Addressing Validation Run Failures

Validation runs may not be re-injected simply on the basis of failure to meet the method targets for precision and accuracy. Data for an entire validation run may be rejected only if there is an assignable cause. Rejection of data due to assignable cause includes documented sample processing errors or for other documented reasons, e.g., the data were lost or corrupted during acquisition or data processing or there was a documented hardware failure. Complete documentation of the failed run and the reasons for the failure should be maintained in the study file. 

If a validation run fails for any other reason, the data should still be processed and included in the vahdation report (Section 10.3.4). If the validation fails repeatedly, the method notebooks and procedures should be reviewed to ensure that it is being run correctly. If there is no apparent reason for the run failures, it will be necessary to perform additional method development experiments, modify the method and re-start the validation. Under no circumstances should the method be modified between vahdation runs. 

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