Jump to main content.


Quality Management Plan: Full View

Quality Management Plan Quick Finder

QMP HomeConcurrences & Approval Index of ViewsForms & Checklists AppendicesAcronyms

This page displays the Region 3 QMP with all sections expanded. The QMP can also be displayed from your point of view, whether you are a manager, a project officer, or a modeler, for example. You will be able to see which modules pertain to you, and what your roles and responsibilities might be.

Click here to read more about the show/hide features, search functionality and easy navigation included in the Region 3 eQMP



Table of Contents



Section A. Quality System Foundation

A.1. Introduction

A.1.a. Mission, Policy, and Scope

Environmental information or data is defined as any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology. For EPA Region 3, environmental information also includes data produced from models, and compiled from other sources such as data bases or literature.

EPA's overarching mission is to protect human health and the environment. To accomplish this mission, EPA utilizes environmental information from a variety of sources. The Region 3 Quality Management Plan (QMP) describes the policies, procedures and management systems within the organization that govern quality control activities of environmental information collection and/or use. Activities involving environmental information and/or data that are covered by the Region 3 Quality System include, but are not limited to:

  • Characterize and/or evaluate the states and/or conditions of environmental or ecological systems and the health of human populations;

  • Characterize and/or evaluate chemical, biological, physical, or radioactive constituents in environmental and ecological systems, and their behavior and associated interfaces in those systems, including exposure assessment, transport, and fate;

  • Establish the ambient conditions in air, water, sediments, soil, etc. in terms of physical, chemical, radiological, or biological characteristics;

  • Determine and/or categorize radioactive, hazardous, toxic, and mixed wastes in the environment and to establish their relationships with and/or impact on human health and ecological systems;

  • Quantify and/or monitor the waste and effluent discharges to the environment from processes and operations (e.g., energy generation, metallurgical processes, chemicals production), during either normal or upset conditions (i.e., operating conditions that cause pollutant or contaminant discharges);

  • Develop and/or evaluate environmental technology for waste treatment, storage, remediation, and disposal; pollution prevention; and pollution control and the use of the technology to generate and/or collect data (e.g., treatability and pilot studies);

  • Map environmental processes and conditions, and/or human health risk data, etc. (e.g., geographic information system);

  • Support enforcement and/or compliance monitoring efforts;

  • Develop or evaluate methods for use in the collection, analysis, and use of environmental data;

  • Develop, evaluate and/or use models to characterize environmental processes or conditions; and

  • Develop, revise, compare, or otherwise use information technology and management systems that impact the environmental data quality (e.g., electronic databases with environmental information including data entry, handling, transmission and analysis and laboratory information management systems).

The primary goal of the Region's quality system is to ensure that all environmentally-related data activities performed by or for the Region will result in the production of data that is of adequate quality to support specific decisions or actions. In order for this data to be used with a high degree of certainty by the intended user, its quality must be known and documented. This goal will be achieved by ensuring that appropriate resources are made available and proper procedures followed throughout each environmental project's planning, implementation and evaluation phase.

Region 3 Quality Policy

It is Region 3 policy that all environmental data and information collected and/or used in the process of decision-making are of known and documented quality, suitable for its intended use, with all aspects of collection and analysis thoroughly documented; such documentation being verifiable and defensible. This policy applies to all data collected under environmental operations and environmental technology activities performed directly by or for the Region. This includes all Federal, State, Tribal and local partners under interagency and financial assistance agreements; contractors funded by EPA; regulated entities and potentially responsible parties.

The Regional Administrator, Senior Leadership and managers ensure that adequate resources (intramural and extramural money, travel and training funds, and personnel) are allocated to achieve the Region's quality policy.

This QMP establishes the foundation for implementing an effective quality system within EPA Region 3. The QMP applies to all Region 3 programs, activities, grants, contracts and interagency agreements that collect and/or evaluate environmental data which is used to make decisions or support actions related to our defined mission and responsibilities. Listed below are specific examples of environmental programs, grants and activities within each Division or Program Office which are covered by the Region 3 Quality System.

Top of page


A.1.b. Programs Covered by the Region 3 Quality System

A.1.b.1. Air Protection Division - Quality Management Plan (PDF) (22 pp, 3.2MB, About PDF)

Clean Air Act
Ambient air quality data (monitoring by states via 105 grants)
Ambient air monitoring - per 40 CFR Part 58
Emissions inventory data (by states as per 40 CFR Part 51
Stack testing (by company, state or EPA)
I/M program statistics (reports by states under 105 grants)
CAA compliance inspections

A.1.b.2. Chesapeake Bay Program Office - Quality Management Plan (PDF) (50 pp, 441K, About PDF)

Mainstream and Tidal Tributary Monitoring Programs
Baywide SAV Aerial Survey Program
Non-tidal Monitoring Program

A.1.b.3. Environmental Assessment and Innovation Division - Quality Management Plan (PDF) (31 pp, 594K, About PDF)

Laboratory analyses - performed at Ft Meade and Wheeling labs
Ocean Dumping Program
Fish tissue surveys
Dredging
Coastal Aerial Survey Program
Coastal waters sampling
Wetland grants
NEPA
Environmental planning/environmental indicator development
Geospatial analysis
Laboratory assessments (CLP, Regional contract laboratories,
    NPDES laboratory assessments of State and regulated laboratories,
    Superfund PRP laboratories, State drinking water laboratories)

A.1.b.4. Hazardous Site Cleanup Division - Quality Management Plan (PDF) (24 pp, 4.5MB, About PDF)

CERCLA and the Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA Title III Chemical Emergency Preparedness and Prevention (CEPP) program
Regional Oil Program pursuant to the Oil Pollution Act (OPA) of 1990

A.1.b.5. Land and Chemicals Division - Quality Management Plan (PDF) (44 pp, 4.6MB, About PDF)

Asbestos
    CAA - NESHAPS
    Asbestos enforcement
    Asbestos hazard in schools (AHERA)
    Asbestos Hazard Abatement Act (ASHAA)
    Asbestos enforcement grants

FIFRA
    Pesticide cooperative agreement grants
    Pesticide environmental stewardship grants

RCRA
    Corrective action
    RCRA compliance and enforcement
    RCRA Subtitle C grants
    RCRA Subtitle I grants
    Delisting

TSCA
    TSCA 404(g) lead grants
    PCB enforcement
    Other TSCA lead grants

A.1.b.6. Office of Enforcement, Compliance and Environmental Justice

Compliance inspections (media specific and multi-media)
Sample collection
Facility inspections that support RCRA (Subtitle C and I, NPDES, pretreatment, TSCA/PCB, EPCRA/TRI reporting and asbestos)

A.1.b.7. Water Protection Division - Quality Management Plan (PDF) (22 pp, 1.1MB, About PDF)

Safe Drinking Water Act
  Public Water System Supervision Program
  Sole Source Aquifer Program
  Comprehensive State Ground Water Protection Program
  Underground Injection Control Program
  Wellhead Protection Program
  Source Water Protection Program

Clean Water Act
  National Pollutant Discharge Elimination System (NPDES) Program
  Water Quality Management Planning (Section 604(b)) Grants Program
  Water Pollution Control (Surface/Groundwater Programs) (Section 106) Grants Program
  Targeted Watershed Initiative
  Non-point Source (Section 319) Grants Program
  Clean Lakes Program
  State Revolving Fund Program
  Water Quality Standards Program
  Nutrient Criteria Program
  Total Maximum Daily Load (TMDL) Program
  Great Lakes Program
  Ambient water monitoring (routing monitoring performed mostly through the states)
  National Estuary Program
  Beaches
  Watershed Protection Program
  Water Quality Management (106) Grants Program

A.1.b.8. Office of Policy and Management

Regional Geographic Initiative Grant Program

A.1.b.9. Office of Public Affairs

Environmental Education Grant Program

A.1.b.10. Delegated Programs

The following programs have been delegated to some or all of the Region 3 Middle Atlantic States - Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia:

RCRA Subtitle C (hazardous waste)
RCRA Subtitle I (underground storage tanks)
Air - Clean Air Act Title I permits, Title V permits, and most of the Title III air toxics
Public Water Supply (except District of Columbia)
Underground Injection Control (except the District of Columbia and Pennsylvania)
Pesticides
National Pollutant Discharge Elimination System (except the District of Columbia)
Pretreatment (except the District of Columbia, Delaware and Pennsylvania)

There are no delegations for the Sludge, Oil Pollution Act, Wetlands, Water Quality Standards, or Chlorofluorocarbons (CFCs) programs. The Total Maximum Daily Load (TMDL) program is not an officially delegated program; however, the states have primary responsibility. The Region's quality assurance (QA) responsibilities in relation to these delegated programs are oversight through mid-year program reviews, end of the year program reviews, and approval of QMPs and QAPPs. Program-specific oversight responsibilities are documented in respective Division/Program Office QMPs.

Top of page


A.2. Region 3 Organization Structure

EPA Region 3 employs a decentralized approach to quality management. Each Division or Program Office is responsible for determining the specific environmental programs and activities to which the quality system will apply. Division/Program Office QA requirements may be more, but not less stringent than those presented in this QMP and are documented in respective Quality Management Plans.

The Region is comprised of five Divisions and six Program Offices. The program-specific Divisions are the Air Protection Division (APD), Environmental Assessment and Innovation Division (EAID), Hazardous Site Cleanup Division (HSCD), Land and Chemicals Division (LCD) and the Water Protection Division (WPD). The six Offices are the Chesapeake Bay Program Office (CBPO), Office of Enforcement, Compliance and Environmental Justice (OECEJ), Office of Regional Counsel (ORC), Office of Public Affairs, Office of State and Congressional Relations and the Office of Policy and Management (OPM). The Region's organizational structure is shown on the organization chart for EPA's Region 3 office.

At this time, the ORC, OPA, and OSCR do not perform or manage environmental data operations and; consequently, do not maintain QMPs. Occasionally, OPM administratively manages (i.e., competition, funding, ensuring completion of deliverables) discretionary funded grants involving environmental data operations. However, a technical representative is always also assigned to assist in the management of such grants. These grants will adhere to the respective Division/Program Office QA requirements and those specified in this QMP, as applicable.

Top of page


A.3. Quality System Roles and Responsibilities

All individuals in the Region who are directly or indirectly involved with environmental data operations have some responsibility for ensuring data quality.

In accordance with EPA Order 5360.1 A2 (CIO Directive 2105.0)(PDF) (12 pp, 94K), overall responsibility for the quality assurance program in Region 3 rests with the Regional Administrator. The responsibility for developing and documenting Regional QA policies, procedures and guidance; overseeing the implementation and assessment of the Regional quality system; and providing QA training has been delegated to the Regional Quality Assurance Manager. The Regional Quality Assurance Manager (RQAM) is located in the Immediate Office of the EAID Division Director and is independent of direct environmental data operations. On issues relative to the Region's quality system, the RQAM reports to the Senior Management Representative to the Regional Quality Council (RQC or Council) and is afforded access to the Regional Administrator / Deputy Regional Administrator, if needed. The mission of the Council is to oversee implementation and ensure the continuous effectiveness of the Region 3 Quality Management Plan and strives to create an environment where an awareness of quality is the norm. Each Division and Program Office that collects and/or evaluates environmental data assigns a Quality Assurance Coordinator to the Council (see Table A.1 for a list of current members). The structure and function of the RQC allows each level of the organization to participate in maintaining and improving the Region's Quality System. An organization chart which shows the reporting relationships for Region 3 QA personnel can be found in Figure 2 (PDF) (1 pg, 83K).


