6.4 Asset Register, Criticality & Spare Parts Policy

InManaging assets in an ISO 9001/13485 environment,environment assetis managementnot extendsan beyondaccounting financialexercise; trackingit tois includea technical discipline of "Process Readiness." An uncalibrated torque driver does not just tighten a screw; it injects a latent failure into the technicalproduct. validation of process readiness. Uncalibrated tools introduce measurement errors that pass defects; aA stockout of criticala spare$50 partssensor extendsthat Meanhalts Timea to$5M Repairline (MTTR)is fromnot minutes"bad toluck"; weeks.it Thisis chaptera definesfailure of planning. We treat the mandatoryAsset protocolsRegister as the single source of truth for equipmentthe calibration,facility's critical spare parts inventory, and lifecycle tracking to ensure continuous processoperational capability.

Calibration Management (M&TE)

All measurementMeasurement and& testTest equipmentEquipment (M&TE) affecting product quality must be calibrated against NIST-traceable to NIST standards. If you cannot prove the tool is accurate, you cannot prove the product is good.

Database & Labeling

• Tracking Database: A centralized digital database must track the status of every serialized tool.
  • LabelingAction:: Every tool must bearcarry a calibrationunique labelID indicating:and a "Calibration Due" label.
  • If Date is Expired -> 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 monthsThen orTool is effectively broken. Physically remove it to the "Quarantine Cage" immediately. Do not use "Just for today."5,000 cycles.
  • Digital Multimeters: Annually.
  • ESD Surface Resistance Meters: Annually.

• Out-of-Tolerance (OOT) Protocol

  • If: IfTool afails toolcalibration is-> foundThen to be out of tolerance during calibration, aTrigger Reverse Impact Analysis.
  • Logic: You must beidentify conductedevery on all productsproduct measured withby that tool since the last successfulpassing calibration.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

  ToInventory minimizeis machinecapital, downtime,but adowntime strategicis bufferlost ofrevenue. criticalThe componentsgoal mustis benot maintained"Zero on-site.Inventory"; it is "Zero Stockouts on Critical Path."

  Class A: Strategic Insurance

  • Classification:
    • Class A (Critical)Definition:: Parts that causestop immediatethe line stoppage(Showstoppers) andwith haveLead leadTime times> >1 week (e.g., conveyorConveyor motors,Motors, headCPU control cards)Cards).
    • Mandate: Mandate: 1 unitUnit on-site.On-Hand at all times.
    • Rule: When the spare is installed, the Purchase Order (PO) for replacement is cut within 24 hours.

    Class BB: (Consumable)Consumables

    • Definition:: Wear parts with(Nozzles, predictableFilters, life (e.g., nozzles, vacuum filters, belts)Belts).
    • Mandate: Mandate: Min/Max logic based on usage.
    logic.
  • 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:Trigger: Reorder points (ROP) must be set in the ERP system to trigger purchasing automatically when stock hits the minimum"Min" threshold.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 & IdentificationConfiguration

  TraceabilityYou ofcannot equipmentmanage configurationwhat isyou requireddo fornot 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:track. A "Machine Passport" (digital log) must befollow maintainedthe forasset eachfrom asset,installation recording:to decommissioning.

    Configuration Control

    • Software/FirmwareIf VersionsFirmware/Software is updated -> Then: UpdatesValidate mustprocess becapability validatedbefore byreleasing Processto Engineering before deployment.production.
    • HardwareRisk: Upgrades:A Installation"minor" ofpatch newcan heads,alter cameras,servo timing or rails.
    • location:vision Currentalgorithms, physical location oninvalidating the factoryReflow floor.
    Profile or Placement Accuracy.

  Feeder Maintenance

  SMT(The componentHigh feedersVolume are the highest volume asset and the leading cause of pick errors.Risk)

  • Maintenance IntervalTrigger:: Feeders must be servicedService every 1,000,000 picks or 12 monthsMonths.
  • ValidationAction:: Post-maintenance validation must be performedValidate on a Feederdedicated Calibration Jig to verify index accuracy and pitch..
  • StatusStatus: Flags:
    • Use visual tags: Green: Calibrated(Ready), &Red Ready.
    • Red:(Repair), DefectiveYellow / Needs Repair.
    • Yellow: Due for Maintenance.
    (Due).

  Final Checklist

  Asset Category	Parameter	FrequencyMetric / MandateRule	LimitCritical State
  Calibration Status	TorqueExpired DriversTool	Quarantine Immediately
  OOT Event	6Impact	Reverse MonthsAnalysis
  Class A Spares	Stock Level	Min 1 Unit
  Class B Spares	Reorder Logic	Auto-Trigger at Min
  Torque Tools	Interval	5,000 Cycles / 6 Mo
  CalibrationFeeder Service	OOT Action	As OccursInterval	Reverse1M Impact AnalysisPicks
  SparesFirmware Change	Class A Stock	ContinuousValidation	1 Unit MinMandatory
  SparesAsset Tagging	Checkout	Per TransactionMethod	LinkUnique toID Work+ Order
  Feeders	Service Interval	1M Picks	Verify on Jig
  Equipment	Firmware Update	As Needed	Eng Validation Req.
  Tooling	Expired Tools	Daily Check	QuarantineBarcode