Basic HTML Version
8
results, and supervises Dr. Elisa Taviani and Graduate Research Assistants at MPRI to assure appropriate
microbial sample collection and handling, and analysis of microbial samples according to relevant SOPs.
Dr. Daniel Fisher, Director of Maryland Department of the Environment's Bioassay Laboratory located at
WREC, is responsible for developing SOPs for toxicity testing and residual byproduct chemical analyses,
review test results, and oversees WREC staff involved in these activities, including Dr. Lance Yonkos,
Assistant Research Scientist, and Gregory Ziegler, Faculty Research Associate.
Dr. Fred Dobbs, Professor and Graduate Program Director,Department of Ocean, Earth and Atmospheric
Sciences at Old Dominion University, is responsible for scientific review of all SOPs and test results, and
for logistic support for MERC testing in Norfolk, VA.
Katherine Davis Ziombra, at CBL/UMCE,S is the Data Manager and is responsible for the compilation,
review, management and storage of all data collected during MERC testing.
The Data Manager will
coordinate with the Quality Assurance Manager on revisions to the data.
A.4.5.
Quality Assurance Manager
Dr. Earle Buckley is the Quality Assurance (QA) Manager for MERC and provides independent oversight
of the MERC quality system. For MERC BWTS testing, Dr. Buckley will:
•
review the draft and final QAPP and Test Plans;
•
attend the BWTS test kick-off meeting and lead the discussion of the QA elements of the testing;
•
prior to the start of testing, verify the presence of applicable training records, including any vendor
training on test equipment;
•
prepare audit checklists;
•
conduct a technical systems audit at least once near the beginning of each BWTS test;
•
conduct audits to verify data quality;
•
prepare and distribute an audit report for each audit;
•
verify that audit responses for each audit finding and observation are appropriate and that corrective
action has been implemented effectively;
•
maintain real-time communication with the PC on QA activities, audit results, and concerns,
•
communicate to the PC and/or technical staff the need for immediate corrective action if an audit
identifies QAPP and/or Test Plan deviations or practices that threaten data quality;
•
recommend a stop work order if audits indicate that data quality or safety is being compromised;
•
work with the PC and MERC Director to resolve data quality concerns and disputes;
•
provide a summary of the QA/quality control (QC) activities and results for the final reports;
•
review the draft and final test reports;
•
review and approve QAPP and Test Plan amendments and deviations.
A.4.6.
Manufacturer
Manufacturer representatives will:
•
review the draft Test Plan and provide comments and recommendations;
•
approve the final Test Plan;
•
interface with the MERC PC to make all arrangements for the test;
•
sign a MERC manufacturer agreement to participate in the test;
•
provide operational treatment systems for the agreed upon test site(s) for the duration of the test;