Operational Qualification, often abbreviated to OQ, is the set of tests that verifies requirements are implemented correctly. This is probably the most straight-forward of the protocols: “see requirement : verify requirement.”

Of course, that’s a gross simplification and verifying requirements can be extremely challenging; but the concept is straight-forward.

If you have vague requirements, verification is difficult, at best

Examples

For example, if a requirement was established for the system to “run fast,” it’s not possible to verify this. Fast is in the eye of the beholder.

The best case is to ensure verifiable requirements.

For example, “Response time to a query shall always be within 15 seconds.” Not great but at least it’s quantifiable.

If vague requirements do “slip through” then at least define something quantifiable in the test. This could be done in textual description of the test objectives.

Clear and Quantifiable

Be sure to have clear and quantifiable expected results. Using the above example, you could write a test case that has a step to submit a query and an expected result that the reply is “fast.”

There’s nothing to base an assessment on in this case.

A good expected result will give the tester a clear path to determine whether or not the objective was met.

OQ needs to confirm error and alarm conditions are properly detected and handled, startup and shutdown perform as expected, confirm all applicable user functions and operator controls, examine maximum and minimum ranges of allowed values.

Generally, OQ only needs to be executed on a ‘representative’ set of equipment. This should be defined in the Validation Plan.

21 CFR Part 11

OQ can also be used to verify compliance to required external standards.

For example, if 21 CFR Part 11 is required, OQ would be the place where the system’s ability to maintain the audit trail would be confirmed.

The OQ is where the bulk of tracing from requirements to verification occurs.

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