Matteo Bernasconi

Quality 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.

The objective of this paper is to examine the relationships between technical and social lean bundles as well as operational performance in the context of the pharmaceutical industry. We investigate the direct and mediating effects of the lean bundles Total Productive Maintenance (TPM), Total Quality Management (TQM), Just-In-Time (JIT), and Human Resource Management(HRM) on operational performance. Our analysis relies on 113 manufacturing facilities from the St.Gallen OPEX benchmarking database. The results show that HRM has a positive indirect effect on operational performance mediated by the technical lean bundles.

For years, manufacturing companies have been implementing Operational Excellence (OPEX) programs with the goal of effectively and sustainably improving their performance. Now, companies are also gradually recognizing the possibilities of Digitalization for advancing their operational processes. Even though both OPEX and Digitalization are directed towards the same goal of improved operational performance, there is neither an answer in research nor in practice on how they are or can be interlinked. That is, how processes and the organization to align and reconcile should look like? To address this question, we conducted 25 interviews with pharmaceutical companies. Thereby we interviewed corporate OPEX functions and Digitalization experts over a timespan of three years. That way we also examine whether companies have adapted and investigate patterns in their development. Our findings acknowledge that pharmaceutical companies aim to exploit synergies between OPEX and Digitalization for achieving higher operational performance. We further applied a dynamic capabilities perspective to identify how companies align OPEX and Digitalization. Our limitation is that we conducted interviews only within the Pharmaceutical Industry and that each company is unevenly reflected over the duration of the investigation. However, we mitigate that limitation by considering a rather large number of cases reflected in a sample size (16 companies) with a good balance of different company sizes (2.000 –110.000 employees) and business areas (generics, labelled, and contract manufacturing).

Quality risk management plays a key role within pharmaceutical production. Being able to predict quality issues and proactively maintain regulatory compliance prevents production downtimes and disruptions of medicine supply. This article outlines a comprehensive approach how to address and predict quality risks by utilising internal and external metrics.