IDQTF Uniform Federal Policy for Implementing Environmental Quality Systems

Introduction

Purpose

The Uniform Federal Policy for Implementing Environmental Quality Systems (UFP) outlines essential elements of a Quality System for management of environmental data collection and use and environmental technology programs. The UFP will serve as a high-level policy for documenting and implementing acceptable Quality Systems for Federal agencies. The UFP provides a framework to ensure that essential elements are addressed. The UFP must be used to develop a new Quality System or to evaluate the adequacy of an existing Quality System. The results of that evaluation must then be used to develop plans for correcting identified deficiencies.

The policy was developed as a joint initiative between the U.S. Environmental Protection Agency (EPA), the Department of Defense (DoD), and the Department of Energy (DOE) to resolve data quality inconsistencies and/or deficiencies to ensure that:

• Environmental data are of known and documented quality and suitable for their intended uses, and
• Environmental data collection and technology programs meet stated requirements.

Ultimately, the benefits of a consistent policy for Quality Systems across Federal agencies include:

• Improved effectiveness of Federal environmental programs by focusing on results, quality of data and services, and customer satisfaction;
• Clarification of roles and responsibilities in managing and overseeing environmental data and environmental technology programs;
• Sufficient confidence in the systems such that duplication of oversight efforts are minimized; and
• Enhanced accountability and public confidence in environmental decisions.

Scope

This document provides requirements and guidelines to Federal agencies for documenting and implementing Quality Systems for management of environmental data collection and use and environmental technology programs. It becomes the policy for an agency when formally adopted by that agency; each agency will determine how best to implement the policy.

This document represents a voluntary consensus policy. Implementation is, therefore, not subject to oversight by another Federal agency or to a Notice of Violation if one agency fails to implement all or part of the policy.

Background

In 1997, an audit report from the EPA Inspector General (Audit Report No. E1 SKB6-09-004107100132) examined laboratory data quality at Federal facility National Priorities List Superfund sites. An audit report from the DoD Office of the Inspector General (OIG Report 97-098, Laboratory Support Service for Environmental Testing, February 21, 1997) addressed similar issues. These reports found that real or perceived inconsistencies and deficiencies in data quality within and across governmental organizations had resulted in greater costs, time delays, and the potential for increased risk.

In response to these and other audit reports, as well as to environmental data quality issues related to Federal facilities in general, EPA established the Intergovernmental Data Quality Task Force (IDQTF), chaired by the Director of the Federal Facilities Restoration and Reuse Office (FFRRO). The IDQTF operates as a partnership, reaching decisions through consensus. In addition to the chair, other consensus members of the task force include:

• The Department of Defense, represented by the DoD Environmental Data Quality Workgroup (EDQW) chairperson;
• The Department of Energy, represented by the Office of Safety, Health and Security (EM-5);
• The EPA Quality Staff, Office of Environmental Information;
• The EPA Offices of Emergency and Remedial Response and Solid Waste in the Office of Solid Waste and Emergency Response; and
• EPA Regional Offices, represented by quality assurance staff from EPA Regions 1, 2, and 8 and Federal Facility Program staff in Region 5.

DoD and DOE entered into separate MOUs with EPA. These MOUs have the following goals:

• The development of a written consensus agreement on what constitutes an adequate Quality System for environmental data collection, and
• The development of a consensus agreement that outlines the roles and responsibilities of EPA and Federal agencies with regard to data management.

The parties agreed to meet these goals first by developing them in the context of hazardous waste program management with the understanding that this will establish a framework for further work under other environmental media programs.

Basis for the Intergovernmental Quality System

ANSI/ASQC E4 was selected as the basis for the intergovernmental Quality System because it is a national standard that specifically addresses environmental data collection and use and environmental technology programs. The E4 standard is written in three parts:

• Part A addresses the management elements of a Quality System,
• Part B addresses project-specific requirements related to the collection and evaluation of environmental data, and
• Part C addresses the Quality System issues related to “design, construction and operation of environmental technology.”

The UFP is designed to clarify and provide additional direction for the implementation requirements of ANSI/ASQC E4 Part A. Other documents under development by the IDQTF will address ANSI/ASQC E4 Part B requirements. These include:

• Draft Federal Consensus Guidance for the Preparation of Quality Assurance Project Plans
• Presumptive Quality Assurance/Quality Control Measures for Superfund

The IDQTF is not developing a project-specific work product to address ANSI/ASQC E4 Part C: Design, Construction, and Operation of Environmental Technology.

To satisfy the second goal of the MOU, the IDQTF is developing an additional document, Roles and Responsibilities Framework for Federal Facility Oversight.

