🟡 Biopharma Risk Management Ontology
Maturity: 🟡 Provisional
IRI: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
RDF: BiopharmaRiskManagement.rdf
The Biopharma Risk Management Ontology provides constructs for representing risk in biopharmaceutical development and manufacturing. It supports modeling how risks are identified, analyzed, evaluated, controlled, communicated, and reviewed, as well as the documented outputs of those activities. The module enables hazards, hazardous situations, possible harm states, risk estimates, residual risks, and method-based assessments to be represented in relation to biopharmaceutical processes, materials, equipment, products, and lifecycle decisions. It is intended to support consistent representation of risk-management knowledge across development, manufacturing, technology transfer, contamination control, process characterization, and ongoing lifecycle management.
Annotations
Copyright
Copyright (c) 2022, 2023, 2024, 2025, 2026 Open Applications Group
License
http://opensource.org/licenses/MIT
Classes (26)
| Class | Definition |
|---|---|
| failure mode and effects analysis specification | risk management method specification that prescribes systematic identification of potential failure modes and evaluation of their … |
| harm likelihood value expression | value expression that represents the assessed likelihood that a specified harm will occur in relation to one or more specified pot… |
| harm severity value expression | value expression that represents the magnitude of possible or actual harm |
| harm specification | information content entity that describes an adverse condition, consequence, or loss |
| harmed state | material state of one or more persons, property, or an environment in which a person is injured or has damaged health, or property… |
| hazard detectability value expression | value expression that represents the degree to which a specified hazard can be discovered or determined to exist |
| hazard identification process | planned process that systematically uses available information to recognize and record potential hazards relevant to a risk questi… |
| hazard operability analysis method specification | risk management method specification that prescribes the systematic qualitative identification of potential hazards and operabilit… |
| hazard specification | information content entity that describes one or more potential sources of harm |
| hazardous situation | process in which one or more persons, property, or an environment is exposed to one or more potential sources of harm |
| quality risk management process | risk management process that systematically performs risk assessment, risk control, risk communication, and risk review for risks … |
| residual risk estimate | risk estimate that is a combination of the assessed likelihood of harm and the assessed severity of that harm after risk reduction… |
| risk acceptance process | planned process in which an agent makes an informed decision to accept an estimated risk |
| risk analysis process | planned process that estimates the magnitude of risks associated with identified hazards by evaluating the likelihood of harm and … |
| risk assessment process | planned process that consists of the identification of hazards and the analysis and evaluation of the risks associated with those … |
| risk assessment result | information content entity that is the output of a risk assessment process and that records the characterization of risk for one o… |
| risk communication process | planned process in which information about estimated risk and risk management is shared between the decision makers and other stak… |
| risk control process | planned process in which risk is reduced or accepted, or both |
| risk estimate | information content entity that is a combination of the assessed likelihood of harm and the assessed severity of that harm |
| risk evaluation process | planned process that compares analyzed risks against predefined criteria to determine the significance of the estimated risk |
| risk management method specification | plan specification that prescribes a proper part of a risk management process |
| risk management plan specification | plan specification that prescribes a risk management process |
| risk management process | planned process that systematically performs risk assessment, risk control, risk communication, and risk review |
| risk ranking and filtering specification | risk management method specification that prescribes criteria and procedures for prioritizing identified risk-relevant factors acc… |
| risk reduction process | planned process that consists of actions taken to lessen an estimated risk |
| risk review process | planned process in which the outcomes of risk management activities are monitored or evaluated |
Table of contents
- 🟧 failure mode and effects analysis specification
- 🟧 harm likelihood value expression
- 🟧 harm severity value expression
- 🟧 harm specification
- 🟧 harmed state
- 🟧 hazard detectability value expression
- 🟧 hazard identification process
- 🟧 hazard operability analysis method specification
- 🟧 hazard specification
- 🟧 hazardous situation
- 🟧 quality risk management process
- 🟧 residual risk estimate
- 🟧 risk acceptance process
- 🟧 risk analysis process
- 🟧 risk assessment process
- 🟧 risk assessment result
- 🟧 risk communication process
- 🟧 risk control process
- 🟧 risk estimate
- 🟧 risk evaluation process
- 🟧 risk management method specification
- 🟧 risk management plan specification
- 🟧 risk management process
- 🟧 risk ranking and filtering specification
- 🟧 risk reduction process
- 🟧 risk review process