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Agency-wide Quality System Documents

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Specifications for EPA Organizations

Quality specifications for EPA organizations are defined EPA Directives. These are internal policy documents and apply only to EPA organizations.

Notice: The Agency is transitioning to a new numbering scheme for the EPA Quality Policy and Quality Manual documents.

EPA Order 5360.1 A2 is now CIO 2105.0 and EPA Manual 5360 A1 is CIO 2105-P-01-0. During the transition you may see one or both of the above numbers referenced. The contents of the policy and procedure have not changed. Only the document numbers have changed.

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Internal EPA Directives

Title Directive and Date Description
Policy and Program Requirements for the Mandatory Agency-wide Quality System, May 2000 CIO 2105.0 (formerly EPA Order 5360.1 A2) This establishes policy and program requirements for the preparation and implementation of quality management systems for EPA organizations that produce or use environmental data. For more information and resources, see Policies and Procedures for EPA Organizations.
EPA Quality Procedure for Environmental Programs, May 2000 CIO 2105-P-01-0 (formerly EPA Manual 5360 A1) This procedure describes the Agency quality system to ensure that environmental programs and decisions are supported by data of the type and quality needed and expected for their intended use. For more information and resources, see Policies and Procedures for EPA Organizations.
EPA QA Field Activities Procedures, September 2014

CIO 2105-P-02.0

This procedure describes how the Agency quality system shall be applied to sampling and non‐sampling field activities.
CIO Notification Procedure for Environmental Data Quality Issues, April 2018

CIO 2105-P-03.0

This procedure describes the comprehensive, coordinated due diligence process for evaluating environmental data quality issues that could adversely impact EPA organizations.
The EPA Quality Program Policy for Agency products and services, October 2008 EPA Quality Program Policy - CIO 2106.0 An internal memorandum issued on December 10, 2010 clarified implementation of this policy for the preparation of management systems.
The EPA Quality Program Procedure for Agency products and services, October 2008 EPA Procedure - CIO 2106-P-01.0 An internal memorandum issued on December 10, 2010 clarifying the implementation of the policy also applies to this procedure for the implementation of management systems according to CIO 2106.0.

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Specifications for non-EPA Organizations

Quality specifications for non-EPA organizations are defined in the Code of Federal Regulations. The Office of Environmental Information's Environmental Quality Management Division (EQMD) issues documents to provide information on satisfying the Federal Regulations for organizations receiving financial assistance from EPA through extramural agreements (e.g.: 

  • contracts,
  • grants,
  • cooperative agreements,
  • and interagency agreements).

These documents may be used by EPA organizations as well.

Specifications for Non-EPA Organizations Invoked Through Individual Agreements or the Code of Federal Regulations

Title Publication
Number and Date
Description
EPA Requirements for Quality Management Plans (QA/R-2)

EPA/240/B-01/002
March 2001

Quality Document Reissue Notice May 2006

Specifications for Quality Management Plans for organizations that receive funding from EPA. These specifications are equivalent to Chapter 3 of EPA Manual CIO 2105-P-01-0. For more information and resources, see Tools - Quality Management Plans.
EPA Requirements for QA Project Plans (QA/R-5)
EPA/240/B-01/003
March 2001

Quality Document Reissue Notice May 2006
Specifications for QA Project Plans prepared for activities conducted by or funded by EPA. These specifications are equivalent to Chapter 5 of EPA Manual CIO 2105-P-01-0. For more information and resources, see Tools - QA Project Plans.

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General Guidance

The EQMD issues documents to assist in the development and implementation of a suitable Quality System for both EPA and non-EPA organizations.

These documents provide guidance to program managers and technical staff. They do not impose legally binding requirements and may not apply to a particular situation based on the circumstances.

EPA retains the discretion to adopt approaches on a case-by-case basis that differ from these guidance where appropriate. EPA may periodically revise these guidance without public notice.

General Guidance

Title Publication
Number and Date
Description
Overview of the EPA Quality System for Environmental Data and Technology EPA/240/R-02/003
November 2002
Information on existing Agency policies, responsibilities, and resources to use in implementing both the EPA Quality System and your organization's Quality System. For more information and resources, see Policies and Procedures for EPA Organizations and Quality Specifications for Non-EPA Organizations.
Guidance for Developing Quality Systems for Environmental Programs (QA/G-1)
EPA/240/R-02/008
November 2002

Quality Document Reissue Notice January 2008
Guidance on developing and documenting the elements of a functional quality system in organizations that carry out environmental data operations within, or on behalf of, EPA.
Guidance on Assessing Quality Systems (QA/G-3)
EPA/240/R-03/002
March 2003
Guidance on assessing the adequacy and effectiveness of an environmental quality system.
Guidance on Systematic Planning using the Data Quality Objectives Process (QA/G-4)
EPA/240/B-06/001
February 2006

This document is an expanded version of the August 2000, Guidance for the Data Quality Objectives Process and includes both decision making and estimation using the Data Quality Objectives (DQO) Process. It provides information on how to apply systematic planning to generate performance and acceptance criteria for collecting environmental data.

