1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Defective emergency light - NC against 8.5.1

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

Thread Status:
Not open for further replies.
  1. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    The bulb rated life may have expired at the time of the audit and this will be checked by the hospital staff or maintenance personnel on the next scheduled test. Fortunately and unfortunately, this was discovered by the auditor. Equipment wears and some with parts that expire. It's not an NC that this fact of life happens. A nonconformity is if the organization doesn't maintain their equipment and still use them despite of the unsuitable condition.
     
    Jennifer Kirley and Andy Nichols like this.
  2. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    That was exactly the case. An auditor found a defective emergency light at the high risk ward at the time of the audit. There was no write up that maintenance or inspection was not performed.
    Yes. I agree that the issue can be easily rectified. But initiating rectification by issuing a formal NC should not be the appropriate approach.
     
    John C. Abnet and Andy Nichols like this.
  3. Katrijn

    Katrijn Member

    Joined:
    Apr 4, 2019
    Messages:
    37
    Likes Received:
    16
    Trophy Points:
    7
    Golfman,
    I agree. As I said before, broken emergency lights are often a symptom of something deeper... We need to know more about the system and finding to know if it actually is worth writing a NC or not ...

    And if he didn't question or investigate, only saw a dead light and based only on that sole fact wrote a NC, then he was wrong. It was an ISO 9001 audit, not a building maintenance inspection.
     
    Last edited: May 7, 2019
    tony s likes this.
  4. Katrijn

    Katrijn Member

    Joined:
    Apr 4, 2019
    Messages:
    37
    Likes Received:
    16
    Trophy Points:
    7
    But was there write up that it was?

    That I can't say without knowing the exact situation of their maintenance procedures.
    As John C Abnet said, an audit should be based on a system. I agree that this auditor shouldn't just write NC's at random.

    My approach would have been to check their maintenance system... Do they have a functioning system to notice, report and repair defective items? How did this particular defect escape their system? ... Might have led to a whole different set of NC's... (or maybe non at all)
     
    Andy Nichols likes this.
  5. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    926
    Likes Received:
    1,081
    Trophy Points:
    92
    Location:
    Ontario, Canada
    MODERATOR NOTE | Apologies for any disconnects in this thread. We attempted to pull the off-topic posts into a new thread and then return some inadvertently pulled posts. Quoted posts may not necessarily be located in this thread but over in the newly created thread focusing on auditor qualifications. Everything should be where it belongs now. :)
     
    Andy Nichols likes this.
  6. KyleG

    KyleG Active Member

    Joined:
    Nov 7, 2018
    Messages:
    96
    Likes Received:
    68
    Trophy Points:
    17
    Location:
    Reno Nevada
    Would it be an Infrastructure issue? I mean it seems like a very petty NC, but if my equipment wasnt serviced or maintained at proper intervals according to our schedule wouldnt that be a NC? So, if the the emergency lights was apart of their infrastructure maintenance program and a light was out then i get it. but still petty, (i could also be way off was just a thought)
     
    RoxaneB and Andy Nichols like this.
  7. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    926
    Likes Received:
    1,081
    Trophy Points:
    92
    Location:
    Ontario, Canada
    It does appear that a few of us are saying the same thing as you, Kyle, just in different ways.

    At the end of the day, however, what are we debating?

    (A) The raising of a light's "defective state" as a non-conformance

    - OR -

    (B) The validity of the finding because of its wording

    We don't have all of the story that led up to the discovery of the emergency light's state. They may have been following a maintenance/test process through and discovered it. Or maybe the auditor inadvertently discovered it while waiting on something else. We don't know if there was a discussion on how the hospital staff address the discovery of nonconforming equipment outside of maintenance/test periods. There is just too much here that is unknown and it is these types of situations that can make for great (and fun) debates among auditors, as well as a chance for us to stretch our minds and traditional ways of thinking.

    Is it a finding in the spirit in which it was (possibly) intended or not a finding because of its (probable) documentation loophole?

    Could the hospital argue that the finding isn't valid? Probably. Should they? Probably not.

    With all of the unknown variables and the usage of words such as "probably", "possibly", and "likely", no one can say with 100% certainty that his/her opinion is the only correct one in this situation.
     
