EPA/600/8-91/003 PREPARATION AIDS FOR THE DEVELOPMENT OF CATEGORY I QUALITY ASSURANCE PROJECT PLANS by Guy F. Simes Risk Reduction Engineering Laboratory Printed on Recycled Paper This material has been funded by the United States Environmental Protection Agency. Although it has been subject to the Agency's review, and has been approved for publication as an EPA document, it does not necessarily reflect EPA policy. Foreword Today's rapidly developing and changing technologies and industrial products and practices frequently carry with them the increased generation of materials that, if improperly dealt with, can threaten both public health and the environment. The U.S. Environmental Protection Agency is charged by Congress with protecting the Nation's land, air, and water systems. Under a mandate of national environmental laws, the Agency strives to formulate and implement actions leading to a compatible balance between human activities and the ability of natural systems to support and nurture life. These laws direct the EPA to perform research to define our environmental problems, measure the impacts, and search for solutions. The Risk Reduction Engineering Laboratory is responsible for planning, implementing, and managing the research, development, and demonstration programs to provide an authoritative, defensible engineering basis in support of the policies, programs, and regulations of the EPA with respect to drinking water, wastewater, pesticides, toxic substances, solid and hazardous wastes, and Superfund-related activities. This publication is one of the products of a quality assurance outreach program that provides a vital communication link between the researcher and the user community. Perhaps the greatest benefit to the users of this document comes from its emphasis on up-front planning -- do the right thing, right, the first time. While this sounds straightforward, managers know that determining the right course in a complex and uncertain situation is anything but simple. Determining customer requirements up-front, and then having the processes and procedures in place to accomplish them, averts costly mistakes. Resources are conserved in two ways: by avoiding rework to correct efforts that do not initially meet management or customer specifications; and by performing to the specifications required and not beyond them. In these ways, this "Preparation Aids" document can help management achieve its mission with more effective utilization of diminishing resources. E. Timothy Oppelt, Director Abstract Data collection activities performed for the Risk Reduction Engineering Laboratory (RREL) of the U.S. Environmental Protection Agency are divided into four categories, depending on the intended use of the data. Quality Assurance (QA) Project Plans are written to ensure that project needs will be met and that quality control procedures are sufficient for obtaining data of known quality. The level of QA required, however, depends on the project category selected for a given project. Projects that are of sufficient scope and substance that their results could be used directly, without additional support, for compliance or other litigation are identified as Category I projects. Such projects are of critical importance to the Agency goals and must be able to withstand legal challenge. Accordingly, the QA requirements will be the most rigorous and detailed in order to ensure that such goals are met. To assist professional scientists and engineers in preparing QA Project Plans, separate guidance manuals in an easy-to-read format have been developed for each category. The Category I manual contains detailed descriptions of each of the 15 required elements of a Category I QA Project Plan. Also included are definitions and explanations of frequently used terms, examples of QA forms and charts, sample equations, and numerous types of tables suggested for summarizing information. |