Defining the Critical Phase
Quality does not mean compliance with a checklist of standards but rather “fitness for use.” Compliance with a checklist of standards will only assure quality if the standards specifically address the intended use of the final results. In the design of a quality assurance program, the emphasis is upon quality controls and monitoring schedules for those aspects of the study that significantly alter the variability of the final results and alter the variability to the extent that the final results are no longer useful. Therefore, the principal researcher in conjunction with the quality assurance staff contribute to the quality of a study by applying combined expertise in the design of specific reference standards that both address the fitness for use criterion and the more comprehensive government standards.