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4.4 Supplier Nonconformance (SCAR) Management

A quality system is not defined by its perfection, but by its reaction speedvelocity when thingsentropy go wrong.strikes. Nonconforming material is a radioactive asset; it must be isolated, identified, and dispositioned immediately to prevent contamination of the production line. This chapter defines the Non-Conformance Material Report (NCMR) workflow, the Material Review Board (MRB) authority, and the emergency protocols for "Quality Escapes."

Nonconforming Material Control (The NCMR)

Any material that deviates from the drawing, specification, or approved sample is "Nonconforming." It is not "Suspect"; it is guilty until proven innocent.

    Immediate Action Protocol:

    1. IdentificationIdentification:: The moment a defect is confirmed, physically tag the material must be physically tagged with a Red "REJECT" Label.
    2. Segregation (The Red Cage)::
      • RuleRule:: Nonconforming material cannot reside on the active floor. ItMove must be movedit to the locked MRB Cage or a designated Red Zone within 1 hour of detection.
    3. System LockLock:: The SQE must place the Lot on "Quality Hold" in the ERP to prevent accidental scanning/picking.

The Material Review Board (MRB)

The MRB is the "Supreme Court" of quality. It is a cross-functional team authorized to decide the fate of detained material.

  • Voting MembersLogic::

    • Quality (SQE):: Chair. Owns the final decision on risk.
    • EngineeringEngineering:: Validates functional impact.
    • PurchasingPurchasing:: Executes the commercial transaction (Credit/Return).

  • Disposition PathsPaths::

      • Return to Vendor (RTV):: Default action. Supplier owns the defect. Purchasing issues a Debit Memo.
      • ScrapScrap:: Material is destroyed on-site. Supplier pays for the material + disposal costs.
      • Sort/ReworkRework::
        • Constraint:Constraint: Only permitted if the rework process is documented and approved by the SQE.
        • Cost:Cost: Supplier pays for internal labor (e.g., $50/hour) to screen the stock.
      • Use As Is (UAI)::
        • ConstraintConstraint:: Requires a signed Concession/Deviation from Engineering. Never allowed for Safety or Regulatory characteristics.

Pro-Tip: Do not use the MRB as a "permanent storage" solution. Set a hard limit (e.g., 5 days) for disposition. If no decision is reached, default to RTV.

The Containment Playbook (The Fire Drill)

When a defect is found, the clock starts. The goal is to "Fence the Problem."

Time-Based Containment:

  • Phase 1: Internal Containment (T + 2 Hours)::
    • Stock SweepSweep:: Check Warehouse, Line-Side Stock, and WIP. Quarantine everything with the suspect Date Code.
    • Clean PointPoint:: Tag the first known "Good Unit" on the line with a Green Label.
  • Phase 2: External Containment (T + 24 Hours)::
    • Stop ShipShip:: Formally notify the supplier to cease shipments immediately.
    • Controlled Shipping (CS1):: Mandate that the supplier performs 100% inspection offline before shipping new lots. The supplier must mark each box with a "100% Inspected" stamp.

Escape Handling (Field/Line Spills)

An "Escape" occurs when a defect bypasses the SQ/IQC firewall and reaches the Manufacturing Line or the End Customer. This is a system failure.

  • ImmediateRecovery ActionsLogic::

    1. Traceability ReportReport:: SQE pulls the "Where Used" report to identify every finished unit containing the bad lot.
    2. Risk AssessmentAssessment:: Engineering determines severity (Safety vs. Nuisance).
    3. NotificationNotification::
      • InternalInternal:: Notify Operations Director immediately.
      • SupplierSupplier:: Issue a Level 1 SCAR (See Chapter 4.6). The supplier has 24 hours to submit an initial containment plan.

  • The "3-Lot Rule":

    • IF: After an escape,escape occurs -> THEN the next 3 incoming lots from that supplier must undergo Level III (Tightened) Inspection or 100% Measurement at the supplier's expense.

    Final Checklist

    Action

    Standard

    Risk of Failure

    Quarantine

    Locked Cage < 1 Hour

    Bad parts mixed with goodgood.

    MRB Vote

    Unanimous Required

    Pocket vetos / hidden risksrisks.

    UAI (Concession)

    Engineering Sign-off

    Liability for design failurefailure.

    Containment

    Clean Point Defined

    Defect leakage continuescontinues.

    Supplier Notification

    Formal SCAR

    Supplier repeats the errorerror.

    Costs

    Charged to Supplier

    DannieWe absorbsabsorb poor quality costscosts.


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