Advertisement
Review Article| Volume 37, ISSUE 1, P85-96, March 2017

Six Sigma Quality Management System and Design of Risk-based Statistical Quality Control

Published:December 22, 2016DOI:https://doi.org/10.1016/j.cll.2016.09.008

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribers receive full online access to your subscription and archive of back issues up to and including 2002.

      Content published before 2002 is available via pay-per-view purchase only.

      Subscribe:

      Subscribe to Clinics in Laboratory Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Sandberg S.
        • Fraser C.G.
        • Horvath A.R.
        • et al.
        Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine.
        Clin Chem Lab Med. 2015; 53: 833-835
        • Westgard J.O.
        Useful measures and models for analytical quality management in medical laboratories.
        Clin Chem Lab Med. 2016; 54: 223-233
        • Panteghini M.
        • Sandberg S.
        Total error vs. measurement uncertainty: the match continues.
        Clin Chem Lab Med. 2016; 54: 195-196
        • Oosterhuis W.P.
        • Theodorsson E.
        Total error vs. measurement uncertainty: revolution or evolution.
        Clin Chem Lab Med. 2016; 54: 235-239
        • Farrance I.
        • Badrick T.
        • Sikaris K.A.
        Uncertainty in measurement and total error – are they so incompatible?.
        Clin Chem Lab Med. 2016; 54: 1309-1311
        • Kallner A.
        Is the combination of trueness and precision in one expression meaningful? On the use of total error and uncertainty in clinical chemistry.
        Clin Chem Lab Med. 2016; 54: 1291-1297
        • Westgard J.O.
        • Carey R.N.
        • Wold S.
        Criteria for judging precision and accuracy in method development and evaluation.
        Clin Chem. 1974; 20: 825-833
        • Westgard J.O.
        • Westgard S.A.
        Assessing quality on the sigma-scale from proficiency testing and external quality assessment surveys.
        Clin Chem Lab Med. 2015; 53: 1531-1535
        • Westgard J.O.
        • Westgard S.A.
        Quality control review: implementing a scientifically based quality control system.
        Ann Clin Biochem. 2016; 53: 32-50
        • Westgard J.O.
        • Westgard S.A.
        Basic quality management systems.
        Westgard QC, Madison (WI)2014
        • ISO 15189
        Medical laboratories – particular requirements for quality and competence.
        ISO, Geneva (Switzerland)2012
        • Westgard J.O.
        • Burnett R.W.
        Precision requirements for cost-effective operation of analytical processes.
        Clin Chem. 1990; 36: 1629-1632
        • Chesher D.
        • Burnett L.
        Equivalence of critical error calculations and process capability index Cpk.
        Clin Chem. 1997; 43: 1100-1101
        • Bais R.
        Use of capability index to improve laboratory analytical performance.
        Clin Biochem Rev. 2008; 29: S27-S31
        • Harry M.
        • Schroder R.
        Six sigma: the breakthrough management strategy revolutionizing the World’s top corporations.
        Currency, New York2000
        • Kuchipudi L.
        • Yundt-Pacheco J.
        • Parvin C.A.
        Computing a patient-based sigma metric.
        Clin Chem. 2010; 56 ([Abstract]): A35
      1. Yundt-Pacheco J, Parvin CA. System and method to determine sigma of a clinical diagnostic process. US Patent 8,589,081 B2. 2013.

        • Woolworth A.
        • Korpi-Steiner N.
        • Miller J.J.
        • et al.
        Utilization of assay performance characteristics to estimate hemoglobin A1c result reliability.
        Clin Chem. 2014; 60: 1073-1079
        • Coskun A.
        • Serteser J.
        • Kilercik M.
        • et al.
        A new approach for calculating the sigma metric in clinical laboratories.
        Accred Qual Assur. 2015; 20: 147-152
        • Cembrowski G.S.
        • Cervinski M.A.
        Demystifying reference sample quality control.
        Clin Chem. 2016; 62 ([Editorial]): 907-909
        • Westgard J.O.
        • Falk H.
        • Groth T.
        Influence of a between-run component of variation, choice of control limits, and shape of error distribution on the performance characteristics of rules for internal quality control.
        Clin Chem. 1979; 25: 394-400
        • Westgard J.O.
        • Barry P.L.
        Cost-effective quality control: managing the quality and productivity of analytical processes.
        AACC Press, Washington, DC1986
        • Koch D.D.
        • Oryall J.J.
        • Quam E.F.
        • et al.
        Selection of medically useful quality-control procedures for individual tests done in a multitest analytical system.
        Clin Chem. 1990; 36: 230-233
        • Parvin C.A.
        Assessing the impact of the frequency of quality control testing on the quality of reported patient results.
        Clin Chem. 2008; 54: 2049-2054
        • Yundt-Pacheco J.
        • Parvin C.A.
        Validating the performance of QC procedures.
        Clin Lab Med. 2013; 33: 75-88
        • Yago M.
        • Alcover S.
        Selecting statistical procedures for quality control planning based on risk management.
        Clin Chem. 2016; 62: 959-965
      2. Parvin CA, Yundt-Pacheco J. System and method for analyzing a QC strategy for releasing results. US Patent 8,938,409 B2. 2015.