risk evaluation process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskEvaluationProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › risk evaluation process
Definition
planned process that compares analyzed risks against predefined criteria to determine the significance of the estimated risk
Explanatory Notes
Risk evaluation is the comparison of estimated risk against predefined risk criteria, using a qualitative or quantitative scale, in order to determine the significance of the risk. It interprets the results of risk analysis in light of criteria such as regulatory thresholds, process capability limits, or business objectives.
Examples
- comparing FMEA-derived risk-priority numbers (RPNs) for dissolved-oxygen variation against an established risk-ranking scale; comparing the value of the RPN+B indicator for a scenario of high pressure between the gasometer membranes of an anaerobic digester against defined risk acceptability categories
Adapted From
- ISO 31000:2018 and https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-2_en.pdf
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
RiskEvaluationProcess(x) → PlannedProcess(x) ∧ ∃a∃r(RiskAnalysisProcess(a) ∧ RiskEstimate(r) ∧ precededBy(x,a) ∧ hasSpecifiedOutput(a,r) ∧ hasInput(x,r))
Semi-Formal Natural Language Axioms
if x is a ‘risk evaluation process’ then x is a ‘planned process’ that is ‘preceded by’ some ‘risk analysis process’ and ‘has input’ the ‘risk estimate’ produced by that same ‘risk analysis process’
Description Logic
constr:RiskEvaluationProcess ⊑ constr:PlannedProcess
constr:RiskEvaluationProcess ⊑ ∃ bfo:preceded_by .constr:RiskAnalysisProcess
constr:RiskEvaluationProcess ⊑ ∃ constr:hasInput .constr:RiskEstimate
SubClassOf: constr:PlannedProcess
SubClassOf: bfo:preceded_by some constr:RiskAnalysisProcess
SubClassOf: constr:hasInput some constr:RiskEstimate