Table A.1. Regional Quality Council Membership

Division/Office or Responsibility Representative
Alternate Rep
Mail Code Phone Email
Sr. Management Representative Walter Wilkie, EAID 3EA00 (215) 814-2150 wilkie.walter@epa.gov
Regional QA Manager Terry Simpson, EAID 3EA00 (410) 305-2739 simpson.terry@epa.gov
APD Jacqueline Lewis
Kia Hence
3AP21
3AP40
(215) 814-2037
(215) 814-2111
lewis.jacqueline@epa.gov
hence.kia@epa.ogv
CBPO Rich Batiuk
Mary Ellen Ley
3CB10
3CB10
(410) 267-5731
(410) 267-5750
batiuk.richard@epa.gov
ley.mary@epa.gov
EAID Charlie Jones 3EA00 (215) 814-2734 jones.charlie@epa.gov
EAID - IQG Officer John Graves 3EA10 (215) 814-5710 graves.john@epa.gov
HSCD Jeff Tuttle 3HS41 (215) 814-3236 tuttle.jeffrey@epa.gov
LCD David Friedman 3LC10 (215) 814-3395 friedman.davidm@epa.gov
OECEJ Jose Jimenez 3EC00 (215) 814-2148 jimenez.jose@epa.gov
OPM Norman Rodriguez 3PM60 (215) 814-5274 rodriguez.norman@epa.gov
WPD Larry Merrill
Bill Richardson
3WP30
3WP30
(215) 814-5452
(215) 814-5675
merrill.larry@epa.gov
richardson.william@epa.gov

A.3.a. Regional Administrator and Senior Leadership

The Regional Administrator (RA), Deputy RA (DRA), Assistant RA (ARA) and Senior Managers (Division/Office Directors and Deputies) have overall responsibility for the Regional QA Program as described in EPA Order 5360.1 A2 (CIO Directive 2105.0) (PDF) (12 pp, 94K). Specifically, the RA, DRA, ARA and Senior Managers are responsible for ensuring that:

  • All Regional components and programs comply fully with the requirements of EPA Order 5360.1 A2 (CIO Directive 2105.0) (PDF) (12 pp, 94K);

  • Quality program management is an identified activity with associated resources adequate to accomplish its program goals and is implemented as prescribed in the Region 3 QMP;

  • QMPs covering Division or Program Office environmental data operations are developed, updated and effectively implemented;

  • All environmental data operations are covered by the appropriate documentation (i.e., Quality Assurance Project Plans, Sampling and Analysis Plans, Standard Operating Procedures, etc.);

  • All environmental data operations implemented through extramural agreements comply fully with applicable QA/QC requirements;

  • Training in the fundamental concepts and practices of quality management is available for state, local, and tribal governments performing environmental data operations for EPA;

  • Internal quality assessments are performed to ensure that programs comply with QA requirements. Deficiencies highlighted in the assessments are appropriately addressed;

  • Agency policy and guidance are applied in identifying work products subject to peer review, determining the type and timing of such review, and documenting the process and outcome of each peer review;

  • Performance Agreements for supervisors, senior managers, and appropriate staff contain performance measures that are commensurate with their assigned quality management responsibilities;

  • Each Division or Program Office which collects, evaluates and/or uses environmental data is represented on the Regional Quality Council by a Quality Assurance Coordinator; and

  • Disputes regarding quality system requirements, QA/QC procedures, assessments or corrective actions are resolved.

Top of page


A.3.b. Program Managers

Program Managers may be Branch Chiefs, Section Chiefs or Team Leaders and are the stewards of environmental data in Region 3. EPA staff involved with environmental data operations performed under financial assistance agreements, contracts, and extramural nonsupported measurement are responsible for incorporating QA requirements into grant conditions; contracts; and voluntary, consensual or unilateral enforcement agreements, decrees and orders. Program Managers have technical expertise in a specific program area (e.g., TMDL, permits, enforcement, etc.) and serve as the focal lead for a specific environmental program. In this role, they must ensure that:

  • All intramural and extramural projects within their program that involve environmental data operations are performed in accordance with the Regional and Divisional QMPs and an approved QAPP;

  • Resources required to implement Program QA requirements are identified and provided;

  • Adequate procedures are in place to address QA requirements in all applicable program operations, including those delegated to state agencies;

  • All environmental data operations are covered by the appropriate documentation (i.e., Quality Assurance Project Plans, Sampling and Analysis Plans, Standard Operating Procedures, etc.);

  • Internal quality assessments are performed to ensure that programs comply with QA requirements. Deficiencies highlighted in the assessments are appropriately addressed;

  • Agency policy and guidance are applied in identifying work products subject to peer review, determining the type and timing of such review, and documenting the process and outcome of each peer review;

  • Performance Agreements for supervisors, team leaders, and appropriate staff contain performance measures that are commensurate with their assigned quality management responsibilities;

  • The Division or Program Office cooperates with QA reviews or audits and submits requested information in a timely manner;

  • Appropriate corrective action recommended by audit findings is implemented;

  • QA concerns with the Division/Office QA Coordinator and/or RQAM are discussed;

  • Disputes regarding quality system requirements, QA/QC procedures, assessments or corrective actions are resolved;

  • QA training needs for his/her specific environmental program are identified and reported to the QA Coordinator; and

  • Pre-dissemination review for an information product will be planned and implemented at the start of each applicable project.

Top of page


A.3.c. Project Managers / Project Officers

Project Officers (POs), Project Managers, Site Assessment Managers (SAMs), Remedial Project Managers (RPMs), On-Scene Coordinators (OSCs) and Work Assignment Managers (WAMs) are assigned responsibility for specific projects supported by EPA through contracts, cooperative agreements, grants or interagency agreements (IAGs).

For the purposes of this document, Region 3 uses the terms Project Manager, Project Officer (Technical & Administrative), Site Assessment Manager, Remedial Project Manager, On-Scene Coordinator and Work Assignment Manager interchangeably.

Since POs and WAMs may not be closely familiar with QA procedures, they are encouraged to work with their Divisional/Program Office QA Coordinator to ensure that QA requirements are addressed.

The specific responsibilities of Project Managers/Project Officers are to ensure that:

  • All extramural projects which generate and/or compile environmentally related data, adhere to QA requirements found in Agency, Regional and Divisional policy and/or QMPs;

  • All grant and IAG recipients or contractors conducting projects which involve environmental data operations submit a QMP, which documents their quality system, as appropriate. If applicable, the QMP must be submitted to the EPA Project Officer at least 45 days prior to the initiation of environmental data operations per the Region 3 Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000 (Appendix A) and Section B.3.b of this QMP;

  • All grant and IAG recipients or contractors conducting a project which involves environmental data operations have an approved QAPP prior to initiating any data generation, compilation and/or use per the Region 3 Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000 (Appendix A) and Section B.3.b of this QMP;

  • For contracts, the Quality Assurance Review Form for Contract Actions (PDF) (5 pp, 148K) is completed, and approved in writing by the RQAM (or designee) and Project Officer (see Section E.2 for a description of specific procedures);

  • For grants and assistance agreements, the funding recommendation form in IGMS is completed to indicate whether QA requirements apply;

  • Data from environmental programs delegated to state and local governments are of sufficient quantity and adequate quality for their intended use and are used consistent with such intentions;

  • Agency policy and guidance are applied in identifying work products subject to peer review, determining the type and timing of such review, and documenting the process and outcome of each peer review;

  • Determine whether an information product will be disseminated and ensure that a predissemination review is completed; and

  • Plan for dissemination of the information at the start of the project.

Top of page


A.3.d. Regional Quality Council

The Regional Quality Council (RQC) oversees the Regional Quality System and ensures the effective implementation of practices and policies defined by the Regional Quality Management Plan. The RQC consists of a Senior Management Representative, RQAM, Regional Quality Assurance Officer and a QA Coordinator from each Division or Program Offices conducting environmental data operations. The primary responsibilities of the RQC are to:

  • Review and update the Region's QMP;

  • Develop & oversee implementation of Regional QA policies and procedures;

  • Develop QA training and Quality System Assessment plans for the Region;

  • Review and implement quality system assessment recommendations;

  • Establish QA priorities for each new fiscal year; and

  • Resolve disputes regarding quality system requirements, QA/QC procedures, assessments or corrective actions.

Top of page


A.3.e. Senior Management Representative to the Regional Quality Council

The Senior Management Representative to the RQC serves as a liaison between the Senior Managers and the RQC. The Regional Administrator shall appoint the Senior Management Representative to the RQC. Specifically, the Senior Management Representative:

  • Provides Senior Managers with periodic updates on the status of the Region's Quality System;

  • Provides the RQC with periodic updates from the Senior Managers about issues that impact the Region's Quality System; and

  • Resolves disputes regarding quality system requirements, QA/QC procedures, assessments or corrective actions.

Top of page


A.3.f. Regional Quality Assurance Manager

The Regional Quality Assurance Manager (RQAM) has been delegated primary responsibility for the oversight of the Regional Quality System. Specifically, the RQAM is responsible for:

  • Facilitating the development of the Region's QMP and preparing updates to the approved QMP;

  • Representing the Region at national quality meetings, such as the RQAM monthly conference call, national QA conferences, etc. Also, serves as primary Regional liaison with the Quality Staff in EPA Headquarters and Region 3 State QA contacts;

  • Providing expert assistance to Regional staff on QA/QC policies, requirements, and procedures applicable to procurement, financial assistance and technical activities/services;

  • Reviewing and approving QMPs submitted by Region 3 Divisions and Offices and by holders of extramural agreements;

  • Performing periodic assessments of Regional organizations conducting environmental data operations to determine the conformance of their mandatory quality systems to their approved QMPs and the effectiveness of their implementation;

  • Coordinating and submitting the Annual QA Report and Workplan to Senior Regional Managers and the Office of Environmental Information (OEI) Quality staff;

  • Authorizing organizations (i.e., states and local governments) to review and approve QAPPs;

  • Providing, scheduling and/or notifying Regional staff of QA training and briefings;

  • Distributing Agency QA guidance documents, policies, and procedures;

  • Initiating and/or revising Regional QA policy & procedures; and

  • Facilitating the discussion of disputes regarding quality system requirements, QA/QC procedures, assessments and/or corrective actions.

Top of page


A.3.g. Regional Quality Assurance Officer

The Regional Quality Assurance Officer (RQAO) serves as a technical QA expert and liaison to the Quality Assurance Coordinators within the Region. As liaison, the RQAO is expected to keep program QACs informed of activities and test results. In the RQAM's absence, the RQAO serves as the Region's liaison with the Quality Staff in EPA Headquarters. The RQAO's primary responsibilities are to:

  • Serve as QA Coordinator for EAID (see duties under Section A.3.i.);

  • Facilitate the development of EAID's QMP and preparing updates to the approved plan;

  • Provide technical assistance to Regional staff on QA/QC policies, requirements, and procedures applicable to procurement, financial assistance and technical activities/services;

  • Review QAPPs submitted by holders of extramural agreements financed by EAID;

  • Provide, schedule and/or notify Regional staff of QA training and briefings;

  • Review and certify drinking water laboratories;

  • Administer the SDWA and NPDES Proficiency Testing (P/T) studies;

  • Participate in assessments of Regional and State QA programs to assure that they adhere to their approved QMPs; and

  • Serve as Discharge Monitoring Report Quality Assurance (DMRQA) Evaluation Study Coordinator.

Top of page


A.3.h. Information Quality Guidelines Officer

The Information Quality Guidelines Officer (IQGO) is located in EAID Office of Environmental Information and Analysis. The IQGO serves as a Regional coordinator for Information Quality Guidelines activities. The IQGO coordinates IQG activities with the RQAM and the Region's Product Review officer. Specific responsibilities are as follows:

  • Provide technical assistance to Regional staff on IQG policies, requirements, and procedures;

  • Serve as point of contact on IQG procedures;

  • Help implement IQG pre-dissemination review procedures in the Region;

  • Facilitate communication on IQG policies and procedures within the Region and with HQ Quality Staff; and

  • Coordinate responses from Region 3 information owners to requests for correction and requests for reconsideration with HQ Quality Staff

Top of page


A.3.i. Quality Assurance Coordinators

Each Division and Program Office conducting environmental data operations shall have a Quality Assurance Coordinator (QAC). QACs are responsible for coordinating the implementation of the quality system within their Division or Program Office. The QAC:

  • Disseminates QA information to Division or Program Office staff;

  • Conducts QA briefings for Division or Program Office Directors;

  • Participates in RQC meetings;

  • Facilitates preparation and/or revision of his/her Division or Program Office's QMP;

  • Helps implement the Division or Program Office's QMP;

  • Helps Project Managers and/or Project Officers resolve data quality issues with contractors and financial assistance recipients;

  • Reviews and/or approves program/project QAPPs and SOPs (according to the policies and procedures described in the Division or Program Office QMP);

  • Assesses Division or Program Office's QA-related training needs and arranges the delivery of training;

  • Provides assistance to Project Managers/Project Officers with completion of QA Review Forms for acquisitions/contracts/work assignments;

  • Reviews and signs QA Review Forms for acquisitions/contracts/work assignments;

  • Assists Project Managers/ Project Officers with completion of QA-related questions on the funding recommendation form in IGMS for grants, cooperative agreements, and interagency agreements;

  • Tracks the number of projects in progress within his/her Division or Program Office; the number of projects involving environmental data operations; and the title, preparer and date of QAPPs received, reviewed and approved;

  • Provides reports on above to RQAM at a frequency to be determined by the RQC (at least annually);

  • Consolidates Division or Program Office's QA information for the QA Annual Report and Work Plan and delivers it to the RQAM; and

  • Participates in and/or conducts assessments of Divisional or Program Office and state QA programs to assure that they adhere to their approved QMPs.

Top of page


A.3.j. Technical Services Branch

The Technical Services Branch is comprised of the Regional Sample Brokerage and Quality Assurance (QA) Staff. It is organizationally placed in EAID Office of Analytical Services and Quality Assurance (OASQA) and geographically located in Fort Meade, MD. The Branch serves as the focal point for procurement of analytical services for environmental data operations and providing quality assurance support to Divisions and Program Offices in Region 3. The branch's primary responsibilities include:

  • Determining the most cost-effective means for acquiring environmental sample analyses;

  • Procuring and/or scheduling sample analysis through national or regional contracts;

  • Evaluating and assessing environmental data for contract compliance;

  • Conducting laboratory inspections for the Superfund Contract Laboratory Program (CLP), and other contract laboratories;

  • Assisting with environmental project planning;

  • Reviewing QAPPs, SAPs, and other QA documentation;

  • Assisting the RQAM with review of external Quality Management Plans;

  • Providing technical assistance on QA/QC policies, requirements, and procedures applicable to technical activities;

  • Participating in assessments of QA and QC activities;

  • Working with the RQAM to develop Regional QA policy & guidance documents; and

  • Providing, scheduling and/or notifying Regional staff of QA training courses.

