Quality Assurance in Analytical Chemistry Applications in Environmental, Food and Materials Analysis, Biotechnology, and Medical Engineering

by Funk, Werner; Dammann, Vera; Donnevert, Gerhild; Iannelli, Sarah; Iannelli, Eric

• ISBN13: 9783527311149
• ISBN10: 3527311149
• Edition: 2nd
• Format: Hardcover
• Copyright: 2006-12-15
• Publisher: Wiley-VCH

Summary

This best-selling title both in German and English is now enhanced by a new chapter on the important topical subject of measurement uncertainty, plus a CD-ROM with interactive examples in the form of Excel-spreadsheets. These allow readers to gain an even better comprehension of the statistical procedures for quality assurance while also incorporating their own data.Following an introduction, the text goes on to elucidate the 4-phase model of analytical quality assurance: establishing a new analytical process, preparative quality assurance, routine quality assurance and external analytical quality assurance.Besides updating the relevant references, the authors took great care to incorporate the latest international standards in the field.Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.

Author Biography

The late Werner Funk was professor at the University of Applied Science in Gießn-Friedberg (Germany).

Vera Dammann is a senior scientist at the University of Applied Science in Gießn-Friedberg (Germany) since 1978. She has been working in areas such as computing, electrical engineering, electrical and biophysical measurement technology, and clinical engineering. She is project manager for the international study course 'clinical engineering' and a member of the board of the German association for biomedical instrumentation.

Gerhild Donnevert is laboratory engineer in the laboratory for analytical chemistry at the University of Applied Science in Gießn-Friedberg (Germany). She is an active member of the German standardization committees for the examination of water, wastewater and sludge as well as of the Technical Committee 147 'Water Quality' of the International Standards Organization ISO.

Table of Contents

Preface.

List of Symbols.

0 Introduction.

0.1 General Differentiation of Analytical Processes.

0.2 Quality of Analytical Processes and Results.

0.3 The System of Analytical Quality Assurance.

0.4 The Four-Phase Model of Analytical Quality Assurance.

1 Phase I: Establishing a New Analytical Procedure.

1.1 Introduction.

1.2 Calibration of the Fundamental Analytical Procedure.

1.3 Analyses at Very Low Concentrations.

1.4 Validation of Individual Process Steps and Examination of Matrix Influences.

1.5 Additional Statistical Methods.

1.6 Use of Internal Standards.

1.7 Preparing for Routine Analysis.

1.8 Summary of the Results of Phase I (Process Development): Documentation.

2 Phase II: An Analytical Process Becomes Routine; Preparative Quality Assurance.

2.1 Introduction.

2.2 Selection of the Analytical Procedure.

2.3 The “Training” Phase of the Process.

2.4 Establishment of Quality Objectives to be Adhered to in Routine Usage.

2.5 Control Samples for Internal Quality Assurance.

2.6 The Control Chart System.

3 Phase III: Routine Quality Assurance.

3.1 Introduction.

3.2 Fundamental Measures of Internal Quality Assurance.

3.3 Routine Quality Control.

3.4 Special Quality Problems in Routine Analysis.

3.5 Corrective Measures.

3.6 Documentation and Archiving.

4 Phase IV: External Analytical Quality Assurance.

4.1 Introduction.

4.2 Audits.

4.3 Interlaboratory (or Round Robin) Tests.

4.4 Effects of Internal Quality Assurance on the Results of Interlaboratory Tests.

4.5 Conclusion.

5 Definitions.

5.1 Quality and Quality Management.

5.2 Analytical Terms.

5.3 Analytical Results.

5.4 Deviation, Uncertainty.

5.5 Materials, Samples.

5.6 Statistical Tests.

6 References.

Appendix 1.

A1 Sample Calculations.

A1.1 Fundamental Calibration.

A1.2 Linearity Tests.

A1.3 Phases II and III: Control Charts.

Appendix 2.

A2 Statistical Tables.

Appendix 3.

A3 Contents of the CD.

Subject Index.