🟡 Biopharma Deviation Management Ontology
Maturity: 🟡 Provisional
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
RDF: BiopharmaDeviationManagement.rdf
The Biopharma Deviation Management Ontology provides constructs for representing deviations from approved plans, procedures, requirements, limits, and ranges in biopharmaceutical development and manufacturing. It supports modeling how deviation events are documented, contained, investigated, assessed for impact, resolved, and closed, including root-cause determination and corrective and preventive action planning. The module enables deviation-management information to be represented in relation to affected processes, materials, batches, equipment, and product quality decisions. It is intended to support consistent representation of deviation knowledge across GMP manufacturing, process monitoring, batch review, investigations, CAPA follow-up, and lifecycle quality management.
Annotations
Copyright
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
License
http://opensource.org/licenses/MIT
Classes (17)
| Class | Definition |
|---|---|
| corrective action | planned process that is carried out to eliminate the cause of a detected non-conformity or other undesirable situation |
| corrective action preventive action effectiveness check | planned process in which the effectiveness of implemented corrective actions or preventive actions is evaluated |
| corrective action preventive action plan specification | plan specification that prescribes one or more corrective actions or preventive actions |
| deviation containment process | planned process carried out after recognition of a deviation event in which actions are taken with respect to affected material en… |
| deviation description | information content entity generated as part of deviation management to describe the occurrence and relevant circumstances of a de… |
| deviation event | event in which a departure occurs from an applicable plan, requirement specification, or specified range, target or limit |
| deviation event classifier | classifier that classifies a deviation event |
| deviation impact assessment | planned process in which the actual or potential impact of a deviation event is evaluated |
| deviation impact assessment result | information content entity that describes the actual or potential impact of a deviation event on one or more material entities or … |
| deviation investigation process | planned process in which an agent gathers and analyzes information about a deviation event to assess its cause and actual or poten… |
| deviation investigation report | information content entity that records the findings and conclusions of a deviation investigation process |
| deviation management plan specification | plan specification that prescribes a deviation management process |
| deviation management process | planned process for the identification, documentation, classification, investigation, assessment, resolution, and closure of devia… |
| deviation root cause description | information content entity that records a conclusion concerning the root cause or most probable cause of a deviation event |
| deviation root cause investigation | planned process that evaluates candidate causes of a deviation event using relevant evidence to determine the most probable cause … |
| preventive action | planned process that is carried out to eliminate the cause of a potential non-conformity or other undesirable potential situation |
| process excursion | event in which the value of a variable monitored during a planned process is beyond a predefined limit or outside a predefined ran… |
Table of contents
- 🟧 corrective action
- 🟧 corrective action preventive action effectiveness check
- 🟧 corrective action preventive action plan specification
- 🟧 deviation containment process
- 🟧 deviation description
- 🟧 deviation event
- 🟧 deviation event classifier
- 🟧 deviation impact assessment
- 🟧 deviation impact assessment result
- 🟧 deviation investigation process
- 🟧 deviation investigation report
- 🟧 deviation management plan specification
- 🟧 deviation management process
- 🟧 deviation root cause description
- 🟧 deviation root cause investigation
- 🟧 preventive action
- 🟧 process excursion