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  FMEA Handbook - and - Should vs Shall

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Author Topic:   FMEA Handbook - and - Should vs Shall
SPatel
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posted 08 July 1998 10:45 AM     Click Here to See the Profile for SPatel   Click Here to Email SPatel     Edit/Delete Message   Reply w/Quote
Is it mandatory to use and comply to all the requirements set forth in AIAG's FMEA manual?
Can I use other manuals like Ford's FMEA handbook and comply to its requirements. I am looking for other's experience in this regard since during our QS9K audit one of the auditor insisted on using and complying to the AIAG's manuals only because they are the only manuals referred in QS 9000 standard.

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Howard Atkins
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posted 09 July 1998 11:05 PM     Click Here to See the Profile for Howard Atkins   Click Here to Email Howard Atkins     Edit/Delete Message   Reply w/Quote
This reply was posted to the QS9000 forum by Massimo Tosi
Hi,
I think that you can find the answer to your question by looking up the following Handbooks :

1) "Quality System Requirements" QS-9000
On page 1 : Introduction/Approch, the sentence :
"...The word, 'shall' indicates mandatory requirements.
The word, 'should' indicates a preferred approch ..."

2) "Potential Failure Mode and Effects Analysis FMEA" (Reference
Manual).
On the FOREWORD chapter you can read :
"...Accordingly, this manual and format, which is approved and endorset
by
Chrysler, Ford and General Motors, SHOULD be used by suppliers
implementing
FMEA techniques into their design/manufacturing processes..."

3) "Advanced Product Quality Planning and Control Plan APQP"
About both design FMEA Checklist on page 64 and for process FMEA on
page 78
the question 1 asks if you have had performed the analysis according to
QS-9000's
requirements or not.
So I think it is possible to follow the second chance ... do you agree?

By the way. When I wrote the procedures for performing the FMEA in my
factory, I suggested
to use QS-9000 requirements. But according to the wishes of the Customer
we can follow
other forms too. In any case it is mandatory to agree with FMEA's
checklists.

Best regards :

[This message has been edited by Howard Atkins.]

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SPatel
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posted 10 July 1998 03:06 PM     Click Here to See the Profile for SPatel   Click Here to Email SPatel     Edit/Delete Message   Reply w/Quote
Thanks for the input.

My understanding about shall and should requirements in Quality System Requirements- QS 9000 is that it is only limited to shall and should of QS 9000 only. Do we have to comply to all shall and should of all the reference manuals (i.e. FMEA, SPC, MSA etc).
Moreover, in the same forward page of the "Potential Failure Modes and Effects Analysis" it cites that "This manual also is not intended to be a comprehensive FMEA reference source or training document". Does that mean that we can use other documents as FMEA reference.

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Howard Atkins
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posted 11 July 1998 02:08 AM     Click Here to See the Profile for Howard Atkins   Click Here to Email Howard Atkins     Edit/Delete Message   Reply w/Quote
In the QS9000 edition 3 4.2.3.5 it says "refer to the Potential Failure Mode and Effects Analysis reference manual"
This would imply that it is not mandatory.
Further 4.2.4.1 "The supplier shall fully comply with all requirements of the PPAP manual.
In the PPAP manual III 10. "refer to the PFMEA Manual."
This would imply to me that it is possible to use any method as long as the FMEA is approved by the customer.

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Marc Smith
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posted 05 August 1998 08:09 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I believe Howard is right.

In QS shall means you must while should only gives you an option in how you approach compliance to the intent.

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Howard Atkins
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posted 06 August 1998 12:31 AM     Click Here to See the Profile for Howard Atkins   Click Here to Email Howard Atkins     Edit/Delete Message   Reply w/Quote
I am closing this thread , please post FMEA quaestions in future to the FMEA forum

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