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Is it necessary to classify nonconformance as minor, major, observations in an IQA?

M

miwriter

#1
I am asked to conduct an IQA as part of our gap assessment and found a lot of nonconformances. Is it necessary to classify them as minor, major or observations? I was looking at our SOP and previous records but they have not mentioned about classifying nonconformances. They issue CAPA and just list the non conformances. Can anyone advise me on this?
 
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somashekar

Staff member
Super Moderator
#2
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

I am asked to conduct an IQA as part of our gap assessment and found a lot of nonconformances. Is it necessary to classify them as minor, major or observations? I was looking at our SOP and previous records but they have not mentioned about classifying nonconformances. They issue CAPA and just list the non conformances. Can anyone advise me on this?
Please do not spend time in this classifying activity. It is an internal audit you speak of and the root cause, corrective action and followup activities that are performed on all the non conformances helps you to strengthen your system. These actions can be appropriate to the nonconformance noted in the IQA.
 
J

Jasonliu

#3
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

I also think so ! No need spend so much time on this ,the key point is how to correct these nonconformances and continue improvement actions .
 

Randy

Super Moderator
#4
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

NO!

Most of the time all you'll get out of that practice is confusion and bad feelings.
 
M

miwriter

#5
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

thanks guys for the inputs :)
 

John Broomfield

Staff member
Super Moderator
#6
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

I am asked to conduct an IQA as part of our gap assessment and found a lot of nonconformances. Is it necessary to classify them as minor, major or observations? I was looking at our SOP and previous records but they have not mentioned about classifying nonconformances. They issue CAPA and just list the non conformances. Can anyone advise me on this?
miwriter,

Avoid overwhelming the CA process. Do an 80/20 (Pareto) based on the value of the CA and issue CARs for those.

Remember, as an internal auditor "you will be back". Hopefully by then the operators, supervisors and managers will be doing a better job of monitoring their processes and initiating their own CA.

BTW, PA comes before CA everywhere except in the standard!

John
 
K

Ka Pilo

#7
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

I am asked to conduct an IQA as part of our gap assessment and found a lot of nonconformances. Is it necessary to classify them as minor, major or observations? I was looking at our SOP and previous records but they have not mentioned about classifying nonconformances. They issue CAPA and just list the non conformances. Can anyone advise me on this?
Could be "yes" in terms of prioritizing nonconformities to address. But please note that all nonconformities should be addressed be it minors, majors, or potential problems.
 
#8
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

Could be "yes" in terms of prioritizing nonconformities to address. But please note that all nonconformities should be addressed be it minors, majors, or potential problems.
Not unless everyone in management has a well based understanding in the grading of audit findings and the content of the audit report it relates to!

As has been stated in many other threads, grading is of no consequence if the issue that's being reported doesn't have the same 'gravity' in managements' eyes. Grading is, for the most part, an external audit technique to give those who weren't at the audit some sense of the importance of the issue and its correlation to the recommendation - approval as a supplier or for ISO certification, come to mind. What relevance does that have to an internal audit?
 
K

Ka Pilo

#9
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

Not unless everyone in management has a well based understanding in the grading of audit findings and the content of the audit report it relates to!
Agreed. Otherwise, it will just complicate the audits.

As has been stated in many other threads, grading is of no consequence if the issue that's being reported doesn't have the same 'gravity' in managements' eyes.
Again, it coukd help prioritize actions based on the severity and likelihood of nonconformities.

Grading is, for the most part, an external audit technique to give those who weren't at the audit some sense of the importance of the issue and its correlation to the recommendation - approval as a supplier or for ISO certification, come to mind.
If it works for external audits, it should work for internal audits.
What relevance does that have to an internal audit?
It might be beneficial in some circumstances. Perhaps the benefit or detriment depends on the top management, employees, and/or grading system.
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#10
Re: Is it necessary to classify nonconformance as minor, major, observations in an IQ

Grading Internal audit nonconformities? Don't waste your time on it.

Here's an example I use in my training classes:

Whether your observe a minor or a major leak in your car tire (tyre); fix the damn thing!!
If you start arguing about a small or a big leak, you won't be moving for a while...

Stijloor.
 
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