risk estimate
IRI: https://spec.industrialontologies.org/ontology/construct/RiskEstimate
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › risk estimate
Direct subclasses:
Definition
information content entity that is a combination of the assessed likelihood of harm and the assessed severity of that harm
Explanatory Notes
1) Risk estimate may apply to processes, materials, equipment, or other operational elements and can be expressed as a numerical score, category (e.g., high–medium–low), or risk-priority number (RPN). 2) In regulatory documents such as ICH Q9 (R1), this same concept is typically referred to simply as risk. The term risk estimate is used here to emphasize its informational nature as the assessed level of risk rather than the underlying harmful event or hazard itself. 3) Likelihood is used here instead of ‘probability of occurrence’ to cover both numerical probabilities (quantitative estimation) and defined ordinal categories/ratings (qualitative range descriptions). 4) In some risk management tools, an assessed detectability value for a specified hazard also factors in the estimation of risk.
Examples
- The estimated risk that pH variability during the production culture process results in patient harm via reduced product availability, because it can cause harvest titer below the acceptance criterion (leading to batch rejection or reduced supply), is medium (likelihood rating = 2, severity = 3, risk score = 6); The estimated risk that lower temperature (<38 °C) during the anaerobic digestion of a biogas production process leads to H2S accumulation and resulting toxic exposure to personnel has an RPN+B (Risk Priority Number that also considers biohazardous aspects) value of 42 (severity=5, frequency of occurrence = 3, countermeasures existence= 2, associated biohazards= 2). This estimated risk is based on possible failures in the CPH (combined heat and power) system, temperature control loop and sludge stirrer
Adapted From
- 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 to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
RiskEstimate(x) → InformationContentEntity(x) ∧ ∃h∃m(HazardSpecification(h) ∧ HarmSpecification(m) ∧ isAbout(x,h) ∧ isAbout(x,m) ∧ isAbout(h,m))
Semi-Formal Natural Language Axioms
if x is a ‘risk estimate’ then x is an ‘information content entity’ that ‘is about’ some ‘hazard specification’ and some ‘harm specification’ that the same ‘hazard specification’ ‘is about’
Description Logic
constr:RiskEstimate ⊑ constr:InformationContentEntity
constr:RiskEstimate ⊑ ∃ constr:isAbout .constr:HarmSpecification
constr:RiskEstimate ⊑ ∃ constr:isAbout .constr:HazardSpecification
SubClassOf: constr:InformationContentEntity
SubClassOf: constr:isAbout some constr:HarmSpecification
SubClassOf: constr:isAbout some constr:HazardSpecification