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Use of raw materials by two supplier

#1
Hello :):)

Our company is preparing for CE MDR. (We make filler and are Class III.)
I have a queastion about supplier of main raw materilas.
Could we set up two main raw material suppliers? or could we use raw materials from one supplier for one product?
 
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planB

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#2
Sieun Baek,

it is entirely up to you how many (raw materials) suppliers you want to qualify. In case you determine these raw material suppliers being critical suppliers, it might make sense to include them all right from the start, since a change in critical suppliers after submission may trigger a change notification to your notified body.

Hope this helps,
 

Ron Rompen

Trusted Information Resource
#3
i agree completely with planB. you can have as many suppliers as you feel are necessary - just be sure that they are PPAP'd correctly (both to you, and in your PPAP to your customer).
The other thing to consider is proper tracking/traceability. If there ever IS an issue which is related to material, you need to be able to identify which product was made with material from Supplier A, and which from Supplier B.
 
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