The Equipment Validation Process

What is an IQ, OQ, PQ, and why is it important?

An IQ, OQ, PQ is a three-step equipment validation process.  It ensures that your instrument operates properly and is appropriate for its intended use.  The three steps – IQ, OQ, and PQ – stand for Installation Qualification, Operation Qualification, and Performance Qualification.

Installation Qualification

The first step, the Installation Qualification, ensures that the instrument is properly installed, and that the environment that it is installed in is appropriate for the use of this instrument.  In order to fulfill this step, reference is made to the manufacturer’s specifications.  These include electrical requirements such as voltage and frequency ratings, along with environmental requirements such as temperature and humidity.

Operation Qualification

Next is the Operation Qualification.  The purpose of this step is to document that the instrument is operating according to its specifications.  This includes testing the general functions of the instrument.  It is also useful to test the instrument at its specified range limits to ensure that it will still operate properly.  The Operation Qualification can be thought of as a check on the overall functionality of the instrument.

Performance Qualification

The last step is the Performance Qualification.  This is the process of demonstrating that the instrument performs according to a specification appropriate for its routine use.  During this step, the instrument must pass specific tests which ensure that it will reliably perform adequately for its intended use.  This may include adhering to industry standards and requirements.  For example, in the pharmaceutical industry, a PQ for an analytical balance will include USP requirements, such as passing a repeatability test with a 0.10 % tolerance specification.  It may also include a minimum weight calculation in order to verify the lower limit of the calibration range.

These three steps combine to form a comprehensive validation procedure for your instrument.  While the IQ, OQ, PQ validation is required in many industries, the main reason for it is to give you peace of mind that your instrument is performing as intended for your process in its specified environment.

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