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

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.