6.4 Asset Register, Criticality & Spare Parts Policy

Managing assets in an ISO 9001/13485 environment is not an accounting exercise; it is a technical discipline of "Process Readiness." An uncalibrated torque driver does not just tighten a screw; it injects a latent failure into the product. A stockout of a $50 sensor that halts a $5M line is not "bad luck"; it is a failure of planning. We treat the Asset Register as the single source of truth for the facility's operational capability.

Calibration Management (M&TE)

All Measurement & Test Equipment (M&TE) must be traceable to NIST standards. If you cannot prove the tool is accurate, you cannot prove the product is good.

Database & Labeling

• Action: Every tool must carry a unique ID and a "Calibration Due" label.
• If Date is Expired -> Then Tool is effectively broken. Physically remove it to the "Quarantine Cage" immediately. Do not use "Just for today."

Out-of-Tolerance (OOT) Protocol

• If Tool fails calibration -> Then Trigger Reverse Impact Analysis.
• Logic: You must identify every product measured by that tool since the last passing date and quarantine that stock for re-verification.

Cycles vs. Time

• Torque Drivers: Calibrate every 6 Months or 5,000 Cycles, whichever comes first.
• Physics: Springs fatigue with use, not just time.

Critical Spare Parts Strategy

Inventory is capital, but downtime is lost revenue. The goal is not "Zero Inventory"; it is "Zero Stockouts on Critical Path."

Class A: Strategic Insurance

• Definition: Parts that stop the line (Showstoppers) with Lead Time > 1 week (e.g., Conveyor Motors, CPU Cards).
• Mandate: 1 Unit On-Hand at all times.
• Rule: When the spare is installed, the Purchase Order (PO) for replacement is cut within 24 hours.

Class B: Consumables

• Definition: Wear parts (Nozzles, Filters, Belts).
• Mandate: Min/Max logic.
• Trigger: Reorder automatically when stock hits the "Min" level (Lead Time Demand + Safety Stock).

Pro-Tip: Create a "Shadow Board" for Class A spares in the maintenance cage. If the outline of the motor is visible, you are exposed. The empty shadow screams "Reorder."

Asset Lifecycle & Configuration

You cannot manage what you do not track. A "Machine Passport" must follow the asset from installation to decommissioning.

Configuration Control

• If Firmware/Software is updated -> Then Validate process capability before releasing to production.
• Risk: A "minor" patch can alter servo timing or vision algorithms, invalidating the Reflow Profile or Placement Accuracy.

Feeder Maintenance (The High Volume Risk)

• Trigger: Service every 1,000,000 picks or 12 Months.
• Action: Validate on a dedicated Calibration Jig.
• Status: Use visual tags: Green (Ready), Red (Repair), Yellow (Due).

Final Checklist