# 138 - Operations vs. Quality, KPI's, Management Controls, Process Improvement, Balancing Capability/Capacity and Improvement Culture with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-05-29
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/138---Operations-vs--Quality--KPIs--Management-Controls--Process-Improvement--Balancing-CapabilityCapacity-and-Improvement-Culture-with-Larry-Mager-e2k7srh

## Summary

Larry Mager, founder of Mgmt-Ctrl and PQMCoach.com, argues that quality management must be integrated into operational business frameworks rather than isolated in compliance silos. He details a top-down management control approach using KPIs to balance operational capability and capacity against market demand, ensuring executives can make informed decisions without being overwhelmed by data. Mager emphasizes the importance of role-based processes, effective CAPA execution, and building a culture of continual improvement to maintain regulatory readiness and business profitability.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=0) Introduction: Larry Mager and the Philosophy of Integrated Quality
- [3:22](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=202) The Problem with KPIs and Management Review Data Overload
- [8:43](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=523) Operational Framework: Rev Ops, Manufacturing Ops, and Biz Ops
- [16:49](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=1009) Effective Business Processes: RACI, Roles, and Work Instructions
- [24:06](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=1446) Understanding Role Expectations and Aggregating Work for Capacity
- [24:06](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=1446) Management Review: Strategy, Tactical, and Systemic Levels
- [24:06](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=1446) Balancing Capability and Capacity Against Market Demand
- [24:06](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=1446) Improvement and Execution: Dedicated Teams vs. Line Staff
- [34:40](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=2080) The Role of CAPA in Quality Management and FDA Inspections
- [41:30](https://hardwarepodcasts.com/podcast/lets-combinate/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing#t=2490) Building a Culture of Quality and Continual Improvement

## Topics

- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Factory operations & automation](https://hardwarepodcasts.com/topic/factory-operations)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)

## Most relevant to

established companies

## Mentioned

- Mgmt-Ctrl (company)
- PQMCoach.com (other)
- FDA (other)
- RACI (tool)

## 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)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [Tips for Running Better Management Reviews](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-19-tips-for-running-better-management-reviews) (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)
- [Does Your CAPA Process Need a CAPA?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa) (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/2024-05-29-138-operations-vs-quality-kpis-management-controls-process-improvement-balancing. 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.