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Approval of raw material suppliers which do not manufacture the material

C

Charlie Brown1

#1
Hi all,

In case of raw material suppliers, how far back do we need to go throughout the supply chain?
Is it enough to approve the supplier of a raw material, which does not manufacture the material? Should I also approve the manufacturer of the raw material or is it the responsibility of the supplier?

Thanks in advance.
 
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Golfman25

Trusted Information Resource
#2
Hi all,

In case of raw material suppliers, how far back do we need to go throughout the supply chain?
Is it enough to approve the supplier of a raw material, which does not manufacture the material? Should I also approve the manufacturer of the raw material or is it the responsibility of the supplier?

Thanks in advance.
This is a tough one. I assume you're using some type of service center or distributor. In our case, it's mill ---> Service center ----> Us. We are automotive and focus primarily at the service center level. But the mill issue comes up every so often. I have yet to get a workable answer. My own feeling is if your buying material to a commercial standard, certification to that standard is close enough.
 
#3
Hi all,

In case of raw material suppliers, how far back do we need to go throughout the supply chain?
Is it enough to approve the supplier of a raw material, which does not manufacture the material? Should I also approve the manufacturer of the raw material or is it the responsibility of the supplier?

Thanks in advance.
Your supplier is your supplier. If you use a distributor, why go back any further? They exist for a reason. You select them as you would any supplier. Some actual manufacturers don't have a face to the (buying) customer, so what's the point?

Have you run into an audit question on this?
 

Miner

Forum Moderator
Staff member
Admin
#4
One complication that using a distributor can add is where you order a commodity (e.g., M3 x 6mm fastener) from the distributor and they in turn source this from 2 or 3 fastener suppliers. The fasteners from one of the suppliers is acceptable, while fasteners from the other are not. I know of a similar scenario that resulted in a recall when the distributor changes sources.
 
#5
One complication that using a distributor can add is where you order a commodity (e.g., M3 x 6mm fastener) from the distributor and they in turn source this from 2 or 3 fastener suppliers. The fasteners from one of the suppliers is acceptable, while fasteners from the other are not. I know of a similar scenario that resulted in a recall when the distributor changes sources.
If this potential exists, it should become part of the PO/Contact...
 

Mark Meer

Trusted Information Resource
#6
If this potential exists, it should become part of the PO/Contact...
Agree with AndyN. Any particular controls you need should be established between you and the supplier either in a supply agreement/contract, or in the terms of individual purchase orders.

For example, if you want to ensure a specific raw-material supplier, or require that they must inform you if they are planning to make any changes.

The implications otherwise would be absurd. You could potentially follow a supply chain right to where the raw-materials were pulled out of the ground! But this, obviously, would be :bonk:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
In case of raw material suppliers, how far back do we need to go throughout the supply chain?
It is tricky to answer this authoritatively without really knowing your business and regulatory context. Based on the forum you started this thread, I assume you are in the medical device/life sciences supply chain. While you are not obliged to approve the raw material source, your organization might be obliged to comply with requirements such as REACH, RoHS, avoidance of Conflict Minerals. Some stakeholders might expect you to have an Ethical Sourcing policy, etc...

Proper determination of context is paramount to determine how much control over the product flow chain is required. So, while you might not be required to directly approve raw material suppliers, you might have to have controls in place to ensure that your suppliers do.
 
Last edited:

somashekar

Staff member
Super Moderator
#8
Hi all,

In case of raw material suppliers, how far back do we need to go throughout the supply chain?
Is it enough to approve the supplier of a raw material, which does not manufacture the material? Should I also approve the manufacturer of the raw material or is it the responsibility of the supplier?

Thanks in advance.
Since you are asking about Medical devices, a risk based approach is your step to approval, as you are focusing on the safety and performance of the device and parts that may come in contact with the patient body and various levels could be in scope., where the bio-compatibility of the device you make is challenged.
Its precisely for such risk that the new standard 2016 version has included in the 7.4.2 the 'shall' requirement about written agreement to notify changes prior to making the change.
 
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