Quality assurance in analytical chemistry / Elizabeth Prichard and Vicki Barwick.

Enhanced descriptions from Syndetics:

The issue of quality assurance in the analytical chemistry laboratory has become of great importance in recent years.

Quality Assurance in Analytical Chemistry introduces the reader to the whole concept of quality assurance. It discusses how all aspects of chemical analysis, from sampling and method selection to choice of equipment and the taking and reporting of measurements affect the quality of analytical data. Finally, the implementation and use of quality systems are covered.

Table of contents provided by Syndetics

• Series Preface (p. xi)
• Preface (p. xiii)
• Acknowledgements (p. xv)
• Acronyms, Abbreviations and Symbols (p. xvii)
• About the Authors (p. xxi)
• 1 The Need for Reliable Results (p. 1)
• 1.1 Why Analytical Work is Required (p. 1)
• 1.2 Social and Economic Impact of a 'Wrong Analysis' (p. 2)
• 1.3 What do we Mean by 'Quality' (p. 4)
• 1.4 Customer Requirements (p. 5)
• 1.5 Purpose of Analysis (p. 7)
• Reference (p. 9)
• 2 General Principles of Quality Assurance and Quality Control (p. 11)
• 2.1 Introduction to Quality Assurance (p. 11)
• 2.2 Quality Management System, Quality Assurance (QA) and Quality Control (QC) (p. 14)
• 2.3 Different Standards and their Main Features (p. 15)
• 2.3.1 Common Features of ISO 9001, ISO/IEC 17025 and ISO 15189 (p. 18)
• 2.3.2 Features of ISO 9001:2000 (p. 19)
• 2.3.3 Features of ISO/IEC 17025:2005 (p. 20)
• 2.3.4 Features of ISO 15189:2003 (p. 20)
• 2.3.5 Good Laboratory Practice (GLP) (p. 21)
• 2.4 Best Practice (p. 21)
• References (p. 24)
• 3 Sampling (p. 25)
• 3.1 Sampling Defined (p. 26)
• 3.2 Types of Samples (p. 29)
• 3.2.1 Representative Sample (p. 29)
• 3.2.2 Selective Sample (p. 30)
• 3.2.3 Random Sample (p. 30)
• 3.2.4 Composite Sample (p. 31)
• 3.3 The Sampling Plan (p. 31)
• 3.3.1 Legal and Statutory Requirements (p. 32)
• 3.3.2 Types of Sampling (p. 33)
• 3.4 Sample Numbers and Sample Size (p. 35)
• 3.4.1 Sampling Uncertainty (p. 36)
• 3.4.2 Number of Primary Samples (p. 37)
• 3.5 Subsampling (p. 41)
• 3.5.1 Subsampling Procedures (p. 42)
• 3.6 Sample Handling and Storage (p. 45)
• 3.6.1 Holding Time (p. 48)
• References (p. 49)
• 4 Preparing for Analysis (p. 51)
• 4.1 Selecting the Method (p. 51)
• 4.2 Sources of Methods (p. 52)
• 4.3 Factors to Consider when Selecting a Method (p. 55)
• 4.3.1 Limit of Detection (p. 56)
• 4.3.2 Precision (p. 57)
• 4.3.3 Bias/Recovery (p. 58)
• 4.3.4 Accuracy (p. 58)
• 4.3.5 Time (p. 59)
• 4.3.6 Equipment Required (p. 59)
• 4.3.7 Sample Size (p. 59)
• 4.3.8 Cost (p. 60)
• 4.3.9 Safety (p. 60)
• 4.3.10 Selectivity (p. 60)
• 4.3.11 Making Your Choice (p. 61)
• 4.4 Performance Criteria for Methods Used (p. 62)
• 4.4.1 Criteria for the Determination of Analytes by Selected Techniques (p. 66)
• 4.5 Reasons for Incorrect Analytical Results (p. 69)
• 4.5.1 Incompetence (p. 69)
• 4.5.2 Method Used (p. 70)
• 4.5.3 Contamination (p. 70)
• 4.5.4 Interferences (p. 70)
• 4.5.5 Losses and/or Degradation (p. 73)
• 4.6 Method Validation (p. 73)
• 4.6.1 Selectivity (p. 78)
• 4.6.2 Precision (p. 78)
• 4.6.3 Bias/Trueness (p. 82)
• 4.6.4 Measurement Range, Limit of Detection (LoD) and Limit of Quantitation (LoQ) (p. 86)
• 4.6.5 Ruggedness Testing (p. 90)
• 4.6.6 'Sign-off' and Documentation (p. 92)
• References (p. 93)
• Appendix Layout for Method Documentation (p. 94)
• 5 Making Measurements (p. 99)
• 5.1 Good Laboratory Practice (p. 99)
• 5.1.1 Before Starting an Analysis (p. 100)
• 5.1.2 During the Analysis (p. 102)
• 5.1.3 After the Analysis (p. 102)
• 5.2 Calibration of Measurement (p. 104)
• 5.3 Achieving Metrological Traceability (p. 108)
• 5.3.1 Reference Materials (p. 109)
• 5.3.2 Chemical Standards (p. 111)
• 5.4 Quality Control (p. 115)
• 5.4.1 Blanks (p. 117)
• 5.4.2 Quality Control Samples (p. 117)
• 5.4.3 Repeat Samples (p. 117)
• 5.4.4 Blind Samples (p. 118)
• 5.4.5 Chemical Standards and Spikes (p. 118)
• 5.5 Environment (p. 118)
