G
GTJunghoon
I'm validating a liquid filling process. The risks associated with the product failure have been assessed and preventative measures have been put in place. So, I am confident that the product will rarely fail the QC inspections.
It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".
How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2?
It appears that the Jefes' want to eventually release a product lot of up to 1400 items after QC inspects and passes 2 items selected from that same product lot. I suppose this means I have to prove that the process is capable of this "lot release criteria".
How do I statistically prove that the defect rate of a process is so low that a lot of 1400 items is released after inspecting 2?