When I have completed process validations that met the QSR/FDA requirements We validated all process that could not be verified to a "high degree of assurance".
Here's what we did:
Wave solder and Reflow: Verified the thermal configurations for each component that would be subjected to the process. From that data we found the most sensitive components. Those were the parts we had a thermal probe on during the first article run. We ran those assemblies first and also attached a sidekic recorder. We were able to verify the top temps and dwell times for the most sensitive components. We made any adjustments and re-ran the sidekic until we had a process defined that did not compromise the integrity of the component thermally. Then a final report was written stating the test methods, equipment used, cal cert's, first article inspection and test reports.
Wire crimps: We used a force gage to test the crimps. We verified compliance using UL tensile strength guidelines. We then in-process tested each at a change of: job, operator, material or shift.
Potted material was cut up and verified that the material had sufficient encapsulation, visual inspection and functional testing was also used.
Component prep was verified that the prep did not destroy the component by putting stresses on the lead attachment, stress relief was within spec's, cutting blades were set up properly so the cutting stresses went down the lead away from the component not towards the component.
Hand soldering was validated to confirm the operator's were trained in the techniques that would be required, thermal constraints were known and the process was developed around those, cleanliness in a post operation were defined.
Hope this helps. I don't believe that the ISO is as tough as the FDA was. Their big hang up was "to a high degree of assurance".
Kathy
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<DIV>When I have completed process validations that met the QSR/FDA requirements
We validated all process that could not be verified to a "high degree of
assurance". </DIV>
<DIV> </DIV>
<DIV>Here's what we did:</DIV>
<DIV> </DIV>
<DIV>Wave solder and Reflow: Verified the thermal configurations for each
component that would be subjected to the process. From that data we found
the most sensitive components. Those were the parts we had a
thermal probe on during the first article run. We ran those assemblies
first and also attached a sidekic recorder. We were able to verify the top
temps and dwell times for the most sensitive components. We made any
adjustments and re-ran the sidekic until we had a process defined that did not
compromise the integrity of the component thermally. Then a final report
was written stating the test methods, equipment used, cal cert's, first article
inspection and test reports. </DIV>
<DIV> </DIV>
<DIV>Wire crimps: We used a force gage to test the crimps. We
verified compliance using UL tensile strength guidelines. We then
in-process tested each at a change of: job, operator, material or
shift. </DIV>
<DIV> </DIV>
<DIV>Potted material was cut up and verified that the material had sufficient
encapsulation, visual inspection and functional testing was also used.
</DIV>
<DIV> </DIV>
<DIV>Component prep was verified that the prep did not destroy the component by
putting stresses on the lead attachment, stress relief was within spec's,
cutting blades were set up properly so the cutting stresses went down the lead
away from the component not towards the component. </DIV>
<DIV> </DIV>
<DIV>Hand soldering was validated to confirm the operator's were trained in the
techniques that would be required, thermal constraints were known and the
process was developed around those, cleanliness in a post operation were
defined. </DIV>
<DIV> </DIV>
<DIV>Hope this helps. I don't believe that the ISO is as tough as the FDA
was. Their big hang up was "to a high degree of assurance". </DIV>
<DIV> </DIV>
<DIV>Kathy </DIV></BODY></HTML>
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