risk management plan specification
IRI: https://spec.industrialontologies.org/ontology/construct/RiskManagementPlanSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: plan specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › risk management plan specification
Definition
plan specification that prescribes a risk management process
Explanatory Notes
1) A risk management plan specifies the approach, management components, and resources to be applied in managing risk. 2) Management components may include procedures, practices, assignment of responsibilities, and the sequence and timing of activities. 3) A risk management plan may apply to a particular product, process, project, organizational unit, or the organization as a whole.
Examples
- a plan specifying how contamination risks in media preparation will be assessed, controlled, documented, and reviewed during a development campaign; a plan specifying the responsibilities, decision criteria, and review schedule for managing product quality risks across commercial manufacturing; a plan specifying the resources, procedures, and assigned roles for managing magnet quench risk in an MRI facility;
Adapted From
- https://www.iso.org/obp/ui/en/#iso:std:iso:31073:ed-1:v1:en
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
See the general discussion under information content entity
Formal Axioms
First-Order Logic Axioms
RiskManagementPlanSpecification(x) → PlanSpecification(x) ∧ ∃m(RiskManagementMethodSpecification(m) ∧ hasContinuantPartAtAllTimes(x,m)) ∧ ∀y(prescribes(x,y) → RiskManagementProcess(y))
Semi-Formal Natural Language Axioms
if x is a ‘risk management plan specification’ then x is a ‘plan specification’ that ‘has continuant part at all times’ some ‘risk management method specification’ and only ‘prescribes’ ‘risk management process’
Description Logic
constr:RiskManagementPlanSpecification ⊑ constr:PlanSpecification
constr:RiskManagementPlanSpecification ⊑ ∀ constr:prescribes .constr:RiskManagementProcess
constr:RiskManagementPlanSpecification ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:RiskManagementMethodSpecification
constr:PlanSpecification ⊓ ∃ bfo:has_continuant_part_at_all_times .constr:RiskManagementMethodSpecification ⊓ ∃ constr:prescribes .constr:RiskManagementProcess ⊑ constr:RiskManagementPlanSpecification
SubClassOf: constr:PlanSpecification
SubClassOf: constr:prescribes only constr:RiskManagementProcess
SubClassOf: bfo:has_continuant_part_at_all_times some constr:RiskManagementMethodSpecification
constr:PlanSpecification and bfo:has_continuant_part_at_all_times some constr:RiskManagementMethodSpecification and constr:prescribes some constr:RiskManagementProcess SubClassOf: constr:RiskManagementPlanSpecification