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4.
Is it likely that sufficient samples were taken to enable the reviewer to see an effect if it was really
present?
Assessments generally take place at one of two points in the data generation process. First, as data are
generated, aspects of the project such as observation of field and laboratory operations, consistency of the
data with MQOs, and/or successfully completing performance evaluation sample studies can be used to
arrive as an assessment of whether the data are valid and acceptable. Once data have been examined and
assessed, and they are found to be of known and acceptable quality, then the results can be evaluated in
the context of the Data Quality Objectives for the test. An assessment must also be made as to whether
there is a sufficient quantity of data to support test decisions, and whether the original sampling design
was appropriate. In some cases, the data may suggest that additional data are required to achieve a higher
statistical confidence level. This could be because too many data points were invalidated, that samples
were not collected over a long enough time period, or that a vital sampling area not previously considered
important, was missed. In other cases, an assessment might show that data of a different type are required,
or that the sensitivity of the instrument used in the measurement was not adequate to meet test objectives.
Thus, both types of assessments are vital to the successful completion of a BWTS test.
10.2.4.
Assessment Reporting
Authority to effectively report TSAs, PEAs, and ADQs is assigned to MERC QA Manager. These written
reports should:
•
identify and document problems that affect quality and the achievement of objectives required by
the QMP, QAPP, Test Plan, and any associated SOPs;,
•
identify and cite noteworthy practices that may be shared with others to improve the quality of
their operations and products;
•
propose recommendations (if requested) for resolving problems that affect quality;
•
independently confirm implementation and effectiveness of solutions;
•
provide documented assurance (if requested) to line management that, when problems are
identified, further work performed is monitored carefully until the problems are suitably resolved.
Quality assessments of project activities are reported to the MERC Program Coordinator and Director.
The Program Coordinator and the Director are responsible for ensuring that findings from these
assessments of project activities are appropriately addressed.
10.2.5.
Qualifications and Authority of Assessors
The principal MERC assessor is the MERC QA Manager, who will have an extensive quality assurance
laboratory and field inspection background, and technical and management experience, and who will be
directly familiar with MERC assessment requirements. The QA Manager must be independent of the
work being reviewed, free of conflict of interest, and knowledgeable in the area being assessed. The QA
Manager will have the responsibility and authority to:
•
identify and document problems affecting the quality of BWTS test results;
•
propose recommendations for resolving these problems;
•
independently confirm implementation and effectiveness of solutions;
•
recommend that work during a BWTS test be stopped if safety and quality are threatened.