Internal Audit Findings - Major vs. Minor Finding - Defining the differences

[Jim Biz]

Hello all:

I'm now working with a "client" and re-devloping/updating from the 1994 to the 2000 standards..

What I would really be interested in is what viewpoint should be taken from an internal standpoint as the difference between a Major and Minor nonconformance...

Seems to me that the differences from an external/registrars view is fairly clear --- Majors are required to be corrected within fewer days and there is a $$$$ penealty attached to them.

Does anyone here actually define in their procedures the differences internally? If so what would be an appropriate "penalty" for a Major finding (assuming of course that Top Management would back it up)

[Brandon Kerkstra]

Jim,

A major NC would be a systematic breakdown where a minor would be a "Single" lapse in the system. There are many times you can find a few minors that refer to the same lapse in the system. These would typically be combined onto a single NC, but only if they truely are the same instance. Many times the multiple single lapses in the system that occur in different areas are an indication of a systematic breakdown and therefor would constitute a major NC.

As far as response, a Corrective action must be comenserate with the NC. Appropriate responses to a Major would be further follow-up including adjusting the Internal Audit schedule to increase the frequency in the particular area or process.

Having said all that, I would say the most important part to stress in the training and Internal Audit Process is that bigger problems need more effort to correct. I am alway more happy to see this in a system and audit process then the semantics of calling the NC by major or minor, especially when it is borderline.

Hope this helps - Brandon

[M Greenaway]

When classifying NC's you should also consider the effect of the lapse on the actual product and/or customer satisfaction.

i.e. a single gauge beyond its due calibration date might be minor, but if the gauge is subsequently accepting what is actually defective product then this might be considered major.

[Claes Gefvenberg]

What I would really be interested in is what viewpoint should be taken from an internal standpoint as the difference between a Major and Minor nonconformance...

As a matter of fact we don't separate the two... We only have one kind of nonconformance.

What we do instead is to treat the deadline differently: For a "normal" nonconformance we agree on action and deadline as usual. They depend on the impact of the nonconformance and the resources available to take action.

What you would call a major would result in a request for immediate action.

/Claes

[db]

I tend to agree with Claes, I recommend NOT using majors and minors. I found this is the one area that causes the greatest level of argument: "What do you mean it is a major...?" If it is nonconforming, it must be corrected. Regardless of what you call it. Forget the label and fix it.

[Jim Biz]

The situatin with this client - may or may not be real unique

Seems that their current internal procedures do not clearly define any differences between major/minor findings... (which is not a biggie "as long as" those involved know they need to and actually work on fixing the identified problem)

But.... the audit report they have developed does contain a major/minor checkbox allowing the internal auditors to choose what level the nonconformance is in their opinion. (Due from what I gather was an imrovement suggestion from their external auditor- so effectiveness of the auditing system can be assessed.)

Now after the internal audit system has been in use they have found the attitude of internal auditees to be "If I dont do what I have said I would or disagree and don't fix what "the ISO folks say needs fixed- there is no written or even implied penalty involved - tell me it's major - tell me its minor - I don't care. If I simply disregard what has been identified as a problem - nothing is done.

The situation has now evloved to where the Top Management folks (instead of taking direct management action) have asked the ISO rep to include wording in a "procedure" Defining response days for both catagories and outlining the diciplinary actions that will be taken for not following procedures.

[Bruce Wade]

From our "control of nonconformance" Level II procedure (BTW: We have an integrated ISO 9001:2000 and ISO 14001:1996 system):

(SNIP BEGIN)
LEVELS OF NONCONFORMANCE:

Observation:
An observation is an identification of an item that could be of value for the improvement of the quality and environmental management system.

Minor nonconformance:
A minor nonconformance is a system nonconformance that judgment or experience indicates is not likely to result in the failure of the quality and environmental management system. A minor process or product nonconformance does not result in the release of product not suitable for use or not meeting Client requirements. A minor environmental nonconformance does not result in harm to humans, flora or fauna or release of regulated or harmful substances into the environment.

Major nonconformance:
A major nonconformance is a system nonconformance that judgment or experience indicates may result in the failure of the quality and environmental management system. A major process or product nonconformance may result in the release on product not suitable for use or not meeting Client requirements. A major environmental nonconformance may result in harm to humans, flora or fauna or release of regulated or harmful substances into the environment. A major nonconformance will require initiation of Corrective Action (see MSP 23).
(SNIP END)

These definitions are used to determine the level of response required for product, process, vendor and environmental nonconformance.

While the standards do not require defining nonconforming conditions by severity, the system appears helpful in delivering response commensurate to the nonconformance. Also, many (most/all) registrars use such a system when performing registration and surveillance audits to determine conformance of the total system to the standards...

[Randy Stewart]

Jim,
One of the things I take into consideration is what is needed to correct the situation, along with the systemic breakdown. Typically I don't separate them in my reports to management. However, there has been instances where the individual responsible for the area felt they needed support to get "Exec Management" to move (i.e. Purchasing) and I issued a Major to open eyes. As Management Rep I once requested a minor to be raised to a major from our registrar for the same reason. (It was a QS audit not just ISO). For the most part, my internal audits don't separate minors from majors either.