OPSPECOperational Specification
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Depending on the sophistication of the operator and the workload and subtle factors involving willingness of the persons at that office to work with the operator, getting an amendment to the OpSpecs and GOM can take a few weeks or several months.
This authorization is found in the OpSpecs for typical Part 135 IFR operations rather than the FARs, and requires only that the weather be at or above the lowest applicable approach minimums (considering only visibility).
Figure 4 is an OPSpecs chart showing the inaccuracy (on the "y" axis) and imprecision (on the "x" axis) allowable with various QC procedures.
Subsequent sections, "Learning Program Operation" and "Rule Selection Methodology", give a more general background with an outline of the selection procedure based on the OPSpecs chart concept, partly as excerpts from earlier publications.
The necessary error detection is available from any QC procedure whose operating limits are above the method's operating point (x = |s.sub.meas~, y = |bias.sub.meas~).|5,6~ From the OPSpecs chart, the best choice of an acceptability criterion for the potassium example is a |1.sub.2.5s~ control rule (or control limits set as the mean |+ or -~ |2.5s.sub.meas~), which should provide approximately 90% detection of medically important errors with only 3% false rejections.
The preponderance of the book serves to explain the OPSpecs Chart to the initiate (the first 15 chapters contain ~40 of these charts and 150 references to the charts).
That is, the OPSpecs charts do not take into account the fact that a patient result will only be reported when the quality control (QC) run associated with the patient specimen is considered to be in control.
OPSpecs [TM] charts [8] were prepared by using the QC Validator [TM] computer program [9] (Westgard Quality Corp., Ogunquit, ME).
Critical-error graphs and charts of operating specifications (OPSpecs charts) were then prepared with the QC Validator program.
The program displays performance characteristics-in the form of OPSpecs charts, critical error graphs, and power function graphs--for various sets of QC rules.
The OPSpecs manual: operating specifications for precision, accuracy and quality control.