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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 12 of 24 <br />SOP NUMBER 28.0 Analytical Data Validation <br />equal to the RL/PQL). When the RL/PQL is adjusted for sample weight, percent moisture, and <br />dilution factor for individual samples, the result is a sample-specific quantitation limit or SQL. <br />To reflect the higher degree of uncertainty associated with values reported between the IDL/MDL <br />and RL/PQL, these results are qualified as estimated ("J"). A qualifier code of SQL, denoting <br />sample quantitation limit, is assigned to results qualified for this reason. A bias direction of <br />indeterminate is assigned. <br />4.1.9 Other Items Identified in the Case Narrative <br />If an issue identified in the case narrative is not covered by the subsections above and is found to <br />potentially adversely affect data quality, the data reviewer shall evaluate the problem based on <br />the quality assurance plan and/or method requirements, as applicable. If the quality assurance <br />plan and/or analytical method does not specify requirements related to the criterion under <br />evaluation, the data reviewer should utilize professional judgement to evaluate the effect of the <br />reported item or condition on the associated analytical data. All uses of professional judgement <br />shall be described in the report of the data validation process. <br />4.1.10 Completeness of the Data Package <br />The analytical data packages are evaluated for completeness of deliverables against the <br />following criteria: <br />• Presence of tabulated results for all specified compounds identified and quantified and RLs <br />for all analytes. <br />• Presence of results for all methods requested on the COC forms for each sample. <br />• Presence of a case narrative, COC forms, and the sample receiving forms. <br />• Presence of QC summary forms for blank results; QC summary forms for MS results with <br />calculated percent recoveries; QC summary forms for post-digestion spike recoveries (as <br />required) with calculated percent recoveries; QC summary forms for laboratory duplicates <br />and/or spike duplicate results and calculated RPDs; QC summary forms for serial dilution <br />test with calculated %Ds; and QC summary forms for LCS sample results with calculated <br />percent recoveries. <br />• When full data packages are requested, the package will also be reviewed for QC summary <br />forms for initial and continuing calibration verification as well as supporting raw data for all <br />of the aforementioned items and any pertinent review parameter discussed in Section 4.2. <br />Data package deliverables that do not meet the above criteria are documented, and the missing <br />deliverables will be requested from the contracted laboratory. Any documents not obtainable <br />from the laboratory are noted in the data review narrative. <br />4.2 REVIEW OF LABORATORY PERFORMANCE PARAMETERS <br />The review of laboratory performance parameters includes evaluating operations that are in the <br />control of the laboratory, but are independent of the field samples being analyzed. Evaluation of <br />these parameters provides an overall representation of the analytical system at the time of <br />analysis. For laboratory performance parameters will be reviewed for 10% of the data packages <br />Powertech <br />R Squared Inc <br />Rev 28-1 JAB Attachment A <br />4/23/2007
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