Sample Procedure from Contract Manufacturer Prospective

LUFAN

Starting to get Involved
#1
Hi everybody,

Risk is my not my particular area of expertise. That said, I am representing a contract manufacturer of consumables for a customer's main device, and I am wondering if anyone had a outline/procedure they might be able to share from the prospective of a CM rather than the manufacturer. I intend to write the procedure reduced in scope to the processes performed by us during product realization and not design, as we are not design responsible. I've read Rob Packard's article and gained some insight from that but still struggling a little bit to decipher 14971/24971 and pick out the areas important to a CM Risk Procedure.

Any help is appreciated.
 
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yodon

Staff member
Super Moderator
#2
As a CM, you can't own the whole risk management process. Your customers (the "legal manufacturers") must own it as only they can establish risk acceptability criteria and they need to provide the clinical expertise to determine severity.

When we (we're a contract R&D shop specializing in medical device development) drive a Risk Management process for our clients, the CM usually is only involved in a Process FMEA. The CM can identify ways the assembly process can fail and the likely impact to the device but the legal manufacturer still has to be responsibility for establishing the severity. (Aside: the PFMEA is only where we use a detectability rating still.) The CM and legal manufacturer work together to establish suitable tests / inspections to mitigate the likelihood of the assembly failure.

If I were a CM, I'd write my risk management process to reflect that. Note that this should drive your client agreements.
 
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