deviation root cause description

IRI: https://spec.industrialontologies.org/ontology/construct/DeviationRootCauseDescription

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 root cause description

Definition

information content entity that records a conclusion concerning the root cause or most probable cause of a deviation event

Examples

• Root cause documented as incorrect equipment setup before batch execution; Inadequate cleaning procedure identified as the root cause of residue carryover; Operator training gap identified as the root cause of repeated batch record errors; Sensor calibration drift identified as the root cause of an out-of-limit temperature reading; Raw material mix-up identified as the root cause of use of an incorrect media component; Bioreactor temperature-control failure identified as the root cause of a culture temperature excursion;

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

DeviationRootCauseDescription(x) → InformationContentEntity(x) ∧ ∃d (isAbout(x, d) ∧ DeviationEvent(d)) ∧ ∃e (describes(x, e) ∧ Entity(e) ∧ ¬SpatialRegion(e))

Semi-Formal Natural Language Axioms

if x is a ‘deviation root cause description’ then x is an ‘information content entity’, x ‘is about’ some ‘deviation event’, and x ‘describes’ some ‘entity’ that is not a ‘spatial region’

Description Logic

constr:DeviationRootCauseDescription ⊑ constr:InformationContentEntity

constr:DeviationRootCauseDescription ⊑ ∃ constr:describes .(bfo:entity ⊓ ¬ bfo:spatial_region)

constr:DeviationRootCauseDescription ⊑ ∃ constr:isAbout .constr:DeviationEvent

SubClassOf: constr:InformationContentEntity

SubClassOf: constr:describes some (bfo:entity and not bfo:spatial_region)

SubClassOf: constr:isAbout some constr:DeviationEvent