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  Objective Evidence of Review

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Author Topic:   Objective Evidence of Review
Steven Truchon
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Posts: 89
From:Fort Lauderdale, FL USA
Registered: Jul 2000

posted 28 July 2000 01:28 PM     Click Here to See the Profile for Steven Truchon   Click Here to Email Steven Truchon     Edit/Delete Message   Reply w/Quote
A recent QS9000 surveillance audit resulted in a corrective action for the following in regard to 4.16.
The finding was in our Contract Review section where our procedure requires that PO's be signed "for a record of review". The QS requirement quoted to support the write-up was in paragraph 2 of 4.16 (3rd Edition), "Quality Records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system." We review everything during our contract review process that includes final approval signatures from all participating personnel, but there is no signature on the PO itself after we receive it. A signed acknowledgement is sent to the customer, but...
It was part of demonstrating conformance (ensuring that the PO was reviewed & approved) and of having a quality system that operates effectively that resulted in the auditor also stating that supplier certifications such as raw material, plating, heat-treating, etc, which require certifications also require that there be a signature, initials, a stamp, or something that would provide objective evidence that the document had been reviewed and accepted (or approved). I understand that this would be important for accountability purposes, but I have a question mark as to the validity of the auditors claim.
After reading about electronic record systems in these posts I can see some possibilities to facilitate the "reviewed and approved" signoff but its going to be a bit dicey to pull together.
To sign or not to sign... I ask and thank all for your input.

Steve

[This message has been edited by Steven Truchon (edited 28 July 2000).]

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Jim Biz
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From:ILLINOIS
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posted 31 July 2000 12:12 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Wanted to bring this subject back to the top:

Our ISO 9002 auditors have indicated that we are required to "SHOW evidence that EACH purchase order is reviewed and verified to the current contract review records - Prior to a Work Order release for shop floor processing.

Our account reps handle 300 - 500 plus po's per month - many are nothing more than "repeat" (date release) of a prior accepted "contract reviewed" blanket order.

Should I now ask them to hand initial 4000-5000 documents yearly? - We could add this task electronically but - I'm unsure it would be effective and fairly sure it is not value added.

A case could be made either way that it is not effective "Evidence" every individual PO has actually been reviewed signed/ electronic input dosen't seem to matter?

Regards
Jim

[This message has been edited by Jim Biz (edited 31 July 2000).]

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Steven Truchon
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From:Fort Lauderdale, FL USA
Registered: Jul 2000

posted 12 August 2000 11:39 AM     Click Here to See the Profile for Steven Truchon   Click Here to Email Steven Truchon     Edit/Delete Message   Reply w/Quote
Jim,
Your scenario seems it would be serious overkill. I suppose my only exception is that there is a quantity and delivery variable that becomes the point of "approval" into your system. I suppose in the interest of 100% On-Time delivery requirements, evidence of review and approval would fit as a requirement, also for it to be clearly auditable.

Regards,
Steve

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Sam
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Registered: Sep 1999

posted 14 August 2000 09:06 AM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
The requirement of 4.16 is to maintain quality records;
The requirement of 4.3.2 is to review "the submission of a tender, contract or order.
Nothing is said about signatures.

Incoming P.O's should be reviewed and documented as part of the APQP process, with the degree of review based on complexity of the order.

Outgoing P.O.'s are reviewed by members of the purchasing department (there responsibility). This can be done with the aid of a checklist developed during the planning process. Normally the name of the purchasing agent is on the P.O. therfore tracability for review is established.

Signing P.O.'s is not required by the standard. If, however, your procedure requires that P.O.'s be signed . . . . start signing or change your procedure.

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Steven Truchon
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From:Fort Lauderdale, FL USA
Registered: Jul 2000

posted 24 August 2000 04:03 PM     Click Here to See the Profile for Steven Truchon   Click Here to Email Steven Truchon     Edit/Delete Message   Reply w/Quote
Regarding incoming or customer PO's, there does need to be evidence of purchase order review somewhere in the form of identification traceable to a qualified person. Tis would apply to blanket or multiple release orders as delivery dates are critical as well.

The same holds tru for certifications from material suppliers, platers, heat-treaters, etc. Certs need to have evidence of review by a qualified person with a sig, stamp, date, etc. Otherwise one merely has possession of a record that could say anything at all.
I was reminded that whenever considering a need or requirement in ISO or QS, one should always ask themselves, "What is the risk to my customer if I... or if I do not...?"

