The three Qs, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) are a trio of protocols used in the validation process of hardware and software. It is vital to complete equipment validation using these protocols because they form part of the Quality Assurance (QA) requirements that can identify minute variations that could result in a complication that, if unchecked, could prove to be damaging in one way or another. In this article, we will explore the importance of QA, and break down what each of the three Qs means and what they are used for in the validation process.
The Importance of Equipment Validation
QA Standards, as the name implies, ensure that high-quality standards are used when validated equipment is used in the manufacture of products. The Food and Drug Administration (FDA), for example, requires verification protocols for equipment utilized in industries with strict regulations. This includes the production of medical devices and medications such as vaccines and drugs. In simple terms, the validation process ensures that the products you use are safe when manufactured by equipment that meets specific quality requirements when being made.
What Is IQ (Installation Qualification)?
Installation Qualification is the first step of the validation protocols. IQ verifies that the proper equipment has been delivered to the correct recipient, has been properly installed and configured according to either manufacturer specifications or to an installation checklist that was previously approved for the installation. The importance of IQ relates to the fact that the way the equipment is installed will affect the performance of the equipment. In other words, if the equipment is not installed according to specifications, a risk of failure exists that could result in product damage or loss. You can read more about the possible consequences of a poor IQ process in Dickson’s IQ OQ PQ guide.
Why IQ Matters
Essentially, for equipment to function properly, it requires certain conditions. This can be adequate floor space, correct connections to other equipment (if necessary), and an inspection to ensure all parts are in good working order. Again completing IQ is also required should the equipment be moved, upgraded, or modified in any way.
What Is OQ (Operational Qualification)?
The second step in the validation process is Operational Qualification. In this phase, equipment features undergo individual testing to verify that each of the features meets the manufacturer’s specified operational ranges. During the testing process, OQ examines how the features affect the quality of the products being produced. This can lead to the identification of potential problems, if they exist. Another way of looking at OQ is to consider it the step that proves whether or not the equipment being tested will properly create the products it is meant to produce.
Why OQ Matters
There are four main areas of OQ focus. They include: startup of the equipment, overall operation of the equipment, equipment maintenance, and equipment safety. This is accomplished through various tests that may include temperature controls, speed controls, all switches, and moving parts within the machinery.
What Is PQ (Performance Qualification)?
Performance Qualification is the final step in the verification protocol process. This is the part of the process in which the equipment is tested in real-world conditions to ensure that it will produce the products expected. Although this may sound much like what happened in the OQ phase, there is a very distinct difference between the two. During the OQ process, individual features of the equipment were tested. In the PQ part of the validation process, the equipment is tested with all features operating together to verify that they are working together as they should be.
Why PQ Matters
During tests conducted in this phase, such things as noise, vibration, temperature, and pressure are monitored. The tests use a real load to see the results of the operation of the equipment just as if it were working on a specific project. The purpose of PQ is to verify that product quality standards are being achieved on an ongoing basis over a given time frame.
More On QA
It is important to note that Quality Assurance measures are protocols used on certified equipment. That is because any equipment that will be used in a manufacturing plant setting has to meet the standards set within the industry they are being used for. Machinery that has not been produced by verifiable sources and does not have certifications from regulatory authorities should not be used for the mass production of any product where quality is the top priority. Although the three Qs can be conducted by in-house staff, it is recommended that the entire process be outsourced to a specialist in this field. Although outsourcing this process may prove to be more expensive than having it done in-house, the overall cost is less when you consider the ongoing training required to have staff fully qualified at all times to conduct the Quality Assurance protocols. Plus, by having a third party conduct the verifications, your business will face less downtime.
Standards control many . They control how certain products are manufactured which ensures safety from the production floor to the consumer. One set of safety protocols developed to address this issue is something known as the three Qs – IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). These three steps are conducted with certified equipment to verify that the manufacturing process can be conducted with safe equipment that has been installed properly, operates within the manufacturer’s specifications, and performs the tasks it was created to perform with ease and high quality from start to finish. Another important factor to consider about the use of the QA protocols is that any manufacturing facility that follows these guidelines will tell you that they are professional and adhere to specific standards that will be extended to your products. Knowing that such validation systems are in place should also be a relief to companies that rely on manufacturing facilities to produce their products for the consumer market.