Top of page


A.3.k. OASQA Laboratory Technical Director

The OASQA Laboratory Technical Director (TD) monitors lab technical operations and conformance to OASQA quality system components at the laboratory. Specific duties are detailed in the current version of the EPA Region 3 OASQA Laboratory Quality Manual.

Top of page


A.3.l. OASQA Laboratory Quality Assurance Officer

The OASQA Laboratory QAO is responsible for the design and management of OASQA's laboratory quality system. Specific responsibilities are detailed in the current version of the EPA Region 3 OASQA Laboratory Quality Manual.

Top of page

A.4. Communication

This QMP will be distributed to all individuals responsible for implementing the policies and procedures found in this document. Several mechanisms will be used to distribute QA information. On a regular basis, the RQAM will keep the EAID Director, Senior Management Representative, RQAO, RQC and senior managers apprised of QA issues that impact the Region's quality system. In addition, new QA developments, policies, and procedures will be distributed to all Division and Program Offices and posted on the internet/intranet sites, as applicable. The Region 3 QMP will be posted on the Region's internet/intranet site(s) and/or shared directories of the Region's Local Area Network, as applicable. When the Region 3 QMP is revised, the new version will be posted and older versions archived. Organizational QMPs and project-specific QAPPs will be posted on the Region's internet/intranet site, as applicable.

The RQC, as the primary cross-Divisional group for addressing QA topics that impact the entire Region, meets quarterly to discuss and resolve issues about QMP implementation and its impact on data quality. The RQC also discusses ways to improve the Region's Quality System. Communication of an Agency-wide nature, takes place among the RQAM, the OASQA QA Staff, other RQAMs and Headquarters during monthly teleconferences.

Top of page


A.5. Dispute Resolution

In order to resolve disputes related to quality assurance, the Region will strive to resolve the issue at the lowest administrative level practicable. The dispute resolution process shall begin when either disagreeing party declares an issue to be irresolvable and sends written correspondence to the other party defining the disputed issue, and presenting supporting arguments for the first party's position on the issue. All parties shall make every effort to resolve disputes through discussion and negotiation. Should agreement not be reached at this level, the issue will be directed to the Divisional QAC. If the issue is not resolved, it will be directed to the RQAM. If necessary, the RQAM will work to resolve the problem with the Senior Management Representative to the RQC and ultimately the RA/DRA. The resolving officials will document the resolution and provide it to the disputing parties.

Top of page


A.6. Resources for the Region 3 Quality System

The level of QA resources needed for an environmental program or project is determined by the relevant Regional program. Since an assigned national program element for QA does not exist, most resources needed for QA are taken from a variety of program elements which utilize QA functions and services. Each Division or Office Director shall ensure that there are adequate resources to successfully implement QA requirements for their environmental programs.

Top of page


A.7. Principal Components of the Quality System

The Region 3 Quality System consists of the people, functions, tools and procedures used to ensure that data of known quality and sufficient quantity is generated for Regional data users and decision makers. Successful implementation of the Region 3 Quality System requires a consistent and graded approach for QA practices commensurate with the intended use of the data. A variety of tools and procedures are employed for planning, implementing and evaluating the Region's Quality System. Managers and staff members are informed of the availability and use of these tools through their Divisional QACs.

The principal components of the Region 3's Quality System exist at the program and project-level. A list of these components is provided below:

Program-level Project-level
Quality Management Plans Data Quality Objectives
Laboratory Quality Manuals Quality Assurance Project Plans
Quality Assurance Annual Report and Work Plan Standard Operating Procedures
Quality Systems Assessments Technical System Audits
Training Plans Proficiency Testing Samples
Information Quality Guidelines Data Quality Assessments
Quality Management Plan Status Reports Pre-dissemination Reviews
Newly Awarded Grants Reports Assessment Factors

Top of page


A.8. Quality Management Plans

A.8.a. Region 3 Quality Management Plan

The Region 3 QMP complies with the requirements found in the EPA Quality Manual (PDF) (63 pp, 369K), EPA Order 5360 A1 (CIO Procedure 2105-P-01-0), May 5, 2000 and Policy and Program Requirements for the Mandatory Agency-wide Quality System (PDF) (12 pp, 94K), EPA Order 5360.1 A2 (CIO Directive 2105.0), May 5, 2000.

The Region 3 QMP contains the policies and procedures being implemented to ensure that environmental data generated, collected, compiled, analyzed, and/or utilized by and for the Region are of adequate quality for its intended use.

This document serves as the "umbrella" document for all Regional programs and describes the quality system in terms of organizational structures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, and evaluating activities conducted.

The QMP is developed by the RQAM with assistance from the Regional Quality Council and the OASQA QA Staff and is intended to be used by all Regional staff. This QMP shall be reviewed and approved by all Division and Program Office Directors and the Regional Administrator. Final approval of the Region 3 QMP shall be granted by the Director of the EPA Office of Environmental Information (OEI) Quality Staff. The approval is valid for up to five years; however, pursuant to EPA Order 5360.1 A2 (CIO Directive 2105.0) (PDF) (63 pp, 369K), updates or revisions to the QMP are required as a result of organizational and/or Regional policy/process changes, or findings from quality system assessments. The Region 3 QMP shall be reviewed for such changes and updated, as necessary, on an annual basis.

Top of page


A.8.b. Division/Program Office Quality Management Plans

Each Region 3 Division and Program Office that conducts environmental data operations shall develop and maintain its own QMP. This QMP shall describe the organization's QA management policies, objectives, and internal procedures. These documents shall be consistent with the requirements found in the most recent version of the EPA Quality Manual 5360A1 (CIO Procedure 2105-P-01) (PDF) (63 pp, 369K) and EPA Order 5360.1 A2 (CIO Directive 2105.0) (PDF) (12 pp, 94K). Division and Program Office QMP requirements may be more, but not less, stringent than those presented in the Region 3 QMP. All Division/Program Office's QMPs require approval by Division/Program Office management and the RQAM, or designee.

The most recent version of the Quality Management Plan Review Checklist (PDF) (10 pp, 2.3MB) may be used to review these QMPs. Approval of the Division/Program Office QMP is valid for a period up to five years and is subject to review and revision by the Quality Assurance Coordinator annually. Minor organizational and/or policy changes shall be documented in the Division/Program Office QA Annual Report and Work Plan. When there are substantial organizational or policy changes that impact a Division or Program's quality system, the Division/Program Office QMP shall be updated and resubmitted to the RQAM for review and approval.

Top of page


A.8.c. Quality Management Plans for Extramural Projects

Likewise, financial assistance recipients' quality policies and practices shall be documented in a QMP, or equivalent document, in accordance with the most recent version of EPA Requirements for Quality Management Plans, EPA QA/R-2, March 2001 (PDF) (30 pp, 87K).

Region 3 Policy

Recipients of Region 3 financial assistance (i.e., grants, cooperative agreements, contracts and interagency agreements) that involve the generation, collection, compilation and/or use of environmental data must develop and implement QA policies and practices that are sufficient to produce data of adequate quality to meet program objectives.

Should there be multiple programs involved in a grant, cooperative agreement, IAG or contract, the recipient may submit a single QMP covering all of the programs in the grant, cooperative agreement, IAG or contract or a separate QMP for each program receiving such funds, per the Region 3 Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000 (Appendix A).

The recipient's QMP shall be approved internally by its Quality Assurance Manager, or equivalent and the organization's senior management. Financial assistance recipients at all levels, must submit their QMP or combined QMP/QAPP to the EPA Project Officer/Project Manager at least 45 days prior to the initiation of environmental data operations, per the Region 3 Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000 (Appendix A). The QMP or combined QMP/QAPP shall be forwarded to the RQAM, or designee, for review. The most recent version of the Quality Management Plan Review Checklist (PDF) (10 pp, 2.3MB) may be used to facilitate the review. When applicable, the Region 3 QACs will be asked to facilitate the QMPs' review by conducting a review of the technical activities and programs documented in QMPs for extramural organizations being funded by their Division or Program Office. The QMP or combined QMP/QAPP must be approved by the RQAM prior to the conduct of environmental data operations. EPA approval is valid up to five years. The recipient shall review its QMP annually and report minor organizational and/or policy changes in its annual report to the Agency, as applicable. When there are substantial organizational and/or policy changes that impact the recipient's quality system, the recipient shall update and resubmit its QMP to the RQAM for review and approval.

For smaller or single program/project organizations there may be situations when a single document is more applicable. By applying a graded approach to these situations, the RQAM and/or Division/Program Office QACs may identify more appropriate quality system documentation required from the organization receiving financial assistance. Each situation will be determined on a case-by-case basis by the RQAM and/or Division/Program Office QAC, as applicable. In general, organizations receiving financial assistance may be granted an exception or modification to the QMP requirement if they meet criteria which may include, but not be limited to, the following:

  • small grants as defined by the EPA Small Grants Guidance [Entering intranet];
  • one-time, short-term, and special projects or projects of limited scope; and
  • organizations generating, collecting, compiling and/or using environmental data for public education purposes.

Upon receipt of a QMP or combined QMP/QAPP, the RQAM shall update the Region 3 QMP Status Report. This report contains the name of the organization that submitted the QMP, the receipt date, the review status and the approval status. The QMP approval shall be formally documented in a letter to the financial assistance recipient, a memorandum to the Project Manager/Officer, and/or both. The status of a QMP may be:

Approved:   The Quality Management Plan adheres to requirements found in EPA Requirements for Quality Management Plan (PDF) (30 pp, 86K), EPA QA/R-2. QMP is valid for five years from date of approval.

Conditional:   The cursory review of this document indicates that the grantee has documented the basic components of a quality system. However, minor revisions to the grantee's QMP are required to ensure conformance to EPA Requirements for Quality Management Plan (PDF) (30 pp, 86K), EPA QA/R-2. Conditional approval allows grantees to perform activities that include the generation and/or use of environmental data while making revisions to finalize their plan.

Resubmit:   The Quality Management Plan is in need of significant revision in order to meet the basic components of a quality system. The grantee/contractor is required to ensure conformance to EPA Requirements for Quality Management Plan (PDF) (30 pp, 86K), EPA QA/R-2 prior to performing activities that include the generation and/or use of environmental data.

Expired:   The Quality Management Plan on file with EPA Region 3 is no longer current and needs to be revised and resubmitted for review.

In Progress: The Quality Management Plan has been received by EPA Region 3 and is undergoing review.

Each month, the updated Region 3 QMP Status Report shall be posted on the Region's intranet site and distributed to the Region 3 Division/Program Office QACs; the Office of Policy and Management (OPM's) Grants and Audit Management Branch; and OPM's Contracts Branch. The Grants and Audit Management Branch and Contracts Branch shall distribute the updated QMP Status Reports to all Region 3 Project Officers. Region 3 Project Officers shall use this information to ensure that extramural agreement holders under their purview have fulfilled their EPA QA requirements.

Top of page


A.9. Laboratory Quality Manuals

A.9.a. Office of Analytical Services and Quality Assurance

The EAID Office of Analytical Services and Quality Assurance (OASQA) Quality System is based on the requirements of ISO 17025 General Requirements for the Competency of Testing and Calibration Laboratories, and the National Environmental Laboratory Accreditation Program (NELAP) Chapters 2 and 5. Analytical services provided by OASQA are documented in the most recent version of the OASQA Laboratory Quality Manual. This manual describes the laboratory's quality system policies and procedures. The Laboratory's Quality System is NELAP accredited by the State of New Jersey Department of Environmental Protection (NJDEP), an approved Accrediting Body. Each person involved in the laboratory's operations shall be familiar with OASQA's quality system and the technical requirements of the tests being conducted. The OASQA Laboratory Quality Manual and a list of SOPs are available upon request from the OASQA Director.

Top of page


Section B. Planning

PIE graphic
Figure 3. The Quality System PIE

The acronym PIE is used to describe Region 3's Quality System components. "P" stands for planning; "I" for implementation; and "E" for evaluation. Planning is described here, in Section B. Implementation is described in Section C and Evaluation in Section D.

A major goal of Region 3's Quality System is to promote effective planning for the collection, analysis and processing of environmental information and/or data. Quality planning must occur at three levels to ensure that such data meets Regional programmatic and quality goals: Region-Wide, Program-Specific and Project Level.

B.1. Region-Wide Planning

B.1.a. Internal Strategic Planning

The Region 3 Strategic Plan is the foundation for all programmatic priorities and environmental data operations. Using the projected annual budget for the Region, and guidance from the various program offices in EPA Headquarters, the Regional Administrator and the Senior Leadership meet early in the fiscal year to set Regional priorities. The Regional Administrator and Senior Leadership rely in part on Logic Models developed for all Region 3 programs having 10 or more FTE's to set conceptual priorities. The setting of priorities for programs within Region 3 is evaluated using tools such as the Multi-criteria Integrated Resource Assessment (MIRA) application. Region 3 recognizes the Logic Model and MIRA processes as systematic planning. These priorities are then reflected in the Regional Strategic Plan, which establishes program goals, resource utilization plans and budget allocations. Annual action plans developed by the individual Divisions and Offices, tied to the Strategic Plan and budget distribution process, further specify the types of environmental data operations that will occur and the corresponding requirements for QA and QC procedures.

