Define IQ, OQ, PQ in equipment qualification and provide a CBM T6 example.

• A. IQ installation qualification; OQ operational qualification; PQ performance qualification; example: validating a calibrated instrument setup, function, and performance.
• B. IQ quality issue; OQ quality oversight; PQ product quality.
• C. IQ initial qualification; OQ ongoing quality; PQ process qualification.
• D. IQ internal quality; OQ external quality; PQ process quality.

Answer: (A)

In equipment qualification, three checks form a progression to prove the equipment is ready for use. Installation Qualification confirms the device has been installed correctly, with all utilities, connections, software, and documentation in place and verified. Operational Qualification tests that the equipment operates as intended across its specified functions and operating ranges, including controls, interlocks, alarms, and safety features. Performance Qualification then shows that the equipment performs reliably under real production conditions, delivering results that meet predefined acceptance criteria with actual materials or simulated loads.

In CBM T6 terms, you’d approach a calibrated instrument like a temperature sensor in a production line this way: IQ verifies the sensor is correctly installed, wired, powered, and configured, with calibration certificates and manufacturer specifications on file. OQ checks that the sensor responds correctly to setpoint changes, reads within tolerance across its range, and that alarms and interlocks function as designed. PQ demonstrates that during an actual production run, the sensor continues to provide accurate measurements and stable performance, ensuring process control and data integrity. This alignment—installation, operation, and performance—is why the defined sequence is considered the best fit. The other options move away from these standard definitions by describing quality issues or ongoing/process quality rather than the established qualification stages.