deviation root cause investigation

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

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › deviation root cause investigation

Definition

planned process that evaluates candidate causes of a deviation event using relevant evidence to determine the most probable cause or causes and any contributing factors

Examples

• Root cause investigation evaluating equipment history, calibration records, alarm data, control-loop performance, operator actions, and batch records after a bioreactor temperature excursion

Adapted From

• https://www.pharmtech.com/view/regulation-and-compliance-deviation-investigations and https://www.gmp-inspection.com/en/glossary/deviation-management/

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

DeviationRootCauseInvestigation(x) → PlannedProcess(x) ∧ ∃d∃e∃r∃p(DeviationDescription(d) ∧ DeviationEvent(e) ∧ describes(d,e) ∧ hasInput(x,d) ∧ DeviationRootCauseDescription(r) ∧ isAbout(r,e) ∧ hasSpecifiedOutput(x,r) ∧ DeviationInvestigationProcess(p) ∧ occurrentPartOf(x,p))

Semi-Formal Natural Language Axioms

if x is a ‘deviation root cause investigation’ then x is a ‘planned process’, x ‘has input’ some ‘deviation description’ describing a ‘deviation event’, x ‘has specified output’ some ‘deviation root cause description’ that ‘is about’ that same ‘deviation event’, and x is ‘occurrent part of’ some ‘deviation investigation process’

Description Logic

constr:DeviationRootCauseInvestigation ⊑ constr:PlannedProcess

constr:DeviationRootCauseInvestigation ⊑ ∃ bfo:occurrent_part_of .constr:DeviationInvestigationProcess

constr:DeviationRootCauseInvestigation ⊑ ∃ constr:hasInput .constr:DeviationDescription

constr:DeviationRootCauseInvestigation ⊑ ∃ constr:hasSpecifiedOutput .constr:DeviationRootCauseDescription

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:occurrent_part_of some constr:DeviationInvestigationProcess

SubClassOf: constr:hasInput some constr:DeviationDescription

SubClassOf: constr:hasSpecifiedOutput some constr:DeviationRootCauseDescription