Let's Combinate - Drugs + Devices
Let's Combinate - Drugs + Devices
Subhi Saadeh
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
22 minutes Posted Oct 23, 2024 at 10:00 am.
Introduction and Guest Welcome
Questioning the Quality Unit's Independence
Avoiding Conflicts of Interest in Quality
Organizational Structures and Quality
Centralized, Decentralized, and Federated Quality Models
Understanding Quality Reactivity
Insights from the McKinsey Study
The Importance of Quality Culture
Identifying Problematic Structures
Designing Non-Reactive Quality Systems
Quality Management System (QMS) Structures
QA vs. QC: Key Differences
Conclusion and Final Thoughts
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Show notes
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.
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.