Laboratory Quality Assurance

Abstract

For over a century, AOAC INTERNATIONAL has provided the methods of analysis required for the measurement of analytes of interest to those government agencies that regulate products associated with agriculture, public health, and the environment.But during the past several decades, analysts realized that providing measurements based on methods validated and approved through collaborative study was not enough.Analytical results had to be accompanied by concurrent proof that the measurements were correct.That proof could be obtained by the application of the concepts of quality assurance, long used in the industrial world, to analytical measurements. Scope of Laboratory Quality AssuranceA good analytical method is necessary to obtain valid concentration estimates, but it is not su cient.The laboratory equipment must be running in accord with speci cations.Analysts must be performing their work in a professional manner, and a suitable checking process must be in operation to ensure the quality of analytical results.The primary reason for performing laboratory analyses is to obtain information that can be used to make informed decisions.Analytical data reported by a laboratory must be t for its intended purpose and of a su cient degree of quality, whether the purpose is to enforce standards, determine economic value, or protect the public health.Data must be comparable to those generated in other laboratories.It is no longer su cient for a laboratory simply to believe or maintain that it is generating quality data.Laboratories must be able to demonstrate that their analyses are correct and in statistical control.Proof of technical competency and comparability is now a requirement in the global marketplace.AOAC O cial Methods are designed for the measurement of speci c analytes in de ned matrixes.An approved AOAC method has been demonstrated to produce reliable results when applied by a representative sample of laboratories expected to use it in practice.Nevertheless, whenever the method is applied subsequently, each user laboratory must demonstrate that it can produce results comparable to those attained in the original interlaboratory study.This demonstration is necessary when a laboratory analyzes

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