ORBi: Detailled Reference

Article (Scientific journals)

Total Error and Uncertainty: Friends or Foes?

Rozet, Eric; Dewe, Walthere; Rudaz, Serge et al.

2011 • In TrAC: Trends in Analytical Chemistry, 30 (5), p. 797-806

Peer Reviewed verified by ORBi

Permalink
https://hdl.handle.net/2268/81653

DOI
10.1016/j.trac.2010.12.009

Files (1)Send to Details Statistics Bibliography Similar publications

Files

Full Text

TRAC13684.pdf

Publisher postprint (737.07 kB)

All documents in ORBi are protected by a user license.

Send to

RIS BibTex APA Chicago Permalink X Linkedin

Details

Keywords :

total error; uncertainty; systematic error; random error; validation; results quality

Abstract :

[en] The guidelines ISO 17025 and ISO 15189 aim at improving the quality assurance scheme of laboratories. Reliable analytical results are of core importance due to the critical decisions that are taken with them. Therefore among other topics, these documents require that analytical methods be validated and that laboratories should be able to provide measurement uncertainty of their measured routine results. To evaluate analytical methods fitness of purpose, total error has been and is more and more applied to assess reliability of results generated by analytical methods. However, the ISO requirement to estimate measurement uncertainty seems in opposition with the total error concept, leading to delays in their implementation by laboratories and increased confusion for the analysts. Thus, this article aims at clarifying the divergences between total error and measurement uncertainty, but also to discuss their main similarities and give some emphasise to their implementations.

Disciplines :

Pharmacy, pharmacology & toxicology

Author, co-author :

Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Dewe, Walthere

Rudaz, Serge

Marini Djang'Eing'A, Roland ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie

Boulanger, Bruno

Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique

Language :

English

Title :

Total Error and Uncertainty: Friends or Foes?

Publication date :

2011

Journal title :

TrAC: Trends in Analytical Chemistry

ISSN :

0165-9936

eISSN :

1879-3142

Publisher :

Elsevier Science, London, United Kingdom

Volume :

30

Issue :

5

Pages :

797-806

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 11 January 2011

Statistics

Number of views

366 (46 by ULiège)

Number of downloads

36 (14 by ULiège)

