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

Let's Combinate - Combining Drugs and Devices

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

00:31 Larry's Perspective on Quality

03:21 Importance of KPIs in Management Review

04:13 Management Review and Control

09:09 Operational Framework and Business Structure

18:46 Effective Business Processes

24:42 Understanding Role Expectations and Aggregating Work

25:51 Management Review: Strategy and Tactical Levels

28:47 Operational and Systemic Levels of Management

30:15 Balancing Capability and Capacity

31:37 Improvement and Execution in Business Operations

37:25 The Role of CAPA in Quality Management

44:54 Building a Culture of Quality and Continual Improvement

46:36 Conclusion and Resources for Further Learning

Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [e-mail]