
In my case, I don't have a separate SOP for this type of change, but I mention it in the management SOP and keep a record for tracking process changes. Some examples of changes that must be documented include:
- Changes in company activities or scope
- Changes in services offered
- Changes affecting product design
- Changes affecting manufacturing
- Changes in any QMS operational process
- Changes in critical suppliers or subcontractors
- Any change that might impact product safety or efficacy
For each change, we describe and document the impact, criticality, affected documents, and those responsible for change control. This record helps with planning, resource evaluation, and risk assessment related to process changes. Hope this helps.