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Agency-wide Quality System Documents

Directions for accessing available documents and software are contained in Information About Downloadable Files.

You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you have difficulty accessing these PDF documents, please contact the Quality Staff at 202-564-6830 or quality@epa.gov for assistance.

 


Specifications for EPA Organizations

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

 
Internal EPA Directives
Title
Directive and Date
Description
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 (PDF 12pp, 94K About PDF) and EPA Manual 5360 A1 is CIO 2105-P-01-0 (PDF 62pp, 169K About PDF) . During the transition you may see one or both of the above numbers referenced. The contents of the policy and manual have not changed. Only the document numbers have changed.

 
Policy and Program Requirements for the Mandatory Agency-wide Quality System, May 2000 Quality specifications for EPA organizations that produce or use environmental data. For more information and resources, see Policies and Procedures for EPA Organizations.
EPA Quality Manual for Environmental Programs, May 2000 Specifications for satisfying the mandatory Quality System defined in CIO 2105.0. For more information and resources, see Policies and Procedures for EPA Organizations.

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Specifications for non-EPA Organizations

Quality specifications for non-EPA organizations are defined in the Code of Federal Regulations. The Quality Staff 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) 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) 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 Quality Staff 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

(PDF 35pp, 160K About PDF)
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) 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. For more information and resources, see Tools - Quality Management Plans.
Guidance on Assessing Quality Systems (QA/G-3) Guidance on assessing the adequacy and effectiveness of an environmental quality system. For more information and resources, see Tools - Quality Systems Assessments.
Guidance on Systematic Planning using the Data Quality Objectives Process (QA/G-4) 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 Tools - Systematic Planning.
Systematic Planning: A Case Study for Hazardous Waste Site Investigations
(QA/CS-1)
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)
This document shows the use of systematic planning using the Data Quality Objectives (DQO) Process. This case study shows how the DQO Process was applied to a particulate matter ambient air monitoring problem.
Decision Error Feasibility Trials (DEFT) Software (QA/G-4D)
EPA/240/B-01/007
September 2001
User's Guide (PDF 59pp, 275K About PDF) and Software (EXE 436K About EXE files)
PC-based software for determining the feasibility of data quality objectives defined using the Data Quality Objectives Process.  Note: This version replaces the original software issued September 1994 (EPA/600/R-96/056). For more information and resources, see Tools - Systematic Planning.
Data Quality Objectives Process for Hazardous Waste Site Investigations (QA/G-4HW)
No longer available. Removed March 2006
For an example on applying the DQO process to hazardous waste site investigations, see Systematic Planning: A Case Study for Hazardous Waste Site Investigations. For more information and resources on the DQO Process and systematic planning, see Tools - Systematic Planning.
Guidance for Quality Assurance Project Plans (QA/G-5) 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). For more information and resources, see Tools - QA Project Plans.
Guidance for Geospatial Data Quality Assurance Project Plans (QA/G-5G) EPA/240/R-03/003
March 2003

(PDF 106pp, 1.5MB About PDF)
Guidance on developing Quality Assurance Project Plans for geospatial data projects. For more information and resources, see Tools - QA Project Plans.
Guidance on Choosing a Sampling Design for Environmental Data Collection (QA/G-5S) EPA/240/R-02/005
December 2002

(PDF 178pp, 1.0MB About PDF)
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

(PDF 121pp, 616K About PDF)
Guidance on developing Quality Assurance Project Plans for modeling projects. For more information and resources, see Tools - QA Project Plans.
Guidance for Preparing Standard Operating Procedures (QA/G-6) 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). For more information and resources, see Tools - Standard Operating Procedures.
Guidance on Technical Audits and Related Assessments for Environmental Data Operations (QA/G-7) Guidance to help organizations plan, conduct, evaluate, and document technical assessments. For more information and resources, see Tools - Technical Audits.
Guidance on Environmental Data Verification and Data Validation (QA/G-8) EPA/240/R-02/004
November 2002

(PDF 96pp, 387K About PDF)

Reissue Notice January 2008 (PDF 2pp, 91K About PDF)
Guidance to help organizations conduct data verification and data validation activities. For more information and resources, see Tools - Data Verification and Data Validation.
Data Quality Assessment: A Reviewer’s Guide (QA/G-9R) 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. For more information and resources, see Tools - Data Quality Assessment.
Data Quality Assessment: Statistical Tools for Practitioners (QA/G-9S) 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 different problems using a systematic methodology. For more information and resources, see Tools - Data Quality Assessment.
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).

A Cross-Walk (PDF 6pp, 46K About PDF) between QA/G-9 and QA/G-9S is available.

DataQUEST (QA/G-9D)
No Longer Available.
The DataQUEST software is no longer available. For links to other free software for performing data quality assessment, see Quality-Related Resources - Software. EPA has a site license for SAS for EPA employees - for information, email: quality@epa.gov.
Guidance for Developing a Training Program for Quality Systems (QA/G-10) Guidance on developing a program-specific quality systems training program for all levels of management and staff. For more information and resources, see Tools - Training Programs.
Guidance on Quality Assurance for Environmental Technology Design, Construction and Operation (QA/G-11) 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. For more information and resources, see Tools - Environmental Technology

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Quality System Documents Undergoing Peer Review

There are no Quality System documents currently undergoing peer review.

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