corrective action preventive action effectiveness check

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

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 › corrective action preventive action effectiveness check

Definition

planned process in which the effectiveness of implemented corrective actions or preventive actions is evaluated

Explanatory Notes

CAPA effectiveness check may involve review of monitoring results, follow-up observations, subsequent deviations or nonconformities, process or product data, audit findings, or other relevant records.

Examples

• Review of subsequent batch records to confirm that retraining reduced recurrence of batch record execution errors; Review of cleaning verification results after a cleaning procedure revision to confirm that residue carryover has not recurred; Review of temperature monitoring data after equipment repair to confirm that temperature excursions have not recurred;

Adapted From

• https://www.bioprocessintl.com/qa-qc/biopharmaceutical-quality-managing-good-manufacturing-practice-deviations

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

CorrectiveActionPreventiveActionEffectivenessCheck(x) → PlannedProcess(x) ∧ ∃a (Agent(a) ∧ hasParticipantAtSomeTime(x, a)) ∧ ∃p ((CorrectiveAction(p) ∨ PreventiveAction(p)) ∧ precededBy(x, p))

Semi-Formal Natural Language Axioms

if x is a ‘corrective action preventive action effectiveness check’ then x is a ‘planned process’, x ‘has participant at some time’ some ‘agent’, and x is ‘preceded by’ some ‘corrective action’ or ‘preventive action’

Description Logic

constr:CorrectiveActionPreventiveActionEffectivenessCheck ⊑ constr:PlannedProcess

constr:CorrectiveActionPreventiveActionEffectivenessCheck ⊑ ∃ bfo:has_participant_at_some_time .constr:Agent

constr:CorrectiveActionPreventiveActionEffectivenessCheck ⊑ ∃ bfo:preceded_by .(constr:CorrectiveAction ⊔ constr:PreventiveAction)

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:has_participant_at_some_time some constr:Agent

SubClassOf: bfo:preceded_by some (constr:CorrectiveAction or constr:PreventiveAction)