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

[miwriter]

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?

[somashekar]

In Reply to Parent Post by miwriter

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.

[Jasonliu]

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]

NO!

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

[miwriter]

thanks guys for the inputs

[John Broomfield]

In Reply to Parent Post by miwriter

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

[Ka Pilo]

In Reply to Parent Post by miwriter

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.

[AndyN]

In Reply to Parent Post by Ka Pilo

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?