1 rich Libsyn https://www.libsyn.com 90 600 Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools. &amp;nbsp; Key Takeaways: 01:11 Introducing Michael and his Background 02:31 Does the FDA have a clear expectation for the use of risk assessment tools? 06:13 The importance of a risk plan 09:20 Why companies must all have an SOP for risk assessment Contact us at solabs-podcast@solabs.com Automating Quality https://docs.solabs.com/hc/en-us/sections/360006683193-Automating-Quality-Podcast <iframe title="Libsyn Player" style="border: none" src="//html5-player.libsyn.com/embed/episode/id/29172828/height/90/theme/custom/thumbnail/yes/direction/forward/render-playlist/no/custom-color/88AA3C/" height="90" width="600" scrolling="no" allowfullscreen webkitallowfullscreen mozallowfullscreen oallowfullscreen msallowfullscreen></iframe> https://assets.libsyn.com/secure/item/29172828