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

[Cari Spears]

No. You don't need to create an OFI for updating a form, regardless of the nature of the change.

 

[John Broomfield]

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]

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.

 

[Jim Wynne]

Thanks! So we only need tocreate an OFI form for major updates like a completely new and re-formed doc (sufficient major changes).

You still haven't clarified what's meant by "OFI," but why do you think you need a form?

 

[Al Rosen]

I think the OP is asking if an OFI should be generated to revise a Form, not if a Form should be created to document an OFI.

 

[AndyN]

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"?

 

[EMP]

I wouldn't necessarily - does it add value? How big is the organisation?

 

[JoshuaFroud]

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.

 

[Randy]

All you're doing is creating more work and increasing the potential for non-conformance.

 

[AndyN]

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...