Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control.
Six sigma concepts provide a quality management system (QMS) with many useful tools for managing quality in medical laboratories. This Six Sigma QMS is driven by the quality required for the intended use of a test. The most useful form for this quality requirement is the allowable total error. Calculation of a sigma-metric provides the best predictor of risk for an analytical examination process, as well as a design parameter for selecting the statistical quality control (SQC) procedure necessary to detect medically important errors. Simple point estimates of sigma at medical decision concentrations are sufficient for laboratory applications.
Department of Pathology and Laboratory Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI 53705, USA; Westgard QC, Inc, Madison, WI 53717, USA. Electronic address: james@westgard.com.
James O
JO
Westgard
Westgard QC, Inc, Madison, WI 53717, USA.
Sten A
SA
Westgard
D003951:Diagnostic Errors / Q000517:prevention & control*; D006801:Humans; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D012306:Risk; D017749:Total Quality Management / Q000379:methods* / Q000592:standards
Analytical run; Frequency of QC; Process capability; Quality management system; SQC; Six Sigma