Supplier components

evan_kim90

Involved In Discussions
Hi, all

I have question regarding for supplier components.

So, I will go with example for easy explanation.
Fuse is critical components in our medical device and if we purchase contract supplier, we treat as ciritical supplier.
But sometimes, we should by fuse in grey market (MacMaster or other) because of stock reason. But they are medium risk.

So, normally, how other people do in this case? and if it requires definition in SOP, how define it?
 
Critical parts should only be purchased from suppliers who are qualified to provide you with that part. Supplier risk level should be assigned based on the risk associated with the part. However, your supplier management process could take other information into account when assigning a supplier risk level, such as history of providing acceptable components. You need to ensure your procedure clearly defines how to assign a supplier risk level (item risk should be a large factor) and how to ensure parts are only received from suppliers approved to provide that part.
 

Bev D

Heretical Statistician
Leader
Super Moderator
A few things to keep in mind: risk has two independent meanings.
The first is the severity of a faliure; this determined by science and knowledge of the function. Think of it As “what is at risk”.
The second meaning is the probability - or more useful meaning - the frequency of occurence. This can only be determined by testing although too many people just guess and usually guess dangerously low. Think of it as “what are the odds”; or as I like to say “hold my beer”.

A critical supplier is one that provides critical parts. The criticality of the part is determined by the severity. Changing suppliers such as from the manufacturer to a distributor who will source parts from any manufacturer they can find dos not change the severity of the part it only changes the probability of a failure. Thus both the original manufacturer and the distributor are critical suppliers. What should change when this type of change for suppliers occurs is how you change your inspection & testing of the supplied part. This is mitigation of ‘risk’; probability only not severity. However, history shows us that buying your critical parts from Joe’s Fish Bait and Part Supplier Down by the River (aka grey or black market) is a very “risky business” choice. Grey market parts are usually just floor sweepings of marginal and failing parts…
 

Enternationalist

Involved In Discussions
Without speaking too much about 'criticality', which can mean different things depending on your audience - Generally, you will need to balance how important the part is with the level of oversight on the supplier, and the level of oversight you apply to the parts themselves. If your supplier is lower quality, you obviously need to apply more scrutiny or otherwise adjust your design to reduce the risk associated with the part.

It's not a zero-sum game with supplier management evaluation.
You should be able to pull up your existing evaluation, and find your justification for the current level of oversight. When justifications don't apply, time to decide on a different level of oversight that reduces the risk back down to an acceptable level. Then document that in your new evaluation.

You might even do something like 100% inspection of part performance until the new supplier is qualified.
 
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