Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Operational Qualification Protocol for SCADA System in Manufacturing Automation
Objective: The objective of this Operational Qualification (OQ) protocol is to verify that the SCADA System operates according to its intended use and meets the specified acceptance criteria in compliance with URS Annex 11 and 21 CFR Part 11.
Scope: This protocol applies to the SCADA System utilized in the production area for supervisory control and monitoring of manufacturing processes, 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.
- IT Department: Responsible for providing technical support and ensuring system integrity.
Prerequisites:
- Completion of the Installation Qualification (IQ) protocol.
- Availability of the SCADA System and necessary documentation.
- Training of personnel on the SCADA System.
Equipment Description:
The SCADA System is a software application used for supervisory control and monitoring of manufacturing processes. It provides functionalities such as data collection, alarm management, and access control to ensure data integrity and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify audit trail functionality. | Audit trail logs all user actions accurately. | Audit trail report. |
| OQ-02 | Test alarm functionality. | All alarms trigger as expected and are logged. | Alarm log report. |
| OQ-03 | Check data integrity measures. | Data integrity is maintained without unauthorized changes. | Data integrity report. |
| OQ-04 | Validate access control settings. | Access control settings restrict unauthorized access. | Access control audit report. |
Detailed Test Cases:
- Test Case OQ-01: Execute a series of user actions and verify that each action is logged in the audit trail with timestamps and user IDs.
- Test Case OQ-02: Trigger various alarms and confirm that they are logged accurately in the alarm history.
- Test Case OQ-03: Conduct data entry tests and verify that no data can be altered without proper authorization.
- Test Case OQ-04: Attempt to access the system with various user roles and confirm that access is granted or denied as per the defined roles.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions implemented as necessary.
Approvals:
- __________________________
- Validation Team Lead
- Date: _______________
- __________________________
- Quality Assurance
- Date: _______________
Data Integrity Checks:
- Regular audits of the audit trail to ensure completeness and accuracy.
- Periodic review of alarm logs to confirm that all alarms are functioning correctly.
- Access control logs reviewed monthly to ensure compliance with user access policies.