risk management method specification

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

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/

SubClass Of: plan specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › risk management method specification

Direct subclasses:

• failure mode and effects analysis specification
• hazard operability analysis method specification
• risk ranking and filtering specification

Definition

plan specification that prescribes a proper part of a risk management process

Examples

• An FMEA method specification for a bioreactor operation prescribes that the team enumerate failure modes for each selected function or process step, document causes and effects, and score severity, occurrence, and detectability using a defined rubric; A HAZOP method specification for an ortho-xylene oxidation reaction in a fixed-bed catalytic reactor prescribes that the team analyze deviations for selected process parameters, document their causes, consequences, and existing safeguards, and recommend risk-reduction actions where needed.

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

See the general discussion under information content entity

Formal Axioms

First-Order Logic Axioms

RiskManagementMethodSpecification(x) → PlanSpecification(x) ∧ ∀y (prescribes(x, y) → PlannedProcess(y) ∧ ∃z (RiskManagementProcess(z) ∧ properOccurrentPartOf(y, z)))

Semi-Formal Natural Language Axioms

if x is a ‘risk management method specification’ then x is a ‘plan specification’ that only ‘prescribes’ a ‘planned process’ that is ‘proper occurrent part of’ some ‘risk management process’

Description Logic

constr:RiskManagementMethodSpecification ⊑ constr:PlanSpecification

constr:RiskManagementMethodSpecification ⊑ ∀ constr:prescribes .(constr:PlannedProcess ⊓ ∃ bfo:proper_occurrent_part_of .constr:RiskManagementProcess)

SubClassOf: constr:PlanSpecification

SubClassOf: constr:prescribes only (constr:PlannedProcess and bfo:proper_occurrent_part_of some constr:RiskManagementProcess)