Performance Qualification vs Operational Qualification

Performance Qualification vs Operational Qualification Medium Image

What does your dream home look like? Maybe it’s a beautiful home way up in the mountains, where the air is fresh and the land is quiet. You sit on your porch, enjoying a hot coffee as the weather turns brisk… And the first snowflake of the year falls. How exciting! This is your first winter up on the hill, and you had just bought the perfect truck to get through the winter weather.

The next morning, you wake up to a beautiful blanket of thick, fluffy snow. You smile knowingly, because you are sure you won’t be late for work. But when you go out to start your truck… It won’t start. You fiddle with it for a few minutes before you realize the battery has built up so much corrosion that the freezing weather killed it. Luckily, you are a handy person who can replace a battery. Soon, the truck is purring and ready to go. But as you move to drive down the road, it won’t shift into 4 wheel drive.

You slam the wheel, frustrated beyond belief. You had spent good money on this truck and invested hours researching it! You went to the dealership and told them exactly what you needed and they had just sold you this truck, promising it would get you down the hill in the winter. But here you are… stuck.

When you make large investments, it is important you do your own research, yes, but it is also important to work with people you trust who conduct the necessary tests to ensure the product will meet your needs.

In the cleanroom world, we see this a lot with Environmental Management Systems (EMS). Vendors will cut corners on testing and customers can only test for so much. That is why a solid URS, PQ, and OQ that work together and independently are critically important. But what exactly does that mean?

Let’s get into it!

What Is A PQ?

A PQ is a Performance Qualification for an EMS. Essentially, this is a test that is conducted by the user or the vendor of the EMS before the system becomes operational. This is often confused with an Operational Qualification (OQ), which we’ll address in a moment, but it should be different.