Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are a set of protocols involved in equipment (both hardware and software) validation.  Equipment validation is a critical component of Quality Assurance (QA), as even slight inconsistencies can lead to serious problems.

Using these protocols helps to ensure that QA standards will be met when the equipment is used in product manufacturing. Verification of equipment specifications is required by the FDA and is especially important in highly-regulated industries such as the production of pharmaceuticals and medical devices.

In this article, we’ll go over what is generally involved in the three protocols, including what is being qualified, why it’s important, and what the protocol typically entails. 

Installation Qualification (IQ)

Installation Qualification (IQ) is used to verify that the equipment has been delivered, installed and configured in accordance with a pre-determined and approved installation checklist or the manufacturer’s specifications. IQ is important as the performance of the equipment will depend on how it is installed.

According to the FDA, the general goal of IQ is to ensure that the “system has the necessary prerequisite conditions to function as expected.”

Depending on the equipment in question, specifications to be inspected may include materials, dimensions, working temperatures and pressures, volume, flow rate, and torque. There will also be checks to ensure that the equipment is not damaged and that it has been installed in the appropriate location and correctly connected with other pieces of equipment, where applicable. 

From a facility standpoint, the IQ process might include ensuring the equipment has ample bench or floor space and checking it has the proper utilities supply. 

If the equipment is moved or modified, or undergoes major maintenance, it must be re-qualified. In addition, ongoing IQ can be built into routine QA protocols.

Operational Qualification (OQ)

Once IQ is complete, the next step is Operational Qualification (OQ). The main goal here is to determine that the equipment performs as expected. This sounds like it would fall under performance qualification, but we’re not quite there yet. During OQ, equipment features are tested separately to ensure that they meet the operating ranges specified by the manufacturer. In particular, OQ looks at any features that could have an impact on the quality of the final product.

The overall goal of the OQ protocol is to review any applicable procedures that relate to startup and operation, as well as maintenance and safety. It’s important that every component is tested individually so that any issues can be easily isolated.

Features that might be tested during OQ include temperature controls (include overheating or low temperature alarms), pressure and vacuum controls, fan or motor speed controls, and display units. Some tests might be very simplistic, for example, sending power to the unit to ensure a switch works. Others will be more involved, for example, flow or pressure tests.

Performance Qualification (PQ)

Finally, once IQ and OQ are complete, Performance Qualification (PQ) can commence. At this point, the equipment is tested under real-world conditions to check that it will function as expected and provide reproducible results. Whereas OQ tested components individually, PQ seeks to ensure that all components work together as required. Aside from testing the viability of the equipment for its purpose, results from PQ can set a benchmark for ongoing process validation.

The general goal of PQ is to ensure that product quality standards are met on an ongoing basis by documenting the equipment’s performance for select processes over a given period of time.  

Testing will involve a real load or medium and examines how the equipment works as a whole system across its specified parameters. Some of the things that could be monitored for in this phase of testing are vibration or noise, excessive heat, backflow of the medium, and pressure differentials.

Additional Comments

It should be noted that these protocols do not replace the need for certified equipment. Any equipment used in a production environment must still meet industry standards and carry certifications from relevant bodies. Indeed, a common component of an IQ protocol is gathering manuals and certifications for the equipment.

While these protocols may be carried out by in-house personnel, there may be benefit to outsourcing some or all of the components involved. In either case, equipment qualification and validation will come at a cost. While outsourcing may be more expensive, it can be beneficial to work with someone specializing in this area instead of training in-house staff to work on equipment validation on an ad hoc basis.