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Recurring Nonconformity will result to a Major NC

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Apr 18, 2018.

  1. tony s

    tony s Well-Known Member

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    I was told by a QMR of one organization that according to their CB if a nonconformity that was previously raised during the certification audit recurs and detected on the surveillance audit, this will result to a Major NC and will cause revocation of the certificate.

    What's your take on this?
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Tonys
    The answer is, “it depends”. If there is a lack of or complete break down of a required and/or stated system/component, then as with any other situation it is a MNC. If, within a complex existing and functioning system (an example may be control of documented information), a document was again found obsolete, this singular “finding” is not necessarily indicative of a missing or complete breakdown of a system/component. If, however , examples continue to be found audit over audit with no identifiable and effective corrective action, then numerous clauses may be considered for a major . (eg: mgmt review, corrective action, etc...)
    Hope this helps.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I have heard it before, but it was at an IATF 16949 audit. If your experience was with "vanilla" ISO 9001, I'd suggest it's "mission creep", from the automotive rules. Of course, CBs will always make up their own rules. One I know of said that 4 minors in one element/clause was a major! If only it was that simple. Crazy...
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    Yeah. That's a hold over from the fourth ed rules from TS. You would get hit on the the original nc, and get a major on your corrective action process. It made the stupid dot your Is cross your Ts nonconformities a real problem.
     
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  5. tony s

    tony s Well-Known Member

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    Fortunately they are only certified to the ISO 9001:2015 standard.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Mission creep by the auditor?
     
  7. tony s

    tony s Well-Known Member

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    I'll give you that:rolleyes:
     
  8. RoxaneB

    RoxaneB Moderator Staff Member

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    To echo John's response, it does depend. I'll get back to this is a moment...

    My own opinion on that kind of approach (i.e., 4 minors = 1 major) is that the organization was attempting to standardize their auditors' results. There is still some grey when it comes to auditing - especially with newbie auditors. Giving them some logic to follow was perhaps a way to help them determine what type of finding to write up. They decided, for whatever reason, that 4 hiccoughs = 1 systematic issue. I'm not saying I agree with this approach, but I can understand if that was the thought process behind it.

    Let's face it, sure we have a standard and we have organizational processes, but there is still some grey when it comes to auditing. There is "what is written" and then there is the "spirit" or "intent" of the requirements. There is also a desire to help an organization succeed and if they've improved from the previous visit but still just aren't quite there, do we penalize them or do we find some way to highlight the improvement while quietly pointing out that they're not quite meeting the requirements to the fullest extent possible? I'll be honest, and this probably why I will never work for a CB, I'd rather celebrate their achievements and forward progress, than to say "yeah, you're still not there." Grey area, however, it depends on the organization, maturity, leadership involvement, etc. It's usually easy to tell the difference between an organization going for just the paper on the wall versus one that genuinely wants to improve and ensure a wonderful experience for all Stakeholders.

    Back to Tony's question, again, there is no black and white answer here. If the minor nonconformity was in one department for let's say document control, and the organization corrected it...and this time around the finding is in a different department, but still with document control, is that a major finding? It could be a completely different root cause - and we don't know this at the time because we're not there to solve the problems - so classifying it as a major seems a little non-value-add to me.

    To the CB's point, however, their intent is probably focused on the spirit of corrective action - identify it, fix it, reduce the likelihood of it recurring...because if it recurs, perhaps we did not have the right root cause or a robust-enough action plan. It's too inflexible of an approach in my mind. There are other variables which the auditors may not be aware of.

    At that point, however, I'd be questioning the organization's corrective action process, not so much the fact that the issue has recurred...;)
     
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  9. BradM

    BradM Moderator Staff Member

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    The wife was on a jury for something (I believe, aggravated assault; man assaulted a woman). The jury (initially) swung from one who wanted to let him go (awww, he was sorry for what he did) to one wanted the Death Penalty!
    Even something that seems clear cut like speed limit... most law enforcement allows 5-7 mph over that for various contingencies.

    I think if a CB tries to maintain too strong of a path on the high road, they may be the only ones on that road.

    Certainly no one would desire a CB to recommend certification on an organization that honestly has no desire to improve and develop good quality processes. But having a "one and out" policy (two strikes you're out; etc.) doesn't foster a culture of improvement and excellence. It will instill Fear, resentment, and cause individuals to go back into caves when it comes to auditors/auditing, in my opinion.
     
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  10. Leonid

    Leonid Well-Known Member

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    ISO 17021-1:2015 "Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1 Requirements" gives no hint on revocation of the certificate due to recurring NC.

    The standard defines the major nonconformity as "nonconformity that affects the capability of the management system to achieve the intended results.
    Non-conformities could be classified as major in the following circumstances:
    — if there is a significant doubt that effective process control is in place, or that products or services will meet specified requirements;
    — a number of minor nonconformities associated with the same requirement or issue could demonstrate a systemic failure and thus constitute a major nonconformity".

    In the tony s' case, the major nonconformity can be issued only if it affects the capability of the MS to achieve the intended results.
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As mentioned in an earlier post, CBs have their own rules by which clients are bound.
     
  12. Leonid

    Leonid Well-Known Member

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    You are right. ISO 17021 cl. 9.6.5.1 reads: "The certification body shall have a policy and documented procedure(s) for suspension, withdrawal or reduction of the scope of certification, and shall specify the subsequent actions by the certification body". But CB's policies and procedures are subject to approval of AB and I doubt that such tough procedure can be acceped.
     
  13. Leonid

    Leonid Well-Known Member

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    Agree. But CB procedures are subject to AB approval and I doubt that such tough procedure can be accepted.
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Go ahead and believe what you wish...
     
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