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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 13 of 24 <br />SOP NUMBER 28.0 Analytical Data Validation <br />received per analysis type per sampling event/episode. If review of any of the laboratory <br />performance parameters indicates a systematic problem may exist, that review parameter will be <br />evaluated for all data packages from that laboratory for that sampling event/episode. <br />Each of the subsections below describes in general how each laboratory performance parameter <br />is evaluated. As noted in the introduction to Section 4, the hierarchy for criteria used to evaluate <br />each parameter is as follows. A parameter is first evaluated against the requirements set forth in <br />the quality assurance plan. If the quality assurance plan addresses that parameter, the parameter <br />is evaluated against the requirements stated in the analytical method. If the method does not <br />specify acceptance criteria, results for the parameter are compared to acceptance ranges based on <br />laboratory historical data. <br />While conducting the review described below, the data reviewer will evaluate whether the case <br />narrative adequately summarizes all issues potentially affecting data quality (i.e., is the case <br />narrative a reliable indicator of potential problems within the entire data package?). This <br />assessment will be used to determine the need to evaluate specific laboratory performance <br />parameters for the entire data set rather than just the predetermined portion of the data set (i.e., <br />10%). <br />4.2.1 Initial Calibration <br />The requirements set forth in the quality assurance method, as applicable, will be used to <br />evaluate whether: <br />• The initial calibration was performed at the required frequency using the proper number of <br />standards at the proper concentrations, <br />• Whether the RL or CRQL is supported by the low point standard, <br />• Whether adequate response was obtained for each analyte for each standard, <br />• Whether the applicable linearity criteria were met, and <br />• Whether the initial calibration was verified properly. <br />If the initial calibration evaluation criteria for any analyte are not satisfied, then all results for <br />that analyte associated with the initial calibration will be qualified as estimated (" PUJ" ). A <br />qualifier code of "ICAL" or "ICY" will be used depending on whether the condition was due to <br />the initial calibration or verification of the initial calibration. If the data reviewer can discern a <br />probable magnitude and/or direction of bias to the associated sample results based on the <br />information provided, then appropriate qualifier bias codes will be assigned. <br />4.2.2 Continuing Calibration Verification <br />The requirements set forth in the quality assurance plan and/or method, as applicable, will be <br />used to evaluate whether: <br />• The continuing calibration verification was performed at the required frequency using the <br />proper standard at the proper concentration, <br />• Whether adequate response was obtained for each analyte, and <br />Powertech <br />R Squared Inc <br />Rev 28-1 JAB Attachment A <br />4/23/2007
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