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August 1998

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Subject:
From:
Paul Klasek <[log in to unmask]>
Reply To:
TechNet E-Mail Forum.
Date:
Mon, 10 Aug 1998 15:07:30 +1000
Content-Type:
multipart/mixed
Parts/Attachments:
text/plain (2102 bytes) , QM043_labbooks.doc (28 kB)
Hi Scott , if you manage to decipher this , it may help .
Hope the Word clip will get through .

See you
Paul
http://www.resmed.com



> I not sure about all that, but here is what the validation report has
> to have in it:
>
> 1. a D-number from the master number register
>
> 2. Purpose: "To report on tests carried out as per protocol D000-500"
>
> 3. Test 7.1 Paste dispenser visual inspection: PASS (See Lab Book XYZ
> pages ? to ? for details of when & who inspected the samples)
>
> 3. Test 7.1 Pick & Place  visual inspection: PASS (See Lab Book XYZ
> pages ? to ? for details of when & who inspected the samples)
>
> 4. Test 7.3.1 Process parameter adjust: PASS  (See lab Book XYZ pages
> ? to ? for details of when,  who and printout of reflow profiles used
> while adjusting the oven [ max peak temp, min peak temp, max time
> above 183, min time above 183, etc, etc. ie: the records of work done)
>
> 5. Test 7.3.2 Repeatability study: PASS  (See lab Book XYZ pages ? to
> ? for details of when,  who and printout of reflow profiles used while
> to prove the ovens repeatability, ie: the records of work done)
>
> 6. Test 7.5.3 Joint Failure Criteria: PASS (See lab Book XYZ pages ?
> to ? for details of when,  who and records of work done, equip used,
> continuity interruptions, printouts, etc)
>
> 7. Test 7.6 Optical Microscopy: PASS (see attached report form ADI)
>
> 8, Test 7.7 Shear testing: The average joint strength of new sample un
> - aged = ?.
> The std deviation is ??. Subsequent batches will be compared to this
> as process control.
>
> 9. CONCLUSION:
> All tests passed, therefore the SMT line is recommended for producing
> production grade printed circuit assemblies.
>
> 10. General 7.8: cross reference a Lab book which documents what
> samples where built, by who, when, using what, equip list used, etc.
>
> I will be reviewing the report, and the lab books together prior to
> sign off to see it all fits together. Better to take the bitter
> medicine now than at audit time.
>
> hope this helps
>
> ps: a draft lab book procedure to help you in filing them out
>
>
> Roman Greifeneder
> Quality assurance Dept.
> ext. 475
>
>
>


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