227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics

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

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: https://www.linkedin.com/in/georgdigel/

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.