• 5.5.1 Factors Affecting Quality (p. 119)
• 5.5.2 Laboratory Design (p. 119)
• 5.5.3 Siting of Instruments (p. 120)
• 5.5.4 Monitoring Changes (p. 120)
• 5.6 Equipment and Glassware (p. 120)
• 5.6.1 Selection (p. 120)
• 5.6.2 Suitability (p. 122)
• 5.6.3 Equipment Qualification (p. 122)
• 5.6.4 Cleaning (p. 125)
• 5.6.5 Drying (p. 125)
• 5.7 Chemicals and Consumables (p. 126)
• 5.7.1 Grade (p. 126)
• 5.7.2 Labelling (p. 127)
• 5.7.3 Preparation (p. 131)
• 5.7.4 Manipulation (p. 132)
• 5.7.5 Containers (p. 132)
• 5.7.6 Storage (p. 134)
• 5.7.7 Safety (p. 134)
• 5.7.8 Disposal (p. 135)
• 5.8 Maintenance and Calibration of Equipment (p. 136)
• References (p. 138)
• 6 Data treatment (p. 139)
• 6.1 Essential Statistics (p. 140)
• 6.1.1 Populations and Samples (p. 140)
• 6.1.2 Describing Distributions of Data (p. 140)
• 6.1.3 Essential Calculations (p. 143)
• 6.2 Control Charts (p. 147)
• 6.2.1 The Shewhart Chart (p. 147)
• 6.2.2 Moving Average Chart (p. 150)
• 6.2.3 CUSUM Charts (p. 150)
• 6.2.4 Range Charts (p. 154)
• 6.3 Measurement Uncertainty (p. 156)
• 6.3.1 The Measurement Process (p. 156)
• 6.3.2 Definition of Uncertainty (p. 157)
• 6.3.3 Errors (p. 157)
• 6.3.4 Precision, Bias and Accuracy (p. 159)
• 6.3.5 Evaluating Uncertainty (p. 162)
• 6.3.6 Expanded Uncertainty (p. 174)
• 6.3.7 Putting Uncertainty to Use (p. 175)
• References (p. 177)
• 7 Benchmarking Your Laboratory (p. 179)
• 7.1 Proficiency Testing Schemes (p. 180)
• 7.2 Organization of Proficiency Testing Schemes (p. 182)
• 7.3 The Statistics Used in Proficiency Testing Schemes (p. 184)
• 7.3.1 The Assigned Value (p. 184)
• 7.3.2 The Target Range (p. 187)
• 7.3.3 Performance Measures (p. 188)
• 7.3.4 Combination of z-Scores (p. 191)
• 7.3.5 Interpretation of Performance Scores (p. 191)
• 7.3.6 Robust Statistics (p. 193)
• 7.4 Making the Most of Participation in Proficiency Testing Schemes (p. 196)
• 7.5 Collaborative Studies (p. 198)
• References (p. 199)
• 8 Documentation and its Management (p. 201)
• 8.1 Documentation (p. 201)
• 8.1.1 Quality Manual (p. 201)
• 8.1.2 Supporting Documentation (p. 202)
• 8.1.3 Record Management (p. 203)
• 8.1.4 Records (p. 203)
• 8.1.5 Generating Records (p. 205)
• 8.1.6 Record Identification (p. 205)
• 8.1.7 Document and Record Control (p. 206)
• 8.1.8 Reporting Results (p. 207)
• 8.1.9 Copying Records (p. 209)
• 8.1.10 Storing and Archiving Records (p. 210)
• 8.2 Opinions and Interpretations (p. 210)
• 8.2.1 Examples where Opinions and Interpretations may be Requested (p. 210)
• 8.2.2 Accreditation of Opinions and Interpretations (p. 211)
• References (p. 212)
• 9 Managing Quality (p. 213)
• 9.1 The Management System (p. 214)
• 9.1.1 The Benefits of a Management System (p. 215)
• 9.1.2 Types of Management Standards for Laboratories (p. 217)
• 9.2 Standards Available for Laboratories (p. 219)
• 9.2.1 Good Laboratory Practice (GLP) Requirements (p. 219)
• 9.2.2 ISO/IEC 17025 Requirements (p. 226)
• 9.2.3 ISO 9001 Requirements (p. 228)
• 9.3 Quality Manual and other Documentation (p. 229)
• 9.4 Audit (p. 230)
• 9.4.1 Responsibility for Internal Quality Audits (p. 232)
• 9.4.2 Planning of Internal Quality Audits (p. 233)
• 9.4.3 Training of Auditors (p. 233)
• 9.4.4 Conduct of Internal Quality Audits (p. 234)
• 9.4.5 Coverage of Internal Quality Audits (p. 235)
• 9.4.6 The 'Vertical Audit' (p. 236)
• 9.4.7 Types of Nonconforming Work (p. 236)
• 9.5 Management Review (p. 238)
• 9.5.1 Organization and Coverage of Management Review (p. 238)
• 9.6 Responsibilities of Laboratory Staff for Quality (p. 239)
• 9.6.1 Laboratory Management's Responsibilities for Quality (p. 240)
• 9.6.2 The Quality Manager's Responsibilities (p. 240)
• 9.6.3 Responsibilities of Individual Members of Staff (p. 240)
• References (p. 241)
• Appendix Two-Tailed Critical Values for Student t-Tests (p. 253)
• Responses to Self-Assessment Questions (p. 255)
• Bibliography (p. 275)
• Glossary of Terms (p. 277)
• SI Units and Physical Constants (p. 283)
• Periodic Table (p. 287)
• Index (p. 289)

