Operational Excellence across Manufacturing and Quality Control - A Guideline to Avoid Optimizing Silos in Pharmaceutical Production

Producing pharmaceutical goods is associated with numerous challenges nowadays: Steady drug shortages and product recalls go along with increasing regulatory requirements. Manufacturers are persistently forced to enhance effectiveness of their operations. At the same time, emerging global competition and tremendous price pressure from healthcare systems cause a strong need to increase efficiency. Initial research shows that there seems to be no correlation between effectiveness in manufacturing operations and quality control of production sites. Applying the principles of Lean Management and Continuous Improvement to steer plants in the direction of becoming best in class is not new to pharma. However, the industry is lacking a comprehensive strategy along the value chain. Instead, empirically observable performance patterns lead to the assumption of optimized silos as a consequence of departmental improvement initiatives. Operational Excellence is a management philosophy that paves the way to achieve superior performance by optimizing quality, delivery, and cost in a well-balanced manner. Additionally, it aims to introduce practices and deploy capabilities which enable an organization to continuously improve itself. The present thesis develops a management guideline to comprehensively approach Operational Excellence across pharmaceutical manufacturing and quality control. Thereby, it demonstrates the potential of interdepartmental alignment to conjointly improve effectiveness, efficiency, and compliance throughout production facilities. The manifoldness of the research subject motivates a mixed-methods approach combining quantitative and qualitative techniques. Underpinned by the theoretical understanding of contingencies, constraints, and dynamic capabilities, an iterative research procedure is pursued. Three core research phases mutually stimulate each other: The studies start by deeply investigating the interrelation of performance between manufacturing and quality control based on benchmarking data. Furthermore, recommendations for managing capabilities across departments are drawn from literature revealing powerful levers beyond the current standard in the pharmaceutical industry. On top of that, proven successful practices applied by leading pharmaceutical companies are uncovered through a survey and subsequently detailed in individual case studies. Concludingly, implications are compiled and transferred into an actionable format. All findings add up to the overarching management guideline, which comes with specific instructions for implementation. This dissertation makes an impact in practice and addresses an existing gap in theory at the same time. It enriches the current state of research with an object of consideration not priorly explored by scholars and unleashes improvement potentials in the industry. The findings constitute tangible benefits to the scientific community, pharmaceutical manufacturers, regulators, and patients.

Producing pharmaceutical goods is associated with numerous challenges nowadays: Steady drug shortages and product recalls go along with increasing regulatory requirements. Manufacturers are persistently forced to enhance effectiveness of their operations. At the same time, emerging global competition and tremendous price pressure from healthcare systems cause a strong need to increase efficiency. Initial research shows that there seems to be no correlation between effectiveness in manufacturing operations and quality control of production sites. Applying the principles of Lean Management and Continuous Improvement to steer plants in the direction of becoming best in class is not new to pharma. However, the industry is lacking a comprehensive strategy along the value chain. Instead, empirically observable performance patterns lead to the assumption of optimized silos as a consequence of departmental improvement initiatives. Operational Excellence is a management philosophy that paves the way to achieve superior performance by optimizing quality, delivery, and cost in a well-balanced manner. Additionally, it aims to introduce practices and deploy capabilities which enable an organization to continuously improve itself. The present thesis develops a management guideline to comprehensively approach Operational Excellence across pharmaceutical manufacturing and quality control. Thereby, it demonstrates the potential of interdepartmental alignment to conjointly improve effectiveness, efficiency, and compliance throughout production facilities. The manifoldness of the research subject motivates a mixed-methods approach combining quantitative and qualitative techniques. Underpinned by the theoretical understanding of contingencies, constraints, and dynamic capabilities, an iterative research procedure is pursued. Three core research phases mutually stimulate each other: The studies start by deeply investigating the interrelation of performance between manufacturing and quality control based on benchmarking data. Furthermore, recommendations for managing capabilities across departments are drawn from literature revealing powerful levers beyond the current standard in the pharmaceutical industry. On top of that, proven successful practices applied by leading pharmaceutical companies are uncovered through a survey and subsequently detailed in individual case studies. Concludingly, implications are compiled and transferred into an actionable format. All findings add up to the overarching management guideline, which comes with specific instructions for implementation. This dissertation makes an impact in practice and addresses an existing gap in theory at the same time. It enriches the current state of research with an object of consideration not priorly explored by scholars and unleashes improvement potentials in the industry. The findings constitute tangible benefits to the scientific community, pharmaceutical manufacturers, regulators, and patients.