SPIFAN MCPD/GE ERP New Member Book

OMB Expectation Parameters

Comparison to Standard/ Acceptance Criteria

Single Laboratory Validation

Reproducibility/ Uncertainty

Documented method performance versus a SMPR, recognized reference standard (materials), recognized reference method, or general method end user community guidance and/or acceptance criteria

Qualitative methods: inclusivity (or equivalent), exclusivity (or equivalent), robustness, repeatability, POD (or equivalent), cross reactivity, matrix scope, etc…

Qualitative methods: - probability of detection or equivalent

Quantitative methods: demonstrated method linearity, accuracy, repeatability, selectivity, LOD/LOQ, Matrix scope, etc….

Quantitative methods: demonstrated method reproducibility and/or uncertainty

Document reasons for acceptability if it doesn’t meet the standard or acceptance criteria