deviation management process
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationManagementProcess
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 management process
Definition
planned process for the identification, documentation, classification, investigation, assessment, resolution, and closure of deviations, including the definition, implementation, and follow-up of appropriate corrective and preventive actions
Explanatory Notes
1) Deviation management is typically broader than the investigation of a single deviation. 2) It includes the overall framework for identifying, documenting, classifying, investigating, assessing, resolving, and closing deviations, as well as defining and following up corrective and preventive actions.
Examples
- Site-level deviation management process for handling manufacturing deviations from discovery through documentation, classification, investigation, impact assessment, CAPA planning, and closure; Deviation management process for batch execution deviations identified during upstream or downstream processing; Deviation management process for laboratory deviations identified during sample handling, testing, result review, or data entry; Deviation management process for raw material or consumable deviations identified during incoming inspection, CoA review, or release-to-use assessment; Deviation management process for storage or transport excursions affecting materials, intermediates, or products;
Adapted From
- 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
DeviationManagementProcess(x) → PlannedProcess(x) ∧ ∃p (prescribedBy(x, p) ∧ DeviationManagementPlanSpecification(p))
Semi-Formal Natural Language Axioms
if x is a ‘deviation management process’ then x is a ‘planned process’ and x is ‘prescribed by’ some ‘deviation management plan specification’