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

John Broomfield

Fully retired...
Staff member
Super Moderator
#12
No, the process owner could simply respond to a marked up version of the document.

Some organizations find a Change Request Form useful.

But I’d ditch the OFI form because mimicking the registrar may suggest to employees that your organization doesn’t have its own ideas for effectively managing quality.
 

Marc

Retired Old Goat
Staff member
Admin
#13
Opportunity for improvement
An opportunity for improvement is a situation where the evidence presented indicates a requirement has been effectively implemented, but based on auditor experience and knowledge, additional effectiveness or robustness might be possible with a modified approach.

Also see: ISO 9001:2015 - Definition of Opportunities (Per 6.1.1)

But I’d ditch the OFI form because mimicking the registrar may suggest to employees that your organization doesn’t have its own ideas for effectively managing quality.
I agree.
 

AndyN

A problem shared...
Staff member
Super Moderator
#16
Yes, however I am new to this so do we still need to make an OFI for an updated form?
Before anyone can answer, definitively, you might check with your document control process. Does that mention "OFI" or what method is sued to update such forms? In principle, the FIRST place you should check to answer your question is your organization's Quality Management process(es).

BTW - how did you come to call it an "OFI"?
 
Last edited:

JoshuaFroud

Involved In Discussions
#18
You only need to create an OFI Form when your system tells you, you have to.

The QMS I administer has no such thing as an OFI form. We are 9001:2015 and 13485:2016 certified. There is nothing within the 9001:2015 standard that states you must have an OFI form.

With regards to documents as long as they are approved prior to implementation you are covered.
 

AndyN

A problem shared...
Staff member
Super Moderator
#20
With regards to documents as long as they are approved prior to implementation you are covered.
Unless they haven't done some of the "other stuff" ISO 9001:2015 requires for effective control. To dismiss the situation and simply being approval of the first version, you might mislead readers who are not yet fully familiar with what effective control looks like...
 

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