deviation investigation report

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

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 investigation report

Definition

information content entity that records the findings and conclusions of a deviation investigation process

Examples

• Deviation investigation report for a major temperature excursion affecting a raw material lot in warehouse storage, including investigation findings and conclusions; deviation investigation report for a sterilization-cycle failure affecting equipment or materials intended for aseptic processing, including investigation findings, conclusions, and resulting corrective actions; deviation investigation report for a bioburden excursion detected in a purification pool, including investigation findings and conclusions

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

DeviationInvestigationReport(x) → InformationContentEntity(x) ∧ ∃p∃d∃e∃i∃c(DeviationInvestigationProcess(p) ∧ isSpecifiedOutputOf(x,p) ∧ DeviationDescription(d) ∧ hasContinuantPartAtAllTimes(x,d) ∧ DeviationEvent(e) ∧ describes(d,e) ∧ DeviationImpactAssessmentResult(i) ∧ hasContinuantPartAtAllTimes(x,i) ∧ isAbout(i,e) ∧ CorrectiveActionPreventiveActionPlanSpecification(c) ∧ hasContinuantPartAtAllTimes(x,c))

Semi-Formal Natural Language Axioms

if x is a ‘deviation investigation report’ then x is an ‘information content entity’ that ‘is specified output of’ some ‘deviation investigation process’, ‘has continuant part at all times’ some ‘deviation description’ describing a ‘deviation event’, ‘has continuant part at all times’ some ‘deviation impact assessment result’ about that same event, and ‘has continuant part at all times’ some ‘corrective action preventive action plan specification’

Description Logic

constr:DeviationInvestigationReport ⊑ constr:InformationContentEntity

constr:DeviationInvestigationReport ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:CorrectiveActionPreventiveActionPlanSpecification

constr:DeviationInvestigationReport ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:DeviationDescription

constr:DeviationInvestigationReport ⊑ ∃ bfo:has_continuant_part_at_all_times .constr:DeviationImpactAssessmentResult

constr:DeviationInvestigationReport ⊑ ∃ constr:isSpecifiedOutputOf .constr:DeviationInvestigationProcess

SubClassOf: constr:InformationContentEntity

SubClassOf: bfo:has_continuant_part_at_all_times some constr:CorrectiveActionPreventiveActionPlanSpecification

SubClassOf: bfo:has_continuant_part_at_all_times some constr:DeviationDescription

SubClassOf: bfo:has_continuant_part_at_all_times some constr:DeviationImpactAssessmentResult

SubClassOf: constr:isSpecifiedOutputOf some constr:DeviationInvestigationProcess