Book reviews

Abstract

This forms an excellent bible for a quality assurance programme in a modern laboratory. It gives a simple start up for laboratories wishing to aim for accreditation in, for example, BS 5750 and also for laboratories aiming for an FDA approval. Having a well-defined layout it is very simple to locate any section as required.Chapter one concerns itself with QA and planning. I think the most important section is the evaluation of costs and benefits. This ensures that senior managemnent can readily see cash savings.The QA manual ensures that written procedures are both implemented and adhered to. At the moment there is no standard format. However, as pointed out, a company must treat the manual with a profile status that it deserves.Chapter two is devoted to statistics and control charts. Placing it as such leaves the company with the choice of taking as little o r as much of a statistical approach as is needed or required.Chapter three deals with personnel considerations. This format ensures that a value is there for everybody, be it from the laboratory manager or director down to the most junior of non-supervisory staff. An important section is self evaluation, as I feel that this is of paramount importance to every employee.Chapter four is devoted to equipment and supplies. It points out the necessity to implement service contracts when purchasing equipment. Many auditors now insist on seeing that regular servicing by competent people is carried out. The section on standards and standard solutions stresses the necessity to formalize both the purchase and use of such.Chapter five pulls together the need for sample and record handling. This ensures total traceability of all data including raw data. It also ensures the safe storage of any sample as required by the quality manual.