Critical Suppliers vs Non-critical Suppliers

[SallyOV]

Hi,

I’m having a lot of difficulty determining where to draw the line between a critical and a non-critical supplier.

I’m basing my assessment on the NBOG 2010-1 guidance document, and from my understanding, suppliers such as packaging providers or laboratories involved in the biocompatibility evaluation of our device are considered critical suppliers (according to the guidance document).

We are currently putting together a rationale to justify the criticality status of each supplier — but I wonder if this rationale could be challenged by the competent authorities. In our cases, for example, we haven't initially considered biocompatibility lab or packaging supplier as critical suppliers but just reading the guidance makes me think I am not on the right path..

Any input would be greatly appreciated!

 

[ScottK]

the guidance seems to be pretty straight forward - "A critical supplier is a supplier delivering materials, components, or services that may influence the safety and performance of the device."
So packaging will depend on what packaging? Is it packaging that must ensure sterility? That's critical. An overpack shipper or master carton probably would not be.
I would also consider the lab you're using for biocompatibility a critical supplier because if they give you a erroneous result and you got to market with the product, it could harm a patient. I'd say that any lab you're using for validation activities would be a critical supplier.

 

[yodon]

I would add on to the @ScottK post regarding biocompatibility testing supplier - you also want to ensure they are accredited for what you need done. Biocompatibility will get considerable scrutiny during the review process and you don't want any questions coming up because you used a less-than-totally-reliable supplier. No question that a biocompatibility test supplier is going to be critical.

I wonder if this rationale could be challenged by the competent authorities

Short answer: yes. They can challenge anything they want to!

 

[mattador78]

Speaking on an AERO side we class anything that comes into contact with the product or is required for its finish/manufacture as critical therefore the suppliers are critical. Paper into the office non critical paper used to pack the work critical. supply of inspection lights critical LED lights in the canteen non critical.

 

[planB]

In case you follow the NBOG guidance most conservatively, you will end up with every supplier being critical, for which @mattador78 has given you examples. This will be tedious and burdensome, because changes to critical suppliers will result in costly change notifications to your NB, plus you are expected to establish contracts with these critical suppliers that allow your NB to audit them in an unannounced way with findings then raised against you.

In my experience you can limit the number of critical suppliers - in a way still acceptable to an NB - by a solid approach, that is based on risk management, resulting in a conclusion that only suppliers are classified as being critical that are related to basic safety in terms of sterilisation, biocompatibility and electrical safety. As an example, sterilisation-related suppliers could then be your contract steriliser, your microbiology lab, plus all suppliers involved in forming your sterile barrier system.

HTH,