How to categorize Minor, Major or Observation for Internal Audit NCR

Hello everyone,

I would like to get a more clearer picture of how to categorize a NCR as minor, major or observation for internal audit. Would appreciate if someone can lend me a hand on this

Re: How to categorize minor, major or observation for internal audit NCR?

Hi KCIPOH,
In our procedure, Major Nonconformance was defined as any nonconformance that could:
1. adversely affect safety as related to products, persons or property;
2 impact the usability of a product, performance of a service, or the integrity of the quality system;
3 significantly increase product cost;
4 potentially affect the ability to meet the customer’s requirements. Examples: incorrect process parameters, missing inspections or processing steps, failure to record required data, missed or out-of-tolerance calibration
5 result from failure to implement a corrective action from the previous audit.
6 Violated the ISO9001 requirements.

Minor Nonconformance was defined as any non-systemic, isolated nonconformance that does not:
1 adversely affect the usability of a product, performance of a service, or the integrity of the quality system;
2 affect any product or process output. Example: paperwork oversights, minor changes to procedures for clarification.

And Observation was defined as a statement of fact made during an audit and substantiated by objective evidence and auditor’s informational comments based on an assessment of a special process or quality system.

Hope this helps.
Best regards,
Raffy

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

In addition to Raffy's post, there are quite a few existing discussion threads here on Differences between Major and Minor Nonconformances. Hope this helps.

Re: How to categorize minor, major or observation for internal audit NCR?

Hello Raffy,

Many thanks to your explanations as i got the picture of where am i suppose to head on during my internal audit time

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

KCIPOH said:

Hello everyone,

I would like to get a more clearer picture of how to categorize a NCR as minor, major or observation for internal audit. Would appreciate if someone can lend me a hand on this

Click to expand...

Why do you want to categorise them major/minor? I can see the benefit of differentiating between N/C and observation not major/minor.

If you do use major and minor N/C's, what do you expect people to do different when they address them? The only thing I can see is the timescale by which they are resolved - which should always be on any corrective action anyway. By not categorising you avoid the problems of people spending longer worrying over the grade rather than the content of the N/C; you avoid auditors 'glorifying' the fact they have raised a major; you avoid 'tit for tat' grading of majors; etc.

I raise N/C's to get things changed where they need to be changed, if they are more serious we reduce the time allowed to put in place the changes.

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

Colin asks some very important questions!

The fact is that, however an auditor may grade a non-conformity, (often simply by checking or ticking a box) it is how the issue is described that counts. It's quite normal for an auditor to 'feel' the issue warrants a particular grade, but the issue isn't described as such

My advise, for internal audit use, is not to bother. It won't make much difference to most audit findings and each auditor will be grading things differently, despite the 'rules'.

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

Colpart said:

Why do you want to categorise them major/minor? I can see the benefit of differentiating between N/C and observation not major/minor.

If you do use major and minor N/C's, what do you expect people to do different when they address them? The only thing I can see is the timescale by which they are resolved - which should always be on any corrective action anyway. By not categorising you avoid the problems of people spending longer worrying over the grade rather than the content of the N/C; you avoid auditors 'glorifying' the fact they have raised a major; you avoid 'tit for tat' grading of majors; etc.

I raise N/C's to get things changed where they need to be changed, if they are more serious we reduce the time allowed to put in place the changes.

Click to expand...

I believe we've had this discussion before but as I have donned my ISO 9001/14001 auditing hat again to help a site out - not a Corporate gal for the next few hours at least - I'm going to jump in with my thoughts.

Why differentiate? Because of the value-added approach to problem-solving.

In my production experience, we treat a "minor" with a correction. We log it. We acknowledge it. But it's a small little hiccup in the grand scheme of things. Root cause analysis is NOT required for a hiccup. We simply wish to get rid of the annoyance....I mean, nonconformance.

I guess this would be aligned with the "observation". However, observation implies "Hey, we found something, but you don't necessarily need to do anything about." And that, to be honest, is typically unacceptable within my organization. An observation says that there is some nonconformance against requirements, does it not?

A major, on the other hand, is big issue. It implies high (potential of) risk and/or loss. It is a systematic issue and we want to get rid of it for our own sanity and the health of the management system.

An Opportunity for Improvement is for those cases where requirements are conformed to, however there is the potential to improve the process/practice/results. It is optional to implement.

When we do system audits in my company, we may note "minors" on individual processes, and we inform the area before we leave of the situation. However, at each team caucus meeting - held at the end of each day - we discuss what was found and if there are multiple minors against a particular requirement (e.g., lots of documents found to be out-of-date, unapproved but used, etc.), we'll issue a major against document control.

To summarize, why classify Minor or Major?...to ensure we take a value-added approach to treating the nonconformance.

It works for us.

Whether or not it works for others....well, I did have the local ASQ chapter president ask me to speak at a meeting on our method...

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

I think like you do RC, but I'm an old timer and in the recent years the 'trend' has been away from the old Major and Minor distinctions. Also has come "Observations'.

Old school:

Major: The absence of, or total breakdown of a quality management system element.
Minor: A single or minor system failure or lapse in conformance.

Also see: Major Nonconformity vs. Minor Nonconformity - Definition and Differences. See howste's post 8. Technically it's a TS 16949 definition, but...:

Major nonconformity
Is one or more of the following:
• The absence or total breakdown of a system to meet an ISO/TS 16949:2002 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 judgement and experience indicate is likely either to result in the failure of the quality management system or to materially reduce its ability to ensure control of processes and products.

Minor nonconformity
Is a failure to comply with ISO/TS 16949:2002 which based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products. It may be one of the following:
• A failure in some part of the client's quality management system relative to ISO/TS 16949:2002.
• A single observed lapse in following one item of a company's quality management system.

Here is an *old* page: Major vs. Minor Nonconformances.

While I understand the difference between an internal audit and an external audit, I still see significant value in assigning nonconformances as Major or Minor.

As to Observations, in Internal Audits they're fine but my *personal opinion* is that Observations by registrar auditors are stretching into Consulting.

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

For Internal Audits, I prefer no categorization as lot of time is wasted in difference of opinion as to why its major and not minor or why its critical and not major and so on.

With all these discussions, the core issue gets loses steam

Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

I'm sure, as Roxanne says, that some organizations find grading effective. I offer a word of caution, however, to others tempted or even doing such grading:

Firstly, as I posted previously, the quantitative and qualitative information in the nc report has to support the grading!

Secondly, auditors' competencies must be demonstrated in respect to grading to ensure consistency of approach.

Thirdly, management/supervision will aggressively debate 'majors' to have the auditor downgrade them to minor! This is all part of the numbers game that people see as being more important.

I can say from past experience of all of these aspects, that it is a potentially challenging task for any audit manager to keep auditors 'calibrated' on grading, such that the two facets of audit reports are congruent. IMHO - and years of experience - it's a waste of time and better to ensure the content of the nc is value added, not a simple 'grade'!