Skip to main content

Analytical procedure in terms of measurement (quality) assurance

  • Chapter
Validation in Chemical Measurement
  • 2156 Accesses

Abstract

In the ordinary sense the term “analytical procedure” means a description of what has to be done while performing an analysis without reference to quality of the measurement. A more sound definition of “analytical procedure” can be given in terms of measurement (quality) assurance, in which a specified procedure to be followed is explicitly associated with an established accuracy of the results produced. The logic and consequences of such an approach are discussed, with background definitions and terminology as a starting point. Close attention is paid to the concept of measurement uncertainty as providing a single-number index of accuracy inherent in the procedure. The appropriateness of the uncertainty-based approach to analytical measurement is stressed in view of specific inaccuracy sources such as sampling and matrix effects. And methods for their evaluation are outlined. The question of a clear criterion for analytical procedure validation is also addressed from the standpoint of the quality requirement which measurement results need to meet as an end-product.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 179.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Holcombe D (1999) Accred Qual Assur 4: 525–530

    Article  Google Scholar 

  2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (1994) Text on validation of analytical procedures. ICH Quality topic Q2A: Definitions and terminology (http://www.ifpma.org/ich5q.html)

    Google Scholar 

  3. Cameron JM (1976) J Qual Technol 8: 53–55

    Google Scholar 

  4. Currie LA (1978) Sources of error and the approach to accuracy in analytical chemistry. In: Kolthoff IM, Elving PE (eds) Treatise on analytical chemistry. Part I. Theory and practice, vol.1, 2nd edn. Wiley, New York, pp 95–242

    Google Scholar 

  5. Kaiser H (1978) Spectrochim Acta 33B: 551–576

    Google Scholar 

  6. Kaiser H, Specker H (1956) Fresenius Z Anal Chem 149: 46–66

    Article  Google Scholar 

  7. Taylor JK (1983) Anal Chem 55: 600A–604A, 608A

    Google Scholar 

  8. BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML (1993) International vocabulary of basic and general terms in metrology, 2nd edn. International Organization for Standardization (ISO), Geneva

    Google Scholar 

  9. Wilson AL (1970) Talanta 17: 21–29

    Article  Google Scholar 

  10. Doerffel K (1998) Fresenius J Anal Chem 361: 393–394

    Article  Google Scholar 

  11. Shaevich AB (1989) Fresenius Z Anal Chem 335: 9–14

    Article  Google Scholar 

  12. Terms, definitions, and symbols for metrological characteristics in analysis of substance (1975) Zh Anal Chim 30: 2058–2063 (in Russian)

    Google Scholar 

  13. Youden WJ (1960) Anal Chem 32(13): 23A–37A

    Google Scholar 

  14. Youden WJ (1961) Mat Res Stand 1: 268–271

    Google Scholar 

  15. Zemelman MA (1991) Metrological foundations of technical measurements. Izdatelstvo standartov, Moscow (in Russian)

    Google Scholar 

  16. Eisenhart C (1963) J Res Nat Bur Stand 67C: 161–187

    Google Scholar 

  17. Campion PJ, Burns JE, Williams A (1973) A code of practice for the detailed statement of accuracy. National Physical Laboratory, Her Majesty's Stationery Office, London

    Google Scholar 

  18. BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML (1993) Guide to the expression of uncertainty in measurement. ISO, Geneva

    Google Scholar 

  19. EURACHEM/CITAC Guide (2000) Quantifying uncertainty in analytical measurement, 2nd edn (http://www.eurachem.bam.de/guides/quam2.pdf)

    Google Scholar 

  20. Ellison SLR, Barwick VJ (1998) Analyst 123: 1387–1392

    Article  Google Scholar 

  21. Ramsey MH (1998) J Anal Atom Spectr 13: 97–104

    Article  Google Scholar 

  22. van der Veen AMH, Alink A (1998) Accred Qual Assur 3: 20–26

    Article  Google Scholar 

  23. Valcárcel M, Ríos A (1993) Anal Chem 65: 781A–787A

    Google Scholar 

  24. ISO 5725 (1994) Accuracy (trueness and precision) of measurement methods and results. Parts 1–6. International Organization for Standardization, Geneva

    Google Scholar 

  25. IUPAC (1995) Protocol for the design, conduct and interpretation of method-performance studies. Pure Appl Chem 67: 331–343

    Google Scholar 

  26. Makulov NA (1976) Zavod Lab 42: 1457–1464 (in Russian)

    Google Scholar 

  27. Parczewski A, Rokosz A (1978) Chem Analityczna 23: 225–230

    Google Scholar 

  28. EURACHEM (1998) The fitness for purpose of analytical methods. A laboratory guide to method validation and related topics. LGC, Teddington

    Google Scholar 

  29. Wegsheider W (1996) Validation of analytical methods. In: Günzler H (ed.) Accreditation and quality assurance in analytical chemistry. Springer, Berlin, etc., pp 135–158

    Google Scholar 

  30. Bruce P, Minkkinen P, Riekkola M-L (1998) Mikrochim Acta 128: 93–106

    Article  Google Scholar 

  31. ISO/IEC 17025 (1999) General requirements for the competence of testing and calibration laboratories. International Organization for Standardization, Geneva

    Google Scholar 

  32. Jülicher B, Gowik P, Uhlig S (1999) Analyst 124: 537–545

    Article  Google Scholar 

  33. van der Voet H, van Rhijn JA, van de Wiel HJ (1999) Anal Chim Acta 391: 159–171

    Article  Google Scholar 

  34. GOST R 8.563-96 State system for ensuring the uniformity of measurements. Procedures of measurements. Gosstandart of Russia, Moscow (in Russian)

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2002 Springer-Verlag

About this chapter

Cite this chapter

Kadis, R. (2002). Analytical procedure in terms of measurement (quality) assurance. In: De Bièvre, P., Günzler, H. (eds) Validation in Chemical Measurement. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-27034-5_27

Download citation

Publish with us

Policies and ethics