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MERC ER01-12
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10. QA Results
Technical System Audit:
A Technical Systems Audit (TSA) is a thorough, systematic,
on-site qualitative audit of MERC’s sampling and measurement processes and procedures
associated with a specific BWTS test. The objective of the TSA is to assess and document the
conformance of on-site testing procedures with the requirements of the MERC QAPP, the
specific Test Plan, and associated SOPs. The MERC QA Manager conducts a TSA at least once
during each BWTS test.
The MERC Quality Assurance (QA) Manager conducted a TSA during the uptake cycle
of a biological efficacy test (Hyde-03) at the MERC Mobile Test Platform on May 14-15, 2012.
The audit included a review of staff, test procedures (sample collection, sample analysis, data
processing, etc.), facilities, and documentation to assure compliance with the MERC Quality
Assurance Project Plan (QAPP), Standard Operating Procedures (SOPs), and the Test Plan for
the Hyde BWMS evaluation. Bacterial sample transport to and processing at the University of
Maryland, Center of Marine Biotechnology Laboratory, was observed, but a full TSA of the
laboratory was not done.
The TSA’s’ findings are all positive in nature and indicate that the Hyde BWMS
evaluation was being implemented in a manner consistent with the MERC QAPP and SOPs. All
phases of the implementation of the test reviewed during the TSA were acceptable and
performed in a manner consistent with MERC data quality goals. There were several deviations
in the Test Plan, which were approved by both the MERC Director and the vendor’s
representative. There are no findings that indicate a quality problem requiring corrective action.
The overall quality assurance objectives of the test were met.
MERC technical personnel are well-qualified to implement the program, and
demonstrated expertise in pertinent procedures. Communication and coordination among all
personnel was frequent and effective. The MERC staff understands the need for QC, as shown
in the conscientious development and implementation of a variety of QC procedures.
All samples and instrument measurements were collected, analyzed and cataloged as
described in the MERC QAPP, SOPs and the Hyde Test Plan. For samples transported and
analyzed by other affiliated laboratories, chain-of-custody (COC) protocols were practiced,
specifying time, date, sample location, unique sample number, requested analyses, sampler
name, time and date of transaction between field and laboratory staff, and name of receiving
party at the laboratory. Examination of maintenance and calibration logs provided evidence of
recent and suitable calibration of sampling and analytical equipment.
MERC’s internal record keeping and document control is both well organized and
generally meets or exceeds EPA requirements.
Audit of Data Quality:
The MERC QA Manager conducted an Audit of Data Quality
(ADQ) on verified data to document the capability of MERC’s data management system
(hardcopy and electronic) to collect, analyze, interpret, and report data as specified in the QAPP,
SOPs, and Hyde Test Plan. The ADQ involved an examination of data after they have been
collected and verified by MERC personnel. A representative set of no less than 10% of the data
on core parameters was traced in detail from raw data from field and laboratory logs and
instrument readouts through data transcription or transference through data manipulation through
data reduction to summary data, data calculations, and final reported data.