corrective action preventive action plan specification

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

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

SubClass Of: plan specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › corrective action preventive action plan specification

Definition

plan specification that prescribes one or more corrective actions or preventive actions

Examples

CAPA plan specification prescribing retraining after repeated batch record errors; CAPA plan specification prescribing procedure revision after an inadequate cleaning instruction is identified; CAPA plan specification prescribing equipment repair after a temperature-control failure; CAPA plan specification prescribing supplier corrective action after repeated raw material documentation issues;

Synonyms

CAPA plan specification

Adapted From

https://database.ich.org/sites/default/files/Q10%20Guideline.pdf#page=12.37

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

See the general discussion and rationale provided for informational entities under ‘information content entity’.

Formal Axioms

First-Order Logic Axioms

LA1: CorrectiveActionPreventiveActionPlanSpecification(x) → PlanSpecification(x) ∧ ∀y (prescribes(x, y) → (CorrectiveAction(y) ∨ PreventiveAction(y)))

LA2: PlanSpecification(x) ∧ ∃y(prescribes(x,y) ∧ (CorrectiveAction(y) ∨ PreventiveAction(y))) → CorrectiveActionPreventiveActionPlanSpecification(x)

Semi-Formal Natural Language Axioms

LA1: if x is a ‘corrective action preventive action plan specification’ then x is a ‘plan specification’ and x ‘prescribes’ only ‘corrective action’ or ‘preventive action’

LA2: if x is a ‘plan specification’ that ‘prescribes’ some ‘corrective action’ or ‘preventive action’ then x is a ‘corrective action preventive action plan specification’