Top of page


B.1.b. External Data Coordination

Region 3 also coordinates environmental data operations with numerous government agencies, academic and private organizations. Close coordination and planning is essential to ensure that data are of sufficient quality to support the intended uses and can also be shared with other organizations. The Region encourages data sharing wherever possible and supports the data quality planning to make that possible.

Top of page


B.2. Program-Specific Planning

Programs are functional areas of work authorized by statutory reference (e.g., the Air Toxics Program) or by Executive or Agency direction (e.g., the Volunteer Monitoring Program). All Regional environmental data operations conducted in support of these programs are covered by this QMP, though not all require the same level of QA. When initiating a new program or incorporating major statutory changes, the program shall establish the minimum quality system components required to achieve program compliance.

For many ongoing environmental monitoring programs, the National Program Offices at EPA Headquarters have established standard QA/QC requirements. These QA/QC requirements may be documented in a generic Program QMP, QAPP or SOP. In these cases, the Region shall defer to these national program documents. Any modifications or deviations from these documents shall be documented.

Top of page


B.3. Project-Level Planning

B.3.a. Systematic Planning Process

Region 3 Policy

A systematic planning process shall be used for all environmental data operations conducted by or on behalf of Region 3.

The systematic planning process is a mechanism for balancing conflicting demands and data quality needs to ensure that environmental data operations will effectively support decision-making. EPA's Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4, February 2006 (PDF) (121 pp, 1.6MB) describes one such process, but any other systematic planning process may be used as long as it is based on the scientific method and complies with Chapter 3 of the EPA Quality Manual (PDF) (63 pp, 369K), 5360 A1 (CIO Procedure 2105-P-01).

Elements of a systematic planning approach shall include:

  • Identification and involvement of the Project Manager/Project Officer, sponsoring organization and responsible official, project personnel, stakeholders, scientific experts, etc. (i.e., all customers and suppliers);

  • Description of the project goal, objectives and questions/issues to be addressed;

  • Identification of project schedule, budget, milestones, and any applicable requirements (e.g., regulatory requirements, contractual requirements);

  • Identification of the type of data needed and how the data will be used to support the project's objectives;

  • Determination of the quantity of data needed and specification of the performance criteria for measuring quality;

  • Description of how, when, and where the data will be obtained including existing data and identification of any constraints on data collection;

  • Specification of needed QA and QC activities to assess the quality performance criteria (e.g., QC samples for both the field and laboratory, audits, technical assessments, performance evaluations, etc.);

  • Description of how the acquired data will be analyzed (either in the field or the laboratory), evaluated (i.e., QA review, validation, verification), and assessed against its intended use and the quality performance criteria.

The Project Manager/Project Officer is responsible for ensuring that a systematic planning process is used and documented and that all organizations and/or parties who contribute to the quality of the environmental project or use the results are identified and participates in the planning process. Guidance and technical support for using a systematic planning process are available from the RQAM and OASQA Quality Staff, upon request.

Top of page


B.3.b. Quality Assurance Project Plans

Region 3 Policy

All projects and tasks involving environmental data operations that are conducted by or for Region shall have an approved QAPP in place prior to the start of data generation or use.

The systematic planning process described above results in the development of a sampling network design, generation of appropriate data quality indicators, selection of measurement and analytical methodologies, standard operating procedures, etc. Region 3 policy requires that the results of the systematic planning process be documented in a Quality Assurance Project Plan (QAPP) and approved by authorized personnel prior to implementation. The only exception to this requirement shall be for environmental projects that require immediate action to protect human health and the environment or operations conducted under police powers.

The Region has embraced the "graded approach" as defined in Section 2.4.2 of EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations, EPA QA/R-5, March 2001 (PDF) (40 pp, 121K). The level of detail found in the QAPP shall be commensurate with the nature of the work being performed and the intended use of the data.

The QAPP shall be prepared in accordance with EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations (PDF) (40 pp, 120K), EPA QA/R-5, March 2001. EPA's Office of Solid Waste and Emergency Response (OSWER) has issued OSWER Directive 9272.0-17 (PDF) (5 pp, 160K), stating that the Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) is designated for use in Federal facility projects where environmental data are collected (e.g., CERCLA, RCRA, Brownfields). EPA Region 3 subscribes to this policy and strongly encourages the use of the UFP-QAPP for Federal facility and other hazardous waste projects. QAPP requirements apply to all environmental data operations conducted by Regional staff or through grants, cooperative agreements, contracts, Interagency Agreements and compliance orders.

Project Managers/Project Officers shall ensure that QAPPs are developed and approved for all projects under their authority. The decision to approve or reject a QAPP is based on the Project Manager/Project Officer's technical expertise and the comments received from the EAID QA Staff. To date, the RQAM has not delegated the review and approval of QAPPs to any extramural agreement recipient.

The title(s) of the individual(s) responsible for the review of QAPPs shall be documented in all Division/Program Office QMPs. All individuals' assigned responsibility for QAPP reviews shall be knowledgeable of EPA QA/R-5 and/or UFP-QAPP and have completed the Region's required training for QAPP reviewers. These individuals should also have professional knowledge of chemical and biological principles, theories, practices and established methods, statistical techniques commonly used in quality control, data assessments, and data management practices. Extensive knowledge of the principles and practices of quality assurance and the ability to adapt these applications to Agency programs is also required. The Quality Assurance Project Plan Review Checklist (PDF) (23 pp, 834K) developed by the OASQA Quality Assurance Staff may be used for this review.

The QAPP approval shall be formally documented in accordance with procedures specified in the approved Division or Program Office QMP. The status of a QAPP may be:

Approved   The document was found to address the key QA issues satisfactorily.

Conditionally Approved The document satisfactorily addressed most of the key elements; however, minor deficiencies were noted. Sampling and analysis may begin while these minor deficiencies are being resolved.

Resubmission Required The document was found to be deficient in describing the key elements. Further clarification of specific issues is required. Modification to specific procedures that may influence data quality should be accomplished prior to approval of the plan and initiation of the data collection activity.

Once all critical issues have been addressed, the Project Manager/Project Officer shall indicate QAPP approval via signature or approval memorandum; ensure it is implemented as written; and include a copy in the project file. For continuous projects, the QAPP must be reviewed annually by the authoring organization. Annual review shall be documented in the organization's annual report to EPA Region 3. Additionally, the QAPP must be revised and submitted to EPA for review every three to five years, based upon the original approval date, to ensure that the documented procedures are still accurate. Revisions to the approved QAPP shall be documented in a second or subsequent revision or an addendum. Sometimes the scope of a project can change which may have the potential to affect the quality of the data. If these changes are significant (as determined by the Project Manager/Project Officer) and affect the scope and objectives of the project, data use, or data quality; the revised QAPP or addendum must be reviewed and approved in the same manner as the original QAPP. The Project Manager/Project Officer is responsible for ensuring all appropriate personnel receive a copy of the revised QAPP or addendum once it is approved.

Top of page


B.3.c. Generic or Program Quality Assurance Project Plans

For multiple projects or sites with the same objective(s) and/or environmental decision(s), a Generic or Program QAPP may be desirable and appropriate. A Generic or Program QAPP shall adhere to the QAPP requirements specified in Section B.3.b. The Generic or Program QAPP shall include the elements which remain constant among the different projects or sites. Most Generic or Program QAPPs will be supported by a site-specific or project-specific plan which addresses the QA elements that are unique to each site or project. The Generic or Program QAPP shall include the procedures being used for the preparation, review, and approval of the site-specific or project-specific plan. If the site-specific or project-specific plan contains analytical and/or sampling procedures that are not found in the Generic or Program QAPP, the site-specific or project-specific plan must be reviewed in accordance with the procedures documented in the appropriate Division/Program Office QMP and Section B.3.b of this QMP.

The appropriateness of a Generic or Program QAPP is determined on case-by-case basis by the Project Manager/Project Officer in cooperation with the RQAM, RQAO, QAC or Quality Assurance Staff. The Project Manager/Project Officer shall ensure that the approved Generic or Program QAPP is reviewed annually for changes to organization, policy, and/or procedures and updated every three to five years. Any minor changes can be appended to the original document. Substantial changes require that the document be resubmitted to EPA for review and approval.

Top of page


B.3.d. Secondary Use of Environmental Information or Data

Secondary use data is defined as data that is collected for other purposes or from other sources, such as literature, industry surveys, compilations from computerized databases and the results from computerized or mathematical models of environmental processes and conditions.

Prior to its use, environmental data collected from secondary sources shall be evaluated to ensure a level of quality that is commensurate with its intended use(s). The Project Manager/Project Officer is responsible for ensuring that such data collection is addressed in a project-specific QAPP, if applicable. The project QAPP shall:

  • Identify the types of data needed for project implementation or decision making;

  • Describe the intended use of the data;

  • Define the acceptance criteria for the use of data;

  • Specify any limitations on the use of the data;

  • Identify the individual(s) responsible for evaluating and qualifying the data.

For those projects which involve the compilation and use of environmental data from secondary sources exclusively (i.e., there will be no direct environmental data generation performed to accomplish the project), a project-specific QAPP is still required. Per the graded approach, the level of detail for this QAPP will differ from that for a direct environmental data generation project. Assistance with determining the appropriate elements for a QAPP for projects involving secondary use data may be provided by the RQAM or the OASQA Quality Assurance Staff, upon request. The Project Manager/Project Officer is responsible for ensuring a QAPP is prepared for these types of environmental data projects.

Top of page


B.4. Information Quality Guidelines

"Information" generally includes any communication or representation of knowledge, position or policy such as facts or data, in any medium, or form. This includes "preliminary" information endorsed or adopted by EPA, and also conclusions or facts drawn from or based upon other existing information.

The Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the EPA, 260R-02-008, December 2002 (PDF) (61 pp, 896K), or more commonly known as the IQGs, contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information the Agency disseminates and complements EPA's Quality System for assuring the quality of EPA's products and information. This QMP incorporates by reference all definitions, principles, policies, and procedures found in EPA's IQGs.

The Region will ensure that EPA disseminated information products are presented in an accurate, clear, complete and unbiased manner. The Region will also ensure that the integrity of EPA Region 3 web sites will be protected from unauthorized access or revision.

Top of page


B.4.a. Implementation Policy and Procedures

In accordance with EPA's IQGs, Region 3 has established policies and procedures (Information Quality Guidelines Pre-Dissemination Review Checklist for complying with these guidelines with emphasis on using existing Regional processes or procedures wherever possible. The Region 3 Information Quality Guidelines Officer works with communications and web coordinators in each division when an information product is proposed to be disseminated.

Top of page


B.4.b. Requests for Correction

The IQGs allow for affected persons to request correction of information if that information does not comply with EPA or Office of Management and Budget (OMB) Information Quality Guidelines. The Office of Environmental Information (OEI) Quality Staff will receive the requests for correction (RFC) and forward them to the Region 3 IQG Officer when the information in question belongs to or involves Region 3. The IQG Officer will then work with the OEI Quality Staff and the information owner to formulate a response. A schematic for the RFC process is presented as Figure 4 (PDF) (1 pg, 32K).

Top of page


B.4.c. Requests for Reconsideration

Affected persons may appeal EPA responses to RFC's under a formal Request for Reconsideration (RFR). When an RFR is received for a Region 3 product, the IQG Officer will work with the information owner and the OEI Quality Staff on the response. This process is depicted in Figure 5 (PDF) (1 pg, 31K).

Top of page


B.4.d. Pre-Dissemination Review

The review process is intended to ensure the quality of products the Region disseminates. Pre-dissemination review should begin at the planning stage for information products. Region 3 programs may use one or more review processes to satisfy pre-dissemination review as specified by EPA's Pre-dissemination Review Guidelines. Region 3 programs may also use the Information Quality Guidelines Pre-Dissemination Review Checklist (PDF) (1 pg, 102K) for pre-dissemination of information.

Top of page


Section C. Implementation of Work Processes

PIE graphic
Figure 3. The Quality System PIE

The implementation of the procedures specified in this section shall ensure that all environmental data operations being conducted within the Region conform to the requirements found in this QMP, the EPA Order 5360.1 A2 (CIO Directive 2105.0) (PDF) (12 pp, 94K) and the EPA Quality Manual, 5360 A1 (PDF) (63 pp, 369K). These procedures are currently being implemented at the program and project level.

C.1. Program Implementation

Annually, the Region 3 QMP shall be reviewed by the RQC to ensure that the documented QA policies and procedures are current and accurate. The Region 3 QMP shall also be reviewed whenever there is a major reorganization or there are significant policy and/or procedural changes that impact the Region's Quality System. In addition, every five years, based upon the original approval date, the Region 3 QMP will undergo a more in-depth review. If revisions are required, the RQC shall revise the QMP and distribute it to Senior Managers for review and approval. After the QMP has been approved by the Regional Administrator, it shall be delivered to the Director of the OEI Quality Staff for review and approval. Upon final approval, a copy of the QMP will be filed with each Regional Division/Program Office via the Region 3 intranet and/or shared directories on the Regional local area network and to external organizations through the Region 3 home page. An e-mail announcement about the newly approved Region 3 QMP shall be sent to all staff from the RQAM.

