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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 16 of 24 <br />SOP NUMBER 28.0 Analytical Data Validation <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 />all revised and all superseded data accordingly. <br />4.2.7 Method Specific Quality Control Checks <br />The supporting QC data will be reviewed to evaluate if the method-specific QC checks were <br />conducted and whether the method-specified acceptance criteria were met. The table below <br />summarizes the method specific QC checks typical of each analytical technique. The reviewer <br />will consult the quality assurance plan and analytical method for evaluation criteria used to <br />evaluate method-specific QC checks. <br /> <br /> <br />QC Check <br /> <br />ICP-LS 1 -7 <br />wet <br />ICP-NIS Chemistry - <br /> <br />GC GC/1IS <br /> <br />HPLC <br />Tuning ? <br />Interference Check Sample ? ? <br />Thermal Stability ? <br />Spectral Resolution ? ? <br />Mass Calibration ? ? <br />Chromatography ? ? ? ? <br />ICP-ES = Inductively coupled plasma atomic emission spectroscopy. <br />ICP-MS = Inductively coupled plasma mass spectroscopy. <br />GC = Gas chromatography. <br />GUMS = Gas chromatography mass spectroscopy. <br />HPLC = High pressure liquid chromatography. <br />5.0 DOCUMENTATION <br />This section describes the documentation that will be generated as part of the data review <br />procedure. Section 5.1 describes data review worksheets which are generic tools the validator <br />may elect to use to facilitate the review. All data validation results will be documented in a <br />narrative report. Section 5.2 describes the contents of the resultant data validation reports. <br />5.1 DATA REVIEW WORKSHEETS <br />Figures 1 and 2 provide generic data review worksheets for the sample-specific criteria and <br />laboratory performance criteria reviews, respectively, which may be used to facilitate the data <br />review process. These forms are intended to be used as general guides for each of the <br />parameters requiring evaluation under each type of review; use of these forms is not mandatory. <br />Due to space limitations and the number of analytical methods, the specific evaluation criteria <br />are not included in the tables. The analytical methods should be consulted for specifications of <br />all pertinent evaluation criteria. The data reviewer may choose to jot these criteria on the forms <br />in the column titled "criteria." A separate form may be completed for each method. Additional <br />pages may be added as necessary to detail all aspects of the data review. <br />Powertech <br />Rev 28-1 JAB Attachment A <br />4/23/2007 <br />R Squared Inc
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