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Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI)

MDRexpert

Involved In Discussions
#1
Hi Folks,

I was wondering in case a supplier cannot comply to your requirements, but you have to add them to our vendor list then how do you do it?

We are registered with ICCBBA (FDA UDI) and our procedures call out that we add them as a Major supplier. But they wont provide us the information required since they are a non profit organization.
How have you managed this?

Thank you!
 
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MDRexpert

Involved In Discussions
#3
Our company requires a assessment form which I admit is fairly lengthy.
Since the company is a not for profit membership based organization they do not supply traditional goods and services. so they also do not believe that these forms are applicable to them (which I agree) but our procedure does not allow that.

Is there a way around this?
 

dr1vn

Involved In Discussions
#4
Depending on your QMS, use the non-conformance or deviation portion of the QMS to document why you do not need to follow your QMS for this instance. Then have the appropriate folks review and approve the non-conformance/deviation and you've closed the loop.
 

Tagin

Trusted Information Resource
#5
I was wondering in case a supplier cannot comply to your requirements, but you have to add them to our vendor list then how do you do it?

We are registered with ICCBBA (FDA UDI) and our procedures call out that we add them as a Major supplier. But they wont provide us the information required since they are a non profit organization.

You have a defect in your supplier approval process if 1) supplier will continue to be used and 2) supplier doesn't conform to approval process.

I'd suggest as an option that your approval process be modified so that if a supplier doesn't provide necessary information (or other conditions), then a risk assessment is performed to determine if the supplier should be approved. Obviously your company doesn't think there is a risk in continuing to use this supplier, so why not make that risk determination an option in your approval process?
 

MDRexpert

Involved In Discussions
#7
You have a defect in your supplier approval process if 1) supplier will continue to be used and 2) supplier doesn't conform to approval process.

I'd suggest as an option that your approval process be modified so that if a supplier doesn't provide necessary information (or other conditions), then a risk assessment is performed to determine if the supplier should be approved. Obviously your company doesn't think there is a risk in continuing to use this supplier, so why not make that risk determination an option in your approval process?
Thank you so much!
 

yodon

Staff member
Super Moderator
#8
so they also do not believe that these forms are applicable to them (which I agree) but our procedure does not allow that.
As others have stated, changing your process is a good idea. One size does NOT fit all. My company does R&D work only and I can't tell you how many times I've had to fill out assessment forms that were tailored for manufacturers. Useless and a waste of everyone's time (there was one case where I think we answered 'no' to everything ... and still magically got approved).
 
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