In regulated industries, quality isn’t just important, it is mandated. In these industries, products that don’t adhere to a certain quality standard are very likely to do harm to a consumer if that product becomes ineffective or has design flaws. In the case of many of these products, the consumer generally isn’t able to tell the difference between a good quality product and an unsafe one with the naked eye.

For these reasons, regulatory bodies step in and prescribe a certain level of quality assurance (QA) in specific industries. Some of these highly regulated industries include the pharmaceutical, hospital and healthcare, medical device manufacturing, food and beverage, and aerospace industries.  

To comply with these regulations, companies in these industries must incorporate stringent quality assurance processes into manufacturing steps and even the design of workspaces. One process that is critical in establishing that new systems or equipment can get the job done as needed is called IQ OQ PQ. We will explain exactly what this process is, how it works, and how it relates to quality assurance in this brief guide to IQ OQ PQ.

Defining IQ OQ PQ

IQ OQ PQ is shorthand for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). It is a quality assurance process that is used to qualify new equipment or systems as they come online and become part of their processes. According to Dickson’s IQ OQ PQ guide, it is the primary standard regulated industries use to ensure product quality.

For any organization, each step allows those in charge of quality assurance to examine the equipment in a different way to make sure that it is what it should be, does what it needs to do, and ultimately works as part of the organization’s greater process. It is only after IQ OQ PQ has been finalized that a piece of equipment or new system can be fully and confidently integrated into the manufacturing process.

Installation Qualification (IQ)

The first step of IQ OQ PQ is the installation qualification. This step provides the roadmap to get new equipment up to and through the installation process. The process starts before companies even take delivery of the new equipment. 

QA checks happen here, based on spec sheets and by reviewing the results of any pre-shipping tests that were run, to make sure that the product meets the specifications the buyer needs.  The QA steps continue through the shipping, handling, and installation processes. 

As the first setup, this also sets the tone for all the other steps to follow. Making sure that the equipment is properly installed will allow you to thoroughly follow the OQ and PQ steps without having to worry about the equipment working properly. 

Proper IQ will also help save your company money. If you can find and remedy any problems before the equipment is installed, rather than later, it will save an incredible amount of time and money .  

Operational Qualification (OQ)

The second step, or more precisely, step 1B is OQ. This step happens concurrently with IQ and continues after IQ is complete. When you have verified the specifications of the equipment in the IQ process, the next step is to turn it on and see if it runs as specified. This is the beginning of the OQ process. 

During the OQ process, QA professionals are looking for specific factors. They want to determine that each part of the equipment is properly working. They want to be certain that everything is hooked up correctly to utilities. And, they want to find out that all the safety features, redundancies, and troubleshooting mechanisms work as specified. 

When it is confirmed that each aspect of the equipment is working correctly, it is time to move on to the second stage of OQ. Phase two tests the operational parameters of the machine. This means testing what happens to the equipment and its processes when running. 

In this stage, you want to find out how long functions take, what temperatures the machine reaches, and how much pressure it exerts. This is where you learn if a piece of equipment runs too hot or if the process slows down after running for a certain amount of time. 

Performance Qualification (PQ)

Last but not least comes PQ. This is the stage where you finally integrate the new piece of equipment or system into your specific process and see how it fares. First, you want to make sure it is compatible with all your other systems and equipment and that they all run smoothly together. 

If everything fits nicely, you can run the equipment under as close to normal conditions as possible to see if the new piece fits in with your overall process. Here is where you also push the equipment as far as you can to create high and low operational ranges. This allows you to be prepared for any eventuality and know how hard you can push the equipment. 

This is the last chance you have to catch any issues you may have missed in the IQ and OQ stages. Most times, by this point you have everything cleared up but that is why you go through a three-stage process, just in case something was missed. 

PQ is also the time you finalize your standard operating procedures (SOPs). These guidelines will tell anyone who will be using the equipment how to use it and the best practices to go through to get it to operate safely and effectively. This is a critical final step in the QA process. 

Conclusion

In every industry, quality should be of the utmost importance. In highly regulated industries, not maintaining high-quality standards can incur major costs. This is why it is so important to put QA procedures in place such as IQ OQ PQ. This vital quality assurance process will help ensure that anytime you bring something new into your process, it meets the highest standards and works as advertised. If you do this through the rigorous IQ OQ PQ process, you can rest assured that you’ve done everything in your power to qualify your new equipment or system.