hazard specification
IRI: https://spec.industrialontologies.org/ontology/construct/HazardSpecification
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 › hazard specification
Definition
information content entity that describes one or more potential sources of harm
Explanatory Notes
1) A potential source of harm is commonly referred to as a hazard. 2) A hazard may be a material entity, an information content entity, a process, or an attribute of any of these. 3) A hazard identification result may also include as a part, or may reference, criterion values for a material entity attribute or process parameter that determine when the attribute or parameter is treated as a potential source of harm. These criterion values may be qualitative or quantitative, for example a threshold, a limit, an acceptable range, a variability criterion, or a categorical level such as high, low, or out of tolerance. 4) A process specified as a potential source of harm may be planned or unplanned relative to an applicable plan specification for an execution. This includes omission cases in which a required action does not occur within the time window or at the specified point in the plan. 5) A hazardous situation is distinct from a potential source of harm, because it is a circumstance of exposure in which one or more potential sources of harm can act on a target and is modeled separately
Examples
- Hazard record that specifies a cytotoxic cleaning agent present in product contact equipment as a potential source of harm that can lead to product quality failure; Hazard record that specifies trace iron concentration in culture medium above 5 ppm as a potential source of harm that can lead to CQA being out of specification; Hazard record that specifies unintended omission of the required sterile filter integrity test as a potential source of harm that can lead to contamination; Hazard record that specifies misaddition of base during pH adjustment as a potential source of harm that can lead to increased aggregation; Hazard record that specifies dissolved oxygen below the approved operating range as a potential source of harm that can lead to reduced cell viability and titer; Hazard record that specifies that high temperature (> 39 °C), high pH of the substrate, and low Carbon to Nitrogen ratio in the fed substrate are identified as potential hazards to the formation of a high amount of ammonia; Hazard record that specifies temperature, pressure, and presence of oxygen as potential hazards to the formation of a flammable/explosive mixture inside the batch reactor
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
HazardSpecification(x) → InformationContentEntity(x) ∧ ∃h (HarmSpecification(h) ∧ isAbout(x, h)) ∧ ∀y (describes(x, y) → Entity(y) ∧ ¬SpatialRegion(y))
Semi-Formal Natural Language Axioms
if x is a ‘hazard specification’ then x is an ‘information content entity’ that ‘is about’ some ‘harm specification’ and only ‘describes’ entities that are not ‘spatial region’
Description Logic
constr:HazardSpecification ⊑ constr:InformationContentEntity
constr:HazardSpecification ⊑ ∀ constr:describes .(bfo:entity ⊓ ¬ bfo:spatial_region)
constr:HazardSpecification ⊑ ∃ constr:isAbout .constr:HarmSpecification
SubClassOf: constr:InformationContentEntity
SubClassOf: constr:describes only (bfo:entity and not bfo:spatial_region)
SubClassOf: constr:isAbout some constr:HarmSpecification