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.

Classification based on timing:

• Non-conformances identified before production (e.g. a substitute component due to a shortage) should be processed as a Production Permit / Deviation. This forward-looking approval authorizes a specific build strategy.
• Non-conformances identified after production (e.g. a cosmetic scratch or a marginal test result) should be processed as a Concession. This backward-looking approval 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.

Authority escalation pathways:

• Requests involving Safety, Regulatory, or Reliability parameters (e.g. creepage distance, fuse rating) must be REJECTED. No deviations are permissible in these critical areas.
• Deviations impacting Form, Fit, or Function (3FR) mandate a signature from Customer Engineering & Quality.
• Deviations that are exclusively Cosmetic (on internal surfaces) or Process-related (a non-critical parameter) require approval from the Internal Quality Manager, though notifying the customer remains a best practice.

Pro-Tip: “Open-Ended” deviations must never be granted. 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: The affected units must be isolated in the ERP system. They must not be merged with “Clean” lots.
• Physical Labeling: A secondary label (often yellow or orange) must be applied to the lowest level packaging (PCBA 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.

Expiration protocols:

• Upon deviation expiration (Date passed or Quantity reached), production must halt immediately. The process reverts to the master specification, and continued production requires an entirely 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: A centralized log of all active and historical deviations must be maintained. 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. A Permanent Engineering Change (ECN) or a Corrective Action (CAPA) must be initiated to fix the root cause.

Final Checkout: Deviations / waivers / concessions

Control Point	Metric / State	Non-Negotiable Rule
Scope	Fixed Qty / Date	Must define exactly how many units or until what date. No “Until further notice.”
Authority	Tech Signature	Sales/Account Managers cannot approve technical deviations.
Traceability	Tagged	Box and Unit must carry visual indication of the Deviation ID.
Safety	Compliant	Never waive safety standards, regulatory markings, or dielectric strength limits.
Disposition	Segregated	Do not mix deviated stock with standard stock in the same shipment.