IQ / OQ / PQ Checklist
The three phases of process validation, as a checklist you can work through and print. Check items off as you complete them; nothing is stored.
How to run this study
IQ/OQ/PQ is the standard three-phase path to a validated process. Installation Qualification proves the equipment is installed and calibrated; Operational Qualification establishes the process window and challenges its edges; Performance Qualification proves the process holds over extended production. Work the phases in order — each depends on the one before.
Procedure
- 01IQ — verify machine specs, utilities, calibration, and software before running anything.
- 02OQ — run a DOE to establish the process window and challenge its extremes; document the operating limits.
- 03PQ — run extended production across the planned lots and demonstrate capability (Cpk ≥ 1.33) on the critical dimensions.
- 04Check items off as you complete them; a phase is done only when every required item passes.