material test assessment

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

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

SubClass Of: information content entity

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › material test assessment

Direct subclasses:

out of specification assessment

Definition

information content entity that records the outcome of evaluating measurement results against a specified testing criterion

Explanatory Notes

1) The value expression of a material test assessment records the outcome of the evaluation, such as within limit, outside limit, pass, fail, identity confirmed, detected, not detected, or inconclusive. 2) A material test assessment is distinct from its value expression. The assessment identifies the measurement information evaluated and the testing criterion applied, while the value expression records the resulting outcome category. In the future a categorical value expression will be developed to strengthen the distinction. 3) A material test assessment is also distinct from a material testing information content entity. A material testing information content entity represents the broader informational result of a material test and may contain multiple measurement information content entities and material test assessments. 4) A material test assessment may be about a measurement information content entity or one or more measured value expressions. A measured value expression should be used when the assessment concerns a particular value within measurement information containing several values. The measurement information content entity should be used when a spectrum, profile, image, curve, observation record, or other measurement output is evaluated as a whole. 5) The reporting of a measurement result alone does not constitute a material test assessment. A material test assessment requires the measurement result to be evaluated against a specified testing criterion as part of a material testing process. For example, recording the pH of a bioreactor during processing is measurement or monitoring, whereas evaluating a laboratory pH result from a material sample against a release criterion produces a material test assessment. 6) A material test assessment is an information content entity, not the process of performing the evaluation. The evaluation process produces or informs the material test assessment.

Examples

a material test assessment that records ‘within limit’ after the pH measured on a representative sample of a prepared buffer lot is evaluated against the release criterion of pH 6.8 to 7.2; a material test assessment that records ‘identity confirmed’ after the infrared spectrum and specified chemical-reaction results obtained from a representative sample of a raw-material lot are evaluated against the identity criteria prescribed by the test method; a material test assessment that records ‘inconclusive’ after finished-product sterility testing because the required growth is not observed in the positive-control vessels, preventing a valid interpretation of the absence of microbial growth in the product test vessels

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

MaterialTestAssessment(x) → InformationContentEntity(x) ∧ ∃r∃m∃v(RequirementSpecification(r) ∧ isAbout(x,r) ∧ (MeasurementInformationContentEntity(m) ∨ MeasuredValueExpression(m)) ∧ isAbout(x,m) ∧ ValueExpression(v) ∧ hasValueExpressionAtAllTimes(x,v))

Semi-Formal Natural Language Axioms

if x is a ‘material test assessment’ then x is an ‘information content entity’ that ‘is about’ some ‘requirement specification’, ‘is about’ some entity that is a ‘measurement information content entity’ or a ‘measured value expression’, and ‘has value expression at all times’ some ‘value expression’