Matteo Bernasconi
Title
Dr.
Last Name
Bernasconi
First name
Matteo
Email
matteo.bernasconi@unisg.ch
ORCID
Phone
+41 71 224 72 71
24 results
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Item type:Publication, The Impact of Current Good Manufacturing Practices Inspections on Continuous Improvement Mindset in the Pharmaceutical Industry(Springer Science and Business Media LLC, 2025-10-29); ; Oliver von DzengelevskiPurpose Regulatory inspections ensure consumer safety and product quality. In tightly regulated industries, compliance and organizational improvement efforts must align to achieve operational excellence. This study examines how surveillance current good manufacturing practice (CGMP) inspections influence the relationship between quality management practices and a continuous improvement mindset at pharmaceutical manufacturing facilities. Methods The study builds on a regression analysis of pooled cross-sectional data from drug manufacturers and the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), supplemented by ten interviews with operational excellence leaders. Results Quality management practices catalyze continuous improvement. Inspections may provide useful external nudges in this context; however, the results suggest that their frequency should be carefully planned. In particular, we observe that a moderate frequency of CGMP inspections has the potential to support quality management efforts, whereas longer frequencies show a negative interactive effect. CGMP inspections validate quality management improvements and foster further improvements; however, this effect decays over time. Conclusion Regulatory agencies must carefully plan their surveillance inspection scheduling. If more frequent surveillance inspections are not feasible, they should consider complementing them with other initiatives —such as the Quality Management Maturity program—to further support the enhancement of quality practices and extend the duration of their positive effects on manufacturers.Type:journal articleJournal:Journal of Pharmaceutical InnovationVolume:20Issue:6Scopus© Citations 1 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Riding the bell curve of lean and digitalisation programme alignment – a social capital perspective(Informa UK Limited, 2025-09-24); ; ; With the rise of digital technologies, manufacturing companies pursue new performance gains. While digitalisation programmes often aim to complement lean programmes, many firms struggle to realise expected benefits when managing both simultaneously. Drawing on social capital theory, this paper focuses on the perspective of lean and digitalization program managers (L&DPMs), their alignment challenges and strategies. We conducted a multiple case study over a 1.5-year period analysing 10 pharmaceutical manufacturing companies. Primary data was collected through 29 semi-structured interviews, follow-up discussions and workshop observations. The robustness of our findings was enhanced through triangulation with 650 pages of company presentations documenting lean and digitalisation programmes. We found that L&DPM’s alignment follows a bell-shaped challenge trajectory across three distinct stages: loose, evolving, and close alignment. In the loose alignment stage, challenges are limited but begin to multiply rapidly, reaching their peak during evolving alignment. As L&DPMs transition into close alignment, the continuous refinement of alignment strategies leads to a gradual reduction of challenges. The extent to which these strategies take root is largely determined by the strength of social capital relationships. Our findings add nuanced understanding to the interrelated socio-technical management of lean and digitalisation and open new research avenues.Type:journal articleJournal:International Journal of Production Research - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Riding the bell curve of lean and digitalisation programme alignment – a social capital perspective(Informa UK Limited, 2025-09-24); ; ; With the rise of digital technologies, manufacturing companies pursue new performance gains.While digitalisation programmes often aim to complement lean programmes, many firms struggleto realise expected benefits when managing both simultaneously. Drawing on social capital theory,this paper focuses on the perspective of lean and digitalization program managers (L&DPMs), theiralignment challenges and strategies. We conducted a multiple case study over a 1.5-year periodanalysing 10 pharmaceutical manufacturing companies. Primary data was collected through 29semi-structured interviews, follow-up discussions and workshop observations. The robustness of ourfindings was enhanced through triangulation with 650 pages of company presentations document-ing lean and digitalisation programmes. We found that L&DPM’s alignment follows a bell-shapedchallenge trajectory across three distinct stages: loose, evolving, and close alignment. In the loosealignment stage, challenges are limited but begin to multiply rapidly, reaching their peak duringevolving alignment. As L&DPMs transition into close alignment, the continuous refinement of align-ment strategies leads to a gradual reduction of challenges. The extent to which these strategies takeroot is largely determined by the strength of social capital relationships. Our findings add nuancedunderstanding to the interrelated socio-technical management of lean and digitalisation and opennew research avenues.Type:journal articleJournal:International Journal of Production Research - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Shaping 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 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, The 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 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Benchmarking the Quality Practices of Global Pharmaceutical Manufacturing to Advance Supply Chain ResilienceType:journal articleJournal:AAPS JournalVolume:24Issue:6Scopus© Citations 17 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Holistic 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 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Investigating 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 LogisticsDOI:10.15488/13437 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, A Holistic View On Production Systems Management(2022); ; Type:conference paperJournal:3rd Conference on Production Systems and LogisticsDOI:10.15488/12161Scopus© Citations 1
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