Updated: Aug 10
In part 1, I cautiously questioned that the big-guy change control system should be used for every change.
Let me give an example area: the QC-laboratories.
Let me lean on the related EDQM QM document: Management of changes.
In section 3, some specific examples are described where they don't think the change control should be the driving process:
'Typical examples which would not trigger a change management process include:
• New batch of a chemical substance used in an analytical method and quality defined in the relevant SOP (change identified to be “within the design space”)
• Change of typical method parameters , e.g. incubation time, temperature (already covered via validation and verification)*
• Change of test equipment (already covered via PQ and verification of test method)
• Any single occurrence or non-conformity covered by the corrective action plan or elsewhere (e.g. complaint management).
• Changes/amendments to technical records'
I think this gives a lot to think if we can make our lab's continuous improvement more efficient.
* Naturally, the sanctity of the DMF must be kept, but QC needs to have access to all necessary regulatory documents to be able to decide which parameter change would need a full change control process, involving RA.