Document Control
Document ID: OQ-HMI-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for HMI System
Objective: To verify that the HMI System operates according to specified requirements and is suitable for use in the production environment.
Scope: This protocol applies to the Operational Qualification of the HMI System used for operator interface in equipment control within the production area. It covers critical parameters that impact product quality.
Responsibilities:
- Validation Team: Prepare, execute, and report OQ activities.
- Quality Assurance: Review and approve the protocol and results.
- IT Support: Ensure system availability and integrity during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of necessary documentation (URS, SOPs, etc.).
- Training of personnel on HMI System functionalities.
Equipment Description:
The HMI System is a software interface that allows operators to control manufacturing equipment. It includes features for monitoring, data entry, and system alerts, ensuring operator access control and system integrity.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify audit trail functionality | Audit trail captures all operator actions | Audit trail report |
| OQ-02 | Test operator access controls | Access control prevents unauthorized access | Access control logs |
| OQ-03 | Validate system integrity checks | System integrity checks pass without errors | Integrity check report |
Detailed Test Cases
Test Case OQ-01: Verify Audit Trail Functionality
Objective: Ensure that the audit trail accurately logs all operator actions.
Procedure: Perform a series of actions on the HMI System and review the audit trail report.
Acceptance Criteria: The audit trail must show a complete log of actions performed during testing.
Expected Results: Audit trail report generated correctly reflecting all actions.
Test Case OQ-02: Test Operator Access Controls
Objective: Confirm that the access control system restricts unauthorized access.
Procedure: Attempt to access the system with unauthorized credentials and verify the response.
Acceptance Criteria: The system must deny access and log the attempt.
Expected Results: Unauthorized access attempts are logged and denied.
Test Case OQ-03: Validate System Integrity Checks
Objective: Check that all system integrity checks are functioning correctly.
Procedure: Execute integrity check procedures and review the results.
Acceptance Criteria: All integrity checks must pass without errors.
Expected Results: Integrity check report confirms no discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the qualification process.
Approvals
Prepared by: ____________________ Date: ___________
Approved by: ____________________ Date: ___________