With strict regulations in place, healthcare companies must keep quality assurance processes as a top priority. When you consider the potential risk associated with medical equipment that does not meet strict quality assurance guidelines, it makes the process of verifying the function of that equipment before it gets used all that more important. In this article, we take a look at those processes and break down how each fits within the healthcare system.
IQ OQ PQ – What Do They Mean?
A quality assurance system outlines the equipment and process validation protocols necessary for delivering consistent, high-quality healthcare services. This is accomplished through the implementation of the IQ OQ PQ processes used to validate equipment and utilities used in the healthcare industry. IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) are the three main phases that comprise the quality assurance and validation process. This system is used for each new piece of equipment before it can be used. The IQ OQ PQ system must be followed in sequential order to demonstrate that the equipment offers a high level of quality assurance and that it will consistently meet all regulatory and quality requirements. Typically, IQ OQ PQ protocols are used in industries with heavy regulations. Examples would include the aerospace, healthcare, and medical device industries. IQ OQ PQ protocols are also commonly implemented in settings where product quality may affect consumer safety such as in hospital operating rooms, medical laboratories, medical devices, and pharmaceuticals. In other words, wherever cGMP (current good manufacturing practices) are in place, IQ OQ PQ protocols are also used.
IQ (Installation Qualification) In Healthcare
This is the first step of quality assurance that newly modified, upgraded, or installed medical equipment must pass. The goal is to determine if the equipment can deliver the expected results outlined by the design qualification. The design qualification (DQ) is the set of protocols that verify the ability of the product design to meet the requirements of that design. In the IQ phase, the equipment, hardware, or software is tested to see if it washandled, delivered, and installed following the DQ requirements. The IQ step in the healthcare industry may include such things as inspecting the item to see if there are any damaged or missing parts, verifying that the contents meet the packaging list, that all connections work, the confirmation of software installation, and more.
OQ (Operational Qualification) In Healthcare
When all IQ steps are completed, the second phase begins. During the OQ step, medical equipment undergoes testing to ensure that it works according to the specifications of the design. Tests are conducted under controlled conditions to see if it performs well within the manufacturer’s established operating range. The testing includes all parts, features, and aspects of the medical equipment being examined. The goal of this phase of quality assurance is to determine if and how different environmental conditions affect equipment performance. The OQ part of the process requires a more in-depth look at software or hardware operation, equipment startup, safety, and, if applicable, related maintenance protocols.
PR (Performance Qualification) In Healthcare
This is the final step in the quality assurance process. As the name implies, this is where the performance of the equipment being tested is checked. The specific goal is to verify and document evidence that the medical equipment, software, or device does what it is supposed to do. It must perform its duty with consistency with easily reproduced outcomes that fall within a specified performance range. Testing is conducted under what would be considered normal working conditions. A carefully executed test plan must be used that aligns with the description of the process. Once the equipment has passed through this phase, it is deemed worthy of beginning its intended operation.
The Reason For IQ OQ PQ
Safety is the primary purpose of the IQ OQ PQ protocol. At times products that come out of a mass-produced setting don’t work properly. Sometimes a piece is missing or a feature of the product fails because it was damaged during transport. The IQ OQ PQ protocol provides the steps necessary to follow the product from unboxing to implementation where it is examined and tested to make sure it contains everything it is supposed to have and works in the way it is supposed to work. If a problem is detected anywhere along the IQ OQ PQ process, specific steps exist to rectify these issues. Often, this involves contacting the manufacturer for a solution. The purpose of following the IQ OQ PQ steps is to identify issues before the equipment goes live thereby preventing the potential for an incident that may result in damage to the equipment or harm to someone using it. Although quality control processes exist at the manufacturing phase, IQ OQ PQ takes over when the product is received by the consumer. Think of the process as the final steps to make sure everything works as it should according to the specifications the item was designed to meet.
Final Thoughts
If everything worked the way it was supposed to, there would be no need for quality assurance systems. However, not everything goes according to plan, and sometimes a piece of equipment, software, or hardware, leaves the manufacturing plant with a hidden problem. Using IQ OQ PQ protocols assist in identifying those problems before the equipment is used in normal conditions. In heavily regulated industries such as healthcare, the risks of equipment failure are best avoided. This is why quality assurance protocols such as IQ OQ PQ are implemented. They provide data that indicates whether or not a piece of equipment is safe to use and that it does the job it was created to do correctly. Thankfully, when these protocols are used they build trust within the healthcare industry.
