IQ / OQ / PQ

Installation Qualification

IQ verifies that what was installed is what was specified and that it was installed correctly. It is largely a verification-of-fact exercise, and it is the stage most often rushed.

• Equipment identification, model, serial number, location
• Materials of construction and product-contact surface documentation
• Utility connections and supply verification
• Instrument list with calibration status and traceability
• Software and firmware versions, configuration baselines
• Drawings, manuals, spare parts and maintenance documentation
• Safety features and environmental conditions

Operational Qualification

OQ challenges the equipment across its intended operating range, including boundary and worst-case conditions where those conditions are meaningful. Passing every test at nominal setpoints proves very little.

• Functional testing of each critical operating function
• Operating range and setpoint challenge testing
• Alarms, interlocks, permissives and failure recovery
• Power loss and restart behavior
• Security, user roles and privilege verification
• Data capture, printing, export and audit trail behavior

Performance Qualification

PQ demonstrates repeatable performance under actual or simulated production conditions with intended materials, trained personnel and approved procedures. For some systems PQ merges into process validation; for laboratory instruments it often merges into ongoing performance verification.

Execution discipline and common findings

• Protocols approved before execution, with pre-defined acceptance criteria
• Contemporaneous recording — no transcription from scrap paper
• Calibration valid at time of test, with instrument identification recorded
• Deviations raised, assessed for impact, and resolved before approval
• Attachments legible, complete and referenced from the protocol
• Summary report that states the conclusion and any restrictions on use

Steam sterilizer evidence is more than a completed protocol

An autoclave qualification plan should define intended loads and cycle parameters, calibrated measurement devices, chamber and load temperature studies, acceptance criteria and the rationale for worst-case configurations. Physical measurements and biological indicators, where justified by the process, answer different questions. Equipment qualification does not by itself establish every product sterilization process as validated.

• Keep IQ installation evidence separate from OQ operating-range challenges
• Justify PQ load configurations, repeatability and the acceptance decision
• Assess cycle, software, load and utility changes before continued use