Robust Optimization, Design Space and Tolerance Design

Course Description

This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Robust optimization and tolerance design presents the methods and practices associated with designing and optimizing products and processes. Tolerance design methods to protect product quality and clinical benefits are discussed. The course requires 16 hours of instruction.


This course is required for all scientists, engineers and quality professionals who actively work on all aspects of discovery, product and ROTD.


ESDA and DOE are recommended prerequisites.

Course Objectives

  1. Learn and apply the principles of robust product design.
  2. Design experiments appropriate for the information of interest.
  3. Use and apply the structures of orthogonal arrays for product and process development and problem solving.
  4. Ensure the experimental design is efficient.
  5. Use regression techniques in order to analyze the results and make process/product improvements.
  6. Optimize the response at its most robust condition.
  7. Tolerance the factors and responses.
  8. Use JMP software to design and analyze experiments.

Detailed Course Outline

Section I: Distribution and tolerance design foundations

System, parameter and tolerance design
Tolerance design methods

Section II: DOE review and robust design principles

Eight robust design principles

Section III: DOE using custom designs

Custom designs
Strategies to minimize experimental size
Adding covariate and uncontrolled factors
Special topics for custom designs (optional)
Blocking designs
Setting constraints in the design

Section IV: Robust optimization methods

Tighten the tolerance of X
Design to the flats
Use interactions to tune out sensitivities
Use parameter combinations

Section V: Tolerance design and margin analysis

Tolerance design procedure
Tolerance stack up analysis