Six Sigma Validation Process (IQ-OQ-PQ)¶

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