Does anyone have experience with how MDD unanounced audits of suppliers are going?

[ScottK]

Just wondering how it's impacting suppliers to medical device companies and if anyone has had any direct experience.
Are the NB's seeing resistance when they come knocking?
My last place was pretty low risk and still hasn't had an unannounced supplier audit. Neither had my current place.

 

[pkost]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

One of my suppliers was subjected to an unannounced visit due to their role as a subcontractor of a manufacturers ClassIII device.

It apparently went smoothly, no significant issues found, although it was raised that it was challenging speaking to the right people...mainly because it was unannounced and people were out of the office....I imagine this will be a regular problem

Other than this single inspection, I'm unaware of of any other unannounced audits being conducted on my supplier base, although I wouldn't place our products in the highest risk areas.

 

[SarahB1]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

One of my suppliers (based in China) has also had an unannounced audit from their NB. All went well and was quite straightforward

 

[Laughing Pierre]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

Don't know if this answers the question as we haven't any direct experience, however I had a conversation with our NB auditor at our last surveillance audit. He has been involved in carrying out unannounced audits and has been refused entry once. The auditee relented after a persuasive call from the NB head office. Apparently the NB has suspended a number certificates as a direct result of unannounced audits. He stated that cooperation levels have been varied. Of course this is hearsay, but it should be taken as read that the NBs are carrying out their due responsibilities.

 

[Laughing Pierre]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

Had an unannounced audit on Tuesday.
A fairly intense day but quite straight forward. As expected it was a vertical, product focused affair, so differed from the normal certification and surveillance audits. The only surprise was that one of the auditors had been to us many times before. I was expecting to see two new faces, but it appears that limited resources meant otherwise.

 

[Pads38]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

We too had our first unannounced this week.

We got a ten minute warning "courtesy" telephone call and, like Pierre, were slightly surprised to be dealing with our usual auditor (plus one other).

By coincidence the day it happened was the one day of the week when our quality consultant was on site - which helped a lot.

We were asked to nominate a particular product, ideally in current production. Then, using a single serial numbered device as an example from final stock, we traced the paper trail back, from the initial works order that initiates a batch, through test records, through manufacturing records to critical component traceability.

All this we managed OK, but we hope to use the 'practice' to improve and simplify the paper trail especially the traceability, which is too reliant on one persons knowledge.

We did get a 'minor CAR' (corrective action request) for insufficient engineering consideration given to a product change, but not-too-bad!

We were thanked for our openness and honesty. The auditors were concerned with detail without being 'picky' (2 dates on a test result sheet had been inadvertently transposed; once this was clear it was not considered to be much of a problem).

All in all, - relatively painless! (but I haven't seen the auditors invoice yet).

 

[HAYATI ABDULLAH]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

Hi Pads38,

Sound greats the unannounced audit conducted on yoursite, we haven't experience it yet. By the way, would you mind to share with us how the procedure of unannounced audit should look like/cover what scope?

Looking forward your positive response.

 

[HAYATI ABDULLAH]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

One of my suppliers was subjected to an unannounced visit due to their role as a subcontractor of a manufacturers ClassIII device.

It apparently went smoothly, no significant issues found, although it was raised that it was challenging speaking to the right people...mainly because it was unannounced and people were out of the office....I imagine this will be a regular problem

Other than this single inspection, I'm unaware of of any other unannounced audits being conducted on my supplier base, although I wouldn't place our products in the highest risk areas.

Hi Pkost,

Sound greats the unannounced audit conducted on yoursite, we haven't experience it yet. By the way, would you mind to share with us how the procedure of unannounced audit should look like/cover what scope?

Looking forward your positive response.

 

[pkost]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

As I said, it was one of my suppliers that experienced the unannounced audit so I do not have first hand experience, my understanding is that it was similar to Pads38 experience

 

[RA Lille]

Re: Does anyone have experience with how MDD unanounced audits of suppliers are going

Directly related or not...
Regarding the possibility that a supplier refuses the unannounced audit and the potential removal of our CE certificate...

our NB said :
''Unannounced audits are mandatory to organize; Notified Bodies need to consider to go the critical subcontractors/crucial suppliers.
If the Notified Body is not allowed to enter the site of one of your critical subcontractors/crucial suppliers for an unannounced audit, this will lead to a major non-conformity and, if not corrected, lead to a cancellation of the certificate."

Regarding the fact that a supplier could have about 800 ISO13485-certified customers... it could lead to one audit a day for this peculiar supplier... and could be considered non receivable by the supplier....
"the Commission stress the importance of unannounced audits: if this would result in every single day one una audit on site, then it would be like that. Indeed, some companies will receive more than one UNA audit every year: which indicates they manufacture for."
"(...) in these contracts you have with critical subcontractors/crucial suppliers, the possibility of an UNA audit really needs to be described (if not-> this would be a major CAR)"

Did anyone live this experience ? How could we face the fact that chemical suppliers are not ISO13485-certified and do not want to support ISO13485 UNA audits ?
Any experience ?
thanks and regards,