residual risk estimate
IRI: https://spec.industrialontologies.org/ontology/construct/ResidualRiskEstimate
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: risk estimate
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › risk estimate › residual risk estimate
Definition
risk estimate that is a combination of the assessed likelihood of harm and the assessed severity of that harm after risk reduction measures have been implemented
Explanatory Notes
1) It is the level of risk that remains after controls, safeguards, or mitigation measures have been applied to address an identified risk. 2) Severity is referred to as ‘impact’ in other domains, such as cybersecurity (ISO/IEC 27001). 3) In many domains the residual risk estimate is calculated iteratively until it reaches an acceptable value.
Examples
- A residual risk estimate of 4 (Medium / Acceptable) has been assigned to the occurrence of microbial contamination in a sterile fill-finish stage of a pharma process, using a 5x5 residual risk matrix evaluation method, after changing both the laminar airflow system over the filling line and the Restricted Access Barrier System (RABS) that minimizes operator access
Adapted From
- https://www.iso.org/obp/ui/en/#iso:std:iso-iec:guide:51:ed-3:v1:en:term:3.9
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
ResidualRiskEstimate(x) → RiskEstimate(x) ∧ ∃a (RiskAnalysisProcess(a) ∧ isSpecifiedOutputOf(x, a) ∧ ∃r (RiskReductionProcess(r) ∧ precededBy(a, r)))
Semi-Formal Natural Language Axioms
if x is a ‘residual risk estimate’ then x is a ‘risk estimate’ that ‘is specified output of’ some ‘risk analysis process’ that is ‘preceded by’ some ‘risk reduction process’
Description Logic
constr:ResidualRiskEstimate ⊑ constr:RiskEstimate
constr:ResidualRiskEstimate ⊑ ∃ constr:isSpecifiedOutputOf .(constr:RiskAnalysisProcess ⊓ ∃ bfo:preceded_by .constr:RiskReductionProcess)
SubClassOf: constr:RiskEstimate
SubClassOf: constr:isSpecifiedOutputOf some (constr:RiskAnalysisProcess and bfo:preceded_by some constr:RiskReductionProcess)