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  Final Product Audit (4.10.4.2)

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Author Topic:   Final Product Audit (4.10.4.2)
Carl Scaringelli
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From:Fort Wayne, IN, 46804
Registered: Feb 99

posted 16 February 1999 01:34 PM     Click Here to See the Profile for Carl Scaringelli   Click Here to Email Carl Scaringelli     Edit/Delete Message   Reply w/Quote
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 Smith
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posted 19 February 1999 06:10 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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?

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Marc Smith
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posted 21 February 1999 02:41 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Who is your registrar??

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Carl Scaringelli
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From:Fort Wayne, IN, 46804
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posted 26 February 1999 11:30 AM     Click Here to See the Profile for Carl Scaringelli   Click Here to Email Carl Scaringelli     Edit/Delete Message   Reply w/Quote
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

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barb butrym
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posted 26 February 1999 01:12 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
Marc...I agree ...full dimensional is way out of line....they gotta get real

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Marc Smith
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posted 27 February 1999 06:18 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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 [b]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).]

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Marc Smith
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posted 13 April 1999 08:12 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Don't miss https://elsmar.com/ubb/Forum1/HTML/000071.html for more on Dock Audits!

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Mike525
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posted 23 April 1999 11:46 AM     Click Here to See the Profile for Mike525   Click Here to Email Mike525     Edit/Delete Message   Reply w/Quote
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.

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Marc Smith
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posted 25 April 1999 08:04 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
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.

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Jada
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From:Melbourne, Australia
Registered: Mar 99

posted 25 April 1999 10:23 PM     Click Here to See the Profile for Jada   Click Here to Email Jada     Edit/Delete Message   Reply w/Quote
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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Carl Scaringelli
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From:Fort Wayne, IN, 46804
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posted 26 April 1999 11:26 AM     Click Here to See the Profile for Carl Scaringelli   Click Here to Email Carl Scaringelli     Edit/Delete Message   Reply w/Quote
Here's an update.

The response from the account manager was supportive of the auditor, but a little softer. He indicated that is our system was well defined (more than just control plan inclusion)that DNV would audit to our procedures.

I did submit this to the IASG and received a response from Peter Lake of SRI. He indicated with the conversations at the Dec 18 IASG meeting.Here is the response:
"Beyond the requirement for final inspection of a finished product is that a 'final product audit' be conducted. The audit of the product is conducted after it has been packaged, labeled, and ready to leave the loading dock. By virtue of the title'Final Product audit,' the audit is a verification of records that product, packaging, labeling, etc. conform to the customers requirements. The intent is not to incur added cost by duplicating tests already satisfactorily conducted. This final product audit should be based on sampling and can be reduced in frequency when customers PPM's are met."

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Marc Smith
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posted 20 April 2000 09:38 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Has anyone had any problem as of late with the Dock Audit requirement?

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ALM
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From:Philadelphia
Registered: Jun 1999

posted 25 April 2000 02:55 PM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message   Reply w/Quote
My registrar is BSI...

Our auditor felt that a dimensional inspection was necessary, though we did not debate "full" dimensional inspection versus "key" dimensional inspection.

So, our minimum requirement is inspection of:

1) Packaging for adequacy.
2) Labeling for adequacy.
3) A minimum of one part pulled for dimensional evaluation.

(All as defined by the customer plus whatever else we deem as appropriate.)

The timing of the dock audits are determined by us (currently a minimum of ONE random part in finished goods each month).

Our auditor was satisfied.

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Laura M
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From:Rochester, NY US
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posted 25 April 2000 03:25 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
For alot of product "dimensional" issues may not be whats important. For example, in fuel system business, calibration is considered important and dock audit parts are run on a flow stand. Key visual items are checked, especially if product is currently in containment for anything. I can't see where the registrar can require full dimensional. You can use the build date or pack date information to trace records and "make sure" everything was done, then use common sense for physical features to check. Worked for a BSI audit.

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Laura M
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From:Rochester, NY US
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posted 25 April 2000 03:26 PM     Click Here to See the Profile for Laura M   Click Here to Email Laura M     Edit/Delete Message   Reply w/Quote
Oops, not just common sense, customer PPM data!

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