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

Jim Wynne

Staff member
Admin
#11
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

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 :cool: - 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what was found and if there are multiple minors against a particular requirement (e.g., lots of documents found to be out-of-date, unapproved but used, etc.), we'll issue a major against document control.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...
What you need to know about any NC is whether or not it's an outlier or part of a larger, systemic issue. For example, an internal auditor might find an instance of nonconforming material not being properly identified as such. This is evidence of a systemic breakdown, but not proof. Evidence should lead to further investigation. How that further investigation happens (what triggers it and who does it) is what should be in question here, not how a given NC is characterized or named.

Roxanne's company seems to have developed a system that works, but that doesn't mean that simply characterizing NCs as major or minor is the solution. There has to be a system in place for reviewing NCs in order to rationally determine how to proceed. I favor a system in which internal auditors report their findings and management decides what to do, if anything, about them. This doesn't mean that some other process won't work, though.

I think that one good reason to avoid the major/minor thing is that we should avoid designing IA processes that mimic CB audits.
 
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RoxaneB

Super Moderator
Super Moderator
#12
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

One of the reasons we've retained the "minor/major" classifications is the concept of value-added. Again, if we find a case or two where documents and reality to not align, that is typically a minor (depending on where the process stands on our critical task analysis - yes, I know, that's not part of ISO but it is part of our business system). We also do system audits - all processes, all clauses at one time...akin to an external audit. During our team caucus meetings, we discuss the findings. If we find a plethora of "minors" in a process and/or clause, we upgrade the finding to a major. There is a evidence supporting a systematic breakdown and supporing the audit team's decision.

Our auditors are also subjected to a rigorous training programme, including assessments of competency by our lead auditor and feedback from auditees (on traits such as fairness, open-mindedness, investigative skills, etc.).

I can appreciate the trend to observations and "majors", but when it comes to using our peoples' time effectively, a classification of minor/major/OFI allows the recipient to take steps suitable to the finding.
 
D

DrM2u

#13
Re: 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:nope:
In my humble opinion (and I won't dwell into my experience) the first thing to look at is what standard you are working with and what it requires. For example, and as some other posters have indicated, the TS 16949 is specific in how to categorize the audit findings; however that is applicable to the registrars and their auditors, not to internal audits. I know for sure that nowhere in the wording of ISO 9001, TS 16949 or ISo 13485 is a requirement to clasify findings, not even implied. I might be wrong but I am not aware of any standard that requires findings to be classified as minor or major. Anyone, please correct me on this one.

The second place to look at is your internal procedure and what it specifies. Most companies define their approach in their procedures. Keep in mind however that it is YOUR procedure and you can change it as you can see fit.

My position on clasifying findings is that it is a waste of time and a futile exercise, and I'll try to explain why (I will need you to forget what you know about corrective and preventive actions for a minute, though). Any action that an organization takes is an improvement action, unless it is sabotaje or a mistake (remember mistake proofin' in corrective actions!). Therefore, it makes no difference what triggers the need or perceived need to take action as long as it results in improvement. I also believe that most value added is derived from treating all actions equally with regard to root cause analysis and/or anticipating the effects of the actions to be taken. Just because you see a small symptom it does not mean that you don't have a fundamental cause lurking around (remember the iceberg concept). Not doing a root cause analysis means that you do not identify the cause therefore you cannot verify if your actions addressed it and if they are effective (a.k.a. 'band-aid syndrome' that is all so common). In a nutshell, don't waste time categorizing the reason for taking actions, instead spend some time to analyze what actions could have the largest positive impact on the organization and tackle those first.

Now my position might seem at odds with the traditional thinking and difficult to sell. However, always talk money to the executive management, engineering to engineers, less work and an easier job (and rework) to the operators, then you'll be successful. I encoutered difficulties when implementing this approach but nothing but positive results after. I know organizations that do not care anymore if anything is called a major or minor or an opportunity/observation; the question they ask is "How is me taking action going to impact my organization?" and that is where the auditor has to justify the value added of a finding.

Any thoughts?!?
 
R

Rosyio

#14
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

Hi everyone,
I really enjoyed this forum as folks here are so resourceful, informative, most helpful and vocal.

