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Frequent Questions - EPA's Quality System

  1. What are the goals of EPA's Quality System?
  2. What are the benefits of EPA's Quality System?
  3. What is the relationship between the EPA Quality System and EPA's Information Quality Guidelines?
  4. What activities does the EPA Quality System cover?
  5. Who is responsible for the EPA Quality System?
  6. What are the roles and responsibilities of the Quality Staff?
  7. What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel?
  8. What are the main components of the EPA Quality System?
  9. How is a 'graded approach' applied to EPA's Quality System?
  10. Is there a document that contains the above information?

What are the goals of EPA's Quality System? The goals of the Agency-wide Quality System are to ensure that environmental programs and decisions are supported by data of the type and quality needed and expected for their intended use, and that decisions involving environmental technology are supported by appropriate quality-assured engineering standards and practices.

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What are the benefits of EPA's Quality System? Successful implementation of the EPA Quality System leads to:

Overall, implementation of the EPA Quality System will reduce the Agency's vulnerabilities and increase EPA ability to make reliable, cost-effective, and defensible decisions.

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What activities does the EPA Quality System cover? The EPA Quality System covers the collection, evaluation, and use of environmental data by and for the Agency, and the design, construction, and operation of environmental technology by the Agency. This includes environmental programs such as the demonstration of environmental technology; investigation of chemical, biological, physical, or radioactive constituents; development, evaluation, and use of computer or mathematical models; use of data collected for other purposes or from other sources (also termed "secondary data"); and the collection and use of data pertaining to the occupational health and safety of personnel in EPA facilities. A list of some example activities are contained in Example Activities.

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What is the relationship between the EPA Quality System and EPA's Information Quality Guidelines? EPA's quality system policy includes procedures for developing and implementing program-specific quality-related activities. These activities then serve as a framework for information product developers to ensure that information products meet the specifications of the Information Quality Guidelines (IQG). For more information, see EPA's Information Quality Guidelines.

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Who is responsible for the EPA Quality System? The EPA Quality System is decentralized so each EPA organization designs, implements, and manages its own quality system. The Assistant Administrator for Environmental Information is the Senior Quality Management Official for the Agency as stated in EPA Order CIO 2105.0 (formerly 5360.1) and is responsible for the assessment and approval of each EPA organization's quality system. The Quality Staff, Office of Environmental Information, supports the Assistant Administrator and is responsible for the development of Agency-wide policy and procedures and for the oversight of implementation of the EPA Quality System. The EPA Assistant Administrators, Associate Administrators, and Regional Administrators have official quality responsibilities and are responsible for the success of their quality system. Line managers within each organization are responsible for the quality of data collected or used by their programs.

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What are the roles and responsibilities of the Quality Staff? The Quality Staff is responsible for coordinating the implementation of the Agency Quality System, developing Agency policies and procedures on quality, and providing training on quality issues. The Quality Staff accomplishes these activities by:

For more information on the policies and procedures for the Quality Staff, see Policies and Procedures for EPA Organizations: Agency-wide Oversight.

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What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel? EPA Quality Assurance Managers are tasked with reporting on quality issues to their senior management, providing independent oversight, and assuring the implementation of the organization's quality system. This individual must function independently of direct environmental data generation, model development, or technology development responsibility. The Order also defines the responsibilities of the Quality Assurance Manager and other quality management personnel to include: facilitating the development and maintain the organization's Quality Management Plan; representing the organization on matters pertaining to quality management; providing expert assistance to project personnel on quality assurance and quality control issues; developing and implementing a Quality Assurance Training Program; reviewing and/or approving quality management documentation; providing quality management support to project personnel; overseeing and assessing the organization's quality system. In addition to these general responsibilities, each EPA organization's Quality Management Plan defines specific responsibilities for its Quality Assurance Manager and other quality management personnel.

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What are the main components of the EPA Quality System? The main components of the EPA Quality System are described below. Each EPA organizations consider these components when developing their individual Quality System.

Quality System Policies - Policies for EPA organizations are contained in internal policy documents. See Policies and Procedures for EPA Organizations for more information about these policy documents. Policies for non-EPA organizations are contained in the Federal Acquisition Regulations. See Quality Specifications for non-EPA Organizations for more information on these Federal Regulations.

Quality System Documentation - Documentation that describes the authorities, policies, and procedures specific to an organization's quality. EPA organizations are required to develop a Quality Management Plan as documentation.

Annual Reviews and Planning - A yearly review of the activities within, and changes to, an organization's quality system; work accomplished; and future projects requiring quality management attention. EPA organizations are required to submit a Quality Assurance Annual Report and Work Plan to document this review.

Management Assessments - Assessments of a program and/or organization to determine the conformance of the quality system to policies, compliance with regulations, and conformance to the organization's quality system documentation. EPA uses Quality Systems Assessments and Audits and other management assessments to assess EPA organizations and some supporting organizations.

Training - Methods and techniques to ensure that all personnel having responsibility within the quality system for management and data collection activities have the skills and knowledge to complete their tasks in accordance with their quality system's policies and procedures. EPA organizations are required to document their Training Program in their Quality Management Plan.

Project Planning - Systematic planning (for example, the Data Quality Objective Process) is used to develop performance criteria for the data (i.e., the type, quantity, and quality of data needed to serve their needs) or technology design, to develop a plan to satisfy these criteria, and to determine the level of oversight and quality control activities needed to ensure the criteria are satisfied. The results from the systematic planning are documented in a Quality Assurance Project Plan.

Project Implementation - Data are collected and environmental technology is implemented according to the methods and procedures documented in the approved Quality Assurance Project Plan, Standard Operating Procedures, and design documentation. During data collection, oversight may be performed using technical audits that are conducted to assess whether or not data are being collected as stated in the Quality Assurance Project Plan.

Project Assessment - Analysts use technical knowledge and statistical methods to determine whether or not the collected data meet the user's needs. The data are formally verified and validated to ensure that the measured values are free of gross errors due to procedural or technical problems and then are analyzed to determine if they meet the performance criteria documented in the Quality Assurance Project Plan (data quality assessment) or other design documentation.

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How is a 'graded approach' applied to EPA's Quality System? Because of the diversity of work conducted by the Agency, EPA recognizes that a "one size fits all" approach to quality specifications will not work. Therefore, the implementation of the EPA Quality System is based on a graded approach. Applying a graded approach means that quality systems for different organizations and programs will vary according to the specific objectives and needs of the organization. For example, the quality controls of a fundamental research program are different from that of a regulatory compliance program because the purpose or intended use of the data is different. Once a graded approach has been applied to the components of a quality system, a graded approach is then applied to the documentation required by that system.

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Is there a document that contains the above information? The above information is documented in the the Overview of the EPA Quality System for Environmental Data and Technology (PDF 35pp, 160K About PDF).

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