Process Validation

DOE Factorial, DOE Response Surface and VTA (Variation Transmission Analysis)

Process Development Components

This training on Process Optimization and Robustness will show how to find the manufacturing recipe for the operating conditions and process inputs that will result in the best process performance. This scientific methodology will help you meet process CPk’s equal to 1.5 or higher in order to achieve the Six Sigma Quality. This level of quality will ensure consistency meeting specification requirements and will reduce the overall cost.

WHO SHOULD ATTEND

Upper Management, Managers, Supervisors, Engineers, Technicians and individuals who are involved with product and process Validations / Optimizations.

BENEFITS

When the training is complete you will have a clear understanding in how to move from the traditional process Validation to Process Optimizations and Robustness using DOE Response Surface and VTA methodologies. You will be certain to obtain significant improvements in the overall Cost and Quality for your organization.

TRAINING TOPICS:

INTRODUCTION
    • PD Process Development
    • OQ Operation Qualification
    • PD Performance Qualification
  • SCOPE
  • REFERENCE DOCUMENTS
  • RESPONSIBILITIES
  • DEFINITIONS, ABREVIATIONS, AND ACRONYMS
  • PROCESS VALIDATION PREREQUISITES
  • PROCESS THAT SHOULD BE VALIDATED
  • ELEMENTS OF PROCESS VALIDATION
  • DETERMINING THE SCOPE OF ELEMENTS TO BE COVERED IN THE PROCESS VALIDATION
  • CONDUCTING THE VALIDATION
METHODOLOGIES
  • FACTORIAL EXPERIMENTS
    • Purpose of Factorial Experimental design
    • Full Factorial Experiments
    • Fractional Factorial Experiments
    • Use of Minitab
    • Examples from real manufacturing processes
  • DOE RESPONSE SURFACE
    • Purpose of Response Surface design
    • Response Surface Methodologies and Designs
    • Second – Order Model
    • Use of Minitab
    • Examples from real manufacturing processes
  • PROCESS ROBUSTNESS THROUGH VTA
    • Purpose of Robustness
    • Use of MINITAB and VTA (Variation Transmission Analysis) software
    • Examples from real manufacturing processes