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Operational Qualification (OQ)

Documents which establish, through testing, that all critical components and “direct impact” systems are capable of operating within established limits and tolerances.

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Operational Qualification (OQ) is a critical phase in the validation process, particularly in regulated industries such as pharmaceuticals, biotechnology, medical devices, and manufacturing. OQ is designed to verify and document that equipment or systems operate within their specified operational ranges and consistently meet their intended functions.

Aspects of Operational Qualification

Here are key aspects of Operational Qualification:

Scope Definition

The scope of the OQ process is established, outlining which aspects of the equipment or system will be tested and the criteria for success.

Preparation

Prior to testing, all necessary resources, equipment, and materials are prepared. This includes ensuring that the equipment is properly installed and calibrated.

Test Protocol Development

A detailed test protocol is created, outlining the specific tests to be conducted, the acceptance criteria, and the procedures to be followed. This protocol is often based on the equipment manufacturer’s recommendations and regulatory guidelines.

Execution of Tests

The defined tests are performed systematically, assessing various aspects of the equipment’s performance. Common tests may include:

Functional Testing

Verifying that the equipment performs its intended functions accurately.

Performance Testing

Evaluating the equipment’s performance under different conditions, including worst-case scenarios and boundary conditions.

Safety Testing

Ensuring that the equipment operates safely, with proper alarms and safety features.

Environmental Testing

Assessing the equipment’s performance under various environmental conditions, such as temperature and humidity.

Data Collection

During testing, data is collected meticulously, including measurements, observations, and any deviations from expected results.

Acceptance Criteria

The acceptance criteria, as defined in the test protocol, are used to determine whether the equipment or system passes or fails each test. If deviations or failures occur, they are thoroughly investigated and documented.

Documentation

Detailed records are maintained throughout the OQ process, including the test protocol, test results, deviations, and any corrective actions taken.

Review and Approval

The results of the OQ tests are reviewed by relevant stakeholders, including quality assurance and validation teams. Approvals are obtained based on the assessment of whether the equipment meets its operational requirements.

Final Report

An OQ report is generated, summarizing the entire OQ process. It includes a description of the tests conducted, the results, any deviations, and any corrective actions taken. The report serves as critical documentation for regulatory compliance.

Where does Operational Qualification fit in

Operational Qualification demonstrates that the equipment or system functions as intended within its specified operational limits. It is typically followed by Performance Qualification (PQ), which further assesses the equipment’s performance under actual operating conditions and ensures that it consistently produces reliable results.

OQ, along with Installation Qualification (IQ) and PQ, forms a comprehensive validation process that helps ensure the quality, reliability, and compliance of equipment and systems in industries where precise and consistent performance is essential.

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