Process Control Design using SPC

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 control 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. The course
requires 16 hours of instruction.

Attendees:
This course is required for all scientists, engineers 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.

 

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

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

Prerequisites: ESDA and DOE are recommended courses prior to taking PCD-SPC.

Detailed Course Outline:

Introduction and 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, closing the loop and out-of-control action plans (OCAP)
Process documentation
Operator and engineering training
Database
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 and Responsibilities
Management
Process engineer
Process control specialist
Supervisor
Operator