My company had an OFI raised in our certification audit that we should define what's major and minor NC. I went like 'HUH???' and thot what's the value-add? You see our philosophy and attitude towards NC is that we take a serious view irregardless of whether its major or minor and we put in every effort to resolve them. The value-add of even a negative such as an NC is that we can make the neccessary positive improvements to the system. My 2 cents worth is that such definitions are relevant to mainly certification bodies as they need to decide whether certification can be awarded.

Wow I cant believedid my first post! Hurray!
Ros
 
#15
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

My 2 cents worth is that such definitions are relevant to mainly certification bodies as they need to decide whether certification can be awarded.

Wow I cant believedid my first post! Hurray!
Ros
So you did. Welcome among the posters. :bigwave: Your two cents also happen to coincide with mine: Why bother to classify them? It is not required, and the main thing is that proper action is taken.

/Claes
 
D

Del Foster

#16
Re: 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:nope:
Why even try to use a category? There's only potential for liability should something bad happen and a dream team convinces a jury you made a bad choice based on a wrong classification. Registration auditors have a requirement to classify findings as such, internal auditors do not. The standard requires "corrective actions shall be appropriate to the effects of the nonconformities encountered" and that's an excellent groundrule.
 
#17
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

Hi everyone,
I really enjoyed this forum as folks here are so resourceful, informative, most helpful and vocal.

My company had an OFI raised in our certification audit that we should define what's major and minor NC. I went like 'HUH???' and thot what's the value-add? You see our philosophy and attitude towards NC is that we take a serious view irregardless of whether its major or minor and we put in every effort to resolve them. The value-add of even a negative such as an NC is that we can make the neccessary positive improvements to the system. My 2 cents worth is that such definitions are relevant to mainly certification bodies as they need to decide whether certification can be awarded.

Wow I cant believedid my first post! Hurray!
Ros
Welcome! So, it would be interesting to know why this auditor thought it would be an improvement! This is what I find most challenging about OFIs. Don't we need to know more about what the perceived improvement is? Or why what's happening even needs improving?

It's a little like when I go to the doctor, the doctor says, you need to lose weight! I think, well, if I do, it'll cost more in new clothes, why should I? But if the dr says, you need to lose weight, it is causing "X", "Y" and "Z" health problems, and you can shorten your lifespan, then I might think about it differently!
 

somashekar

Staff member
Super Moderator
#18
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

Hi everyone,
I really enjoyed this forum as folks here are so resourceful, informative, most helpful and vocal.

My company had an OFI raised in our certification audit that we should define what's major and minor NC. I went like 'HUH???' and thot what's the value-add? You see our philosophy and attitude towards NC is that we take a serious view irregardless of whether its major or minor and we put in every effort to resolve them. The value-add of even a negative such as an NC is that we can make the neccessary positive improvements to the system. My 2 cents worth is that such definitions are relevant to mainly certification bodies as they need to decide whether certification can be awarded.

Wow I cant believedid my first post! Hurray!
Ros
Welcome to the Cove Ros ~~~
People find copycat QMS an easy solution and thanks also to some fly by night consultants who offer prescriptive QMS solutions. So many organizations try copycat of the CB audit way (not the auditing depth though) where the CB classify NC based on their guidelines which are necessary to be followed.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#19
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

well it's an OFI so you can ignore it.
however, it does sound warning bells about this auditor. you can probably expect more rote or opinion based OFIs and findings in the future...

some people find it helpful to rate findings by the severity of their effect in order to prioritize actions. fro exampel a very minor effect may only get a correction while a very serious effect may get a very fast containment action, corrective action to prevent recurrence (both short and long term actions)
 

Raffy

Quite Involved in Discussions
#20
Re: How to categorize Minor, Major or Observation for Internal Audit NCR?

With regard to OFI and/or Observation, we ensure that all findings are documented and implemented so that when they return for another cycle of audits, we are prepared to show to them what we did after they highlight the issue.
Giving the company an observation sounds to be consulting but I just dunno if this is what we call "add-value" to the company? And I can say, if it is, it was a "BIG HELP" for the company.
Raffy :cool:
 
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