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Defective emergency light - NC against 8.5.1

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by tony s, May 3, 2019.

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  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    People post all kinds of things on the web. Do these come from any authoritative source? IAF? ISO/TC 176? JoeBlowCertification.ca?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think you'd need to qualify which auditor you're posting about. It's a rather sweeping statement and other readers here might get the wrong impression. As has been pointed out in other statements, there's a lot more needed to come to a definitive conclusion. No-one can post for an entire auditor population given the minimal information.
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So, one light out, doesn't meet either criteria it seems. It's neither a breakdown of the system and it's not one of multiple examples.
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    I agree. Without looking at the maintenance program, there is no evidence of a systemic breakdown.
     
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  5. Bev D

    Bev D Moderator Staff Member

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    I’ve read through this thread and there is one question that seems important but hasn’t been asked: what kind of emergency light was it? Was it a patient/room unique “I’m in trouble’ light? Or was it emergency lighting in the case of a power outage? If the latter, were there other lights that would have provided sufficient light? IF the former was there any redundant/backup way to signal that the patient needed help?

    My gosh there is just too much missing from this scenario...perhaps we could all calm down a bit and do our due diligence regarding the nature of the event?
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No effective auditor needs to "defend" anything they report. Why would a defense be necessary? Why would a client argue? Using words like that make me think there's an underlying issue with the way the auditor goes about things. Clients often don't argue because, as they say, "I refuse to have a battle of wits with an unarmed man". Some clients fear "retribution".
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Totally agreed, Bev. I think it's been from Tony's original assertion (post) that this shouldn't have even been an NC. There's so much missing.
     
  8. Bev D

    Bev D Moderator Staff Member

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    And this still doesn’t tell us anything about the purpose or context of the light. It only tells about the patients in the ward.
    Debates about conjecture are not debates. They are simply emotional churn. We used to call it gossip in high school or Harper valley or Peyton place.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed 100% Nothing stimulating about them at all. And totally uninteresting IMHO.
     
  10. tony s

    tony s Well-Known Member

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    Yes. It's just one in case of sudden brown-out. However, the hospital has a standby generator set in case of a power outage.
     
  11. tony s

    tony s Well-Known Member

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    Isn't it CB auditors should stick with the definition provided by ISO/IEC 17021-1:2015? See below:

    Major Nonconformity - nonconformity that affects the capability of the management system to achieve the intended results. Nonconformities could be classified as major in the following circumstances:

    • If there is a significant doubt that effective process control is in place, or that product 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.
    From this definition, I don't see that a defective emergency light found at the time of the audit, which the lives of the patients, including the intended results of the hospital, do not depend upon, will warrant a nonconformity as defined above.
     
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  12. tony s

    tony s Well-Known Member

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    Yes I don't see this issue is an NC. And if this is an NC, an NC against what? The hospital medical equipment are all functioning and they have a maintenance program. There is also maintenance for non-medical equipment, including the utilities and building equipment. Periodical checks on facility equipment, including fire management equipment, are being carried out. It's just that one emergency light in the "high risk" ward was found defective (not because maintenance people are not doing their job, but could be just that its lamp has expired on that day).
     
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  13. Bev D

    Bev D Moderator Staff Member

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    ...and just to clarify it is a light for illumination in the area in case of a power outage. It is not to ‘notify’ anyone of an emergency and there is a generator system that will power the area’s many lights that provide regular illumination that will kick in rapidly? So the effect of teh ‘broken’ light is trivial? There is no threat of harm or concern to the patients or staff?
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The grade isn't affected by the number of "voters". That's bizarre! It either is or isn't!
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    As all effective auditors know, there has to be A REQUIREMENT. There's none. All that's being done is stringing a bunch of emotive keywords together to make a point. Being an effective auditor is to evaluate the (systems) and qualitative and quantitative information - 1 light doesn't make a major and, hardly warrants a non-conformity.
     
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  16. Qualmx

    Qualmx Well-Known Member

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    T
    Tony's, could you answer this recent post?
    7.2 and 9.1.3.
    I'd like to hear your opinion.
    Thanks
     
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No. End of.
     
  18. Golfman25

    Golfman25 Well-Known Member

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    I certainly don't want my major/minor classification to be subjective. One bad auditor and you have nothing but grief.
     
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  19. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I seem to recall it's both a requirement of ISO 9001:2015 AND ISO 19011 that audits and the selection of auditors shall ensure objectivity and impartiality...
     
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  20. tony s

    tony s Well-Known Member

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    Yes to all your questions Bev.
     
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