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The statistics of the PTI test is based on normal distribution.  We have a database collected that demonstrates that this assumption of normality is appropriate.  To challenge the test, though, we have studied a number of non-normal distributions and recently non-normal distributions that have been suggested by the agency to be very challenging non-normal distributions.

Our investigations have revealed that with the revised PTI test coefficients, the PTI test assures less than 5.1 percent type I error at the limiting quality for all normal and for most non-normal situations.  For a few extreme distributions, 5 percent is exceeded at the limiting quality.  These extreme distributions are not reflective of real products.  They are significantly off-target, relatively symmetric distributions with extremely short tails or they could also be significantly off-target, notably asymmetric distributions with the longer tail in the off-target direction.  Now, we conclude that the PTI test is appropriate for real products.

Zero tolerance has also been a criterion, mostly because it's part of the present guideline test.  It has been under consideration whether or not the

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