5.6 Corrective Action System

A Supplier Corrective Action Request (SCAR) is not a "Complaint Form." It is a formal demand for an engineering investigation into a process failure. The goal is not to fix the part (that is Rework); the goal is to fix the system that produced the part. This chapter defines the mandatory 8D methodology, the response timelines, and the validation protocols required to close a SCAR.

SCAR Triggers and Escalation

We do not issue SCARs for every minor scratch. We issue them when the process is out of control.

• Level 1: Critical (Stop Ship)
  • Trigger: Safety hazard, Regulatory violation, or "Line Down" event > 4 hours.
  • Mandate: 24-hour initial response required.
• Level 2: Major (Systemic)
  • Trigger: Repeat defect (same MPN, same failure mode within 3 months) or > 1% Defect Rate.
  • Mandate: Standard 8D required.
• Level 3: Minor (Trend)
  • Trigger: Negative trend in Supplier Scorecard or documentation errors.
  • Mandate: Informal "Corrective Action Plan" (CAP) accepted.

The 8D Methodology (Mandatory Format)

Suppliers must submit their response using the standard Eight Disciplines (8D) format. "Email explanations" are rejected.

• D3: Interim Containment Action (ICA)
  • Goal: Stop the bleeding.
  • Requirement: The supplier must define exactly how they have segregated suspect stock and what screening method is in place for new shipments.
  • Timeline: Must be submitted within 24 hours.
• D4: Root Cause Analysis (RCA)
  • Goal: Identify the "Escape Point" and the "Creation Point."
  • Prohibition: "Operator Error" is not a Root Cause. If an operator made a mistake, the root cause is the process that allowed the mistake (e.g., lack of fixtures, confusing instructions).
  • Tools: Must use 5 Whys or Fishbone Diagram.
• D5/D6: Permanent Corrective Action (PCA)
  • Goal: Systemic change.
  • Requirement: Implementation of Hardware Changes (e.g., modified tooling, new sensors) or Poka-Yoke (Mistake Proofing). Training is considered a weak countermeasure.
• D7: Prevention
  • Requirement: Update the FMEA (Failure Mode Effects Analysis) and Control Plan to reflect the new risk controls.

Response Timelines

A SCAR is a ticking clock. Delays trigger automatic escalation.

Phase	Milestone	Deadline (from Issuance)	Consequence of Delay
Acknowledgement	D1	24 Hours	Buyer Notification
Containment	D3	24 Hours	New Business Hold
Root Cause	D4	5 Business Days	Supplier Scorecard Deduction
Final Report	D8	14 Business Days	Management Escalation

Effectiveness Verification (VoE)

A SCAR is never closed based on a promise. It is closed based on evidence.

• The Validation Window: The SCAR remains in "Monitoring" status for 3 consecutive shipments after the PCA implementation.
• Verification Methods:
  1. Incoming Data: IQC performs 100% check on the specific defect for the next 3 lots.
  2. Audit: SQE verifies the physical fix (e.g., the new sensor) during the next site visit.
  3. Capability Data: Supplier submits new Cpk data showing process shift.
• Closure: Only the Dannie SQE has the authority to close the SCAR.
• Re-Open Trigger: If the defect recurs within 6 months, the SCAR is re-opened as a Level 1 Escalation (Management Intervention required).

Final Checklist

SCAR Element	Standard	Risk of Failure
Containment	< 24 Hours	Factory contamination
Root Cause	No "Operator Error"	Recurring defects
Corrective Action	Hardware/Process Change	Weak "training" fixes
Verification	3 Clean Lots	False sense of security
Document Update	FMEA & Control Plan	Knowledge loss

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