Nonconformance
Nonconforming Product or Output
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Any product, material, process output, or system state that fails to meet a specified requirement or acceptance criterion. Distinct from a deviation, which describes an unplanned departure from an approved procedure, nonconformance describes the resulting output itself and drives a disposition decision — use-as-is, rework, or reject.
Nonconformance is most formally defined in device and general quality management vocabulary: a nonconforming product is one that does not meet specified requirements, whether identified during incoming inspection, in-process checks, or final release testing. The organization must segregate, evaluate, and disposition the nonconforming item before it can proceed.
Disposition options typically include use-as-is (with documented justification), rework to bring the item into conformance, regrade to a lower specification if applicable, or reject/scrap. Each disposition decision is itself a quality-unit-approved record, and repeated or high-impact nonconformances are expected to trigger investigation and, where warranted, corrective and preventive action.
In drug GMP terminology the equivalent concept is usually captured under deviation and out-of-specification handling, but device, laboratory, and ISO-certified quality systems use “nonconformance” as the formal term for the same underlying control.
- —Describes a nonconforming output, not the procedural departure that caused it
- —Requires segregation and a documented disposition decision
- —Disposition options: use-as-is, rework, regrade, or reject
- —Recurring nonconformances should feed the CAPA system
ISO 13485:2016 Clause 8.3 (Control of nonconforming product); 21 CFR 820.90 (Nonconforming product)
Frequently asked questions
What does Nonconformance stand for?
Nonconformance stands for Nonconforming Product or Output.
What is Nonconformance?
Any product, material, process output, or system state that fails to meet a specified requirement or acceptance criterion. Distinct from a deviation, which describes an unplanned departure from an approved procedure, nonconformance describes the resulting output itself and drives a disposition decision — use-as-is, rework, or reject.
Which regulations cover Nonconformance?
ISO 13485:2016 Clause 8.3 (Control of nonconforming product); 21 CFR 820.90 (Nonconforming product)