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In regulated industries, quality assurance is paramount. It is important in many industries but in those that are regulated by the government, quality assurance takes on a critical role. Not adhering to strict quality assurance guidelines can not only mean losing customers, it can jeopardize people’s health and safety in addition to running afoul of the government. This can lead to very harsh penalties.
Because quality assurance is so important in such heavily regulated industries as the pharmaceutical, food and beverage, aerospace, healthcare, and medical device industries, companies in these areas must adhere to extremely particular quality assurance practices and procedures. One of the intensive quality assurance practices in these industries is known as IQ OQ PQ.
Many people may not be familiar with IQ OQ PQ but most of the products we use in our everyday life are created with equipment that underwent this process. Adhering to IQ OQ PQ ensures product quality and helps make our lives safer. To help people understand more about this quality assurance process, we will explain what are IQ OQ PQ and how they relate to product quality.
What is IQ OQ PQ?
These three acronyms stand for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). This quality assurance process is widely used in many industries but is especially important in heavily regulated industries. We’ll describe what each term means below. If you’re really interested in digging deeper, Dickson has a detailed guide to each step of the IQ OQ PQ process for additional information.
The main idea behind this quality assurance procedure is that IQ OQ PQ is used to qualify new manufacturing equipment or systems before they become part of the company’s manufacturing processes. It makes sure that systems and equipment can meet all process requirements before ever making a product that goes to the public. It is an incredibly important first step towards quality assurance in any highly-regulated industry.
Installation Qualification (IQ)
Installation qualification is the first step of IQ OQ PQ. Companies begin the IQ process before they accept delivery of the equipment or system. In this step, companies want to make sure that the specifications of the equipment they bought are indeed met in the equipment received. If this is confirmed, IQ continues by making sure the equipment is shipped, handled, and installed properly. To do this, the people responsible for IQ must consult the specification sheets, installation instructions, and review any tests that may have been done on the equipment pre-delivery.
These steps may be the most important part of the IQ OQ PQ process, if not the most important. It is definitely the one that will save companies the most time and money when done right. Catching an issue with any new piece of equipment before it is even installed in a facility is much better and more cost-effective than catching the problem later. When this is done right, it sets the equipment or system up for quality assurance success all the way down the line.
Operational Qualification (OQ)
Some parts of operational qualification start at the same time or even before the IQ happens and some steps follow that part of the process. The main idea behind OQ is to test the equipment to make sure it runs properly and that all the systems and safety measures work as specified. The first part of OQ, performed with or before IQ, is occasionally called a “Factory Acceptance Test”. This can be done upon delivery or before the equipment even leaves the manufacturer’s warehouse.
This first stage of OQ involves turning the machine on and seeing how it runs. This may sound simple but many pieces of equipment operate with multiple systems that have to be checked when the machine is up and running. This includes all mechanical parts, digital systems, and safety features the equipment is supposed to have. If the OQ goes well, then you can finish with the IQ step and move on to the second part of OQ.
The second part of OQ involves running the equipment to establish parameters for the equipment while it is working. This means gauging the time it takes to do its job or the temperature or pressure ranges at which it should be run. Operators can also test other factors in this process such as the capacity of the equipment. When this stage is finalized, it is time to move on to the last piece of IQ OQ PQ.
Performance Qualification (PQ)
Performance qualification is the third and final step of this quality assurance process. Following IQ and OQ, the equipment should be fully operational and the inspectors should be aware of the normal parameters within which the equipment can function. During PQ, the equipment is integrated into the process it will eventually become a part of and is tested and fine-tuned under real-world conditions.
Running under real conditions helps uncover a few fine points about the equipment. It will show if using it in your specific process changes the parameters at all and prove that it can handle the task in a repeatable way that is conducive to good quality.
In this stage, the equipment can also be tested under adverse conditions to see how it will run in a situation that is not ideal. This will better prepare the employees for what to do if they encounter external problems in the future. The fine-tuning piece of this process also lets companies develop their own set of standard operating procedures (SOPs) to use with the equipment.
Conclusion
In heavily regulated industries, quality is everything. It keeps people safe and keeps companies out of trouble with the governing bodies that regulate an industry. When adding new equipment or systems to a manufacturing process, IQ OQ PQ is a vital first step. This quality assurance process gives a company a firm base of knowledge that the equipment they are integrating into their procedures is of the highest quality and is capable of producing the best quality products.
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