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Matteo Bernasconi
Title
M.A. HSG
Last Name
Bernasconi
First name
Matteo
Email
matteo.bernasconi@unisg.ch
ORCID
Phone
+41 71 224 72 71
Now showing
1 - 9 of 9
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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.Type: journal articleJournal: American Pharmaceutical ReviewVolume: 26Issue: 2
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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)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.Type: journal articleJournal: International Journal of Industrial and Manufacturing EngineeringVolume: 17Issue: 2
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PublicationBenchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain Resilience(Springer, 2022)
;Fellows, Matt ;Li, Ye ;Maguire, Jennifer ;Rakala, Nandini ;Ritz, Marten ;Seiss, Mark ;Stiber, Neil ;Swatek, MatViehmann, AlexType: journal articleJournal: AAPS JournalVolume: 24Issue: 6 -
PublicationHolistic Risk-Based Site Surveillance – A Data-Based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical IndustryType: journal articleJournal: Level 3Volume: 16Issue: 1
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PublicationInvestigating the role of digitalization in operational excellence programs - a case study from the pharmaceuitcal industryFor 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).Type: conference paperJournal: 4th Conference on Production Systems and Logistics
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PublicationA Holistic View On Production Systems Management( 2022)Type: conference paperJournal: 3rd Conference on Production Systems and Logistics
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PublicationLearn from your Metrics - Using Operational Data to Improve Operations in Pharmaceutical Manufacturing and QC Labs(Pharma Focus Asia, 2022)
;Ritz, MartenType: newspaper articleJournal: Pharma Focus AsiaIssue: 48 -
PublicationThe Link between Plant Performance & Maturity - Seeing the whole pictureType: newspaper articleJournal: Pharma Focus AsiaIssue: 45
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PublicationPredicting Quality Risks in Pharmaceutical Production Incorporating Internal and External SignalsQuality 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.Type: newspaper articleJournal: Pharma Focus AsiaIssue: 44