# 002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2021-10-14
- Length: 58m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/002---Seeing-David-in-the-Stone-Predictive-Quality-Management-with-Larry-Mager-e16gk5n

## Summary

Larry Mager, founder of Management Control and author of 'The Quality Journey' and 'Seeing David in the Stone', explains his framework for Predictive Quality Management in the medical device industry. He distinguishes between 'Big Q' (the Quality Management System) and 'Little Q' (everyday quality owned by all employees), arguing that management responsibility is the critical driver of success. Mager emphasizes that organizations must shift from reactive compliance to proactive, predictable quality by focusing on process constraints, adequate resourcing, and post-market feedback loops rather than just design controls.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=1) Introduction: Larry Mager and Management Control
- [2:47](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=167) Big Q vs. Little Q and Management Responsibility
- [7:07](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=427) The 'Seeing David in the Stone' Metaphor
- [10:08](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=608) Origin Story: From FDA 483 to 'The Quality Journey'
- [18:22](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=1102) Core Components of Predictive Quality Management
- [22:51](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=1371) Pressure Testing Processes and Resourcing
- [29:06](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=1746) Prioritization: CAPA, Management Review, and Constraints
- [33:49](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=2029) Applying Predictive Quality to Design Control and Post-Market
- [41:21](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager#t=2481) Books, Culture, and Consulting Philosophy

## Topics

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

## Most relevant to

established companies

## Mentioned

- Management Control (company)
- The Quality Journey (other)
- Seeing David in the Stone (other)
- Philip B. Crosby (other)
- Quality is Free (other)
- Good to Great (other)
- 0 to One (other)
- ISO 13485 (other)
- FDA (other)
- QSR (other)

## Related episodes from other shows

- [#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)
- [#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)
- [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)
- [#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)

## Citing this page

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