Introduction : Since the time of Hippocrates the Latin phrase “primum non nocere” i.e. “first, do no harm” has been taught to medical students. In laboratory practice, this is applicable to minimizing error rates,as clinical decision making is based largely in accordance with the laboratory results. Modern quality management tools such as Six Sigma can be the solution towards achieving error free laboratory reports. Six sigma refers to world class quality with a defect rate of 3.4 defects or errors per million opportunities.. The present study was undertaken to analyse the performance of biochemical parameters routinely tested in our laboratory in terms of six sigma scale and to develop a strategy for continuous quality improvement process.

Materials and Methods: This was retrospective study to analyse and evaluate the performance of 25 biochemical tests in our laboratory from January to December 2017. All the biochemical analytes were run on Dade Dimension RxL Max. Internal and External controls were procured from Biorad Laboratories, USA. Two levels of IQC Normal (Level 1) and Abnormal (Level 2) were run for each parameter twice a day. The TEa for calculating sigma metrics were taken from CLIA Guidelines.  

Results :-. In Level 1, 4 analytes: Chloride, SGPT (ALT), Calcium and Urea sigma value was below 3, 7 analytes: Lipase, Albumin, Direct Bilirubin, Total Bilirubin, Cholesterol, Creatinine and Glucose sigma value was between 3–6, 14 analytes: Potassium, Sodium, Alkaline Phosphatase, Amylase, SGOT (AST), HDL Cholesterol, LDL Cholesterol, GGT, Iron, Phosphorus, Total Protein, TIBC, Triglycerides, Uric Acid sigma value was above 6. In Level 2, 2 analytes: Chloride, Calcium sigma value was below 3, 7 analytes: Lipase, Albumin, Total Bilirubin, Direct Bilirubin, Cholesterol, Glucose, Total Protein and TIBC, sigma value was between 3 – 6, 16 analytes: Potassium, Sodium, Alkaline Phosphatase, SGPT (ALT (SGPT)), Amylase, SGOT (AST (SGOT)), Total Bilirubin, Direct Bilirubin, HDL Cholesterol, LDL Cholesterol, Creatinine, GGT, Iron, Phosphorus, Triglycerides, Uric Acid sigma value was above 6.

Conclusion: A Rational QC design is needed to be optimize the QC procedures, reduce the cost of running daily QC and to solve analytical problems and decrease the number of errors to a minimal level. Using six sigma in clinical laboratories has been shown to refine patient care by eliminating the need to retrace steps, correcting errors in laboratory reports and re-performing tests which are wasteful processes both in terms of economics as well as patient dissatisfaction and discomfort 

Keywords: Six Sigma; Total Quality Management; QC.