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FOOD AND DRUG ADMINISTRATION - page 108 / 263

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to be rejected, and as Dr. Adams mentioned, the court decision would lead that to be taken as evidence that my process isn't in proper control.

On the other hand, if I apply the proposed parametric test, I'm going to be accepting more than 95 percent of my batches, based on this test.  Now, as has been often mentioned, there are more than one test that gets done to a batch before it goes out the door, and this test isn't necessarily the gatekeeper.

But still, in my hypothetical example of batches that tend to have a standard deviation of 11, I'm going to accept most of my batches and release them, based on this test, using the proposed test, but I'm going to be rejecting an unacceptable percentage of my batches if I use the FDA test.

The issue is that the FDA test is doing the wrong thing and the proposed test is doing the right thing, if a batch of standard deviation 11 is acceptable to the public health.  On the other hand, the FDA test is doing the right thing and the proposed test is doing the wrong thing, if a standard deviation of 11 is not acceptable to the public health.

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