Design Specification ‐ MBR User Functions, Use Cases, and Dialog Specifications - lucasgsantos/BIM GitHub Wiki
MES System – Detailed User Functions, Use Cases, and Dialog Specifications
This section provides a detailed breakdown of user functions, use cases, and required dialogs for the MES modules:
- Master Batch Record (MBR) Management
- Recipe Design & Workflow
- Process Instructions & Operator Execution
- Electronic Batch Record (EBR) Execution
1. Master Batch Record (MBR) Management
1.1. User Functions
| Role | Function |
|---|---|
| Process Engineer | Create, edit, and approve MBRs |
| QA Manager | Review and release MBRs |
| Operator | View MBRs during execution |
1.2. Use Cases
| Use Case | Description |
|---|---|
| UC-MBR-001: Create MBR | Define batch structure, materials, and process steps. |
| UC-MBR-002: Approve MBR | QA reviews and approves with e-signature. |
| UC-MBR-003: Version Control | Track changes and roll back if needed. |
| UC-MBR-004: Link to BOM | Associate materials with batch steps. |
1.3. Dialogs & Functionalities
| Dialog | Functionality |
|---|---|
| MBR Editor | Drag-and-drop process steps, define parameters, set dependencies. |
| MBR Approval | Digital sign-off with reason for approval/rejection. |
| MBR Version History | Compare versions, restore previous MBRs. |
| BOM Linker | Assign materials to process steps (auto-validate against ERP). |
2. Recipe Design & Workflow
2.1. User Functions
| Role | Function |
|---|---|
| Process Engineer | Design and configure recipes. |
| Production Supervisor | Adjust parameters for a batch. |
| Operator | Execute recipe steps. |
2.2. Use Cases
| Use Case | Description |
|---|---|
| UC-REC-001: Create Recipe | Define phases, parameters, and equipment. |
| UC-REC-002: Scale Recipe | Adjust batch size (automatically recalculate quantities). |
| UC-REC-003: Conditional Logic | Set rules (e.g., "If temperature > X, extend mixing time"). |
| UC-REC-004: Recipe Simulation | Test workflow before execution. |
2.3. Dialogs & Functionalities
| Dialog | Functionality |
|---|---|
| Recipe Builder | Visual workflow editor (phases, transitions, parameters). |
| Parameter Configurator | Set min/max values, formulas, units. |
| Recipe Simulator | Dry-run execution to validate logic. |
| Equipment Assignment | Link steps to specific machines (with availability checks). |
3. Process Instructions & Operator Execution
3.1. User Functions
| Role | Function |
|---|---|
| Operator | Follow guided instructions, input data. |
| Supervisor | Monitor progress, intervene if deviations occur. |
| Maintenance | Respond to equipment alerts. |
3.2. Use Cases
| Use Case | Description |
|---|---|
| UC-OP-001: Guided Execution | Step-by-step instructions with mandatory checks. |
| UC-OP-002: Data Entry | Manual input (e.g., pH readings) with validation. |
| UC-OP-003: Deviation Handling | Record exceptions and trigger alerts. |
| UC-OP-004: Multimedia Support | View images/videos for complex steps. |
3.3. Dialogs & Functionalities
| Dialog | Functionality |
|---|---|
| Operator HMI | Touch-friendly interface with progress tracking. |
| Data Entry Form | Structured input fields (numeric, dropdown, barcode scan). |
| Deviation Log | Record issues, attach photos, assign corrective actions. |
| Real-Time Alerts | Pop-up notifications for critical deviations. |
4. Electronic Batch Record (EBR) Execution
4.1. User Functions
| Role | Function |
|---|---|
| Operator | Execute and record batch steps. |
| QA Reviewer | Verify compliance before release. |
| Auditor | Trace historical batch data. |
4.2. Use Cases
| Use Case | Description |
|---|---|
| UC-EBR-001: Batch Initiation | Start a new batch from an approved MBR. |
| UC-EBR-002: Automated Data Capture | Pull sensor/PLC data into EBR. |
| UC-EBR-003: Batch Review | QA checks completeness before approval. |
| UC-EBR-004: Batch Report Export | Generate PDF/Excel for compliance. |
4.3. Dialogs & Functionalities
| Dialog | Functionality |
|---|---|
| Batch Dashboard | Overview of active batches, status, alerts. |
| EBR Viewer | Timeline of executed steps with data. |
| QA Review Panel | Approve/reject with comments and e-signature. |
| Batch Report Generator | Customizable templates (PDF, CSV). |
5. Integration & Compliance Dialogs
| Dialog | Functionality |
|---|---|
| Audit Trail Viewer | Track all changes (who, when, what). |
| Electronic Signature | Role-based sign-off (FDA 21 CFR Part 11 compliant). |
| ERP/LIMS Sync | Real-time material & QC data exchange. |
6. Summary of Key UI/UX Requirements
- Role-Based Dashboards: Different views for operators, engineers, QA.
- Minimal Clicks: Guided workflows reduce errors.
- Real-Time Validation: Auto-check inputs (e.g., "Weight must be 50-100g").
- Offline Mode: Continue execution if network fails (sync later).
7. Next Steps
- Prototype UI/UX for operator and engineer screens.
- Conduct User Testing with real operators.
- Validate Compliance against GxP regulations.
This specification ensures the MES system is user-friendly, compliant, and efficient for batch manufacturing. Adjust based on industry-specific needs (Pharma, Food, Chemicals).