Hardware Podcasts

102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry

Let's Combinate · 13 Sept 2023 · 32m

What this episode covers

Amy Wilson and Cliff Berry, authors of "Do Quality Differently," discuss human and organizational performance in biopharma and manufacturing. They argue that "human error" is a symptom of system design flaws rather than individual failure, advocating for a shift from blaming individuals to analyzing system constraints. The guests explain the "Blue Line vs. Black Line" concept, distinguishing between work as imagined (procedures) and work as actually performed, and emphasize the importance of good written human guidance and appropriate deviation categorization to drive real quality improvements.

Most relevant to

established companies

Topics

Mentioned

Companies
BioGen
Products
Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing
Tools
Devonway, Kappa Striker

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