Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 6: Applying Design for Six Sigma (2020)

In this series, we will discuss the principles of quality by design.


  1. The improvement journey
  2. Improve phase objectives
  3. Improve roadmap
  4. Evaluating potential solutions
  5. Reasons for experiments
  6. Desired results of experiments
  7. Design of experiments
  8. Definition: Design of experiments
  9. Verifying results
  10. How process capability impacts cycle time and resource allocation
  11. What have we learned from six sigma?
  12. DFSS - What is it?
  13. Why DFSS?
  14. The big picture
  15. The benefits of DFSS
  16. DFSS tools
  17. Taguchi loss function
  18. Taguchi methods
  19. Taguchi methods - Loss function
  20. Toyota production system (TPS)
  21. TPS timeline
  22. Kanban System
  23. Jidoka
  24. Andon
  25. Toyota production system house
  26. Thought of the week
    • Change management phases (planning, managing and implementing changes)


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.