Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.

Timestamps

• 00:00 Welcome and Guest Intro
• 00:53 The Hairiest CAPA Case
• 03:02 Human Error Root Cause
• 04:58 Common CAPA Misconceptions
• 06:11 Why Root Cause Fails
• 12:16 When to Open CAPA
• 17:26 CAPA Inputs and Triggers
• 19:28 One Process or Two
• 22:28 How to Investigate Properly
• 25:09 Tools for Root Cause
• 26:20 Problem Statement Basics
• 27:48 Wrap Up and Where to Find

Resources

• Georg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.