Notified Body not issuing 'Improvement Potentials' anymore (ISO 13485)

At the end of our latest ISO 13485 audit we only received nonconformities and no improvement potentials as they were called earlier by the same notified body. Improvement potentials were non-binding pieces of advise as they were/are issued by most notified bodies I believe. Although I always wondered why improvement potentials were not classified as nonconformities they were usually useful pieces of advise and in some cases an 'early warning' that could be used to prevent future nonconformities.

The auditor mentioned that they stopped formulating improvement potentials because they raised too many questions about why they were not issued as nonconformities. He did give some suggestions during the audit but only verbally.

Firstly, do other people have the same experience?

Secondly, be aware that this might be the case for your notified body as well and make notes of any suggestions from the auditor, they might not turn up in the audit report!

Re: Notified body not issuing 'Improvement Potentials' anymore

I usually call those "NCs threats", cause the whole idea was, "this is a possible NC which, if you do not act upon, will turn on a NC on our next visit". Usually those have nothing to do with improvement.

Totally weird.

Re: Notified body not issuing 'Improvement Potentials' anymore

Luwak said:

Firstly, do other people have the same experience?

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A very large percentage of auditors working for certification and notified bodies have indeed stopped recording findings classified as opportunities for improvement (OFI) in their audit reports. And the primary reason for that is the fact that many of the so called observations, comments and OFI's, when scrutinized by an independent reviewer, would indicate that a requirement was being violated and the auditor had found evidence to that effect, which, by definition is a nonconformity.

The practice of softgrading exists in the management system conformity assessment world and, most interested parties have been fighting against it. Accreditation body auditors tend to scrutinize CB audit reports, looking for instances of softgrading.

Because of that, many auditors have stopped the reporting of any type of findings, other than nonconformities and noteworthy efforts.

Re: Notified body not issuing 'Improvement Potentials' anymore

The FDA and Health Canada are involved in a pilot program that, among other things, discourages OFI's in audit reports. See 2.3.3 of the attached for info.

Re: Notified body not issuing 'Improvement Potentials' anymore

Doug Tropf said:

The FDA and Health Canada are involved in a pilot program that, among other things, discourages OFI's in audit reports. See 2.3.3 of the attached for info.

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It is true it discourages OFI's, but it encourages observations and other relevant findings:

However, as an important component of a complete and accurate record of the audit, observations and findings should be reported. Observations can include situations which appear to be non-conforming but where insufficient audit evidence was collected.

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Re: Notified body not issuing 'Improvement Potentials' anymore

The problem here is the word "improvement".

If something is a possible NC but the auditor has insufficient evidence, anything that the manufcturer do about it is preventive action, not improvement.

Re: Notified body not issuing 'Improvement Potentials' anymore

ISO 17021:2011 reads:

9.1.9.6.2 Opportunities for improvement may be identified and recorded, unless prohibited by the requirements of a management system certification scheme. Audit findings, however, which are nonconformities in accordance with 9.1.15 b) and c) shall not be recorded as opportunities for improvement.

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Re: Notified body not issuing 'Improvement Potentials' anymore

Oh yes, I know what 17021 says, but, interestingly enough, it does not have a definition for OFI.

Re: Notified body not issuing 'Improvement Potentials' anymore

Marcelo Antunes said:

The problem here is the word "improvement".

If something is a possible NC but the auditor has insufficient evidence, anything that the manufcturer do about it is preventive action, not improvement.

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Isn't it just semantics? Why wouldn't a preventive action be considered "improvement"? And vice versa - almost any "pure" improvement can be presented as some sort of preventive action. Can't it?

As an auditor, I think one of the key problems is that you are always aware of the implications of an NC, and in particular the time frame for real corrective action. If this is beyond the limits allowed by the certification body (typically 3 months), and auditor would be reluctant to raise an issue as a formal NC. Thus, an "Improvement potential" was a way to flag issues without formally raising an NC.

Of course, the problem is that if it is a real NC, then the issue should be formally raised, regardless of the implications.

I believe that this problem was addressed by allowing the manufacturer to reply to an NC with an action plan rather than real correction action, but this probably depends on the certification body's rules, and also the scheme or regulation.