4.7 Change control and deviations

The "Golden Process" validated during qualification is the only approved way to manufacture the part. Any variation from this baseline—whether intentional (Change Request) or accidental (Deviation)—introduces unknown variables. This chapter defines the "No Surprises" policy: suppliers are strictly prohibited from changing the "4M" (Man, Machine, Material, Method) without prior written approval from Dannie Supplier Quality.

Supplier Change Control Requirements(PCN)

A Process Change Notification (PCN) is the formal mechanism for a supplier to request a permanent modification to their process.

• Trigger Events (What changesRequires requireApproval?):
  1. Material: SQChanging approval:resin materials,grade, processsolder parameters,paste equipment/tooling,type, site,or sub-tier process,source.
  2. Machine: Moving molds to a new press, replacing a reflow oven, or adding a new SMT line.
  3. Method: Changing cure time/temp, altering the inspection plan, or modifying test method,software.
  4. Location: packaging,Moving firmware/programmingproduction method.to Requireda evidencedifferent building or facility.
• The Notification Window: Suppliers must issue a PCN at least 90 days prior to the proposed implementation date.
• Validation Requirements:
  • Risk Assessment: FMEA update showing the new risk profile.
  • Capability Data: New Cpk study verifying process stability.
  • Validation: 3-Lot Safe Launch (100% Inspection) results.
• Approval: Requires SQE and validationEngineering depth.
  sign-off. Silence is NOT approval.

Deviation and Concession Control

HowA SQDeviation evaluatesis riska temporary permission to ship product that does not meet the specification. It is a "Get Out of Jail Free" card that expires.

• Types of Deviation:
  1. Pre-Production: Request to use a temporary process (e.g., Soft Tooling) during NPI.
  2. Production: Request to ship a lot with a known minor defect (e.g., cosmetic scratch) to avoid line-down.
• Risk Evaluation Logic:
  • Critical/Safety: Never Approved.
  • Functional: Approved only with 100% Screening and Engineering concurrence.
  • Cosmetic: Approved with "Limit Sample" and commercial concession (discount).
• Mandatory Constraints:
  • Quantity/Time Bound: The deviation must specify an exact Quantity (e.g., 500 units) or Expiration Date (e.g., 2 weeks).
  • Traceability: Every box shipped under deviation must be clearly labeled: "DEVIATION #XXXX".
  • Expiry: Once the limit is reached, the permission is automatically revoked. Unauthorized shipments beyond this point will be rejected at the dock.

Unauthorized Changes (The "Silent Killer")

Changing a process without notifying Dannie is a breach of contract and trust.

• Definition: Examples include "Regrinding" plastic without approval, changing a capacitor brand to a "cheaper equivalent," or skipping a cure cycle to speed up the line.
• Consequence:
  • Immediate Business Hold: Supplier is placed on "Do Not Source" status.
  • Liability: Supplier is liable for aall deviationvalidation request:costs, defectfield mechanism,recalls, detectability,and duration/qty/lotscrap boundaries,associated extrawith controls,the expiry,unauthorized post-actionchange.
  • Audit: review.Mandatory on-site "For Cause" audit to re-qualify the process.

Final Checklist

Control Element	Standard	Risk of Failure
PCN Window	90 Days Prior	Unvalidated process shifts
Sub-Tier Change	Requires Approval	Unknown material risks
Deviation Scope	Qty/Time Limited	Permanent "temporary" fixes
Labeling	Visible on Box	Polluting stock with bad parts
Silent Change	Contract Breach	Catastrophic field failure

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