control limit value expression

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

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

SubClass Of: limit value expression

Class Hierarchy

owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › value expression › limit value expression › control limit value expression

Direct subclasses:

• initial control limit value expression
• long-term control limit value expression

Definition

limit value expression that is a statistical or operational threshold beyond which a process is considered to be out of control

Explanatory Notes

1) A statistical control limit is derived from process data (such as mean ± 3σ) and reflects the natural variability of a stable process. 2) An operational control limit is defined using process knowledge, equipment capability, or risk assessment when statistical data are limited or when physical or engineering constraints dictate the threshold. 3) In biopharmaceutical manufacturing, control limits are typically refined during continued process verification to support ongoing monitoring and evaluation of the validated state of control.

Examples

• For a temperature setpoint of 37 °C, the normal operating range is 36.5–37.5 °C and the operational control limits are 36.0 °C for the lower control limit and 38.0 °C for the upper control limit. Values outside the control limits indicate that the process is outside its expected controlled behavior and require investigation

Synonyms

• control limit

Adapted From

• https://www.biophorum.com/download/cvp-case-study-interactive-version/ and https://www.6sigma.us/cause-variation/what-are-control-limits/ and https://www.sigmaaldrich.com/RS/en/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/monoclonal-antibody-manufacturing/continued-process-verification

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 necessary and sufficient conditions.

Formal Axioms

First-Order Logic Axioms

ControlLimitValueExpression(x) → LimitValueExpression(x)

Semi-Formal Natural Language Axioms

If x is a ‘control limit value expression’ then x is a ‘limit value expression’

Description Logic

constr:ControlLimitValueExpression ⊑ constr:LimitValueExpression

SubClassOf: constr:LimitValueExpression