Hardware Podcasts

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

Let's Combinate · 24 Feb 2026 · 28m

What this episode covers

Georg Digel, founder of Elevate CAPA, explains to host Subhi Saadeh how to determine when to open a Corrective and Preventive Action (CAPA) and how to conduct effective investigations. Digel argues that 'human error' is rarely an acceptable root cause and warns against political pressure that leads to scapegoating instead of systemic fixes. He advocates for defining clear triggers based on trend data and risk, rather than arbitrary thresholds, and recommends using structured problem statements (5W2H) and tools like Ishikawa diagrams and 5 Whys to identify true root causes.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Elevate CAPA
Tools
Ishikawa, 5 Whys, FTA, 5W2H
Also
Subhi Saadeh, Georg Digel, QMSR, QSR, ISO 13485, FDA, Notified Body

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