hazard identification process
IRI: https://spec.industrialontologies.org/ontology/construct/HazardIdentificationProcess
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 › hazard identification process
Definition
planned process that systematically uses available information to recognize and record potential hazards relevant to a risk question or problem description
Semi-Formal Definition:
every instance of ‘hazard identification process’ is defined as exactly an instance of ‘planned process’ that ‘has input’ some ‘objective specification’ and ‘has specified output’ some ‘hazard specification’
Explanatory Notes
1) Hazard identification establishes the foundation for risk assessment by revealing possible events, conditions, or process factors that may influence quality, safety, or performance outcomes. It answers the question “What might go wrong?” by using information such as historical data, theoretical analysis, expert judgment, and stakeholder concerns to build a structured understanding of potential risks. 2) The axiom specifies an objective specification as an input because the hazard identification process must be scoped by some stated objective, question, or problem. The input axiom does not enumerate all informational inputs used during hazard identification, because historical data, theoretical analysis, expert judgment, stakeholder concerns, prior incidents, and tacit experience may all contribute to the process and may not all be explicitly represented in the ontology.
Examples
- Hazard identification process conducted to identify factors that may pose hazards to cell-culture viability, resulting in documentation of temperature, pH, and nutrient feed rate as potential hazards; Hazard identification process conducted to identify potential hazards associated with the anaerobic digestion stage of biogas production, resulting in the documentation of low substrate pH, low temperature (< 38 °C), and high sulfur concentration in the fed substrate as potential hazards to the formation of high levels of hydrogen sulfide; Hazard identification process conducted to identify potential hazards associated with the batch polymerization stage of PVC batch manufacturing, resulting in the documentation of temperature, pressure, and the presence of oxygen as potential hazards to the formation of a flammable/explosive mixture inside the batch reactor
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
HazardIdentificationProcess(x) ↔ PlannedProcess(x) ∧ ∃o (ObjectiveSpecification(o) ∧ hasInput(x, o)) ∧ ∃h (HazardSpecification(h) ∧ hasSpecifiedOutput(x, h))
Description Logic
constr:HazardIdentificationProcess ≡ constr:PlannedProcess ⊓ ∃ constr:hasInput .constr:ObjectiveSpecification ⊓ ∃ constr:hasSpecifiedOutput .constr:HazardSpecification
EquivalentTo: constr:PlannedProcess and constr:hasInput some constr:ObjectiveSpecification and constr:hasSpecifiedOutput some constr:HazardSpecification
SubClassOf: constr:PlannedProcess