More statistics

Scopus citations^®

28

Scopus citations^®
without self-citations

22

OpenCitations

27

Bibliography

International Organization of Standardization (ISO), ISO/CEI 17025: General requirements for the competence of testing and calibration laboratories, ISO, Geneva, Switzerland, 2005.
International Organization of Standardization (ISO), ISO 15189: Medical laboratories - Particular requirements for quality and competence, ISO, Geneva, Switzerland, 2007.
Westgard J.O., Carey R.N., Wold S. Clin. Chem. 1974, 20:825.
Westgard J.O. Clin. Chem. Lab. Med. 2010, 48:31.
Krower J.S. Clin. Chem. 2003, 49:1818.
Joint Committee for Guides in Metrology, JCGM 100:2008, Evaluation of measurement data - Guide to the expression of uncertainty in measurement (GUM), 2008 (available from the website http://www.bipm.org.
Dybkaer R. Scand. J. Clin. Lab. Invest. 1999, 59:579.
Dybkaer R. Accred. Qual. Assur. 1999, 4:401.
Kristiansen J. Clin. Chem. 2003, 49:1822.
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L. J. Pharm. Biomed. Anal. 2004, 36:579.
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Chiap P., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L., Rozet E. J. Pharm. Biomed. Anal. 2007, 45:70.
Hubert Ph., Nguyen-Huu J.-J., Boulanger B., Chapuzet E., Cohen N., Compagnon P.-A., Dewé W., Feinberg M., Laurentie M., Mercier N., Muzard G., Valat L., Rozet E. J. Pharm. Biomed. Anal. 2007, 45:82.
Viswanathan C.T., Bansal S., Booth B., DeStefano A.J., Rose M.J., Sailstad J., Shah V.P., Skelly J.P., Swann P.G., Weiner R. AAPS J 2007, 9:E30.
International Conference on Harmonization (ICH): Quality Risk Management Q9, Geneva, Switzerland, 2005 (available from the website http://www.emea.eu.int/Inspections/docs/ICHQ9Step4QRM.pdf.
US Food and Drugs Administration (US FDA), Process Analytical Technology (PAT) Initiative, US FDA, Rockville, MD, USA, 2004 (available from the website: ICH Q9). http://www.fda.gov/cder/OPS/PAT.htm.
Panteghini M. Clin. Chem. Lab. Med. 2010, 48:7.
Joint Committee for Guides in Metrology, JCGM 200:2008, International Vocabulary of Metrology - Basic and general concepts and associated terms (VIM), 2008 (available from the website http://www.bipm.org.
International Organization of Standardization (ISO), ISO 5725, Application of the statistics-accuracy (trueness and precision) of the results and methods of measurement - Parts 1 to 6, ISO, Geneva, Switzerland, 1994.
Linsinger T.P.J. Trends Anal. Chem. 2008, 27:916.
US Federal Government, Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Rockville, MD, USA, May 2001.
International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, Geneva, Switzerland, 2005.
Krouwer J.S. Arch. Path. Lab. Med. 1992, 116:726.
Krouwer J.S. Clin. Chem. 2002, 48:919.
Ricós C., Baadenhuijsen H., Libeer J.-K., Petersen P.H., Stöckl D., Thienpont L., et al. Eur. J. Clin. Chem. Biochem. 1996, 34:159.
Hund E., Massart D.L., Smeyers-Verbeke J. Trends Anal. Chem. 2001, 20:394.
Mandel J. The Statistical Analysis of Experimental Data 1964, Dover, New York, USA, pp. 104-105.
S.L.R. Ellison, M. Rösslein, A. Williams, (Editors), EURACHEM/CITAC Guide, Quantifying Uncertainty in Analytical Measurement, Second edition, 2000 (available from the website http://www.citac.cc/QUAM2000-1.pdf.
Fuentes-Arderiu X. Clin. Chem. 2000, 46:1437.
Furman W.B., Layloff T.P., Tetzlaff R.F. J. AOAC Int. 1994, 77:1314.
Burns M. Trends Anal. Chem. 2004, 23:393.
Kuselman I. To what extent can an uncertainty calculation be general?, in: Conference volume ''Measurement uncertainty in chemical analysis''. Accred. Qual. Assur. 1998, 3:131.
Joint Committee for Guides in Metrology, JCGM 101:2008, Evaluation of measurement data - Supplement 1 to the "Guide to the expression of uncertainty in measurement" - Propagation of distributions using a Monte Carlo method, 2008 (available from the website http://www.bipm.org.
Duchesne S., Beck M., Reda A. Water Sci. Technol. 2001, 43(7):311.
P. Pestiaux, F. Chebana, Ph. Dutot, F. Espinoux, Measurement uncertainty evaluation in oil industry laboratories: the only reasonable way to do it, in: XIIth International Metrology Congress, Lyon, France, 20-23 June 2005.
King B. Fresenius' J. Anal. Chem. 2001, 371:714.
Visser R. Accred. Qual. Assur. 2002, 7:124.
Visser R. Accred. Qual. Assur. 2004, 9:717.
Hund E., Massart D.L., Smeyers-Verbeke J. Anal. Chim. Acta 2003, 480:39.
Maroto A., Boqué R., Riu J., Rius F.X. Trends. Anal. Chem. 1999, 18:577.
Gonzalez A.G., Herrador M.A. Trends. Anal. Chem. 2007, 26:227.
Thompson M., Ellison S.L.R., Wood R. Pure Appl. Chem. 2002, 74:835.
European Commission, Method Validation and Quality Control procedures for Pesticide Residues, in: Doc. SANCO/2007/3131, 31 October 2007 (available at the website http://www.crl-pesticides.eu/library/docs/srm/AqcGuidance.pdf.
European Commission, 2002/657/EC: Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC Concerning the Performance of Analytical Methods and the Interpretation of Results. Off. J. Eur. Commun. L221 (2002) 8.
Eurachem, The Fitness for Purpose of Analytical Methods, Eurachem, Teddington, Middlesex, UK, 1998.
Hoffman D., Kringle R. Pharm. Res. 2007, 24:1157.
Phillips S.D., Eberhardt K.R. J. Res. Natl. Inst. Stand. Technol. 1997, 102:577.
Patriarca M., Castelli M., Corsetti F., Menditto A. Clin. Chem. 2005, 51:277.
Synek V. Talanta 2005, 65:829.
Petersen P.H., Stöckl D., Westgard J.O., Sandberg S., Linnet K., Thienpont L. Clin. Chem. Lab. Med. 2001, 39:589.
Feinberg M., Boulanger B., Dewe W. Ph. Hubert, Anal. Bioanal. Chem. 2004, 380:502.
O'Donnell G.E., Hibbert D.B. Analyst (Cambridge, UK) 2005, 130:721.
Vardeman S.B. Am. Stat. 1992, 46:193.
Guttman I. Statistical Tolerance Regions: Classical and Bayesian 1969, Hafner, Darian, CT, USA.
Hahn G.J., Meeker W.Q. Statistical Intervals: A Guide for Practitioners 1991, Wiley, Chichester, East Sussex, UK.
Mee R.W. Technometrics 1984, 26:251.
Boulanger B., Rozet E., Moonen F., Rudaz S., Hubert Ph. J. Chromatogr., B 2009, 877:2235.
Maroto A., Boqué R., Riu J., Rius F.X. Accred. Qual. Assur. 2002, 7:90.
Magnusson B., Ellison S.L.R. Anal. Bioanal. Chem. 2008, 390:201.
Lee J.C., Ramsey M.H. Analyst (Cambridge, UK) 2001, 126:1784.
Thompson M., Wood R. Accred. Qual. Assur. 2006, 10:471.
Horwitz W., Kamps L.A., Boyer K.W. J. Off. Anal. Chem. 1980, 63:1344.
Carroll R.J., Ruppert D. Transformation and Weighting in Regression 1987, Chapman and Hall, New York, USA.
ILAC, ILAC-G8:03/2009, Guidelines on the reporting of compliance with specification (available at the website http://www.ilac.org/documents/ILAC_G8_03_2009.pdf.
Joint Committee for Guides in Metrology, JCGM 106, May 12, 2009 Draft, Evaluation of measurement data. The role of measurement uncertainty in conformity assessment (available at the website http://www.bipm.org.
International Organization of Standardization (ISO), ISO 10576-1:2003(E) Statistical methods. Guidelines for the evaluation of conformity with specified requirements. Part 1: General principles, ISO, Geneva, Switzerland, 2003.
Czaske M. Accred. Qual. Assur. 2008, 13:645.
ASME B89.7.3.1-2001 Guidelines for decision rules: considering measurement uncertainty in determining conformance with specifications (available at the website http://www.ilac.org/documents/ILAC_G8_03_2009.pdf.
S.L.R. Ellison, A. Williams (Editors), EURACHEM/CITAC Guide, Use of uncertainty information in compliance assessment, 2007 (available at the website http://www.eurachem.org/guides/pdf/UfS_2007.pdf.
Desimoni E., Brunetti B. Accred. Qual. Assur. 2010, 15:45.
Golze M. Accred. Qual. Assur. 1998, 3:227.
King B. Accred. Qual. Assur. 2004, 9:369.

Similar publications