Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update?

[skb76]

there is NO need, for OFI to documented ..
BUT, you need to 'do something' to prove to auditor that you/organisation improvement been made in regard of the OFI that been raised to you,

 

[John Broomfield]

there is NO need, for OFI to documented ..
BUT, you need to 'do something' to prove to auditor that you/organisation improvement been made in regard of the OFI that been raised to you,

Auditors should not issue their “good ideas” (aka OFIs) to require improvement. If they see evidence of a potential nonconformity then they should find out why the system has not prompted the auditee to take preventive action. That is the value an auditor can add and it may be a nonconformity, issuing an OFI suggests they ran out of time to do this investigation.

And never run your system just to keep an auditor happy.

 

[JoshuaFroud]

Yes, that is true, but the specific question was related to are OFI's required for documentation updates. The answer was no; however, they do need to be approved prior to implementation of the new procedure. Yes there are other basic 9001 requirements in place to do with document control but this was a question about OFI's being needed.

 

[Al Rosen]

When you document the change, you can include in the reason for the change that it was a preventive action. Keep a log or excel spreadsheet with a column to identify the change as a preventive action. It can later be sorted to find your PAs.