Mean and variance quality control for multiple correlated levels of replicated control samples
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John H. Livesey
Abstract
Mean and variance rules for quality control are more powerful than rules based on individual values. An algorithm for applying such rules is described that controls type I errors (false alarms), while allowing for multiple levels of quality control samples, correlation between levels, small numbers of preliminary values, replication of samples and autocorrelation arising from random effects. Based on ANOVA and empirical approximations for small samples, the algorithm maintains a low per-batch probability of type I errors. Three statistics are computed, zm, zb and zw, which are shown by simulations to be primarily sensitive to a concordant shift in the quality control values, a discordant shift in the values, and an increase in random variability, respectively. Simulations also show that for a Gaussian distribution of analytical errors, the per-batch probability of a type I error is likely to be within the range 0.0045–0.0071 for two to four levels where there are 20–100 preliminary batches and the inter-level correlations are between zero and 0.8. This partial separation of out-of-control alarms into three components provides more assistance with trouble-shooting than do multivariate quality control schemes based on Hotelling's T2, while retaining comparable power.
References
1. Shewhart WA. Economic control of quality of manufactured product. New York: Van Nostrand, 1931:501 pp.Suche in Google Scholar
2. Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol 1950; 20:1059–66.10.1093/ajcp/20.11_ts.1059Suche in Google Scholar PubMed
3. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981; 27:493–501.10.1093/clinchem/27.3.493Suche in Google Scholar
4. Montgomery DC. Introduction to statistical quality control, 4th ed. New York: Wiley, 2001:796 pp.Suche in Google Scholar
5. Linnet K. Mean and variance rules are more powerful or selective than quality control rules based on individual values. Eur J Clin Chem Clin Biochem 1991; 29:417–24.10.1515/cclm.1991.29.7.417Suche in Google Scholar PubMed
6. Parvin CA. New insight into the comparative power of quality-control rules that use control observations within a single analytical run. Clin Chem 1993; 39:440–7.10.1093/clinchem/39.3.440Suche in Google Scholar
7. Jansen RT, Laeven M, Kardol W. Internal quality control system for non-stationary, non-ergodic analytical processes based on exponentially weighted estimation of process means and process standard deviation. Clin Chem Lab Med 2002; 40:616–24.10.1515/CCLM.2002.107Suche in Google Scholar PubMed
8. Dechert J, Case KE. Multivariate approach to quality control in clinical chemistry. Clin Chem 1998; 44:1959–63.Suche in Google Scholar
9. Marquis P, Masseyeff R. Évaluer une méthode contrôle de qualité interne: application au contrôle multidimensionel. Ann Biol Clin (Paris) 2000; 60:607–16.Suche in Google Scholar
10. Wolf FM. Meta-analysis: quantitative methods for research synthesis. Beverley Hills, CA: Sage, 1986:65 pp.10.4135/9781412984980Suche in Google Scholar
11. Scholz FW, Tosch TJ. Small sample uni- and multivariate control charts for means. In: 1994 Proceedings of the Section on Quality and Productivity of the American Statistical Association. Alexandria, VA: American Statistical Association, 1994.Suche in Google Scholar
12. Press WH, Teukolsky SA, Vettering WT, Flannery BP. Numerical recipes in C: the art of scientific computing, 2nd ed. Cambridge, UK: Cambridge University Press, 1992:994 pp.Suche in Google Scholar
13. Abramowitz M, Stegun I, editors. Handbook of mathematical functions. New York: Dover, 1965:1046 pp.Suche in Google Scholar
14. Ryan TP. Statistical methods for quality improvement, 2nd ed. New York: Wiley, 2000:555 pp.Suche in Google Scholar
15. Westgard JO. Internal quality control: planning and implementation strategies. Ann Clin Biochem 2003; 40:593–611.10.1258/000456303770367199Suche in Google Scholar PubMed
16. Jones RD. Reevaluation of the power of error detection of Westgard multirules. Clin Chem 2004; 50:762–4.10.1373/clinchem.2003.025585Suche in Google Scholar PubMed
17. Prabhu SS, Runger GC. Designing a multivariate EWMA control chart. J Qual Technol 1997; 29:8–15.10.1080/00224065.1997.11979720Suche in Google Scholar
18. Pignatiello J, Runger G. Comparisons of multivariate CUSUM charts. J Qual Technol 1990; 22:173–86.10.1080/00224065.1990.11979237Suche in Google Scholar
19. Cembrowski GS. Thoughts on quality-control systems: a laboratorian's perspective. Clin Chem 1997; 43:886–92.10.1093/clinchem/43.5.886Suche in Google Scholar
©2005 by Walter de Gruyter Berlin New York
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- Impact of standardized calibration on the inter-assay variation of 14 automated assays for the measurement of creatinine in human serum
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