Can Process Validation actually be Design Verification?

W

Wicker

#1
The FDA identifies "Product Performance Qualification" which includes functional testing. Functional requirements are considered design inputs. Sometimes it is not realistic to identify all design outputs needed to relate back to your design inputs. For example: if you have bond strength of 3 lbs. as your design input, we don't measure the dimensions, adhesive properties and surface finish needed to guarantee a good part, we just do the pull-test.

Therefore when you perform product performance qualification as part of process validation, are you really doing design verification since you are verifying the design inputs?:confused:
 
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yodon

Leader
Super Moderator
#2
We have, for one client in the past, used process validation results to verify design requirements. No question was raised by the FDA. We showed the linkage from design to test, showed the test had pre-approved acceptance criteria and recorded the results.
 

Randy

Super Moderator
#3
Wow, you have asked a good question, and seeing that I just finished creating an 8-hour training course on Design Verification & Validation (per ISO 9001, 7.3) that I have to deliver next week I'll wade in.

Based upon my extensive research (lots of hours googling and from responses supplied by many of my friends here) I fell comfortable saying "YES"!:yes::agree1:

Verification and validation are at times used synonymously and often the two "processes" may overlap so much that you can't hardly tell one from another. What you have described is one of those cases or areas of overlap...we can't say the design really meets the specifications until we actually test it in operation.
 
R

Roland Cooke

#4
Never allow arbitrary/semi-arbitrary definitions to get in the way of logic and common-sense.

BUT

as with everything, it is key to not only be compliant, but to be be able to sell the fact that you are compliant (not always the same thing!)
 
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