deviation impact assessment result
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationImpactAssessmentResult
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › deviation impact assessment result
Definition
information content entity that describes the actual or potential impact of a deviation event on one or more material entities or processes that are affected or potentially affected
Examples
- Assessment result describing the potential impact of a temperature excursion on a stored raw material lot; Assessment result describing the potential impact of a missed in-process sample on a manufacturing batch; Assessment result describing the potential impact of an out-of-limit pH event on a buffer preparation process; Assessment result describing the potential impact of a bioburden excursion on an in-process purification pool;
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. In particular, details about impact modeling are missing.
Formal Axioms
First-Order Logic Axioms
DeviationImpactAssessmentResult(x) → InformationContentEntity(x) ∧ ∃d (isAbout(x, d) ∧ DeviationEvent(d)) ∧ ∃y (describes(x, y) ∧ (Process(y) ∨ MaterialEntity(y)))
Semi-Formal Natural Language Axioms
if x is a ‘deviation impact assessment result’ then x is an ‘information content entity’, x ‘is about’ some ‘deviation event’, and x ‘describes’ some ‘process’ or ‘material entity’
Description Logic
constr:DeviationImpactAssessmentResult ⊑ constr:InformationContentEntity
constr:DeviationImpactAssessmentResult ⊑ ∃ constr:describes .(bfo:process ⊔ bfo:material_entity)
constr:DeviationImpactAssessmentResult ⊑ ∃ constr:isAbout .constr:DeviationEvent
SubClassOf: constr:InformationContentEntity
SubClassOf: constr:describes some (bfo:process or bfo:material_entity)
SubClassOf: constr:isAbout some constr:DeviationEvent