risk review process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskReviewProcess
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 review process
Definition
planned process in which the outcomes of risk management activities are monitored or evaluated
Explanatory Notes
1) This process is used to determine whether the outcomes of risk management activities remain appropriate typically in light of new knowledge, experience, or events relevant to the risk. 2) Risk management activities are planned processes that are parts of a risk management process. 3) This process may occur periodically or in response to planned or unplanned events that could affect a risk-related decision, its basis, or the adequacy of associated risk controls. 4) Planned events may include product review, inspections, audits, change control activities, or scheduled trend evaluation. 5) Unplanned events may include deviations, failure investigation findings, complaints, recalls, or newly identified sources of risk. 6) Information considered in this process may include monitoring data, trend data, investigation outcomes, change records, audit observations, and other records relevant to the risk. 7) This process may lead to confirmation of current or prior outcomes or to their revision, including updates to risk acceptance decisions, risk controls, or associated records
Examples
- A biopharmaceutical manufacturer evaluates prior risk management outcomes concerning raw material variability after a supplier change; An organization evaluates prior risk management outcomes after an audit identifies that an existing approval step is not being performed consistently; A team evaluates prior risk management outcomes in light of findings from a failure investigation; During a periodic review, monitoring data and change records are considered to determine whether an existing inspection frequency remains appropriate
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
RiskReviewProcess(x) → PlannedProcess(x) ∧ ∃r(RiskManagementProcess(r) ∧ occurrentPartOf(x,r) ∧ (∃p(PlannedProcess(p) ∧ occurrentPartOf(p,r) ∧ precededBy(x,p)) ∨ ∃p(PlannedProcess(p) ∧ occurrentPartOf(p,r) ∧ isTemporallyOverlappedBy(x,p))))
Semi-Formal Natural Language Axioms
if x is a ‘risk review process’ then x is a ‘planned process’ that is ‘occurrent part of’ some ‘risk management process’ and either is ‘preceded by’ some ‘planned process’ that is ‘occurrent part of’ that same ‘risk management process’, or is ‘temporally overlapped by’ some ‘planned process’ that is ‘occurrent part of’ that same ‘risk management process’
Description Logic
constr:RiskReviewProcess ⊑ constr:PlannedProcess
constr:RiskReviewProcess ⊑ ∃ bfo:preceded_by .(constr:PlannedProcess ⊓ ∃ bfo:occurrent_part_of .constr:RiskManagementProcess) ⊔ ∃ constr:isTemporallyOverlappedBy .(constr:PlannedProcess ⊓ ∃ bfo:occurrent_part_of .constr:RiskManagementProcess)
constr:RiskReviewProcess ⊑ ∃ bfo:occurrent_part_of .constr:RiskManagementProcess
SubClassOf: constr:PlannedProcess
SubClassOf: bfo:preceded_by some (constr:PlannedProcess and bfo:occurrent_part_of some constr:RiskManagementProcess) or constr:isTemporallyOverlappedBy some (constr:PlannedProcess and bfo:occurrent_part_of some constr:RiskManagementProcess)
SubClassOf: bfo:occurrent_part_of some constr:RiskManagementProcess