Setting Specifications and Investigating Out-of-Specification Results - Analytical Validation - page 114

Title, Study or Project #

Name of Study Director

Sample ID

preinvestigation phase

■ Yes or ■ No—Was the error readily apparent to the analyst or supervisor, for
example, was the error a result of transcription, miscalculation,
incorrect or incomplete transfer of solutions, incorrect dilution,
incorrect setting of instrument parameters, etc.? Where "yes" is
indicated, list the cause on the raw data records, analyst and
supervisor initial and date, and continue with the analysis without
further consideration of the invalid results.

Investigation phase

■ Yes or ■ No—The analyst is knowledgeable in the performance of the procedure,
skilled in the tasks required to complete the procedure, and properly
executed the correct procedure.
■ Yes or ■ No—The raw data (including chromatograms, spectra, etc.), transcriptions,
and calculations were reviewed and found to be free of errors or
aberrant information.
■ Yes or ■ No—The reagents, reference standards, test substances, and the solutions
prepared from the same were found to be appropriate.
■ Yes or ■ No—The performance of the instrument was found to be adequate (system
suitability, check standards, bracketed standards, etc.) and free of
sporadic failure.
■ Yes or ■ No—The analytical method used to perform the analysis was reviewed
and found to be adequate for the intended purpose.
■ Yes or ■ No—An assignable cause was identified, and the OOS result is invalidated
based on laboratory error.

Area supervisor/Functional Area manager or study director date

FIgure 6.4 Example result investigation summary.

6.13.2.1 Assignable cause
A laboratory investigation may uncover the fact that an error was made or that there
was equipment malfunction, and in this case the test result may be invalidated due
to an assignable cause. In this case, the analysis is rerun according to the approved
procedure, and the new result is reported. In this instance, the laboratory does not
have a current good manufacturing practice (cGMP) obligation to report the initial