Quality Assurance in Analytical ChemistryISBN: 978-0-470-01203-1
Hardcover
316 pages
October 2007
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Acknowledgements.
Abbreviations, Acronyms and Symbols.
1.2 Social and Economic Impact of a Wrong Analysis.
1.3 What do We Mean by Quality.
1.4 Customer Requirements.
1.5 Purpose of Analysis.
References.
2.2 Quality Management System, Quality Assurance and Quality Control.
2.3 Different Standards and their Main Features.
2.3.2 Features of ISO 9001:2000.
2.3.3 Features of ISO/IEC 17025: 2005.
2.3.4 Features of ISO 15189: 2003.
2.3.5 Good Laboratory Practice (GLP).
2.4 Best Practice.
References.
3.2 Types of Samples.
3.2.2 Selective Sample.
3.2.3 Random Sample.
3.2.4 Composite Sample.
3.3 The Sampling Plan.
3.3.2 Types of Sampling.
3.4 Sample Numbers and Sample Size.
3.4.2 Number of Primary Samples.
3.5 Subsampling.
3.6 Sample Handling and Storage.
References.
4.2 Sources of Methods.
4.3 Factors to Consider when Selecting a Method.
4.3.2 Precision.
4.3.3 Bias/Recovery.
4.3.4 Accuracy.
4.3.5 Time.
4.3.6 Equipment Required.
4.3.7 Sample Size.
4.3.8 Cost.
4.3.9 Safety.
4.3.10 Selectivity.
4.3.11 Making your Choice.
4.4 Performance Criteria for Methods Used.
4.5 Reasons for Incorrect Analytical Results.
4.5.2 Method Used.
4.5.3 Contamination.
4.5.4 Interferences.
4.5.5 Losses and/or Degradation.
4.6 Method Validation.
4.6.2 Precision.
4.6.3 Bias/Trueness.
4.6.4 Measurement Range, Limit of Detection and Limit of Quantitation.
4.6.5 Ruggedness Testing.
4.6.6 Sign-off and Documentation.
References.
5.1.2 During the Analysis.
5.1.3 After the Analysis.
5.2 Calibration of Measurement.
5.3 Achieving Metrological Traceability.
5.3.2 Chemical Standards.
5.4 Quality Control.
5.4.2 Quality Control Samples.
5.4.3 Repeat Samples.
5.4.4 Blind Samples.
5.4.5 Chemical Standards and Spikes.
5.5 Environment.
5.5.2 Laboratory Design.
5.5.3 Siting of Instruments.
5.5.4 Monitoring Changes.
5.6 Equipment and Glassware.
5.6.2 Suitability.
5.6.3 Equipment Qualification.
5.6.4 Cleaning.
5.6.5 Drying.
5.7 Chemicals and Consumables.
5.7.2 Labelling.
5.7.3 Preparation.
5.7.4 Manipulation.
5.7.5 Containers.
5.7.6 Storage.
5.7.7 Safety.
5.7.8 Disposal.
5.8 Maintenance and Calibration of Equipment.
References.
6.1.2 Describing Distributions of Data.
6.1.3 Essential Calculations.
6.2 Control charts.
6.2.2 Moving Average Chart.
6.2.3 CUSUM Charts.
6.2.4 Range Charts.
6.3 Measurement Uncertainty.
6.3.2 Definition of Uncertainty.
6.3.3 Errors.
6.3.4 Precision, Bias and Accuracy.
6.3.5 Evaluating Uncertainty.
6.3.6 Expanded Uncertainty.
6.3.7 Putting Uncertainty to Use
References.
7.2 Organization of Proficiency Testing Schemes.
7.3 The Statistics Used in Proficiency Testing Schemes.
7.3.2 The Target Range.
7.3.3 Performance Measures.
7.3.4 Combination of z-Scores.
7.3.5 Interpretation of Performance Scores.
7.3.6 Robust Statistics.
7.4 Making the Most of Participation in Proficiency Testing Schemes.
7.5 Collaborative Studies.
References.
8.1.2 Supporting Documentation.
8.1.3 Record Management.
8.1.4 Records.
8.1.5 Generating Records.
8.1.6 Record Identification.
8.1.7 Document and Record Control.
8.1.8 Reporting Results.
8.1.9 Copying Records.
8.1.10 Storing and Archiving Records.
8.2 Opinions and Interpretations.
8.2.2 Accreditation of Opinions and Interpretations.
References.
9.1.2 Types of Management Standards for Laboratories.
9.2 Standards Available for Laboratories.
9.2.2 ISO/IEC 17025 Requirements.
9.2.3 ISO 9001 Requirements.
9.3 Quality Manual and Other Documentation.
9.4 Audit.
9.4.2 Planning of Internal Quality Audits.
9.4.3 Training of Auditors.
9.4.4 Conduct of Internal Quality Audits.
9.4.5 Coverage of Internal Quality Audits.
9.4.6 The ‘Vertical Audit’.
9.4.7 Types of Nonconforming Work.
9.5 Management Review.
9.6 Responsibilities of Laboratory Staff for Quality.
9.6.2 The Quality Manager’s Responsibilities.
9.6.3 Responsibilities of Individual Members of Staff.
References.
Bibliography.
Responses to Self Assessment Questions.
Glossary of terms.
Appendix: Critical values for Student t tests.
Index.
