Defective emergency light - NC against 8.5.1

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.

 

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.

 

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.

 

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...

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.