Implementation of Quality Assurance Requirements for Organizations Receiving EPA Financial Assistance | US EPA

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Requirement

For projects involving environmental programs and environmental information operations, EPA assistance agreement recipients must implement or have implemented a quality system conforming to the American National Standard ASQ/ANSI E4:2014 Quality management systems for environmental information and technology programs—Requirements with guidance for use. This is referred to as a by EPA. The quality program shall be applied to all environmental programs within the scope of the assistance agreement. Environmental information operations is a collective term that encompasses the collection, production, evaluation, or use of environmental information and the design, construction, and operation of environmental technology. Environmental Information can include data and information that describe environmental processes or conditions direct measurements of environmental parameters or processes; analytical laboratory testing results of environmental conditions (e.g., geophysical or hydrological conditions); information on physical parameters or processes collected using environmental technologies; calculations or analyses of environmental information; information provided by models; and information data compiled or obtained from databases, software applications, decision support tools, websites, existing literature.

Documentation Needed From Applicant

Quality assurance documentation is required for awards that involve environmental information operations. EPA Project Officers will work with recipients on quality assurance (QA) requirements.

Once the award is made, if a Quality Management Plan (QMP) and/or Quality Assurance Project Plan (QAPP(s)) is required as specified in the term and condition for the agreement, the recipient shall develop the document(s) and submit to the project officer for EPA’s approval, usually within 60 days of award. The EPA Quality Assurance Manager (or designee) shall approve the documents. Recipients cannot begin environmental information operations until EPA approves the QMP and/or QAPP.

• Quality Management Plan (QMP): If conducting environmental information operations, the recipient may be required to develop a QMP. The QMP describes an organization’s Quality Program. Requirements for QMPs are found in the most recent version of EPA’s Quality Management Plan (QMP) Standard (pdf) .  A QMP documents the technical activities to be performed and how the program will integrate QA, quality control, QAPPs, training, etc., into all its environmental information operations. The QMP Standard requirements applies to all new and supplemental grant awards issued on or after February 17, 2023.  All new and supplemental assistance agreements requiring QMPs awarded as of that date must be in compliance with the new Standard and must include an updated term and condition that links to the Standard. Previously awarded grants will continue to use QA/R-2, unless they are amended to add new activities requiring a QMP, in which case the requirements of the new Standard must be followed.
• Quality Assurance Project Plan (QAPP): If conducting environmental information operations, the recipient is required to develop a QAPP(s). A QAPP describes how environmental information operations are planned, implemented, documented, and assessed during the life cycle of a project. Requirements for QAPPs are found in the most recent version of EPA’s Quality Assurance Project Plan Requirements/Standard. 

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 ASQ/ANSI E4. 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

ASQ/ANSI E4 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 extramural 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:

These documents may be obtained from the Office of Mission Support’s Enterprise Quality Management Division at:

Enterprise Quality Management Division (2821T)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave N.W.
Washington, DC 20460
Phone: (202) 564-6830
e-mail: [email protected]

The documents may also be downloaded from Managing the Quality of Environmental Data.

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.

ASQ/ANSI E4 is an American National Standard and is protected by copyright. Copies may be obtained from the American Society for Quality (ASQ), Quality Press, at 600 North Plankinton Ave, Milwaukee, Wisconsin 53202, or by calling Quality Press at (800) 248-1946.