Major vs. Minor vs. Opportunity for Improvement - Product as well as Office Processes

[Bob_M]

I am trying to update our Internal Audit Procedure, Forms, and eventually training presentation.

We are a small metal stamping company with very few Internal Auditors.

Our last training session on HOW to audit went well.

Will just discussing the needed changes to our IA procedure, my boss and I were struggling to come up with good definitions of Major and Minor audit non-conformances.

I am looking for suggestions and examples.

Please note our our audit program is NOT as ISO focused as the most everyone else's programs seem to be.
ISO9000:2000 upgrade will be incorportated in the schedule, and procedure, but it is NOT the main focus of the program. Improving and detecting problems in our system is.

So we need some ISO and general definition of Major and Minor NCs that apply to product as well as Office processes.

Any help will be greatly appreciated.
Thanks Bob_M

 

[Jimmy Olson]

Hi Bob,

I think the idea of Major and Minor nonconformances is slowly dissapearing.

We basically have our program set up so that you either have a finding or an observation (whether it's based on ISO or our own procedures or anything else doesn't really mater). Generally a finding will be something that will require a CAR and an observation is something that has potential to be a problem or a potential area to improve. I know this is kind of a short and quick answer, but hope it helps.

 

[Bob_M]

Typical good and quick responses from Jim and Richard.

I like the idea of dropping the major/minor and leaving it as Finding/Suggestions...

Our intent with the updated IA procedure and our newer Corrective/Preventive Action procedure is to raise the BIG RED flag only when necessary...

HMMM I might discuss this with the boss...
We really had a hard time defining MINORS...
Major are easy to define...

Thanks for the "food for thought".


Bob M

 

[zhugxian]

Classification of NC

Dear Sir,

Minor Nonconformity

This refer to a minor deficiency to comply with the standard which based on judgement and experience is not likely to result in the failure of the management system or reduce its ability to assure controlled processes or products/services. It may be one of the following:

- a failure in some part of the organisation’s documented quality system relative to the standard requirements

- a single observed lapse in one item of the organisation’s management system.


Hopes that help

 

[Randy Stewart]

Bob,
Jim and Richard have summed it up. We've begun utilizing a basic Issue/Action sheet for documenting non-conformances with status being tracked by the green, yellow, red method.
What I like to stress to our auditors is not the finding of non-conformance but more of pointing out Oportunities for Improvement. This seems to promote the "Best in Class" type of improvement, and at least here, it has been very beneficial in the standardization across the different facilities and operations of the company.

 

[gpainter]

You may want to do a search, I believe there are some good definitions posted.

 

[Randy]

Jim Wade said:

Hi Bob

A suggestion
... why not simply drop the terms completely and make every finding an opportunity for improvement (positive) rather than a nonconformance (negative)?

rgds Jim

I'll double what Jim said.

The IA "process" is the single most important function or "process" in your system, and has to be both used and viewed as a positive/pro-active activity. The term "nonconformance" is not now and will never be identifed as a positive thing, it's negative.

Switch your thinking and state "Preventive and corrective action" with the emphasis on "preventive", this goes a step beyond what Jim said, but not much. Focus on identifying opportunities for improvement (finding things before they come N/C's should be the goal). I emphasize this to no small degree when I instruct IA and implementation courses. Positive, proactive.

 

[Freddiem11]

I also agree with Jim and Randy. But if you simply have to put an importance tag on a finding, look at the severity of what was actually found. If bad product is knowingly being shipped, this obviously has a greater severity than a missing record or something that the customer could probably care less about. By the way, we have a whole binder full of these minor CAR's! But they big are a part of improvement, corrective, and preventive action.
One definition sometimes seen is:
Major= Systemic Nonconformity- many ocurrences per sampling, Missing ISO 9001 required procedure or records, system breakdown, could cost certification.
Minor= Isolated nonconformity-few or one ocurrence per sampling, no system breakdown, probably won't cost certification unless unaddressed.
What ya think Randy? Maybe I paid attention during that part? Ha, ha. Did I get it?

 

[Randy]

Ha, ha!!!! Not bad for regurgitation, but then my wife could have said the same thing and she never spent $2000+ tax dollars.

Your focus should be on keeping from having to use those nomenclatures or terms in the 1st place. The focus should be on preventive actions followed by corrective ones if something does crop up. As for Major, minor or whatever, who really gives a krap? You either have deviations or you don't. Don't get wrapped around the axle with terms and words.

 

[Randy Stewart]

If your focus is on NC's your IA will become viewed as a witch hunt instead of a positive operation. Your people will see holes, before you come out, and put some type of temp covering over them hoping you won't notice. It doesn't help.
It takes time to get everyone to see it as another set of eyes looking at their process for improvement. It doesn't help you the system or the company if the IA's are viewed as "I bet you can't find the problem".
I'm not saying it happens all the time, but more and more often I have people come in and tell me that they question a particular operation and either want help fixing it or tell us how they are planning on attacking the problem or issue! It makes my job much easier and it is getting us closer to eliminating the need (not requirement) for internal audits.
:thedeal: