Abstract
The process for implementing Total Quality is circular. It involves planning, execution of the plan, evaluation of how well the plan worked, the incorporation of improved processes into the new plan, and so on. In an ideal quality world, problems in the conduct of any toxicology study would always be identified and evaluated at the end of a study. At this time, the quality of the study could be evaluated in a relaxed and reflective manner through such measures as the number and nature of protocol amendments required, the number of raw data edits required, the time required by the QAU to inspect and audit all aspects of the study, the sponsor's review comments, and whether or not the project was successfully incorporated into an NDA or other regulatory package. Improvements in process could be discussed in detail with all team members, and staff could be thoroughly educated in the new approaches before a new study commenced. In the real world of regulated toxicology research, it is necessary to evaluate study quality on an ongoing basis and to incorporate improvements in the study process in a piecemeal fashion while meeting all other study requirements and timelines. Thus, improving the study process is a more complicated undertaking than the total quality cycle would suggest. It must occur both during and at the conclusion of a study.