ISO 13485:2016 - Processes exempt from process validation

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RUBI

Registered
#12
I always think that there's some misconceptions when we talk about process validation.

First, we need to separate between before a process is put into service/operating - A (which related to the process planning) and after the process is put into service/operating - B.

Process validation requirements are application to B, not A - special processes are processes where I cannot verify that the output of the process, when the process is operating that, and thus I cannot guarantee conformity (please note that ISO 13485:2016 also includes the situation where you do not WANT to verify the output, thus transforming the process into a special processes.

In relation to A, any process needs verification. So, when you plan the process, you define process requirements, and, before putting the process into service/operating, you need to verify that it can proceed the expected results. In this way, you are verifying that the process can be put into service/operating.
Thanks Marcelo.

I am looking your guidance on orthopaedic devices process validation which include annodizing, electropolishing, vibropolishing & ultrasonic cleaning as per CFR 820 (USFDA). I have recieved NC on validation process due to following reasons:
Justify the batch size ( What is ideal batch size for validation process)
Statistical tools to justify the process.

It would be really appreciating if you can help me with this.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#13
1) What is involved in validation/verifying this step?
2) What does your risk review indicate would happen if this weren't to standard?
 
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