Process Control Design using SPC / PAT

Course Description

This course is specifically designed to meet the analytical needs of those individuals working within FDA regulated industries. Course covers the basic concepts and methodologies associated with designing closed loop process controls using statistical process controls for variables and attributes data. Variation assessment, subgroup formation, sample size selection, SPC control chart selection, out of control action plan generation are presented along with measures of process capability.


This course is required for all scientists, engineering and quality professionals who actively work on all aspects of discovery, product and process development where the goal is to characterize, optimize and improve product and process performance.


 ESDA and DOE are recommended prerequisites.

16 Hours

Contact Information


1 (650) 967-2700

P.O. Box 2103
Sunnyvale, CA 94087-0103

Course Objectives

Upon completion of the course the participants will be able to:

  • Understand the language and compute the basic statistics associated with SPC • Apply the ten process control requirements to achieve process control
  • Determine rational subgroup formation, sample size and frequency
  • Select appropriate control chart for control requirements
  • Compute appropriate control limits
  • Develop appropriate SPC Charts and associated OCAPs
  • Determine process capability
  • Describe the roles and responsibilities for using SPC
  • Use JMP to analyze process variation patterns, generate SPC charts and determine process capability

Course Outline:

Introduction & Basic Statistics
SPC a basis for control
Basic statistics
Normal distribution
Standard error of the mean
Central limit theorem

Ten Requirements for Designing Effective Process Control
Clear product specifications
Effective metrology
Process characterization
Sampling plan
Control chart selection (variables and attributes)
Alarms and out of control action plans (OCAP)
Process documentation
Operator and engineering training
Routine line audits

Process Capability
Determining process stability prior to computation of capability
Cp and Cpk
Sigma and z as measures of process capability
Tests for normality
Distribution fitting for nonnormal parameters

Process Control Implementation Roles & Responsibilities
Process Engineer
Process Control
Specialist Supervisor