The basic structure of the DQO Process is unchanged but there are some minor revisions in the names of the seven steps of the Process. For more information and resources, see EPA's Elements of Systematic Planning.

Systematic Planning: A Case Study for Hazardous Waste Site Investigations
(QA/CS-1)
EPA/240/B-06/004
February 2006
This document shows the use of systematic planning using the Data Quality Objectives (DQO) Process in the form of a case study.
Systematic Planning: A Case Study of Particulate Matter Ambient Air Monitoring (QA/CS-2) EPA/240/B-07/001 March 2007 This document shows the use of the Data Quality Objectives (DQO) Process in the form of a case study involving particulate matter ambient air monitoring.
Guidance for Quality Assurance Project Plans (QA/G-5)
EPA/240/R-02/009
December 2002
Guidance on developing Quality Assurance Project Plans that meet EPA specifications. Note: This version replaces the original document issued in February 1998 (EPA/600/R-98/018).
Guidance for Geospatial Data Quality Assurance Project Plans (QA/G-5G) EPA/240/R-03/003
March 2003
Guidance on developing Quality Assurance Project Plans for geospatial data projects.
Guidance on Choosing a Sampling Design for Environmental Data Collection (QA/G-5S) EPA/240/R-02/005
December 2002
Guidance on applying standard statistical sampling designs (such as simple random sampling) and more advanced sampling designs (such as ranked set sampling, adaptive cluster sampling) to environmental applications.
Guidance for Quality Assurance Project Plans for Modeling (QA/G-5M) EPA/240/R-02/007
December 2002
Guidance on developing Quality Assurance Project Plans for modeling projects.
Guidance for Preparing Standard Operating Procedures (QA/G-6)
EPA/600/B-07/001
April 2007
Guidance on the development and documentation of Standard Operating Procedures. Note: This version replaces the previous document issued in March 2001 (EPA/240/B-01/004).
Guidance on Technical Audits and Related Assessments for Environmental Data Operations (QA/G-7)
EPA/600/R-99/080
January 2000

Quality Document Reissue Notice May 2006
Guidance to help organizations plan, conduct, evaluate, and document technical assessments.
Guidance on Environmental Data Verification and Data Validation (QA/G-8)

EPA/240/R-02/004
November 2002

Quality Document Reissue Notice January 2008

Guidance to help organizations conduct data verification and data validation activities.
Data Quality Assessment: A Reviewer’s Guide (QA/G-9R)
EPA/240/B-06/002
February 2006

General guidance to organizations on assessing data quality criteria and performance specifications for decision making. G-9R is non-technical document and shows a reviewer what constitutes an appropriate Data Quality Assessment (DQA), and how to recognize situations or reports where a DQA has been conducted.

Data Quality Assessment: Statistical Tools for Practitioners (QA/G-9S)
EPA/240/B-06/003
February 2006

This document can be considered the technical aspect of G-9R. The document is designed as a "tool-box" of useful techniques in assessing the quality of data. The overall structure of the document will enable the analyst to investigate many

Guidance for Data Quality Assessment: Practical Methods for Data Analysis (QA/G-9)
No Longer Available. Removed March 2006

This document is replaced by Data Quality Assessment: A Reviewer’s Guide (QA/G-9R), and the companion document Data Quality Assessment: Statistical Tools for Practitioners (QA/G-9S).

Guidance for Developing a Training Program for Quality Systems (QA/G-10)
EPA/240/B-00/004
December 2000

Quality Document Reissue Notice May 2006
Guidance on developing a program-specific quality systems training program for all levels of management and staff.
Guidance on Quality Assurance for Environmental Technology Design, Construction and Operation (QA/G-11)
EPA/240/B-05/001
January 2005
Guidance on basic quality assurance and quality control procedures, and good engineering principles/practices, that may be used in the design, construction or operation of environmental technologies.

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Quality System Documents Undergoing Peer Review

There are no Quality System documents currently undergoing peer review.

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