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Quality Assurance in Analytical Chemistry

ISBN: 978-0-470-01203-1
316 pages
October 2007
Quality Assurance in Analytical Chemistry (047001203X) cover image
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.

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Preface.

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.

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Elizabeth Prichard, B.Sc., Ph.D., FRSC, CChem.

Elizabeth Prichard obtained a first degree in Chemistry from the University College 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 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.

In 1992, Elizabeth was seconded from the University of Warwick to the Laboratory of the Government Chemist (which became LGC in 1996) to manage the production of the first edition of this book which was part of the ACOL Series. Elizabeth had been an editor for this series since its inception in the late 1980s. In 1997, Elizabeth joined the staff of LGC as Head of Education and Training. She developed there a Quality Assurance Training Programme and continues to deliver these courses. As part of the Valid Analytical Measurement (VAM) programme, she also developed courses in analytical science appropriate for A-level chemistry teachers and a Proficiency Testing (PT) competition for the students. She has been involved in the production of a number of quality assurance products for all levels of learning from school to the professional analyst, including books, videos, CDs and web-based e-learning material. In addition, Elizabeth has been a partner in EU projects in the area of quality assurance – these include the QUACHA and SWIFT-WFD projects.

During the last fifteen years, Elizabeth has lectured and delivered training courses on quality assurance topics in the UK, Europe and USA.

Vicki Barwick, B.Sc

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 colourants 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 DTIfunded Valid Analytical Measurement (VAM) programme. In this role, she was responsible for providing advice and developing guidance on method validation, measurement uncertainty and statistics. One of her key projects involved the development of approaches for evaluating the uncertainty in results obtained from 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.

In 2002, Vicki moved into a full-time education and training role at LGC. She is currently the Project Manager for VAM knowledge transfer projects aimed at promoting the adoption of the principles of valid analytical measurement. This involves the production of training resources and the organization of workshops for A-level students and their teachers, undergraduate and postgraduate students, and professional analysts. Vicki is also responsible for the development and delivery of LGC’s Quality Assurance Training Courses.

Over the last ten years, Vicki has lectured extensively on quality assurance topics and has co-authored a number of papers, books and guides.

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  • Covers the whole analytical process from commissioning the analysis to delivering the results
  • Introductory text with little prior knowledge of QA and QC assumed/required
  • Self-paced learning text
  • QA and QC for a laboratory with routine and/or research activities
  • Coverage of management and technical requirements
  • Simple language with rigorous use of terminology.
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"An excellent open learning text … .Everyone will learn something from this book and I recommend it to anyone involved in analytical chemistry from junior laboratory technician to UKAS assessor." (The Higher Education Academy Physical Sciences Centre, June 2008)

"The benefit of this book is the comprehensive and up to date approach to the topic is reliability in analytical measurements." (Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement, August 2008)

"Offers analysts a new learning route to achieving the quality objectives in their work." (International Journal of Environmental and Analytical Chemistry, 2008)

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