5.2 Deviations / waivers / concessions

While strict adherence to specifications is the foundation of quality, the realities of manufacturing sometimes require a degree of flexibility to keep production moving. For instance, a shortage of a specific component brand or a minor cosmetic flaw on a non-visible surface shouldn’t automatically stop an entire assembly line. The Deviation process provides a controlled, temporary method for accepting product that does not meet the established specification, thereby converting an uncontrolled defect into a managed and documented risk. It’s important to understand that this is not a loophole for poor quality; it is a deliberate engineering decision to prioritize delivery while ensuring the product’s functional integrity remains intact.

Classification: deviation vs. concession

The key distinction between a deviation and a concession lies in the timing of the request, which determines the appropriate approval workflow.

Classification based on timing:

If a non-conformance is identified before production begins—such as needing to use a substitute component due to a shortage—it should be processed as a Deviation. This is a forward-looking approval that authorizes a specific build strategy in advance.
If a non-conformance is identified after production is complete—like a cosmetic scratch found during inspection or a marginal test result—it should be processed as a Concession. This is a backward-looking approval that authorizes the release of existing non-conforming inventory.

Approval authority and risk assessment

The level of authorization required must correspond to the severity and impact of the departure from the specification. A blanket approval from a non-technical role, such as a sales representative, is not valid; a technical review and sign-off are mandatory.

Authority escalation pathways:

Requests that involve Safety, Regulatory, or Reliability parameters—such as creepage distance, fuse ratings, or flammability—must be REJECTED. No deviations or concessions are permissible in these critical areas.
Deviations that impact Form, Fit, or Function (3F) require a signature from Customer Engineering and Quality representatives.
For deviations that are purely Cosmetic (affecting only internal surfaces) or related to a non-critical Process parameter, approval from the Internal Quality Manager is sufficient. However, it is considered a best practice to inform the customer even in these cases.

Traceability and identification

Product manufactured under a deviation is, by definition, non-compliant with the standard specification. Therefore, it must be clearly identifiable and kept separate from standard inventory. This segregation is crucial for facilitating any future recalls, rework, or warranty analysis.

Identification protocol:

Unique Batch Code: The affected units must be isolated within your ERP or inventory management system. They should never be merged with standard, compliant lots.
Physical Labeling: Apply a secondary label—typically in a distinct color like yellow or orange—to the lowest level of packaging (such as the PCBA or unit) and the shipping carton. This label must clearly reference the Deviation ID.
Certificate of Conformance (CoC): All shipping documentation must explicitly list any active Waiver or Deviation ID that applies to the shipment.

Expiration protocols:

Once a deviation expires—whether by reaching its specified date or quantity limit—production must immediately halt. The process must revert to the master specification. To continue producing under the non-conforming condition, you must initiate an entirely new deviation request; you cannot simply extend the old one.

The deviation register and closure

Think of a deviation as a technical debt that must be repaid. Allowing deviations to remain active indefinitely can mask underlying process failures or chronic supply chain issues.

Management rules:

The Register: Maintain a centralized log of all active and historical deviations. This register is essential for managing an “Expiry Watchlist” to ensure timely closure.
Closure: Upon a deviation’s expiration, the Quality team must verify that production has successfully returned to the standard process.
Correction: If the same issue requires a deviation request more than twice, it is no longer a temporary event. At this point, you must initiate a Permanent Engineering Change (ECN) or a Corrective Action (CAPA) to address and resolve the root cause.

Recap: Deviation/Concession Approval and Traceability

Parameter	Requirement	Approval Authority	Traceability Action
Classification	Deviation (pre-production) / Concession (post-production)	—	—
Safety/Regulatory/Reliability	Deviation/Concession PROHIBITED	REJECTED	—
Form, Fit, Function (3F) Impact	Deviation/Concession permitted	Customer Engineering & Quality signature required	Apply unique batch code & physical label with Deviation ID
Cosmetic/Non-Critical Process	Deviation/Concession permitted	Internal Quality Manager signature required	Apply unique batch code & physical label with Deviation ID
Validity & Closure	Must have specific quantity/date limit; No open-ended approvals	—	Document on CoC; Segregate inventory; Close upon expiry; Trigger ECN/CAPA if repeated >2x