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Saturday, April 17, 2021

The Quality Assurance Practice More Organizations Need in 2021

There is a lot going on in the world right now that manufacturing companies can’t control. For some, it is the rules and lock downs put in place to stop the spread of Covid-19. For others, it is the increased demand for items that can help us get past this terrible time, like vaccines. Regardless of how chaotic times might feel, the one thing that manufacturers can control is the quality of what they produce.

A commitment to quality assurance (QA) is a big factor that will separate successful companies from the unsuccessful ones in 2021. This is especially true in certain industries, including highly regulated industries such as aerospace, food and beverage, and industries that are very much in the news right now such as the pharmaceutical, healthcare, and medical device industries.

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One of the best ways to commit to quality insurance is by adopting IQ OQ PQ principles. This stands for installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), and is a widely-accepted quality assurance standard. The idea behind IQ OQ PQ is to qualify all new manufacturing equipment or systems before implementing them into the manufacturing process.

This helps ensure that a machine or system is up to the task before it gets fully implemented in the live manufacturing process. Here we’ll discuss each step of this process in detail to illustrate why this is the quality assurance practice more organizations need in 2021.

IQ

The first step of the IQ OQ PQ process is installation qualification. This occurs at or before the time a new piece of equipment or a new system is first delivered. The goal of IQ is to make sure that what is delivered matches the specifications of what was purchased and that these specs match the needs of the manufacturer. Once the specs are confirmed, the IQ process confirms that the equipment is properly handled, delivered, and installed into the plant or factory.

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To confirm that these parameters are met, the manufacturer receiving the goods needs to consult both the product specifications as well as the installation instructions set forth by the manufacturer of the equipment. If there are any tests done on the equipment prior to delivery and installation, those results also need to be examined.

IQ is an important first step of the IQ OQ PQ process because catching any issues with equipment or systems early is the best and most cost-effective way to avoid QA issues down the line. If a manufacturer realizes that something is not up to spec or is not installed properly after the manufacturing process starts, it will not only cost time and money to remedy the problem, but chances are that any products that are already produced by this piece of equipment or system will not be up to quality standards.

OQ 

Following the IQ step of the process is the operational qualification (OQ) process. The first part of OQ should be done concurrently with the IQ process. This involves testing the equipment before it is delivered to make sure that it works in accordance with the required specifications and that all the individual systems and safety measures also work as intended.

 

This step is sometimes referred to as a Factory Acceptance Test and is done at the manufacturer’s factory before delivery so that the buyer can see that the equipment is working to spec and that all the systems work as intended. It is, again, another way to head off any problems before you integrate the equipment into your processes and issues would become major costs. It is a “try before you buy” way of ensuring quality.

 

The second part of the OQ process happens once the equipment is installed and the IQ process is complete. This involves running the equipment or system to establish parameters for operation and to see how or if the operation of the equipment affects the materials in the manufacturing process.

 

This second step shows you how to run the machine in order to achieve the desired results with the material you work with. How hot does the machine need to get to melt what it needs to melt? How much pressure does it need to exert to bond two things together? How much capacity can it handle and still get the job done? These are all questions that need to be answered during the OQ process.

PQ

The final step in IQ OQ PQ is the performance qualification (PQ) process. Just as the OQ process builds on the IQ process, the PQ process builds on the OQ process. After the equipment is run and tested on its own to understand the overall parameters that it can and should operate at, the PQ process integrates the equipment or system in the full manufacturing process to make sure that it can hold up its end of the process and create the quality products in a repeatable way.

This part of the process involves running your entire process, including the new equipment, under real-world conditions and with the operators who will be using the equipment on an everyday basis. Here is where you also want to test the equipment under extreme conditions to understand how hard or how far you can push it and still get the desired results.

This final stage is also where you fine-tune the process and make sure it meets the highest QA standards. This means fine-tuning the standard operating procedures that come out of the OQ process and confirming that the equipment meets all the regulatory standards for your industry.

When you are finished with the IQ OQ PQ process, you should be incredibly confident that the equipment you have brought on is of the highest quality and that the products it helps produce will be of the highest quality as well. If you’re looking for more detail on the IQ OQ PQ process, Dickson’s guide is a good place to start.

Conclusion

In these uncertain times, quality assurance is one of the most important processes that manufacturers can control. One of the best ways to do this is by putting new equipment and systems through the IQ OQ PQ process. When you qualify new equipment from the time you order it from the manufacturer to the time you run it live in your plant or factory, the quality of the products you produce should improve and be at the top of your industry.

 

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