Quality Assurance in Analytical Chemistry

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.

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.

Series Preface	p. xi
Preface	p. xiii
Acknowledgements	p. xv
Acronyms, Abbreviations and Symbols	p. xvii
About the Authors	p. xxi
The Need for Reliable Results	p. 1
Why Analytical Work is Required	p. 1
Social and Economic Impact of a 'Wrong Analysis'	p. 2
What do we Mean by 'Quality'	p. 4
Customer Requirements	p. 5
Purpose of Analysis	p. 7
Reference	p. 9
General Principles of Quality Assurance and Quality Control	p. 11
Introduction to Quality Assurance	p. 11
Quality Management System, Quality Assurance (QA) and Quality Control (QC)	p. 14
Different Standards and their Main Features	p. 15
Common Features of ISO 9001, ISO/IEC 17025 and ISO 15189	p. 18
Features of ISO 9001:2000	p. 19
Features of ISO/IEC 17025:2005	p. 20
Features of ISO 15189:2003	p. 20
Good Laboratory Practice (GLP)	p. 21
Best Practice	p. 21
References	p. 24
Sampling	p. 25
Sampling Defined	p. 26
Types of Samples	p. 29
Representative Sample	p. 29
Selective Sample	p. 30
Random Sample	p. 30
Composite Sample	p. 31
The Sampling Plan	p. 31
Legal and Statutory Requirements	p. 32
Types of Sampling	p. 33
Sample Numbers and Sample Size	p. 35
Sampling Uncertainty	p. 36
Number of Primary Samples	p. 37
Subsampling	p. 41
Subsampling Procedures	p. 42
Sample Handling and Storage	p. 45
Holding Time	p. 48
References	p. 49
Preparing for Analysis	p. 51
Selecting the Method	p. 51
Sources of Methods	p. 52
Factors to Consider when Selecting a Method	p. 55
Limit of Detection	p. 56
Precision	p. 57
Bias/Recovery	p. 58
Accuracy	p. 58
Time	p. 59
Equipment Required	p. 59
Sample Size	p. 59
Cost	p. 60
Safety	p. 60
Selectivity	p. 60
Making Your Choice	p. 61
Performance Criteria for Methods Used	p. 62
Criteria for the Determination of Analytes by Selected Techniques	p. 66
Reasons for Incorrect Analytical Results	p. 69
Incompetence	p. 69
Method Used	p. 70
Contamination	p. 70
Interferences	p. 70
Losses and/or Degradation	p. 73
Method Validation	p. 73
Selectivity	p. 78
Precision	p. 78
Bias/Trueness	p. 82
Measurement Range, Limit of Detection (LoD) and Limit of Quantitation (LoQ)	p. 86
Ruggedness Testing	p. 90
'Sign-off' and Documentation	p. 92
References	p. 93
Layout for Method Documentation	p. 94
Making Measurements	p. 99
Good Laboratory Practice	p. 99
Before Starting an Analysis	p. 100
During the Analysis	p. 102
After the Analysis	p. 102
Calibration of Measurement	p. 104
Achieving Metrological Traceability	p. 108
Reference Materials	p. 109
Chemical Standards	p. 111
Quality Control	p. 115
Blanks	p. 117
Quality Control Samples	p. 117
Repeat Samples	p. 117
Blind Samples	p. 118
Chemical Standards and Spikes	p. 118
Environment	p. 118
Factors Affecting Quality	p. 119
Laboratory Design	p. 119
Siting of Instruments	p. 120
Monitoring Changes	p. 120
Equipment and Glassware	p. 120
Selection	p. 120
Suitability	p. 122
Equipment Qualification	p. 122
Cleaning	p. 125
Drying	p. 125
Chemicals and Consumables	p. 126
Grade	p. 126
Labelling	p. 127
Preparation	p. 131
Manipulation	p. 132
Containers	p. 132
Storage	p. 134
Safety	p. 134
Disposal	p. 135
Maintenance and Calibration of Equipment	p. 136
References	p. 138
Data treatment	p. 139
Essential Statistics	p. 140
Populations and Samples	p. 140
Describing Distributions of Data	p. 140
Essential Calculations	p. 143
Control Charts	p. 147
The Shewhart Chart	p. 147
Moving Average Chart	p. 150
CUSUM Charts	p. 150
Range Charts	p. 154
Measurement Uncertainty	p. 156
The Measurement Process	p. 156
Definition of Uncertainty	p. 157
Errors	p. 157
Precision, Bias and Accuracy	p. 159
Evaluating Uncertainty	p. 162
Expanded Uncertainty	p. 174
Putting Uncertainty to Use	p. 175
References	p. 177
Benchmarking Your Laboratory	p. 179
Proficiency Testing Schemes	p. 180
Organization of Proficiency Testing Schemes	p. 182
The Statistics Used in Proficiency Testing Schemes	p. 184
The Assigned Value	p. 184
The Target Range	p. 187
Performance Measures	p. 188
Combination of z-Scores	p. 191
Interpretation of Performance Scores	p. 191
Robust Statistics	p. 193
Making the Most of Participation in Proficiency Testing Schemes	p. 196
Collaborative Studies	p. 198
References	p. 199
Documentation and its Management	p. 201
Documentation	p. 201
Quality Manual	p. 201
Supporting Documentation	p. 202
Record Management	p. 203
Records	p. 203
Generating Records	p. 205
Record Identification	p. 205
Document and Record Control	p. 206
Reporting Results	p. 207
Copying Records	p. 209
Storing and Archiving Records	p. 210
Opinions and Interpretations	p. 210
Examples where Opinions and Interpretations may be Requested	p. 210
Accreditation of Opinions and Interpretations	p. 211
References	p. 212
Managing Quality	p. 213
The Management System	p. 214
The Benefits of a Management System	p. 215
Types of Management Standards for Laboratories	p. 217
Standards Available for Laboratories	p. 219
Good Laboratory Practice (GLP) Requirements	p. 219
ISO/IEC 17025 Requirements	p. 226
ISO 9001 Requirements	p. 228
Quality Manual and other Documentation	p. 229
Audit	p. 230
Responsibility for Internal Quality Audits	p. 232
Planning of Internal Quality Audits	p. 233
Training of Auditors	p. 233
Conduct of Internal Quality Audits	p. 234
Coverage of Internal Quality Audits	p. 235
The 'Vertical Audit'	p. 236
Types of Nonconforming Work	p. 236
Management Review	p. 238
Organization and Coverage of Management Review	p. 238
Responsibilities of Laboratory Staff for Quality	p. 239
Laboratory Management's Responsibilities for Quality	p. 240
The Quality Manager's Responsibilities	p. 240
Responsibilities of Individual Members of Staff	p. 240
References	p. 241
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
Table of Contents provided by Ingram. All Rights Reserved.

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Quality Assurance in Analytical Chemistry

Summary

Author Biography

Table of Contents

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