Episode 60: Investigative Methods with Michael Tyo

Episode 60: Investigative Methods with Michael Tyo

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today's episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations.

Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.

Key Takeaway

01:24 Introducing today's guest: Michael Tyo

01:55 Today's topic is investigative methods and what happens when things go wrong

03:36 The Fishbone method

06:28 Why human error cannot be a root cause?

07:55 The 5 Whys method

09:35 What needs to be included in the investigation report?

11:30 What does the FDA expect from investigations?

12:38 Lessons from recent FDA's warning letters

Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting

Contact solabs at solabs-podcast@solabs.com

Episoder(64)

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

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Episode 31: Guest Tribute Show: 'Best of' Moments from the Last Two Seasons!

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Episode 26: Current Hot Trends in the Medical Device Industry

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Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

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