Operational Qualification (OQ): Protocol, Tests & Examples

Operational Qualification.: Documented verification that the system or subsystem performs as intended over all anticipated operating ranges.

Requirements and procedures for operation (or use), calibration, maintenance and cleaning should be prepared before OQ and approved prior to PQ.

• Utilities and equipment should operate correctly and their operation should be verified in accordance with an OQ protocol. OQ normally follows IQ but, depending on the complexity of the utility or equipment, it may be performed as a combined installation/operation qualification (IOQ). This should be justified and documented in the validation master plan (or qualification protocol).
• OQ should include, but is not limited to, the following:
  • tests that have been developed from the knowledge of processes, systems and equipment, to ensure the utility or equipment is operating as designed;
  • tests over the operating limits.
• Training of operators for the utilities and equipment should be provided and training records maintained.
• Calibration, cleaning, maintenance, training and related tests and results should be verified to be acceptable.
• Deviations and non-conformances observed should be recorded, investigated and corrected or justified.
• The results for the verification of operation should be documented in the OQ report.
• The outcome of the OQ should be recorded in the conclusion of the report, normally before PQ is started.