Similarly, each Division or Program Office QA Coordinator shall review his/her organization's QMP. Minor changes to the QMP will be documented in the Division/Program Office's annual report. Significant policy and/or procedural changes require revision to the QMP and submission to the RQAM for approval. After the QMP has been approved, the QA Coordinator shall distribute the newly revised QMP to managers and supervisors. Older versions of Division/Program Office QMPs shall be removed from circulation.

Approved QMPs for extramural projects shall be updated every five years, or whenever there are major organizational changes that impact the documented quality system. Extramural agreement holders are required to review their QMP annually and report the outcome of the review in their annual report. If revisions are required, the revised QMP shall be resubmitted to EPA Region 3 for review and approval in accordance with the procedures specified in Section A.8.c. The QMP Status Report is used to document the approval status of QMPs for extramural projects.

Annually, the Region shall submit a Quality Assurance Annual Report and Work Plan (QAARWP) to the Director of the OEI Quality Staff. The QA report will summarize the QArelated resources, training, accomplishments (i.e., innovative practices, technical assessments, QMP revisions, QA guidance, technical assistance, etc.) and quality system assessments/audits that have been conducted in the previous fiscal year. The QAARWP will also include a list of QA activities planned for the upcoming fiscal year. Each Division or Program Office that is a part of the Region's Quality System shall provide its information to be compiled into a Region-wide report. The QAARWP will be prepared according to Chapter 4 of the most current version of the EPA Quality Manual (PDF) (63 pp, 369K), 5360 A1 (CIO Procedure 2105-P-01) by the RQAM with cooperation from the QA Coordinators and OASQA Quality Staff. The QAARWP will also be used to identify minor changes or updates to Region 3's QMP. The QAARWP will be distributed to the RQC for concurrence. Prior to its distribution to the Director of the EPA OEI Quality Staff, the report shall be reviewed and approved by the Regional Administrator or his/her designee.

Top of page


C.2. Project Implementation

C.2.a. Quality Assurance Project Plans

Once final approval has been received, the Project Managers/Project Officers shall ensure that all project personnel have a copy of the newly approved QAPP. The Project Manager/Project Officer shall also ensure that obsolete versions of the QAPP are removed from work areas. Verification of the changes to the QAPP shall be determined during a project's technical system audit. The approved QAPP must be implemented as prescribed; however, the QAPP may be modified and/or amended at any time to ensure project objectives are met. Modifications and/or amendments to the QAPP must follow the appropriate submission and approval procedures outlined in Section B of this QMP.

Top of page


C.2.b. Standard Operating Procedures

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity that shall be followed.

The use of SOPs serves as a mechanism to ensure comparability across programs and individual environmental data operations. SOP use is encouraged as a means of ensuring that routine or repetitive activities, processes or procedures are performed consistently within acceptable timeframes and with acceptable quality. SOPs can describe both technical and administrative operational elements. SOPs will thoroughly describe steps and techniques, and will be sufficiently clear to be understood by a person with knowledge in the general concept of the procedure or process. Any limitation on the use or applicability of a specific SOP will be documented in the SOP itself.

The need for an SOP for a specific activity or operation can be identified by any staff member in the Region, and can be written by any Regional staff member who is knowledgeable of the activity, equipment, procedure, or process to be addressed. In general, the SOP is implemented by staff that perform the activity, process or procedure to which the SOP pertains. It is the responsibility of the individual users of an SOP to follow the procedures contained in the SOP or to document any deviations. It is the responsibility of managers to ensure that specific SOPs that pertain to their program operations are implemented. It is the responsibility of Project Managers / Project Officers to ensure that SOPs referenced in specific QAPPs are implemented. The implementation of QA-related SOPs is a responsibility of the QAC of the respective Division/Office. Implementation of SOPs will be assessed through internal QSAs and TSAs.

The primary guidance document for the preparation of SOPs in Region 3 is Guidance for the Preparation of Standard Operating Procedure, EPA QA/G-6, April 2007 (PDF) (60 pp, 336K). All SOPs shall be reviewed and approved by the manager of the organization within the respective Division/Office originating the SOPs and by the Division/Office QAC or his/her designee. All SOPs will be reviewed every 3 years or periodically, as specified in the respective Division/Office QMP. Detailed procedures/processes for SOP development, review, approval, revision and withdrawal are further documented in each Division/Office QMP. The RQAM, or designee, shall ensure that the procedures each organization conducting environmental data operations uses to develop, review, approve and implement SOPs are found in its respective QMP.

Top of page


C.2.c. Inspection and Oversight of Facilities and Work Processes

Compliance inspections occur at active municipal, industrial and/or federally owned facilities. These inspections are primarily focused on making compliance determinations based upon facility representative interviews, facility records and facility documents. However, samples may be collected to help identify whether a potential violation exists.

The vast majority of sampling conducted during compliance inspections would be considered "opportunistic" sampling. These sampling activities are not planned. The inspector makes a decision to collect samples as a result of observations made during the course of the inspection. If sampling is required, samples are collected in accordance with SOPs developed by the Office of Enforcement, Compliance and Environmental Justice (OECEJ) Field Inspection Program. For inspections being conducted to support criminal investigations, the Criminal Investigation Division (CID) investigator in charge of the case manages the sampling activities. CID investigators often rely on the technical expertise of the OECEJ field inspectors to help determine where to sample and how many samples to collect.

OECEJ field personnel rarely conduct sampling in support of the Region 3 Superfund program. However, when this type of sampling is required, OECEJ field personnel work closely with the Project Manager/Project Officer to ensure that all of the necessary sampling objectives are met. Prior to sampling, OECEJ field personnel familiarize themselves with the site's QAPP and/or Sampling and Analysis Plan (SAP). To the extent practicable, OECEJ field personnel ensure that their sampling activities are consistent with those specified in the site's approved QAPP and/or SAP. Any deviations between OECEJ sampling procedures and those specified in the sites approved QAPP and/or SAP are discussed with the Project Manager/Project Officer.

Samples collected for compliance and multi-media inspections are transported to the OASQA Regional Laboratory. Occasionally, samples are shipped to a laboratory that is secured by the Region's Sample Brokerage. Analytical data reports are sent to the OECEJ inspector. The inspector shall be responsible for evaluating the analytical results and submitting a written report to the appropriate Region 3 Division/Program Office. The written report shall include the inspector's conclusions regarding the data and its regulatory implication.

Top of page


Section D. Evaluation

PIE graphic
Figure 3. The Quality System PIE

The Region uses a variety of tools (i.e., quality system audits, technical audits, etc.) to ensure that the procedures documented in this QMP are being implemented. These independent audits, reviews and assessments evaluate the conformance of the Region's Quality System with the procedures described in this QMP.

Region 3 uses the terms audit, review, assess, and evaluate interchangeably.

Annually, the RQC will assess the adequacy of QA resources and the level of expertise necessary to support the various programs in the Region. This assessment will evaluate the Region's environmental program activities to determine if the number and type of QA resources are adequate. The assessment will also evaluate the adequacy of intramural and extramural funding to determine if adequate funding is provided for QA-related activities.

The results of this assessment will be documented in the Region's Quality Assurance Annual Report and Work Plan (QAARWP) described earlier. Region 3 Senior Leadership is responsible for making final decisions about the allocation of QA resources.

Top of page


D.1. Assessment Tools

Selection of the appropriate assessment tool depends upon whether a quality system or technical system is being assessed. Technical system assessment tools are also dependent upon the stage of the project being assessed. The following table outlines the types of assessment tools that may be used in Region 3.

Quality System Assessments

Level Appropriate Tool Comments
Assessment of Quality System Quality System Assessment (QSA) Assesses conformance to a documented quality system through collection of information and documented evidence of implementation.

Technical (Project-level) Assessments

Project Stage Appropriate Tool Example(s)
Planning QA Project Plan Review; Site Scoping Meeting and/or Visit QAPP Review; Peer Review
Sampling Technical Systems Audit Field Sampling Audit
Analysis Technical Systems Audit Laboratory (Field or Fixed) Audit; Proficiency Testing Sample
Data Evaluation/Assessment Data Audit Data Audit Inspection; Data Verification and Validation
Data Usability Data Quality Assessment Data Quality Assessment; Usability Report; Peer Review

Top of page


D.1.a. Dispute Resolution

If disputes are encountered as a result of evaluations, the dispute resolution process as defined in Section A.5 of this QMP shall apply.

Top of page


D.2. Quality System Assessments

Each year, the RQAM and RQC shall evaluate the Region's conformance with the EPA Order 5360.1 A2 (CIO Policy 2105.0) (PDF) (12 pp, 94K) and the EPA Quality Manual, 5360 A1 (CIO Procedure 2105-P-01) (PDF) (63 pp, 369K). Each October, the RQAM requests, compiles, and reviews information regarding Regional quality resources and activities, including: 1) quality management resources; 2) QA/QC training; 3) quality system-related accomplishments; and 4) assessments of quality and technical systems. For any area found to need improvement, an action plan is developed and incorporated in the QA Annual Report and Work Plan. The QAAWRP will summarize the findings of each QSA conducted during the previous fiscal year. A summary of corrective actions initiated as a result of these QSAs shall also be included. The RQC shall use these reports to inform decisions on the QA priorities for the following year.

Top of page


D.2.a. Internal Quality System Assessments

It is the goal of Regional Quality Council to conduct an internal QSA of at least one division/office per year, and complete QSAs on all divisions/offices within a 3-year cycle. The RQAM and RQC are responsible for regional-level QSAs of each division/office. The RQAM shall be responsible for assembling the assessment team and coordinating activities. At a minimum, the team shall consist of the RQAM (or designee) and at least one member of the RQC. The team may also include a member of the OASQA Quality Assurance Staff and a representative from outside the program being assessed. The audited Division or Program Office's QA Coordinator shall assist the QSA Team in handling the logistics of the assessment and scheduling interviews.

Upon completion of the assessment, the preliminary results of the regional-level QSA shall be shared with the Division or Program Office's Senior Leadership during an exit briefing. Approximately 60 days following the QSA, the assessment team shall submit a written draft findings report documenting the results of the QSA to the Division or Program Office's Senior Management. Findings may include noteworthy accomplishments and/or objective evidence of non-conformance with the organization's quality system. The Division or Program Office shall review the draft findings report to ensure it accurately describes the QA procedures being implemented by their organization. The Division or Program Office shall then provide the assessment team with formal comments on the draft findings report. If the QSA team concurs with these comments, the findings report shall be revised and finalized. If concurrence with the formal comments can not be achieved, dispute resolution specified in Section A.5 shall be used to achieve consensus on the content of the final findings report. The assessment team shall submit the final report to the Division or Program Office's Senior Management.

Upon receipt of the final findings report, the Division or Program Office shall prepare a written corrective action plan and submit it to the RQC. The Corrective Action Plan must identify the corrective action, responsible official(s), and the projected completion date for each finding requiring corrective action. Upon acceptance by the RQC, implementation may begin. The Division or Program Office's QA Coordinator and the RQC shall periodically review the status of the Division or Program Office Corrective Action Plans.

All members of the assessment teams shall be familiar with the QA requirements found in EPA Order 5360.1 A2 (CIO Policy 2105.0) (PDF) (12 pp, 94K) and this QMP. The individuals should also have professional knowledge of chemical and biological principles, theories, practices and established methods. Knowledge of the principles and practices of quality assurance and the ability to adapt these applications to Agency programs is also desired.

Information found in EPA's Guidance on Assessing Quality Systems, QA/G-3, March 2003 (PDF) (83 pp, 555K) may be used in the development of the QSA. A standard checklist, developed by the RQAM (the Quality System Audit Checklist (PDF) (7 pp, 101K), is used to help ensure that the appropriate QA requirements are evaluated during the QSA. During the QSA, managers and active participants in the organization's quality system are interviewed. Project files, previous audit reports and corrective action plans are also reviewed.

Likewise, it is the goal of each division/office to conduct a QSA of at least one program element within its division/office per year. More frequent review may be needed if serious deficiencies are detected. The respective division/office QAC and line managers are responsible for the assessments of program elements within the respective division/office. Assessments conducted at the division/office level follow similar procedures as discussed above, depending upon the program element assessed, with one exception. The RQC is not typically involved in the briefing, reporting, or corrective action processes. The RQC may be employed in the event of disputes. Further details on the procedures for planning, conducting, documenting, and reporting QSAs at the division/office level are documented in the QMP of each respective division/office.

Top of page


D.2.b. Independent External Assessments

Independent assessments are conducted by the OEI Quality Staff, the Office of Inspector General, the Government Accountability Office, or Headquarters' program office personnel. The frequency of these assessments is determined by the office conducting the QSA. In the case of the OEI Quality Staff, a quality review of Region 3's Quality System occurs every three years. The quality review may take the form of a traditional QSA or a newly implemented review process known as the Quality Program Assessment Visit (QPAV).

