sample plan

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

Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaMonitoringAndControl/

SubClass Of: plan specification

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › sample plan

Definition

plan specification that prescribes how, when and how often samples are to be taken during a particular process

Explanatory Notes

1) A sampling plan in the context of production and quality management refers to a documented strategy that defines how, when, and how often samples are to be taken from materials, products, or processes for testing or inspection. 2) Key aspects of a sampling plan include: Frequency: Specifies how often samples should be taken (e.g., every batch, every tenth delivery, or at regular time intervals). Sample Size: Defines the number or quantity of items to be sampled at each interval.

Examples

  • Sampling plan that prescribes in-process sampling on Days 5, 7, and 9 for glycan profiling of the expressed monoclonal antibody; Sampling plan that prescribes post-harvest sampling to assess product titer and host cell protein levels before downstream purification; Sampling plan that prescribes manual collection of 20 tablets per batch for disintegration and hardness testing in the QC lab; Sampling plan that prescribes taking an aliquot from every third eluate fraction during protein A chromatography for titer and impurity analysis (HCP and DNA)

Synonyms

  • sampling plan
  • sampling strategy

Adapted From

  • https://itl.nist.gov/div898/handbook/ppc/section3/ppc33.htm

Primitive Class

This class is declared primitive and it does not have necessary and sufficient condiftions defined.

Primitive Rationale

There are insufficient constructs in this release to fully capture the structure of a sample plan

Formal Axioms

First-Order Logic Axioms 

SamplePlan(x) → PlanSpecification(x) ∧ ∃y(SamplingProcess(y) ∧ prescribes(x, y))

Semi-Formal Natural Language Axioms

if x is a ‘sample plan’, then x is a ‘plan specification’ that ‘prescribes’ some ‘sampling process’

Description Logic

constr:SamplePlan ⊑ constr:PlanSpecification

constr:SamplePlan ⊑ ∃ constr:prescribes .constr:SamplingProcess

SubClassOf: constr:PlanSpecification

SubClassOf: constr:prescribes some constr:SamplingProcess