EU Commission requires NB (Notified Body) Unannounced Visits

[parr05]

I was told by our NB that It is now a proposal from the EU Commission that the Notified Body will have to perform unannounced visits to the premises. They also have to do unannounced visit in case of vigilance cases giving them reason for concern. He said that they will be checked by their Competent Authority that we are actually performing unannounced visit.
I wonder if any of you guys know more about it.
Thanks.

 

[pkost]

Re: NB Unannounce visits.

The European Association Medical devices - Notified Bodies (TEAM-NB) updated their code of conduct last year, such that it now requires it's members to conduct unannounced audits

http://www.team-nb.org/documents/2012/Team-NB-Press-release-COC.pdf
http://www.team-nb.org/documents/2012/Code_of_Conduct_Medical_Notified-Bodies_v3-0.pdf

This is a clarification of what is already permitted by the MDD and becoming an expectation of the authorities following the breast implant scandal.

The proposed medical device regulation clarifies it further and makes the requirement explicit.

 

[parr05]

Re: NB Unannounce visits.

Great information. Thank you very much.
I see that this will affect the cost for the annual surveillance and re-certification.
Also, the part that got my attention reading the Methodology for determining audit duration, was that table in IAF MD 9:2011. annex D. Table D1. "days of audit duration for 10 to 15 effective number of personnel is 4.5 days. any comments?
Once again, Thank you.

 

[Pads38]

I noted on the NB-Med site some minutes from one of their committee meetings when unannounced visits were discussed.

At that time several of the NBs represented had done a "UV" (unannounced visit). They reported that their reception had not been very friendly and suggested to others to "take their own lunch with them". And they did speculate that getting invoices paid may prove problematic!

The "standard" UV is reported as being 1 day long with 2 auditors.

 

[pkost]

I noted on the NB-Med site some minutes from one of their committee meetings when unannounced visits were discussed.

At that time several of the NBs represented had done a "UV" (unannounced visit). They reported that their reception had not been very friendly and suggested to others to "take their own lunch with them". And they did speculate that getting invoices paid may prove problematic!

The "standard" UV is reported as being 1 day long with 2 auditors.

Not sure what else they would expect...Planned visits mean the the necessary people are on site and have time scheduled for the audit. UV's are likely to encounter key staff out of the office and other staff having to drop their current prioirties for a visit. We don't wait around just for them to audit!

Taking their own lunch...again this is planned in advance, although I'm surprised the typical delay of "lets go out for lunch" isn't used by the company!

 

[Wes Bucey]

I expect some folks would see this "rule" as creating a police force without badges who are essentially being granted "no knock" search warrants to seek out innocent as well as intended misbehavior. Worse, the object of the search warrant must pay whether there is misbehavior or not.

Maybe I've become a Libertarian in my dotage, but this smacks of "Kwality Kop" to me. The auditors who do NOT find reportable error will find themselves suspected of being on the take. Worse, there may be some auditors who will engage in extortion to give a clean bill of health to the auditee.

At the same time, I KNOW there are bad apples who violate the letter and spirit of 3rd party registration and they should be discovered and punished. My discomfort is that this police work is done by "private contractors" - in effect, mercenaries. Many bad things are attributed to mercenaries in various parts of the world. Let us hope the present scandals don't expand to include auditors.

 

[Ron Boumans]

There is a time and a place for unannounced visits. But this should be considered well. As an inspector for a competent authority I have some experience with them. There can be a big difference in what you find coming with or without prior notification. In the past we have only used this tool after careful consideration and then it was often very useful. I am not sure how this will develop in the near future when we are supposed to do this on a more routine basis.

In my view there are still lessons to be learned from the PIP case. Would unannounced visits really have made a difference?

 

[Pads38]

My understanding was that, in the PIP case, they were moving the non-approved chemicals they used to make their own silicone to storage facilities that were completely unknown to the auditor. That is, they were hiding the stuff off-site.

An unannounced visit would have not allowed them any time to hide their secrets and could have stopped the fraud at an earlier stage.

 

[Ron Boumans]

My understanding was that, in the PIP case, they were moving the non-approved chemicals they used to make their own silicone to storage facilities that were completely unknown to the auditor. That is, they were hiding the stuff off-site.

An unannounced visit would have not allowed them any time to hide their secrets and could have stopped the fraud at an earlier stage.

The question is if unannounced visits would have found these problems. What should a notified body or competent authority be looking for, and how should they gather data? Is it technically possible to identify counterfeight in a factory? And how about manufacturers that don't have their own production? I don't know, and as far as I know, nobody knows because I haven't seen a proper evaluation of the inspection process. That is all I want to say about this.

 

[Marcelo]

IMHO regulations and standards are created to those that want to apply and be in conformity with them.

The PIP case was a police case, not a regulatory case.

If we create a regulation or standard with the premise that the user is lying or counterfeiting or whatever like this, we will really have to change the approach and act more like the police.