Development of Quality Management at the Medical Products Agency in Sweden

Abstract

In order to develop the Medical Products Agency (MPA) as a highly competent drug regulatory agency, different kinds of quality systems have been studied such as ISO 9000 and the Swedish Quality Award, as well as various systems for total quality management. The decision has been made not to follow one single system but to choose the best and most important parts from each of several systems. One management tool for operational planning and controlling has already been implemented. This system includes 10 steps: analysis of the environment, intention, strategies, short- and long-term objectives, activities, personnel analysis, development plans, organization, and reports.

Continuous quality improvement requires that different categories of managers and personnel interact and integrate their knowledge and experiences. To achieve this, the MPA has started continuous education programs for the entire staff concerning MPA's objectives and priorities and ways of responding to customers' needs. The education program for executive leaders also includes strategic planning and leadership. The MPA strives for individual development plans for all employees in accordance with its objective. These plans are established in annual discussions between each employee and his/her closest manager. The goal is to create a learning organization with continuous and open two-way communication that should result in even more motivated and committed personnel.

As of July 1, 1993 the MPA has a new organizational structure with units that integrate different disciplines. Special managers have been assigned responsibility for quality assurance and competence development within each discipline. A quality assurance group, with representatives from each discipline, has been introduced for interdisciplinary quality assurance.

Time based management (TBM) projects intended to improve and speed up administrative procedures, have been started. The aim is to involve all personnel in quality development. The front line personnel have already suggested simplifications and improvements in some of the routines. Concomitantly, the computer-based information system is being improved to simplify administrative routines and to allow various applications to be continously followed during processing. Customers and stakeholders as well as the government authorities will be continuously informed about quality developments to assure mutual compliance.