Roberticus
ASQ CQE
We are having difficulty ensuring Customer acceptance due to complications involving "recently re-assigned" outsourcing responsibility on parts longtime considered finished. This follows a round of similar NCs and CARs a year ago for the same issues, which were only closed after a Customer acceptance to resume purchasing the uncoated version p/n (both on same master print) as the final part. When the modified p/n prefixes indicating the final coating per Customer spec./ASL reappeared on the shop floor en masse, I was sure to review my CAR records to be prepared for recurrences.
Essentially, SS parts built for our largest medical OEM (30+ percent) were, since '05, bought as finished p/n prior to an outside coating. What was our Final QC became an In-process QC with all of the previous checks, then the Outside process, and our QC Final for the coating. We were responsible for about a year, then the Customer for maybe 9 months; it's just become ours again after New Years'.
We are under a renewed barrage of issues similar to the prior cycle.
As a QE, I accept my role to operate effectively within the requirements agreed to by those responsible for the contract decisions, without (my) knowing all the (projected/ actual) $$$ implications.
Really wish though, I could find an overarching Quality principle which would advise against our ownership of a process over which our firm has limited expertise, acceptance discretion, or vendor influence and is performed after a full QC acceptance for all print specs. controlled by our Operations, which ARE fully documented in our WI and such.
Submitted for your esteemed thoughts, experiences and/or opinions...
Essentially, SS parts built for our largest medical OEM (30+ percent) were, since '05, bought as finished p/n prior to an outside coating. What was our Final QC became an In-process QC with all of the previous checks, then the Outside process, and our QC Final for the coating. We were responsible for about a year, then the Customer for maybe 9 months; it's just become ours again after New Years'.
We are under a renewed barrage of issues similar to the prior cycle.
As a QE, I accept my role to operate effectively within the requirements agreed to by those responsible for the contract decisions, without (my) knowing all the (projected/ actual) $$$ implications.
Really wish though, I could find an overarching Quality principle which would advise against our ownership of a process over which our firm has limited expertise, acceptance discretion, or vendor influence and is performed after a full QC acceptance for all print specs. controlled by our Operations, which ARE fully documented in our WI and such.
Submitted for your esteemed thoughts, experiences and/or opinions...
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