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.
