Changes in 🟡 Biopharma Risk Management Ontology

• Maturity: 🟡 Provisional

New ontology in this release, review all classes: 🟡 Biopharma Risk Management Ontology

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Added

Classes

Construct	Definition
FailureModeAndEffectsAnalysisSpecification	risk management method specification that prescribes systematic identification of potential failure modes and evaluation of their causes and effects
HarmLikelihoodValueExpression	value expression that represents the assessed likelihood that a specified harm will occur in relation to one or more specified potential sources of harm
HarmSeverityValueExpression	value expression that represents the magnitude of possible or actual harm
HarmSpecification	information content entity that describes an adverse condition, consequence, or loss
HarmedState	material state of one or more persons, property, or an environment in which a person is injured or has damaged health, or property or the environment is damaged
HazardDetectabilityValueExpression	value expression that represents the degree to which a specified hazard can be discovered or determined to exist
HazardIdentificationProcess	planned process that systematically uses available information to recognize and record potential hazards relevant to a risk question or problem description
HazardOperabilityAnalysisMethodSpecification	risk management method specification that prescribes the systematic qualitative identification of potential hazards and operability problems in a process, evaluation of their causes, consequences, and existing safeguards, and, where appropriate, identification of recommended risk-reduction action
HazardSpecification	information content entity that describes one or more potential sources of harm
HazardousSituation	process in which one or more persons, property, or an environment is exposed to one or more potential sources of harm
QualityRiskManagementProcess	risk management process that systematically performs risk assessment, risk control, risk communication, and risk review for risks to drug product quality across the product lifecycle
ResidualRiskEstimate	risk estimate that is a combination of the assessed likelihood of harm and the assessed severity of that harm after risk reduction measures have been implemented
RiskAcceptanceProcess	planned process in which an agent makes an informed decision to accept an estimated risk
RiskAnalysisProcess	planned process that estimates the magnitude of risks associated with identified hazards by evaluating the likelihood of harm and the severity of that harm
RiskAssessmentProcess	planned process that consists of the identification of hazards and the analysis and evaluation of the risks associated with those hazards
RiskAssessmentResult	information content entity that is the output of a risk assessment process and that records the characterization of risk for one or more identified hazards
RiskCommunicationProcess	planned process in which information about estimated risk and risk management is shared between the decision makers and other stakeholders
RiskControlProcess	planned process in which risk is reduced or accepted, or both
RiskEstimate	information content entity that is a combination of the assessed likelihood of harm and the assessed severity of that harm
RiskEvaluationProcess	planned process that compares analyzed risks against predefined criteria to determine the significance of the estimated risk
RiskManagementMethodSpecification	plan specification that prescribes a proper part of a risk management process
RiskManagementPlanSpecification	plan specification that prescribes a risk management process
RiskManagementProcess	planned process that systematically performs risk assessment, risk control, risk communication, and risk review
RiskRankingAndFilteringSpecification	risk management method specification that prescribes criteria and procedures for prioritizing identified risk-relevant factors according to their relative risk level
RiskReductionProcess	planned process that consists of actions taken to lessen an estimated risk
RiskReviewProcess	planned process in which the outcomes of risk management activities are monitored or evaluated