Design and Performance Qualification Explained

The true key to business longevity lies in your products. What you offer has to work as expected — more than that, it has to be safe, functional, and fit any standards you and other governing bodies have set forth. Ensuring that requires testing and more testing, and that's what performance qualification is all about.

What Is Performance Qualification?

The United States Food and Drug Administration (FDA) defines performance qualification (PQ) as establishing confidence in your finished product or process by testing it before release. This testing should determine whether:

• The product meets functionality and safety requirements.
• Any results can be easily reproduced.

For example, HunterLab's MiniScan EZ 4500 portable spectrometer can identify color using some of the most common color scales and indices. We promise this capability in the product's description. Before we could release that information, we had to complete performance qualification.

To do so, we tested hundreds of color samples to ensure that our spectrometer got the answer right every time. When it didn't, we adjusted our product and tested it again and again until it was as accurate as possible. By the time the product hit the market, we were sure it was ready for wide release.

What Are IQ, OQ and PQ Protocols?

Performance qualification is just one aspect of what is known as design qualification (DQ). There are three sections of DQ — IQ, OQ, and PQ. Each is vital in making sure your business offers what it says it does, preventing liability concerns and instilling trust of your products in your clients.

Installation Qualification (IQ)

Installation configuration concerns itself with the manner in which the product has been installed. An IQ check considers the manufacturer's specifications for factors such as:

• Floor space requirements
• Product damage
• Software compatibility
• Power connections
• Ancillary part installation
• Adequate operating conditions

Operational Qualification (OQ)

Once IQ is complete, it's time for OQ. Operational qualification measures output levels and performance to determine whether they're within specified manufacturers operational guidelines. During this stage, tests can include:

• Instrument accuracy
• Instrument repeatability
• Temperature controls
• Pressure controls
• Humidity levels
• Fan speed
• CO2 controls

Performance Qualification (PQ)

PQ is the final step in the DQ process. It tests the system as a whole for suitability for its intended purpose, so you can see how consumers will interpret the final product.

Invest in Color Measurement Solutions From HunterLab

Simplify your design qualification process by shopping our selection of benchtop spectrometers and portable spectrometers. They integrate seamlessly with our quality control solutions and will let you spend less time testing and more time developing new processes.