Definitions for Minor & Major Nonconformances

  • Thread starter luis.armendariz
  • Start date
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luis.armendariz

#1
Where can I find the adequate definition for Major and Minor Non Conformity?
Neither ISO9000:2005, nor ISO17021:2011, nor ISO9001:2008, nor ISO/TS16949:2009 have it, do you know where?

Thanks
 
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Stijloor

Staff member
Super Moderator
#2
Re: Where can I find Definitions for Minor & Major Nonconformances?

For starters, scroll to the bottom of this page (Similar discussion threads) and click on the links there.
 

Ajit Basrur

Staff member
Admin
#3
Re: Where can I find Definitions for Minor & Major Nonconformances?

Where can I find the adequate definition for Major and Minor Non Conformity?
Neither ISO9000:2005, nor ISO17021:2011, nor ISO9001:2008, nor ISO/TS16949:2009 have it, do you know where?

Thanks
We have lot of threads on the related subject. Some of them are :

http://Elsmar.com/Forums/showthread.php?t=2402

http://Elsmar.com/Forums/showthread.php?t=31370

http://Elsmar.com/Forums/showthread.php?t=12546

http://Elsmar.com/Forums/showthread.php?t=18685

http://Elsmar.com/Forums/showthread.php?t=7881
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Off hand I'm not aware of any standard with a definition for Major and Minor Nonconformance(s). I did this some years ago as an FYI: http://Elsmar.com/level2/m-vs-m.html

Basically they all run the same theme:

Minor Nonconformance:
A nonconformity that, based on the judgment and experience of the auditor, is not likely to result in the failure of the management system or reduce its ability to assure controlled processes or products. It may be either:
- A failure in some part of the supplier's management system relative to a specified requirement.
- A single observed lapse in following one item of a company's management system.

Major Nonconformance:
A nonconformity that is either:
- The absence (omission, not addressed) or total breakdown (commission, failure, not implemented) of a system to meet a specified requirement. A number of minor nonconformities against one requirement can represent a total breakdown of the system and thus be considered a major nonconformity.
- Any noncompliance that would result in the probable shipment of a nonconforming product. Conditions that may result in the failure of or materially reduce the usability of the products or services for their intended purpose.
- A noncompliance that, in the judgment and experience of the auditor, is likely to either to result in the failure of the management system or to materially reduce its ability to assure controlled processes and products.

From: ISO Standards Discussion
Date: Tue, 18 Apr 2000 08:22:10 -0500
Subject: Re: Q: Severity of Noncompliances /Owen/Humphries
From: Edwin Humphries

There's absolutely nothing in ISO9000 to cover this. It's just one of those things that SLAGIATT (seemed like a good idea at the time), became standard practice, and has grown to be almost axiomatic.

I think it grew from formal auditing practice, where a Major nonconformance was enough by itself to warrant refusal of certification/registration, a Minor was enough to insist on corrective action (and if there were enough minors, refuse certification), and an observation was not one where corrective action was mandatory.

However, given that it had to do with what was allowed and mandated, it has little relevance in any responsible approach to internal auditing or classification of nonconformances. In internal auditing, there are either things that need to be fixed or things that don't: the things that need to be fixed can be regarded as problems, nonconformances, issues, or improvement recommendations. In classification of product/service nonconformances, I suggest only two classifications: acute, where immediate corrective action is warranted (we never want this to happen again), and chronic, where Pareto prioritisation should precede corrective action (this is happening too often).

Edwin Humphries
 

John Broomfield

Staff member
Super Moderator
#5
Where can I find the adequate definition for Major and Minor Non Conformity?
Neither ISO9000:2005, nor ISO17021:2011, nor ISO9001:2008, nor ISO/TS16949:2009 have it, do you know where?

Thanks
Luis,

Why rate your nonconformities for internal audits?

I can understand how rating them may help with yes/no recommendations from second and third party audits but beyond that, what is the point?

The unhappy coincidence of three minor nonconformities could kill someone.

John
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
I won't disagree with those saying not to differentiate, but then again one needs to be able to classify findings if only to decide which (if any) need "significant" corrective actions. As a couple others here have said, it really doesn't matter what you call them, but there must be some sort of way to decide which findings are of importance (sometimes a finding is critical) and which are not.
 

harry

Super Moderator
#9
I won't disagree with those saying not to differentiate, but then again one needs to be able to classify findings if only to decide which (if any) need "significant" corrective actions. ...............
Marc, it depends on the objective of the audit. For those whose objective is improvement and which should be the case of most internal audits, an NC should result in a small or big improvement that nobody can be sure of at the onset, so there isn't much meaning to classify it.
 
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