# 179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-03-12
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/179---Quality-is-NOT-Everyones-JobWhy-Thats-a-GOOD-Thing-e2vl2hp

## Summary

Host Subhi Saadeh argues that the phrase 'everyone owns quality' is flawed because it blurs accountability, asserting instead that top management holds ultimate responsibility for quality systems in medical devices and pharma. He references Joanna Gallant’s article 'Someone, Everyone or No One' to illustrate how clear ownership prevents the cultural disconnects seen in facilities where quality staff are ostracized. Saadeh cites regulatory frameworks like ISO 13485 and 21 CFR 820, which mandate that while authority can be delegated, responsibility cannot, using the Ranbaxy scandal as a cautionary tale of leadership failure.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing#t=0) Introduction: The Flaw in 'Everyone Owns Quality'
- [1:13](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing#t=73) Joanna Gallant on Quality Culture and Ownership
- [4:09](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing#t=249) Regulatory Frameworks: ISO 13485 and 21 CFR 820
- [7:03](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing#t=423) The Ranbaxy Scandal and Leadership Failure
- [7:54](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing#t=474) Conclusion: Leadership Must Own Quality

## Topics

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

## Most relevant to

large enterprises

## Mentioned

- Joanna Gallant (other)
- ISO 13485 (other)
- ICH Q10 (other)
- Ranbaxy (company)
- Catherine Eban (other)
- Dinesh Tucker (other)
- FDA (other)

## Related episodes from other shows

- [#324 Management Responsibility: The most important part of a QMS](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-22-324-management-responsibility-the-most-important-part-of-a-qms) (Global Medical Device Podcast)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)
- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [Building a Culture of Quality](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-20-building-a-culture-of-quality) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-12-179-quality-is-not-everyones-job-why-thats-a-good-thing. 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 Let's Combinate.