Folks,
I am looking for some clarity on a topic which has come up for me recently regarding signed meeting minutes. I had been told recently that an auditor can ask for signed meeting minutes from the design stage of a project and can question how and why design decisions were made from the project period before the design was finalised. My understanding was that the DQ closed out the design stage of the project and the following statement could then be made “We are now happy that the design as it has been documented should be capable of meeting all requirements as stated in the URS, validation testing shall verify this fact”. That means any questions on design are answered by showing the DQ / or deisgn review report or other equivalent.
The question is:
[i][b]Can an auditor as to see evidence of how and why design decisions were made from the project period before the design was finalised?
Should Design meeting minutes be approved?[/b][/i]
I have never worked on a project where the minutes of design phase meetings were an approval requirement.
As far as I am aware once the Design Specification is approved that should be sufficient.
If an auditor wants to see how the design is satisfied, show them the trace matrix and explain how each design component has been incorporated and tested.
I agree with Graham. I’ve never seen such questions raised.
The only thing I can think of that might drive such questions (other than an auditor being out of line) is that you have something in your procedures that say you do these things?
I presume you have approved design specifications and that should suffice for approval.
Don’t hesitate to ask the auditor what the basis for the question is. I have known auditors that ‘push the envelope’ a bit for whatever reason. It’s never bad to ask for clarification regarding the requirement. Could end up being a simple misunderstanding! If the auditor doesn’t give you a satisfactory answer, may be time to change auditors!