hazard detectability value expression
IRI: https://spec.industrialontologies.org/ontology/construct/HazardDetectabilityValueExpression
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: value expression
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › hazard detectability value expression
Definition
value expression that represents the degree to which a specified hazard can be discovered or determined to exist
Examples
- hazard detectability value expression of high assigned to low bioreactor temperature when continuous temperature monitoring and alarm functions are active; Hazard detectability value expression of medium assigned to oxygen presence in a batch polymerization vessel when oxygen presence is inferred from pressure behavior but not directly measured; Hazard detectability value expression of low assigned to trace metal variability in a powdered medium lot when the material is qualified by supplier certificate of analysis but not routinely tested in-house for each lot
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 to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
HazardDetectabilityValueExpression(x) → ValueExpression(x) ∧ ∃h (HazardSpecification(h) ∧ continuantPartOfAtAllTimes(x, h))
Semi-Formal Natural Language Axioms
if x is a ‘hazard detectability value expression’ then x is a ‘value expression’ that is ‘continuant part of at all times’ some ‘hazard specification’
Description Logic
constr:HazardDetectabilityValueExpression ⊑ constr:ValueExpression
constr:HazardDetectabilityValueExpression ⊑ ∃ bfo:continuant_part_of_at_all_times .constr:HazardSpecification
SubClassOf: constr:ValueExpression
SubClassOf: bfo:continuant_part_of_at_all_times some constr:HazardSpecification