# Auditing the Auditor

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-01-07
- Length: 41m
- Episode: 298
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor
- Listen: https://podcast.greenlight.guru/episode/auditing-the-auditor

## Summary

Sara Adams, a Medical Device Guru at Greenlight Guru, explains the nuances of conducting and receiving audits, distinguishing between internal, supplier, notified body, and FDA inspections. She shares her experience managing approximately 25 audits annually at a previous contract manufacturing role and details how to negotiate findings by asking auditors to cite specific regulations. Adams emphasizes building a culture of quality where audits are viewed as opportunities for improvement rather than punitive checks, warning against treating quality management systems as static 'checkbox' exercises.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=0) Introduction: Sara Adams and Greenlight Guru
- [3:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=188) Sara Adams' Audit Background and Volume
- [5:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=314) Internal Audit Training and Conflict of Interest
- [6:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=393) Building a Collaborative Quality Culture
- [9:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=581) Sara's First Audit: The Forklift Finding
- [13:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=801) Negotiating Audit Findings and Citing Regulations
- [19:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=1189) Differences Between FDA, Notified Body, and Supplier Audits
- [24:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=1485) The 'Sweat in Peace' Mindset and Supplier Partnerships
- [30:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-07-auditing-the-auditor#t=1852) Common Pitfalls: Static QMS and Tribal Knowledge

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Sara Adams (other)
- Etienne Nichols (other)
- BSI (company)
- FDA (other)
- ISO 13485 (other)
- CDRH (other)
- Seaber (other)
- EQMS (other)
- ASQ (company)
- Greenlight Guru Academy (other)
- MedTech Excellence Community (other)

## Related episodes from other shows

- [249 - The Best Audit Advice Nobody Told Me](https://hardwarepodcasts.com/podcast/lets-combinate/2026-08-05-249-the-best-audit-advice-nobody-told-me) (Let's Combinate)
- [168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal) (Let's Combinate)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (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/2023-01-07-auditing-the-auditor. 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.