5582 SERA United States Environmental Protection Agency Office of Research and Development Washington DC 20460 March 1980 905R80135 The Quality Assurance Program: An Overview ------- I mm ------- Quality Assurance and Monitoring Systems Division The U.S. Environmental Protection Agency (EPA) is charged to carry out the responsibilities outlined in a number of Federal laws designed to protect and en- hance the quality of the Nation's air, land, and water. The EPA establishes and oversees the attainment of standards of environmental quality to meet these responsibilities. This effort requires extensive research and monitoring of the various aspects of the environ- ment. Environmental monitoring is defined as the system- atic collection and evaluation of physical, chemical, biological, and other related data pertaining to the parameters which characterize environmental quality. An enormous amount of monitoring data is collected, mostly by State and local agencies, for EPA use in: • Identifying environmental problems • Establishing standards and regulations • Measuring compliance with standards • Evaluating the effectiveness of EPA's programs These data must be scientifically valid, legally defensi- ble, representative, comparable, complete, and of known precision and accuracy. Quality Assurance (QA) plays the key role in the production of such data through a variety of planned and systematic activities and procedures. Thus, QA is the sum of activities that document and maintain the quality of monitoring data. A QA program is a vital management tool that not only supports efforts to protect public health and welfare, but also saves money by greatly reducing the production of useable data. It is the means of assur- ing that only proven measurement methods are used, that instruments are properly calibrated and main- tained, that uniform operating procedures are estab- lished and followed, and that field and laboratory per- formances are audited. The techniques and pro- cedures outlined in EPA's QA program must be strict- ly followed to produce data that can be used by the Agency to answer questions concerning environmen- tal quality, pollution abatement, and control measures to create policies that will protect and preserve the environment. 1 ------- Organization Structure Office of Research and Development (ORD) Program Offices In May 1979, the EPA Administrator adopted a policy making participation in the QA program mandatory for all monitoring and measurement activities funded, operated, or required by the Agency. To accomplish this, QA must extend to all of the Agency's monitor- ing program offices, laboratories, and through the Regions, to all State and local agencies providing data to EPA. The ORD is responsible for developing the guidelines and criteria of the Agency-wide program and directing and coordinating its implementation. This includes the review, evaluation, and approval of program QA plans and activities; the provision of special guidance and assistance in specific areas of QA as requested; and the preparation of reports for the Administrator on the overall program progress and efficiency. In connection with these responsibilities, ORD is considered the Central QA Authority and is the source of information on new methods and equipment for use in QA in ac- tivities as they become designated for EPA use, and keeps current on all QA associated activities in government agencies, technical societies, and the private sector. The Program Offices are responsible for developing their own QA plans based on the specific guidelines and criteria set forth by ORD and for ensuring that all intramural and extramural programs are consistent with Agency policies. Implementation responsibilities extend to all internal monitoring and measurement ef- forts as well as external — contracts, grants, and Interagency Agreements. For the purpose of this policy, ORD is considered a program office and the responsibilities of implementation include the ORD research laboratories and extend to their contractors and grantees. ------- Regional Offices DAA Committee on Monitoring and Information Management QA Advisory Committee Regional offices follow the policies and criteria set forth for the Agency-wide program. Implementation and coordination of the program within each Region has been, and continues to be, the responsibility of the Regional Administrator. This responsibility also ex- tends to external monitoring and measurement activi- ties of State, local, and other agencies and labora- tories involved in providing data to their appropriate Regional office. The Deputy Assistant Administrator (DAA) Commit- tee is chaired by the Administrator's Principle Science Advisor and is composed of key DAAs from the Agency's Program Offices along with representation from the Regional Offices. The Committee has the authority to recommend monitoring and information management policy for the Agency and is responsible to the Administrator for ensuring that the policies of the mandatory QA program are implemented. The QA Advisory Committee's function is to ensure proper coordination of the national effort by providing advice on the development of Agency-wide QA policies and technical recommendations. The Commit- tee has representation from the Program Offices, Staff Offices, Regional Offices, and the States, and is chaired and administratively supported by the ORD. Thus, ORD is charged with the overall guidance and coordination of the mandatory QA program, but it is the responsibility of each program manager, laboratory director; and analyst to ensure that these provisions are effectively used and that QA is prac- ticed in all monitoring activities. ------- Overview The following six categories summarize ORD's responsibilities for the direction and coordination of EPA's QA program and provide an overview of its major objectives and functions. • Program Direction and Coordination — Planning, directing, and coordinating the QA program. • Criteria and Procedures — Planning, preparing, and distributing criteria and procedure documents and manuals to be used in (a) the development of the QA plans from program offices. State and local monitor- ing agencies, and (b) the establishment of minimum QA requirements to be met by monitoring and mea- surement projects under contracts, grants, and Inter- agency Agreements. • Testing and Standards — Testing, approving, and promulgating official measurement methods and developing and distributing reference samples, reference materials, and quality control samples for use in performance tests and routine procedures checks. • Quality Control and Data Analysis — Developing and evaluating quality control procedures, statistical methods for data validation, and QA requirements for Agency data banks, and conducting surveys and preparing reports on data quality and systems perfor- mance. • Evaluation and Certification — Reviewing, approv- ing, and assisting in the development of QA plans and requirements for Agency monitoring and measurment activities, grants, contracts, Interagency Agreements, and for evaluation of certification of laboratories. • Reports — Preparing reports concerning the QA program status for the EPA Administrator. ------- i.. «...