risk communication process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskCommunicationProcess
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 communication process
Definition
planned process in which information about estimated risk and risk management is shared between the decision makers and other stakeholders
Examples
- a quality manager communicates an identified contamination risk to manufacturing staff during a shift handover meeting; a process engineer communicates a high-risk parameter deviation to the production supervisor by email and in the batch review system; a risk management team communicates the outcome of an FMEA to project decision makers through a risk assessment report and a review meeting; a risk management team communicates the additional filtration step that was proposed and accepted to reduce the contamination risk during media preparation
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
RiskCommunicationProcess(x) → PlannedProcess(x) ∧ ∃a (Agent(a) ∧ hasParticipantAtSomeTime(x, a)) ∧ ∃r (RiskManagementProcess(r) ∧ occurrentPartOf(x, r))
Semi-Formal Natural Language Axioms
if x is a ‘risk communication process’ then x is a ‘planned process’ that ‘has participant at some time’ some ‘agent’ and is ‘occurrent part of’ some ‘risk management process’
Description Logic
constr:RiskCommunicationProcess ⊑ constr:PlannedProcess
constr:RiskCommunicationProcess ⊑ ∃ bfo:has_participant_at_some_time .constr:Agent
constr:RiskCommunicationProcess ⊑ ∃ bfo:occurrent_part_of .constr:RiskManagementProcess
SubClassOf: constr:PlannedProcess
SubClassOf: bfo:has_participant_at_some_time some constr:Agent
SubClassOf: bfo:occurrent_part_of some constr:RiskManagementProcess