Release of Product without Process Validation

#1
If any one have an idea regarding the release of product without process validation.
Can we release the product for human release without performing a process validation in any exceptional case based on the justification of V&V testing and end qualification .
 
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S

SteveK

#2
If any one have an idea regarding the release of product without process validation.
Can we release the product for human release without performing a process validation in any exceptional case based on the justification of V&V testing and end qualification .
Waziz,

Depends, if it relates to:

ISO 9001/13485 Clause 7.5.2

“The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.”

However, this is a clause that can be excluded if all production is monitored and/or measured i.e. it is verified. This should be recorded as such e.g. in your Quality Manual.:2cents:

Steve
 
C

Chris Ford

#3
If any one have an idea regarding the release of product without process validation.
Can we release the product for human release without performing a process validation in any exceptional case based on the justification of V&V testing and end qualification .
Your question is very vague and ambiguous. You need to determine your validation needs, first. If the output of a process can't be verified by subsequent inspection, that process should be validated. Check statutory requirements, as well. Depending on where you're marketing the device, the licensing / approval / clearance process may require that you provide validation data.
 
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