deviation investigation process

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

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 investigation process

Definition

planned process in which an agent gathers and analyzes information about a deviation event to assess its cause and actual or potential impact and to establish a CAPA plan specification that addresses the deviation event

Semi-Formal Definition:

every instance of ‘deviation investigation process’ is defined as exactly an instance of ‘planned process’ that ‘has input’ some ‘deviation description’ describing a ‘deviation event’, ‘has occurrent part’ some ‘deviation impact assessment’ that uses that description and produces a ‘deviation impact assessment result’ about that same event, ‘has occurrent part’ some ‘planned process’ that produces a ‘corrective action preventive action plan specification’, ‘has participant at some time’ some ‘agent’, ‘has specified output’ some ‘deviation investigation report’ containing that same description, impact assessment result, and CAPA plan specification, and is ‘occurrent part of’ some ‘deviation management process’

Explanatory Notes

1) The investigation typically begins with fact gathering (for example interviews, record review, inspections/testing, observation, review of similar past events, and, when appropriate, experiments/simulations) and should result in an analysis that supports cause determination rather than a restatement of the problem. 2) The extent of investigation activities can be scaled based on risk, and it can include determining the scope of affected materials/batches and whether immediate containment actions are needed. 3) This process includes establishing a corrective and preventive action plan specification that addresses the deviation event. Implementation of the specified actions may occur subsequently. 4) In the case of a minor deviation, a formal root cause investigation may not be needed because the cause may be obvious.

Examples

• Deviation investigation process for a major temperature excursion affecting a raw material lot in warehouse storage; Deviation investigation process for a sterilization-cycle failure involving equipment or materials intended for aseptic processing; Deviation investigation process for a bioburden excursion detected in an in-process purification pool; Deviation investigation process for use of an incorrect buffer during a downstream processing step; Deviation investigation process for an equipment-control failure during cell culture;

Adapted From

• https://www.gmp-inspection.com/en/glossary/deviation-management/ and https://www.bioprocessintl.com/qa-qc/biopharmaceutical-quality-managing-good-manufacturing-practice-deviations

Formal Axioms

First-Order Logic Definition

DeviationInvestigationProcess(x) ↔ PlannedProcess(x) ∧ ∃d∃e∃a∃i∃p∃c∃g∃r∃m(DeviationDescription(d) ∧ DeviationEvent(e) ∧ describes(d,e) ∧ hasInput(x,d) ∧ DeviationImpactAssessment(a) ∧ hasOccurrentPart(x,a) ∧ hasInput(a,d) ∧ DeviationImpactAssessmentResult(i) ∧ hasSpecifiedOutput(a,i) ∧ isAbout(i,e) ∧ PlannedProcess(p) ∧ hasOccurrentPart(x,p) ∧ CorrectiveActionPreventiveActionPlanSpecification(c) ∧ hasSpecifiedOutput(p,c) ∧ Agent(g) ∧ hasParticipantAtSomeTime(x,g) ∧ DeviationInvestigationReport(r) ∧ hasSpecifiedOutput(x,r) ∧ hasContinuantPartAtAllTimes(r,d) ∧ hasContinuantPartAtAllTimes(r,i) ∧ hasContinuantPartAtAllTimes(r,c) ∧ DeviationManagementProcess(m) ∧ occurrentPartOf(x,m))

Description Logic

constr:DeviationInvestigationProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:has_participant_at_some_time .constr:Agent ⊓ ∃ bfo:has_occurrent_part .constr:DeviationImpactAssessment ⊓ ∃ bfo:has_occurrent_part .(constr:PlannedProcess ⊓ ∃ constr:hasSpecifiedOutput .constr:CorrectiveActionPreventiveActionPlanSpecification) ⊓ ∃ bfo:occurrent_part_of .constr:DeviationManagementProcess ⊓ ∃ constr:hasInput .constr:DeviationDescription ⊓ ∃ constr:hasSpecifiedOutput .constr:DeviationInvestigationReport

constr:DeviationInvestigationProcess ⊑ constr:PlannedProcess

EquivalentTo: constr:PlannedProcess and bfo:has_participant_at_some_time some constr:Agent and bfo:has_occurrent_part some constr:DeviationImpactAssessment and bfo:has_occurrent_part some (constr:PlannedProcess and constr:hasSpecifiedOutput some constr:CorrectiveActionPreventiveActionPlanSpecification) and bfo:occurrent_part_of some constr:DeviationManagementProcess and constr:hasInput some constr:DeviationDescription and constr:hasSpecifiedOutput some constr:DeviationInvestigationReport

SubClassOf: constr:PlannedProcess