deviation management plan specification
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationManagementPlanSpecification
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 › deviation management plan specification
Definition
plan specification that prescribes a deviation management process
Explanatory Notes
1) A deviation management plan specification prescribes the overall approach by which deviations are to be detected, documented, classified, investigated, assessed, resolved, and closed. 2) It may prescribe roles, required documentation, classification criteria, timelines, decision points, closure conditions, and expectations for defining, implementing, and following up corrective and preventive actions. 3) In many quality systems, it functions as a higher-level specification that is implemented through more detailed procedural specifications and work instructions.
Examples
- Deviation management plan specification defining how deviations are detected, documented, classified, investigated, assessed, resolved, and closed; Site deviation management plan specification defining the process for handling minor, major, and critical deviations; Deviation management plan specification defining escalation paths, investigation expectations, closure conditions, and follow-up requirements; Deviation management plan specification for manufacturing deviations occurring during batch execution;
Synonyms
- deviation management strategy
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
DeviationManagementPlanSpecification(x) → PlanSpecification(x) ∧ ∀y (prescribes(x, y) → DeviationManagementProcess(y))
Semi-Formal Natural Language Axioms
if x is a ‘deviation management plan specification’ then x is a ‘plan specification’ and x ‘prescribes’ only ‘deviation management process’
Description Logic
constr:DeviationManagementPlanSpecification ⊑ constr:PlanSpecification
constr:DeviationManagementPlanSpecification ⊑ ∀ constr:prescribes .constr:DeviationManagementProcess
constr:PlanSpecification ⊓ ∃ constr:prescribes .constr:DeviationManagementProcess ⊑ constr:DeviationManagementPlanSpecification
SubClassOf: constr:PlanSpecification
SubClassOf: constr:prescribes only constr:DeviationManagementProcess
constr:PlanSpecification and constr:prescribes some constr:DeviationManagementProcess SubClassOf: constr:DeviationManagementPlanSpecification