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xii a second edition might be in order, and readily agreed. Although the basic principles remain the same, discussions with analysts, laboratory supervisors, and managers indicated many areas where improve ments could be made. For example, new chapters have been added on sampling and quality assurance; laboratory facilities and quality assurance; and auditing for quality assurance. Very little of the first edition has been discarded, but many topics have been expanded considerably. The chapter on computers has been completely rewritten in view of the rapid changes in that field. The chapter in the first edition on planning and organizing for quality assurance has been split into two chapters, one on planning for quality assurance and the other on organizing and establishing a quality assurance program, and new material on mandated quality assurance programs has been combined with the material on laboratory accreditation. Numerous examples, especially those involving mathematical calculations, have been added at the suggestion of some readers. In short, this edition is very nearly a new book, and I can only hope it is as well received as the first edition. CHAPTER 1 Qual ity, Qual ity Control, and Quality Assurance One of the strongest trends in modem society is the continuing ev olution from a manufacturing to a service-oriented economy.
List of contents
1. Quality, Quality Control, and Quality Assurance.- Quality.- Quality Control.- Quality Assurance.- Quality Assurance and Laboratory Management.- 2. Error and Elementary Statistics.- Error.- Statistics.- 3. Statistical Quality Control Techniques.- Control Charting.- Blind Samples.- Performance Evaluation Samples.- 4. Sampling and Quality Assurance.- Sampling Plans.- Documentation for Quality Assurance.- 5. Analytical Methods.- Sources of Analytical Methods.- Evaluation of Analytical Methods.- Writing Analytical Methods.- Authorization of Analytical Methods.- 6. Quality Assurance and Instruments, Equipment and Materials.- Instruments and Equipment.- Materials.- 7. Documentation for Quality Assurance.- General Principles.- Data Acquisition.- Analytical Methods.- Sampling and Sample Handling.- Instrument Calibration and Maintenance.- Reagents and Reagent Solutions.- Personnel Training Records.- Analytical Reports.- Filing Quality Assurance Documentation.- 8. Organizing for Quality Assurance.- Management Commitment.- The Quality Assurance Officer.- Responsibility for Quality Assurance.- Motivating Personnel for Quality Assurance.- 9. Establishing a Quality Assurance Program.- Defining the Quality Assurance Program.- The Written Program.- Standard Operating Procedures.- Consolidating the Program.- Monitoring and Evaluating the Program.- Writing the Quality Assurance Manual.- 10. Quality Assurance Auditing.- Internal Audits.- External Audits.- 11. Laboratory Facilities and Quality Assurance.- General Requirements.- Sample-Handling Facilities.- Glassware-Cleaning Facilities.- Archives.- 12. Computers and Quality Assurance.- Laboratory Information Management System.- Laboratory Robotics.- 13. Mandated Quality Assurance Programs and Laboratory Accreditation.- The Good Laboratory Practices.- Other Mandated Quality Assurance Programs.- Laboratory Accreditation.- Additional Readings.
