Observations Outside of the Audit Scope

I

Illuminatus

#21
Look, I don't know how to quote sections so bear with me.

"One piece of equipment had an incomplete validation record" - regardless, though mabey "anal", it shows a problem in the process. Which, even if not at the time could eventually effect a machine producing product for their part, it shows the potential for a problem down the road.

Just deal with it and even if it's trivial to YOU, it was obvious to YOUR customer (perhaps).

It shouldn't matter if THAT particular customers parts were manufactured on that piece of equipment. Your system should ensure ALL equipment is calibrated (as appropriate) maintained, and that records are available to demonstrate such.
I'm not disputing that there is something that needs to be fixed and I never said it was trivial. Just because it's not a current priority doesn't imply it's trivial.

What I am disputing that this was not in the scope of this audit and therefore should not have been classified as a major or even a finding at all because their product does not and will not run on this equipment.
It should have been an "observation not affecting the results of the audit" as some of our other customers have phrased things like this.
 
Elsmar Forum Sponsor
#22
I'm not disputing that there is something that needs to be fixed and I never said it was trivial. Just because it's not a current priority doesn't imply it's trivial.

What I am disputing that this was not in the scope of this audit and therefore should not have been classified as a major or even a finding at all because their product does not and will not run on this equipment.
It should have been an "observation not affecting the results of the audit" as some of our other customers have phrased things like this.
In principle, you are utterly and totally correct! We know it, you know it, the customer auditor wouldn't agree!

In practice, it was issued and it is what it is - so, the customer auditor wasn't competent and if you're looking for them to recant, it won't happen! It's just one of those things. But we're happy to be, 'on your side' as far as principles are concerned. In practice, you may have to eat it!;)
 
J

Jason PCSwitches

#23
Regardless of cause & fault, it still can fall under the scope if multiple clause's were outlined including, but not limited to, 7.5, 7.5.1, 7.5.2, 7.5.3, 7.6, I can go on but I've got work to do.

As Andy stated, just deal with it - it's trivial to begin with. Some battles are best won with submission.
 

Solinas

Involved In Discussions
#24
Great discussion!!!

My take:
Jennifer brought up a very interesting point.

As an auditor, you're really there to audit the systems. If, for example, there are issues with the calibration SYSTEM, documentation SYSTEM, training SYSTEM - I would not restrict myself to making them observations, based on who the material would ship to. The systems fail, and if it's major, it's major.

As a customer - seeing sloppy business practices in other areas of the company would make me question how well my stuff would be handled the day after I left the facility.

As an audit host, I'd not let this happen. The AGREED UPON schedule should allow the auditor time to write up any nonconformances and observations, and should allow time for a discussion. These end of day discussions about audit results are critical - I've seen may cases where a misunderstanding on the part of of an auditor could get clarified, new evidence shown, and the issue of nonconformance completely dropped before the auditor hit the parking lot.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#25
This really is a good discussion. :agree1:

And it raises the point of professionalism while auditing customers. But I would venture a guess that my organization would sooner sprout wings and fly than send me to audit a supplier! There's good reason for that. I am looking at systems, and the guy who ends up going is more interested in specific engineering and manufacturing processes, possibly something related to an issue we've experienced and he wants to investigate.

So the person who does the customer audits is technically brilliant but does NOT know the protocols - nor does he care. And for him, that's effective. He finds out what he wants to know.

The lesson I can draw from that is that 2nd party auditing is such a different animal than 1st or 3rd party auditing that as others have mentioned, the rules should be written and agreed upon before you even start.

But whereas the issue presented here is the nonconformance, the issue for that customer is what he saw. He's going to go back to his people, and recommend action based on that and what happens next. And there's no controlling that unless things can be physically shielded from his view.

So, when they are coming be sure to be ready, or else!
:2cents:
 

jkuil

Quite Involved in Discussions
#26
As a supplier audit, you want to assess the quality system applied by the supplier in manufacturing the products you purchase. It does not matter if you asses the system through examples that do not directly relate to your purchased product, as long as it is representative for the process that is applied. During the audit, you as a supplier should manage the audit as well to assure that the auditor only observes representative data.