For the traditional QSA, a team consisting of members from the OEI Quality Staff and at least one person from another Region or EPA Headquarters Program Office conducts the review. The scope of their assessment is determined by the OEI QSA Team, but generally involves the review of quality-related documents and interviews of Regional management and staff. The QSA focuses on conformance to quality requirements and practices and effectiveness of management controls prescribed in the organization's QMP. Conclusions are supported by detailed review of quality assurance planning documents and project records.

The findings of the OEI QSA are documented in a Draft Findings Report. After the Region's Senior Management and the OEI QSA Team reach consensus on the accuracy of the observations made in the QSA Draft Findings Report, the Findings Report is finalized. If corrective actions are required, the RQC with input from Senior Managers shall develop the Region's Corrective Action Plan. Milestones will be developed so that progress on corrective actions can be measured. This information will be included in the assessment file, which is maintained by the RQAM, or designee. Region 3 managers are responsible for ensuring compliance with the approved corrective actions. The RQC will periodically provide Senior Managers with information about the Region's progress on implementation of the Corrective Action Plan.

The framework for the QPAV includes the elements (planning, conducting, reporting) defined in the traditional QSA. However, the QPAV is different in the approach to evaluating the effectiveness of an organization's quality program. In the effort of continuous improvement, the QPAV seeks to better understand the successes and challenges in implementing the organization's quality program, from management's perspective. Dialogue between the Region's Senior Management and the Quality Staff Director provides a dynamic forum to discuss what is working well, to identify program-specific opportunities for improvement, and to address concerns with implementing CIO 2106.0 (PDF) (11 pp, 129K). Lack of corrective action from this approach encourages open discussion and sharing of ideas. Success of the QPAV will be evident in: (1) cross-Agency implementation of comprehensive approaches to life cycle management of information quality, (2) customer satisfaction with the utility of the Region's disseminated products and services, and (3) the development of measurable performance metrics for EPA's Quality Program.

In either case, the RQAM and RQC assists the OEI QSA team by handling the logistics and scheduling interviews.

Top of page


D.3. Technical Systems Audits

The goal of the technical systems audit (TSA) is to determine whether environmental data operations and related results comply with the project's QAPP and other planning documents. A TSA compares the implemented activity against the documented (i.e., QAPP, SOP, manual, etc.) activity. TSAs may also be used as an investigative tool when problems are suspected. It is usually project-specific, and is usually conducted in the field or laboratory.

A technical systems audit is a systematic and objective examination of the facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management and analysis, and reporting aspects of an environmental measurement system.

Grantees with approved QMPs may conduct TSAs of their own environmental data operations. In some instances, Region 3 is required by regulation to conduct TSAs of certain delegated program activities (e.g., state drinking water analysis laboratories and state ambient air quality monitoring networks). To maximize the efficient use of resources, Region 3 will often times combine the TSA with mid- and end-of-year program reviews. EPA remedial and field investigation team contractors are required to conduct TSAs of their own environmental data operations.

At a minimum, each QAPP shall include the scope and frequency of TSAs to be conducted during the life of the project. The QAPP shall also include the title(s) of individual(s) responsible for conducting the TSA and the procedures to be used to implement corrective actions. The QAPP reviewer shall ensure that information about TSAs is documented in the QAPP. The Project Manager or Project Officer is responsible for ensuring the specified TSAs are accomplished. The individuals conducting the technical system audit should be knowledgeable of the procedures being audited. These individuals should also have professional knowledge of chemical and biological principles, theories, practices and established methods. Extensive knowledge of the principles and practices of quality assurance and the ability to adapt these applications to Agency programs is also required.

All programs in the Region that employ environmental data operations are subject to a TSA. EPA's Guidance on Technical Audits and Related Assessments for Environmental Data Operations, EPA QA/G-7, January 2000 (PDF) (101 pp, 254K) may be used as a resource for planning, conducting, evaluating and documenting technical systems audits and related assessments. The RQAM (or designee) shall ensure that a description of applicable TSAs is included in all QMPs and that all QMPs include the title(s) of the individual(s) responsible for conducting TSAs.

Top of page


D.4. Laboratory Audits

The OASQA Technical Director, with the support of OASQA staff, conducts assessments of laboratories that support the National Pollution Discharge Elimination System (NPDES) program and the Safe Drinking Water Act (SDWA) program. OASQA personnel may also conduct assessments of laboratories being used by some Superfund Potentially Responsible Parties (PRPs). Sample Brokerage personnel conduct assessments of laboratories that participate in the Contract Laboratory Program and the Regional laboratory contract procurement process. OASQA also performs inspections under the National Environmental Laboratory Accreditation Program (NELAP) for the review of Accrediting Bodies (AB).

Top of page


D.4.a. National Pollution Discharge Elimination System

OASQA conducts laboratory assessments of National Pollution Discharge Elimination System (NPDES) permittees' and commercial laboratories analyzing compliance samples. Inspections are performed at the request of and in partnership with the State Authority and may be announced or unannounced to the facility. The goals of these assessments are to:

  • improve Discharge Monitoring Reports Quality Assurance (DMRQA) performance;

  • provide technical assistance to States that have limited expertise in certain analytical methodology;

  • improve analytical QA/QC procedures; and

  • improve documentation procedures.

A DAI consists of recalculating the results from unprocessed instrument results and comparing them to the results reported on the Discharge Monitoring Reports (DMRs).

During the DMRQA laboratory assessments, analytical procedures; sampling procedures; equipment; instrumentation; record keeping; documentation; analytical data and Proficiency Testing (P/T) sample results are reviewed. A Data Audit Inspection (DAI) is also conducted. If routine problems are found in the P/T sample results, a more extensive tracking of P/T sample results will occur until successful performance is achieved. Laboratory assessment reports are completed within 30 days of the assessment and follow-up corrective actions are tracked (corrective action reports are required within 45 days of the assessment through the issuance of a Deficiency Notice). The OASQA Technical Director is responsible for tracking corrective actions for NPDES permittee laboratories and commercial laboratories analyzing compliance samples. The procedures employed are described in NPDES Self-Monitoring Data and Data Inspections DAIs, EPA-903-R-94-043, Fall 1994.

Top of page


D.4.b. Safe Drinking Water Act

OASQA performs laboratory inspections of Region 3 State Laboratories using procedures specified by the Agency's Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004, January 2005 (or most current version) and the OASQA SOP, On-site Laboratory Assessments in the Drinking Water Laboratory Certification Program, R3-QA801.0, September 2001 (or most current version). The procedures for the Data Audit Inspections are similar to those described above. On-site assessments are conducted every three years and corrective actions are tracked and official certification update reports are issued. The OASQA Technical Director is responsible for tracking corrective actions. OASQA also performs reviews of the Region 3 State Safe Drinking Water Act (SDWA) Laboratory Certification Programs as per the laboratory certification manual. Every three years, the assessments and program are reviewed by the Office of Ground Water and Drinking Water through yearly questionnaires and on-site inspection.

Top of page


D.4.c. Laboratories Used by Potentially Responsible Parties

OASQA personnel may conduct limited inspections of laboratories used by Region 3 Superfund Potentially Responsible Parties (PRPs). The Region 3 Hazardous Site and Cleanup Division (HSCD) selects the PRP laboratories to be inspected. These laboratory inspections are conducted in accordance with the procedures found in the Standard Operating Procedure for Onsite Inspection of Superfund PRP Monitoring Procedures, December 2000 (or most current version). The procedures for the Data Audit Inspections are similar to those described above. The PRP laboratory inspections include the review of PT sample results; the site's QAPP and/or SAP; and the site's third party data validation reports. Prior to distribution of the laboratory inspection findings report to the appropriate HSCD Project Officer, the report shall be reviewed by the OASQA Quality Assurance Staff. The OASQA Technical Director is responsible for tracking the corrective actions for PRP laboratories.

Top of page


D.4.d. Contract Laboratory Program

The Contract Laboratory Program (CLP) Project Officer conducts annual on-site audits of CLP laboratories located in Region 3. These audits are conducted in accordance with procedures found in the applicable CLP Statement of Work. The national Contract Laboratory Program processes the data through an automated Data Assessment Tool (DAT). DAT is a complete data assessment package that incorporates Contract Compliance Screening (CCS) and data usability reviews to provide EPA Regions with electronic data usability and compliance reports, spreadsheets, and files within 24 to 48 hours from the receipt of data from laboratories. This automated tool facilitates the transfer of analytical data into Regional databases. In addition to the Regional electronic reports, the CLP laboratories are provided with a data assessment report that documents the instances of non-compliance. The CLP Quality Assurance and Technical Support (QATS) contractor performs data evaluation and review services. This three-step review process provides the CLP customer with data of known and documented quality.

When the data package is delivered to the Regional Sample Control Center, the package is subject to an evidentiary audit to evaluate the documentation for chain-of custody and sample handling procedures. It also undergoes a data validation process following the National Functional Guidelines (most current version), to further assess the quality and usability of the data.

The above described activities are used to assess a CLP laboratory's overall performance. Corrective actions from these laboratory checks are monitored by the Region 3 CLP Project Officer. If there are significant contract non-conformances, the Region 3 CLP Project Officer forwards this information to the National CLP Program Manager and Contracting Officer for appropriate action. This action may include the rejection of data and/or a reduction in payment.

Top of page


D.4.e. Other Analytical Services

For the analysis of samples for non-CLP methods, the Region contracts laboratories via its own procurement process. Whenever possible, the Region will use laboratories participating in the CLP for non-CLP analytical services. The use of a CLP laboratory, provides the Region with access to information about a laboratory's performance (i.e., quarterly blind Proficiency Testing sample results, on-site audit reports, etc.). Prior to contract award, laboratories must provide a copy of their quality manual, which should include the laboratory's quality policy; a description of the laboratory facilities; a list of personnel with qualifications; measurement and calibration procedures; procedures for data review and corrective action procedures. For nonroutine methods, the laboratory must also submit an initial demonstration of capability for the non-routine method. OASQA evaluates the laboratory's quality documentation to determine its capability to conduct the requested analyses.

OASQA also conducts on-site audits of the regionally contracted laboratories. The procedures in the applicable CLP Statement of Work may be used to conduct these on-site audits. If applicable, the CLP on-site audit checklist may be used for specific analytical fractions (i.e., volatiles, semi-volatiles, pesticides, metals, cyanide, etc.). The Regional contract laboratory data is subject to the same evidentiary audit and data validation procedures as CLP data. Corrective actions are monitored by the Region 3 Project Officer. If significant contract nonconformance is found, the Region 3 Project Officer may recommend rejection of the data and/or reduction in payment.

Top of page


D.4.f. National Environmental Laboratory Accreditation Program

OASQA participates in inspections under the National Environmental Laboratory Accreditation Program (NELAP) for the review of Accrediting Bodies (AB). The procedures for conducting these inspections are documented in Chapter 6 of the National Environmental Laboratory Accreditation Conference (NELAC) standards Exit EPA Disclaimer. The results of the inspections are documented in a checklist. Findings are resolved with the ABs and the final reports are sent to the NELAP Board for final review and approval. The program's procedures, assessments and accreditation are reviewed annually by the NELAP Board as described in Chapter 6 of the NELAC standards.

Top of page


D.5. Proficiency Testing Samples

A Proficiency Testing (P/T) sample is used as a quantitative audit of analytical results generated by a measurement system. Whenever possible, the proficiency testing sample shall mimic the matrix of the routine field sample. The concentration of the P/T sample shall be unknown to the analyst. The results of the P/T sample are used to determine if a measurement system's results are within the measurement quality objectives specified by the Program (i.e., CLP, Drinking Water, Quality Assurance Technical Support laboratory, etc.) or found in the QAPP. The procedures being used for the acquisition and evaluation of proficiency testing samples shall be included in the QMP, Laboratory Quality Manual or project QAPP.

Top of page


D.6. Data Verification & Validation

Data verification and data validation are key steps in the assessment phase. Data verification is the process of evaluating the completeness, correctness, and conformance/compliance of a specific data set against the method, procedural, or contractual requirements. The goal of data verification is to ensure and document that the reported results reflect what was actually done. Data verification may be performed by personnel involved with the collection of samples or data, generation of analytical data, and/or by an external data verifier. Some programs may require the conduct of external data verification upon receipt of data packages to confirm the completeness of the data package and to permit authorization of payment for the work.

Data validation is an analyte- and sample-specific process that extends the evaluation of data beyond verification to determine the analytical quality of a specific data set. The goal of data validation is to evaluate whether the data quality goals established during the planning phase have been achieved. Data validation is typically performed by person(s) independent of the project activity. The appropriate degree of independence will be determined on a program specific basis. At a minimum, the individual(s) conducting the validation should not belong to the same organizational unit with immediate responsibility for producing the data set. Data quality indicators (such as precision, bias, comparability, sensitivity, representativeness, and completeness) are typically used as expressions of the quality of the data.

