Study on assessing internal quality control procedures with charts of operational process specifications / 中华医院管理杂志

ABSTRACT

Objective To explore the assessment of precision, accuracy, and quality control(QC) procedures needed to satisfy the external quality assessment criteria with "operational process specifications" (OPSpecs) derived from an analytical quality-planning model. Methods The routine operating specifications were presented in the form of an OPSpecs chart, which described the operational limits for imprecision and inaccuracy when a desired level of quality assurance was provided by a specific QC procedure. Results OPSpecs charts could be used to compare the operational limits for different QC procedures and to select a QC procedure that was appropriate for the precision and accuracy of a specific measurement procedure. The inaccuracy and imprecision observed for a measurement procedure was plotted on the OPSpecs chart to define the current operating point, which was then compared with the operational limits of candidate QC procedures. Conclusion The general design approach is applicable in all instrument systems.