The question here: Practically, what is the primary difference between a major and minor non-conformance?

I can give the formal answers, may lots of words. But what is the most practical answer?

All experts here, any expertise?

Also, what is the best effective corrective action steps? 8D, or something else?


:thanx: :thanx: :thanx:

To start, take a read through:

http://Elsmar.com/Forums/showthread.php?t=2402
and
http://Elsmar.com/Forums/showthread.php?t=4458
and
http://Elsmar.com/Forums/showthread.php?t=6212

Agree with Cleas's opinion that not discriminating between "major" and "minor" is the way to go. And with Barb in that internally, it is acceptable to define the terms yourself.

I myself also believe that the difference is too subjective to be unitarily defined in a manner that would really help and not just cause more banter on interpretation.

As an example, if I was auditing corrective actions and found 1 report had not been completed per procedure I would consider it a minor infraction. If I found multiple instances I would believe the system is broken and in need of "major" repair. Both would still require some type of corrective action.:bigwave:

Al...

As an example, if I was auditing corrective actions and found 1 report had not been completed per procedure I would consider it a minor infraction. If I found multiple instances I would believe the system is broken and in need of "major" repair. Both would still require some type of corrective action.:bigwave:

Al...

Yes, but would they both require "root cause" corrective action? Herein is where we define the differences: A "minor" nonconformity - single incident (no impact on overall product conformity, or personnel health and safety) - Correction of the nonconformity is required, but no requirement for "root cause" corrective action. Example: A trained operator, with a current process before them, makes one error (misspelled word, a single paint run, a non-critical screw tightened to 20 in/oz in-lieu of the required 18 in/oz, etc.) out of numerous opportunities. The error is documented, root cause is determined as a single operator error, and the error/nonconformity is corrected. No further action is required.

A "major" nonconformity defined as either multiple/recurring "minor" incidents, or nonconformities that impact product quality/performance or personnel health and/or safety - requires full 8D process.
:bigwave:

I think designating some findings "major" is a useful tool. Around here at least it gets people's attention. To my thinking, which admittedly is lacking on a Friday, a minor is exactly what was pointed out earlier - a single infraction among a crowd of compliances. An oversight. A major is a cluster (excuse the reference) - a group of all the same kind of findings across several areas OR a major breakdown of the system somewhere - something that is CLEARLY required and someone clearly knew they were supposed to be doing it and just didn't. In those cases I don't mind putting a "MAJOR" on it because it often serves as a wake-up call.

Example: A trained operator, with a current process before them, makes one error (misspelled word, a single paint run, a non-critical screw tightened to 20 in/oz in-lieu of the required 18 in/oz, etc.) out of numerous opportunities. The error is documented, root cause is determined as a single operator error, and the error/nonconformity is corrected. No further action is required.


Rut Roe....I can't believe my tired ole eyes. It's the system...It just has to be. Operator Error is totally unacceptable. Shame! Y'all have a nice weekend. :vfunny: :agree:

Corrective action for the root cause:

Fire all the operators and the people that wrote the procedures. Save only those management personnel that dis-avow all knowledge of the system as it is. If they were informed, it would be different!!!!:bonk: :thedeal: :ca:

Al...

Minor = Oops!

Major = Aw #&*%@(&)!!!!

Kinda what I've heard a time or two when I've found them :vfunny:

As a internal auditor I dont state Major or Minor I use Acceptable, Un-Acceptable, & Concern. I would translate a Major and bad product being able to get out to the customer as Un-Acceptable, and i would translate a Minor as a brief procedure breaking a concern. Of course lack of Procedure is Un-Acceptable. As far as 8-D's goes they are good but we use what the customer wants us to for them. Its all in our CPARS. :biglaugh:

I'm with Dave here. We all have resource issues and can't fight every problem. Further, some detected issues are Common Cause issues and many of these are of the ‘minor’ problems variety. I think that it's helpful, albeit an inexact science, to bin things.

When I am performing 3rd party audits, the definitions are:

1. Major- total breakdown of the system

2. Minor- partial breakdown of the system

Also when a nonconformity affects the product, it could be classified as a major.

When I perform internal audits, I do not classify the nonconformities as major or minor.

IMHO
major - lack of procedure or process that would cause non-conformance
minor - procedure or process exist but lack of practice or not strictly followed that will may result conformance.

Aside from the obvious rhetorical description of major and minor in the certification scheme from a TS2 perspective is that a major requires a re-visit.

Question:
During our surveillance audit, I was issued a minor as I didn't directly define under which circumstances a corrective action is issued for an internal audit. I inherited the system a year ago, and have looked back over our internal audit records. In our findings, we show 'M' as meets the intent, with minor inconsistencies, and 'O' for complete noncompliance - issue noncompliance report.

