Can NonConformance (NC) be raised against Effectiveness? (Ineffectiveness)

J

JaneB

Let me sincerely apologize for what I said, mainly due to my poor command of English language.

I indeed very grateful for having the opportunity to learn from many dedicated professionals here! Let me say thank you and sorry once again!
No problems, Pinpin. (that's a bit of Australian slang, meaning any or all of: 'it's all OK, Fine, No one is unhappy, Everything is OK'. People are happy to help, as you can see from the number and range of responses.

The only reason I mentioned the wording issue was to increase your knowledge and provide better alternatives in case you need them in future. (I used to teach English to immigrants to Australia at one time) Believe me, I bet everyone else is as impressed as I am that you can communicate in what must be at least a second language as well as you do!

You see, you've asked some interesting questions, and as Andy says:
There's some great stuff surfacing in this post!
 
Elsmar Forum Sponsor
P

pinpin - 2009

First of all, let me express my gratitudes to you: Doug Tropf, Jane B, AndyN, Bev D and Helmut Jilling...and the rest that are coming along....

It must be remembered, that external auditors (and many internal ones as well) are trained to write a NC with 3 items of information:

1. the violation, failure statement, nonconformance. It must be a clear nonconformance against a requirement. We are often taught to phrase it: "the xyz process was not effective...in meeting its intent." I don't like that wording, but it is how we were taught.

2. The reference in the standard or procedure that was violated, i.e.: cl 6.2.2, or QSP #7.5.001. There has to be a link to a requirement.

3. The actual objective evidence of the incident that was observed, i.e.: "Observed somone dumping the scrap parts into a dumpster, rather than the required bin."

We are required to identify all 3 parts on each NC, which leads to the default statement of, 'xyz process was...not effective."
I was taught the same way but was not taught to write NC saying ".....is not effective", that is why I ask whether it is legitimate to write so.

I always agree and believe that being a good auditor is to surface ineffective practice so that auditee can benefit from this audit process ! But I just could not find anywhere in ISO/TS clauses that allow me to raise NC with "...not effective"! I dare not do so even though I have good intention to help the auditee, that is why I use the approach like Bev D, Andy N, and Doug Tropf.

The auditor that I mentioned is a good auditor in a way that he surfaced many ineffecctive practices or practices that are not carried out properly. But I just found some of the incidences were rather subjective even though with evidences cited. Almost all of the incidence he found, he phrased it with wordings such as "...is not effective", "...not effectively carried out", "...not effectively conducted", "...not sufficiently indicate its effectiveness", "....not effectively utilised".... though I do not agree with such wordings and found few of the clauses cited may not be exactly correct, but I like him, honestly! Because he dares to face the likelihood of disputes with an intention to make the auditee improved!! Any opinions on those wordings he used?

I just worry that some auditees might dispute and challenge on the legitmacy of using such wordings, unless somewhere in ISO/TS or CB's contract with auditee mentioned clearly that auditor can rightfully use such wordings!

Of course, if there are many areas are ineffective or effectiveness of many controls within auditee's area are insufficient, the auditee organization cannot provide quality assurance to its customer, thus result in a MAJOR failure! ...which I will cite an NC against effectiveness on 1.1 b (but without saying "...not effective"). Is that correct? or Wrong?

Again, :thanks::thanx:
 

Helmut Jilling

Auditor / Consultant
...
I was taught the same way but was not taught to write NC saying ".....is not effective", that is why I ask whether it is legitimate to write so.

...But I just could not find anywhere in ISO/TS clauses that allow me to raise NC with "...not effective"! I dare not do so even though I have good intention to help the auditee...
Please review Randy's post #89. It says very clearly where the Standard gives you the right to say this.
 
P

pinpin - 2009

Please review Randy's post #89. It says very clearly where the Standard gives you the right to say this.
Dear Helmut Jilling,

I read again but I am sorry that I need to reconfirm and I need your advice. , For the example I cited earlier, that is many QCs applied Ansi ASQ Z1.4 or 9 incorrectly, but they had been evaluated by their Quality Manager, could you teach me how to phrase the NC and using which clause number?

:thanks::thanx:
 

Bev D

Heretical Statistician
Staff member
Super Moderator
Dear Helmut Jilling,

I read again but I am sorry that I need to reconfirm and I need your advice. , For the example I cited earlier, that is many QCs applied Ansi ASQ Z1.4 or 9 incorrectly, but they had been evaluated by their Quality Manager, could you teach me how to phrase the NC and using which clause number?

:thanks::thanx:

OK I'll give this boat anchor of a thread oen more shot:
IF your last example quoted herein is correct you would cite the following:
8 Measurement, analysis and improvement
8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes
needed
a) to demonstrate conformity of the product...

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

You would then cite EXACTLY how ANSI Z1.4 or Z1.9 was incorrectly used.

Additionally you would then need to cite EXACTLY how this incorrect use led to ineffective demonstration of conformity of product.

For example, if QC is charged with (by the customer or their own procedural requirements) determining that the lot they are inspecting meets a specific AQL level and that the sample plan they chose has allowed them to (Customer rejections?) or creates the potential (you better be able to demonstrate the OC curves of the intended plan and the actual implemented plan!) to accept lots that are far more defective than intended or that QC is rejecting lots that do in fact meet the AQL. In this example we must be very careful because AQL means the defect level that will be accepted 95% of the time not rejected...additionally, we must be aware that no samplin gplan is perfect so an occassional mis acceptance or mis rejectance is to be expected...

writing up the NC is not the difficult part - as stated many times simply find the requirement in the standard and then provide evidence that while the group is meeting the written requirement, their implemenation is not effective in meeting the intent...

