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C.1.1.
Performance Evaluation Audits
PEAs are described in Section 10.2.3.1 of the MERC QMP. A PEA will be conducted to assess the
quality of the variable measurements made in each BWTS test. A PEA involves submitting performance
evaluation samples for analysis for each analytical method used in the test. The PE samples contain
analytes of interest for the test, preferably in the anticipated concentrations of field samples. The PEA
answers questions about whether the measurement system is operating within control limits and whether
the data produced meet the analytical QA specifications.
The MERC QA Manager will submit “blind” PE samples to the laboratory as part of a field-sampling
event. The QA Manager will evaluate the results of the PE samples as soon as they are received from the
laboratory. The critical elements for review of PE results include:
•
correct identification and quantitation of the PE sample analytes;
•
accurate and complete reporting of the results;
•
measurement system operation within established control limits for precision and accuracy.
The concentrations reported for the PE samples will be compared to the known or expected
concentrations spiked in the samples. The percent recovery will be calculated and the results compared to
the accuracy criteria. The QA Manager will submit the results of the PE samples and the associated
calibration and quality control data to the MERC PC and Director. If the accuracy criteria are not met,
the laboratory will investigate the cause of the failure and submit a corrective action report to the QA
Manager, PC, and MERC Director.
C.1.2.
Technical Systems Audits
TSAs are described in Section 10.2.3.2 of the MERC QMP. The MERC QA Manager will perform a
TSA at least once during each BWTS test. The purpose of this audit is to ensure that the tests are being
performed in accordance with the MERC QMP, this QAPP, and the specific Test Plan.
During this audit, the MERC QA Manager will compare actual test procedures to those specified or
referenced in this plan and review data acquisition and handling procedures. The QA Manager will
include a review of the testing facility, equipment (calibration, maintenance, and operation) and
observation of testing and records (including custody forms). The QA Manager also will check data
acquisition procedures and may confer with the vendor and technical staff. The TSA will be guided by a
project-specific checklist based on this QAPP.
A TSA report will be prepared as a memo to the MERC PC within 10 business days after completion of
the audit; the completed checklist will be attached. The MERC Director will be copied on the memo. The
MERC PC will respond to the audit within 10 business days. The MERC QA Manager will verify that all
audit Findings and Observations have been addressed and that corrective actions are appropriately
implemented. A copy of the complete TSA report with corrective actions will be provided to the MERC
Director within 10 business days after receipt of the audit response. The TSA findings will be
communicated to technical staff at the time of the audit and documented in a TSA report.
C.1.3.
Data Quality Audits
The MERC QA Manager will audit at least 20% of the sample results acquired in the BWTS test and
100% of the calibration and QC data per the QAPP requirements. A checklist based on the QAPP will