The Operation Qualification OQ is a test process that evaluates the correct functioning of a facility or an appliance. During the Operation Qualification OQ, all items specified in the test plan are processed and documented in writing, to ensure that the system functions in accordance with specifications. Tests in accordance with the OQ can under some circumstances (otherwise only normal for the Performance Qualification PQ) only be performed with a loaded chamber. The (successfully) performed Operation Qualification OQ is a prerequisite for the technical acceptance of a facility or appliance. The Operation Qualification OQ may only be performed after a successfully completed Installation Qualification IQ. The documentation for an Operation Qualification normally consists of:
OQ test plan: Contains detailed information of the tests to be performed on the respective equipment/software in the context of the Operation Qualification OQ This test plan contains detailed specifications on the course of the test itself.
OQ report: After completion of the Operation Qualification OQ, the results are summarized, evaluated and compiled in an OQ report. All deviations, as well as measures taken to eliminate these, are documented. After the deviations have been eliminated, these must be tested again, documented and evaluated in a new OQ report.