«* *8SS wMJM S i ii^ti ll MmW ------- Guidelines and Criteria QA has been an integral part of EPA, State and local monitoring programs for some time. Within EPA, the responsibility of QA has been divided between the operating monitoring programs and ORD. ORD's QA and Monitoring Systems Division (QAMSD), En- vironmental Monitoring Systems Laboratories in Las Vegas, Nevada and Research Triangle Park, North Carolina, and the Environmental Monitoring and Sup- port Laboratory in Cincinnati, Ohio, have, in the past, developed many basic tools, procedures, and mate- rials to help guide and support QA activities in the various monitoring programs. EPA's new QA program is based upon this past experience and acquired knowledge. The guidelines and criteria of the manda- tory program are derived from the following major ob- jectives and associated activities developed over the years by ORD/QAMSD and its laboratories. ------- Objective 1 Provide methods and materials necessary to produce reliable data from operating monitoring programs. Under this objective, ORD provides standardized measurement methods and sampling procedures that have been validated, through collaborative testing, for precision and accuracy. Included are the development and documentation of the statistical validation and standardization of the total measurement system. Some of the parameters of the total measurement systems considered are: • Site Selection — the location, placement, and number of monitoring stations and instruments to be used. • Sampling Frequency — the rate at which samples must be collected to provide the minimum number of samples to adequately characterize environmental conditions at a particular site. • Sampling, Collection, Handling, and Preservation — the specific procedures for collecting, transporting, and storing samples The second activity under this objective is to provide quality control samples and materials. These include a broad range of samples and instruments used by the laboratories to check instruments, measurement methods, and performances. For example, air pollu- tion reference materials have been developed through a cooperative effort with the National Bureau of Stan- dards and are used to calibrate such instruments as sulfur dioxide permeater devices and ozone generators. In other cases, standard solutions such as radionuclides in milk, or trace metals in water are distributed. The third output is QA manuals and guidelines. These documents set forth the procedures to be followed for QA activities associated with sampling, collecting, and other analytical procedures. (To obtain a listing of these documents, see the back page of this brochure.) ------- Objective 2 Develop and implement a system for continually evaluating the performance of monitoring laboratories and personnel and the adequacy of methods and in- struments used. This objective includes activities that are intended to provide both an internal evaluation of the program of- fices, research laboratories, and an external check on the quality of the data from the field laboratories. This function is important not only to identify problem areas but also to provide a comparison between dif- ferent monitoring laboratories and programs. One such activity is interlaboratory testing, in which reference samples of known concentration are ana- lyzed by various laboratories. The labs receive reports of the results and possible corrective actions needed to enhance the quality of the data being generated. The on-site evluation, another QA activity, supplies important information on facilities, instrumentation, personnel, and the QA activities being implemented. Together with interlaboratory testing, on-site evalua- tions provide the basic information upon which deci- sions can be made on the quality of the data. Data auditing includes those activities that examine data prior to acceptance into a data system. The pro- cedure involves screening for data with obvious outliers, improbable values, and improper station iden- tifications. The certification program, which currently applies only to those laboratories anlayzing public drinking water supplies, contains all of the essential elements incorporated in the evaluation activities. ------- Objective 3 Enhance the overall capability and performance of monitoring activities. A number of activities provide assistance and informa- tion to maintain or improve the performance of a monitoring system. For example, training courses, workshops, conferences, and seminars give laboratory directors, program managers, and analysts informa- tion on the latest QA practices as well as a forum to discuss problems of mutual concern. Technical assistance is an important QA-supporting activity that laboratories may receive upon request. It includes such areas as the proper use of test pro- cedures, reagent preparation, instrument calibration, and data reporting. To round out efforts to upgrade monitoring capa- bilities, ORD publishes the QA Newsletter. The News- letter maintains a central line of communication among all of the laboratories involved in QA activities and contains up-to-date information concerning new methods and materials, training courses, and recent QA advances or problems. ------- Objectives and Associated Activities of EPA's Mandatory Quality Assurance Program Provide Methods and Materials Standardized Measurement Methods and Sampling Procedures • Site Selection • Sampling Frequency • Sampling Collection, Handling, and Preservation Quality Control Samples and Materials • Calibration Standards • Standardized Samples and Instruments Guidelines and Procedure Manuals Evaluate Performance of Monitoring Activities • Interlaboratory Tests • On-Site Evaluations • Data Audits • Laboratory Certification Enhance Capabilities and Performance of Monitoring Activities • Workshops and Seminars • Technical Assistance • QA Newsletter 10 ------- QA in Perspective EPA's mandatory QA program is an essential element in all monitoring programs. By ensuring that the data collected are of known precision and accuracy, QA is the first step towards correctly assessing the state of the environment. From those assessments come deci- sions, policies, and regulations that protect and preserve the environment for future generations. EPA's QA program provides the methods and mate- rials needed to produce data of know quality. The evaluation of monitoring performances ensures that the methods and materials are in use and operating properly. The third element of the QA program pro- vides a means to identify possible problems and discuss necessary corrections and improvements to the overall program. ------- For a complete listing of quality assurance manuals and documents, request "The Quality Assurance Bibliography," (EPA-600V4-80-Q09) U.S. Environmental Protection Agency Technical Information Operations Staff Environmental Research Center 26 West Saint Clair St. Cincinnati, OH 452-268 For more information on EPA's Quality Assurance Program, write: U.S. Environmental Protection Agency QA and Monitoring Systems Division (RD-680) 401 M St., S.W. Washington, D.C. 20460 FTS: 426-2026 COMMERCIAL: (202) 426-2026 12 ------- If ------- ------- |