Personnel performing data verification and validation should have professional knowledge of chemical and biological principles, theories, practices and established methods, statistical techniques commonly used in quality control, data assessments, and data management practices. Extensive knowledge of the principles and practices of quality assurance and familiarity with the project-specific data quality indicators is also necessary. The specific procedures and title(s) of the individual(s) responsible for data verification and validation shall be included in the project's QAPP or SAP. Results of the data verification and validation should be documented and provided to the Project Manager/Project Officer. EPA's guidance documents Guidance on Environmental Data Verification and Data Validation, EPA QA/G-8, November 2002 (PDF) (96 pp, 387K) and US EPA's Contract Laboratory Program National Functional Guidelines, available at http://www.epa.gov/superfund/programs/clp/guidance.htm may be used to conduct the data verification and validation processes.

Top of page


D.7. Data Quality Assessment

The scope of the DQA should be commensurate with the project objectives and intended use of the data. EPA's guidance documents Data Quality Assessment: A Reviewer's Guide (PDF) (61 pp, 255K), EPA QA/G-9R, February 2006 and Data Quality Assessment: Statistical Methods for Practitioners (PDF) (198 pp, 2.4MB), EPA QA/G-9S, February 2006, may be used to conduct the DQA. The specific procedures to be followed for data quality assessments shall be included in the project's QAPP or SAP. The title(s) of the individual(s) responsible for the DQA process shall also be included in the project QAPP or SAP. The results of the DQA should be documented and provided to the Project Manager/Project Officer.

A Data Quality Assessment (DQA) is the scientific evaluation of data to determine if they meet the planning objectives of the project, and thus are of the right type, quality, and quantity to support their intended use.

At a minimum, all environmental data shall be reviewed to ensure that the analytical measurement criteria specified in the approved QAPP has been achieved. Data shall be qualified in accordance with the data validation criteria specified in the approved QAPP.

Top of page


D.8. Peer Review

Peer review is intended to uncover any technical problems or unresolved issues in a preliminary work product through the use of independent experts. This information is then used to revise that draft product so that the final work product will reflect sound technical information and analyses. Peer review is a process for enhancing a scientific or technical work product so that the decision or position taken by the Agency, based on that product, has a sound, credible basis. To be most effective, peer review of a scientific and/or technical work product should be incorporated into the up-front planning of any action based on the work product - this includes obtaining the proper resource commitments and establishing realistic schedules. Peer review takes many different forms depending on the nature of the work product, relevant statutory requirements, and office-specific policies and practices. It is Region 3 practice that Project Managers/Project Officers, in consultation with their first line supervisors, senior managers and technical staff, will make the decision on whether his/her project should be peer reviewed and what level that peer review will take. When applicable, Region 3 follows the procedures and guidance found in EPA's Peer Review Handbook, 3rd Edition, EPA/100/B-06/002, 2006.

Top of page


D.9. Quality Improvement

The quality assurance procedures described in this QMP establish a foundation for ensuring that data of acceptable quality for its intended use will be used to make environmental decisions. One of the goals of the Region 3 Quality System is to incorporate quality assurance as a critical component of all the work functions within our programs.

All Regional personnel are encouraged to raise issues that impact the quality of data and information being generated and/or used by the Region. Issues should be raised to the designated Division or Program Office QA Coordinator. If these issues impact more than one Division or Program Office, the QA Coordinator will facilitate a discussion of the issue during the scheduled RQC meeting. Based on these discussions, the RQC will make a recommendation to Senior Management about ways to resolve the issue and improve the Region's Quality System. If the issue requires immediate action, it will be forwarded to the Senior Management Representative to the RQC. The Senior Management Representative to the RQC will then determine the appropriate mechanism to resolve the issue. Whenever possible, the RQC will be involved in discussions about issues that impact the Region's Quality System.

Top of page


Section E. Infrastructure

E.1. Qualifications and Training

Region 3 Policy

It is Region 3's policy to provide the training necessary to ensure that all persons involved in handling environmental data understand the Region's Quality System.

All Regional personnel involved with environmental data operations shall be required to have the appropriate QA training. It shall be the responsibility of the Directors of all Region 3 Divisions and Program Offices to ensure that the individuals in their organizations meet the minimum QA training requirements for their assigned activities. The following sections describe Region 3's QA training program and the requirements for Regional personnel involved with environmental data operations.

Top of page


E.1.a. Region 3 QA Training Program

The Region is committed to ensuring that all personnel have the necessary skills to effectively accomplish the tasks that have been assigned. To facilitate this process, it is imperative that all individuals involved with environmental data operations obtain information about EPA QA requirements and understand their QA roles and responsibilities.

Each Region 3 Division or Program Office shall determine their organization's QA training needs in accordance with the procedures specified in their Division/Program Office QMP. EPA's Guidance for Developing a Training Program for Quality Systems, EPA QA/G- 10, December 2000 (PDF) (58 pp, 190K) may be used as a tool for this exercise. Senior Managers must ensure that adequate resources are available to implement the Region 3 QA Training Plan. Annually, the RQC shall review these QA training needs to determine if the training needs for Divisions and Programs are similar. When similar QA training needs have been identified, the RQC shall determine the feasibility of offering a Region-wide QA training course(s). The RQC shall then identify the most cost-effective method(s) to obtain Region-wide QA training.

The implementation of QA requirements for extramural agreements is a critical component of the Region's Quality System. Project Managers/Project Officers/Work Assignment Managers are responsible for assisting major assistance agreement holders obtain necessary QA-related training.

This section describes the desired core Region-wide QA training courses, the program logistics, associated documentation and requirements. The Region is in the process of rebuilding its QA training program.

Top of page


E.1.b. Courses

Table E.1 describes the core QA courses that are being developed and offered to Region 3 personnel and Region 3 state and local government agencies. More courses may be developed as additional training needs are identified.

Table E.1. Core Quality Assurance Courses

Course Title Description
Region 3 Quality System Awareness A detailed overview of the Agency's quality system requirements and how they are implemented in Region 3.
Systematic Planning for Environmental Data Operations This course shall provide an overview of systematic planning. During this course, participants will learn the elements of a systematic planning approach based on the scientific method.
Quality Assurance Project Plans This course shall provide an overview of the twenty-four QAPP elements found in QA/R-5 and the UFPQAPP. During this course, the need for systematic planning and EPA's graded approach to project plan development shall be emphasized. Based on the training needs of the audience, the course may either focus on how to write a QAPP or how to review a QAPP.
Data Evaluation This course shall provide an overview of data validation and usability. Participants will acquire knowledge of 1) the importance of data validation; 2) Region 3's data validation procedures; and 3) the usability of data against project objectives.
Information Quality Guidelines Participants will acquire: 1) knowledge of the origin and intent of the 2001 Data Quality Act; 2) information on the implementation of EPA's Information Quality Guidelines (IQGs); 3) insight on managing IQG requests; and 4) appreciation of the impact of the IQGs on enhancing EPA's Quality System.
QA Refresher (On-line - under development) A briefing on updates/changes to the quality system; required for Region 3 staff every 2 years to maintain QA proficiency.

Top of page


E.1.c. Logistics

The Region 3 QA training program shall be administered through a collaborative effort between the Region's EAID and the RQC. Additional training support for non-routine topics may be provided by the OEI Quality Staff, other Regions, other Federal Agencies, local universities, contractors and professional organizations. The Region 3 OPM shall arrange for training announcements and training rooms. When additional QA training is required, Program Managers shall forward this training request to their Division or Program Office QA Coordinator, who is then responsible for bringing it to the attention of the RQAM and RQC.

Top of page


E.1.d. Documentation of Training

After completion of each QA training course, attendees shall receive a certificate of completion from the organization providing the training. For this reason, attendance at all courses shall be recorded. OPM shall maintain a record of all QA training taken by all personnel. This record shall be maintained in OPM's training data base. Upon request, OPM shall provide Division and Program Office Directors with a list of individuals within their Division/Program Office who have completed core QA training courses. Division and Program Office Directors shall use this information to determine whether appropriate members of their staff meet the minimum training requirements for their assigned activities. At the end of each fiscal year, the RQAM or designee shall provide a summary of the QA training courses that have been offered in the Region in the QA Annual Report and Work Plan. This summary shall include, but is not limited to the courses offered, the number of attendees and a list of all non- EPA participating organizations.

Top of page


E.1.e. Training Requirements

Table E.2 illustrates the required QA-related training courses by functional role/title.

Table E.2. Training Requirements by Functional Role/Title

Region 3 Quality System Awareness Systematic Planning for Environmental Data Operations Quality Assurance Project Plans Data Evaluation Quality System Assessment Information Quality Guidelines Refresher
Regional Administrator & Senior Leadership X
(briefing only)
        X
(briefing only)
 
Program Managers (Branch Chiefs / Section Chiefs / Team Leaders) X         X X
Project Managers / Project Officers / Work Assignment Managers / etc. X X X X   X X
Regional QA Manager X X X X X X X
Regional QA Officer X X X X X X X
Quality Assurance Coordinators X X X X X X X
Information Quality Guidelines Officer X         X X
Technical Services Branch QA Staff X X X X X X X
Client Services Staff X X X X X X X
Laboratory Branch & Freshwater Biology Team per respective Laboratory Quality Manuals

Top of page


E.2. Procurement and Financial Assistance

E.2.a. Procurement - Contracts

The Contracts Branch within the Office of Policy and Management is responsible for developing and keeping current Regional purchasing policies and procedures. Quality assurance requirements for contracts are set forth in the EPA Contracts Management Manual (CMM) [Intranet] Section 7.3.5.3 and Chapter 46 and the Federal Acquisition Regulation (FAR) 46.202-4 and 52.246-01. All procurements originating in Region 3 must meet established quality assurance requirements contained in the EPA CMM and FAR.

In order to assure that contractually procured environmental data operations are scientifically valid, defensible, and of known precision and accuracy, Contract Project Officers, Contracting Officer Representatives, and Contracting Officers are responsible for adhering to EPA's Guidance for Use of Higher-Level Contract Quality Requirements in Acquisitions, Procurement Policy Notice 01-02, March 2001. Requirements include the Quality Assurance Review Form for Contract Actions (PDF) (5 pp, 148K). The QA Review Form shall be completed and signed by the Project Manager/Project Officer. The Project Manager/Project Officer signature indicates that the agreement clearly describes the item or service needed and that associated technical and quality requirements are defined. The RQAM reviews and signs the QA Review Form to assure that all environmental data operations contractually funded by EPA are in compliance with EPA Order 5360.1 A2 (CIO Policy 2105.0) (PDF) (12 pp, 94K). Where QA requirements apply, the Contracting Officer will assure that quality assurance terms and conditions are included in contract statements of work. The quality assurance term and condition requires contractors to document its quality system in a Quality Management Plan and submit quality assurance project plans or appropriate planning documents that meet EPA program-specific project goals and objectives. The EPA Project Manager/Project Officer will assure that the contractor complies with the conditions and deliverables.

Region 3 Policy

Contracts procured by Region 3 (as opposed to those originating at Headquarters) involving environmental data operations shall submit a QMP prepared in accordance with the specifications provided in the most current version of EPA Requirements for Quality Management Plans, QA/R-2 (PDF) (30 pp, 86K).

The QMP documents and describes the quality system implemented by the applicant. The QMP shall be reviewed and approved by the EPA Contracting Officer, the EPA Project Manager/Project Officer, and the RQAM as described in Section A.8.c of this QMP as a condition for award of any contract. The QMP should ideally be submitted as part of the application.

If the QMP is not submitted as part of the application and EPA decides to award the contract, EPA will include a term and condition in the contract. This term and condition requires the recipient to submit the QMP within a specified time after award of the contract and notifies the recipient that they may not begin work involving environmental data operations until the EPA Contracting Officer informs them that the QMP has been approved.

The contractor shall also be required to submit QAPPs to EPA for review and approval by the EPA Project Manager/Project Officer according to the procedures described in Section B.3.b of this QMP prior to undertaking any work involving environmental programs.

Region 3 typically employs the use of contract vehicles procured at the headquarters level; however, when a contract originates at the regional level and involves the generation and/or use of environmental data, the RQAM or an individual knowledgeable in QA (e.g., a member of the Quality Assurance Staff or the division/office Quality Assurance Coordinator) may be included as part of the Technical Evaluation Panel (TEP) to evaluate the satisfaction of technical and quality requirements. The TEP develops the evaluation criteria and the Statement of Work for the solicitation and performs the technical evaluation of offers. Ultimately, the Project Manager/Project Officer is responsible for ensuring that procured items and services conform to specifications and needs of the program prior to payment as well as throughout the life of the contract or purchase. The quality requirements of the items or services to be purchased for a given program are defined in its Division/ Program Office QMP. The quality requirements of the items or services to be purchased for a given project are defined in the project QAPP, SOP or other planning document. When program needs/requirements change and the changes affect the technical specifications of the required goods and services, these changes need to be documented in the applicable QMP, QAPP, SOP or other planning document prior to initiating additional purchases or change orders.

Top of page


E.2.a.1. Small Purchases
Region 3 Policy

Procurement of environmentally related measurements or data generation which qualifies as small purchases under the Federal Acquisition Regulations (FAR) is subject to QA requirements.