This came from two different registrars today and a prominent UK consultant recently.

Anyone agree or disagree with this?

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CarolX
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From:Illinois, USA
Registered: Jun 2000

posted 25 August 2000 08:58 AM     Click Here to See the Profile for CarolX   Click Here to Email CarolX     Edit/Delete Message   Reply w/Quote
Steve,

I am not very familiar with the QS requirements, but here's my thoughts ....

If you are making hard drive mounting brackets for a computer manufacturing, wouldn't this be overkill??

But, if you are making landing gear componenets for an aircraft builder, wouldn't you want a signed, certified material test report on your raw material??

It depends on what your making ... you have to determine the potential risks.

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Jim Biz
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posted 25 August 2000 12:03 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
To clarify - my facilities position currently is that

1) we get an offer - Review & quote - stamp file reviewed - enter the information into a computer tracking system.

2) customer issues a partial (qty/date-due)Po to that part number/rev level information

Any further date "Release" comes in under the same Po number (blanket) - the information is updated in the computerized ordering/tracking system. Prior to shop/work order generation.

What they are explaining is that - by the act of entering the information into the system it is "evidence" of Po review - no initials - no sign-off etc. But if it "had not been "reviewed" it would/could not have been entered.

If/when/should the incomming information be in conflict with the revision level entered under the current reviewed information - it is Pulled from the files and returned to the review authority.

It remains to bee seen if this can be viewed as "objective" - although in physical practice it "is done" with each incomming purchase order..

Regards
Jim

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Sam
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posted 25 August 2000 01:59 PM     Click Here to See the Profile for Sam   Click Here to Email Sam     Edit/Delete Message   Reply w/Quote
"evidence of purchase order review somewhere in the form of identification traceable to a qualified person."
Refer to 4.1.2.2 - Who would be more qualified then the buyer? And for complex contracts; the APQP team.

"qualified person with a sig, stamp, date, etc."
Refer to 4.1.2.2 - Inspectors trained in the process of comparing certs to spec sheets


"I was reminded that whenever considering a need or requirement in ISO or QS, one should always ask themselves, "What is the risk to my customer if I... or if I do not...?"

Sounds good, but , ISO and QS contain requirements not needs. "Needs" are those additional steps you take to go above and beyond your customer requirements.


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Steven Truchon
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From:Fort Lauderdale, FL USA
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posted 28 August 2000 07:06 AM     Click Here to See the Profile for Steven Truchon   Click Here to Email Steven Truchon     Edit/Delete Message   Reply w/Quote
Jim, I agree, and I was informed by our registrar that entering the PO data into the system did in fact qualify as objective evidence, and in agreement with your post, it makes sense.

Sam, my focus is on the actual evidence of review, not specifically who performs it, although I appreciate your reference to 4.1.2.2

I suppose my best example of where evidence lacks is on a material certification that exists in a file and while I review this certification, how am I to know if the data contained on this certification has been reviewed for compliance to our requirements unless there is evidence present showing me that it was reviewed. Whether it be a stamp, initials, a log elsewhere that might reference this identifiable cert, etc.

This whole topic came up in response to the question of the presence of acceptable evidence of review and in what form(s).


Sam wrote "Sounds good, but , ISO and QS contain requirements not needs. "Needs" are those additional steps you take to go above and beyond your customer requirements. "

I said "requirements" and included needs. I wasnt implying anything beyond requirements however the consideration is a valid one. What is the risk to the customer? Its a effective safeguard whenever in doubt regarding a QS or ISO "requirement". If the result exceeds requirements and ends up as a legitimate added value then I dont see any problem.

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Jim Biz
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From:ILLINOIS
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posted 28 August 2000 07:22 AM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Steve-Sam-Carol
We have an external - scheduled for later today - as this issue is a left over "non closed" minor I'll let everyone know if the approach is acceptable to our auditor.

Regards
Jim

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Jim Biz
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From:ILLINOIS
Registered: Mar 2000

posted 29 August 2000 04:07 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Well the results are in - our aditor did in fact see the position that we explained ---

Incoming purchase order information is posted (input) in our database system prior to processing release - therefore this action is enough objective evidence that it had been reviewed. Physically it could not hvae been input without the review taking place.

Regards
Jim

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