4.6 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. We operate under a "No Surprises" policy: suppliers are strictly prohibited from changing the "4M" (Man, Machine, Material, Method) without prior written approval. Uncontrolled change is the primary driver of catastrophic field failures.

Supplier Change Control (PCN)

A Process Change Notification (PCN) is the formal contract modification for a permanent process shift. It is not an "FYI" email; it is a request for validation.

Trigger Events (What Requires a PCN?):

• IF Material changes (e.g., Resin grade, Solder paste type, sub-tier source) -> THEN PCN Required.
• IF Machine changes (e.g., New mold, New SMT line, Reflow oven replacement) -> THEN PCN Required.
• IF Method changes (e.g., Cure time/temp, Inspection logic, Test software update) -> THEN PCN Required.
• IF Location changes (e.g., Moving production to a new building) -> THEN PCN Required.

The 90-Day Rule:

Suppliers must issue a PCN at least 90 days prior to the planned implementation. This allows time for:

1. Risk Assessment: Updating the FMEA.
2. Validation: Running a new Cpk study and a 3-Lot Safe Launch (100% Inspection).
3. Approval: Engineering and Quality sign-off. Silence is NOT approval.

Deviation and Concession Control

A Deviation is a temporary permission to violate the law. It is a "Get Out of Jail Free" card that expires. It is used to keep the line moving, not to lower the standard permanently.

Decision Logic:

• IF Defect is Safety/Regulatory -> THEN Denied. No exceptions.
• IF Defect is Functional -> THEN Conditional Approval (Requires 100% screening at Supplier expense).
• IF Defect is Cosmetic -> THEN Concession (Approved with Limit Samples and commercial discount).

Constraints:

• Time/Quantity Bound: Every deviation must have a hard stop (e.g., "Max 500 units" or "Expires 01-Nov").
• Visual Flag: Every box shipped under deviation must be labeled "DEVIATION #XXXX" in neon/bold text.
• Expiry: Once the limit is reached, the permission auto-revokes. Any further shipments are rejected.

Unauthorized Changes (The "Silent Killer")

Changing a process without notifying Dannie is a breach of contract and an act of negligence.

Examples of "Silent Changes":

• Using "Regrind" (recycled plastic) > 20% without approval.
• Swapping a capacitor for a "cheaper equivalent" without testing.
• Skipping a cure cycle to speed up throughput.

Consequences:

• Immediate Business Hold: Supplier status downgraded to "Do Not Source."
• Liability: Supplier is liable for 100% of validation costs, field recalls, and scrap.
• Audit: Mandatory "For Cause" on-site audit to re-qualify the entire line.

Final Checklist