Operational Qualification (OQ) is defined as establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances. Operational Qualification should follow on from Installation Qualification (IQ) and should include tests that have been developed based on detailed knowledge of equipment, systems or processes. Tests should be developed to demonstrate compliance with the requirements identified in the correspondingFunctional Specification and should include testing at upper and lower operating limits.
The purpose of Operational Qualification is to demonstrate that the newly acquired equipment (or facilities, services or systems) functions as expected; that all parts and components operate correctly, motors run in the right direction and at the correct speed, all moving parts move freely over the full operating range; that all controls perform the intended function and that all gauges and indicators are calibrated and display the correct value. Operational Qualification will also verify the correct operation of any safety devices such as Emergency stop buttons and protective guards. Essentially Operation Qualification is to ensure that a system really does do everything that the user wants it to do.
Many modern systems have been built by the supplier to meet the requirements of a number of users each of whom has their own set of requirements; it is likely therefore that, unless a bespoke system has been purchased, a newly acquired system will include at least some functionality that is not required. It is not necessary to test during Operational Qualification functionality that will not be used during routine operation; however a decision not to test any individual function must be recorded and justified.
Completion of the Operational Qualification will allow the finalisation of key items such as the Standard Operating procedures, user training and scheduling of calibration and preventative maintenance tasks. Operational Qualification will normally be followed by Performance Qualification (PQ) or Process Validation.