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Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor?

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stanislavd

#1
During our internal audits we have found that the different auditors have different criteria for what is Major/Minor nonconformity? Is there any documented criteria how to classify the observations/nonconformities found during the audit? I am also a little bit curios how external auditors manage this...
 
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Antonio Vieira

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#3
In the case of QS-9000 those things are clearly defined.
They should also be for ISO 9001..., but unfortunately it’s not the same for different registrars.:(
 

Coury Ferguson

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#5
stanislavd said:
During our internal audits we have found that the different auditors have different criteria for what is Major/Minor nonconformity? Is there any documented criteria how to classify the observations/nonconformities found during the audit? I am also a little bit curios how external auditors manage this...

In my opinion, a Major is one that has shown to be plant/business wide (breakdown) and a Minor is one that is found only to exist as one time and not plant/business wide.

Coury Ferguson
 

Sidney Vianna

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#6
Not all NC's are created equal

Al Rosen said:
There is no distinction for internal audits. There are only non conformities.
That is correct. However, an organization might decide to rank/rate their internally discovered nonconformities in order to prioritize actions on the ones that have a higher impact or risk. Not all nonconformities will affect the organization in the same manner. So a "risk evaluation" approach might be beneficial.

If an organization decides to develop a criteria to "rate" NC's, such as critical, major, minor, etc... they can develop their own system.
 
#7
Sidney Vianna said:
That is correct. However, an organization might decide to rank/rate their internally discovered nonconformities in order to prioritize actions on the ones that have a higher impact or risk. Not all nonconformities will affect the organization in the same manner. So a "risk evaluation" approach might be beneficial.
Indeed. It is up to the organization.

I must say however, that I have always found the major/minor discussion a totally unnecessary complication in internal audits. We do not use it.

/Claes
 

Ragnar

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#8
At our facility we have decide that an internal audit finding with potential to negitivly impact our customer gets a "Major" ranking while findings that do not potientialy impact our customer are concidered "Minor" an example would be nonconforming product not properly identified or segregated from production would equal a major N/C because that product could be shipped. An expired Quality Alert still hanging in the work cell would equal a minor. We as an audit team have also included ANY repeat audit finding where corrective actions were not adaquate and root cause not properly determined would also receive a "Major" rating.
So far no complaints about our approach from the registrar.:cfingers:
 

Antonio Vieira

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#9
Ranking the nonconformities in internal audits can be a very wise decision.
I do it all the time.
It’s also a good idea when you have quality objectives related to the number of nonconformities in internal audits.
This way you can state a number of observations, a number of minor nonconformities and a number of major nonconformities as maximum values for this kind of objective to be achieved.
Anyway it’s also a good idea to rank these nonconformities just to be in accordance with what 3rd and 2nd party audits are doing...
 

Cari Spears

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#10
Claes Gefvenberg said:
...I have always found the major/minor discussion a totally unnecessary complication in internal audits. We do not use it.
Same here. Our internal audit findings are either nonconformances or opportunities for improvement.
 
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