Do Management Review records have to be on a controlled form?

Sidney Vianna

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#21
Sounds like your auditor is spinning the requirement into something that they want it to be. I would contest the finding. If anything this is an OFI.
If you are referring to the NC reported by @jradford , the solution is very simple: they outsourced an internal audit and the result of such audit is nonconforming. They can demand the hired auditor to delete the unsupported finding. Or.....withhold payment...:naughty:
 
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Ronen E

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#22
You might also ask the auditor, with regard to the absence of a sign-in sheet, what would prevent anyone from signing in and immediately leaving.
:sarcasm:
They could institute 2 sign-in sheets, one on commencement and another before leaving.
Hang on, but then someone might leave and return just in time for the closing sign-in!
Better have a sign-in sheet every 15 minutes throughout the meeting. :lmao:
 

Ronen E

Problem Solver
Staff member
Moderator
#23
If the auditor was concerned about the involvement and awareness of some of the people who should be participating in the management review, s/he could easily speak with them to ascertain what happened. One of the advantages of auditing a small organization is the fact that you normally have access to everyone in a very short time.
I don't think it's about actually finding out who attended or verifying that the alleged attendees were there. It's about whether the attendance was captured on record, and that the capturing is true (in short, documented verification). If that was a real requirement (representing some rational, real need), it would have applied 5 years later as well, when the specific individual may have already left the org or simply wouldn't remember. The more important point is that there is no such requirement - not in 13485, and apparently also not in the org's SOP.
 

Sidney Vianna

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#25
Unethical.
The job was done and should be paid for. One disputed entry doesn't necessarily render the whole output worthless.
Why Unethical? If a supplier of tangible hardware ships defective products should they get paid what they would get paid for good products? The answer is no. Return to Vendor for rework, repair, credit, etc. are typical dispositions for non conforming products. Why the provider of services should be treated differently? Not only the write up is not supported by a requirement, but adds no value. Archaic auditing gotcha finding.

is there a special code of ethics for consultants in search of monetization that I am not aware of?
 

Ronen E

Problem Solver
Staff member
Moderator
#26
Why Unethical? If a supplier of tangible hardware ships defective products should they get paid what they would get paid for good products? The answer is no. Return to Vendor for rework, repair, credit, etc. are typical dispositions for non conforming products. Why the provider of services should be treated differently? Not only the write up is not supported by a requirement, but adds no value. Archaic auditing gotcha finding.

is there a special code of ethics for consultants in search of monetization that I am not aware of?
"Withhold payment" implies not pay at all. "Reduce payment proportionally" or formally initiate a dispute, with a view to reduce payment (or otherwise), under the provisions of the contract - that's different.

I don't think drawing parallels directly from tangible goods supply is very illuminating in this case. Normally contracts to supply tangible goods include explicit provisions for lacking supply or supply of damaged/non-compliant goods, and I believe that that scenario is otherwise well-covered in commercial law. If similar provisions were included in the current case's contract, that's fine - let them be fully implemented. Otherwise I'm not aware of any laws that support not paying at all when a tiny portion of the scope is in dispute.
 

Philip B

Involved In Discussions
#29
We issue minutes in a plain Word document and list the attendees. We have never been challenged on this. NBs are looking for evidence of top management commitment and can find this in various ways, not least the top management interview our NB carries out at least once per audit cycle.
 

pziemlewicz

Involved In Discussions
#30
If you are referring to the NC reported by @jradford , the solution is very simple: they outsourced an internal audit and the result of such audit is nonconforming. They can demand the hired auditor to delete the unsupported finding. Or.....withhold payment...:naughty:
I'd advocate that the company take the same actions they would with a notified body. Auditors are human and sometimes make mistakes; create a concise argument pointing out why this shouldn't be a NC. It never hurts to exercise the channels you may have to use someday.
 
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