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Author Topic:   4.9.g.1 Preventive Maintenance
Dawn
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Posts: 245
From:St. Marys, PA
Registered: Sep 98

posted 19 December 1999 12:26 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
Can someone please interpret for me?
"The requirements for any qualification of process operations, including associated equipment and personnel (see 4.18), shall be specified.

Such processes requiring pre-qualification of their process capability are frequently referred to as special processes.

Records shall be maintained for qualified processes, equipment and personnel, as appropriate. (see 4.16).

QS standard - I think I missed the boat with this at Assesement. He didn't look at it. I'm not sure I'm covered or not, cuz I'm not sure what they are looking for.
Thanks ahead for all your help!!!

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Marc Smith
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posted 21 December 1999 04:22 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Thgis just says you have to document your qualification plan with details such as "...associated equipment and personnel..."

The question to you is do you have any 'special' processes?

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jjolly
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posted 21 December 1999 03:30 PM           Edit/Delete Message   Reply w/Quote
As long as we are talking about 4.9, could you help me with an interpretation? "The supplier shall identify and plan the production, installation and servicing process which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following: c) compliance with references standards/codes, quality plans and/or documented procedures." This is where my question lies. What reference standards/codes are we talking about. We have our interpretations of this but would like some out side input to help clear it up.

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Roger Eastin
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posted 22 December 1999 03:34 PM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
I believe this means if, for instance, a gov't agency (FAA,DOT,FDA,etc) "imposes" some sort of standard or code that you must meet to make your product (or service), then you must account for that in your process. It most likely would occur in your work or test methods, with at least, a reference to the particular standard of interest.

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Dawn
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From:St. Marys, PA
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posted 22 December 1999 08:05 PM     Click Here to See the Profile for Dawn   Click Here to Email Dawn     Edit/Delete Message   Reply w/Quote
Marc,
I don't know what you mean by a qualification plan?

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Marc Smith
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posted 22 December 1999 08:30 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Prior to manufacturing a product, a company typically 'qualifies' the manufacturing process in some way. Often in the 'old world' the plans were not have been documented - either in a proposed plan or in maintainined records of the results. Now days you write up a qualification plan. This may include capability calculations, run at rate and other specifics. You could also call this Process Validation - you set everything up and make product for a pre-defined time and/or quantity and/or goal state.

In the QS world, they use the APQP model for product life. In APQP there are a lot of qualification schemes starting with equipment manufacturers. The end of the INITIAL qualification is the PPAP. I emphasize 'initial' as you may make process changes which may trigger a PPAP.

There is also qualification of special processes which is really the same thing (documented plan) except involves destructive testing - remember that Special Proceses are those where there is a critical / special characteristic which cannot be verified except in a destructive test.

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