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PublicationShaping the Future of Pharmaceutical Manufacturing Quality: From Quality Metrics to Quality Management Maturity and BeyondQuality excellence is a key factor in pharmaceutical manufacturing that differentiates the high performers from the less successful companies. Quality Metrics research identified that ‘high performer’ manufacturing plants excel for most Pharmaceutical Quality System (PQS) effectiveness metrics, achieve this with lower inventory levels, all while handling more Stock Keeping Units (SKUs).6 On the other hand, the research also confirms that manufacturing plants with low PQS excellence, report a higher share of indirect QA/QC labor full time equivalents (FTEs), in response to underlying operational stability problems. Quality Excellence is described as an advanced approach to quality which goes beyond merely being compliant with regulations. Quality excellence is patient-driven, culturally embedded and built into the processes and behavior of an organization. This article provides an overview of quality metrics research undertaken by the authors on behalf of FDA and the development of a machine learning based, predictive risk surveillance model.
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PublicationThe Role of Social and Technical Lean Implementation in Improving Operational Performance: Insights from the Pharmaceutical Industry(World Academy of Science, Engineering and Technology, 2023)
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PublicationThe role of management in lean implementation: evidence from the pharmaceutical industry(Emerald, 2023-03-06)Purpose – The purpose of this study is to investigate how soft lean practices moderate the performance effects of hard lean practices. The authors provide new evidence from the pharmaceutical industry, which is characterized by a highly regulated and technical environment and has been largely uncharted in the lean literature. Design/methodology/approach – Based on a review of the literature, the authors define a set of soft and hard lean practices. The authors test the hypotheses using factor analysis and moderated hierarchical linear regression on a unique dataset containing survey data and real performance measures of 351 pharmaceutical plants. Findings – The results show that soft lean practices can be both enabling and constraining. When management engages in performance measurement, visualisation and employee empowerment the relationship between hard lean practices and performance is positively moderated. On the other hand, when managers emphasise goal setting and work standardisation the performance outcomes are reduced.Type:Journal:Volume:Issue:
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PublicationEnttäuschende Nachfrage nach Energiespar-Innovationen.(Staatssekretariat für Wirtschaft (Seco), 2023-06-20)Type:Journal:Volume:Issue:
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PublicationEnergieeffizienz als Geschäftschance für den Maschinen- und Anlagenbau?( 2023)
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PublicationScaling Digital Solutions in Healthcare: Paradoxical Tensions in Provider – Customer Relations and Coping Strategies(IEEE, 2023-10-18)An aging population, a lack of qualified medical staff, and rising costs in the healthcare sector pose major challenges to many societies. Implementing digital solutions in hospitals is a promising response to these challenges without compromising the quality of patient care. Nevertheless, the adoption of digital solutions in the healthcare environment is progressing more slowly than might be desirable. Adopting a paradox perspective, we study tensions in the relationship between the providers of digital solutions and hospitals (their customers) that can explain the slow uptake. Drawing on 39 interviews, our findings reveal nine tensions related to the three dimensions of a business model (value proposition; value creation and delivery; value capture). We also identify four coping strategies that allow solution providers to deal with these tensions, especially when building digital solutions in new ecosystems. The strategies to cope with paradoxical ten sions in interorganizational relationships include accommodation, avoidance, concession, and confrontation.
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PublicationQuality of Pharmaceuticals and Outsourcing / Understanding the Inherent Risks to the Patient – Part 1(Editio-Cantor-Verl. für Medizin und Naturwiss., 2022)This article provides a comprehensive overview of outsourcing in pharmaceutical manufacturing. It discusses the motivation of the industry to leverage outsourcing advanteages, especially to China and India, but also related disadvantages. Key facts about quality issues related to outsourcing are outlined with examples. The increasing complexity of pharmaceutical manufacturing supply chains an an aggravated oversight of suppliers with the loose of control are just one explanation for that. Furthermore, the article describes how outsourcing impacts quality risks and draws on examples from the past. To mitigate these, practical advice for supplier due diligence, contractor selection and assessment process, and how to achieve operational excellence in outsourcing and internal manufacturing is drawn from a cost and risk perspective.Type:Journal:Volume:Issue:
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PublicationQuality of Pharmaceuticals and Outsourcing / Understanding the Inherent Risks to the Patient – Part 2(Editio-Cantor-Verl. für Medizin und Naturwiss., 2022)Type:Journal:Volume:Issue:
