hazardous situation
IRI: https://spec.industrialontologies.org/ontology/construct/HazardousSituation
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: bfo:process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › hazardous situation
Definition
process in which one or more persons, property, or an environment is exposed to one or more potential sources of harm
Explanatory Notes
Potential source of harm is commonly known as a hazard and is in this case an entity that is described by a hazard specification
Examples
- sampling a cell culture bioreactor while the operator and culture are exposed to contamination and pressurized-fluid hazards; performing an aseptic media transfer while the product-contact path is exposed to possible microbial ingress; conducting a viral inactivation hold while personnel, equipment, and product are exposed to hazardous low-pH conditions; transferring bulk drug substance between vessels while product, equipment, and the surrounding area are exposed to leakage or contamination hazards; initiating a clean-in-place cycle while personnel and equipment are exposed to corrosive cleaning chemicals; retrieving cryogenic cell bank vials while operators and storage materials are exposed to liquid nitrogen and extreme cold; refilling an NMR cryostat with liquid helium while operators, equipment, and the room environment are exposed to cryogenic, asphyxiation, and quench-related hazards.
Adapted From
- https://www.iso.org/obp/ui/en/#iso:std:iso:14971:ed-3:v1:en:term:3.21
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
HazardousSituation(x) → Process(x) ∧ ((∃c ∃s (Continuant(c) ∧ HazardSpecification(s) ∧ hasParticipantAtSomeTime(x, c) ∧ (describedBy(c, s)))) ∨ (∃p ∃s (Process(p) ∧ HazardSpecification(s) ∧ occurrentPartOf(x, p) ∧ (describedBy(p, s)))))
Semi-Formal Natural Language Axioms
if x is a ‘hazardous situation’ then x is a ‘process’ and either x ‘has participant at some time’ some ‘continuant’ that is ‘described by’ some ‘hazard specification’, or x is ‘occurrent part of’ some ‘process’ that is ‘described by’ some ‘hazard specification’
Description Logic
constr:HazardousSituation ⊑ bfo:process
constr:HazardousSituation ⊑ ∃ bfo:has_participant_at_some_time .(bfo:continuant ⊓ ∃ constr:describedBy .constr:HazardSpecification) ⊔ ∃ bfo:occurrent_part_of .(bfo:process ⊓ ∃ constr:describedBy .constr:HazardSpecification)
SubClassOf: bfo:process
SubClassOf: bfo:has_participant_at_some_time some (bfo:continuant and constr:describedBy some constr:HazardSpecification) or bfo:occurrent_part_of some (bfo:process and constr:describedBy some constr:HazardSpecification)