If you have a process where you can fully verify the critical features of the product coming from that process is there a need for process validation ie. do you need to define your inputs and outputs and prove the capability of the process etc. or can you simply prove that you can verify the output of the process on the verification system and validate the verification system?
For example manufacturing a metallic implant from a lathe. Parts from this process are then 100% verified for geometrical accuracy on a coordinate measuring system. Surface finish is also verified on an inspection system.
Is an equipment lifecycle validation on the lathe plus a full scale validation on the measuring/inspection systems sufficient from a compliance point of view or does the lathe process need to undergo process validation to prove its in control and capable?