Icologiq Knowledge · Quality event
Nonconformance
A situation in which a product, process, activity or result fails to meet a defined requirement, specification, procedure or standard.
Also known as:
Non-conformity, nonconformity, NC
At a glance
Type
Quality event
Topic
CAPA & Incidents
Applies to
Cross-industry
Current version
Status
Last reviewed
September 14, 2026
Definition
A nonconformance occurs when a specified requirement is not met. It can relate to a product, service, process, document, supplier, procedure or management-system requirement. Organizations typically record the issue, assess its impact and determine whether correction, investigation or CAPA is needed.
Why it matters
Nonconformances matter because deviations from requirements can affect quality, safety, compliance or customer expectations. Recording and evaluating them consistently helps determine containment, investigation, corrective action and whether wider trends need attention.
Describe what did not conform, the applicable requirement and the affected product, process, document or service.
Identify and record the requirement failure
1
Contain or segregate affected items and manage immediate risk while the issue is assessed.
Control affected outputs or conditions
2
Determine impact, recurrence, regulatory or customer implications and whether similar nonconformance may exist elsewhere.
Evaluate significance and scope
3
Use Root Cause Analysis for significant, systemic or recurring issues rather than automatically opening a full investigation for every case.
Investigate cause where required
4
Document what will happen to the affected output and whether systemic action or CAPA is necessary.
Decide correction, disposition and Corrective Action
5
Confirm actions and approvals are complete and retain traceability between the requirement, evidence, disposition and closure.
Verify evidence and close
6
Quality event explained
Managing a Nonconformance to controlled closure
A Nonconformance is a failure to meet a requirement. The management process should distinguish immediate correction from deeper Corrective Action, evaluate impact and retain enough evidence to explain disposition and closure.
A structured process for addressing causes of actual or potential problems through corrective or preventive measures and verifying that actions are effective.
CAPA
Process
· CAPA & Incidents
An unplanned departure from an approved procedure, process, specification or expected condition that should be documented and evaluated for impact.
Deviation
Event
· CAPA & Incidents
An observation or conclusion from an audit that identifies conformity, nonconformity or another issue requiring evaluation or follow-up.
Audit Finding
Concept
· Audit
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