Changes in 🟡 Biopharma Deviation Management Ontology
- Maturity: 🟡 Provisional
New ontology in this release, review all classes: 🟡 Biopharma Deviation Management Ontology
Added
Classes
| Construct | Definition |
|---|---|
CorrectiveAction | planned process that is carried out to eliminate the cause of a detected non-conformity or other undesirable situation |
CorrectiveActionPreventiveActionEffectivenessCheck | planned process in which the effectiveness of implemented corrective actions or preventive actions is evaluated |
CorrectiveActionPreventiveActionPlanSpecification | plan specification that prescribes one or more corrective actions or preventive actions |
DeviationContainmentProcess | planned process carried out after recognition of a deviation event in which actions are taken with respect to affected material entities or processes to prevent the deviation or its effects from propagating further |
DeviationDescription | information content entity generated as part of deviation management to describe the occurrence and relevant circumstances of a deviation event |
DeviationEvent | event in which a departure occurs from an applicable plan, requirement specification, or specified range, target or limit |
DeviationEventClassifier | classifier that classifies a deviation event |
DeviationImpactAssessment | planned process in which the actual or potential impact of a deviation event is evaluated |
DeviationImpactAssessmentResult | information content entity that describes the actual or potential impact of a deviation event on one or more material entities or processes that are affected or potentially affected |
DeviationInvestigationProcess | planned process in which an agent gathers and analyzes information about a deviation event to assess its cause and actual or potential impact and to establish a CAPA plan specification that addresses the deviation event |
DeviationInvestigationReport | information content entity that records the findings and conclusions of a deviation investigation process |
DeviationManagementPlanSpecification | plan specification that prescribes a deviation management process |
DeviationManagementProcess | planned process for the identification, documentation, classification, investigation, assessment, resolution, and closure of deviations, including the definition, implementation, and follow-up of appropriate corrective and preventive actions |
DeviationRootCauseDescription | information content entity that records a conclusion concerning the root cause or most probable cause of a deviation event |
DeviationRootCauseInvestigation | planned process that evaluates candidate causes of a deviation event using relevant evidence to determine the most probable cause or causes and any contributing factors |
PreventiveAction | planned process that is carried out to eliminate the cause of a potential non-conformity or other undesirable potential situation |
ProcessExcursion | event in which the value of a variable monitored during a planned process is beyond a predefined limit or outside a predefined range during that process |