The difficulty is making sure that the implementation is actually ineffective. It takes much more subject matter expertise and greater analysis and evidence than a simple NC would. As a nother example one of your origianl examples was a SPC subgroup size of n = 2. (or somethign liek this) As many posted, there is nothing inherently wrong with this sample size. Only a detailed analysis of the exact conditions would enable anyone to say that n = 2 is not effective.

my last parting shot would be to state that the only way we can actually help you at this point is if you give very specific examples and evidence to go on. otherwise we can only give general advice which you don't seem very happy with as you keep coming back and asking the same question despite teh numerous responses you have received.
 
P

pinpin - 2009

Dear Bev D,

Thank you so much for your patience to guide me!!!!! :thanks:

Below are what I posted earlier:



Say for example, all the auditee QC personnel apply Ansi-ASQ Z 1.4 Sampling Plan incorrectly, but they have been trained and evaluated by their Quality Manager, do we raise NC by saying:

1) ".....the evaluation process is not effective (6.2.2)"? or

2) "3 out of 3 QC personnel interviewed applied Ansi-ASQ Z 1.4 Sampling Plan incorrectly and incorrect sampling size used were found in many QC Reports (such as QC Report No. 123, 133, 168), this is nonconformity with 6.2.1"?, or


Let say after further assessment through the interview with the Quality Manager, I found that he did evaluation by testing (with records) the QC with different lot sizes to determine whether they were able to determine the correct sample sizes and result were satisfactory.

Now the fact is the QC were incompetent, if we don't raise NC against 6.2.1, do we raise against 6.2.2 (d) that the QM do not ensure....? Or against 6.2.2.2 (which is the same requirement as 6.2.1) that their personnel is not qualified....Or to prevent argument or dispute, can I simply cite 1.1 as no matter how the fact indicates that the auditee was not able to assure conformity to customer requirement because probability of nonconforming goods delivered to customer is high....

If we say "sampling size used was incorrect", against what clause can we raise against?

Anyway, anyone will raise this against "ineffectiveness of action taken"?



Clause 8.1 says "shall plan and implement.....shall determine applicable methods...", which I interpret that there is no nonconformity against this clause because they determined the sampling methods (Ansi...), planned and implemented, except that the "persons" (QCs) determined incorrect sampling size.

Is it acceptable for me to raise a NC saying "ineffective" through theoretical analysis before seeing the result in actual implementation?

Even if it is deemed "ineffective" or less "effective", is it acceptable to say it is not a nonconfomrity as the ISO/TS Standard says "to continually improve" rather than saying "shall be effective", therefore as long as auditee takes actions to continually searching for "effective" ways, they meet the INTENT of the Standards?

Kindly once again provide your guidance, I guess these are my last questions.

I appologize to all that running out of patience with me! :eek::(
 

Bev D

Heretical Statistician
Staff member
Super Moderator
pinpin, you are overthinking this example in my opinion. This appears to be a very simple case of inspectors not following the documented procedure.

*I* would not even cite the standard.

*I* would write a very simple NC stating that the sample sizes selected were not in accordance with the documented procedure.

*You* might write up a finding to this effect and cite 6.2.2 c in the standard (ISO9000) "the organization shall...evaluate the effectiveness of the actions taken". (in this case the manager did train and test the inspectors and they passed teh test, yet in practice they are occassionally selecting the incorrect sample size...)

HOWEVER, this is a VERY minor use of the term "effective" as you have not demonstrated any effect on the conformity of the product. You haven't shown any evidence (theoretical or practical) that bad product has escaped at an unacceptable rate. You haven't demonstrated that the original documented plan was even effective in ensuring the conformity of the product.

you have been given plenty of good advice from mnay posters. do what you will with it.
 
P

pinpin - 2009

Dear Bev D,

I agree and always believe, there shall be factual evidence of outcomes resulted from the implementation before saying that it is "ineffective" in any matters, in my own opinion.

I started this thread because that was the first time I came across audit findings with so many "ineffective" or "less effective", etc kind of remark, yet actual outcomes proving its ineffectiveness were not shown. To me, some of it should be raised as an observations for consideration of monitoring on its effectiveness rather than NCs. HOWEVER, just my own opinion.

I am sorry that I cannot literally shown those NCs here...I apologize for this!

I attended auditor trainings, be it ISO/TS Auditor courses, and other auditor enhancement courses; but I have not come across examples of "effectiveness" findings.:nope::(

I would like to say a MILLION THANKS to ALL of the professionals here once again, without your patience and sincerity in providing me the guidance so far, I would not have learnt so much within this short period of time. A MILLION THANKS To Elsmar Cove!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

:thanks::thanx::magic:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
Not to resurrect this thread, but, at least in the Aerospace ICOP scheme, we are proceeding to make it clear that the expectation if for auditors to verify process and system effectiveness, in addition to conformance to requirements.

Attached a presentation material on the progress of the 9101 document, which makes clear the shift towards effectiveness focus.
 

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