Journal
CLINICS IN LABORATORY MEDICINE
Volume 37, Issue 1, Pages 85-+Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.cll.2016.09.008
Keywords
Six Sigma; Quality management system; Process capability; SQC; Analytical run; Frequency of QC
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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.
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