# 014B - "The Second P: Process" with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-01-05
- Length: 50m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/014B---The-Second-P-Process-with-Larry-Mager-e1ccj92

## Summary

Larry Mager, Principal and Founder of Mgmt-Ctrl, explains the 'Process' component of quality management in medical device companies, distinguishing it from a basic Quality Management System (QMS). He outlines a five-step internal control framework: establishing a control environment, implementing risk mitigation, defining control activities, managing information flow, and conducting management review. Mager argues that this structured approach allows organizations to identify constraints and drive continuous improvement rather than just maintaining compliance. The discussion emphasizes that effective process management requires active leadership oversight and clear communication of objectives across all sites.

## Chapters

- [1:01](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=61) Introduction: Larry Mager and Mgmt-Ctrl
- [3:21](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=201) Distinguishing Quality System from Quality Management System
- [5:55](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=355) Establishing the Control Environment and Governance
- [18:06](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=1086) Process Risk Management and Mitigation
- [21:43](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=1303) Defining Control Activities and Mechanisms
- [31:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=1899) Information Flow and Communication Strategies
- [39:33](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=2373) Monitoring Activities and Executive Management Review
- [44:08](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014b-the-second-p-process-with-larry-mager#t=2648) Addressing Constraints and Continuous Improvement

## 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

established companies

## Mentioned

- Mgmt-Ctrl (company)
- FDA (company)
- ASQ (company)
- 21 CFR 820 (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)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [How to Build a QMS for a Medical Device](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-08-how-to-build-a-qms-for-a-medical-device) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-23-412-how-to-build-a-qms-that-actually-works-from-startup-to-scale-in-medtech) (Global Medical Device Podcast)

## Citing this page

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