At a previous company (ISO 13485 and FDA) I was a QE.
I would routinely work with customers to identify where we could lower our sample size for
FINAL INSPECTION.
Rough Process:
1) Identify the dimensions that were jacking up up the AQL
2) Perform process capability studies on each identified dimension. CPK had to be <=1.33 over X number of runs (usually three). If everything checked out the AQL could then be lowered for that dimension only. We'd hit all of the tight dimensions on a print & push it until we had parts moving a lot faster through the whip. Many parts that were 100% inspect jobs for many years were turned into three piece operations. Was really nice. Customer was a stickler about paperwork due to the med registrations but it was worth it in the end.
3) Every 5th, 8th, or 10th lot (depending on the customer) we'd have to jack to AQL back to "normal" to demonstrate our continuous capability.
The above has to be supported by a robust
in process inspection system as well as a production team that plays along. Everyone has to check their work and follow their process plans but if they did, it worked.
Most companies I have seen try to do stuff like this fail because people get lax over time. If you're the type of company where things taper off after a couple of months of a certain initiative, this isn't for you.
At a previous company (ISO 13485 and FDA) I was a QE.
I would routinely work with customers to identify where we could lower our sample size for
FINAL INSPECTION.
Rough Process:
1) Identify the dimensions that were jacking up up the AQL
2) Perform process capability studies on each identified dimension. CPK had to be <=1.33 over X number of runs (usually three). If everything checked out the AQL could then be lowered for that dimension only. We'd hit all of the tight dimensions on a print & push it until we had parts moving a lot faster through the whip. Many parts that were 100% inspect jobs for many years were turned into three piece operations. Was really nice. Customer was a stickler about paperwork due to the med registrations but it was worth it in the end.
3) Every 5th, 8th, or 10th lot (depending on the customer) we'd have to jack to AQL back to "normal" to demonstrate our continuous capability.
The above has to be supported by a robust
in process inspection system as well as a production team that plays along. Everyone has to check their work and follow their process plans but if they did, it worked.
Most companies I have seen try to do stuff like this fail because people get lax over time. If you're the type of company where things taper off after a couple of months of a certain initiative, this isn't for you.
