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 [email protected], Tyo Biotechnology Consulting

Contact solabs at [email protected]