Developing and manufacturing a stable and safe medical device is difficult for even the most experienced manufacturers. How can you ensure you manufacture highly predictable medical devices that offer consistent performance with minimal variation? The answer is process validation.
Process validation is the framework around your medical device manufacturing process that ensures your device is installed and operates appropriately while providing continuous and stable performance.
After Installation Qualification (IQ), the second significant process validation phase is Operational Qualification (OQ).
Operational qualification is performed after you've successfully completed installation qualification and answers the questions "Is my device operating correctly?" and "What are my device's operating limits?".
The FDA defines operational qualification as "…establishing confidence that process equipment and sub-systems are capable of consistently operating within stated limits and tolerances."
Operational qualification should be done when a device has been installed, maintained, or modified. It can also be a part of scheduled quality assurance testing.
Operational testing verifies that all equipment and associated accessories and parts perform according to specifications and pre-set thresholds. You are checking that all the items in the test plan are tested and that the performance and results are documented.
You should review hardware and software and all their associated procedures, such as maintenance, operation, cleaning, and safety. In practice, that includes checking the operation of the whole device and all its parts, which can include:
Short answer: It's required by the FDA.
The longer answer is that, like installation and performance qualification, operational qualification offers several benefits to medical device manufacturers:
When performing operational qualification, you should generally establish an operational process that includes the following activities:
Once you have your process in place, you can start your operational qualification.
The first step is establishing your process window. You do that by choosing input and output factors. For example, for a heat-sealing process, your input factors are temperature, time, and pressure, while your output factor could be seal strength.
Next, you run your operation in worst-case settings or worst-case situations. In the case of our heat-sealing process, upper limits could be 160°C, 2.5 hours, and 3.5 PSI. Once you've tested your device at its upper and lower limits, you know that your device still performs as intended, even in the worst-case scenario.