deviation containment process

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

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

SubClass Of: planned process

Class Hierarchy

owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › deviation containment process

Definition

planned process carried out after recognition of a deviation event in which actions are taken with respect to affected material entities or processes to prevent the deviation or its effects from propagating further

Explanatory Notes

1) In this context, ‘prevent further propagation of the deviation or its effects’ means either preventing the deviation from causing additional impact through the affected material entity or process, or preventing the affected material entity from proceeding further in processing, release, distribution, or use. 2) This process is carried out after recognition of a deviation event and before or alongside (overlaps) subsequent deviation investigation.

Examples

• Placing an affected raw material lot in quarantine after a temperature excursion before the deviation investigation begins; Holding a process intermediate after a bioburden excursion while the deviation investigation is initiated; Restricting release of a batch after an equipment-control failure while the impact assessment and investigation are underway; Pausing a downstream processing step after use of an incorrect buffer before formal investigation activities begin; Segregating affected product units after a labeling deviation while the deviation investigation proceeds; Stopping use of a potentially compromised single-use assembly after an integrity issue is detected before the investigation determines scope and root cause.

Adapted From

• https://oxmaint.com/industries/steel-plant/quality-deviation-management-system

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

DeviationContainmentProcess(x) → PlannedProcess(x) ∧ ∃d(DeviationEvent(d) ∧ (precededBy(x,d) ∨ isTemporallyOverlappedBy(x,d))) ∧ (∃i(DeviationInvestigationProcess(i) ∧ precedes(x,i)) ∨ ∃j(DeviationInvestigationProcess(j) ∧ temporallyOverlaps(x,j)))

Semi-Formal Natural Language Axioms

if x is a ‘deviation containment process’ then x is a ‘planned process’, x is either ‘preceded by’ or ‘is temporally overlapped by’ some ‘deviation event’, and x either ‘precedes’ or ‘temporally overlaps’ some ‘deviation investigation process’

Description Logic

constr:DeviationContainmentProcess ⊑ constr:PlannedProcess

constr:DeviationContainmentProcess ⊑ ∃ bfo:preceded_by .constr:DeviationEvent ⊔ ∃ constr:isTemporallyOverlappedBy .constr:DeviationEvent

constr:DeviationContainmentProcess ⊑ ∃ bfo:precedes .constr:DeviationInvestigationProcess ⊔ ∃ constr:temporallyOverlaps .constr:DeviationInvestigationProcess

SubClassOf: constr:PlannedProcess

SubClassOf: bfo:preceded_by some constr:DeviationEvent or constr:isTemporallyOverlappedBy some constr:DeviationEvent

SubClassOf: bfo:precedes some constr:DeviationInvestigationProcess or constr:temporallyOverlaps some constr:DeviationInvestigationProcess