The modern healthcare system is consumer-driven, tech-heavy, and fast-evolving with the help of technological advances. As part of a heavily regulated industry, healthcare companies must always stay on top of their quality assurance processes because even the tiniest inconsistencies can turn into serious predicaments without the correct validation and qualification protocols in place.
For instance, using a poorly calibrated medical refrigerator can spoil vaccines and medicines, resulting in poor patient outcomes. Similarly, if a piece of equipment in the operating room isn’t working as intended, errors resulting from its continued usage can trigger a chain of dangerous and possibly deadly consequences.
For this reason, carrying out equipment and process validation as part of an overall quality assurance system is absolutely important to delivering consistent, high-quality healthcare services. IQ OQ PQ is a crucial set of protocols for validating medical equipment and utilities.
This explainer article will take a quick look at IQ OQ PQ and its critical role in the healthcare validation process.
What is IQ OQ PQ?
IQ, OQ, and PQ are acronyms for installation qualification, operational qualification, and performance qualification, respectively. Together, they’re called IQ OQ PQ, denoting the three core phases in the quality assurance and validation process that a new piece of equipment must go through before becoming active.
Technically, IQ OQ PQ is a set of sequential protocols or methods which must be executed to demonstrate that the equipment installed or being used offers a high level of quality assurance so that it will consistently meet regulatory and quality requirements.
IQ OQ PQ protocols are typically employed in highly regulated industries, such as medical devices, healthcare, and aerospace. They are also commonly applied in industries where product quality can affect consumer safety, including medical laboratories, hospital operating rooms, medical devices, and pharmaceuticals. As you can see, most of these industries fall under the jurisdiction of the FDA.
IQ OQ PQ is therefore used in areas where cGMP (current good manufacturing practices) are typically employed. The majority of the protocols will be instantly familiar to industry players with an in-depth knowledge of cGMP guidelines.
Because IQ OQ PQ in healthcare comprises complex concepts, we will break them down into more digestible individual phases.
Installation Qualification (IQ) for the Healthcare Industry
IQ is the first step in the equipment qualification process. Newly modified, upgraded or installed medical equipment must first go through the installation validation process to determine if it can deliver the desired outcomes dictated by the design qualification.
Design qualification, or DQ, is a set of protocols that document the verification of the ability of a proposed design to meet quality requirements. In the IQ phase, the piece of equipment, hardware, or software is challenged or tested to verify that it has been handled, delivered, and installed correctly according to the DQ specs.
For healthcare companies, IQ requirements for the equipment may include checking for missing or damaged parts or whether included hardware meets applicable software requirements, such as HIPAA regulations. At this stage, you can also check the contents against the packaging list, verify connections, document computer-controlled instruments, and confirm software installation.
In general, IQ helps verify that a unit of equipment or instrument (along with its supporting systems) has been installed and configured according to the manufacturer’s specs or, at minimum, the installation checklist.
No matter if it’s a hardware or software system being qualified, the FDA makes it clear that the system must have the essential “prerequisite conditions” to work as intended. You must document any applicable cGMP requirements in the Validation Master Plan (VMP) when performing IQ activities.
This isn’t a one-and-done process. The re-qualification process must be carried out each time the equipment is updated or modified. Subsequent IQ can also be performed as part of essential healthcare quality assurance processes.
Operational Qualification (OQ) for the Healthcare Industry
After completing all IQ protocols, it’s time to move onto the operational qualification phase (OQ) of the quality assurance process. During this stage, you will test your medical equipment to make sure it performs according to the design specifications, under controlled conditions. In other words, does it function within the operating range described by the manufacturer?
All parts, features, and aspects of the medical equipment must be tested and the results documented accordingly. In this phase, you must also determine if and how environmental parameters (such as humidity and temperature) affect the performance of the equipment.
In practice, OQ means that you should identify and inspect the equipment thoroughly, making sure to focus on features that can affect performance, quality of care, and patient outcomes. Because OQ is a prerequisite for acceptance of the unit, these protocols can only be executed after the installation qualification has been performed.
In action, operational qualification acts as a more in-depth review of software or hardware operation, startup, safety, and maintenance protocols (if they are relevant). It can only be successful when everything gets the OK from an operating standpoint.
Performance Qualification (PQ) for the Healthcare Industry
Performance qualification (PQ) marks the final phase of the healthcare essential quality assurance process. The name says it all – this step involves verifying and documenting the evidence that the medical equipment, device, or software is performing with steady, reproducible outcomes within a specified performance range simulated in actual working conditions.
You’re not testing and verifying the equipment one component at a time. Instead, PQ protocols are designed to run concurrently and challenge the whole system. If the equipment unit is part of a larger system, it should be tested as such.
However, prior to carrying out PQ tests, the validation team should craft a well-thought-out test plan that aligns with the process description. That’s because the success of the PQ will rely heavily on the completeness and accuracy of the test plan.
IQ OQ PQ protocols are a core component of the healthcare quality assurance process. Their goal is to ensure ongoing quality by verifying and documenting performance for specific healthcare processes, software, and equipment over an extended period.