risk reduction process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskReductionProcess
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 reduction process
Definition
planned process that consists of actions taken to lessen an estimated risk
Explanatory Notes
Risk reduction may be realized through many different kinds of actions and subprocesses, including actions that eliminate a particular hazard, measures that mitigate the severity and/or probability of harm, and measures that improve the detectability of hazards and quality risks. In practice, these measures are typically made explicit in recorded outputs such as risk control plans, control strategy specifications, CAPA (Corrective Action and Preventive Action) plans, change controls, and associated implementation records. However, because the concrete form of risk reduction varies widely across organizations and contexts, the ontology treats these measures primarily as occurrent parts of the risk reduction process, rather than axiomatically constraining a fixed set of required action types or outputs.
Examples
- To prevent human exposure to VCM (Vinyl Chloride Monomer) in the polymerization facility, a new detection system was installed that doubled the number of valves automatically sampling the air in the polymerization room, tripled the sampling frequency, and added a gas chromatography system with an electron capture detector capable of processing the full sample load, reporting results within two minutes of sampling, and detecting increases in VCM concentration at designated sampling points.; To reduce the risk of microbial contamination during aseptic filling, an automated isolator with integrated VHP (Vaporized Hydrogen Peroxide) decontamination was installed for the filling line, and the transfer of sterile components was changed from open handling to closed, decontaminated rapid-transfer port; To reduce the risk of cell-culture viability loss due to pH control failures, redundant pH probes were installed on the production bioreactor, a validated probe calibration and drift-check procedure was implemented, and an automated control logic change was deployed to hold base addition and trigger operator intervention when probe disagreement exceeded the defined threshold
Synonyms
- risk mitigation process
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 present to create a set of necessary and sufficient conditions
Formal Axioms
First-Order Logic Axioms
RiskReductionProcess(x) → PlannedProcess(x) ∧ ∃r (RiskEstimate(r) ∧ hasInput(x, r))
Semi-Formal Natural Language Axioms
if x is a ‘risk reduction process’ then x is a ‘planned process’ that ‘has input’ some ‘risk estimate’
Description Logic
constr:RiskReductionProcess ⊑ constr:PlannedProcess
constr:RiskReductionProcess ⊑ ∃ constr:hasInput .constr:RiskEstimate
SubClassOf: constr:PlannedProcess
SubClassOf: constr:hasInput some constr:RiskEstimate