Document ID: DQ-SCADA-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for SCADA System in Manufacturing Automation
Meta Description: This document outlines the Design Qualification (DQ) Protocol for the SCADA System used in Manufacturing Automation, ensuring compliance with critical parameters and regulations.
Tags: Design Qualification, SCADA, Equipment Validation, Computerized Systems, Manufacturing Automation
Objective
The objective of this Design Qualification Protocol is to ensure that the SCADA System meets all specified requirements for supervisory control and monitoring in production, ensuring data integrity and compliance with regulatory standards.
Scope
This protocol applies to the SCADA System utilized in the production area for supervisory control and monitoring of manufacturing processes. It covers the validation of the system’s critical functionalities and compliance with URS Annex11 21CFR11.
Responsibilities
- Validation Team: Responsible for the execution of the DQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- IT Department: Responsible for providing technical support and ensuring system availability during the validation process.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation of SCADA System in the production environment.
- Availability of necessary documentation, including system architecture and design specifications.
Equipment Description
The SCADA System is a software-based solution designed for supervisory control and monitoring of manufacturing processes. It includes functionalities such as audit trail, alarms, data integrity, and access control, which are critical for ensuring compliance and operational efficiency.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T001 | Verify audit trail functionality | All user actions are logged with timestamps | Audit trail report |
| T002 | Test alarm functionality | Alarms trigger under specified conditions | Alarm log |
| T003 | Check data integrity measures | Data is accurate and unaltered | Data integrity report |
| T004 | Assess access control features | Only authorized personnel can access the system | Access control log |
Detailed Test Cases
Test Case T001: Verify Audit Trail Functionality
Objective: Ensure that the audit trail captures all user actions with timestamps.
Procedure: Log in as a user and perform various actions. Check the audit trail for completeness.
Acceptance Criteria: All actions must be recorded with accurate timestamps.
Evidence: Printout of the audit trail report for review.
Test Case T002: Test Alarm Functionality
Objective: Verify that alarms trigger correctly under specified conditions.
Procedure: Simulate conditions that should trigger alarms and confirm alarm activation.
Acceptance Criteria: Alarms must activate as expected.
Evidence: Alarm log showing triggered alarms.
Test Case T003: Check Data Integrity Measures
Objective: Verify that data remains accurate and unaltered.
Procedure: Input test data and verify that output matches expected results.
Acceptance Criteria: Data integrity must be maintained.
Evidence: Data integrity report comparing input and output.
Test Case T004: Assess Access Control Features
Objective: Ensure that only authorized personnel can access the system.
Procedure: Attempt to access the system with different user credentials.
Acceptance Criteria: Unauthorized access must be denied.
Evidence: Access control log showing attempts and results.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A plan for corrective actions must be developed and implemented.
Approvals
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________