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ISO 9000 - TS 16949 Information Exchange
Definition From KPMG:
An observation that indicates policy or practice contrary to the requirements of applicable standard or documented procedures.
A Major Nonconformity is either:
The absence or total breakdown of a system to meet the ISO 9000 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 nonconforming product.
A condition that may result in the failure or materially reduce the usability of the products or services for their intended purpose.
A noncompliance that judgment and experience indicate is likely either to result in the failure of the quality system or to materially reduce its ability to assure controlled processes or products.
A nonconformance which is of a serious nature.:
May be a long-standing minor nonconformance from previous assessments, or a collection of similar minor nonconformances indicating a widespread problem;
Established as detrimental to quality delivered to customers; or
A failure or significant deficiency in a significant part of the quality system governed by applicable standards.
LRQA calls a 'major' finding a HOLD POINT. They discourage talk about 'major' and 'minor' nonconformances.
An ISO 9000 nonconformance to that judgment and experience indicate is not likely to result in the failure of the quality system or reduce its ability to assure controlled processes or products.
A failure in some part of the supplier's documented quality system relative to ISO 9000, or
A single observed lapse in following one item of the company's quality system.
A nonconformance that is not of the severity indicated by the definition of major nonconformances, above, but which must be actioned.
LRQA calls this a Continuous Improvement point. They discourage talk about 'major' and 'minor' nonconformances.
No major or minor nonconformities were noted in the audit.
From QS 9000's Quality System Assessment (First Edition):
No major or minor nonconformities noted.
From QS 9000's Quality System Assessment (First Edition):
Hello!?! Can YOU Use This?
THE SPECIFIC SUPPLIER DOCUMENTATION MEETS QS-9000 INTENT GIVEN THE SCOPE OF THE SUPPLIER'S OPERATIONS.
The most recent info on this is in this thread. 2001-07-19
An observation is essentially an OPINION. Read this thread for some more thoughts on what an observation is -- If you've never heard of a LOOK ( I hadn't), it's also discussed in the thread. This thread also has some oblique references. When I see an auditor write up an 'Observation' I ask myself this: "Is this person qualified through experience, etc. to be offering what is no more than their advice to me on my business and/or process(es)?" Double check with your registrar -- Ask what their expectations are when (if) they write up an Observation. Some say you can ignore it while others expect the Observation to be addressed in some manner - such as through the corretive ation system.
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).
An action of correction that renders the nonconforming or suspect material to a status that said material will meet all specified requirements.
An action of correction that renders the nonconforming or suspect material to a status that the material fulfills the intend use or purpose but may not meet the specified requirements. The repair action may require additional input from the intended customer regarding the permissibility of this action.
An action that renders the nonconforming or suspect material to a condition which prevents usability of the product in any manner. (Does not meet form-fit-function).
An action that regrades the product for alternative applications or an action that removes usable components, individual parts or subassemblies, from a completed product or larger subassembly for use in product.
Return to Vendor (RTV) or Return to Supplier (RTS)
An action that returns the nonconforming or suspect material to a sub-tier supplier for further disposition and/or correction.
Note: Supplier is commonly used instead of Vendor, however they are synonymous.
Use As Is (UAI)
Acceptance of nonconforming or suspect material for use with or without repair or rework. A UAI action normally requires additional input from the intended customer regarding the permissibility of this action.
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