Unit of Assurance

CredibilityFactor

Software quality assurance

https://uofa.net/nagaraja/cou1/factor/software-quality-assurance

Described in packs/vv40/examples/nagaraja/cou1/uofa-nagaraja-cou1.jsonld

Fields

@type CredibilityFactor
uofa:factorType Software quality assurance
uofa:requiredLevel 3
uofa:achievedLevel 3
uofa:factorStatus assessed
uofa:acceptanceCriteria Goal (c): commercial FEA solvers (Ansys 2019R1, Abaqus 6.14) widely used in medical device industry with active SQA documentation; anomaly lists reviewed by each lab. [Nagaraja Table 1, SQA]
uofa:rationale Three labs (FDA, Ansys, DePuy Synthes) used commercial solvers with documented SQA processes. No major anomalies relevant to compression-bending simulation reported in vendor anomaly lists.
uofa:factorStandard ASME-VV40-2018

Referenced by

Which records point at this identifier, and through which property. This relationship is not written down anywhere in the packages themselves; it is derived by indexing the whole corpus.

RecordPropertySource
https://uofa.net/nagaraja/cou1 uofa:hasCredibilityFactor uofa-nagaraja-cou1.jsonld