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17.28 Method Validation

Confirm Basic Performance Criteria : Robustness Robustness is a term that is commonly used in publica4ons dealing with method valida4on. Robustness tes4ng deals with the cri4cal opera4onal parameters and the tolerances for their control. Robustness is the capacity of a method to remain unaffected by deliberate varia4ons in method parameters. In the

case of trace analysis using ICP, parameters such as: ● temperature (laboratory and spray chamber) ● concentra4on of reagents ● RF power ● nebulizer, spray chamber, and torch design ● torch height ● sampler and skimmer cone design ● sampler and skimmer cone construc4on material

● integra4on 4me ● detector design ● reac4on/collision cell type or condi4ons ● resolu4on capability

17.29 Method Validation

Confirm Basic Performance Criteria : Robustness (cont.)

These are all examples of parameters that could be easily altered, either inten7onally or uninten7onally, that could significantly affect the reliability of the determina7on.

The fact that many procedures specify opera7onal parameters or accessory designs/types is a result of robustness tes7ng where the developing laboratory recognizes that cri7cal parameters must be iden7fied, specified, and controlled for the measurement procedure to be used reliably.