Performance Qualification per GHTF Guidance

[pziemlewicz]

Thanks. I'm not trying to get out of doing a Valildation, I understand the need for it in this case. My question is more about the specfiics of what the PQ portion of that validation should look like - option A or B above or something else altogether?

I would use option A. If something is wrong you want to know that at the operation (via parametric release) as opposed to final inspection when the part is worth more.

 

[indubioush]

As I'm new to the Cove, I can't post links, but if you google "Jeff Boatman a comparison of process validation standards" you should be able to find a PDF. In section on "Validation Of Overall Process" he seems to be saying that the overall manufacturing process always needs validation, irrespecive of the ability to verify individual processes or the final finished product. Would you agree with him on this?

Thanks for sharing this. I found the article, and although it is interesting, the author is not clear about what "Validation of the Overall Process" entails. I would be interested in hearing what others have to say about this.

 

[TWA - not the airline]

I'd agree with pziemlewicz that from an operations point of view I'd like find a problem in my process not with the final inspection of my parts.
Some things to consider from my point of view:
- you could validate a sub-process against a sub-assembly tensile spec, but monitor it using the relevant process parameters determined in the OQ of the validation of the sub-process instead of actual tensile tests on the sub-assembly
- if for a development project you need to perform design verification and validation with final, finished devices this should cover all aspects of a PPQ
- if you validate each sub-process separately, any change to this sub-process later on only needs validation on that level, not on the level on the final, finished device, i.e. a DV&V or PPQ