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PERMIT FILE - 9/3/2008, 9:15:35 AM-MR1
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PERMIT FILE - 9/3/2008, 9:15:35 AM-MR1
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Last modified
8/24/2016 11:28:43 PM
Creation date
9/3/2008 10:56:48 AM
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Template:
DRMS Permit Index
Permit No
P2008043
IBM Index Class Name
PERMIT FILE
Doc Date
8/21/2008
Doc Name
Additional needed items for NOI
From
Powertech (USA) Inc.
To
DRMS
Email Name
ACS
Media Type
D
Archive
No
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Page 15 of 24 <br />SOP NUMBER 28.0 Analytical Data Validation <br />A qualifier code of "LCS" will be assigned to all results qualified as estimated or rejected on the <br />basis of LCS recoveries. <br />4.2.4 Compound Identification <br />For 10% of the results reported in the data packages under going an evaluation of laboratory <br />performance parameters, the reviewer will verify that results positively identified meet all <br />identification acceptance criteria as specified in the analytical method. In addition, the reviewer <br />will examine the data for false negative results. <br />For organics, this may encompass comparing retention times against retention time windows, <br />evaluating the agreement between dual column confirmation results, comparing relative <br />retention times (RRTs) for samples to RRTs for standards, and comparison of mass spectral data <br />to reference spectra, depending on the analytical technique employed (note: this listing is not all <br />inclusive). <br />For inorganic methods, compound identification is generally not reviewable from the data <br />packages. However, for some methods, there are items the reviewer can check such as <br />comparing the %RSDs for replicate measurements to a method specific criterion and that target <br />analytes elute in the proper order and expected retention time. <br />4.2.5 Target Analyte Quantification <br />The reviewer will verify that reported sample concentrations can be recalculated from the raw <br />data for 10% of the reported sample results in the data packages under going an evaluation of <br />laboratory performance parameters. The reviewer will verify that reported results were <br />calculated using the proper signal response for the sample, calibration factor or relative response <br />factor, internal standard response, dilution factor, internal standard concentration or mass, <br />percent solids, sample weights or volumes, final extract volume, etc. as applicable to the <br />analytical method. <br />If errors are found in the reported sample results, the laboratory will be contacted and corrected <br />results will be requested. The data review narrative will detail any such instances and the <br />resultant resolution. The reviewer will collate the revised data into the data package and mark <br />the all revised and all superseded data accordingly. <br />In some cases, multiple analyses for the same sample may be reported. The multiple analyses <br />may be due to high target analyte concentrations that necessitate dilutions, interferences, or QC <br />failures (e.g. low surrogate recoveries). When there is more than one set of data reported for a <br />sample, the reviewer will need to select the best set of data to report based on all of the <br />supporting QC information. This may involve selecting results from each of the multiple <br />analyses. The data review narrative will detail the results selected for reporting and the <br />supporting rationale. The data sheets will be marked to indicate which results were selected for <br />reporting and which were not. <br />4.2.6 Verification <br />The reviewer will verify that information reported on the summary forms was calculated <br />properly and that the results are traceable back to the raw data. In addition, the reviewer may <br />also verify that all spike solutions and standards were used within their recommended shelf lives. <br />Powertech <br />Rev 28-1 JAB <br />4/23/2007 <br />Attachment A <br />R Squared Inc <br />
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