159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin

Let's Combinate - Drugs + Devices

In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. They examine models like centralized, decentralized, and federated structures, supported by industry benchmarks and practical experiences. The conversation emphasizes the necessity of centralized ownership for consistent quality outcomes, despite quality being everyone's responsibility. Additionally, they explore the nuances within pharmaceutical companies, referencing a McKinsey study that underscores the importance of cultural and procedural elements over structural setup. Distinctions between Quality Assurance and Quality Control are clarified, focusing on the need for proactivity and integration for optimal results. This episode provides comprehensive insights into the structural, cultural, and procedural dimensions of effective quality management. 00:00 Introduction and Guest Welcome 00:19 Questioning the Quality Unit's Independence 01:19 Avoiding Conflicts of Interest in Quality 03:39 Organizational Structures and Quality 09:09 Centralized, Decentralized, and Federated Quality Models 12:06 Understanding Quality Reactivity 12:20 Insights from the McKinsey Study 13:36 The Importance of Quality Culture 14:23 Identifying Problematic Structures 15:19 Designing Non-Reactive Quality Systems 17:13 Quality Management System (QMS) Structures 19:05 QA vs. QC: Key Differences 22:07 Conclusion and Final Thoughts

Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.