risk control process

IRI: https://spec.industrialontologies.org/ontology/construct/RiskControlProcess

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 control process

Definition

planned process in which risk is reduced or accepted, or both

Examples

• a process in which contamination risk during media preparation is reduced by introducing additional filtration and the residual risk is then accepted; a process in which the risk associated with dissolved-oxygen variation is reduced by tightening operating ranges and the remaining risk is then accepted; a process in which a previously analyzed low-level equipment risk is accepted without further reduction; a process in which oxygen-deficiency risk following helium discharge is reduced through ventilation and alarm measures and the remaining risk is then accepted

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

RiskControlProcess(x) → PlannedProcess(x) ∧ ∃p ((RiskAcceptanceProcess(p) ∨ RiskReductionProcess(p)) ∧ hasOccurrentPart(x, p)) ∧ ∃a (RiskAssessmentProcess(a) ∧ precededBy(x, a))

Semi-Formal Natural Language Axioms

if x is a ‘risk control process’ then x is a ‘planned process’ that ‘has occurrent part’ some ‘risk acceptance process’ or some ‘risk reduction process’, and is ‘preceded by’ some ‘risk assessment process’

Description Logic

constr:RiskControlProcess ⊑ constr:PlannedProcess

constr:RiskControlProcess ⊑ ∃ bfo:preceded_by .constr:RiskAssessmentProcess

constr:RiskControlProcess ⊑ ∃ bfo:has_occurrent_part .(constr:RiskAcceptanceProcess ⊔ constr:RiskReductionProcess)

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:preceded_by some constr:RiskAssessmentProcess

SubClassOf: bfo:has_occurrent_part some (constr:RiskAcceptanceProcess or constr:RiskReductionProcess)