deviation event classifier
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationEventClassifier
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
SubClass Of: classifier
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › denoter › classifier › deviation event classifier
Definition
classifier that classifies a deviation event
Semi-Formal Definition:
every instance of ‘deviation event classifier’ is defined as exactly an instance of ‘classifier’ that ‘classifies’ some ‘deviation event’
Explanatory Notes
1) A deviation event classifier is used to categorize deviation events for investigation, escalation, disposition, or quality-system handling. Examples include classifiers such as minor deviation, major deviation, critical deviation. This class should be distinguished from deviation event identifiers, such as deviation numbers or tracking IDs, which designate a specific deviation event. 2) The detailed criteria for minor, major, and critical classification are prescribed by the applicable deviation management plan specification and should be based on risk, the nature and scope of the deviation, recurrence, and applicable quality-system requirements.
Examples
- Minor deviation classifier applied to a deviation event with no expected quality impact; Major deviation classifier applied to a deviation event requiring formal investigation; Critical deviation classifier applied to a deviation event with highly probable serious patient-safety or product-quality consequences
Formal Axioms
First-Order Logic Definition
DeviationEventClassifier(x) ↔ Classifier(x) ∧ ∃y (classifies(x, y) ∧ DeviationEvent(y))
Description Logic
EquivalentTo: constr:Classifier and constr:classifies some constr:DeviationEvent
SubClassOf: constr:Classifier