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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. tony s

    tony s Well-Known Member

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    Last month, my friend who works at a hospital had their surveillance audit and they received a nonconformity against 8.5.1 due to "defective emergency light at High Risk Ward". Although it was a minor one, I find it inappropriate to raise as a nonconformity. Of course, a well functioning emergency light will serve well in times of emergencies but is never one of the "controlled conditions" when doctors and nurses routinely care for their patients in hospital wards. What can you say about my friend's plight?
     
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  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Interesting scenario @tony s
    The key issues are...
    1- the standard
    - ISO9001:2015)
    2- the scope of the standard
    - meet customer requirements
    - enhance customer satisfaction

    While this is only one light (out of I'm sure many lights), it makes sense considering ....

    Within 8.5.1...
    d) the use of suitable infrastructure and environment for the operation of the processes....


    ...and , the new emphasis on "customer focus" (5.1.2)..\

    ...that a minor would be issued.

    Why, may I ask, do you find it " ...inappropriate" ?
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I've come to learn that auditors are out of control. They write up whatever they feel is worth their time. I'd appeal it.
     
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  4. BradM

    BradM Moderator Staff Member

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    Hmmm... interesting.
    So during a surveillance audit, someone got involved with testing emergency lighting. Was there a test as part of their quality management system? Why was the emergency light even in the scope of this audit? How was the light tested?

    That would be part of the safety program and their routine testing. Not sure how this became part of a quality audit.
     
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  5. John C. Abnet

    John C. Abnet Well-Known Member

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    So, I'm as quick as any (more so?) to criticize/critique hyperactive auditing. I agree, that many auditors are out of touch beyond the academics of the standard (and in some cases even considering the academics of the standard.)

    Having said that, I have never been a fan of the term "Quality" in Quality Management System. As we all know, many organizations immediately assume that the system only pertains to the Quality Department or Product Quality. In this case, "quality" is in the form of service provided to patients (customer).
    Frankly, I'm just impressed that a medical organization would want to be registered to ISO 9001 (is this common???)

    I also would be interested to know more about how this was discovered during the audit, however, apparently it was discovered and in this case I may actually take the side of the auditor.

    Be well.
     
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  6. BradM

    BradM Moderator Staff Member

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    Hello John!
    You make some really great points! In general I agree with your thought processes here. I too am not a fan of having tunnel vision with respect to audit purpose. After all.... a problem is a problem.

    Someone here is paying to have an auditor review their quality system. At some point, things need to be guided towards the audit objective. Otherwise, an auditor would be there continuously and they would have 40 pages of write up. :)
     
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  7. John C. Abnet

    John C. Abnet Well-Known Member

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    Good point @BradM . Much to consider...thanks for the feedback!

    Be well.
     
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  8. tony s

    tony s Well-Known Member

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    The statement in the standard is "implement production and service provision under controlled conditions" which include "use of suitable infrastructure and environment for the operation of processes". The intent of 8.5.1 here, as clarified by ISO/TS 9002 is "for the organization to establish the controls for providing products and delivering services that ensure that the intended results are achieved". That's why I mentioned in my original post "a well functioning emergency light will serve well in times of emergencies but is never one of the "controlled conditions" when doctors and nurses routinely care for their patients in hospital wards".

    I would not raise an eyebrow if the auditor issued an nc against use of defective surgical lights or any other "suitable" infrastructure for the operation in a hospital. But I will find it "inappropriate" if auditors will slap a hospital, a vehicle/parts manufacturer, a construction company, or other organizations with well functioning "suitable" infrastructure that "ensure that the intended results are achieved" with a nonconformity just because one of their emergency lights is found defective at the time of the audit.
     
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  9. tony s

    tony s Well-Known Member

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    I believe so. Maybe RoxaneB has more in-depth experience in this sector.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's a typically lazy auditor: Did they check to see if maintenance had been informed, for example? Probably not. So many auditors simply write up symptoms. They rarely, if ever, dig into the SYSTEM which is affected. If you asked them if their doctor tells them they have a runny nose, so fix your nose, they'd be shocked, but that all they do. But then, they didn't study for 5 years before becoming an auditor...
     
