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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
Metadata
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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 14 of 24 <br />SOP NUMBER 28.0 Analytical Data Validation <br />• Whether the responses obtained indicate that the instrumentation is still operating within an <br />acceptable range (drift). <br />If the continuing calibration evaluation criteria for any analyte are not satisfied, then all results <br />for that analyte associated with the continuing calibration will be qualified as estimated ("J/UJ" ). <br />A qualifier code of "CCV" or "CCAL" will be used for inorganic and organic methods, <br />respectively. If the data reviewer can discern a probable magnitude and/or direction of bias to <br />the associated sample results based on the information provided, then appropriate qualifier bias <br />codes will be assigned. <br />4.2.3 Laboratory Control Sample Analysis <br />Laboratory control samples (LCSs) are "clean" well-characterized samples used to monitor the <br />laboratory's day-to-day performance of routine analytical methods. LCSs are prepared by <br />spiking samples of a "clean" matrix with known amounts of target analytes and then processing <br />the sample in the same fashion as all other samples. LCSs are used to monitor the accuracy and <br />precision of the analytical process independent of matrix effects. The accuracy of the analytical <br />process is evaluated using the calculated percent recoveries (%Rs) of the spiked analytes. <br />The reviewer will verify that all target analytes were spiked into the LCS sample. The LCS <br />percent recoveries will then be compared to the acceptance limits in the quality assurance plan, <br />method, or laboratory historical limits (if the laboratory acceptance limits are considered to be <br />comparable to those specified in the methods), as applicable. <br />• If the LCS recovery for an analyte is greater than the upper acceptance limit, suggesting a <br />potential high bias in reported results, all positive results for that analyte in all associated <br />samples will be qualified as estimated ("J") whereas nondetect results will be considered <br />acceptable for use without qualification because the high bias does not affect nondetect <br />results. <br />• If the LCS recovery for an inorganic analyte is less than the lower acceptance limit but <br />>_30%, suggesting a potential low bias in reported results, positive and nondetect results for <br />that analyte in all associated samples will be qualified as estimated ("J" or "UJ" ). <br />• If the LCS recovery for an inorganic analyte is <30%, positive sample results will be <br />qualified as estimated ("J"), whereas nondetect results will be qualified as unusable ("R") for <br />all associated sample results. <br />• If the LCS recovery for an organic analyte is less than the lower acceptance limit but >_10%, <br />positive and nondetect results for that analyte in all associated samples will be qualified as <br />estimated ("J" or "UJ" ). <br />• If the LCS recovery for an organic analyte is <10%, positive sample results will be qualified <br />as estimated ("J") whereas nondetect results will be qualified as unusable ("R") for all <br />associated sample results. <br />In the case of unacceptably low LCS recoveries, the reviewer will verify that the laboratory re- <br />prepared and re-analyzed all associated samples; including the LCS and that acceptable results <br />were obtained for the new LCS. <br />Powertech R Squared Inc <br />Rev 28-1 JAB Attachment A <br />4/23/2007
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