Developing and manufacturing stable and safe devices is difficult for even the most experienced manufacturers. How can you ensure you manufacture highly predictable products with consistent performance and minimal variation? The answer is process validation.
Process validation is the framework around your manufacturing process that ensures your device is installed and operates appropriately while providing continuous and stable performance.
The third significant phase of process validation, after Installation Qualification (IQ) and Operation Qualification (OQ), is Performance Qualification (PQ).
Performance qualification answers the questions, "Does my process produce the right results?", and "Is this process safe and consistent?"
The FDA identifies it as "…establishing confidence through appropriate testing that the finished product or process produced by a specific process meets all release requirements for functionality and safety and that procedures are effective and reproducible."
Performance qualification verifies that your device consistently produces the correct results during real-world use and normal conditions. Performance qualification should be performed in conditions as close to real-world use as possible, including being in the facility where the device will be used, trained personnel, using the equipment as intended, and ensuring the same manufacturing processes used when the device is launched into the market.
What tests are performed during performance qualification depends entirely on the device in question. Manufacturers should consider their target user and patient groups and environmental conditions when setting up their performance qualification protocol.
Generally, performance qualification should consider the following:
A performance qualification could demonstrate:
Some potential nonconformities that can be identified during performance qualification include:
The FDA recommends establishing written performance qualification protocols that include the processes and conditions surrounding the qualification. This could include:
Once the performance qualification has been done, you should prepare the report, summarizing all the collected data and addressing any issues or non-conformities. Each step of performance qualification should include instructions, expected results, and actual results. Any discrepancies between expected and actual results should be tracked and resolved before the validation is complete.
It is also essential to analyze the performance qualification data to determine the normal range of variation. The range of variation will help determine if the device or process is operating normally and in a state of control and if it can consistently produce the expected and specified output. Any variations that can be controlled, such as temperature, humidity, light, material variability, and more, should be eliminated to ensure a higher degree of consistency and degree of assurance in the device's performance.
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.
Short answer: It's required by the FDA.
The longer answer is that, like installation and performance qualification, operational qualification offers several benefits to manufacturers: