What is IQ OQ PQ and why do Manufacturers need it?
In manufacturing, the process of designing, testing, and validating equipment and systems is critical to ensuring quality, reliability, and compliance with regulations. One widely accepted method for achieving this is through the validation of IQ OQ PQ.
IQ, OQ, PQ stands for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These are three distinct stages of validation that are carried out sequentially, and each stage involves specific tests and documentation to ensure that the equipment or system being validated meets the requirements and specifications for its intended use.
The IQ stage verifies that the equipment has been installed correctly and that all components are present and properly installed. This includes checking that the equipment is connected to the appropriate power supply, that it is grounded correctly, that all necessary connections have been made, and that the equipment has been calibrated and verified according to its technical specifications.
The OQ stage is where the equipment or system is tested to ensure that it operates according to its specifications under normal conditions. This stage involves testing the system's functionality, verifying that it meets the manufacturer's specifications and that it can perform the tasks for which it was designed. This includes testing things like control systems, alarms, and interlocks, as well as verifying that the system can operate within specific temperature, humidity, and pressure ranges.
The PQ stage is the final stage of the validation process and focuses on demonstrating that the equipment or system consistently produces the desired results under normal operating conditions. This stage involves running the equipment or system for an extended period while monitoring its performance and ensuring that it meets the requirements for its intended use.
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The Relevance of IQ OQ PQ in Manufacturing
IQ OQ PQ compliance provides a structured equipment and system validation approach that ensures quality, reliability, and compliance. By following the IQ OQ PQ approach, manufacturers can ensure that their equipment and systems operate and are installed correctly, that they meet the intended specifications, and that they are consistent and reliable over time.
In addition to ensuring quality and reliability, the use of IQ OQ PQ can also help manufacturers comply with regulatory requirements. Many regulatory agencies require manufacturers to provide evidence that their equipment and systems have been validated before they can be used in production. By using the IQ OQ PQ approach, manufacturers can demonstrate that they have taken the necessary steps to validate their equipment and systems and ensure that they meet regulatory requirements.
Therefore, the IQ OQ PQ process is implemented to:
Create a documented record that demonstrates the correct installation of mechanical, piping, or IT systems and ensures they meet the design specifications. This process also confirms that the system or process yields consistent and reproducible results under varying loads.
Prevent installation, operational, and performance errors from occurring.
Ensure dependable system performance.
“Commissioning” vs the “IQ OQ PQ” Process
The primary purpose of commissioning is to test the engineering aspects of a new plant and ensure it is functioning correctly. This process involves all equipment in the manufacturing facility. On the other hand, the IQ OQ PQ process is distinct in several ways:
It only applies to equipment that has a direct or indirect impact on product quality and user safety, as well as the components within those systems that are product contact critical or operationally critical. This determination is made using system and component impact assessments, as well as risk management tools.
Regulatory authorities place particular emphasis on the IQ OQ PQ process when evaluating the medicines produced in the facility.
The IQ OQ PQ process is much more rigorous, requiring a focus on documentation.
IQ OQ PQ in the Pharmaceutical Industry
During the commissioning and qualification of a new plant or process, even minor installation errors or equipment performance issues can quickly escalate into significant product quality problems that could potentially harm patients. This is particularly concerning with novel or new systems, where there is no prior performance or failure history, and even the smallest problems could result in patients becoming ill or dying.
The IQ OQ PQ process is of utmost importance in the pharmaceutical industry because it ensures that drugs and medical devices are manufactured in a safe, reliable, and consistent manner. The IQ OQ PQ process is also essential to achieving compliance with regulatory bodies such as the FDA, EMA, and MHRA. These regulatory bodies require that pharmaceutical companies follow a comprehensive validation process to demonstrate that their products meet quality and safety standards.
For example, a pharmaceutical company might use the IQ OQ PQ process when introducing a new piece of manufacturing equipment to their facility. During the IQ phase, the company would verify that the equipment was installed correctly, all parts were present and functioning, and that the equipment was designed to meet their specific requirements.
Next, during the OQ phase, the company would perform various tests on the equipment to ensure that it was operating as intended. This would include testing the equipment's performance under different loads and operating conditions, and verifying that the equipment was able to consistently produce the desired output.
Finally, during the PQ phase, the company would produce a large batch of products using the new equipment to ensure that the manufacturing process was capable of consistently producing high-quality products. This would involve monitoring various parameters such as temperature, pressure, and flow rate, to ensure that the process was stable and capable of producing consistent results.
By performing the IQ OQ PQ process, the pharmaceutical company would be able to demonstrate to regulatory bodies that their manufacturing process was robust and capable of consistently producing high-quality products. This would help ensure patient safety and protect the company's reputation in the industry.
IQ OQ PQ in the Food & Beverage Industry
The IQ OQ PQ process is critical in the Food & Beverage Industry to ensure the safety and quality of the products being manufactured. The process involves assessing and validating equipment, systems, and processes that have a direct or indirect impact on food and beverage quality and safety.
Implementing the IQ OQ PQ process helps to identify and prevent potential hazards and risks that could arise during the manufacturing process. It also ensures that the equipment and processes are installed correctly, meet the design specifications, and operate consistently and reliably under varying loads.
