risk acceptance process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskAcceptanceProcess
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 acceptance process
Definition
planned process in which an agent makes an informed decision to accept an estimated risk
Explanatory Notes
Risk acceptance is the decision to accept risk. It may be a formal decision to accept residual risk or a passive decision in which residual risks are not specified.
Examples
- After implementation of a backup pH probe and enhanced calibration checks, the quality unit accepts the residual risk of pH measurement drift for routine manufacturing.
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-2_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
RiskAcceptanceProcess(x) → PlannedProcess(x) ∧ ∃r∃a∃o(RiskEstimate(r) ∧ Agent(a) ∧ InformationContentEntity(o) ∧ hasInput(x,r) ∧ hasParticipantAtSomeTime(x,a) ∧ hasSpecifiedOutput(x,o) ∧ isAbout(o,r))
Semi-Formal Natural Language Axioms
if x is a ‘risk acceptance process’ then x is a ‘planned process’ that ‘has input’ some ‘risk estimate’, ‘has participant at some time’ some ‘agent’, and ‘has specified output’ some ‘information content entity’ that ‘is about’ that same ‘risk estimate’
Description Logic
constr:RiskAcceptanceProcess ⊑ constr:PlannedProcess
constr:RiskAcceptanceProcess ⊑ ∃ bfo:has_participant_at_some_time .constr:Agent
constr:RiskAcceptanceProcess ⊑ ∃ constr:hasInput .constr:RiskEstimate
constr:RiskAcceptanceProcess ⊑ ∃ constr:hasSpecifiedOutput .(constr:InformationContentEntity ⊓ ∃ constr:isAbout .constr:RiskEstimate)
SubClassOf: constr:PlannedProcess
SubClassOf: bfo:has_participant_at_some_time some constr:Agent
SubClassOf: constr:hasInput some constr:RiskEstimate
SubClassOf: constr:hasSpecifiedOutput some (constr:InformationContentEntity and constr:isAbout some constr:RiskEstimate)