How to risk assess tooling? For a medical device and is it needed???


Hi all,

We are a small medical device manufacturing company and have been told by the supplier that we have to risk assess their tooling and tooling for IQ,PQ (VALIDATION) and their moulding process.

1. Where can I find info specifically related to this (standards etc)
2. Does anybody have any experience in doing this? How do I get started?

They have told us that the information needs to come from us.

Any advice would be most welcome.
Utterly confused :/


Super Moderator
One of YOUR suppliers is pushing this on you? I would expect there to be some push from your customer.

You can't really know the risk to the device without your customer's involvement. In essence, if failure from the tool (resulting in a NC part) can lead to patient harm then the severity of the harm needs to drive the degree to which you qualify the equipment and validate the process. You can maybe brainstorm on how the process can fail (PFMEA). The IQ/OQ/PQ process is a pretty standard method for the process validation. Ensure things are set up properly, find out what your process parameter ranges are, dial it in, make parts, confirm they are compliant. You can google the heck out of that.


Trusted Information Resource
This is just an educated guess: The supplier may be used to generating (internal to them, but asked for by other medical device manufacturers they supply) manufacturing process FMEA documents, and they (manufacturer) want you to provide the initial severities (for potential failure modes) and then to do an evaluation/assessment of the controls they've implemented as part of their process.

It is also possible (as I have observed this directly with suppliers of molded components) that the supplier simply wants to begin planning for sample sizes (and commensurate efforts) for (injection mold) tool qualification, and used a risk-based assessment to determine sample sizes and/or determining which dimensions to study.

I suppose it is also possible that the supplier simply tossed this general question to get an assessment of how serious you are!
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