Practical application of Six Sigma management in analytical biochemistry processes in clinical settings.

Background Six Sigma methodology with a zero-defect goal has long been applied in commercial settings and was utilized in this study to assure/improve the quality of various analytes. Methods Daily internal quality control (QC) and external quality assessment data were collected and analyzed by calculating the sigma (sigma) values for 19 analytes based on the coefficient of variation, bias, and total error allowable. Standardized QC sigma charts were established with these parameters. Quality goal index (QGI) analysis and root cause analysis (RCA) were used to discover potential problems for the analytes. Results Five analytes with sigma >= 6 achieved world-class performance, and only the Westgard rule (1(3s)) with one control measurement at two QC material levels (N2) per QC event and a run size of 1000 patient samples between QC events (R1000) was needed for QC. In contrast, more control rules (2(2s)/R-4s/4(1s)) along with high N values and low R values were needed for quality assurance for five analytes with 4 <= sigma < 6. However, the sigma levels of nine analytes were sigma < 4 at one or more QC levels, and a more rigorous QC procedure (1(3s)/2(2s)/R-4s/4(1s)/8(x) with N4 and R45) was implemented. The combination of QGI analysis and RCA further revealed inaccuracy or imprecision problems for these analytes with sigma < 4 and discovered five aspects of potential causes considered for quality improvement. Conclusions Six Sigma methodology is an effective tool for evaluating the performance of biochemical analytes and is conducive to quality assurance and improvement.