Six Sigma Validation Process

The success of Six Sigma programs highlights the importance of teaching students how to perform complete processes.  All the Six Sigma tools apply to Process Validation.  The 11-step validation process below provides a step-by-step procedure for applying the Six Sigma tools to validating a pharmaceutical, medical device, or diagnostic device process per the FDA process validation guidelines.  Dr. Taylor is the author of Annex A of the Process Validation Guidance document released by the Global Harmonization Task Force (GHTF) Study Group #3.  Annex describes how these tools apply to validation.  The validation process below follows the IQ-OP-PQ model laid out in this guidance document:

  • IQ – Installation Qualification
  • OQ – Operational Qualification
  • PQ – Performance Qualification