  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    1,071
    Likes Received:
    722
    Trophy Points:
    112
    Location:
    USA
    When I say "all that" I am referring to that which is in the quote bubble. What was reported in this thread did not positively indicate auditor laziness. "What eludes many auditors" has not been positively proven in this case. In my view, there just isn't enough to go on with this example to reach a conclusion of auditor laziness. None of us was present: you, me, or Tony; we cannot reach a firm conclusion about the auditor's performance or character given the provided information.
     
  9. RoxaneB

    RoxaneB Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    926
    Likes Received:
    1,081
    Trophy Points:
    92
    Location:
    Ontario, Canada
    While I appreciate the effort, we cannot say that you are "replicate(ing) a similar situation" because we don't know from the Original Post what lead up to your first sentence in #6. Maybe it happened exactly as you outlined. Or maybe the auditor was standing around waiting for information on a completely different ask and just happened upon the defective light. We also don't know what happened after the light's status was discovered. Context is key here.
     
    Jennifer Kirley and Andy Nichols like this.
  10. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    816
    Likes Received:
    402
    Trophy Points:
    62
    How do you know the people even knew what they where doing? If it is an emergency light, doesn't it come on automatically when the power goes out? Wouldn't you at least take it a step further and get the maintenance people involved -- find out when the last test/inspection was; have them turn the light on, etc. I really have a hard time when auditors start evaluating complex systems they aren't experts in and don't call in the experts for the audit.
     
  11. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    816
    Likes Received:
    402
    Trophy Points:
    62
    It would depend on the facts and circumstances surrounding the "faulty" Emergency light. If they knew about it and a new one was on order, then no I would not because their system would appear to be working. If it was 3 years since their last inspection/test and they had no clue, the yes I would because it's clear their system may not be working. But I would be asking those responsible about the issue, not my "guide" or someone just walking down the hall.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    As a CB auditor you are, quite possibly, asking the wrong community about issuing non-conformities (and especially grading them). Most people here are a) internal auditors in different industries and b) grading isn't important to them, as a result.

    Yes, one or two contributors are CB auditors, in which case it's purely speculation and there may be some tacit agreement. However asking people who work in machine shops, or other non-hospital environments (without knowledge of regs, company policies, practices or even just day-to-day knowledge) etc is unlikely to obtain the agreement (or argument) that you see to be seeking. As Jennifer suggests, we weren't there. We can debate all day long hypothetical case studies and get no-where.

    I'm sure Tony has his question. I'd suggest closing this thread as done.
     
    Last edited: May 9, 2019
  13. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    A Major NC for a defective emergency light? What's your definition of a Major NC?
     
  14. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    According to my friend, where the issue came from, the high risk ward is just a room where pregnant women with complications rest after the delivery operation.
     
    Andy Nichols likes this.
  15. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Yeah I asked him yesterday to provide additional information for this thread.
     
  16. Golfman25

    Golfman25 Well-Known Member

    Joined:
    Nov 6, 2015
    Messages:
    816
    Likes Received:
    402
    Trophy Points:
    62
    I guess it comes down to "choose your auditors carefully." Good luck.
     
    tony s likes this.
  17. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Wow, how many do you know? I know it's a small world, but my gosh that's a sweeping statement to be making for such a large community, isn't it? Are there rules for what MUST be reported as an NC? They'd have to follow those wouldn't they?
     
  18. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

    Joined:
    Jul 31, 2015
    Messages:
    1,071
    Likes Received:
    722
    Trophy Points:
    112
    Location:
    USA
    Oh...well, if that's all. (rolleyes) I guess my perspective may be somewhat skewed, after laying on a hard bed in a cold room following two births, into thinking an emergency light may be important in such a room if the power were to suddenly go out. I haven't yet seen remarks about what the regulators/Interested Parties say (State or City Fire Marshal, for example; insurer is another possible example) so we are still at the "why does it matter?" question.
     
    Katrijn and RoxaneB like this.
  19. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    I agree that it should be brought to the attention of the organization but not as a formal NC and not against 8.5.1.
     
    Andy Nichols likes this.
  20. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    1,350
    Likes Received:
    1,054
    Trophy Points:
    112
    Location:
    Laguna Philippines
    Defective emergency light a major nc? Why a major nc? Can you define a major nc?
     
Thread Status:
Not open for further replies.