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Approved supplier list - Distributors question

duff999

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#1
Hi Folks,

I have a question regarding the approved supplier list we maintain. Currently we purchase from a supplier that is a distributor for many products that come from different companies. Do we need to maintain the supplier we directly purchase from (yes), as well as the supplier that our direct supplier purchases from since the products are labeled with the indirect suppliers name?

Any help would be appreciated.
 
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William55401

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#2
Who do you control? Do you really want to control and track the sub tiers suppliers within your QMS? If so, you are defeating the power of using a distributor.

Watch outs. Often, especially in the electronics world, Designs are specific to a component from a specific supplier. That's OK. You can get that specific component XYZ123 made by the semiconductor company from a distributor you control in your supplier management program. HTH. Have fun. Enjoy the ride.
 

duff999

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#3
Thanks for the feedback, We do control the distributor and maintain them on or ASL, we do not control who they purchase from.
 

William55401

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#4
Your 14971 risk management program, when extended down to discrete purchased components through the identification of Essential Design Outputs on the specifications, should tell your org what are the critical features on purchased components. If there are no critical features on the components you get from the distributor, you should be OK. If you are buying critical items from the distributor, you will need to account for this in your specifications and incoming verifications as appropriate. Everyone has a story about a simple <inert component name> sourced from a distributor that resulted in <insert cost of poor quality fun> . Ensure the supplier portion of your QMS accounts for potential critical feature control from distributor sourced components.
 

duff999

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#5
Very good information, very well put. I don't think I detailed the critical portion this far in our SOP. We do have incoming inspection on all products but it seems like this needs to be tightened up further.
 

William55401

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#6
Last comment. Getting your design team on board with Critical Feature ID is a best practice and will make your SM program very focussed (read as risk based and easier to implement 13485:2016 requirements in other QMS elements).
 

Tagin

Trusted Information Resource
#7
Very good information, very well put. I don't think I detailed the critical portion this far in our SOP. We do have incoming inspection on all products but it seems like this needs to be tightened up further.
You might also want to track if the distributor is an authorized distributor for the component(s) you are buying, to provide some assurance that the product is not greymarket.
 
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