4.4 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 (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.

• Identification: The moment a defect is confirmed, the material must be 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 (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.

• 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 an escape, 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 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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