4.5 Nonconformance and escapes

A quality system is not defined by its perfection, but by its reaction speed when things go wrong. 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 and(The MRB RulesNCMR)

SQAny rulesmaterial forthat dispositiondeviates paths:from return,the scrap,drawing, rework,specification, use-as-or approved sample is (concession)."Nonconforming." WhoIt approvesis what;not required"Suspect"; evidenceit peris disposition;guilty segregationuntil andproven re-identification rules.innocent.

• ContainmentIdentification: Playbook

The

Standardmoment containmenta actions:defect stop-shipis request,confirmed, lotthe quarantine, 100% sort instruction, additional incoming checks, line-side containment, customer notification triggers. “Containment exit criteria”material must be explicit.physically tagged with a Red "REJECT" Label.

Segregation (The Red Cage):

• Rule: Nonconforming material cannot reside on the active floor. It must be moved to the locked MRB Cage or a designated Red Zone within 1 hour of detection.
• System Lock: 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 Members:
  • Quality (SQE): Chair. Owns the final decision on risk.
  • Engineering: Validates functional impact.
  • Purchasing: Executes the commercial transaction (Credit/Return).
• Disposition Paths:
  1. Return to Vendor (RTV): Default action. Supplier owns the defect. Purchasing issues a Debit Memo.
  2. Scrap: Material is destroyed on-site. Supplier pays for the material + disposal costs.
  3. Sort/Rework:
     • Constraint: Only permitted if the rework process is documented and approved by the SQE.
     • Cost: Supplier pays for internal labor (e.g., $50/hour) to screen the stock.
  4. Use As Is (UAI):
     • Constraint: Requires a signed Concession/Deviation from Engineering. Never allowed for Safety or Regulatory characteristics.

The Containment Playbook (The Fire Drill)

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

• Phase 1: Internal Containment (T + 2 Hours):
  • Stock Sweep: Check Warehouse, Line-Side Stock, and WIP. Quarantine everything with the suspect Date Code.
  • Clean Point: Tag the first known "Good Unit" on the line with a Green Label.
• Phase 2: External Containment (T + 24 Hours):
  • Stop Ship: 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 (Supplier-causedField/Line DefectsSpills)

Found

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.

• Immediate Actions:
  1. Traceability Report: SQE pulls the "Where Used" report to identify every finished unit containing the bad lot.
  2. Risk Assessment: Engineering determines severity (Safety vs. Nuisance).
  3. Notification:
     • Internal: Notify Operations Director immediately.
     • Supplier: Issue a Level 1 SCAR (See Chapter 4.6). The supplier has 24 hours to submit an initial containment plan.
• The "3-Lot Rule": After Release)an

  When defect is found in production/field: immediate actions, trace lots, scopeescape, the suspectnext population,3 communicateincoming internally,lots triggerfrom SCAR,that protectsupplier customer.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 good
MRB Vote	Unanimous Required	Pocket vetos / hidden risks
UAI (Concession)	Engineering Sign-off	Liability for design failure
Containment	Clean Point Defined	Defect leakage continues
Supplier Notification	Formal SCAR	Supplier repeats the error
Costs	Charged to Supplier	Dannie absorbs poor quality costs

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