  11. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Who are the interested parties? What are their requirements? Does this include insurers? Regulators?

    As a facility that provides public health services, it is conceivable that safety infrastructure becomes part of quality system requirements. The questions are:

    1) Is the organization held to this requirement as part of their conforming delivery of service?
    2) If #1 is yes, has the organization recognized it?
    3) If #2 is yes, has the organization established controls to ensure the requirements are met?

    Different clauses apply, but the overall point is that this facility sells wellbeing to people. As such, their requirements can be expected to differ from your usual widget producer.
     
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    To be fair, I did not see reference to whether maintenance had been performed, so I was wondering how you decided the auditor was lazy? While the term "defective" sounds extreme, Websters does not define the term past the symptomatic sense.

    That said, I would have made an effort to understand if there had been a check setup and performed. I could cite the malfunctioning light as defective, but the true issue would have likely been something else. I encourage my trainees to dig deeper, so as to help make sure the corrective action is likely to prevent recurrence/occurrence elsewhere.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Experience. Years of experience. Multiple examples of audits who write symptoms rather than dig into the issue and THEN report that. When auditors cite symptoms, you know they didn't do any digging.
     
  14. tony s

    tony s Well-Known Member

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    So if one emergency light was found to be defective in a hospital ward, would you raise an nc against 8.5.1?
     
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  15. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I probably would not, as I mentioned earlier I would have looked to see if requirements had been recognized, planned for, controls implemented etc.

    As so often happens, I hesitate to draw firm conclusions on these matters as I was not present and we are getting our information second hand.
     
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  16. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    You got all that from a brief description of a writeup, when you were not present?

    I have years of experience too, and from that have learned things are not always as they seem.
     
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  17. Katrijn

    Katrijn Member

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    tony s doesn't give enough information to judge if this NC is justifiable or not and certainly not enough information about the auditor's attitude or professionalism.
    If checking the emergency lights is a routine control (and in a hospital, I should hope it is), and this particular light wasn't checked or has been defective for a while... then it is definitely a NC.
    In my experience, defective emergency lights are usually a symptom of other - more structural - problems.
    Maybe because I'm more experienced in maritime audits (ISM, MLC, ISPS) then in ISO, but I don't see any problem in this.
    Appealing this NC would take a lot more effort than just fixing the light. And it should be fixed anyway.
     
  18. RoxaneB

    RoxaneB Moderator Staff Member

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    Similar to Katrijn, there doesn't seem to be a complete picture of information allowing us to make a decision one way or another.

    That said, I do have some observations/questions:

    • What triggered the auditor to "test" the light - were QMS processes being reviewed at that time such as maintenance, infrastructure, etc.?
    • Consider the notion of risk. In a manufacturing environment, perhaps a malfunctioning emergency light wouldn't be an issue as it relates to the ability to the meet the customer's requirements. In a hospital setting, where the idea is to protect patients from harm, suddenly the idea seems to be higher in risk. How would you approach it if this was discovered on an airplane?
    • While I believe that it would be of value to appeal a finding that was completely inappropriate, in the interest of demonstrating that they put patient safety first and foremost, accepting this finding does feel like the morally correct thing to do.
     
  19. tony s

    tony s Well-Known Member

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    How did we know that the emergency light wasn't checked? If testing is being done on a monthly basis, there is a good chance that its bulb became busted before the next month's test and, unfortunately, the auditor was there to discover it before the next scheduled test.
     
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  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I get "all that" - all what? What I get is precisely what was reported. Let us not forget a couple of key points which elude many, many auditors:

    Auditors report on management systems. There's no mention of any specific system issue. Secondly, the audit report is supposed to be folks who weren't there. Hence, if you had to be there, the auditor has failed to communicate an important issue to those, like us, who weren't there. Double fail.
     
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