Design Specification ‐ Equipment Management - lucasgsantos/BIM GitHub Wiki

MES Equipment Management Module - Design Specification

1. Equipment Master Data Management

1.1. Data Structure

Field Type Validation Example
Equipment ID String (Unique) Regex: ^EQ-[A-Z]{3}-[0-9]{4}$ EQ-MIX-1001
Name String Max 50 chars "Reactor R-101"
Type Dropdown From predefined list Bioreactor, Centrifuge
Location String GIS coordinates optional "Room 205, Bay 3"
Criticality Enum High/Medium/Low High
Commission Date Date < Today's date 01/15/2020
Retirement Date Date > Commission date -
Operational Parameters JSON Schema validation {"maxTemp": 150, "minPH": 6.0}

1.2. User Interface

Equipment Registry Dialog:

  • Search Panel: Typeahead search by ID/name/location
  • Detail View: Tabbed interface (Specs, Documents, History)
  • Action Buttons:
    • Clone Equipment (for similar assets)
    • Print QR Label
    • Export Technical Dossier

1.3. Integration

  • ERP Sync: Asset hierarchy synchronization
  • CAD Integration: P&ID diagram linking
  • Document Management: Attach manuals/certificates

2. Equipment Cleaning Rules

2.1. Cleaning Rule Matrix

Parameter Options Enforcement
Cleaning Type CIP, SIP, Manual Workflow enforcement
Frequency After each use, Every X batches, Time-based System alerts
Validation Required Yes/No Block usage until QA release
Responsible Dept Dropdown Task assignment

2.2. Cleaning Workflow UI

Cleaning Procedure Builder:

  • Step-by-step SOP editor with:
    • Duration timers
    • Chemical concentration checks
    • Verification checkpoints
  • Multimedia support:
    • Attach rinse water test results
    • Embed cleaning validation videos

Status Indicators:

graph LR
    A[Dirty] -->|Cleaning Initiated| B[In Cleaning]
    B -->|Verification Passed| C[Clean - Released]
    B -->|Verification Failed| A

3. Equipment-Material Compatibility

3.1. Compatibility Matrix

Material Class vs Equipment:

Stainless Steel Glass-lined Single-Use
Acidic ✓ ✓ (pH>2) ✓
High-Viscosity ✓ ✗ Limited
Cytotoxic ✓ (dedicated) ✗ ✓

3.2. Campaign Management

Rules Engine:

if (material.category == "Beta-Lactam") {
  requireEquipmentDedication();
  blockCampaignChangeWithoutCleaning();
  enforceQuarantinePeriod(72h);
}

UI Components:

  • Visual campaign scheduler with conflict detection
  • Material cross-contamination risk indicators (traffic light system)
  • Override log (requires QA sign-off)

4. Equipment Maintenance

4.1. Maintenance Types

Type Trigger Documentation Required
Preventive Calendar/Usage Checklist completion
Corrective Failure Report Root cause analysis
Calibration Due Date Certificate upload

4.2. Maintenance Console

Key Features:

  • Drag-and-drop scheduler with Gantt view
  • Parts inventory integration (auto-reserve spares)
  • Mobile checklist execution:
    • Take before/after photos
    • Scan tool calibration stickers

Escalation Rules:

  • Late PMs turn red after due date
  • Critical equipment alerts after 24h overdue

5. Scale Calibration

5.1. Calibration Workflow

  1. Initiate:

    • Select test weights (10%, 50%, 100% capacity)
    • Reference standard certification check

  2. Execution:

    • Guided test sequence
    • Auto-capture readings via serial port

  3. Analysis:

    • Calculate measurement uncertainty
    • Generate calibration curve

  4. Approval:

    • Electronic sign-off by metrology
    • Auto-update equipment status

5.2. UI Components

Calibration Dashboard:

  • Upcoming calibrations (color-coded by priority)
  • Historical accuracy trends
  • Non-conformance reports

Scale Test Dialog:

  • Real-time weight reading display
  • Tolerance violation alerts
  • Manual override log (requires supervisor PIN)

6. Equipment Status Diagram

6.1. State Transition Model

stateDiagram-v2
    [*] --> Idle
    Idle --> In_Use: Production request
    In_Use --> Cleaning: Batch complete
    Cleaning --> Maintenance: Fault detected
    Maintenance --> Qualified: PM complete
    Qualified --> Idle: QA release
    Cleaning --> Quarantine: Validation failed

6.2. Visual Status Board

Color Coding:

  • Green: Available
  • Blue: In operation
  • Yellow: Cleaning in progress
  • Red: Maintenance required
  • Gray: Decommissioned

Filter Options:

  • By production line
  • By criticality level
  • By last maintenance date

7. Equipment Allocation

7.1. Allocation Rules Engine

Priority Logic:

  1. Material compatibility
  2. Cleaning status
  3. Equipment availability
  4. Campaign sequence
  5. Maintenance schedule

7.2. Allocation Console

Features:

  • Conflict detection panel
  • Alternative equipment suggestions
  • Booking system with drag-and-drop rescheduling
  • Utilization heatmaps (last 30 days)

Override Controls:

  • Force allocation (requires approval chain)
  • Temporary capacity adjustments

8. Equipment Logbook

8.1. Log Entry Structure

Field Mandatory Example
Timestamp Yes 2024-05-15 14:32:00
Event Type Yes "Production", "Cleaning"
Related Batch Conditional BATCH-2024-001
Operator Yes User AD-1234
Parameters No {"temp": 37.5, "rpm": 120}
Attachments No Clean-in-place report.pdf

8.2. Advanced Features

  • Voice Logging: Hands-free operator entries
  • Auto-logging: PLC data integration (OPC UA)
  • Trend Analysis: Parameter visualization tools
  • Electronic Witnessing: QA review and countersigning

9. Compliance & Reporting

9.1. Audit Requirements

  • Data Retention: 10+ years for GMP records
  • Change Tracking: Who changed calibration frequency and when
  • Signature Requirements: Dual approval for critical parameter changes

9.2. Standard Reports

  1. Equipment Utilization Report

    • Uptime/downtime analysis
    • OEE calculation

  2. Cleaning Compliance Report

    • Deviations from SOP
    • Validation success rate

  3. Maintenance Cost Analysis

    • Parts consumption
    • Mean time between failures

10. Integration Architecture

flowchart TD
    A[ERP] -->|Asset Hierarchy| B(Equipment Master)
    C[LIMS] -->|Calibration Results| B
    D[CMMS] -->|Work Orders| B
    B --> E[Production Scheduling]
    B --> F[Quality Management]

Interface Standards:

  • ISA-95 for equipment hierarchy
  • OPC UA for real-time data
  • PDF/A for document archiving

11. Prototype UI Mockups

Equipment Status Board:

[ EQ-MIX-1001 ]  [ EQ-COL-2002 ]  [ EQ-FIL-3003 ]
  Status: In Use    Status: Clean     Status: Maintenance
  Batch: B-240515   Ready Since:      Est. Completion:
  Temp: 37.5°C      05/15 08:00      05/16 14:00

Logbook Entry Dialog:

Event Type: [Production ▼]   Batch: [B-240515 ▼]
Start Time: 05/15 14:00      End Time: 05/15 18:30
Parameters:
  Temperature: [37.5] °C     RPM: [120] 
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This specification provides a comprehensive framework for equipment management in regulated manufacturing environments, combining best practices from Siemens Opcenter, Rockwell PharmaSuite, and PAS-X systems. The design emphasizes paperless operations, real-time decision support, and regulatory compliance.