IQ/OQ/PQ – Oh My!

Simplifying IQ/OQ/PQ Protocol

800x300_Medical Compliance

A product is only as good as the factory it is built in. This proves to be especially true in terms of medical devices. From a business perspective, meeting compliance regulations is one of the greatest challenges medical manufacturers struggle with. This is not to say it is always difficult to do (though it can be with such complicated products), but it is a long, time-consuming, and expensive process. Before any medical product can go out to the market, the manufacturer must be able to make sure, and prove, their device meets government regulations. One of the steps in this process is ensuring their factory equipment is meeting IQ/OQ/PQ protocol.

Why so many acronyms, you ask? Because they all affect the quality and the output of the factory. To elaborate there’s IQ - Installation Qualification, OQ – Operational Qualification and PQ – Performance Qualification. Each of these focus on a different performance aspect pertaining to factory equipment and contribute to overall quality execution.

Installation Qualification (IQ)

Every machine or instrument in a factory must be treated as a product on its own. As with any product, it has specific installation and setup instructions for optimal use. IQ is the process to ensure the factory equipment is setup as directed by the equipment manufacturer in optimal settings. The requirements may vary; sometimes size can play a role, or temperature, or both, but whatever that system needs, IQ is there to make sure it gets it.

Operational Qualification (OQ)

So now the equipment is in the door and ready to roll. The question is, does it do what it is supposed to do? OQ determines if the equipment’s performance delivers what was promised based on its documented specifications and within the defined ranges. In action, this means identifying and inspecting equipment features that can impact final product quality. Basically, OQ forces a user to go through all expectations of the system, including how it is run and how it is serviced, and document the results. Those results are then compared to the expectations of the system and confirm they fall within the right limits.

Performance Qualification (PQ)

Lastly, manufacturers must qualify performance of said equipment. This may seem like the most important part of the IQ/OQ/PQ process, but it simply cannot be executed without successful results from the previous two steps. This last point of qualification simulates real-world scenarios within predefined ranges and confirms repeatable results. This essentially determines if the equipment can be relied upon.

Keeping IQ/OQ/PQ Simple

IQ/OQ/PQ protocol is not identical for every medical device manufacturer. Depending on the type of device, environmental requirements, user interaction, etc., the content or order of verifications may change. While each company has their own defined strategy for execution, IQ/OQ/PQ is a global requirement for operations. Documentation of a successful IQ/OQ/PQ execution is needed, and some companies may even be audited by government entities to validate results. Standardization of test equipment is a very simple way to minimize overhead to meet requirements. A test partner that is familiar with not only quality requirements but also the manner in which the specific manufacturing facility is run is a major asset. By knowing the production facility’s standard mode of operation, IQ/OQ/PQ considerations can be implemented from the first design review. This is a golden ticket to better documentation and will minimize the headache of meeting compliance requirements. At the end of the day, these devices are supposed to make us feel better. Simplified manufacturing is a good place to start!

To speak with a test consult regarding medical manufacturing, please contact Averna.


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