Quality assurance in analytical chemistry : applications in environmental, food, and materials analysis, biotechnology, and medical engineering / Werner Funk, Vera Dammann, Gerhild Donnevert.

Enhanced descriptions from Syndetics:

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.

Table of contents provided by Syndetics

• Preface (p. XIII)
• List of Symbols (p. XVII)
• 0 Introduction (p. 1)
• 0.1 General Differentiation of Analytical Processes (p. 3)
• 0.2 Quality of Analytical Processes and Results (p. 4)
• 0.3 The System of Analytical Quality Assurance (p. 4)
• 0.4 The Four-Phase Model of Analytical Quality Assurance (p. 6)
• 1 Phase I: Establishing a New Analytical Procedure (p. 9)
• 1.1 Introduction (p. 9)
• 1.1.1 Objectives of Phase I (p. 9)
• 1.1.2 When Are Characteristic Data Obtained? (p. 9)
• 1.1.3 The Progression of Phase I (p. 10)
• 1.1.4 Results of Phase I; Statistical Data (p. 14)
• 1.2 Calibration of the Fundamental Analytical Procedure (p. 15)
• 1.2.1 Establishment of an Analytical Range (p. 16)
• 1.2.2 Preparation of Standard Samples (p. 16)
• 1.2.3 Determination of the Calibration Function and Process Data (p. 17)
• 1.2.3.1 Process Data for the Linear Calibration Function (p. 18)
• 1.2.3.2 Process Data for the Second-Order Calibration Function (p. 19)
• 1.2.3.3 Calculating Analytical Results with the Aid of the Calibration Function (p. 21)
• 1.2.4 Verification of the Fundamental Calibration (p. 23)
• 1.2.4.1 Verification of Linearity (p. 23)
• 1.2.4.2 Verification of Precision (p. 25)
• 1.3 Analyses at Very Low Concentrations (p. 29)
• 1.3.1 Decision Limit (p. 32)
• 1.3.2 Determining the Minimum Detectable Value (p. 34)
• 1.3.2.1 Minimum Detectable Value, Determined Using the Distribution of Blank Values (p. 34)
• 1.3.2.2 Minimum Detectable Value, Obtained Using the Calibration Function (p. 35)
• 1.3.3 Limit of Quantification (p. 35)
• 1.3.4 Quick Estimation (p. 36)
• 1.3.5 Estimation of the Decision Limit and Limit of Quantification Using the S/N Ratio (p. 37)
• 1.4 Validation of Individual Process Steps and Examination of Matrix Influences (p. 37)
• 1.4.1 Systematic Errors (p. 37)
• 1.4.1.1 Constant Systematic Errors, Additive Deviations (p. 37)
• 1.4.1.2 Proportional Systematic Errors, Multiplicative Deviations (p. 38)
• 1.4.2 Establishment and Assessment of the Recovery Function (p. 38)
• 1.4.2.1 Prerequisites for the Interpretation of the Recovery Function (p. 39)
• 1.4.2.2 Testing for Systematic Errors (p. 40)
• 1.4.3 Application of the Recovery Function (p. 41)
• 1.4.3.1 Checking Individual Process Steps (p. 41)
• 1.4.3.2 Determination of the Recovery Function to Prove the Influence of a Matrix (p. 45)
• 1.5 Additional Statistical Methods (p. 46)
• 1.6 Use of Internal Standards (p. 46)
• 1.6.1 Definition, Purpose (p. 46)
• 1.6.2 Conditions and Limitations of the Use of Internal Standards (p. 47)
• 1.6.3 Procedure (p. 47)
• 1.7 Preparing for Routine Analysis (p. 49)
• 1.7.1 Examination of the Time Dependency of Measured Values (p. 49)
