deviation event
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationEvent
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
SubClass Of: event
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › event › deviation event
Definition
event in which a departure occurs from an applicable plan, requirement specification, or specified range, target or limit
Explanatory Notes
Deviation events may be detected through monitoring, for example, an excursion of a monitored variable beyond an alert, action, control, or specification boundary where the applicable procedure requires the excursion to be handled as a deviation, or through review of records, for example, procedural departures, documentation errors, use of an unintended material lot, or missed sampling or hold-time requirements. In many quality management settings, deviation events are classified based on their actual or potential impact on product safety, identity, strength, purity, and quality, together with applicable biologics-specific considerations such as potency.
Examples
- Occurrence during buffer preparation in which the measured pH exceeded the applicable action limit; execution of media preparation using a raw-material lot other than the one specified; omission of a required in-process sample during batch execution; continuation of processing beyond the specified hold time for a process intermediate.
Adapted From
- https://www.scilife.io/blog/how-to-handle-deviations and https://www.thefdagroup.com/blog/deviation-management and https://www.biopharminternational.com/view/risk-based-approach-deviation-management
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
DeviationEvent(x) → Event(x)
Semi-Formal Natural Language Axioms
if x is a ‘deviation event’ then x is an ‘event’
Description Logic
SubClassOf: constr:Event