corrective action
IRI: https://spec.industrialontologies.org/ontology/construct/CorrectiveAction
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
Definition
planned process that is carried out to eliminate the cause of a detected non-conformity or other undesirable situation
Explanatory Notes
1) 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. 2) Corrective action should not be confused with a control action that adjusts a process or equipment in response to deviation from a target or setpoint. For example, increasing heating-fluid flow when reactor temperature falls below its setpoint is a control action, not a corrective action.
Examples
- Operator retraining performed after a batch record execution error is traced to insufficient training; Cleaning procedure revision performed after residue carryover is traced to an inadequate cleaning instruction; Temperature-control component replacement performed after a temperature excursion is traced to equipment failure; Sensor replacement and calibration-frequency update performed after sensor drift is identified as the cause of an out-of-limit process reading;
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
CorrectiveAction(x) → PlannedProcess(x) ∧ ∃p(CorrectiveActionPreventiveActionPlanSpecification(p) ∧ prescribedBy(x, p))
Semi-Formal Natural Language Axioms
if x is a ‘corrective action’ then x is a ‘planned process’ and x is ‘prescribed by’ some ‘corrective action preventive action plan specification’