# 097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-08-09
- Length: 43m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/097---Predictive-Quality--Business-Process-Capabilities--3-Lines-of-Quality-Defense--TOC--COSO-and-Business-Risk-with-Larry-Mager-e27td2o

## Summary

Larry Mager, Principal at Mgmt-Ctrl and founder of PQMcoach.com, explains his Predictive Quality Management (PQM) framework, which applies the PDCA cycle to business processes rather than just product compliance. He argues that quality organizations must move beyond 'Big Q' compliance to facilitate 'Little Q' across all operations, using concepts like the 3 Lines of Defense and COSO risk management to identify and address constraints. Mager emphasizes that companies must define core capabilities, such as commercial product release, and use data analytics to drive systemic improvements rather than relying on siloed quality teams.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=0) Introduction: Larry Mager and Predictive Quality Management
- [3:34](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=214) Mager's Career and the Shift from Remediation to Transformation
- [7:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=433) Applying PDCA to Business Processes and Core Capabilities
- [12:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=723) GMP vs. Non-GMP: Commercial Product Release and Complaints Management
- [16:29](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=989) Roles in PDCA: Operators, Quality, and Leadership
- [21:14](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=1274) Defining QMS, QSM, and the Plan/Do/Check/Act Phases
- [27:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=1620) Shifting Culture: Capability Mapping and Theory of Constraints
- [30:45](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=1845) The 3 Lines of Defense and COSO Risk Management
- [37:08](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=2228) Adopting COSO and ICH Q10 for Holistic Quality Systems
- [40:24](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-09-097-predictive-quality-business-process-capabilities-3-lines-of-quality-defense#t=2424) The Future of PQM and PQMcoach.com

## 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)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Mgmt-Ctrl (company)
- PQMcoach.com (other)
- Edwards Deming (other)
- COSO (other)
- ICH Q10 (other)
- ISO 13485 (other)
- ISO 14971 (other)

## Related episodes from other shows

- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [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)
- [Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2024-08-27-quality-management-in-a-changing-manufacturing-environment-w-naveen-poonian) (The Manufacturing Executive)
- [We Achieved ISO Certification! Now What?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-17-we-achieved-iso-certification-now-what) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)

## Citing this page

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