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"Non-conforming outputs" - who's happy for this new requirement?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Andy Nichols, Feb 19, 2016.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The 2015 version doesn't distinguish non-conforming products, any longer. It's non-conforming OUTPUTS. To me, this is long overdue. Many organizations have non-product related processes and, therefore, outputs which have gone uncorrected. This new requirement is a great tool to look at the administrative burden on organizations which handle paperwork etc more than once, because information is missing/inaccurate etc.

    What are your thoughts?
     
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  2. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Wouldn't some of these be outside the scope of the QMS? just asking. If its product related, it obviously falls under QMS scope, but many processes are on the 'commercial' side. Example - a company underestimates the cost to manufacture a product. There is no impact to the product, it is still made to spec and marketed. Obviously a company failing, but does it impact the QMS? Companies purposely (for many reasons) low bid a project and then lose money, sometimes this is a strategic move (loss leader), sometimes just incompetence at the senior level.
     
  3. RoxaneB

    RoxaneB Moderator Staff Member

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    Considering I already take this approach in the development of a management system, not a big deal for me.

    For those organizations that are anxious at the potential mounds of bureaucratic red tape this may cause, I have two things to say:

    1. Your organization obviously has a larger problem that you've attempted to ignore/hide...like a kid who "cleans" his/her room by pushing everything into the closet and under the bed (not that I ever did that ;))
    2. Your organization is trying to fit to the standard instead of making the standard fit to your organization.

    No where does it say that every single nonconformance must go through a corrective action process. I've mentioned before that using nonconformance triggers is helpful in managing and focusing on the right nonconformances. If you have sufficient data to analyze nonconformances and say which ones are having the largest impact on the system or the ability to meet requirements (be it Customer, Environment, Safety, whatever), then any nonconformances that occur within a determined time frame (I typically use a year) get the full-blown corrective action treatment. The rest...logged and corrected and closed...a quick 'wham, bam, get back to business' approach.

    As part of our annual strategy planning, we review the year's performance...determine if the nonconformances that were the heavy hitters continue to be so. If yes, they stay as triggers. If we have them under control, we revise our triggers to be the next group having the largest impact on the system.

    At the end of the day, this idea of addressing nonconforming outputs is just good business sense. It's up to organizations to determine what will make it manageable AND value-added for them.
     
    Last edited: Feb 22, 2016
  4. Leonid

    Leonid Well-Known Member

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    I agree with Andy. Control of nonconforming results of processes (outputs) is a new requirement indeed, which overstrains organizations. It is not easy to weaken its effect by reducing the number of processes since most of them, including supporting ones, are explicitly needed for QMS (4.4), i.e. needed to meet the requirements for the provision of products and services (8.1). Control of outputs is provided by monitoring and measurement activities at appropriate stages (8.5.1). What is an appropriate stage for an output is unclear. Who can explain?
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Leonid, are you asking how we know what is the appropriate stage for an output? Output is the outgoing result of a process.
     
  6. Leonid

    Leonid Well-Known Member

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    Agree, that is why I asked what ISO could mean by this requirement which addresses appropriate stages.
     
  7. Leonid

    Leonid Well-Known Member

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    Control of nonconforming outputs was present in 2008 version but it related only to product realization processes. Please refer to cl. 8.3 Control of nonconforming product & cl. 1.1 Note 1: the term “product” applies to any intended output resulting from the product realization processes. In 2008 version, processes needed for the QMS included, in addition to processes for product realization, other processes for management activities, provision of resources, measurement, analysis and improvement.

    Is exclusion of such "other processes" from 2015 "Control of nonconforming outputs" justifiable in terms of 4.3?
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I suggest that this can mean subprocess outputs and components before installed into assemblies.
     
  9. tony s

    tony s Well-Known Member

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    You can also check this previous thread.
     
