Non-Conformance for Not Taking Exclusion

J

JShell55

#1
Hi, Forum:

I have a bit of a question this morning.

A company that I am working for has received a surveillance audit non-conformance under AS9101D for "not taking an exclusion" from certain clauses in the standard.

As far as I was always trained, scope exclusions, a.k.a "reductions in the scope of the quality system" are supposed to be voluntary, at the option of the organization, and "as applicable". I know that typically this is used to exclude 7.3 design-type activities. In either case, the exclusions are supposed to be justified by the organization.

In this case, I guess in the opinion of the auditor, we should have/could have taken a scope exclusion for some of the post-delivery clauses (7.5.1.4) of AS-9101D but did not. The clause does say "as applicable" for this section. We are not out of conformance with the customer requirements, to any extent that we are able to tell, because our agreements with the customers do not require us to do any of these activities.

There is a clause in the auditing standard that allows a registrar to reduce the scope of a client's quality system under certain circumstances:

9.6.5 The certification body shall reduce the client's scope of certification to exclude the parts not meeting
the requirements, when the client has persistently or seriously failed to meet the certification requirements for
those parts of the scope of certification. Any such reduction shall be in line with the requirements of the
standard used for certification.


I can't see where this applies to this case in any sense. I think this one applies if we are doing a variety of activities, the auditor finds out that in the back corner of our shop we are doing one that is not anywhere close to our normal scope, and the registrar is compelled to exclude these activities from our scope of certification to keep us from claiming otherwise.

But, I am hard pressed to find a single place in either the 17021 auditing standard or the AS-9101D Standard that requires a company to exclude any particular clause from its quality system, and allows an auditor to write a non-conformance because we did not exclude a clause that at the time of the audit appeared to be not applicable.


As far as I can tell, it does work the other way in that if we are required to do X, and we have a scope exclusion that says that we do not do X, the auditor can write a non conformance in the other direction, in that we have improperly taken an exclusion from a clause that was applicable to us. Example: We exclude clause 7.3, the auditor finds out that we are doing some of the activities of 7.3, and so we have improperly taken the exclusion... I can see that one pretty easily.

I do some third party auditing myself, and I have an example the other way: I did a readiness review the other day and the client company wanted to claim 7.6 as an exclusion, since they have no measuring devices on site that require calibration. I told them to clear it with the registrar but I thought the exclusion was unnecessary, because if I were auditing it, I would see that there was no requirement, and just shrug and move on. Far be it from me to tell them to either exclude it or not, it is up to them, and up to me to audit the standard and facts as I saw them.

Either way, I would never write them a non conformance because the clause says "the organization will determine the monitoring and measuring activities and measuring equipment needed", and if they determine "none" that is okay by me, and it all comes to the same. Unless, that is, I find out by inspecting a customer PO that some kind of measuring is required.


Anyway, Please, experienced forum participants, try to straighten me out this morning. No amount of caffeine is helping this make sense to me.
 
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dsanabria

Quite Involved in Discussions
#2
Stage 1 already established the scope / exclusion. If changes happened during the year then it is notified to the registrar.

Just out of curiosity - what objective evidence the auditor is using to write this up.

You could appeal it - and you should. Some companies do not take exclusion to 7.5.1.4 even though they never use it because they are in the corner of believing to leave it there just in case...

Second point you are going to do is not invited the auditor again...
 

Mikishots

Trusted Information Resource
#3
As far as I was always trained, scope exclusions, a.k.a "reductions in the scope of the quality system" are supposed to be voluntary, at the option of the organization, and "as applicable". I know that typically this is used to exclude 7.3 design-type activities. In either case, the exclusions are supposed to be justified by the organization.
It's a bit ambiguous, I agree, but I do have a question: if you do not perform these processes and do not take exclusions, how do you audit them?
 
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J

JShell55

#4
You audit them (either internally or externally) by determining if there is a requirement, ex: by sampling a number of customer PO's or specifications to determine customer requirements. If there are no post-delivery activities, then the finding under 7.5.1.4 is nothing.... shrug and move on. In our place there are two main customers that are 90% of the sales volume so no problem to examine a couple of contracts/PO's/blanket terms and conditions.

If there are post delivery activities specified in the terms and conditions of the purchase order, as required by the customer, and the company is not performing them, then it's a non-conformance because of not meeting applicable customer requirements. You can either write it under this clause, or under 7.2 which is not determining the customer requirements somehow.

But, the auditor should be doing this either way, at a minimum, to audit 7.1 and 7.2 contract review and verification of customer requirements.

Objective evidence? I suppose he saw in our scope statement that we did not claim this clause as a scope exclusion, and in his opinion that was sufficient... I suppose.... we did not feel like arguing at the time.

Appeals: Here is another can of worms. We probably ought to appeal it just on general principle to help train the auditor, and make sure no one else has to put up with this stuff.

