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IQOQ stands for Installation Qualification and Operational Qualification, two crucial components in the validation process of laboratory equipment, including automated cell counters. This article discusses about the essence of IQOQ, offering a detailed guide on executing it effectively to ensure your automated cell counter operates accurately and complies with the necessary standards.
IQOQ is a part of equipment validation that ensures it is correctly installed and operates as intended. Installation Qualification (IQ) verifies that the equipment is received as designed and installed correctly. Operational Qualification (OQ) confirms that the equipment functions according to its operational specifications in the selected environment.
IQ involves checking that all system components are correctly installed, including software and hardware, and that the installation meets the manufacturer’s specifications and regulatory requirements.
OQ assesses the equipment’s performance to ensure it operates within its intended operational ranges. This phase tests the equipment under normal operating conditions to verify that it performs consistently and accurately.
Preparing for IQOQ involves gathering necessary documentation, understanding the equipment’s operational requirements, and ensuring the environment is suitable for the equipment’s operation. The execution of IQ involves verifying the installation against checklist items provided by the manufacturer. OQ testing then follows, focusing on verifying the performance specifications through a series of tests.
1.1 Inspect Equipment Delivery: Check that all equipment components, accessories, and documentation have been delivered without damage.
1.2 Verify Installation Requirements: Confirm that the installation site meets the manufacturer’s specified environmental conditions (e.g., temperature, humidity, power supply).
1.3 Install Equipment: Follow the manufacturer’s installation instructions meticulously. This includes assembling the instrument, setting up any software, and connecting any necessary utilities.
1.4 Document the Installation: Record every step of the installation process, including serial numbers, software versions, and any deviations from the standard process.
2.1 Verify Operational Specifications: Consult the manufacturer’s documentation to understand the operational specifications of the equipment.
2.2 Conduct Performance Tests: Perform tests to verify that the equipment operates according to its specifications. This may include running the equipment through its full range of functions, checking for any errors or deviations.
2.3 Record Test Results: Document all test procedures, observations, and results. This documentation will be crucial for future reference and potential audits.
2.4 Address Any Issues: If any deviations or issues are identified, take corrective action as necessary. This may involve adjusting settings, recalibrating the equipment, or contacting the manufacturer for support.
3.1 Review Documentation: Ensure all steps of the IQ and OQ processes have been thoroughly documented and that all test results meet the operational specifications.
3.2 Sign-off: Once the IQOQ process is successfully completed, all relevant personnel should review and sign off on the documentation, officially validating the equipment for use.
3.3 Train Staff: Ensure all operators are trained on the proper use of the equipment, including any specific operational procedures identified during OQ.
3.4 Establish Maintenance and Calibration Schedules: Based on the manufacturer’s recommendations and the results of the IQOQ process, establish regular maintenance and calibration schedules to keep the equipment in optimal condition.
Challenges in the IQOQ process can range from environmental conditions affecting equipment performance to software compatibility issues. Solutions include pre-assessment of the installation environment and ensuring all software and hardware components are compatible.
A well-executed IQOQ process ensures reliability, accuracy, and compliance with industry standards, which is crucial for laboratories that rely on precise cell counting.
IQOQ is a vital process in the lifecycle of laboratory equipment, ensuring that automated cell counters perform accurately and reliably. By following the steps outlined in this guide, laboratories can achieve optimal equipment performance and compliance.
IQ (Installation Qualification) ensures equipment is installed correctly according to manufacturer specifications. OQ (Operational Qualification) tests if the equipment operates as intended under specific conditions.
IQOQ should be performed on automated cell counters initially at installation and then periodically as part of routine maintenance or when significant changes occur, such as after repairs, upgrades, or relocation of the equipment. The frequency can vary based on manufacturer recommendations and regulatory requirements, but an annual review is common practice to ensure ongoing accuracy and reliability.
IQOQ can be performed by trained laboratory staff if they possess the necessary knowledge and skills. However, for complex equipment like automated cell counters, it is often recommended to involve a specialist or the equipment manufacturer’s service personnel to ensure the process is conducted accurately and meets all regulatory requirements.
For IQOQ, you need:
Manufacturer’s manuals
IQOQ protocols and checklists
Equipment specifications
Installation records
Calibration and maintenance records
Test results
Documentation of deviations and corrective actions
Approval signatures
IQOQ plays a crucial role in laboratory accreditation by ensuring that equipment is installed correctly and operates as intended, which is vital for maintaining the accuracy, reliability, and consistency of laboratory results. Successfully completing IQOQ demonstrates a laboratory’s commitment to quality and compliance with industry standards, thereby supporting its accreditation status.
Logos Biosystems offers IQOQ service for all product including automated cell counters. For more information about Logos Bio products, visit www.logosbio.com
