Changing Critical Supplier: What are the requirements

[ElmerF]

Hi,

I'm looking to change a critical supplier. The design verification, validation and process validation has been completed using the original vendor. What is required to qualify a new supplier. Should verification testing be repeated in full? Would we need to sterilize and Accelerate age as with original component? Or is there another way to show equivalence? Are there any additional requirments outside of our supplier evaluation procedure?

Thanks for your comments.

 

[Jim Wynne]

Hi,

I'm looking to change a critical supplier. The design verification, validation and process validation has been completed using the original vendor. What is required to qualify a new supplier. Should verification testing be repeated in full? Would we need to sterilize and Accelerate age as with original component? Or is there another way to show equivalence? Are there any additional requirments outside of our supplier evaluation procedure?

Thanks for your comments.

What industry are you in?

 

[ElmerF]

Hi Jim,

I'm in Medical Devices.

 

[Jim Wynne]

Hi Jim,

I'm in Medical Devices.

Elmer, I'm not familiar with requirements for medical devices, but I moved your post into a medical device forum, and I'm sure one of our resident experts will be along soon.

 

[Ronen E]

Hi,

I'm looking to change a critical supplier. The design verification, validation and process validation has been completed using the original vendor. What is required to qualify a new supplier. Should verification testing be repeated in full? Would we need to sterilize and Accelerate age as with original component? Or is there another way to show equivalence? Are there any additional requirments outside of our supplier evaluation procedure?

Thanks for your comments.

What does this supplier supply you with?

Ronen.

 

[ElmerF]

Hi Ronen,

The material is sterile, coated, braided synthetic absorbable suture.

thanks,

Elmer

 

[Ronen E]

Hi,

I'm looking to change a critical supplier. The design verification, validation and process validation has been completed using the original vendor. What is required to qualify a new supplier. Should verification testing be repeated in full? Would we need to sterilize and Accelerate age as with original component? Or is there another way to show equivalence? Are there any additional requirments outside of our supplier evaluation procedure?

Thanks for your comments.

The material is sterile, coated, braided synthetic absorbable suture.

Hi Elmer,

Is it a proprietary design / process? Can you actually identify an identical material from an alternative source?

I'd start with a side-by-side specification comparison, and proceed to demonstrate equivalence only if the match is close to 100%. Otherwise I tend to think that verification and validation will have to be redone (I'd definitely address product life; sterilization subject to careful analysis of the change and consequences). Be sure to include all aspects important to your device and it's manufacturing processes in the comparison.

The above addresses the design change; I assume that the need for proper supplier qualification is obvious

Cheers,
Ronen.

 

[ElmerF]

Thank you Ronen,

That is what I would have thought but its great to get a second opinion. Both components would match our specification but there would likely be different coatings and there would be other proprietary information we would not have access to. I haven't been able to find any regs that address supplier change but it certainly seems like the prudent route. If you know of any please let me know. Otherwise Thanks again!!

 

[Ronen E]

Thank you Ronen,

That is what I would have thought but its great to get a second opinion. Both components would match our specification but there would likely be different coatings and there would be other proprietary information we would not have access to. I haven't been able to find any regs that address supplier change but it certainly seems like the prudent route. If you know of any please let me know. Otherwise Thanks again!!

Hi,

IMHO your main focus should not be the supplier change. If the coatings differ and/or you don't have access to a detailed specification (I mean the manufacturer's, not yours) then you'd have to treat this as a significant design change and handle it accordingly, as prescribed by part 820.

Regardless of that, regulations applicable to supplier changes are listed under part 820.50 (Purchasing Controls) and are definitely applicable when it comes to a critical component. If you were merely moving to purchase an identical item from a new supplier, you might have done with just that; but I understand that this is not the case.

Cheers,
Ronen.