Operational Qualifications

The OQ protocol of a system or of a piece of equipment operate as specified. This involves testing of all normal operation controls, all alarm points, all switches and displays, interacting controls, and any other indications of operations and functions. The OQ document should provide a listing of SOPs (or reference to specific manual instructions) for operation, maintenance and calibration; information on the training of operators; and instructions for any static or dynamic tests to show that the equipment operates as expected under normal conditions. Specifications and acceptance criteria must be defined for all the operations. The OQ document should include information on equipment or system calibration, pre-operational activities, routine operations and their acceptance criteria.

Continue to "Performance Qualifications"