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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-02-24
- Length: 28m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/227---When-Should-You-Open-a-CAPA--Triggers--Human-Error--and-Investigation-Basics-e3fik3o

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=0) Introduction: Georg Digel and Elevate CAPA
- [0:59](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=59) The Hairiest CAPA Case: Unreplicable Errors and Process Changes
- [4:01](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=241) Why 'Human Error' is an Inadequate Root Cause
- [4:58](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=298) Common CAPA Misconceptions: Punishment and Complexity
- [6:14](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=374) Why Root Cause Fails: Political Pressure and Scapegoating
- [11:23](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=683) When to Open CAPA: Triggers, Trends, and Risk
- [17:26](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=1046) CAPA Inputs and Triggers: QMSR vs. QSR
- [19:11](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=1151) One Process or Two: NC vs. CAPA Integration
- [21:36](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=1296) How to Investigate Properly: Data Gathering and Analysis
- [25:09](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=1509) Tools for Root Cause: Ishikawa, 5 Whys, and FTA
- [26:18](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics#t=1578) Problem Statement Basics: 5W2H Framework

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

early-stage companies

## Mentioned

- Elevate CAPA (company)
- Subhi Saadeh (other)
- Georg Digel (other)
- Ishikawa (tool)
- 5 Whys (tool)
- FTA (tool)
- 5W2H (tool)
- QMSR (other)
- QSR (other)
- ISO 13485 (other)
- FDA (other)
- Notified Body (other)

## Related episodes from other shows

- [Does Your CAPA Process Need a CAPA?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa) (Global Medical Device Podcast)
- [#388: Elements of an Effective CAPA Program](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-24-388-elements-of-an-effective-capa-program) (Global Medical Device Podcast)
- [Most Common Problems Found During FDA Inspections in 2022](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)

## Citing this page

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