Process Definition and Process Validation

[Logan_]

Hi,

I had some issues as to what constitutes a "Production Process". Is testing a "Production Process"?

For example, if i had a PCB with LEDs and I have a Test Rig that I plug the PCB into to test the the LEDs are working, is this a production process?

In my mind the Soldering of the PCB is the production process and the test rig is a means of verifying that process. However if the test rig has become part of the production process does this rig itself need to be verified/validated.

In reality this test rig could be omitted and the soldering could be visually inspected, however since we have introduced a test rig have we made life harder for ourselves by needing to verify/validate extra process steps?

Regards,

Logan.

 

[Sidney Vianna]

If your question is against the backdrop of ISO 13485:2016, I would say that the test rig is a monitoring equipment, covered under § 7.6 of the standard, and, no, I would not consider the test a "production" process in the context of § 7.5 of the same standard.

 

[Logan_]

My company has taken a sort of belt and suspenders approach to process validation. We are validating all test rigs used as part of the production process. So I was coming from a Sec. 820.75 Process validation perspective.

So if i understand correctly in regards to my example above as long as i have correct maintenance/calibration/verification record for these test rigs as per § 7.6 i should be covered without having to complete validation?