Misinterpretation of requirement acceptable as root cause?

Weeder

Involved In Discussions
#1
Hello,

Can anyone tell me if misinterpretation of a requirement, or simply not being aware of a requirement, acceptable as a root cause of a non-conformity?

There are many times different auditors brings different interpretation of the requirements. If a document was acceptable for several years and then suddenly one of the auditor says this is a non-conformity, it can get confusing. The root cause is that you simply did not know this was a non-conformity. Plus how do you prevent such a thing from happening again?

Another scenario is when something needs more clarification or is misunderstood. In your opinion you had provided adequate explanation so all you can do is add more clarification. However, it is hard to do any root cause analysis because the same original explanation was acceptable to one auditor and not to another.

What is the best way to address such non-conformities?
 

AMIT BALLAL

Trusted Information Resource
#2
You can specify the root cause as:
Current practice was to do X / current system doesn't call to do Y

There can always be a gap in the interpretation of a requirement between you and an auditor, and let it be. This is one of the ways they add value to your system, as long as the auditors are not creating their own requirements.
 

Weeder

Involved In Discussions
#4
Can you give an actual example?
Let us say you have provided justification for why the PMCF (Post Market Clinical Follow up) is not necessary and that the requirement has already been fulfilled by the existing documentation. Perhaps your phrasing is not clear and you just need to do a better job of explaining that. The auditor writes a non-conformity that the justification is not enough or adequate.

In this case the root cause is inadequate explanation and you can rephrase your explanation and reasoning with references etc. This would then be the Correction. What I am trying to say is that the root cause was not that you were trying to get out of doing PMCF but it truly was the fact that the justification was not properly explained.

So what kind of Corrective Action do you take so it does not occur again? Well you can't, because it is not in your control how the auditor understands it and it can change from auditor to auditor.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
There are many times different auditors brings different interpretation of the requirements.
Just thinking here, but if it was acceptable by a previous auditor, Auditor Opinion may be creeping in. In the past when I had to deal with what I consider an Opinion issue (automotive and ISO 9001), I have contacted the contact at the registrar to discuss, and I have immediately stopped audits to do that.

or simply not being aware of a requirement
I have never seen not being aware of a requirement as a root cause, or an acceptable situation in any case. Citing the old canard: "Ignorance of the law is no excuse."

NOTICE: I'm not a medical device guy.
 

Jim Wynne

Staff member
Admin
#6
You've posted in a general problem-solving forum and not a medical devices forum, so it's a good idea to spell out abbreviations. In this case, the assumption is that "PMCF" is "post-market clinical followup." If this is incorrect, please advise.

In the example given, the discrepancy should be cleared up before the auditor leaves the building. If the NC was for failure to do the PMCF, it should be a simple thing to provide a verbal explanation and then go back and fix the written justification. There is no root cause for the NC because there is no NC.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
As Amit said, there can always be "a gap in the interpretation of a requirement between you and an auditor" and indeed we hope the auditor is not creating their own requirements, but it does happen. It happened to me and I was forbidden by Management to challenge it to the registrar, so my "root cause" was that we were "unaware" of the auditor's interpretation of the requirement, so it was "a lack of knowledge" on our part. (I had to bite my tongue hard on that one.)
 

Jim Wynne

Staff member
Admin
#8
The example given by the OP is not a case of misinterpretation of the requirements. It's a case of providing a questionable written explanation of why a perceived requirement wasn't fulfilled. As I said in my earlier post, there doesn't seem to be a nonconformity there.

When interpretations are in dispute, the dispute needs to be settled on the day of the audit, and you proceed from there. If the auditor won't back down, appeal the decision with the CB. As @Mike S. points out, many of us have had our hands tied by management in trying to dispute a bogus call by an auditor, and the only thing that can be done is to make something up in response and move on.
 

Tagin

Trusted Information Resource
#10
Hello,

Can anyone tell me if misinterpretation of a requirement, or simply not being aware of a requirement, acceptable as a root cause of a non-conformity?

There are many times different auditors brings different interpretation of the requirements. If a document was acceptable for several years and then suddenly one of the auditor says this is a non-conformity, it can get confusing. The root cause is that you simply did not know this was a non-conformity. Plus how do you prevent such a thing from happening again?

Another scenario is when something needs more clarification or is misunderstood. In your opinion you had provided adequate explanation so all you can do is add more clarification. However, it is hard to do any root cause analysis because the same original explanation was acceptable to one auditor and not to another.

What is the best way to address such non-conformities?
Couldn't it be that the root cause is that the source of the requirement (e.g. standards doc, regulation, etc.) is poorly worded/ill-defined? After all, if there is not even agreement among multiple external auditors, then in what way is it an internal failure?

Of course, one could argue that since other companies are meeting the requirement, therefore your company should also be able to meet it. But maybe those other companies haven't had the 'right' auditor come in yet to tell them they are nonconforming!

That said, from a practical perspective, we have used 'misunderstood the requirement in the standard' as a root cause before. Since the misunderstanding applies to just that one sentence or phrase in the standard, the corrective actions only address the gap; they do not address improving our comprehension of the entire standard. We did not had any issue using this approach. If there were multiple N/Cs with that root cause, though, then I think we'd have had to perform additional training on the standard, or brought in a consultant to review/mentor our understanding & implementation of the standard, etc.
 
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