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4.4 Asset Lifecycle & Spare Parts

In an ISO 9001/13485 environment, asset management extends beyond financial tracking to include the technical validation of process readiness. Uncalibrated tools introduce measurement errors that pass defects; a stockout of critical spare parts extends Mean Time to Repair (MTTR) from minutes to weeks. This chapter defines the mandatory protocols for equipment calibration, critical spare parts inventory, and lifecycle tracking to ensure continuous process capability.

Calibration Management

All measurement and test equipment (M&TE) affecting product quality must be calibrated against NIST-traceable standards.

  • Tracking Database: A centralized digital database must track the status of every serialized tool.
    • Labeling: Every tool must bear a calibration label indicating: ID Number, Calibration Date, Due Date, and Technician Initials.
    • Lockout: Tools past their "Due Date" must be physically removed from production and locked in a quarantine cage.
  • Calibration Cycles:
    • Torque Drivers: Every 6 months or 5,000 cycles.
    • Digital Multimeters: Annually.
    • ESD Surface Resistance Meters: Annually.
  • Out-of-Tolerance (OOT) Protocol: If a tool is found to be out of tolerance during calibration, a Reverse Impact Analysis must be conducted on all products measured with that tool since the last successful calibration.

Critical Spare Parts Strategy

To minimize machine downtime, a strategic buffer of critical components must be maintained on-site.

  • Classification:
    • Class A (Critical): Parts that cause immediate line stoppage and have lead times >1 week (e.g., conveyor motors, head control cards). Mandate: 1 unit on-site.
    • Class B (Consumable): Wear parts with predictable life (e.g., nozzles, vacuum filters, belts). Mandate: Min/Max logic based on usage.
  • Inventory Control:
    • Location: Spares must be stored in a dedicated, access-controlled "MRO Cage" (Maintenance, Repair, Operations).
    • Checkout: Parts must be electronically issued to a specific machine Work Order (WO) to track consumption costs and update inventory levels automatically.
    • Replenishment: Reorder points (ROP) must be set in the ERP system to trigger purchasing automatically when stock hits the minimum threshold.

Asset Lifecycle & Identification

Traceability of equipment configuration is required for change management.

  • Tagging: All capital equipment (Pick-and-Place, Ovens, Printers) must have a permanent metal asset tag.
    • Data: Asset ID, Manufacturer, Model, Serial Number, Installation Date.
  • Configuration Management: A "Machine Passport" (digital log) must be maintained for each asset, recording:
    • Software/Firmware Versions: Updates must be validated by Process Engineering before deployment.
    • Hardware Upgrades: Installation of new heads, cameras, or rails.
    • location: Current physical location on the factory floor.

Feeder Maintenance

SMT component feeders are the highest volume asset and the leading cause of pick errors.

  • Maintenance Interval: Feeders must be serviced every 1,000,000 picks or 12 months.
  • Validation: Post-maintenance validation must be performed on a Feeder Calibration Jig to verify index accuracy and pitch.
  • Status Flags:
    • Green: Calibrated & Ready.
    • Red: Defective / Needs Repair.
    • Yellow: Due for Maintenance.

Final Checklist

Asset Category

Parameter

Frequency / Mandate

Limit

Calibration

Torque Drivers

6 Months

5,000 Cycles

Calibration

OOT Action

As Occurs

Reverse Impact Analysis

Spares

Class A Stock

Continuous

1 Unit Min

Spares

Checkout

Per Transaction

Link to Work Order

Feeders

Service Interval

1M Picks

Verify on Jig

Equipment

Firmware Update

As Needed

Eng Validation Req.

Tooling

Expired Tools

Daily Check

Quarantine