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

Reliability of analytical data depends on appropriate quality assurance methods. This holds true for environmental and food monitoring, materials analysis, but also for analytics in biotechnology or in medicine (in–vitro diagnostics, point–of–care testing).
The authors of this best–selling title describe a proven and integrated concept for quality assurance. The new edition is enhanced by a 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 incorporated the latest international standards in the field.
From reviews of the previous edition:
"extremely informative and comprehensive"
—Accreditation and Quality Assurance
"The book successfully combines the role of authoritative textbook and reference manual, with that of a practical handbook and guide to the selection of an appropriate AQA strategy."
—The Analyst
"This book presents a unique, four–phase strategy for quality assurance."
—Journal of the American Chemical Society

Spis treści:
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 Int roduction.
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.

Nota biograficzna:
The late Werner Funk was professor at the University of Applied Science in Gießn–Friedberg (Germany).
Vera Dammann is a senior scien tist 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.

Okładka tylna:
Reliability of analytical data depends on appropriate quality assurance methods. This holds true for environmental and food monitoring, materials analysis, but also for analytics in biotechnology or in medicine (in–vitro diagnostics, point–of–care testing).
The authors of this best–selling title describe a proven and integrated concept for quality assurance. The new edition is enhanced by a 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 incorporated the latest international standards in the field.
From reviews of the previ ous edition:
"extremely informative and comprehensive"
—Accreditation and Quality Assurance
"The book successfully combines the role of authoritative textbook and reference manual, with that of a practical handbook and guide to the selection of an appropriate AQA strategy."
—The Analyst
"This book presents a unique, four–phase strategy for quality assurance."
—Journal of the American Chemical Society