I would agree that the requirement extends beyond product nonconformances but would suggest that it is limited to those processes and outputs included in Section 8 Operations. Otherwise it would be in a different section.

    Also regarding the example of incorrect PO's or other nonconforming non-product outputs what would be examples of complying then with the requirement for retaining documentation?
     
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  17. tony s

    tony s Well-Known Member

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    IMHO, it's better to say "those outputs of processes that will affect conformity of products and services". Calibration of measuring equipment definitely falls under Clause 7 but will impact product conformity if it produces nonconforming outputs.
    If I placed a nonconforming PO to supplier, let's say wrong specs specified. The following documented information can be retained as per 8.7.2 sub-clauses:
    8.7.2a - email message advising the supplier about the "wrong specs" in the previously sent PO;
    8.7.2b - the attached "corrected" PO on the email message;
    8.7.2c - This is optional. If the supplier has already delivered the item/s, there might be documentation on the ensuing arrangements taken;
    8.7.2d - my identity, as the Purchasing Officer, is indicated on the email message and attachments.​
     
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