risk management process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskManagementProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › risk management process
Direct subclasses:
Definition
planned process that systematically performs risk assessment, risk control, risk communication, and risk review
Semi-Formal Definition:
every instance of ‘risk management process’ is defined as exactly an instance of ‘planned process’ that ‘has occurrent part’ some ‘risk assessment process’, ‘has occurrent part’ some ‘risk communication process’, ‘has occurrent part’ some ‘risk review process’, ‘has occurrent part’ some ‘risk control process’ that is ‘preceded by’ some ‘risk assessment process’, and is ‘prescribed by’ some ‘risk management plan specification’
Examples
- a process for managing contamination risk during media preparation that includes risk assessment, risk control, communication of the results, and periodic review; a process for managing patient safety risk associated with administration of a biologic product that includes hazard identification, risk analysis, risk evaluation, risk control, and review of new safety information; a process for managing oxygen-deficiency risk associated with helium discharge that includes assessment of injury scenarios, implementation of risk reduction measures, communication of residual risk, and periodic review; a process for managing equipment-related risk in manufacturing that includes identification of failure scenarios, analysis and evaluation of associated risks, implementation of risk controls, and review of their continued suitability
Adapted From
- https://www.iso.org/obp/ui/en/#iso:std:iso:31073:ed-1:v1:en
Formal Axioms
First-Order Logic Definition
RiskManagementProcess(x) ↔ PlannedProcess(x) ∧ ∃a ∃r ∃c ∃v ∃p (RiskAssessmentProcess(a) ∧ RiskControlProcess(r) ∧ RiskCommunicationProcess(c) ∧ RiskReviewProcess(v) ∧ RiskManagementPlanSpecification(p) ∧ hasOccurrentPart(x, a) ∧ hasOccurrentPart(x, r) ∧ hasOccurrentPart(x, c) ∧ hasOccurrentPart(x, v) ∧ precededBy(r, a) ∧ prescribedBy(x, p))
Description Logic
constr:RiskManagementProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:has_occurrent_part .constr:RiskAssessmentProcess ⊓ ∃ bfo:has_occurrent_part .constr:RiskCommunicationProcess ⊓ ∃ bfo:has_occurrent_part .constr:RiskReviewProcess ⊓ ∃ bfo:has_occurrent_part .(constr:RiskControlProcess ⊓ ∃ bfo:preceded_by .constr:RiskAssessmentProcess) ⊓ ∃ constr:prescribedBy .constr:RiskManagementPlanSpecification
EquivalentTo: constr:PlannedProcess and bfo:has_occurrent_part some constr:RiskAssessmentProcess and bfo:has_occurrent_part some constr:RiskCommunicationProcess and bfo:has_occurrent_part some constr:RiskReviewProcess and bfo:has_occurrent_part some (constr:RiskControlProcess and bfo:preceded_by some constr:RiskAssessmentProcess) and constr:prescribedBy some constr:RiskManagementPlanSpecification
SubClassOf: constr:PlannedProcess