Process capability and stability of analytical systems assessed from proficiency testing data

Abstract

Abstract Participation in a proficiency testing (PT) program is a valuable adjunct to laboratory activities dedicated to the maintenance of reliable analytical methods. The PT program may facilitate continuous quality improvement if laboratory performance is presented in the context of expectations espoused by healthcare professionals for optimal patient care. Statistical process control (SPC) and capability analysis are tools used by industry in a Total Quality Management environment to characterize and monitor the performance of its processes relative to performance specifications. I conceptualized the use of an analytical system by many laboratories as a process that periodically produces results from the analysis of PT specimens. I treated a set of five PT results (theophylline) reported by a laboratory as a process sample and subjected the samples collected from many laboratories to SPC and capability analysis. The control charts--mean-(X-bar) and s-charts--produced by the analysis readily identify significant analytical errors in the context of peer performance and performance specifications provided by the regulatory program and analytical goal setting. The capability index (desirable Cp > 1.0) determined from clinical specification limits for the three analytical systems evaluated suggests an opportunity for improvement of laboratory performance.