014A - "The First P: Product" with Larry Mager

This Episode is with Larry Mager of Mgmt-Ctrl. In this episode Larry and I continue where we left off in 002 - "Seeing David in the Stone". In that episode he walked the audience through the importance of having Predictive Quality Management or PQM. That it's not an afterthought, but rather a beforethought. It should be intentional. In this episode, Larry and I chop it up about the well where PQM starts: Product. As Product is the output of the existing Process and People, before an organization moves to attempt to remediate systematic issues like QMS or Competency/Training/Development, it should ensure that it's product is Safe and Effective. We go over a quick overview of PQM, Sources of information to feed into risk assessment, Safety Signal Identification and Confirmation, Risk Control, and ensuring the State of the Art(SOTA) benefit of Patient Safety. 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 larry@mgmt-ctrl.com