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Implementation of Quality Assurance Requirements for Organizations Receiving EPA Financial Assistance

REQUIREMENT:

For projects involving environmental programs, EPA assistance agreement recipients must implement or have implemented a quality system conforming to the American National Standard ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. This quality system shall be applied to all environmental programs within the scope of the assistance agreement. Environmental programs include direct measurements or data generation, environmental modeling, compilation of data from literature or electronic media, and data supporting the design, construction, and operation of environmental technology. This requirement is consistent with and for all environmental programs operating under the EPA Quality System.

DOCUMENTATION NEEDED FROM APPLICANT:

1. All applicants for EPA assistance shall submit a Quality Management Plan (QMP) prepared in accordance with the specifications provided in EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001), or documentation determined by EPA to be equivalent to R-2, which describes the quality system implemented by the applicant.

2. The QMP shall be reviewed and approved by the EPA Project Officer and the EPA Quality Assurance Manager (or designee), as a condition for award of any assistance agreement. The QMP must be submitted as part of the application. If the QMP is not submitted as part of the application and EPA decides to fund the project, EPA will include a term and condition in the assistance agreement. This term and condition requires the recipient to submit the QMP within a specified time after award of the agreement and notifies the recipient that they may not begin work involving environmental programs until the EPA Project Officer informs them that the QMP has been approved.

3. The Assistance Agreement requires the recipient to submit Quality Assurance Project Plans (QAPPs) to EPA for review and approval by the EPA Project Officer and EPA Quality Assurance Manager before undertaking any work involving environmental measurements or data generation. QAPPs shall be prepared using EPA Requirements for Quality Assurance Project Plans (QA/R-5) (EPA 2001).

4. Approval of the recipient's QMP by the EPA Project Officer and the EPA Quality Assurance Manager, may allow delegation of the authority to review and approve Quality Assurance Project Plans (QAPPs) to the recipient based on procedures documented in the QMP.

AGENCY DOCUMENTATION:

The Quality Management Plan (QMP) for the EPA organization providing the financial assistance must define the process to be used to ensure that the Assistance Agreement adequately addresses Quality Systems issues and complies with ANSI/ASQC E-4. In addition, the QMP must describe how the EPA organization will conduct oversight of the assistance agreement to assure its implementation as documented.

The same QMP must also define the respective responsibilities of the EPA Project Officer and the EPA Quality Assurance Manager in reviewing and approving QMPs and QAPPs submitted to the EPA Project Officer for review and approval.

RATIONALE:

ANSI/ASQC E4-1994 is a national consensus standard designed specifically for quality systems applied to environmental data collection and environmental technology programs.

The requirements are consistent across all EPA extra mural agreements (e.g., contracts, assistance to State, local and Indian tribal governments, universities and nonprofit organizations).

REFERENCES:

EPA has the following requirements and guidance documents available to assist applicants and recipients in complying with these requirements:

- EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001)

- EPA Requirements for Quality Assurance Project Plans (QA/R-5) (EPA 2001)

- EPA Guidance on Quality Assurance Project Plans (QA/G-5) (EPA/600/R-98/018, 2002)

These documents may be obtained from the Office of Environmental Information's Quality Staff at:

Quality Staff (2811R)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave N.W.
Washington, DC 20460
Phone: (202) 564-6830
e-mail: quality@epa.gov

The documents may also be downloaded from the Quality Staff Home Page under the heading, "Guidance", at URL:

http://www.epa.gov/quality

The Home Page documents are available in the ADOBE Acrobat PDF format and may be printed using the free Adobe Acrobat Reader, which is available on the Internet.

ANSI/ASQC E4-1994 is an American National Standard and is protected by copyright. Copies may be obtained from the American Society for Quality (ASQ), Exit EPA DisclaimerQuality Press, at 600 North Plankinton Ave, Milwaukee, Wisconsin 53202, or by calling Quality Press at (800) 248-1946. The cost of the document is $25.00, with a 10% discount for ASQ members.

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