4.3 Audits and capability verification

Trust is not a quality control strategy. Verification is. A supplier's quality manual in a conference room often bears little resemblance to the reality on their shop floor. The Dannie Operating System mandates a "Go and See" (Gemba) approach. We do not audit paperwork; we audit physics and process. This chapter defines the audit architecture required to validate that a supplier's manufacturing capability matches their commercial promises.

The Audit Program StandardHierarchy

Not all audits are created equal. The Supplier Quality Engineer (SQE) must select the correct tool for the objective.

1. System Audit types(ISO 9001 / IATF 16949)

• Objective: Compliance. Does the supplier have a Quality Management System (initial,QMS)?
• Scope: periodic,Management triggered,Review, remote),Document frequencyControl, byTraining risk,Records, requiredInternal outputsAudit schedules.
• Frequency: Initial Qualification only (findings,unless correctivemajor actions,certification verificationfailure plan)occurs).
• Verdict: DefinesPass “major/minor/systemic”.
  /

  Fail.

2. Process Audit Checklist(VDA (Electronics)6.3 Style)

• Objective:

  SQCapability. checklistIs focusingthe onmanufacturing defectprocess mechanisms:robust ESD,and MSL,reproducible?

• Scope: storage,The traceability,"Turtle calibration,Diagram" solderingof the specific production line. Inputs, Machinery, Manpower, Methods, Environment, and Measurements.
• Focus:
  • ESD Control: Wrist straps tested? Ionizers functional? Grounding points connected?
  • MSL Control: Are Moisture Sensitive Devices baked correctly? Are floor life logs accurate?
  • Solder Profile: Is the oven profile control,validated cleanliness/ionic,daily programmingusing control,a inspection/testprofiler?
• Frequency: coverage,Annual reworkfor discipline.
  Class A suppliers; Triggered for Class B/C.

3. Product Audit (VDA 6.5 Style)

• Objective: Conformance. Does the finished part match the drawing?
• Scope: The SQE pulls a random box from "Finished Goods" (ready to ship) and performs a "Customer Eye" inspection on-site.
• Focus: Cosmetic standards, packaging integrity, label accuracy, and basic fit check.
• Frequency: Every site visit.

Special Process Validation Requirements(The "Black Box")

ForSome processes cannot be verified by inspecting the final output (e.g., you cannot see if a crimp is strong just by looking at it). These "Special Processes" require rigid validation.

• Mandate: Suppliers must maintain a Validation Master Plan for:
  • Soldering: Reflow, Wave, Selective (Profile validation).
  • Chemical: Conformal Coating, Potting, Cleaning (Ionic Contamination test).
  • Mechanical: Crimping (Pull test data), Press-Fit (Force/Distance curves).
• Re-Validation: Must occur annually or after any specialequipment repair/move. The SQE must review these records during the Process Audit.

The Capability Index (C_pk)

We do not accept "good parts"; we demand a "capable process."

• The Requirement: For all Critical to Quality (CTQ) dimensions (e.g., PCB thickness, Connector pitch), the supplier must demonstrate statistical control.
• Metric:
  • P_pk > 1.67: Required for NPI / New Tooling.
  • C_pk > 1.33: Required for Mass Production.
• Data: The supplier must submit X-Bar & R Charts with every shipment of critical custom parts (e.g., Metal Shielding).
• Failure: If C_pk < 1.0, the process is not capable. 100% Inspection is mandatory until the process is fixed.

The Audit Scoring & Consequence

An audit is useless without a score. Dannie uses a Red/Yellow/Green traffic light system.

• Green (> 90%): Approved. Standard surveillance.
• Yellow (80% - 89%): Conditional Approval.
  • Action: Supplier must submit a Corrective Action Plan (CAP) within 14 days.
  • Constraint: New Business Hold until CAP is closed.
• Red (< 80%): Failed.
  • Action: Immediate Business Hold.
  • Containment: Controlled Shipping Level 2 (CS2) - 3rd Party Inspection required at supplier:supplier's reflow/wave/selective,expense.

coating/potting,

Final press-fit,Checklist

crimping,

Audit welding,Type	Focus	Frequency	Standard
System	QMS cleaning,/ test.Paperwork	Qualification	ISO Required9001
Process	Line evidence:/ validationPhysics	Annual	VDA record,6.3
Product	Output control/ limits,Box	Every periodicVisit	IPC-A-610
Special	Soldering revalidation./ Chem	Validation Record	Process Params
Capability	CTQ Dimensions	Lot Data	Cpk > 1.33

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