# 014C - "The Final P: People" with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-01-05
- Length: 49m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/014C---The-Final-P-People-with-Larry-Mager-e1ccjq3

## Summary

Larry Mager, Principal and Founder of Mgmt-Ctrl, discusses the 'People' pillar of his Predictive Quality Management (PQM) framework for medical device companies. He argues that achieving a strong culture of quality requires ensuring personnel are skilled, trained, and proven competent, rather than just checking boxes. Mager illustrates how leadership must foster communication, trust, and personal accountability to move beyond mere compliance, citing a successful turnaround at a large organization that resolved a corporate warning letter by engaging employees directly.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=0) Introduction: Larry Mager and the Final P: People
- [3:03](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=183) Process vs. People: Fujio Cho's Quote and Resource Adequacy
- [8:20](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=500) Defining Competency: Skill, Training, and Certification
- [12:55](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=775) Building Culture: Trust, Accountability, and Leadership Vulnerability
- [25:34](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=1534) Engaging Employees: Understanding the Bigger Picture and Constraints
- [28:47](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=1727) Maintenance and Management Review: Tying Product, Process, and People
- [32:55](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=1975) Origin of the PQM Framework: From Remediation to Paradigm
- [43:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014c-the-final-p-people-with-larry-mager#t=2608) Future of PQM: FDA Pilot Studies and Industry Adoption

## Topics

- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Mgmt-Ctrl (company)
- FDA (other)
- Toyota (company)
- MDIC (other)

## Related episodes from other shows

- [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)
- [#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)
- [#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)
- [#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-05-440-icymi-in-case-you-missed-it-fundamentals-of-quality-regulatory) (Global Medical Device Podcast)
- [S7E7 Mike Romance | Industry 4.0, Production Transfers, & People-Centric Leadership](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-13-s7e7-mike-romance-industry-4-0-production-transfers-people-centric-leadership) (Being an Engineer)

## Citing this page

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