We have not had an 'O' show up in our internal audit for some time now. However, last year I issued several Corrective Actions against various 'M' findings in order to document improvements, procedural changes, etc. (M being the minor inconsistencies)

here's my dilema, some, not all 'M' findings can be tweaked for improvement, - so I really have 3 categories - Not compliant, 'O';, Weak 'M'; and 'Weak and something has to be done' (CAR is issued)

how is this handled out there in the rest of the world?
My thanks for your help
barbt

The system I used was similar to your classifications. Our equivalent to your M was called an observation and was meant to be used if there were procedures that were confusing to follow, an opportunity for improvement or any observation that was made that was not a violation of written standards, policies and procedures. Our equivalent O was a noncompliance finding for a violation of written standards, policies and procedures.

Observations were not recommendations for change (internal auditors were discouraged from blatant internal consulting since they may not be familiar enough with the department being audited) and department managers did not have to act upon or even respond to the observation. Normally they would acknowledge the observation and even agree to change if their review showed they agreed.

Nonconformances required a corrective action description and were tracked for closure in the corrective action report.

I would stick with the 2 categories that you have but document what needs corrective action. I bet the auditor just wanted you to document the difference between the two findings so (s)he could trace it back to corrective actions. You probably created an unexplained gap of findings that required CAR and others that did not.

Bill Pflanz

thanks Bill,
I basically have arrived at the conclusion that Corrective Actions have to be issued independently of any 'findings' - Our corrective action system states that anyone can issue, any time, a CAR, - the validity of which is later determined by either the manager of the corrective action system (plant manager) or myself for audit related issues.

Therefore, for my internal audit, I have now added a separate legend item - CAR- to denote that the CAR has been initiated against a particular finding.

I won't change the 'M for weak but implented' or 'O for Not Compliant'. They will continue to stand as they are.

Comments?
Barbt

I basically have arrived at the conclusion that Corrective Actions have to be issued independently of any 'findings' - Our corrective action system states that anyone can issue, any time, a CAR, - the validity of which is later determined by either the manager of the corrective action system (plant manager) or myself for audit related issues. Comments?
Barbt


:agree1: You are correct in realizing that CAR is for more than just audit findings. Your CAR report should also include responding to customer complaints or internal requests for CAR. Your management team should review the CAR's each month to verify that action is being taken and that it is acceptable. You may want to keep track of how the CAR was generated (audit, customer complaint, internal) since it will help when your auditor visits.

Bill Pflanz

thanks Bill,

We do track where our CARs come from, and one of those indeed is from internal audits.

I was bit CAR happy last year when I took over the system, ready to simplify and reduce our documented system. I issued CARs (against the written procedures) all over the place. Mostly it meant that I re-word the procedures, simplify and clarify excessive verbiage.
This year, there was a marked reduction in the number of CARs issued from internal audits to 'improve' the written procedures, either in their documented format, or in their implementation. Some findings do remain weak, however, but the element is in place and implemented. -

- Problem is, but I didn't formalize under which circumstances I would issue a corrective action for a weak finding.

That's my problem today, the objective remains strengthening the system in such a way that is workable, vlauable, suitable and acceptable to users and auditors alike.

thanks for sharing your thoughts,
barbt

Here is my recommendation. A CAR is issued anytime there is noncompliance. An observation is issued when certain things occur, such as; the system is compliant but weak, the system is compliant but inefficient, the system is compliant but needs to be looked at for some reason, or the system is compliant (and possibly even efficient) but I have a suggestion to make it better.

I can recall from a past life in a MIL-Q-9858A environment, it went like this.

1) Random, no corrective action required.
2) Random, QA will monitor and track for trends
3) Second occurance, C/A required
4) Re-occurring or Repetative, issue CAR to department head
5) Major, issue CAR to top management
6) Critical, issue CAR to top management and shut down operation with white "quarantine" tag.

Any of this sound familar to anybody?

The question here: Practically, what is the primary difference between a major and minor non-conformance?

I can give the formal answers, may lots of words. But what is the most practical answer?

All experts here, any expertise?

Also, what is the best effective corrective action steps? 8D, or something else?


:thanx: :thanx: :thanx:

This stuff "major" and "minor" originated decades ago when there was a good deal of resentment about auditors coming in and "finding" something they did not like. Audits were not as well established as they are today. So, as a kind of palliative "Major and minor" appeared - as I recall, mainly in the defence field (notably in the UK) - mostly to deflect any possibility animosity that might be created.

But, as I wrote years back - the terms inevitably lead to arguments about what is major/ what is minor - all of which sheds more heat than light onto the subject. For that reason, I always refused to assign either of the terms. If the OE showed there was a problem, it needed addressing and, provided it could be justified on the basis of some violation of a standard's clause (e.g. ASME 3, 10CFR50 AppB or ANSI N45.2, back then) I would issue a CAR.

And, when on the receiving end, I never bothered to argue the toss about major and minor - just got on with putting right whatever was found: it was quicker than entering pointless arguments. In any case, whatever might be the "finding" - an expression I detest - it clearly heralded an opportunity.