QUESTION: |
The x-axis is presented in units that are multiples of the standard deviation of the method in order to normalize the graphs and make them applicable to any test in any laboratory. If actual concentration units were used, it would be necessary to generate specific graphs for each test in each laboratory. This would mean each laboratory would need the capability of determining the power curves themselves.
Why aren't the power
curves smooth?They should be. However, in using computer simulation, we have estimated the probabilities at distinct sizes of errors and presented point-to-point power curves for systematic errors corresponding to shifts of 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, and 4.0 times the SD or CV of the method, and random errors corresponding to 1.0, 1.5, 2.0, 2.5, and 3.0 fold increases in the SD or CV of the method.
The probabilities estimated by computer simulation studies are subject to some experimental uncertainty and depend on the number of runs simulated for each error condition. In our work, we have generally used 1000 runs and expect the uncertainty to be about 0.01 to 0.02 for the probability of false rejection and up to 0.05 for the probability of error detection. Therefore, small differences between the estimated performance characteristics of different QC procedures should not be over-interpreted.
We set a general objective of achieving a Ped of 0.90 because that will generally mean that a critical error will be detected in the first run in which it occurs (actual average run length would be 1.1). Achieving higher error detection is often very costly because the power curves plateau as they approach the perfect error detection of 1.0. Going from 0.90 to 0.95 or 0.99 could require doubling the number of control measurements, thus doubling the cost of QC.
