5.2 Deviations / Waivers / Concessions

Rigid adherence to specification is the baseline for quality, but manufacturing reality occasionally demands flexibility to maintain continuity of supply. A shortage of a specific resistor brand or a cosmetic blemish on a hidden chassis surface should not necessarily halt a production line. The Deviation process provides a controlled, temporary mechanism to accept product that departs from the established standard, converting an uncontrolled defect into a managed risk. This is not a loophole for poor quality; it is a calculated engineering decision to prioritize delivery while maintaining functional integrity.

Classification: Deviation vs. Concession

Distinguishing the timing of the request determines the approval workflow.

Logic: State → Classification

• IF the non-conformance is identified before production (e.g., substitute component due to shortage) → THEN process as Production Permit / Deviation. Approval is forward-looking and authorizes a specific build strategy.
• IF the non-conformance is identified after production (e.g., cosmetic scratch, marginal test result) → THEN process as Concession. Approval is backward-looking and authorizes the release of existing non-conforming inventory.

Approval Authority and Risk Assessment

Authorization must scale with the severity of the departure from specification. A blanket approval by a sales representative is invalid; technical underwriting is mandatory.

Decision Logic: Authority Matrix

• IF Impact is Safety, Regulatory, or Reliability (e.g., creepage distance, fuse rating) → THEN REJECT. No deviation is permissible.
• IF Impact is Form, Fit, or Function (3FR) → THEN Requires Customer Engineering & Quality signature.
• IF Impact is Cosmetic (internal surfaces) or Process (non-critical parameter) → THEN Requires Internal Quality Manager signature. Notification to customer recommended.

Pro-Tip: Never grant "Open-Ended" deviations. A deviation without a specific quantity limit or expiration date effectively becomes a permanent engineering change without the documentation to back it up.

Traceability and Identification

Product produced under a deviation is technically non-compliant. It must be segregable from standard inventory to facilitate future recalls, rework, or warranty analysis.

Identification Protocol:

• Unique Batch Code: Isolate the affected units in the ERP system. Do not merge with "Clean" lots.
• Physical Labeling: Apply a secondary label (often yellow or orange) to the lowest level packaging (PCB or Unit) and the shipping carton. The label must reference the Deviation ID.
• Certificate of Conformance (CoC): The shipping documentation must explicitly list the active Waiver/Deviation ID.

Scenario → Action:

• Scenario: Deviation expires (Date passed or Quantity reached).
• Action: Immediate Stop. The process reverts automatically to the master specification. Continued production requires a new deviation request, not an extension.

The Deviation Register and Closure

A deviation is a debt that must be paid. Leaving deviations active masks underlying process failures or supply chain weaknesses.

Management Rules:

• The Register: Maintain a centralized log of all active and historical deviations. This log drives the "Expiry Watchlist."
• Closure: Upon expiration, the Quality team must verify the return to standard process.
• Correction: If a deviation is requested more than twice for the same issue, it is no longer a temporary event. Initiate a Permanent Engineering Change (ECN) or a Corrective Action (CAPA) to fix the root cause.

Final Checklist