The Operational Qualification (OQ) is the fourth document in the validation approval process for bringing a stability chamber online. The OQ testing is a verification that the unit was installed and operates as outlined in the Design Qualification.
In the OQ, the testing is designed to have an acceptance criterion, which must be met, but usually does not have timed duration. This type of testing is done in the Performance Qualification. Depending on the verbiage in a company’s validation program, the Operational Qualification (OQ) can be the incorporated with the Performance Qualification (PQ). In the interchange of the OQ with the PQ, the operational requirements are tested with a timed output requirement.
In Figure 2 the testing documents the compliance to the Design Qualification requirements. As noted in the OQ it only documents the ability to attain the specification. The “Result Found” section can be written in a couple of different formats, that could include a Pass/Fail; Yes/No or as written, a Fill in The Blanks style. The Fill in The Blanks format requires the personnel performing the tests to fill out the blanks as they are performed. In the other two formats it allows the performer to check/circle the result and possibly not perform the function. This format is a more robust style and is a more time consuming process.
In the PQ the testing, this parameter compliance will be documented for a determined amount time to show the ability of the unit to maintain the parameter over time. This documentation is more detailed and is discussed in my upcoming PQ article.
Review and Approval
As with all protocols the OQ needs to be preapproved before execution. During the execution a second person should be reviewing the work to make sure that the data collected is correct and accurate. Any step that fails needs to be corrected and retested before the completion of the IQ. The failure needs to be documented in an exception page in the final protocol to explain the failure.
Once completed the same group needs to approve the completed work.