risk analysis process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskAnalysisProcess
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 analysis process
Definition
planned process that estimates the magnitude of risks associated with identified hazards by evaluating the likelihood of harm and the severity of that harm
Semi-Formal Definition:
every instance of ‘risk analysis process’ is defined as exactly an instance of ‘planned process’ that is ‘preceded by’ some ‘hazard identification process’, ‘has input’ some ‘hazard specification’, and ‘has specified output’ some ‘risk estimate’
Explanatory Notes
Risk analysis transforms identified hazards into measurable or comparable levels of risk. It may be performed qualitatively or quantitatively and can include the likelihood of occurrence, the severity of consequences, and, where appropriate, the ability to detect a failure before harm occurs (detectability). In biopharmaceutical development, it supports Quality-by-Design (QbD) by linking process parameters and material attributes to potential effects on product quality and performance.
Examples
- A team performs a risk analysis for contamination scenarios that have already been identified, using an FMEA scoring rubric to assign severity, occurrence, and detectability ratings for “operator error leading to aseptic breach.” The resulting scores and any derived composite value, such as a Risk Priority Number (RPN), provide a comparable risk characterization that supports prioritizing additional controls and operator training; A team performs a risk analysis for the formation of hydrogen sulfide scenarios that have been identified as part of an Anaerobic digestion stage of a hazard identification process. The team uses an RPN +B (Risk Priority Number that also considers biohazardous aspects) indicator to perform a semi-quantitative risk analysis process, which includes severity and frequency of occurrence of the deviations, associated biohazards, and the existence of countermeasures.
Counter-Examples
- Listing possible contamination causes without estimating likelihood, severity, or any comparable risk characterization
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
Formal Axioms
First-Order Logic Definition
RiskAnalysisProcess(x) ↔ PlannedProcess(x) ∧ ∃h (HazardIdentificationProcess(h) ∧ precededBy(x, h)) ∧ ∃s (HazardSpecification(s) ∧ hasInput(x, s)) ∧ ∃r (RiskEstimate(r) ∧ hasSpecifiedOutput(x, r))
Description Logic
constr:RiskAnalysisProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:preceded_by .constr:HazardIdentificationProcess ⊓ ∃ constr:hasInput .constr:HazardSpecification ⊓ ∃ constr:hasSpecifiedOutput .constr:RiskEstimate
EquivalentTo: constr:PlannedProcess and bfo:preceded_by some constr:HazardIdentificationProcess and constr:hasInput some constr:HazardSpecification and constr:hasSpecifiedOutput some constr:RiskEstimate
SubClassOf: constr:PlannedProcess