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Virtual Test Model Intended Use and Claim Definition

30 Chapters
View Course Samples Online
01
Course overview
the role of intended use and claim definition in virtual test model credibility, regulatory context, and engineering decision-making.
intendeddefinition
02
Virtual test model lifecycle
from model conception through intended use specification, verification, validation, and claim substantiation.
lifecycleconception
03
Intended use statement fundamentals
purpose, scope, context of use, and the distinction between intended use and model capabilities.
Intendedstatement
04
Claim definition fundamentals
what constitutes a claim, claim types (predictive, comparative, diagnostic), and claim strength levels.
definitionconstitutes
05
Stakeholder analysis
identifying model owners, users, reviewers, regulators, and decision-makers and their information needs.
Stakeholderanalysis
06
Requirements elicitation for intended use
translating engineering questions into model use requirements and acceptance criteria.
Requirementselicitation
07
Context of use specification
operating conditions, input domain, boundary conditions, and use-case scenarios for virtual test models.
specificationoperating
08
Model scope and limitations
defining what the model is and is not intended to do, and documenting exclusions and assumptions.
limitationsdefining
09
Linking intended use to verification and validation (V&V) planning
deriving V&V activities from use claims and risk.
intendedverification
10
Risk-informed claim definition
assessing consequence of wrong decisions and setting claim confidence commensurate with risk.
Risk-informeddefinition
11
Evidence hierarchy for claims
simulation, test, field data, and expert judgment as evidence sources and their integration.
Evidencehierarchy
12
Claim substantiation planning
evidence requirements, acceptance thresholds, and traceability from claim to evidence.
substantiationplanning
13
Model credibility factors
verification, validation, uncertainty quantification, and sensitivity analysis in support of claims.
credibilityverification
14
Uncertainty quantification for intended use
characterizing input, parameter, and model form uncertainty and propagating to claims.
Uncertaintyquantification
15
Sensitivity and robustness analysis
identifying influential parameters and assessing claim robustness to variability.
Sensitivityrobustness
16
Validation experiment design
selecting and designing experiments to substantiate specific intended use claims.
Validationexperiment
17
Metrics and acceptance criteria
defining quantitative and qualitative measures for claim validation and decision thresholds.
acceptancecriteria
18
Documentation of intended use and claims
structuring model documentation, claim registers, and traceability matrices.
Documentationintended
19
Review and approval workflows
roles, responsibilities, and gates for intended use and claim definition sign-off.
approvalworkflows
20
Configuration management and version control
maintaining integrity of intended use and claims across model versions.
Configurationmanagement
21
Change management
impact analysis of model changes on intended use, claims, and supporting evidence.
managementanalysis
22
Regulatory and standards landscape
relevant frameworks (e.g., ASME V&V, FDA, NASA, ISO) and their requirements for intended use and claims.
Regulatorystandards
23
Case study
automotive crash simulation model intended use and claim definition for occupant safety.
automotivesimulation
24
Case study
aerospace structural virtual testing intended use and certification claim definition.
aerospacestructural
25
Case study
medical device computational modeling intended use and regulatory claim substantiation.
computationalmodeling
26
Common pitfalls and anti-patterns
vague intended use, overclaiming, unsupported claims, and misalignment with decision needs.
pitfallsanti-patterns
27
Auditing and assessment of intended use and claims
internal and external review, maturity assessment, and gap analysis.
Auditingassessment
28
Tools and templates
intended use statement templates, claim definition worksheets, and traceability tools.
templatesintended
29
Integrating intended use and claims into model-based systems engineering and digital twin frameworks.
Integrating intended use and claims into model-based systems engineering and digital twin frameworks.
Integratingintended
30
Capstone project
develop a complete intended use and claim definition package for a selected virtual test model, including evidence plan and review.
Capstonecomplete