Risk Assessment of Raw Materials? Medical Device product

[Jim-S]

A recent internal audit resulted in a finding stating that “Risk assessment did not address supplied raw materials” for the production of our one medical device product. Our entire company is new to the device and ISO world, so I don't have much confidence in our interpretation of the requirements. Does this finding make sense?

This is for an established medical device product that we purchased and for which we are going to produce one of the two product components in-house. We didn’t change any of the raw materials that we use to manufacture the product, although we did change some raw material suppliers. The materials themselves do not present any kind of risk to really be assessed. Our previous risk assessments did not address the supplied raw materials.

[temujin]

hi Jim,

Risk assessment really is everywhere...so if you did not address it you probably should.
That said, it does not have to be science fiction...

In Reply to Parent Post by Jim-S

The materials themselves do not present any kind of risk to really be assessed.

I guess you wouldn´t state this without a reason. Put the "why" on paper and you have your risk assessment.

(Consider the device and its intended use, intended/unintended patient contact etc...i.e.)


regards
t.

[achorste]

You may want to include raw material supply in your risk assessment - not only can they deliver to specification, but can they supply on time, in full etc - this will have an impact on your supply chain.

We included this requirement due to delayed deliveries causing quality issues where once we did (finally) receive the parts, production were rushing them to get them out the door.