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ROI CalculatorIQ, OQ, and PQ are the acronyms that the industry uses to refer to the three parts of the validation process of a device that are Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). It ensures regulatory compliance and reduces consumer/patient risk. IQ/OQ/PQ demonstrates that all of the equipment used in the production of the device has been validated to consistently and reliably function as designed.
In the medical device manufacturing industry, production process failure can result in serious harm to patients. Here’s an overview of IQ, OQ/PQ and their respective functions in validating manufacturing systems.
Installation Qualification - IQ is the process of validating that any installations of process and/or utilities required for any manufacture of a medical device are installed according to the requirements of the supplier as specified in their manufacturer’s instructions.
Operational Qualification - OQ is the next step of validating that the equipment is able to perform within the established process specification limits, including determining potential failure modes, establishing action levels and determining worst cast scenarios.
Performance Qualification - PQ is the final phase of the validation process ensuring the manufacturing system is capable of producing a medical device that will perform as intended within the specified operating conditions, under so-called “normal” operating conditions.
According to the FDA, “Process validation is the collection and assessment of data, from the stage of developing the process through to commercial production that provides scientific evidence that a process can consistently produce quality products”.
To ensure that the processes are validated correctly, all 3 steps, IQ, OQ and PQ, of the equipment used to manufacture devices must be performed and documented by the manufacturers.
The 3 steps provide different forms of validation of the equipment and processes associated with the equipment.
It is vital to remember that the Validation Process occurs in this order IQ, OQ and PQ, thus, OQ will not occur until the equipment has been installed correctly and PQ will not occur until the equipment is working.
The IQ answers this question, “Have all items been installed correctly?” Before testing for the performance of the equipment you must ensure it was delivered and installed correctly. IQ is a documented process that verifies the equipment and associated parts in accordance with the manufacturer's specifications.
Operational Qualification answers two questions: How do we know everything is functioning correctly? What are the operating limits of this device?
After performing the IQ, Operational Qualification verifies that the device works according to the user's needs and the manufacturer's operating range. OQ makes sure that the device operates as it was designed to.
Performance Qualification answers two questions: How do we know that this process produces the correct result? How do we know that this process is safe and consistent?
Similar to Operational Qualification, Performance Qualification verifies that the device produces the correct result consistently, under actual operating conditions.