• 1.7.1.1 Comparison of the "Within Batch" Standard Deviation (s[subscript w]) with the "Between Batches" Standard Deviation (s[subscript b]) (p. 49)
• 1.7.1.2 Determining the Need for Daily Adjustment of Analytical Equipment (p. 51)
• 1.7.1.3 The Trend Test (p. 51)
• 1.8 Summary of the Results of Phase I (Process Development): Documentation (p. 54)
• 2 Phase II: An Analytical Process Becomes Routine; Preparative Quality Assurance (p. 57)
• 2.1 Introduction (p. 57)
• 2.1.1 Objectives of Phase II (p. 57)
• 2.1.2 Execution of Phase II (p. 57)
• 2.1.3 Progression of Phase II (p. 57)
• 2.1.4 Results of Phase II (p. 58)
• 2.2 Selection of the Analytical Procedure (p. 59)
• 2.2.1 Specificity of the Procedure (p. 60)
• 2.2.2 Selectivity of the Analytical Procedure (p. 60)
• 2.2.3 Working Range (p. 60)
• 2.2.4 Calibration Function, Sensitivity, and Precision of the Procedure (p. 60)
• 2.2.5 Minimum Detectable Value and Limit of Quantification (p. 63)
• 2.2.6 Risk of Systematic Error (p. 61)
• 2.2.7 Effort, Costs (p. 61)
• 2.3 The "Training" Phase of the Process (p. 62)
• 2.4 Establishment of Quality Objectives to be Adhered to in Routine Usage (p. 64)
• 2.4.1 External Quality Requirements (p. 65)
• 2.4.2 Internal Quality Requirements (p. 66)
• 2.5 Control Samples for Internal Quality Assurance (p. 66)
• 2.5.1 Requirements of Control Samples (p. 66)
• 2.5.2 Types of Control Samples (p. 67)
• 2.5.2.1 Standard Solutions (p. 67)
• 2.5.2.2 Blank Samples (p. 67)
• 2.5.2.3 Natural Samples (p. 67)
• 2.5.2.4 Spiked Natural Samples (p. 68)
• 2.5.2.5 Synthetic Samples (p. 68)
• 2.5.2.6 Certified Reference Materials (CRMs) (p. 68)
• 2.5.3 Requirements for Producers of Control Materials (p. 69)
• 2.5.4 Applicability of Control Sample Types (p. 69)
• 2.6 The Control Chart System (p. 70)
• 2.6.1 Introduction: History of the Control Chart (p. 70)
• 2.6.2 Principle of a Control Chart (p. 72)
• 2.6.3 Average Run Length (ARL) and Evaluation of Control Charts (p. 73)
• 2.6.4 Derivation of the Average Run Length (ARL) (p. 74)
• 2.6.4.1 Examples of Theoretical Calculations (p. 75)
• 2.6.4.2 Analytical Example (p. 76)
• 2.6.5 Concept for the Preparation of Routine Quality Control (p. 78)
• 2.6.6 Evaluation of the Preliminary Period (p. 80)
• 2.6.6.1 Variance Analysis (p. 80)
• 2.6.6.2 Adherence to Required Quality Objectives (p. 80)
• 2.6.7 Types of Control Charts and Their Applications (p. 80)
• 2.6.7.1 Shewhart Charts (p. 81)
• 2.6.7.2 R-Chart (Range Control Chart) (p. 89)
• 2.6.7.3 Difference Chart (p. 96)
• 2.6.7.4 Standard Deviation Chart (s-Chart) (p. 98)
• 2.6.7.5 Target Value Charts (p. 99)
• 2.6.7.6 Cusum Chart (p. 100)
• 2.6.8 Summary of the Characterization of Control Charts (p. 112)
• 3 Phase III: Routine Quality Assurance (p. 115)
• 3.1 Introduction (p. 115)
• 3.1.1 Setting the Objectives of Phase III (p. 115)
• 3.1.2 Execution of Phase III (p. 115)
• 3.1.3 Progression of Phase III (p. 115)
• 3.2 Fundamental Measures of Internal Quality Assurance (p. 118)
• 4 Phase IV: External Analytical Quality Assurance (p. 169)
• 4.1 Introduction (p. 269)
• 4.2 Audits (p. 169)
• 4.3 Interlaboratory (or Round Robin) Tests (p. 170)
• 4.3.1 Interlaboratory Tests for Process Standardization (p. 171)
• 4.3.2 Interlaboratory Tests as Proof of Laboratory Performance (p. 171)
• 4.3.3 Other Interlaboratory Tests (p. 172)
• 4.3.4 Planning and Execution of Interlaboratory (or Round Robin) Tests (p. 173)
• 4.3.4.1 Quality Management System of the Provider of an Interlaboratory Test (p. 173)
• 4.3.4.2 Planning the Interlaboratory Test (p. 174)
• 4.3.4.3 Interlaboratory Test Samples (p. 175)
• 4.3.5 Procedures for the Execution and Evaluation of Interlaboratory Tests (p. 176)
• 4.3.5.1 Interlaboratory Test Programs According to ISO 5725-2 (p. 177)
• 4.3.5.2 The Youden Method of Interlaboratory Tests (p. 179)
• 4.3.5.3 Interlaboratory Tests According to ISO Guide 43 (p. 188)
• 4.4 Effects of Internal Quality Assurance on the Results of Interlaboratory Tests (p. 191)
• 4.5 Conclusion (p. 194)
• 5 Definitions (p. 195)
• 5.1 Quality and Quality Management (p. 195)
• 5.2 Analytical Terms (p. 197)
• 5.3 Analytical Results (p. 201)
• 5.4 Deviation, Uncertainty (p. 202)
• 5.5 Materials, Samples (p. 205)
• 5.6 Statistical Tests (p. 206)
• 6 References
• Appendix 1
• A1 Sample Calculations (p. 219)
• A1.1 Fundamental Calibration (p. 219)
• A1.2 Linearity Tests (p. 221)
• A1.2.1 Visual Linearity Test (p. 221)
• A1.2.2 Second-Order Calibration Function (p. 222)
• A1.2.3 Linearity Test: Goodness-of Fit Test (p. 224)
• A1.2.4 Variance Homogeneity Test (p. 226)
• A1.2.5 Outlier Tests for Linear Calibration (p. 228)
• A1.2.6 Securing the Lower Range Limit (p. 230)
• A1.2.7 Decision Limit, Minimum Detectable Value, and Limit of Quantification (p. 231)
• A1.2.8 Recovery Function (p. 236)
• A1.2.9 Testing Analytical Results for Temporal Stability (p. 239)
• A1.2.10 Trend Test (p. 242)
• A1.2.11 Practice Phase: Checking the Analysis Quality Achieved Based on the Process Standard Deviation (p. 243)
• A1.3 Phases II and III: Control Charts (p. 244)
• A1.3.1 Blank Value Control Chart (p. 245)
• A1.3.2 X-Chart for Standard Solutions (p. 246)
• A1.3.3 Recovery Rate (RR) Control Chart (p. 247)
• A1.3.4 Verifying Precision by Means of R-Charts and s-Charts (p. 249)
• A1.3.5 Testing for Series-Internal Drift (p. 251)
• A1.3.6 RR-Control Chart by Addition of a Standard (p. 253)
• A1.3.7 Cusum Chart (p. 254)
• A1.3.8 Equivalency (p. 258)
• A1.3.9 Standard Addition (p. 261)
• Appendix 2
• A2 Statistical Tables (p. 263)
• A2.1 t-Table (p. 263)
• A2.2 F-Table (95%) (p. 264)
• A2.2 F-Table (99%) (p. 265)
• A2.3 Grubbs Table (p. 267)
• A2.4 X[superscript 2]-Table (p. 268)
• Appendix 3
• A3 Contents of the CD (p. 269)
• A3.1 Checklists (p. 269)
• A3.2 Instructions for Using the Calculation Examples (p. 269)
• A3.3 Statistical Table Values (p. 270)
• Subject Index (p. 271)

Author notes provided by Syndetics

The late Werner Funk was professor at the University of Applied Science in Gie'en-Friedberg (Germany).
Vera Dammann is a senior scientist at the University of Applied Science in Gie'en-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 Gie'en-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.