Quality assurance is a systematic procedure for determining whether a product or service meets established requirements (QA). QA establishes and maintains set requirements for creating or manufacturing dependable products. A quality assurance system is intended to increase customer trust and credibility while improving work procedures and efficiency, allowing a business to compete more successfully.
Significance of quality assurance
Quality assurance assists a corporation in developing products and services that fulfill consumers’ demands, expectations, and standards. It leads to high-quality product offers that earn the trust and loyalty of customers. The rules and processes of a quality assurance program aim to prevent product flaws before they happen.
Vital quality assurance
Quality is not only vital but is required in regulated businesses. Products that do not meet a given quality standard are more likely to cause harm to a consumer if they become ineffective or have design defects in these areas. Many of these products are so identical that a consumer can’t distinguish between a high-quality product and one that is hazardous with their naked sight.
As a result, regulatory authorities intervene and mandate a certain quality assurance (QA) level in particular industries. The pharmaceutical, hospital and healthcare, medical device manufacturing, food and beverage, and aerospace industries are a few tightly regulated businesses.
The IQ OQ PQ procedure is one of the most important steps in ensuring that new systems or equipment can perform as expected. Companies in these industries must adopt rigorous quality assurance methods into production operations and even workstation design to comply with these rules. In this quick tutorial to IQ OQ PQ, we’ll go over exactly what this process is, how it works, and how it pertains to quality assurance.
Installation Qualification (IQ)
The installation qualification is the first step in the IQ OQ PQ process. This stage lays forth a plan for getting new equipment into and out of the installation process. The procedure begins even before the new equipment is delivered to the company.
QA checks are conducted here, based on spec sheets and the results of any pre-shipping testing conducted, to ensure that the product fulfills the buyer’s requirements. The quality assurance procedures are carried out throughout the shipping, handling, and installation operations.
The first stage also sets the tone for the rest of the process. Making sure the equipment is installed correctly will allow you to focus on the OQ and PQ procedures without worrying about the equipment failing.
Correct IQ will also help your firm save money. If you can detect and correct any problems before installing the equipment rather than afterward, you’ll save a lot of time and money.
What makes IQ successful?
The success of an installation is usually determined by how closely the process adhered to the manufacturer’s instructions and satisfied their expectations.
The following areas of attention are frequently included (but are not limited to):
- The installation’s location as well as the required floor space
- Any and every computer-controlled instrumentation must be documented.
- Getting all of the manuals and certificates together
- Instruments must be properly unpacked and cross-checked.
- Checking for damage to devices and components
- Ensure proper electrical supply
- Auxiliary devices are being installed.
- Versions of firmware and serial numbers should be documented.
- Operating and environmental conditions
- Examining the software system’s installation and usability
- Dates of calibration and validation of IQ tools are kept on file.
- Verifying peripheral unit connections and communication
Operational Qualification (OQ)
During the OQ process, QA specialists look for specific elements. They want to make sure that every piece of equipment is in functioning order. They want to make sure that all of the utilities are properly connected. They also want to ensure that all safety measures, redundancies, and troubleshooting procedures are functioning properly.
It’s time to move on to the second stage of OQ after confirming that all aspects of the equipment are working properly. The machine’s operational parameters are tested in the second phase. This entails examining what occurs to the equipment and its processes while in operation.
You’ll want to know how long functions take, what temperatures the machine achieves, and how much pressure it puts out at this point. This is where you’ll learn if a piece of equipment becomes too hot or if a process slows down over time.
What makes OQ successful?
The following are common examples (but not limited to):
- Temperature variations and control
- Air flaps and servo motors
- Temperature control devices
- Access control and card readers
- Vacuum and pressure regulators
- Distribution of temperature
- LED signaling and display units
- CO2 regulates
- Humidity control and measurement
- Controls for fans and fan speeds
Performance Qualification (PQ)
PQ is last but not least. This is the point at which you finally integrate the new piece of equipment or system into your unique process and evaluate its performance. First, double-check that it’s compatible with all of your other systems and equipment and that everything is working properly.
If everything goes smoothly, you can test the equipment as close to real-world situations as possible to determine if it fits your overall process. You can also push the equipment to its limits to create high and low operational ranges. This enables you to be ready for any eventuality and define the equipment’s maximum operating range.
This is your final chance to catch any issues you missed during the IQ and OQ rounds. You’ve cleared everything up most of the time by this point, but it’s still a good idea to go through the three-step process just in case something was overlooked.
PQ is also the time when your standard operating procedures are finalized (SOPs). These instructions will show everyone who will be utilizing the equipment how to operate it safely and effectively and the best practices to follow.
Conclusion
Quality should be the most important factor in any industry. In heavily regulated businesses, failing to maintain high-quality standards might result in significant financial penalties. This is why it is critical to implement quality assurance procedures like IQ OQ PQ. This crucial quality assurance procedure will ensure that it meets the highest standards and functions as intended whenever you introduce something new into your process. You may rest comfortably that you’ve done everything possible to qualify your new equipment or system if you go through the IQ OQ PQ process.
