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The key data review requirements for the performance evaluation test are the collection of QC samples as
outlined in the QAPP, a comparison of raw data sheets and comments against final data to flag any
suspect data, and a review of final data to resolve any questions about apparent outliers. The QA audits,
as described within this document are designed to assure the quality of these data. In general, the data
generated during this test will be reviewed by a MERC technical staff member within 5 days of
generation of the data. The reviewer will be familiar with the technical aspects of the BWTS test but will
not be the person who generated the data. This process will ensure that the data have been recorded,
transmitted, and processed properly. Furthermore, this process will ensure that the monitoring systems
data were collected under appropriate testing conditions.
The key data verification requirements for this test are stated in Section B10 of this QAPP. Data
verification will be performed by the MERC PC and QA Manager. The MERC Director will be notified
by the QA Manager when inconsistencies or non-compliant monitoring and/or laboratory data are
discovered. For field activities, it is necessary to determine whether the samples/monitoring data were
collected using the sampling/monitoring design specified in section B1, whether the samples/monitoring
events were collected according to a specific method or SOP as specified in Section B2, whether the
collected samples have been recorded and handled properly as in Section B3, and whether the proper
amount of QC samples and procedures were taken to satisfy the QC requirements specified in Section B5.
For analytical activities, each sample/monitoring event should be verified to ensure that the procedures
used to generate the data (as specified in Section B4) were performed as specified. The proper amount of
QC checks (as specified in Section B5) that were prepared and analyzed during the actual analysis
provide an indication of the quality of the data. Instrument calibrations (as specified in Section B7) are
evaluated to determine whether the correct number of calibration standards were used and the range of the
analysis, whether standards were analyzed in an appropriate sequence specific to the methods used, and
were performed prior to monitoring events and analysis of samples, blanks, and QC samples in an
appropriate time frame.
The MERC PC and QA Manager are responsible for assessing the data against a set of criteria to verify its
validity prior to use. The data validation process summarizes the data and QC deficiencies, and
determines the impact on the overall data quality. Data validation qualifiers (DQIs and MQOs) are
assigned in the data assessment records, flagged on the results tables, and noted in the “Results” section
of the final evaluation reports.
D.2.
Verification and Validation Methods
Data verification is conducted as part of the data review as described in Section B10 of this QAPP. A
visual inspection of handwritten data will be conducted at each level in the field and in the laboratory to
ensure that all entries were properly recorded or transcribed and any erroneous entries were properly
noted. Records produced electronically or maintained as hard copies are subject to data verification.
During field activities, records associated with monitoring events and sample collection such as field data
sheets, COC records, shipper’s air bills, logbook documentation, or electronic devices to log samples or
print sample labels are verified against approved SOPs or procedures. At sample receipt, COC records are
verified along with refrigerator and freezer logs to ensure the integrity of the samples. During the sample
preparation; certificates of analysis for surrogates and spiking compounds, refrigerator and freezer logs,
analytical requests and standard preparation logs are verified. Manufacturer’s certificates for calibration
and/or internal standards, instrument run or injection logs, standard preparation logs, calculation
worksheets, and QC monitoring events/sample results are verified during the analysis of the sample set.
All calculations used to transform the data will be reviewed to ensure the accuracy and the
appropriateness of the calculations. Calculations performed manually will be reviewed and repeated using