Documentation of Intergovernmental Quality Systems

A Quality System is documented at an organizational level in a Quality Management Plan (QMP) and at a program or project level in a Quality Assurance Project Plan (QAPP), or their functional equivalents. The organizational QMP will detail how the Quality System is to be implemented throughout the organization for which it is written. It will include information by which the organization will manage, plan, implement, assess, conduct corrective action upon, and continually improve the products, services, and activities involved in environmental data collection or use or environmental technology management.

Organization

This document is organized according to the 10 elements that must be addressed in an organization’s QMP in order to conform with ANSI/ASQC E4 and this document:

1. Management and Organization
2. Quality System and Description
3. Personnel Qualification and Training
4. Procurement of Products, Services, and Activities
5. Documents and Records
6. Computer Hardware and Software
7. Planning
8. Management of Work Process Implementation
9. Assessment and Response
10. Quality Improvement

Each of these elements is covered in a separate section of the remainder of this document.

Requirements and Guidance

The requirements described in this policy are intended to facilitate implementation of ANSI/ASQC E4 with regard to environmental data collection and use and environmental technology development and implementation. ANSI/ASQC E4 covers both mandatory specifications and nonmandatory guidelines for Quality Systems. In accordance with E4, this document addresses both requirements and guidance. Requirements are presented in the text that makes up the bulk of this document, while guidance is presented in text boxes. The text boxes attempt to illuminate the requirements of this policy and enhance the reader’s understanding. The text boxes are not part of the formal policy. The requirements of this document also incorporate by reference the definitions contained in the E4 standard.

Relationship to Other Standards and Policies

Questions have been raised by reviewers of this document as to the relationship between this document, international standards, and EPA policy documents. The text below is provided to describe those relationships.

Relationship to International Standards

The relationship of this policy to international standards is as follows:

• ANSI/ASQC E4 conforms with the ISO 9000 series of standards, “International Standards for Quality Management,” addressing Quality Systems. E4 and this policy document, however, are specifically written for environmental data collection and environmental technology programs.
• The ISO 14000 series, Environmental Management addresses what an organization does to minimize harmful effects on the environment caused by its products, services, and activities. ISO 14000 does not address the issues covered by E4 or by the ISO 9000 series.
• ISO/IEC Guide 25 (superceded in 1999 by ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories) establishes specifications and requirements for calibration and testing of laboratory systems. ISO 25 is the basis for standards set by the National Environmental Laboratory Accreditation Conference, Chapter 5. While E4 does not explicitly address quality systems for environmental laboratories, it references ISO/IEC Guide 25, and other national standards as the framework for other Quality Systems.

Relationship to EPA Policy

ANSI/ASQC E4 sets forth the general standards for a Quality System for environmental data collection and technology. EPA recently published a number of documents designed to implement E4 throughout EPA and for EPA funded activities. These documents include:

1. Policy and Program Requirements for the Mandatory Agencywide Quality System (EPA Order 5360.1 A2),
2. EPA Quality Manual for Environmental Programs (EPA Manual 5360 A1), and
3. EPA Requirements for Quality Management Plans (EPA QA/R2), which establishes Quality System requirements for external organizations that implement programs for EPA through funding mechanisms (e.g., contracts, grants, and other financial agreements), or through other agreements (e.g., interagency agreements).

The EPA Order and the EPA Manual apply solely to EPA. This document differs from E4 and from QA/R2 in four important ways:

• It provides implementation policies for Federal agencies; therefore, it is more detailed than either E4 or QA/R2.
• It is intended to apply to Federal agencies, whereas QA/R2 applies only to organizations that implement programs for EPA.
• It represents a consensus policy reflecting the views of the IDQTF,
• It benefits from the experience and lessons learned from a broader set of stakeholders involved in managing quality across several Federal agencies.

This document is consistent with the EPA Order and EPA Manual. It is anticipated that Quality Management Plans (QMPs) that meet the requirements of the EPA Order will require little adjustment to conform to this policy.

• The term “Quality System,” as used in this document, is adopted from ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. ANSI/ASQC E4 states that a Quality System is “A structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The Quality System provides the framework for planning, implementing, and assessing the work performed by an organization and for carrying out required quality assurance (QA) and quality control (QC) activities.”

• Whenever the term “Federal agencies” is used in this document, it refers to agencies, departments, and instrumentalities of the United States.

• Other EPA offices and DoD components participated in various IDQTF subgroups and meetings to provide technical expertise. In addition to the above consensus members, participation of various other Federal agencies and EPA offices was actively sought throughout the development of initial IDQTF products. These included the Departments of Agriculture, Commerce (National Oceanographic and Atmospheric Administration), and Interior (U.S. Geological Survey), who were invited to become consensus members.

• A full list of consensus members, alternates, and other regular participants in the IDQTF is found in appendix E of this document.

Articles written by non-EPA authors do not necessarily reflect the views, positions, or policies of the Agency.

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