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nonconformances, audits and auditing, severity ranking (fmea)
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  #1  
Old 18th February 2009, 01:03 AM
Iriza Iriza is offline
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Please Help! Defining a Severity Level of a non-conformance



My friends and I are thinking to put severity level on the non-conformance but we are having a hard-time thinking for the criteria. If we will countify the criteria we have to prove the amount this will take time and we only have limited time to perform the full cycle of audit. but if we will use qualitative approach it will be subjective. Can anyone from this forum share to me how do they put severity level in thier non conformance beside the actual definition of major and minor.


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Old 18th February 2009, 03:37 AM
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Re: Defining a Severity Level of a non-conformance

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My friends and I are thinking to put severity level on the non-conformance but we are having a hard-time thinking for the criteria. If we will countify the criteria we have to prove the amount this will take time and we only have limited time to perform the full cycle of audit. but if we will use qualitative approach it will be subjective. Can anyone from this forum share to me how do they put severity level in their non conformance beside the actual definition of major and minor.

Hello Iriza,

Welcome to The Cove Forums!

Severity can be assessed as the effect it has on the internal and external customer. I don't know if you are familiar with Failure Mode Effects Analysis (FMEA), but failure modes (nonconformities) can be ranked on a scale from 1-10 (1 low 10 High) in terms of how "bad" the customers would be inconvenienced.

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Old 18th February 2009, 04:15 AM
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Re: Defining a Severity Level of a non-conformance

thank you very much for this, yes I'm familiar with the FMEA...I'll study it and align it with what we are doing...

again thank you for this...
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Old 18th February 2009, 06:52 AM
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Re: Defining a Severity Level of a non-conformance

I haven't noticed it since I've been back on the Cove (could be here and I just haven't seen it), but you could consider the cost of the NC as the basis for classification.

This is using actual costs, not what the accounting ppl refer to as "unrealized losses" (like potential lost business) which is what Stijloor points to when he says "how "bad" the customers would be inconvenienced" (potential vs. actual).

E.g. Job shop operation where a team works on a product for 2 weeks and the customer doesn't accept it.

Root cause analysis shows the major cause being ineffective design validation.

The NC cost will include labour (the correct spelling for you non-British-language writers), direct materials, other direct costs and overheads.

At the end of the period you can then report: "We had 6 NCs costing over $1 million, 10 NCs between $500K and $750K, and 87 NCs under $500K".

When you add all NCs within a category, you may find the total cost may surpass the total cost of the category above, e.g. 6 x $1.5million = $9 million vs. 10 x $950K = $9.5 million.
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Old 18th February 2009, 07:01 AM
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Re: Defining a Severity Level of a non-conformance

Also, I have seen a Registrar introduce a "Special minor" between minor and major.

They said it was for NCs which were likely to become majors by the next audit if action was not taken to fix the problem(s).

Last edited by qualitymanager; 18th February 2009 at 07:07 AM. Reason: Accurate term used for NC category
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Old 18th February 2009, 09:55 AM
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Re: Defining a Severity Level of a non-conformance

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In Reply to Parent Post by qualitymanager View Post

Also, I have seen a Registrar introduce a "Special minor" between minor and major.

They said it was for NCs which were likely to become majors by the next audit if action was not taken to fix the problem(s).

"Special minor"?

Next we'll see "Special major" then "Minor major" then "Major minor" and probably "Minor minor" and "Major major"

This kinda like a flat tire...a flat tire isn't really flat 'cause it's still round on the top..........but it has potential to become flat all the way around.

Non-conformance is non-conformance no matter what you call it and and catagorizing them is another way of say that you don't want to be bothered with 'em so the lower ones can wait until you have the time and gumption to fix them.

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Old 18th February 2009, 10:05 AM
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Re: Defining a Severity Level of a non-conformance

I would leave the severity determination up to the management who has been assigned to specify a response to a reported audit observation. Their action plan should be based on a thourough investigation determining the severity and the actual frequency of the observation reported. FMEA principles can be used for that purpose.

In the report the auditor can classify the observations just as
  • major - requirement of the referenced regulations or standard are not implemented; systematic deviation from a regulatory or customer requirement; significant risk for marketed products not meeting their specifications for safety or effectiveness; repeating or frequent minor observations within the same requirement
  • minor - partial implementation of regulatory or standard requirements; partial or incidental deviation from a regulatory or customer requirement

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Old 18th February 2009, 10:14 AM
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Re: Defining a Severity Level of a non-conformance

Iriza, Quantifying ($) a non-conformance (lets call it a audit finding for this discussion) would be a very difficult thing to do, and somewhat costly to perform this analysis.

In my experience, findings are classified in order to identify there severity in terms of impact on your business and more specifically, your customer.

The severity level typically identifies the exposure the finding gets and the sense of urgency required to correct the problem.

I would be happy to share with you how we classify findings in the
Aerospace and Defense industry if you are interested.

Bob
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