操作过程规范图评价室内质量控制方法的研究

目的　探讨从分析质量 计划模型导出“操作过程规范 (OPSpecs)” ,并用于评价满足室间质评性能准则所需的精密度、准确度和质控方法。方法　常规操作规范以OPSpecs图形式表示 ,其描述了当由特定质控方法提供期望的质量保证水平时 ,不精密度和不准确度的操作限。结果　OPSpecs图能用来比较不同质控方法的操作限和选择适合于特定测定方法精密度和准确度的质控方法。将测定方法的不精密度和不准确度绘制在OPSpecs图上作为操作点 ,然后将其与候选质控方法的操作限相比较。结论　对所有自动化分析仪试验项目 ,均能采用类似方式进行质控方法的选择和设计。

Study on assessing internal quality control procedures with charts of operational process specifications

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.