Operational Qualification (OQ)

According to the definition formulated together with EURACHEM, Operational Qualification is "the process of demonstrating that an instrument will function according to its operational specification in the selected environment." [P. Bedson and M. Sargent, Accred. Qual. Assur. (1996) 1, 265-274]

The purpose of OQ is to prove and document that an analytical system functions according to its operating specification while your specific environmental conditions are taken into account. Operational Qualification is usually performed directly after a new device was installed.

On the Qualification menu, Chromeleon provides the Instruments OQ and OQ Setup commands. Select Instruments OQ to perform operational qualification. Select OQ Setup to generate the templates required for performing operational qualification. Usually, this is only necessary after initial installation or when the configuration has been modified.

The individual report pages of the Instrument OQ correspond to the Performance Qualification pages for instruments. However, OQ limits are stricter than PQ limits.

It is also possible to perform Chromeleon Operational Qualification. To do so, select Chromeleon OQ on the Qualification menu. (For more information, refer to Validation and Qualification  Chromeleon Operational Qualification (OQ) in the Administrator Help section.)

 

 Tips:

For more information about Instrument Operational Qualification, refer to the Operational Qualification/Performance Qualification Operating Instructions that you can obtain from Dionex Service.

For more information about Chromeleon Operation Qualification, refer to the Chromeleon Operational Qualification Operating Instructions.

Dionex AutoQ includes the three qualification procedures: Installation Qualification, Performance Qualification, and Operational Qualification.