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No risk rating - NC!?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, Jun 5, 2019.

  1. tony s

    tony s Well-Known Member

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    Early this week, a consultant friend told me that a nonconformity was raised against her client because their method for determining risks/opportunities doesn't have criteria for determining the level of risk (i.e. high, medium, low). The CB auditor was looking for factors such as how the severity of the impact and likelihood of the occurrence of risks are measured.

    I've actually observed such prescriptive calls of CB auditors, fortunately we know how to push back. For others, like my friend's client, who doesn't want to tussle with CB auditors, will just go along with the prescriptive call and accept the nonconformity finding.

    Just want to vent my exasperation and, at the same time, get some two cents (agreeable or dissenting) from the members of this forum.
     
  2. Bev D

    Bev D Moderator Staff Member

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    This is definitely overstepping (and underthinking) on the part of the auditor
     
    John C. Abnet and tony s like this.
  3. Qualmx

    Qualmx Well-Known Member

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    I’m not agree, standard doesn’t require to evaluate level of risk, neither to use some special methodology for the addressing the risks.
     
    tony s likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes! Another auditor who doesn't understand.
     
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  5. tony s

    tony s Well-Known Member

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    Yeah. It's really disappointing. CB auditors should at least read the standards. Below are the statements where both ISO 9001 and ISO/TS 9002 clarified the concept on determining risks:

    Annex A.4 of ISO 9001:2015:
    Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement
    for formal methods for risk management
    or a documented risk management process. Organizations can
    decide whether or not to develop a more extensive risk management methodology than is required
    by
    this International Standard, e.g. through the application of other guidance or standards.

    Section 6.1.1 of ISO/TS 9002:2016:
    There is no requirement in ISO 9001 to use formal risk management (in accordance with ISO 31000
    [19]) in determining and addressing risks and opportunities. An organization can choose the methods
    that suit its needs.
    IEC 31010[23] provides a list of risk assessment tools and techniques that can be
    considered, depending on the organization’s context.
     
    Suraiya Ramkissoon likes this.
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sadly, there's little/no incentive to ensure auditor competency. Registrars don't want to spend money on ensuring their auditors have a clue. We see examples here and at the Cove all the time.
     
  7. Golfman25

    Golfman25 Well-Known Member

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    Auditors fall back on what they consider "best practices" instead of using the standard. Auditees frequently don't know the extent of the standard and take auditors commentary as gospel. It takes several cycles before the Auditee will learn to push back.
     
    tony s likes this.
  8. Qualmx

    Qualmx Well-Known Member

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    Regarding to auditors, once I heard someone to say.
    we see them as Gods and some of them seem feel like that but really....... they are human.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    With the most recent changes to ISO 9001, they don't even have that, because no-one knew what was a "best practice" and, for the most part contract auditors rarely have an opportunity to do consulting (some train, but talking about it instead of practicing isn't the same thing) so they avoid much of what is new and when they do venture into those areas - risk and opportunity - they don't read the guidance. A self proclaimed "expert" auditor who posted here frequently confused the various requirements...
     
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  10. yodon

    yodon Well-Known Member

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    Not disagreeing with any of the above but I wonder if the auditor asked how they addressed this clause (from 6.1.2):

    Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

    (emphasis added).
     
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Experience shows that, if a SWOT analysis is used, by the leadership team, there's rarely any debate about 1) what the risks and opportunities are and 2) the priority for dealing with them. One universal truth, here in the state of Michigan, is the need to grow some skilled people - fast! Management don't need no stinkin' criteria (H-M-L) to start working on THAT!
     
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  12. tony s

    tony s Well-Known Member

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    There's nothing here that implies determining the level of risk. The same intention is also employed in clause 10.2.1 where it says "Corrective actions shall be appropriate to the effects of the nonconformities encountered".
     
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  13. Golfman25

    Golfman25 Well-Known Member

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    To me that's what a "judgement call" is. We make them every day.
     

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