Failed Runs and Re-Analysis

The review of data and evaluation of the run for acceptance based on the criteria established during method validation can be found in Section 10.5.3, but in this section the instance considered is that when the analytical run fails prior to completion of the inj ection sequence or upon inspection of the data and it is apparent that there was a hardware or software failure of some kind. For events of this kind the system will need to be checked for performance to determine the nature of the failure, and repaired if necessary prior to resumption of any additional analyses. Examples for reasons why a run could fail prior to completion include hardware or computer failure, intermittent software failures, clogged injectors or broken syringes. 

For situations where it appears that the system is running properly hut there is a brief interruption in the run, it may he possible to resume the injection sequence immediately provided that some procedure (preferably defined in a sample analysis SOP) is followed to assure that the system is equilibrated and running properly. For other circumstances where it is discovered that the system has been idle for an extended period but appeared to be tunning properly prior to stopping, a system re-start suitabihty test may be used to estabhsh that the instrument is equihbrated prior to restarting the mn at the point where it stopped. Solutions that are used for this purpose can be a cahbration curve standard or a QC sample. The back-calculated concentration of the standard or QC used for re-start suitability must meet the acceptance criteria stated in the method or SOP. The result obtained from a re-start suitabihty injection should not be used in the calibration curve or reported with the sample set QC s. In any event, the fact that there was an interruption in the run and the reason for a system re-start must be documented in the raw data and possibly flagged in the analytical results table. If the system re-start criteria that are specified in the laboratory SOPs are notmet, then the analytical run should be rejected (Section 10.5.3c) and the entire run should be re-injected provided that adequate extract stability has been estabhshed. Alternatively, the samples may be re-assayed (extraction and analysis of a new sample aliquot). 

However, it is important to emphasize that, based on the validation results of analytical restrictions that may be in force at a particular laboratory or for a given method, the restart of analytical runs may not be permitted and the course of action may be restricted to either re-injecting the entire batch, or re-assaying the sample set. 

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