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  10. David Sanabria

    David Sanabria Active Member

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    Is this the paragraph that you are making reference to?

    it looks like they are specifically writing about products and not processes - just my 2 cents...

    and I QUOTE:

    8.7 Control of nonconforming outputs


    8.7.1 The organization shall ensure that outputs that do not conform to their requirements are

    identified and controlled to prevent their unintended use or delivery.


    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.


    The organization shall deal with nonconforming outputs in one or more of the following ways:


    a) correction;


    b) segregation, containment, return or suspension of provision of products and services;


    c) informing the customer;


    d) obtaining authorization for acceptance under concession.


    Conformity to the requirements shall be verified when nonconforming outputs are corrected.
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So a new product design package is product in your experience? If the package doesn't conform and it delivered to suppliers or to inhouse manufacturing and they acted on the specification it wouldn't become non-conforming product?

    Wouldn't the new product design package have to be treated in those ways, before use by manufacturing or the organization's suppliers?

    I'm willing to be open minded here, if I have it wrong...
     
  12. David Sanabria

    David Sanabria Active Member

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    My curiosity was for clarification purposes of your original statement. When you wrote it - were you thinking of this clause 8.7.1.

    If you did then this clause is for nonconforming outputs of product or services.

    If you didn't - which other clauses were you thinking about?
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I don't see the word "product" or "service" anywhere...
     
  14. David Sanabria

    David Sanabria Active Member

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    8.7 Control of nonconforming outputs


    8.7.1 The organization shall ensure that outputs that do not conform to their requirements are

    identified and controlled to prevent their unintended use or delivery.

    "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".
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    In this bit...
     
  16. Gerald

    Gerald Member

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    What is considered appropriate action? Is it resource based? Customer based? Auditor interpretation based?

    Is "appropriate action" the same for a company of 200-300 employees the same as an outfit running at 50-60?

    Must an organization place nonconforming outputs in categories based on their severity and address each category in a different way?

    To me, this sub clause is far too subjective for the auditor, so being objective as an organization only benefits the performance of that company's QMS (a good thing) but may not fit what the auditor wants to see (bad).
     
  17. David Sanabria

    David Sanabria Active Member

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    Yes... "appropriate action" you wrote... but you must also include in your quote the rest of the sentence... - " based on the nature of the nonconformity....

    Interpretation - Each NCR is unique and must be treated as so... some are complex and some are simple.

    Therefore, the organization shall take actions based on the nature and complexity of the nonconformity...

    so to your question - 'appropriate action is not not dependent on the count of employee and yes an organization must evaluate each NCR for its merits and uniqueness.
     
  18. Gerald

    Gerald Member

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    Understandable - yet still a lot of gray area. I agree that treating NC A and NC B the same is bad practice...my question more so speaks to putting a nonconforming output procedure on paper. Is stating "nonconforming material will be addressed based on the nature of the nonconformity" adequate? That just seems too subjective to me...it's a very broad statement that I worry will throw red flags to an auditor because there really isn't any basis to go off of besides saying management review will decide the required action and disposition of a nonconforming output.
     
  19. Tony Wardle

    Tony Wardle Member

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    Surely its based on the risk.
    The fist time the word non conformity appears in the standard, is under the heading 0.3.3 Risk Based Thinking.
    The action should be appropriate based on the risk it poses from the perspective of those criteria "that meet customer and applicable
    statutory and regulatory requirements;" - these being the first benefits quoted in the standard.

    Thats how I would interpret this.

    How you choose place outputs into categories is based on YOUR business.
     
  20. tony s

    tony s Well-Known Member

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    If APQP (advanced product quality planning) is a process and produces a Control Plan with some omissions, I believe 8.7.1 should be triggered since this kind of "output" will surely affect product conformity. The output in this example is not the product itself.

    If calibration is a process and produced an inaccurate report but was identified later, 8.7.1 should be triggered since this kind of "output" may have affected those products that were already delivered to the customer. Again, the output here is not the product itself.
     
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