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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. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    One unfortunate aspect of an information exchange like this one is that inherent limitations too often exist in supplying information realistically needed for a "It is/is not a valid NC" declaration. I additionally feel this constraint when addressing questions involving locations outside of the U.S., as, to be accurate, we would always need to start with the "What is required?" step and go from there.

    During an audit, the site is asked to demonstrate conformance to requirements. That can happen in up to three ways:
    1. Documented information, when an where required by relevant interested parties (both internal and external)
    2. What auditees tell us (verbal information)
    3. Physical observations
    Ideally the auditor will be provides with at least two of these in order to verify effective demonstration of conformance to requirements. But I have not received any of them: Since I was not present, I saw none of the documentation, did not hear or speak in person with auditees, and did not observe the circumstances. Too many of my questions have not been answered, nor can they in this venue.

    While I am not auditing now, I am being asked to take sides and my experience with dealing with data to assess things renders me unable to feel satisfied with what we have here. So I can't reach a conclusion. That is all.

    As for AB pressure to report negative findings, I can only relate my own experiences to the contrary.
     
  2. tony s

    tony s Well-Known Member

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    Major nonconformity against what?

    Many things expire in a hospital, not only emergency lights. But this doesn't mean that hospital personnel are remiss of their job. I believe, at this juncture, I have already provided enough information that the suitable infrastructure are functioning well, there's a standby generator to quickly power the main lights in case of power outage, maintenance and inspection of infrastructure, including emergency equipment, are in place. It just that at the time of the audit, the bulb rated life expires and the auditor discovered it before the next scheduled inspection of the maintenance personnel.
     
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  3. tony s

    tony s Well-Known Member

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    This is post# 100. I believe I have given enough information to elicit unequivocal responses. We don't need to be at the place and time when the auditor rendered his nonconformity findings. More frequent than not, we have to deal with second hand information provided by posters. We cannot always "wash our hands of" and make excuses that we are not present at the place and time so we cannot give definite answers. Whether our responses are agreeable or not to what the poster would like to hear/read from us, at least we don't leave them hanging. We're not supposed to always agree on matters presented to us and that's the beauty of this forum. Let the posters process our responses to form their own conclusion.
     
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I am sorry but I cannot give a definite answer without more clarity in this case. I disagree that I am trying to wash my hands of it; if I feel I don't have enough data to provide a good answer, I will simply say so. Others can feel free to offer their views, and have exercised that freedom. It's fine but something about this scenario gives me the sense there is missing information. I am sorry to be so difficult.
     
  5. Atul Khandekar

    Atul Khandekar Administrator Staff Member

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    OK. This topic has been beaten to death. The thread is now closed.
     
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