failure mode and effects analysis specification
IRI: https://spec.industrialontologies.org/ontology/construct/FailureModeAndEffectsAnalysisSpecification
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: risk management method specification
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › plan specification › risk management method specification › failure mode and effects analysis specification
Definition
risk management method specification that prescribes systematic identification of potential failure modes and evaluation of their causes and effects
Explanatory Notes
1) Failure mode and effects analysis specification prescribes use of a structured, prospective method for evaluating how a process, system, material, or equipment item might fail and what effects those failures may have. 2) FMEA commonly includes identification of failure modes, causes, effects, existing controls, and recommended actions. Many FMEA implementations estimate or rank risk using severity, occurrence, and detectability scores, often combined into a risk priority number or related ranking. 3) In biopharmaceutical manufacturing, FMEA may be used to assess unit operations, equipment, materials, process parameters, and quality attributes, including potential impacts on product quality, process performance, patient safety, or product availability. 4) Recommended actions identified during FMEA may be implemented, followed up, and verified in separate risk control or risk reduction processes.
Examples
- An FMEA method specification for a bioreactor operation prescribes that the team enumerate failure modes for each selected function or process step, document causes and effects, and score severity, occurrence, and detectability using a defined rubric. When carried out, the resulting FMEA record includes “pH probe drift” as a failure mode with scores that yield a high risk ranking or RPN, motivating tighter calibration and redundant sensors.
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf and https://www.fda.gov/media/71535/download
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
FailureModeAndEffectsAnalysisSpecification(x) → RiskManagementMethodSpecification(x)
Semi-Formal Natural Language Axioms
if x is a ‘failure mode and effects analysis specification’ then x is a ‘risk management method specification’