In Part 2 of this episode, Larry and I discuss the Second P: Process. I start the episode by asking Larry to explain the difference between a Quality System and a Quality Management System(QMS) to set the foundation. Larry then moves on to explain have a control environment should be well established(policies, standards, procedures, governance, etc), Risk Management for processes and poking holes in your organization's ways of working, control activities, flow of information, monitoring, management review and continuous improvement.

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 [email protected]