AFAP principe in Supplier pFMEA


Hi everyone,

I am struggling with a nonconformity given to one of my supplier, regarding the AFAP principle of the MDR.
Our NB reviewed the pFMEA of PCB Assembly and stated the pFMEA did not comply to the MDR requirement of As Far As Possible principe.

As you all know MDR state the manufacturer (AKA legal manufacture) is to implement AFAP principle in his risk analysis process.
We are in agreement that manufacturing/industrialization are to be taken in consideration in the RM process.

but that is on our side, our supplier perform pFMEA for their product line (using ALAR principe) this does not cover Patient Risk, nor Benefit as that was out of their scope and they also produce their own competitive device and we dont want to share our clinical information with them.

We propose to improve OUR risk analysis process to clarifie that we took Manufacturing into consideration and improve traceability of process control in production. but that was rejected on the basis the NC was on the supplier side and was to be managed by the supplier.

Base on the MDR text, the implementation of the AFAP principle is on the legal manufacture side and on the RM process (risk patient), pFMEA as long they dont cover the patient risk are not a "direct" part of the RM process, and AFAP rely on the Benefit/risk ratio to be effectively implemented.

Have anyone had a similar issue ?
Have any proposition how to tackle the issue ?

So far the Bazooka proposal is to impose to the supplier the AFAP principle in our SQA, but this will only trigger additional NC, as the supplier will no able to assess the patient risk our product adequately.


Trusted Information Resource
It seems so unfair to impose AFAP on PCB subcontractor who provides services to different industries.
I think the best approach is for you to own the pFMEA where you work with the various manufacturing suppliers to create one controlled hazard analysis table to your name with the complete picture of severity, probability, and detectablity.


Super Moderator
supplier will no able to assess the patient risk our product adequately.
This hits one of the nails on the head and drives home the point @shimonv made.

I'm curious, though, what the reviewer cited as being not reduced as far as possible? Seems rather presumptuous on the surface.

But back to the point - with you owning the PFMEA, you may also be able to put in place additional controls (either imposed on the supplier or done internally upon receiving the boards).


The assessor just cited the "Annex I GSPR 2", quite vague for a reference ....
I was not present during the Audit and the 5 people that was there could not give me additional feedback.
they just accepted the NC, If I would be there I would have try to argument on the definition of the MDR.


Super Moderator
Interesting, thanks. I think the reference is fine. Too bad there were no specifics cited / provided. You might want to at least try to contact the reviewer to get more information. Without that, you may miss the mark on the response.
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