Guidelines for Quality Assurance To order this title, and for more information, click here
Edited By N.F. Lightfoot, Public Health Laboratory Service, Newcastle upon Tyne, UK E.A. Maier, European Commission, Brussels, Belgium
Description With the help of leading Quality Assurance (QA) and Quality Control (QC) microbiology specialists in Europe, a complete set of guidelines
on how to start and implement a quality system in a microbiological laboratory has been prepared, supported by the European Commission
through the Measurement and Testing Programme. The working group included food and water microbiologists from various testing laboratories,
universities and industry, as well as statisticians and QA and QC specialists in chemistry.
This book contains the outcome of their
work. It has been written with the express objective of using simple but accurate wording so as to be accessible to all microbiology
laboratory staff. To facilitate reading, the more specialized items, in particular some statistical treatments, have been added as an
annex to the book. All QA and QC tools mentioned within these guidelines have been developed and applied by the authors in their own
laboratories. All aspects dealing with reference materials and interlaboratory studies have been taken in a large part from the projects
conducted within the BCR and Measurement and Testing Programmes of the European Commission.
With so many different quality control
procedures, their introduction in a laboratory would appear to be a formidable task. The authors recognize that each laboratory manager
will choose the most appropriate procedures, depending on the type and size of the laboratory in question. Accreditation bodies will
not expect the introduction of all measures, only those that are appropriate for a particular laboratory.
Features of this
book:
• Gives all quality assurance and control measures to be taken, from sampling to expression of results
•
Provides practical aspects of quality control to be applied both for the analyst and top management
• Describes the use of reference
materials for statistical control of methods and use of certified reference materials (including statistical tools).
Contents
1. Scope and Purpose . Introduction. Implications of incorrect results. Quality assurance. Types of laboratories. Elements
of a quality assurance programme. Accreditation. Benefits of a quality assurance programme.
2. Implementation of Quality Assurance
Programmes . Introduction. Personnel. Media. Methods. Equipment. Sample handling. Data handling. Quality control systems. Follow-up.
3. People, Management and Organization . Introduction. People. Laboratory accommodation and environment. Safety. Working
procedures. Communication and customer relations. Complaints management.
4. Sampling . Introduction. Distribution of
organisms in food and water. Sampling plans. Food. Water. Sample records. Sampler training. Sample transport. Sample reception. Summary.
5. Equipment Introduction. Types of sterilization apparatus. Steam sterilization. Media preparator. Pressure cooker.
Hot-air sterilizers (dry sterilization). Filter sterilization. Membrane filtration apparatus. Incubators. Water baths. Microwaves. Thermometers.
pH meters. Balances. Deionizing and distillation apparatus. Cold storage. Anaerobic incubation. Colony counters. Microscopes. ELISA plate
readers and plate washers. List of equipment and technical specifications.
6. Materials . Introduction. Sample bottles
and containers. Laboratory glassware. Pipettes. Petri dishes. Metal utensils. Tubes and closures. Membrane filters. Pads. Deionized/distilled
water. Culture media and chemicals.
7. Quantitative Method and Procedure Assessment . Introduction. Principles of microbiological
measurements of water and food. Standardization and validation. Mathematical and technical characteristics of microbiological methods.
Selective methods. Comparison and validation of presence/absence tests. Quantitative expression and estimation of uncertainty in microbiological
methods. Experimental designs for comparing colony count methods.
8. Analytical Quality Control in Microbiology . Introduction.
First-line checks. Second-line checks.
9. Handling and Reporting Results . Introduction. Samples organized or requested
internally. Samples submitted to the laboratory. Examples of request forms and report forms.
10. Accreditation . Introduction.
International aspects of accreditation. The European single market. National accreditation organizations. Accreditation requirements.
Achieving accreditation.
Annex. Statistics for Quality Assurance in Food and Water Microbiology . Some basic calculations.
Some basic distributions. Confidence intervals. Statistical tests. Analysis of variance.
Appendix A. Example of a membrane
filter test, with statistical evaluation.
Appendix B. Preparation of test sample for first-level quality control of
plate and membrane filter counts, with statistical evaluation.
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