The Utilization of Quality KPIs in the Pharmaceutical Industry

• Published in: Journal of pharmaceutical innovation Vol. 9; no. 3; pp. 175 - 182
• Main Authors: Torkko, Marianne, Katajavuori, Nina, Linna, Anu, Juppo, Anne Mari
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.09.2014
• Subjects: Biochemical Engineering; Biomedical and Life Sciences; Biomedicine; Biotechnology; Case Report; Industrial and Production Engineering; Pharmacology/Toxicology; Quality KPI; Pharmaceutical industry; Lean practices; Quality indicator
• ISSN: 1872-5120; 1939-8042
• DOI: 10.1007/s12247-014-9184-3

Purpose The overall aim of this study was to investigate the significance of quality key performance indicators (KPIs) and how comprehensively they are used in the pharmaceutical industry. A specific aim was to find which KPIs were relevant to personnel from the perspective of their own work responsibilities. A further aim was to determine which factors motivate personnel enough to respond to improve KPIs. Methods Qualitative theme interviews of ten staff from one case company were conducted to study the impact of KPIs. Interview data were analyzed using qualitative content analysis and reductive analysis. Results Personnel considered deviations in manufacturing and packaging to be the most important quality KPI when they considered their own work responsibilities. The quality indicators data were utilized quite efficiently, for example, in complaint and deviation handling processes, and they provided useful information for corrective and preventive actions (CAPA)-reporting. The most important factors that motivated supervisors, managers, and experts regarding KPIs were those that affected interviewees own particular work responsibilities, the cooperation within the operators own departments, and the cooperation between different departments. The interviewees opined that the production bonus was the most important motivational factor for production operators to improve upon quality indicator performance. Conclusions Quality indicator feedback data were utilized widely by the case company and were considered to be a useful tool to guide personnel in ensuring or potentially improving the quality of operations.