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Episode 60: Investigative Methods with Michael Tyo
Manage episode 448645966 series 2364916
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
61 episodes
Manage episode 448645966 series 2364916
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
61 episodes
All episodes
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1 Episode 61: Value Added Quality with Ed Siurek 27:07

1 Episode 60: Investigative Methods with Michael Tyo 18:34

1 Episode 59: Introduction to Investigations with Michael Tyo 18:31

1 Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia 15:12

1 Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia 16:36

1 Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam 18:08

1 Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam 15:19

1 Episode 54: Risk Management Tools and Techniques with Michael Tyo 15:32

1 Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo 18:35

1 Episode 52: Supplier Quality Management w. Mandy Gervasio 17:28

1 Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio 20:30

1 Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve 16:06

1 Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve 16:07

1 Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia 14:18

1 Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia 19:02
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