Document Control:
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for Temperature Controlled Warehouse
Objective: To establish a comprehensive Operational Qualification (OQ) protocol for the Temperature Controlled Warehouse to ensure compliance with regulatory standards and maintain product integrity.
Scope: This protocol applies to the Temperature Controlled Warehouse utilized for the storage of raw materials, impacting product quality directly.
Responsibilities:
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Warehouse Manager: Ensures that the warehouse operates within specified parameters.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel on OQ procedures.
Equipment Description:
The Temperature Controlled Warehouse is designed to store raw materials under controlled temperature and relative humidity conditions. It includes temperature and humidity mapping systems, alarms, and an audit trail for compliance monitoring.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Temperature Mapping | Temperature must remain within specified limits as per URS Annex11 Annex15. | Mapping report and temperature logs. |
| OQ-02 | Relative Humidity Mapping | Relative humidity must remain within specified limits as per URS Annex11 Annex15. | Mapping report and humidity logs. |
| OQ-03 | Alarm Functionality Test | Alarms must activate within specified limits. | Alarm test logs. |
| OQ-04 | Audit Trail Verification | Audit trail must capture all critical changes and alarms. | Audit trail report. |
Detailed Test Cases:
- OQ-01: Conduct temperature mapping at various points in the warehouse to ensure compliance with specified limits.
- OQ-02: Conduct relative humidity mapping at various points in the warehouse to ensure compliance with specified limits.
- OQ-03: Test alarm functionality by simulating temperature and humidity deviations.
- OQ-04: Review the audit trail for completeness and accuracy, ensuring all critical data is recorded.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals:
__________________________
Validation Team Lead
__________________________
Quality Assurance Manager
__________________________
Warehouse Manager
Data Integrity Checks:
- Verify that all data logged during testing is timestamped and attributable to the individual performing the test.
- Ensure that all temperature and humidity data is backed up and securely stored.
- Conduct periodic reviews of the audit trail to ensure no unauthorized access or changes have occurred.