So what do we really want to consider? We have to consider the quality assurance region, which means I want the batch to be of this quality, and if it's below this, I'm starting to reject the batch with, say here, 10 percent of rejection. If it's worse than that, I'm going to reject more.
So we need to fix the level to have a good quality control. That's what is question 2 of Dr. Wallace presentation, what is 10 percent, and I think that's the 10 percent interpretation for quality assurance.
Now, we have the discussion and some of those iterations are how we going to set up this point. I think the original one is this one. We have this as, say, that's original FDA procedure. You have 10 percent rejection at this point which is about 9 percent of the standard deviation. And that's what is suggested. Probably we need to start looking at this point for the quality assurance region.
And the gap here does bother us. The longer the gap, that means the further away from assurance quality, and with the sample size increasing, you have higher protection for the producer risk, but you have less