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FOOD AND DRUG ADMINISTRATION - page 105 / 263

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probably would tell him from now on every 10th batch, I'm going to reject one of them, turn it back to you as sort of a penalty.  I don't need to get a complaint from my customers.  So this is a 10 percent rejection which also plays a role in the quality control there.

So we have a couple of points there.  One is the minimum quality, one is the quality assurance I wanted to have the product to be.  So in setting about a quality control procedure, we need to take both of them into consideration.

Now, I wanted to show you this slide here.  This is slide 4 from Dr. Olsson.  Here, it shows that at the lower right-hand which controls the type I, 5 percent type I error rate, which is the consumer protection region but really what it means is it's a not acceptable batch which really we don't want this kind of batch to be released.  And on the right-hand side, it has the producer protection region, but this region is going to be changed with the sample size.  If the sample size increases, this region can be shifted up to here.  That means many of the batches of the area of uncertainty, which it really means for the consumer which is the product, is not totally bad.

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