nonconformances
Failures meeting specifications
Nonconformances are instances where something fails to meet established standards, specifications, or requirements.
The term belongs to quality management and regulatory contexts: The audit revealed several nonconformances in the manufacturing process.
A nonconformance triggers documentation and corrective action.
Also spelled nonconformities.
Departures from a norm
- defectsFaults or imperfections
- discrepanciesDifferences where agreement expected
- auditsFormal account inspections
- corrective actionsSteps taken to fix problems
ISO · inspections · compliance · specifications · standards · documentation · root cause · procedures
Modified versions of something
- anomaliesDepartures from expected patterns
- exceptionsCases not following rules
- tolerancesAllowable limits of variation
- specificationsStated requirements and parameters
trending · statistical · monitoring · sampling · measurements · parameters · calibration · equipment
Breaches of rules
- citationsAcknowledged source mentions
- FDAU.S. health regulator
- inspectionsSystematic examinations for flaws
- complianceAdhering to requirements
warnings · remediation · enforcement · GMP · documentation · regulatory bodies · consent decrees · recalls
deviations
Departures from a norm
- defectsFaults or imperfections
- discrepanciesDifferences where agreement expected
- auditsFormal account inspections
corrective actions · ISO · inspections · compliance · specifications · standards · documentation · root cause · procedures · findings
variations
Modified versions of something
- anomaliesDepartures from expected patterns
- exceptionsCases not following rules
- tolerancesAllowable limits of variation
specifications · trending · statistical · monitoring · sampling · measurements · parameters · calibration · equipment · procedures
violations
Breaches of rules
- citationsAcknowledged source mentions
- FDAU.S. health regulator
- inspectionsSystematic examinations for flaws
compliance · warnings · remediation · enforcement · GMP · documentation · regulatory bodies · consent decrees · recalls · observations
nonconformancesconformances
States of meeting requirements
compliances · conformities · approvals · passes · acceptances