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Final Product Audit (QS-9000 Paragraph 4.10.4.2)

C

Carl Scaringelli

#1
#1
I have received a finding on this element.
The standard requires all specified requirements to be verified.

My interpretation is that it was what we specified on the control plan. My registrar insisted that it was all requirements including functional and all dimensions.

Obviously, I will comply with what my registrar requires. I just wondered if anyone else has had experience with this requirement.
 
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Marc

Marc

Hunkered Down for the Duration with a Mask on...
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#2
#2
I'd fight your registrar. They're asking for a full dimensional? Hot Damn!

So far as I have seen. I understand the requirement to be packaging, labeling and general condition of the product. I do not understand the requirement to be for a full layout.

Anyone face this yet with success? What was the formula?

Barb? R U there?
 
C

Carl Scaringelli

#4
#4
I will take your advice and and go to the IASG. The registrar is DNV. I spoke to the technical manager in Houston to try to convince him that his interpetation was overzealous, after all we no longer have to do annual layouts like we used to.

Thanks for you guidance!

Carl
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
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#6
#6
Well, I hate to do this, but - what the hell. Entela sent out a news letter and they said:


4.10.4.2 Do "Final Produt Audits" (or "dock audits") have to be included on all control plans?

Interpretation: No. They may be included depending on the particular process for final audits that has been defined by the supplier. A dynamic dock audit program that constantly changes and evolves (sic) based upon PPM's and other company performance measures could not logically be defined on a control plan. Reference may be made to the applicable procedure on the control plan.

4.10.4.2 Can Dock Audits be conducted on the mnufacturing / assembly floow prior to actually closing and sealing the containers? Can the same inspector conduct the final inspection as well as the Dock Audit?

Interpretation: Not typically. The intent of the Dock Audit is to inspect the overall inspection and packaging / labeling process. Therefore, product which has been completed (sealed, labeled and moved) and ready for shipment would enable one to inspect the adequacy of packaging and labeling as well as overall product quality. Since the intent is to inspect the overall process, the same inspector being used for both inspections and final dock audit makes the intent negligable (they would be inspecting their own inspection capabilities). Unique situations may warrant different methods and may be acceptable if deemed effective by the auditor.

**NOTE: I disagree that one person could not do both. I don't buy this 'inspecting their own...' logic. As long as requirements are defined, the same person can check their own work - MY opinion.

OK - the last one (damn - I hate retyping stuff like this...

4.10.4.2 Does every single product characteristic appearing on the control plan have to be inspected accordingly (sic) during a Dock Audit? (i.e., flammability, receiving inspection characteristics of material / components, etc.)?

Interpretation: No. Final inspection instructions and packaging / labeling instructions should (at a minimum) be used for the final audit verification.

OK - Dat's All, Folks! From Entela!

[This message has been edited by Marc Smith (edited 02-27-99).]
 
M

Mike525

#8
#8
DNV is our registrar also, and I'm curious to know if that is an independent (personal) interpretation by the auditor (I've known auditors to do that - and have come close to wringing a few necks because of it), or if that is DNV's "official" interpretation (lord help us if it is). We are up for our 1st surveillance audit in July. Our stance is what makes sense for us to do cost-wise, what is reasonable, and what adds value to the process. So, when DO the NEW sanctioned interpretations come out? I'm so glad the 3rd edition is clear as mud.
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
#9
I don't know what DNV considers a dock auit at their organizational level. I suggest you call your account manager (or equivalent functionary) and ask.
 
J

Jada

#10
#10
Interesting finding by DNV.

"The standard requires all specified
requirements to be verified. "

If this is truly the intent of 4.10.4.2. Then what is the purpose of 4.10.4.1 - Layout inspection and Functional Testing? Isn't this sub-element stating that all dimensional aspects (layout) and functional (matl. etc) be verified?

While I can appreciate that 4.10.4.1 is as per customer requirements and 4.10.4.2 is supplier defined, why wouldn't your frequency as a minimum be based on customer requirements (4.10.4.1)

Just my thoughts..
 
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