Operational Qualification Protocol for Air Shower System
Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Air Shower system operates according to its intended use and meets the specified acceptance criteria as outlined in the User Requirements Specification (URS).
Scope
This protocol applies to the Air Shower system used for personnel de-dusting prior to entry into the facility. It covers the verification of critical parameters and ensures compliance with regulatory requirements.
Responsibilities
The Validation Team is responsible for executing the protocol, documenting results, and ensuring compliance with validation guidelines. The Quality Assurance (QA) team is responsible for reviewing and approving the protocol and results.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- All personnel involved in the OQ must be trained on the equipment and procedures.
- All necessary tools and materials must be available and calibrated.
Equipment Description
The Air Shower is a personnel de-dusting system designed to remove particulate contamination from individuals before they enter controlled environments. It operates by directing a high-velocity air stream towards personnel, effectively removing dust and other contaminants.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Measure air velocity at specified locations. | Air velocity meets specification of [X] m/s. | Calibration report and measurement logs. |
| OQ-02 | Verify cycle time for air shower operation. | Cycle time is within [Y] seconds. | Cycle time logs. |
| OQ-03 | Test interlock functionality. | All interlocks function as intended. | Interlock test report. |
Detailed Test Cases
Test Case OQ-01: Air Velocity Measurement
Objective: To ensure that the air velocity meets the specified criteria.
- Set up the anemometer at designated locations.
- Activate the air shower system.
- Record air velocity readings.
- Compare readings against acceptance criteria.
Test Case OQ-02: Cycle Time Verification
Objective: To verify that the air shower cycle time is within the defined limits.
- Start the air shower system.
- Use a timer to measure the duration of the cycle.
- Document the cycle time.
- Ensure it meets acceptance criteria.
Test Case OQ-03: Interlock Functionality Test
Objective: To confirm that all safety interlocks operate correctly.
- Simulate a condition that should trigger the interlock.
- Verify that the system responds appropriately.
- Document the results of the interlock test.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A deviation report must be completed and reviewed by QA.
Approvals
This protocol requires approval from the following individuals:
- Validation Team Lead: ______________________
- Quality Assurance Manager: ______________________