A risk assessment on a piece of equipment was approved by all parties.
After a while, it was noticed that there was an error in the document in the scoring and what were thought to be ‘medium risks’ requiring extra controls, were not necessary.
I want to revise the risk assessment, noting the reason for the change and deleting proposed controls, Then I will ask all parties to approve if they agree with my document.
QA say that I have to first raise a change control form to ask for permission to make the change. No physical changes were made. The risk assessment is not a formula or an SOP or even a qualification protocol…
Is this strictly necessary? are they being picky, or am I being lax!!!..