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.
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.