I am in the middle of a kind of philosophical discussion and would appreciate your thoughts.
The Periodic Review process, irrespectively of being review of equipments, computer systems, process control system, lab equipments, etc…, is it a quality process or not?
Because I would say that as any review, this falls under Quality processes as part of the QMS. I have some colleagues advocating that this should be and Engineering or Validation process, and therefore managed by those departments, but that does not suit well with me. I think that Engineering and Validation must participate in the review process, but should not have the ownership. We are doing quality reviews of the equipment state, therefore an independent review is needed.
Do you agree with this? Can you point me some industry guidelines, that can support my point?
Tks in advance