Equipment Qualification (IQ/OQ/PQ) Protocol Inspection

Inspection template for documenting installation qualification, operational qualification, and performance qualification of manufacturing equipment in line with Annex 15 expectations and internal validation requirements.

Inspection Setup and Qualification Scope

• Equipment identification matches approved qualification protocol
  Record equipment name, asset ID, model, serial number, and location as listed in the approved protocol.
• Qualification stage selected correctly
  Select the current stage being inspected.
• Applicable SOPs, drawings, manuals, and calibration records available

Installation Qualification (IQ)

• Equipment installed in approved location and orientation
• Utility connections verified against specification
  Select all utilities that were verified and confirmed acceptable.
• Installation materials, seals, guards, and access panels intact
• Calibration status verified for installed instruments and gauges
• Environmental conditions within approved installation limits
  Record the measured value for the most relevant environmental parameter, or use comments to document multiple parameters.

Operational Qualification (OQ)

• Start-up, shutdown, and emergency stop functions operate correctly
• Control system alarms and interlocks tested successfully
• Operating parameters tested within approved range
  Select the parameters that were challenged during OQ.
• Measured operating result within acceptance criteria
  Record the measured result for the challenged parameter.
• Safety devices and guarding function as intended

Performance Qualification (PQ)

• PQ run executed under normal production conditions
• Number of successful PQ runs completed
  Enter the count of successful consecutive runs completed during PQ.
• Product or process output met acceptance criteria
• Routine operator and material conditions documented

Deviations, Corrective Actions, and Release

• Any deviations or non-conformances identified
• Impact assessment completed for all deviations
• Equipment approved for release to intended use
• Inspector signature