# Does Your CAPA Process Need a CAPA?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-08-24
- Length: 51m
- Episode: 277
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa
- Listen: https://podcast.greenlight.guru/episode/does-your-capa-process-need-a-capa

## Summary

Mike Drues, president of Vascular Sciences, joins host Jon Speer of Greenlight Guru to discuss why Corrective and Preventive Actions (CAPA) remain the number one reason for FDA 483 observations and warning letters. They analyze specific regulatory citations, such as failure to initiate CAPAs for systemic complaints and lack of documentation for non-initiation, to highlight common quality management system failures. Drues argues that companies must move beyond rigid metrics like closure time and instead test their CAPA efficacy through proactive 'fire drills' to ensure robust root cause analysis and prevention.

## Chapters

- [1:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=70) Introduction: Mike Drues and the CAPA Problem
- [3:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=238) FDA 483 Data: CAPA as the Top Violation
- [7:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=464) Defining CAPA and Regulatory Requirements (21 CFR 820.100)
- [14:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=886) Cultural Barriers and Root Cause Analysis Failures
- [21:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=1292) Case Study 1: Failure to Follow CAPA Procedures
- [30:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=1803) Case Study 2: Ignoring Multiple Complaints
- [36:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=2190) Case Study 3: Lack of Documentation for Non-Initiation
- [41:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa#t=2501) Measuring CAPA Efficacy and Testing Systems

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 13485 (other)
- 21 CFR 820 (other)

## Related episodes from other shows

- [178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know) (Let's Combinate)
- [227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics](https://hardwarepodcasts.com/podcast/lets-combinate/2026-02-24-227-when-should-you-open-a-capa-triggers-human-error-and-investigation-basics) (Let's Combinate)
- [201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-08-13-201-inside-a-300m-fda-remediation-lessons-from-zimmer-to-epipen-warning-letters) (Let's Combinate)
- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.