preventive action
IRI: https://spec.industrialontologies.org/ontology/construct/PreventiveAction
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 › preventive action
Definition
planned process that is carried out to eliminate the cause of a potential non-conformity or other undesirable potential situation
Explanatory Notes
Corrective action is taken to prevent recurrence of a detected nonconformity or other undesirable situation, whereas preventive action is taken to prevent occurrence of a potential nonconformity or other potential undesirable situation.
Examples
- Procedure revision performed after trend analysis identifies increasing risk of batch record errors; Additional operator training implemented before a new process step is introduced to prevent execution errors; Preventive maintenance added for a temperature-control unit after reliability review identifies increased failure risk; Supplier monitoring increased after early warning trends suggest potential raw material documentation issues;
Adapted From
- https://database.ich.org/sites/default/files/Q10%20Guideline.pdf
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
PreventiveAction(x) → PlannedProcess(x) ∧ ∃p (prescribedBy(x, p) ∧ CorrectiveActionPreventiveActionPlanSpecification(p))
Semi-Formal Natural Language Axioms
if x is a ‘preventive action’ then x is a ‘planned process’ and x is ‘prescribed by’ some ‘corrective action preventive action plan specification’