Abstract
The scope of this presentation is to discuss why a Total Quality System is a fundamental and essential entity of the scientific planning, conduct, reporting, and overall management of a research study or program. Inclusive of a total quality system is the partnership realized between science and compliance both from the end product perspective, e.g., meeting testing guidelines/standards, IND and NDA requirements, as well as administrative or regulatory perspective e.g., GLPs, GMPs, or the various clinical regulations/standards. AH study participants interact continually as customers and suppliers and as such must know the requirements of others. The roles often change during this process so communication is key to keeping this conduit open and productive. If, however, interaction is minimal or nonexistent and individuals work in isolation, this will be perceived as an antagonistic and even adversarial state. In the latter, problems which evolve will not be resolved but will manifest themselves in another form. Rarely is the cause of the problem brought to the surface. In this situation, the process still has flaws and the individuals involved feel frustrated, because they were never considered as an integral part of the solution; some may not feel part of the process. This process exists because of the adversarial relationship created and, therefore, someone has to win when, in fact, everyone loses. The cost of rework is also a major consideration since this is an add on to the product or service with no value added. In this scenario this is always a given. A total quality program builds personnel interaction and management involvement into the process; stresses continual communication, and, assures that all requirements are clear and are in harmony with the common goal. For a TQM program to be successful, it must be driven from the top down with all individuals completely involved in the process. Only when science and compliance are in harmony can total quality be achieved.