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

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Episode 16: Continuous Improvement of Quality Management Systems

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Episode 15: Qualifications and Oversight of Contract Service Providers with Lisa Helmonds from MWA consulting

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Welcome to episode 2 of the 6-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial traini...

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Episode 14: Key Elements of Virtual Life Sciences Companies with Lisa Helmonds from MWA consulting

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Episode 13: Recapping Industry Trends in 2018

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Episode 12: Validating a Cloud-based Solution with Philippe Gaudreau

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Episode 11: How to Build an Effective Training Assessment Program with Brian McNamara

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Episode 10: Social and Collaborative Learning with Jay Turner

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Episode 9: Effective Training Methods for Millenials with Graham O'Keeffe

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