CNC Machining Process Validation for Prototypes

#1
Hi, I'm using all useful information on this site for few years and this is my first time posting. :bigwave:

I work with small organizations for development of QMS and also auditing to ISO 9001 & ISO 13485 requirements.

I need your guidance for development of validation procedure for precision machining processes. I found lots of good informations on various threads but my question is how can we apply validation requirement to the process which produce mostly prototype in small quantities? This is toward implementation of ISO 13485 in a precision machining company (Contracted manufacturer of medical devices). We are able to perform IQ but i'm still not very clear how to take the process further for OQ & PQ.

Also, for contracted manufacture as they do not perform design of the medical device what should include our Device Master Records?

Thank you,
Sarah54
 
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Ronen E

Problem Solver
Staff member
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#2
Hi Sarah & welcome to posting on the Cove :bigwave:

A few comments / questions:

- When you refer to ISO 13485 and validation, which clause are you referring to? The answers will be different concerning Design Validation (7.3.6) vs. Process Validation (7.5.2).

- If the organization excludes Design and Development, they're not responsible to validate the design, unless specifically so agreed through contract with the client, in which case I'd expect such validation to be a joint concerted effort of both organizations.

- If a process "mostly"* runs small prototype batches, it wouldn't make sense to validate the process. Rather, verification would be much more appropriate. I believe that for CNC machining most important process outcomes (dimensions etc.) can be reasonably verified. If you have concerns over certain outcomes that can't be, please highlight them in specific so we can focus on that.

*) Process validation is per process. I recommend - in the context of process validation - that you focus on those machine runs that are serial production of significant counts (i.e. >100).

- The DMR should contain everything that is required for making a conforming device; regardless of who designed it, or is regulatorily responsible. BTW, "DMR" is FDA / 21 CFR 820 terminology; in ISO 13485 terms, the equivalent is:

4.2 Documentation requirements
4.2.1 General
(...)
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
Cheers,
Ronen.
 
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