risk ranking and filtering specification
IRI: https://spec.industrialontologies.org/ontology/construct/RiskRankingAndFilteringSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: risk management method specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › risk management method specification › risk ranking and filtering specification
Definition
risk management method specification that prescribes criteria and procedures for prioritizing identified risk-relevant factors according to their relative risk level
Explanatory Notes
1) Risk Ranking and Filtering (RRF) is a semi-quantitative method used to compare the relative importance of risk-relevant factors when multiple factors differ in nature, scale, or available evidence. It may combine criteria such as severity, likelihood, detectability, uncertainty, process knowledge, or potential impact into scores, categories, or rankings to support prioritization. 2) RRF may support risk analysis, risk evaluation, or selection of factors for further study, but it does not necessarily constitute the entirety of risk assessment. 3) In biopharmaceutical process characterization, RRF may be used to identify and prioritize potential critical process parameters (pCPPs), potential critical material attributes (pCMAs), or other factors based on platform knowledge, prior knowledge, and product-specific data. The resulting prioritization can guide experimental design, control strategy development, and resource allocation.
Examples
- A team applies a risk ranking and filtering method specification by defining candidate factors such as feed glucose setpoint, osmolality, and pH control, defining weighted criteria for impact on product quality, and scoring each factor using the prescribed rubric. The resulting ranked list places glucose and osmolality highest, so they are selected as candidate critical parameters for the next DoE study.
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_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
RiskRankingAndFilteringSpecification(x) → RiskManagementMethodSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘risk ranking and filtering specification’ then x is a ‘risk management method specification’