MEERC Quality Assurance Plan

January 9 1997

Dr. Victor S. Kennedy, MEERC Director

TABLE OF CONTENTS

1. Quality Management

1.1 Quality Policy
1.2 Quality Objectives
1.3 Responsibilities and Authority

2. Structure of Quality Systems

2.1 Quality Organizational Structure
2.2 Resources and Personnel
2.3 Operational Procedures
2.4 Quality Manual and Record Keeping
2.5 Review and Evaluation of Quality Systems

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1.Quality Management

1.1 Quality Policy.

The Multiscale Experimental Ecosystem Research Center (MEERC) supports an interdisciplinary program of research and education designed to evaluate scale-dependent ecosystem variability. The overall goals of MEERC are to establish principles for scaling ecosystem structure, function, and dynamics and to use these principles as the basis for predicting ecosystem responses to contaminant perturbations. A wide variety of activities occur under the umbrella of this U.S. EPA Exploratory Research Center, including direct support of laboratory and field investigations, support and training of graduate students, and sponsorship of lectures, seminars, conferences, and visiting scientists. Research activities include both field and laboratory measurements and the development and validation of ecosystem process models.

During the lifetime of this Center, discrete projects will begin and end and personnel will change, but basic quality assurance principles will remain unchanged throughout the tenure of this Center. However, in contrast to shorter duration and narrowly focused research grants, contracts, or cooperative agreements, the MEERC quality assurance program must be inherently flexible to account for the changing nature of a Center.

The goals of this Quality Assurance Plan are to detail the underlying quality assurance principles and to formalize the structure of the MEERC quality assurance program. Each lead investigator is responsible for submitting a project-specific quality assurance plan to the MEERC Quality Assurance Officer before beginning each MEERC-supported research project. The lead investigators will use the underlying principles described in this document as a framework for the more detailed and specific quality assurance plans for each project. This quality assurance plan specifically covers those aspects of MEERC that deal with the measurement of physical, chemical, and biological variables, both in field and in laboratory studies. This plan does not address other MEERC-related activities, including model development and interpretation.

1.2 Quality Objectives.

The overriding hypothesis of this Center is that the responses of ecosystems to environmental perturbations depend upon spatial, temporal and complexity scales. By its very nature, therefore, the Center seeks to compare 'normal' and 'stressed' experimental ecosystems. In addition, the Center seeks to understand whether and how results of simpler and smaller micro- and mesocosm studies can be extrapolated to actual ecosystems. In order for the Center to succeed, the following basic quality principles are established:

1. All measurements will include quantitative determinations of accuracy and precision.

Comparisons between treatments and time series analyses of trends require a thorough knowledge of the accuracy and precision of the analytical methodologies. All in situ and laboratory measurements have finite accuracy and precision that will be quantified through the appropriate analysis of replicates and calibration standards. Precision will be quantified and monitored for each variable through analysis of true replicates. Accuracy will be determined by frequent instrument calibrations, matrix fortifications, analysis of standard reference materials, and participation in round-robin interlaboratory comparisons.

 

Quality Principle #1. Sampling and analytical methodologies will be optimized for each MEERC- supported study in order to accurately discern 10% of the expected response. Ecosystem-level process models may be used to determine the expected response before each experiment during creation of the project work plan.

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2. Methods will be consistent or changes will be rigorously intercalibrated throughout the history of the Center in order to ensure data comparability and confidence in long-term trends.

Throughout the duration of the Center, it is likely that a core set of physical, chemical, and biological variables will be measured in a variety of experiments, ranging from short term (i.e., days to weeks) microcosm experiments to longer term (i.e., seasonal to annual) monitoring of macrocosms. Turnover of investigators, students, and technicians is expected. Analytical methods will very likely evolve and improve during the lifetime of the Center. In order to compare results from individual experiments and to confidently document long-term changes, it is critical that MEERC-supported studies employ a common set of sampling and analytical methodologies.

 

Quality Principle #2. Sampling and analytical methodologies employed in each MEERC-supported study will be internally consistent throughout and will be compatible with previous and contemporary MEERC- supported studies. Changes in procedures, accompanied with appropriate cross calibrations, will be reviewed by the MEERC Quality Assurance Officer before being implemented.

3. Methods will be consistent with or calibrated against those used in established water quality monitoring programs in order to facilitate comparisons.

Often sampling and analytical methodologies employed in research studies result in higher quality (e.g., more sensitive, higher precision) data than those used in large scale monitoring programs. Nonetheless, an important aspect of MEERC is the comparison of experimental ecosystem behavior to that of whole ecosystems. In addition, large scale monitoring programs often provide the only long-term data with which one can examine temporal scaling issues at the ecosystem level. It is necessary, therefore, to be able to quantitatively compare the quality (e.g., sensitivity, precision, accuracy) of the data resulting from MEERC-supported studies to those of relevant monitoring programs. The MEERC Quality Assurance Officer and Quality Assurance/Database Administrator will work with lead investigators and appropriate representatives from the various state and federal agencies to make such comparisons.

 

Quality Principle #3. Sampling and analytical methods employed in MEERC-supported studies will where-ever possible be consistent and compatible with accepted methodologies used in high-quality water quality monitoring programs. Unless they cannot achieve the stated data quality objectives for a particular MEERC-supported study, the water quality methods used in the Chesapeake Bay Mainstem Monitoring Program will used.