Your remark that it depends on the customer's requirements which level of control (in this case validation controls) you apply, gives me the feeling that you have low intrinsic quality objectives. If I want to be negative I would say that in your case, unless customers are very specific in their requirements, you won't meet them. Surely, this is not the impression you want to make. And by adressing the observation, you demonstrate that this is also not the case. Just keep in mind, that to obtain customer satisfaction your quality system requirements must exceed the audit criteria. You even won't create satisfaction if you just simply meet the requirements, because that is what is expected.
 

Colin

Quite Involved in Discussions
#27
Great discussion!!!

My take:
Jennifer brought up a very interesting point.

As an auditor, you're really there to audit the systems. If, for example, there are issues with the calibration SYSTEM, documentation SYSTEM, training SYSTEM - I would not restrict myself to making them observations, based on who the material would ship to. The systems fail, and if it's major, it's major.

As a customer - seeing sloppy business practices in other areas of the company would make me question how well my stuff would be handled the day after I left the facility.

As an audit host, I'd not let this happen. The AGREED UPON schedule should allow the auditor time to write up any nonconformances and observations, and should allow time for a discussion. These end of day discussions about audit results are critical - I've seen may cases where a misunderstanding on the part of of an auditor could get clarified, new evidence shown, and the issue of nonconformance completely dropped before the auditor hit the parking lot.
So how far out of scope should the auditor be allowed to go? If the audit was against ISO 9001 and the auditor saw a breech of environmental systems e.g. improper disposal of waste material, should the auditor raise that as an NC (major?)?
 
T

The Specialist

#28
I agree with all that this is an interesting discussion. Some of the points raised do give pause for thought...

It seems everyone agrees in principle...

I am looking forward to responses to Colin's comment above, perhaps with specifics of how each of us would handle the situation. Would we just "eat it", as AndyN suggests?

I am not disputing that Andy has a point here... I need to think on this more.

Great topic.
 
M

Migre

#29
Hindsight is a wonderful thing. Perhaps now your organisation will give greater consideration to the pre-customer audit detail (parameters, boundaries, 'scope', etc).

But, primarily, unless I've missed this, how important to your organisation is the customer in question? The scope of their audit aside, is their custom important to you? If so, bite the bullet and take some of the 'just run with it' options offered elsewhere within this thread. If not, argue your case. That's not a decision-making process that sits comfortably with my principles but, in these times of austerity, I'm afraid that's not the main point here. The bottom line is what ultimately counts.
 

qusys

Trusted Information Resource
#30
I would like to share my experience of supplier audit.
An organization shall establish who guides this process.
It is usually the Purchasing that has the primary contact with a supplier ( the have knowledhe of the commercial issue as well as contract and requirements) , then in the audit team there shall be a person of Quality ( competent of the standard and protocols) as well as a techinical person ( who has competence of the product/service to be assessed and that use that product or servie as well as has knowledge of eventual lackings of the supplier). This is a multidisciplinary team.
The lead auditor shall establish the audit plan and criteria of the supplier audit, send the agenda to the supplier a certain time before the agreed date of the audit. The lenght of the audit should be usually one day and half or two, it depends upon the agenda , the premises to visit and so on.
Before the audit date ( usually one month before) , the organization send to the supplier a self assement form with specific questions where there is a sort of self assessment of the supplier with a ranking. This form is sent back to the customer and analyzed. The questions will then checked on the premises of the supplier to validate or not.
At the end there is report discussed with the supplier where the auditor issue the strenghts as well as eventual ncn based upon the agreed criteria ( one of these criteria could also be the contract and related requirements signed off).
As a question related to an Environmental ncn, if the customer could raise or not, it depends. It can also depend on the competence of the auditor. However, if in the pre assessment check list , there also some question related the environmental and there are specific requirements on the contract, the ncn could be raised up to the supplier, taking always into account the agreed criteria of the audit with the supplier.
In any case, it can also be reported as an observation, the supplier will be also happy if the customer audit is helpfull for its organization in a view of mutual beneficial relationship between supplier and customer.
Hope this helps:bigwave:
 
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