key performance indicator specification
IRI: https://spec.industrialontologies.org/ontology/construct/KeyPerformanceIndicatorSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaParameter/
SubClass Of: performance indicator specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › performance indicator specification › key performance indicator specification
Definition
performance indicator specification that prescribes a measurable characteristic whose measurements reflect effectiveness with respect to some objective determined as important by a person or organization
Explanatory Notes
1) Per the ISO-22400 standard a good KPI has certain criteria which ensure its usefulness in achieving various goals in the manufacturing operation. For more details the user should take a look at the standard. Also the KPI specification should contain information about its context, including timing, audience, production methodology, effect model diagram, and notes. 2) In case of KPIs for (bio)pharmaceutical manufacturing processes KPIs are indirectly related to CQAs and therefore influenced, as well, by the CPPs. As the CPPs remain within the pre-defined limits, the KPIs should indicate that each production step proceeds accordingly resulting, in the end, in a product having its CQAs within the appropriate limits, too. Also, KPIs reflects the consistency or reproducibility of the associated manufacturing process.
Examples
- Target final harvest titer for the production batch;Target viral clearance log reduction value for purification step; Target batch release time within specified regulatory window
Adapted From
- ISO-22400 and https://www.gmp-compliance.org/gmp-news/fdas-current-thinking-on-kpis-and-quality-metrics
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
This term is expected to remain primitive as different organizations have different criteria for establishing what is key.
Formal Axioms
First-Order Logic Axioms
KeyPerformanceIndicatorSpecification(x) → PerformanceIndicatorSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘key performance indicator specification’ then x is a ‘performance indicator specification’