deviation impact assessment
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationImpactAssessment
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 impact assessment
Definition
planned process in which the actual or potential impact of a deviation event is evaluated
Semi-Formal Definition:
every instance of ‘deviation impact assessment’ is defined as exactly an instance of ‘planned process’ that ‘has input’ some ‘deviation description’ describing a ‘deviation event’ and ‘has specified output’ some ‘deviation impact assessment result’ that ‘is about’ that same ‘deviation event’
Explanatory Notes
The assessment evaluates the actual or potential impact of a deviation event on process and product quality and identifies material entities or processes that are affected or potentially affected.
Examples
- Assessment of whether a temperature excursion affected a stored raw material lot; Assessment of whether a pH excursion during buffer preparation affected buffer suitability for use; Assessment of whether a bioburden excursion affected an in-process purification pool; Assessment of whether use of an incorrect buffer affected a downstream processing step or process intermediate;
Adapted From
- https://www.gmp-inspection.com/en/glossary/deviation-management/ and https://www.pharmtech.com/view/regulation-and-compliance-deviation-investigations#:~:text=Impact%20assessment:%20A%20clear%20and,be%20objective%20and%20scientifically%20valid.
Formal Axioms
First-Order Logic Definition
DeviationImpactAssessment(x) ↔ PlannedProcess(x) ∧ ∃d∃e∃r(DeviationDescription(d) ∧ DeviationEvent(e) ∧ DeviationImpactAssessmentResult(r) ∧ hasInput(x,d) ∧ describes(d,e) ∧ hasSpecifiedOutput(x,r) ∧ isAbout(r,e))
Description Logic
constr:DeviationImpactAssessment ≡ constr:PlannedProcess ⊓ ∃ constr:hasInput .constr:DeviationDescription ⊓ ∃ constr:hasSpecifiedOutput .constr:DeviationImpactAssessmentResult
EquivalentTo: constr:PlannedProcess and constr:hasInput some constr:DeviationDescription and constr:hasSpecifiedOutput some constr:DeviationImpactAssessmentResult
SubClassOf: constr:PlannedProcess