The Utilization of Quality KPIs in the Pharmaceutical Industry

PurposeThe 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.MethodsQualitative 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.ResultsPersonnel 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.ConclusionsQuality 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.

[1]  T. Melton,et al.  The Benefits of Lean Manufacturing: What Lean Thinking has to Offer the Process Industries , 2005 .

[2]  Tom DeWit Lean Techniques: The QC Lab can Reduce Product Lead Times , 2011 .

[3]  Andy Neely,et al.  The success and failure of performance measurement initiatives: Perceptions of participating managers , 2002 .

[4]  Jiju Antony,et al.  Key ingredients for the effective implementation of Six Sigma program , 2002 .

[5]  Nasreddin Dhafr,et al.  Establishing and improving manufacturing performance measures , 2002 .

[6]  Damian George,et al.  Improvement of manufacturing operations at a pharmaceutical company , 2011 .

[7]  James P. Womack,et al.  Lean Thinking: Banish Waste and Create Wealth in Your Corporation , 1996 .

[8]  M. Patton,et al.  Qualitative evaluation and research methods , 1992 .

[9]  Brian H. Maskell,et al.  Performance Measurement for World Class Manufacturing: A Model for American Companies , 1991 .

[10]  Shirley Blenkinsop,et al.  The road to continuous improvement , 1991 .

[11]  A. Gunasekaran,et al.  Performance measures and metrics in a supply chain environment , 2001 .

[12]  Thomas Friedli,et al.  Analysis of the Implementation of Total Productive Maintenance, Total Quality Management, and Just-In-Time in Pharmaceutical Manufacturing , 2010, Journal of Pharmaceutical Innovation.

[13]  M. Patton Qualitative evaluation and research methods, 2nd ed. , 1990 .

[14]  A. Juppo,et al.  Quality KPIs in Pharmaceutical and Food Industry , 2013, Journal of Pharmaceutical Innovation.