Category: Design Space

Why Not Use Design of Experiments for QbD?

Confession Today, I share an embarrassing story… I did not truly appreciate DOE. When I was teaching Six Sigma topics at Stanford University and Keio University, I only scratched the surface level. Main reason was that most project sponsors could not share their proprietary or confidential details (process parameters), hiding real numbers...

JMP Setup Guide for DOE – in 1 Minute

Now that we’ve covered: How to conduct QbD Risk Assessment in a smart way,  I’d like to move onto the next step – QbD Design Space in a smart way. Before we get into details, let’s set up our main tool –JMP– for success. Surprisingly, many JMP users aren’t aware...

Design Space in QbD — Definitions

If you are new to QbD, here are the basic definitions of “Design Space” in QbD. If you have to explain the terminologies to your colleagues, you can refer them to this page as a resource. I’m building a resource page (Start Here) for QbD newcomers. ICH Q8 (R2)...