Establishing Internal Audit Nonconformity Level Criteria - Major vs. Minor?

Sidney Vianna

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#31
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

C.vanDijk said:
When something is prioritized, this usually means that something else is considered not to be as important and before you know it, things end up not being done.Cornelis.
My take is totally the opposite. Managing risks does require prioritization of resources. Some mistakes could have lethal consequences to customers, while others would be just a nuisance.
Management requires prioritization of resources.
If less critical issues don't get resolved, you have organizational discipline problems. But to consider all problems without some type of risk rating does not make any sense, imo.
 
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C.vanDijk

#32
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

Sidney Vianna said:
My take is totally the opposite. Managing risks does require prioritization of resources. Some mistakes could have lethal consequences to customers, while others would be just a nuisance.
Management requires prioritization of resources.
If less critical issues don't get resolved, you have organizational discipline problems. But to consider all problems without some type of risk rating does not make any sense, imo.
Thanks for your explanation on how you view minors or majors. I have never quite looked at it from that perspective.

We seem to have different views on the matter but I do see how you're making a point. We do have a system in place for risk rating and it is translated into the type of action that will be taken, the resources that are assigned and the due date attached to the action. So far, it's working really well.

I would still not be in favor of using the terms minor or major but that's a matter of personal oppinion, I guess.

Cornelis.
 

Rajeeva

Quality Manager, CMQ/OE, CQA
#33
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

RCBeyette said:
Welcome to the Cove, Rajeeva and congratulations on your first post! :bigwave:

When you state "documented requirement" are you referring to the standard or a requirement contained within a documented process?
Thanks! As we are discussing about the internal auditing, it is the requirement of documented procedures/ processes.

Rajeev
 

Rajeeva

Quality Manager, CMQ/OE, CQA
#34
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

Laura M said:
I typically do not rank Internal Audit N/C's because I want them all addressed. I may in a cover letter indicate, if I believe appropriate 'a registrar may assess this to be a major n/c.'
Hi,

I do agree Nonconformance is nonconformance and it must be addressed whether it is major or minor. But without categorizing it in to major or minor, how the auditor can agree/ decide the "proposed action completion date". He/ She must categorize the N/Cs' depending upon the seriousness or level of non-compliance detected and accordingly agree the action.

Internal quality auditing is a very valuable tool for the Management to know whether the system is implemented and maintained, and to know what extent the planned arrangements are suitable to achieve the desired results.

Thus the internal auditor must bear in his/her mind what kind of feedback is he/she giving to Management and with that objective, need to carry out audit to know how seriously documented requirements are understood and implemented.

So, when n/cs found and it is categorized into major or minor, it gives an indication to the auditee how serious is the issue. And accordingly, corrective actions could be discussed and implemented. Similarly, auditor can also categorize clubbing many minor non-conformances of similar issue into a major N/C.

In summary, unless n/cs are categorized, the n/cs do not get the attention they deserve.


Rajeev
 
S

stanislavd

#35
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

As I see, the nonconformities grading is useful and accepted by most of you. The main idea of this topic is "How to categorize them, based on what criterion?". Anyone with experience, please provide some examples.
 
M

Martijn

#36
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

If you really want to get into this in detail I suggest you do the IRCA lead auditor course, but here's the outline:

Question 1:

Is the finding inconsistent with customer agreements, legislation, ISO 9001:2000 standard, policy & goals, procedures, etc?

No --> not a finding to begin with
Don't know --> Finding is an observation, find more info
Yes --> Question 2:

Are the facts recorded (in other words can you prove the finding)?

No --> Finding is an observation, find more info
Yes --> Question 3:

Is the impact on customer satisfaction/product quality/system integrity:

Large? --> Major (for example Customer satisfaction: 7 customer complaints in the last 3 months on exactly the same topic and no proper actions taken, or system integrity: customer review meetings are never done, system is not implemented, or Product Quality: Proof of non functioning quality control resulting in bad products being sent to customer over a longer period of time)

Small? --> Minor (example same as above really, but not something consistent, but more an incident)

Hope this helps. This is always a bit subjective obviously, but if you use common sense and these rules it's not that hard to distinguish major from minor. Mostly a major starts with a feeling that something is really wrong :eek:
 

RoxaneB

Super Moderator
Super Moderator
#37
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

Rajeeva said:
Thanks! As we are discussing about the internal auditing, it is the requirement of documented procedures/ processes.

Rajeev

That's what I thought...so what do you do if a process is not documented? How do you audit the process? How do you classify/categorize findings? Or is the finding just that the process is not documented?

I apologize for my questions but I guess I no longer see merit in auditing solely against the documented procedure. I look at the overall process, the people involved, inputs and outputs, resource allocation and how the results of the process are treated (i.e., improvements, nonconfomances, corrective action, etc.).
 
M

Martijn

#38
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

RCBeyette said:
That's what I thought...so what do you do if a process is not documented? How do you audit the process? How do you classify/categorize findings? Or is the finding just that the process is not documented?

I apologize for my questions but I guess I no longer see merit in auditing solely against the documented procedure. I look at the overall process, the people involved, inputs and outputs, resource allocation and how the results of the process are treated (i.e., improvements, nonconfomances, corrective action, etc.).
:confused: I feel you answer your own question here.

As said in my previous post you can also write findings following from customer agreements, legislation, ISO 9001:2000 standard, policy & goals, etc. That's why for example auditor must now have sound knowledge of the ISO9001:2000, because if there's no procedure, you can still audit against the standard.
 

RoxaneB

Super Moderator
Super Moderator
#39
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

Martijn said:
:confused: I feel you answer your own question here.

As said in my previous post you can also write findings following from customer agreements, legislation, ISO 9001:2000 standard, policy & goals, etc. That's why for example auditor must now have sound knowledge of the ISO9001:2000, because if there's no procedure, you can still audit against the standard.
No worries...my questions were directed to Rajeeva and how his organization conducts internal audits.
 

Rajeeva

Quality Manager, CMQ/OE, CQA
#40
Re: Internal Audits - Establishing nonconformity level criteria - Major/Minor?

RCBeyette said:
That's what I thought...so what do you do if a process is not documented? How do you audit the process? How do you classify/categorize findings? Or is the finding just that the process is not documented?

I apologize for my questions but I guess I no longer see merit in auditing solely against the documented procedure. I look at the overall process, the people involved, inputs and outputs, resource allocation and how the results of the process are treated (i.e., improvements, nonconfomances, corrective action, etc.).
I have seen your query and as well as Martin's reply. I agree that the audits should cover processes, inputs and outputs..... all you mentioned)

Well, when we say internal auditor we mean certified auditors (either internal or lead) which means they are aware of the ISO 9001:2000 requirements.

The main intention of carrying out internal quidts is to ensure that the planned arrangements (documented procedures/ processes) are implemented and maintained, and how effective is the arrangement. So, if any process/ procedure is not documented, and if you see it is implemented, then you must ask who approved the process and how they have communicated. Documented process/ procedure need not necessarily in paper; may be in electronic form.

You can not audit a process/ procedure which is not documented. How do you audit it for compliance or non-compliance. At least you need a documented flow-chart.

Suppose if you feel some of the requirements of ISO 9001:2000 are not implemented, definitely the auditor must bring it to the Management's notice.

Your comments are welcome

Rajeev
 
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