The work to add the above clause to our scope statement is about 15 minutes and I have already burned that much time writing in this forum. As I pointed out to the quality manager, the value added to the company in this is negative: It is not changing the behavior of anybody.

There is the further possibility that the auditor will not be a good sport and the next time he shows up down here scrutinizes us even more heavily. This is a "guy thing", and a lot of these aerospace auditors are former military people who do not tend to look at both sides of the argument, even though open-mindedness is a desired quality in an auditor.

There's an outside shot that the auditor will recognize his error, laugh about it and take it in the spirit of continual improvement, and it we would all be the better for it. I'm thinking the odds of this are low.

This was his first visit to our place, there is a shortage of aerospace auditors, and we might be better off just fixing it, having moral superiority, and moving on....
 
J

JShell55

#5
Update:

There is a reference to this in 1.2 of the ISO9001 standard:

"where any requirement(s) of this international standard cannot be applied due to the nature of an organization and its product, this CAN be considered for exclusion"

"Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and as such exclusions do not affect the organization's ability or responsibility to provide product that meets customer and applicable statutory and regulatory requirements"...


So I am still hard pressed to see whether the organization SHALL or MUST, or even SHOULD claim an exclusion if they don't feel like it, and how it is an auditor, rather than the organization, can decide that.
 

rickpaul01

Involved in HankyPanky
#6
During our last audit, the auditor talked me into dropping 7.5.1.4. He did not write a nonconformance. When I went back to check previous audit reports, the same auditor had written that although we do not perform this function, we had all of the correct procedures in place.
Seem s like it just depends which way the wind is blowing.
 

Big Jim

Super Moderator
#7
There are a couple of rulings that may have bearing here. IAQG has issued clarifications for AS9100C. In that document the question is asked:

If a company does not provide service to products after the part is delivered to a customer, can they take exclusion to clause 7.5.1.4?

To which the answer was given:

It depends. IAQG 9100, Clause 7.5.1.4, Post-Delivery Support, is applicable when servicing of your product is performed after initial delivery. The location of the service is irrelevant no matter whether the servicing is taking place at your facility or in the field. If a warranty is applicable to the product, then the servicing clause 7.5.1.4 is applicable.
Since Clause 7.5.1.4 is contained in section 7, it is possible to take a justified exclusion for portions of this clause that may not be applicable.

My collage business law professor tells me that if you deliver parts with the understanding that you will rework or replace as needed anything that doesn't pass their inspection, you have a warranty.

I would like to develop this further, but my plane is boarding and I must run.
 
J

JShell55

#8
Oh, I think it is pretty clear that by the nature of the product, we could take exclusions to several of the parts of 7.5.1.4 if we wanted to, and we might be better off to do so.

But the question of the day is: are we required to? and secondly, if we choose not to, is it up to the auditor to write a non conformance?
 

Big Jim

Super Moderator
#9
I believe what you are looking for is found in the TC-176 Document: ISO/TC 176/SC 2/N 524R6 which talks about exclusions.

Be aware that AS9100C is actually controlled by both TC-176 for the parts that are from ISO 9001:2008 and IAQG for the aerospace enhancements. The part I'm going to quote from is actually not directly involved with 7.5.1.4, but it should be clear that it sets the precedent and the tone. This is an extract from example 7 (case study) concerning post delivery activity. Pay particular attention to the note.

The relevant parts of Sub-clause 7.5.1 Control of production and service provision state:
“The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable………………
f) the implementation of release, delivery and post-delivery activities.”

The organization is justified in its decision to exclude the post-delivery requirement in sub-clause 7.5.1(f) Control of production and service provision as all its contracts exclude any provision of follow up activities related to the delivered service.

Note also that sub-clause 7.5.1 only requires control of post-delivery activities “as applicable”, making a formal exclusion unnecessary. In addition, all the other requirements of bullet (f) for the "release" or "delivery" of product cannot be excluded.

You would probably find the entire document enlightening.
 
Last edited:

rickpaul01

Involved in HankyPanky
#10
There are a couple of rulings that may have bearing here. IAQG has issued clarifications for AS9100C. In that document the question is asked:

If a company does not provide service to products after the part is delivered to a customer, can they take exclusion to clause 7.5.1.4?

To which the answer was given:

It depends. IAQG 9100, Clause 7.5.1.4, Post-Delivery Support, is applicable when servicing of your product is performed after initial delivery. The location of the service is irrelevant no matter whether the servicing is taking place at your facility or in the field. If a warranty is applicable to the product, then the servicing clause 7.5.1.4 is applicable.
Since Clause 7.5.1.4 is contained in section 7, it is possible to take a justified exclusion for portions of this clause that may not be applicable.

My collage business law professor tells me that if you deliver parts with the understanding that you will rework or replace as needed anything that doesn't pass their inspection, you have a warranty.

I would like to develop this further, but my plane is boarding and I must run.
Hey Big Jim, We have all seen the "clarification" that says "it depends". We want to know what your (and others) recommended solution is.
Thanks!
 
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