4. Quality assurance information will be linked to all data in the MEERC database upon submittal, ensuring that modeling and interpretation efforts will explicitly incorporate uncertainty.

Very often the uncertainty in a measurement is as important as the value itself. Many MEERC-supported studies and resulting modeling efforts seek to distinguish between the behaviors of control and treatment experimental ecosystems or to discern temporal trends. All too often the systematic and random errors inherent in any measurement are lost once the data on results are incorporated into a database, preventing an appropriate uncertainty analysis. The MEERC Quality Assurance/Database Administrator will wok with the lead investigators to ensure that the required uncertainty estimates are generated and reported.

 

Quality Principle #4. Every measurement made during a MEERC-supported study should include an estimate of its uncertainty, which will be linked with the value in the MEERC database. No data should be released from the database without the corresponding uncertainty estimate.

 

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1.3 Responsibilities and Authority.

The responsibilities of the current MEERC investigators are outlined below. This quality assurance plan will be updated periodically to reflect changes in personnel throughout the duration of the Center.

Dr. Victor S. Kennedy, MEERC Director
Horn Point Environmental Laboratory
P.O. Box 775, Cambridge, MD 21613
410-221-8286
kennedy@hpl.umces.edu

As Director, Dr. Kennedy has the ultimate responsibility for ensuring the quality of the data generated at this Center.

Dr. Joel E. Baker, Quality Assurance Officer
Chesapeake Biological Laboratory
P.O. Box 38, Solomons, MD 20688
410-326-7205
baker@cbl.umces.edu

As Quality Assurance Officer, Dr. Baker is responsible for overseeing the MEERC quality assurance program, for reviewing and certifying compliance of each MEERC-sponsored study to its quality assurance program, for addressing out-of-control situations, and for regularly reporting quality issues to the Director.

Mr. John Posey, Quality Assurance/Data Base Administrator
Chesapeake Biological Laboratory
P.O. Box 38, Solomons, MD 20688
410-326-7238
posey@cbl.umces.edu

Mr. Posey is responsible for the day-to-day implementation of the MEERC quality assurance program, including working with investigators to document quality-assured data, identifying out-of-control situations, and maintaining the MEERC database.

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2. Structure of Quality Systems

2.1 Quality Organizational Structure.

Dr. Victor Kennedy is the Director of the Center and is responsible for coordination of all research activities, and for facilitating communication among MEERC participants, the Scientific Advisory Committee, and the U.S. Environmental Protection Agency Project Officer. He has ultimate oversight of all quality assurance issues. Dr. Joel Baker is the MEERC Quality Assurance Officer and is responsible for reviewing and approving the quality assurance plans for each MEERC-supported study, and for final approval of all data before incorporation into the MEERC database. Mr. John Posey, the MEERC Quality Assurance/Database Administrator, reports to Dr. Baker and works closely with each MEERC participant to ensure compliance with all quality assurance plans. In addition, Mr. Posey manages the MEERC database, coordinates data submissions from MEERC participants, and facilitates retrieval of data and associated quality information from the database.

Sampling and analytical quality assurance issues are reviewed by the Quality Assurance Officer, and when necessary, discussed by the MEERC Coordinating Committee (MCC) at their regular meetings.

2.2 Resources and Personnel.

Each participant in MEERC shares responsibility for achieving the quality objectives. Therefore, portions of each project's budget are implicitly allocated to quality assurance. In addition, MEERC supports a Quality Assurance/Database Administrator who is directly involved in the day-to-day implementation of the MEERC quality assurance and data management plans.

2.3 Operational Procedures.

As a Center, the quality assurance operation procedures differ from that of an individual research contract. A portion of the MEERC budget is allocated to support research activities, including individual investigator studies and coordinated projects. In order to achieve the Quality Principles described above, each MEERC-supported study will submit as part of its workplan a project- specific quality assurance plan for approval by the MEERC Quality Assurance Officer before research begins. These plans will detail (1) the specific objectives of the study, including the hypotheses to be tested, (2) the specific data quality objectives for each variable to be measured, (3) the specific sampling and analytical protocols required to meet the data quality objectives, and (4) the person responsible for quality assurance for the study. This plan will be reviewed and approved by the Quality Assurance Officer before the study begins. All out-of-control situations and deviations from the approved quality assurance plan will be reported to the Quality Assurance Officer.

2.4 Quality Manual and Record Keeping.

The Quality Assurance Officer is responsible for maintaining records of all quality assurance activities including the updated MEERC Quality Assurance Plan and individual project quality assurance plans. Lead investigators are responsible for maintaining quality assurance records during their studies, and for including quality assurance information in their final reports. All quality assurance information is incorporated in the MEERC database.

2.5 Review and Evaluation of Quality Systems.

The MEERC Quality Assurance and Data Management Plans will be updated annually in conjunction with the MEERC Annual Report. The MEERC Quality Assurance Officer will summarize the program as part of the MEERC Annual Report. Each MEERC- supported study involving measurements will be reviewed periodically, with out-of-control situations noted, discussed with the lead investigator, and corrected.

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