Non-Conformance vs OFI -- your best descriptions

ISO_Man

Involved In Discussions
#1
I have run into a situation where internal auditors at our company are writing OFIs that should be nonconformances. What are your favorite resources for teaching the differences between an Opportunity for Improvement and a nonconformance?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
That's a good one... that's where the lead auditor should step in a guide.
But I've seen the interpretation be broad even in registrar audits.
For me is somethings is gross or systemic them I'd write a non-conformance.
If it was a small, one-off thing or an actual opportunity to improve things I'd write an OFI.

For example - while looking at production paperwork I see one operator forgot to initial a coupe items that should be initialed. Everything else is good... I'd make that an OFI.
If I see several instances of the same error across several documents, I'd write an NC.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
I have run into a situation where internal auditors at our company are writing OFIs that should be nonconformances. What are your favorite resources for teaching the differences between an Opportunity for Improvement and a nonconformance?
I wonder if they are mimicking/copying your external auditor(s) behavior....this practice is called SOFT GRADING and de-values the results of the audits, as evidence of lack of conformance to requirements means, by definition, a nonconformity, which MUST be treated via a corrective action loop, while OFI's are immediately forgotten.

There should be someone in charge of your internal audit program and s/he should write up a nonconformity for this soft grading. What are the internal auditors afraid of? What kind of culture do you have there? This kind of behavior is, normally, learned.
 

normzone

Trusted Information Resource
#6
" I see one operator forgot to initial a couple items that should be initialed. Everything else is good... I'd make that an OFI. "

I would not take that to the record as an observation - it's either worthy of nonconformance or can be fixed and forgotten on the spot.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
I have only ever audited suppliers but after I preset my audit scope I tell them: " I won't issue OFIs but if you want to ask my personal advice on how I have seen such and such done elsewhere I will share it because holistic improvements help everyone."
 

Tagin

Trusted Information Resource
#8
I have run into a situation where internal auditors at our company are writing OFIs that should be nonconformances. What are your favorite resources for teaching the differences between an Opportunity for Improvement and a nonconformance?
For what its worth, I see an OFI is appropriate where a system is weak or susceptible to failure, but no N/C's were detected.

But it seems more relevant for your org to define the two (OFI & NC), not necessarily how others define it. Then document those definitions (probably with several examples of each) accordingly.
 

John Broomfield

Staff member
Super Moderator
#9
I have only ever audited suppliers but after I preset my audit scope I tell them: " I won't issue OFIs but if you want to ask my personal advice on how I have seen such and such done elsewhere I will share it because holistic improvements help everyone."
Ed,

How do you avoid sharing a previous auditee’s intellectual property (aka holistic improvements) with future auditees?

And that the systems you audit are not reliant on your periodic suggested holistic improvements?

Thanks.
 

John Broomfield

Staff member
Super Moderator
#10
For what its worth, I see an OFI is appropriate where a system is weak or susceptible to failure, but no N/C's were detected.

But it seems more relevant for your org to define the two (OFI & NC), not necessarily how others define it. Then document those definitions (probably with several examples of each) accordingly.
Tagin,

Is a conforming system not meant to invoke preventive action without any help from its auditors?

John
 
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