Abstract
The dictum that “there is no quality if it cannot be measured” has now reached research and development (R&D) within the pharmaceutical industry. Managers are looking to total quality management (TQM) as a means of meeting their goals of improving performance and competitiveness. Quality indicators play an important part in TQM; they are seen as a vital management tool for tracking progress toward these goals. It is, of course, important to select pertinent indicators which can be validated and which are easy to use.
This paper outlines one approach to the measurement of quality. It was developed in the context of nonclinical biomedical research, but can be readily transposed to a manufacturing environment or to clinical studies. The method uses an ensemble of classical tools to gather information and to analyze the results. Tracking quality levels by using indicators has a triple benefit:
To keep management informed about trends (particularly useful during the implementation phase of a new structure, organization, or procedure), To fix priorities based on quantitative information, and To assess the impact of management decisions.
Thus, the use of quality indicators has a real place in the decision making process and in the motivation of staff. Both these elements are essential to achieve an appropriate level of quality.
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