EU Commission requires NB (Notified Body) Unannounced Visits

Edward Reesor

Trusted Information Resource
#21
Thank you for your reply. This is my understanding as well.

My searches have been statements from various Notifying Bodies stating that is is what's expected, not from a regularly updated website with controlled documents. This is where the difficulty lies. Our most recent audit revealed the sole minor non-conformity as not having language that speaks to unannounced audits (although we recognize that it could occur with cause from previous documents) and quite frankly our procedures wouldn't change as we regard our NB as essential partners in our processes. It's difficult to perform a root cause analysis when the source of the changes comes from word of mouth or discussion groups (the first post in this thread was having been told by their NB themselves).
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
Hi,

There were many official publications by the EC commission and other EC governing bodies, so it was quite difficult to dwell in the regulatory professionals environment and not hear about it in any way.

For example visit this webpage, and in particular see this official press release from February 2012. I wouldn't call all that "only word of mouth" though you are right that the regulations haven't changed (didn't need to, as Pkost noted).

Cheers,
Ronen.
 

Marcelo

Inactive Registered Visitor
#24
My searches have been statements from various Notifying Bodies stating that is is what's expected, not from a regularly updated website with controlled documents. This is where the difficulty lies. Our most recent audit revealed the sole minor non-conformity as not having language that speaks to unannounced audits (although we recognize that it could occur with cause from previous documents) and quite frankly our procedures wouldn't change as we regard our NB as essential partners in our processes. It's difficult to perform a root cause analysis when the source of the changes comes from word of mouth or discussion groups (the first post in this thread was having been told by their NB themselves).
Your NB should have warned you and made it clear what the expectations where, and should probably have initiated a review process of your requirements and contractual agreements.

Not so much of a partner, heh...
 

Edward Reesor

Trusted Information Resource
#25
Thank you so much for your responses. This really helps. But again, the actions are based on recommendations, which are not always followed (In Canada, we excel at National Inquiries that result in a considerable amount of recommendations-few of which are acted upon. Perhaps I've become immune). Therefore I have to perform a root cause analysis on failing to acknowledge a recommendation. I think the main issue is that we changed NB's right about when the change was made. I had no involvement with that and as such saw no contracts or papers.

And again, this is a small company, so there's no guarantee that anyone will be in the office when the auditors arrive. I would hate to have them arrive when we're at meetings in town. Personally I think that this is going to rub the manufacturers the wrong way. The fact that they made these visits mandatory and every 3 years is going to be very problematic for the small guys.
 

Marcelo

Inactive Registered Visitor
#26
And again, this is a small company, so there's no guarantee that anyone will be in the office when the auditors arrive. I would hate to have them arrive when we're at meetings in town. Personally I think that this is going to rub the manufacturers the wrong way. The fact that they made these visits mandatory and every 3 years is going to be very problematic for the small guys.
Probably, however, please note that in this particular case, the problem is more related to the NBs and keeping the system as being perceived as "safe" than on the manufacturer actions. So I would say that the problems to the manufacturers, although considered, were deemed something like "that?s what we have for today" (not sure if this expression or a similar exists in english :p), meaning, there surely will be problems, but we cannot recommend less.
 
#27
I attended a (virtual) presentation by our NB on the subject of the Unannounced Audits. They highlighted the fact, as previously mentioned here, that there always has been the option to do such audits.

Apparently, the audit will take the form of a 'Vertical Audit', somewhat different to the routine audit. They will want to follow product from the design phase through all processes to packing and dispatch, so all your 'normal' paper-chains will need to be in place.

What we, as manufacturers have to change is to make sure we have a formal Procedure for Unannounced Audits and that ALL staff are made aware of the procedure and the responsibilities that it creates.

For this purpose we have created a table that shows each of our Quality processes, who is primarily responsible for showing the auditor that process and a first and second reserve, should the Primary Respondent not be available.

On the subject of "what happens if the senior staff are off-site?" - well, as the checks are of the standard day-to-day processes any member of staff involved in that process should be able to demonstrate the correct operation. If they cannot, or if it would only operate with the involvement of (absent) senior staff then the question has to be asked as to whether training is adequate or if there is sufficient supervision in place.

For those manufacturers who sub-contract substantial portions of the design / development / manufacture etc. - the audit can also be conducted at your significant suppliers.

My understanding was that it would be possible to agree with your NB beforehand dates on which they would not do an unannounced audit. This could be used to cover such an eventuality as plant closure over a holiday period, or legitimate reasons where 'normal' operations would not be happening, such as an annual stock take.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#28
For those manufacturers who sub-contract substantial portions of the design / development / manufacture etc. - the audit can also be conducted at your significant suppliers.

.
This is the part that I'm researching right now.
We are a contract manufacturer, essentially, and I just got notification from a customer that we can potentially expect unannounced visits from their Nobo.
How will all of this play out? Can I expect an onslaught of new quality agreements that require we allow UV's from their Nobo's?
If I have a dozen customers that use, say BSI, as their Nobo can I expect BSI to come here a dozen times in the next three years? Plus all of our other customer's Nobo's.
What about NDA's? We have no agreements with BSI or any other Nobo.
I don't like this, but it looks like it's going to be shoved down suppliers' throats as "comply with this or else".
 
R

Reg Morrison

#29
I don't like this, but it looks like it's going to be shoved down suppliers' throats as "comply with this or else".
A smart supplier would negotiate provisions with their medical device customers to be compensated for the support of (numerous) unannounced audits by the customer's NB's.

If you operate in the context of a highly regulated industry, such as the medical device sector, and regulatory/NB oversight is a potential activity, you have to be prepared to deal with it. It is a risk that needs to be managed.

I would communicate with customers about this as soon as possible.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#30
A smart supplier would negotiate provisions with their medical device customers to be compensated for the support of (numerous) unannounced audits by the customer's NB's.
.
Yeah. I know our customers and their supply chain people. They'll smile at that and say "It a cost of doing business with us and don't try to raise your piece price to compensate for it either"

If you operate in the context of a highly regulated industry, such as the medical device sector, and regulatory/NB oversight is a potential activity, you have to be prepared to deal with it. It is a risk that needs to be managed.
We understand this. We host FDA inspections and customers audits. But direct NB oversight is new to this company as the parts we do CE mark on our own are Self Declared, Annex VII. Everything else we do is contract manufacturing so the the technical files are held by the customer.

I would communicate with customers about this as soon as possible.
Our reps in the field are already on it.

Fortunately I have resources to deal with it, so it will be a hadache for us, but not horrible. It's small guys like the 5 man machine shop doing implants for Stryker or instruments for Zimmer that I am curious about.
 
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