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 (bio)pharmaceutical manufacturing, some process-focused KPIs may be related to CQAs and influenced by CPPs. Such KPIs can provide evidence of process consistency, reproducibility, or performance and can support assessment of whether manufacturing steps are proceeding as expected. Other KPIs may address operational performance, such as throughput, cycle time, equipment utilization, or schedule adherence, without being directly related to CQAs or CPPs.
Examples
- final harvest titer specification for the production batch, measured in pooled harvested cell culture fluid at completion of harvest, with a target range of 3.5 to 5.0 grams per liter; viral clearance log reduction value specification for the purification step, calculated from the viral loads measured before and after the step, with a target of at least 4.0; batch release cycle time specification for the production batch, measured from completion of manufacturing to authorization of the batch for release, with a target of no more than 10 calendar days
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’