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.
Steve