Misinterpretation of requirement acceptable as root cause?

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
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.
One must ALWAYS remember that an organization is not audited and certified by "Billy Bob Auditor". You are audited by a CERTIFICATION BODY and it is critical that such CB is concerned with CONSISTENCY. So, the feedback to the CB about inconsistency of auditors is very important.

Having said that, it is ALWAYS important to remember that even regulatory requirements change over time, so one should try to clarify if the "surprise" rejection of the justification has anything to do with recent positioning by regulators.
 
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indubioush

Quite Involved in Discussions
#12
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.
You say it isn't necessary, but then you say you fulfilled the requirement. Contradictory statement. Not sure if this was the actual nonconformity.
 

AMIT BALLAL

Trusted Information Resource
#13
IMHO, there can problems in 2 areas:
On auditor's side:
The NCs should be explained at the audited area (Process), in daily feedback meeting and to top management & management coordinator prior to the closing meeting and in the closing meeting. These levels help to make sure the NC is understood, to seek necessary explanation and evidence in case not acceptable by the audited organization and to make sure NC is accepted prior to leaving the premises. Raising NCs directly at the closing meeting results in conflict.
Although most of the norms & good practices (for Eg. IATF) specify conducting daily feedback meeting & closing meeting (at least) to discuss NCs, it is not being completely & properly followed by auditors which result in such situations.

On the organization's side:
Poor explanations can happen due to a lack of understanding of the process owner/auditee or he/her not being able to explain it properly. And in such case, his/her statements can be considered as objective evidence for raising NC.
I'll share my experience: In one of the organization (I was working in & was handling systems), the auditee was not able to explain our current practices to the auditor, even though it was specified in the procedure. I thought it was a problem of he not being able to explain, but after investigation, I got to know that neither he understood the requirement and nor he implemented it properly.
The procedure was also just specifying what needs to be done and not how it needs to be done.
Therefore we just revised the procedure to incorporate additional guidelines to ensure it's easy to understand so that it can be followed.
Check if such a situation exists at your organization. And I would suggest incorporating the practices in procedures/instructions to ensure it is understood by the process owners for implementation and it will also be self-explanatory to the auditor to prevent such problems of poor explanation, if possible.
 

Weeder

Involved In Discussions
#14
One must ALWAYS remember that an organization is not audited and certified by "Billy Bob Auditor". You are audited by a CERTIFICATION BODY and it is critical that such CB is concerned with CONSISTENCY. So, the feedback to the CB about inconsistency of auditors is very important.

Having said that, it is ALWAYS important to remember that even regulatory requirements change over time, so one should try to clarify if the "surprise" rejection of the justification has anything to do with recent positioning by regulators.
Yes, that is exactly right, the recent positioning of the regulators sometime results in such actions. I think a lot of regulators are now so focused on the MDR that they are using that position to evaluate MDD audits as well. Although it may be beneficial to the company in the long, it is an unfair practice.
 

Weeder

Involved In Discussions
#18
You say it isn't necessary, but then you say you fulfilled the requirement. Contradictory statement. Not sure if this was the actual nonconformity.
Well it is possible to satisfy the requirements of the PMCF without actually performing it (through clinical data directly relevant to your device, etc.) and showing that your device is safe and effective. In this case the justification is that you have already satisfied the purpose of the PMCF and therefore the actual PMCF is not necessary.
 
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