In addition, regulatory bodies such as the FDA and USDA require food and beverage manufacturers to comply with strict regulations and guidelines. Implementing the IQ OQ PQ process can help manufacturers demonstrate compliance with these regulations and guidelines and streamline the approval process.
Let's take an example of a company that produces bottled beverages. The company needs to implement the IQ OQ PQ process to ensure that the equipment used for producing and bottling the beverages is safe, reliable, and meets the required standards.
During the IQ phase, the company will assess and document the installation of the equipment, including the bottling line and packaging equipment. The company will ensure that the equipment is installed correctly and meets the design specifications.
During the OQ phase, the company will conduct testing on the equipment to ensure that it operates consistently and reliably under varying loads. This testing will include checks for temperature control, filling levels, and packaging materials to ensure that they meet quality standards.
During the PQ phase, the company will conduct testing under real-world conditions to ensure that the equipment and processes operate as intended and produce consistent and safe products. This testing will involve producing a large number of bottles of beverages under different conditions and checking that they meet quality standards.
By implementing the IQ OQ PQ process, the company can identify and prevent potential hazards and risks that could arise during the production process, ensure compliance with regulatory requirements, and produce high-quality products that meet consumers' expectations.
IQ OQ PQ in the Automotive Industry
The IQ OQ PQ process is critical in the automotive industry to ensure that the manufacturing processes and equipment used for producing automotive products are safe, reliable, and meet the required standards. Implementing the IQ OQ PQ process in the automotive industry helps to identify and prevent potential hazards and risks that could arise during the manufacturing process. It also ensures that the equipment and processes are installed correctly, meet the design specifications, and operate consistently and reliably under varying loads.
In addition, regulatory bodies such as the National Highway Traffic Safety Administration (NHTSA) and other relevant authorities require automotive manufacturers to comply with strict regulations and guidelines. Implementing the IQ OQ PQ process can help manufacturers demonstrate compliance with these regulations and guidelines and streamline the approval process.
Moreover, in the automotive industry, customers expect high-quality and safe vehicles. Implementing the IQ OQ PQ process can help to ensure that the products are consistent, reliable, and meet customers' expectations, which can lead to increased customer satisfaction and loyalty.
For instance, for an automotive manufacturer that produces car engines the IQ OQ PQ process is essential for ensuring that the engine production process and equipment used are safe, reliable, and meet the required standards.
During the IQ phase, the manufacturer will assess and document the installation of the equipment used to produce the engines. This could include machinery for machining engine blocks, equipment for assembling engine components, and test equipment for engine validation. The manufacturer will ensure that the equipment is installed correctly and meets the design specifications.
During the OQ phase, the manufacturer will conduct testing on the equipment to ensure that it operates consistently and reliably under varying loads. This testing will include checks for torque values, assembly tolerances, and dimensional measurements to ensure that they meet the quality standards.
During the PQ phase, the manufacturer will conduct testing under real-world conditions to ensure that the engines produced meet the required quality standards. This testing will involve producing a large number of engines under different conditions and checking that they meet quality standards.
By implementing the IQ OQ PQ process, the manufacturer can identify and prevent potential hazards and risks that could arise during the engine production process. It also ensures compliance with regulatory requirements, such as emissions standards and safety regulations, and produces high-quality products that meet customer expectations.
Furthermore, the automotive industry is highly competitive, and any defects in the production process can result in costly recalls, damage to reputation, and loss of market share. Implementing the IQ OQ PQ process can help to minimise the risk of defects and ensure that the production process is efficient and cost-effective.
Do SMEs need to implement IQ OQ PQ processes?
Yes, SMEs (Small and Medium-sized Enterprises) can benefit from the IQ OQ PQ process, especially if they are involved in industries where product quality and safety are critical, such as pharmaceuticals, food and beverage, and medical device manufacturing. While the IQ OQ PQ process may seem daunting, it can help SMEs to improve their production processes, ensure compliance with regulatory requirements, and maintain high product quality.
Implementing the IQ OQ PQ process can also help SMEs to identify potential issues early on and prevent costly errors that could negatively impact their reputation or bottom line. Additionally, by establishing a documented evidence trail of their equipment and processes, SMEs can increase their credibility with customers and regulatory bodies.
It's important to note that the level of IQ OQ PQ implementation will vary depending on the size and complexity of the SME's operations. While larger companies may have dedicated personnel and resources to manage the IQ OQ PQ process, SMEs may need to outsource some of the work or seek assistance from a third-party service provider.
By following the IQ OQ PQ approach, manufacturers can ensure that their equipment and systems meet the intended specifications and perform consistently and reliably over time. This, in turn, leads to improved product quality and increased customer satisfaction, making IQ OQ PQ an essential tool for manufacturers looking to improve their operations and meet the demands of their customers.
At Polestar, our engineers are regularly responsible for performing IQ/OQ/PQ tasks for your IT & OT equipment. All validation activities will be documented and approved by key stakeholders throughout the company. Alternatively, we can provide documentation that allows on-site engineers to conduct the necessary validation. Our team is experienced in IQ/OQ/PQ tasks and is available to answer any questions you may have regarding equipment qualification.