Operational Qualification (OQ).

The execution of the Operational Qualification (OQ) protocol verifies that the functionality of the equipment conforms with functionality specified in the Functional Specification (FS) for the system.
This verification is achieved by subjecting the equipment to a range of fully documented inspections and tests. Each test or inspection comprises four parts;

1. A rationale (why the test is necessary).
   
2. A detailed method of executing it.
   
3. The required result.
   
4. A Yes/No, decision whether the desired result was attained.
   

The OQ must be carried out, when the equipment is ready to produce product. It must not form part of the commissioning program. All settings and adjustments must have been established prior to OQ commencing.

FDA Compliant and Validation Online have produced interactive installation qualification protocol templates. The design has been arrived at through many years of authoring similar documents for all the major pharmaceutical companies. Each template is prefixed with an SOP which leads you through the document in a proactive manner. A lot of thought and experience went into the design of these documents, making them extremely user friendly and highly cost effective.

These documents have been priced at around the cost of one hour of a protocol author’s time, and I have never heard of an OQ an hour from these guys. With the template downloaded, it is very easy to auto populate the template in minutes and complete the SOP requirements in a further twenty minutes or so, allowing you to produce an OQ in less than an hour, and sometimes even quicker. Where you save, and save big time is when you have a whole array of equipment, it is quite possible (and we have done it) to raise twenty OQ’s in a morning and have them out for peer review and approval by the afternoon.