Author notes provided by Syndetics

Elizabeth Prichard obtained a first degree in Chemistry from the University lege of Wales, Aberystwyth, where she went on to obtain her doctorate studying infrared spectroscopy. After a Civil Service Research Fellowship, she moved into academia, initially at Bedford College and then Royal Holloway and B Bedford New College, University of London before moving to the University of Warwick as a Senior Research Fellow. While at London University, she continued her research in spectroscopy, as well as some work in biophysical chemistry. At the University of Warwick, she researched the release profiles of steroids from implanted contraceptive devices. During her time at London University, Elizabeth spent sabbatical periods at the Division of Materials Application NPL, the Biophysics and Biochemistry Department, Wellcome research Foundation, Beckenham and then as Associate Professor sponsored by the British Council at the University of Gezira and at the University of Khartoum, Sudan.

Vicki Barwick obtained a first degree in Chemistry from the University of Nottingham. She then joined the Laboratory of the Government Chemist (which became LGC in 1996) as an analyst in the Consumer Safety Group. Vicki was involved with a number of projects to assess the safety of consumer products, including developing test methods for the identification of colorants in cosmetics and the quantitation of phthalate plasticizers in child-care items.
After five years as an analyst, Vicki moved within LGC to work on the DTI-funded Valid Analytical Measurement (VAM) programme. In this role, responsible for providing advice and developing guidance on methods validation, measurement uncertainty and statistics. One of her key project involved the chemical test methods. During this time, Vicki also became involved with the development and delivery of training courses on topics such as method validation, measurement uncertainty, quality systems and statistics for analytical chemists.