Procurements qualifying as small purchases must meet established administrative and QA requirements of the Federal Acquisition Regulations (FAR), Federal Information Resources Management Regulations (FIRMR), Delegation 1-84 (1200 TN310), Office of Information Resource Management (OIRM) Delegation 1-10A (September 27, 1991), ARM's EPA Acquisition Regulations, and Chapters Four and Six of OIRM's Information Resources Management Policy Manual, July 1987 and Region 3 Order 5361.5, Site Location Identification Policy and Responsibilities. Bankcard, blanket purchase order, and federal supply schedule procurements involving environmental data operations will adhere to the above Region 3 requirements.

Top of page


E.2.a.2. Procurement of Analytical Services

Procurement of analytical services obtained through the Region's Sample Brokerage, including the Superfund CLP, Headquarters' non-Routine Analytical Services (non-RAS) contracts, and regionally awarded contracts are subject to QA requirements.

In order to request analytical services, the requester, usually a Project Manager/Project Officer, must produce an approved QAPP or SAP. The QAPP or SAP includes information such as project objectives, number of samples to be collected and analyzed, parameters of interest, reporting limits, and other QA requirements. The QAPP and/or SAP are used to develop the analytical requirements for the procurement, which are incorporated into the Analytical Request Form.

When the analytical requirements are approved, Sample Brokerage personnel, in consultation with the requester, apply the Field and Analytical Services Team Advisory Committee (FASTAC) process to determine the most appropriate mechanism to acquire the data. The data may be acquired via one of the following mechanisms in the order presented:

  1. EPA Regional Lab
  2. CLP lab
  3. Regional contract
  4. Field contractor subcontract

If data are to be acquired via # 3, Regional contracts, Sample Brokerage personnel create a bid solicitation form that incorporates the approved analytical requirements. The bid solicitation is distributed to participating commercial labs for price quotations. Participating labs must provide the most current version of their Quality Manual for review. The lab's Quality System, as documented in the Quality Manual, is assessed to ensure that it conforms to the requirements found in the most recent version of ISO 17025, NELAC Chapter 5 or ANSI/ASQC Q2-1991. If the laboratory's documented quality system is acceptable, the laboratory's solicited bid is considered.

All environmental data acquired through the Sample Brokerage is reviewed to determine whether it meets the analytical requirements specified in the QAPP/SAP and analytical request. Remedies, including request for additional information, data qualification, and/or payment penalties may be applied to data that does not conform to requirements.

Top of page


E.2.b. Financial Assistance

E.2.b.1. Grants and Cooperative Agreements
Region 3 Policy

All applicants for grants or cooperative agreements involving environmental data operations shall submit a QMP prepared in accordance with the specifications provided in the most current version of the EPA Requirements for Quality Management Plans, QA/R-2 (PDF) (30 pp, 86K).

EPA quality assurance requirements for grants and cooperative agreements are contained in 40 CFR 30 for universities and other non-profits and 40 CFR Parts 31 and 35 for state, tribal, and local governments.

The QMP documents and describes the quality system implemented by the applicant. The EPA Project Manager/ Project Officer will ensure the agreement clearly describes the item or service needed and that associated technical and quality requirements are defined. The Project Manager/Project Officer will also indicate on the Funding Recommendation whether the project involves environmental data operations. If it does, EPA will insert a term and condition in the grant or assistance agreement per the Region 3 Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000 (Appendix A). The term and condition requires the recipient to submit the QMP within a specified time and notifies the recipient that they may not begin the work involving environmental data operations until the QMP has been approved by the EPA RQAM.

A condition will also be included in the assistance agreement requiring the recipient to submit a QAPP to EPA for review and approval by the EPA Project Officer prior to the initiation of projects involving environmental data operations. The QAPP shall be prepared in accordance with the specifications provided in the most current version of the EPA Requirements for Quality Assurance Project Plans (PDF) (40 pp, 120K), EPA QA/R-5; which describes the quality assurance and quality control activities to be implemented for the work involving environmental data operations.

The Grants Specialist will assure that the terms and conditions are included in the assistance agreements where QA requirements apply. The EPA Project Manager/Project Officer will assure that the grantee complies with the conditions. On a monthly basis, the RQAM reviews notifications of newly awarded grants, cooperative agreements and IAGs to determine whether QA requirements were appropriately addressed. The results of this review is tabulated and distributed to the Division/Program Office QA Coordinators for follow-up.

For certain financial assistance agreements, a combined QMP/QAPP may be supplemented for the individual QMP and QAPP document(s). The appropriateness and content of the combined QMP/QAPP shall be determined by the Project Manager/ Project Officer in consultation with the RQAM, or designee. At a minimum, the combined QMP/QAPP shall adhere to the QAPP requirements specified in Section B.3.b. of this QMP.

Top of page


E.2.b.2. Inter-Agency Agreements
Region 3 Policy

All IAGs with environmental data operations in which Region 3 funds, or participates, shall require an approved QMP, or equivalent document.

When Region 3 is providing funds to another Federal organization, the organization receiving the funds is responsible for preparing the QMP or equivalent document. If the external organization's documented quality system meets the requirements found in the EPA Requirements for Quality Management Plans (PDF) (30 pp, 87K), EPA QA/R-2, March 2001 or the Intergovernmental Data Quality Task Force: Uniform Federal Policy for Implementing Environmental Quality Systems, EPA-505-F-03-001, March 2005, their QMP, or equivalent document shall be acceptable. If comparable QA procedures do not exist, the QA procedures agreeable to both parties must be negotiated for the Inter-Agency Agreements (IAG). Before any environmental data operations can be performed, the external organization must have an approved QMP and QAPP (or equivalent documents) or successfully negotiated and acceptable to both parties. These QA requirements are in accordance with the specifications provided in EPA Requirements for Quality Assurance Project Plans (PDF) (40 pp, 120K), EPA QA/R-5, March 2001 or the Intergovernmental Data Quality Task Force: Uniform Federal Policy for Quality Assurance Project Plans, EPA-505-B-04-900A, March 2005, as appropriate.

In order to document compliance with the above policy, the EPA Project Manager/Project Officer shall indicate in the IAG Program Decision Memorandum (Program Office Authorization for the Award) whether QA requirements apply. If yes, the EPA Grants Specialist will include a special condition in the IAG. The special condition notifies the other Federal agency that they must submit a QMP and QAPP to the EPA Project Manager/Project Officer and that EPA will review and concur on the QA documents (e.g. QAPPs, SAPs and Workplan).

After the IAG is executed by both parties, it is the responsibility of the EPA Project Manager/Project Officer to assure that the recipient of the IAG is in compliance with the QA condition(s).

Top of page


E.2.c. Evaluation of Deliverables

Project Managers/Project Officers establish the framework for monitoring the quality of items or services by incorporating inspection and acceptance criteria into contract statements of work or work plans for grants/interagency agreements. They are responsible for oversight and for ensuring that products delivered are complete, accurate and meet contract, grant, co-operative and interagency agreement requirements. Oversight of contractor QA-related products is accomplished mainly by the efforts of the RQAM, QA Staff and/or other designated technical specialists (e.g., QACs, risk assessors, hydrologists, etc.) as requested by the Project Manager/Project Officer.

Top of page


E.3. Documentation and Records Management

Records include all books, papers, maps, photographs, machine readable materials, or other documentary materials, regardless of physical form or characteristics, made or received by an agency of the United States Government under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the Government or because of the informational value in them. (44 U.S.C. Chapter 33, Sec. 3301).

Maintaining important QA documents and records is a continuous process in the Region. This process serves as a vehicle for identifying quality-related documents and records requiring management control. Moreover, this process serves to assure that QA documents and records are accessible and protected in storage from damage and deterioration. Finally, the process ensures compliance with all statutory, contractual, and assistance agreement requirements for records from environmental programs, while providing adequate preservation of key records necessary to support the mission of the Region.

Region 3 adheres to the most recent version of the following legislation, regulations, guidance and policies as they pertain to program requirements:

Region 3 Policy

It is Region 3's policy to adopt and implement all Agency-approved records management policies and guidance developed and/or directed by the Office of Administration and Resources Management, and the Office of Environmental Information.

  • 44 U.S.C. Chapter 31, Records Management by Federal Agencies;

  • 44 U.S.C. Chapter 33, Disposal of Records;

  • 18 U.S.C. Chapter 101, Records and Reports;

  • Paperwork Reduction Act of 1995;

  • OMB Circular A-130, Management of Federal Information Resources;

  • 36 CFR Chapter XII, Subchapter B

  • Records Management Policy (CIO Policy 2155.0), U.S. Environmental Protection Agency;

  • Managing Cartographic and Architectural Records (Instructional Guide Series), National Archives and Records Administration (NARA);

  • Managing Electronic Records (Instructional Guide Series), NARA;

  • Federal Records Management Laws and Regulations, NARA;

  • Disposition of Federal Records: A Records Management Handbook, NARA Personal Papers of Executive Branch Officials: A Management Guide (Management Guide Series);

  • Records Disposition Schedules, U.S. Environmental Protection Agency [Entering intranet]

  • A User Guide for Getting Started in ECMS E-mail Records, U.S. EPA; and

  • USEPA Region 3 OASQA Records Management Handbook Standard Operating Procedures [Entering intranet]

The Enterprise Content Management System (ECMS) is the official EPA content management program. EPA is currently in the process of rolling out ECMS for email records to each Program Office and Region. Region 3 began limited implementation of ECMS in 2007. Enterprise content management integrates technologies, tools, and methods in order to capture, manage, store, preserve, and deliver content across an enterprise. ECMS will allow the management of unstructured information including images, office documents, graphics, drawings, and print streams, as well as the new electronic objects such as Web pages and content, e-mail, video and rich media assets throughout the content's lifecycle.

The Project Manager/Project Officer is responsible for managing all project level quality-related documents and records (paper and electronic), including transmittal, distribution, retention, access, preservation (including protection from damage, loss, and deterioration), traceability, retrieval, removal of obsolete documents, and disposition, in accordance with the procedures specified in their Division/Program Office QMP. The Project Manager/Project Officer is also responsible for ensuring that records and documents accurately reflect completed work. The RQAM, QACs and QA Staff are responsible for managing all regional quality-related documents and records, including transmittal, distribution, retention, access, preservation (including protection from damage, loss, and deterioration), traceability, retrieval, removal of obsolete documents, and disposition, in accordance with the policies and guidance listed above. Each Division and Program Office is responsible for managing the custody and confidentiality of evidentiary quality-related documents and records in accordance with applicable regulations. Regional Records Center staff and resources are available to assist in carrying out these responsibilities.

Further information about ECMS and records management in general can be found on EPA Region 3's intranet site [Entering intranet], and the EPA National Records Management Program website [Entering intranet]. Region 3 staff may also contact the Records Manager with requests for technical assistance and/or training.

Top of page


E.3.a. Ensuring Documents and Records Accurately Reflect Completed Work

Each office is responsible for establishing and implementing procedures for ensuring consistency and technical accuracy of its work products. It is the Senior Leadership's responsibility to ensure that each Division/Program Office uses established procedures to ensure that disseminated information products are of adequate quality for their intended use and comply with EPA's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency, EPA/260R-02-008, October 2002 and EPA Region 3's Information Quality Guidelines Pre-Dissemination Review, PDR Version 1.1, July 2007.

Top of page


E.4. Computer Hardware and Software

The Environmental Protection Agency's ability to fulfill its mission is dependent upon a strong information technology infrastructure. Mission objectives rely on an infrastructure that is capable of supporting environmental information and dynamic communication among EPA offices. One of the most critical components of the EPA infrastructure is information technology. The hardware, software, and communications components that are encompassed by information technology form the foundation for environmental information and EPA-wide communication. The management of information technology, therefore, is critical to the success of the EPA.

The Office of Environmental Information (OEI) is responsible for managing the EPA's information technology infrastructure and components. In that role, OEI has established information technology standards to manage and ensure that information technology components integrate properly into the infrastructure.

Top of page


E.4.a. Roles and Responsibilities

The Computer Services Branch (CSB) is responsible for local area and wide area network support; managing and operating the regional computer center; providing data communications services; personal computer planning and operational support; information technology security; and management of regional word processing support. CSB also participates in overall information management for the Region in cooperation with the Environmental Assessment and Innovation Division (EAID) and the Information Services Branch (ISB). CSB focuses on desktop applications when participating in information management activities.

ISB is responsible for the life cycle management of information systems (i.e., feasibility study, analysis, design, programming, implementation, testing, operations, maintenance and systems review). It provides management and operational support to the operating divisions for all information systems utilized by the region; and for managing and operating the Regional Center for Environmental Information (RCEI). ISB also participates in overall information management for the Region in cooperation with EAID and CSB for matters concerning information systems.

Top of page


E.4.b. Region 3 Information Management Systems

All information management system development, improvements, and updates will comply with Information Resources Management Policy, CIO Policy 2100.0 to include a systematic and comprehensive dialogue among the data providers, data and system users, and system developers, prior to the design of the system.

It is Region 3 policy to work closely with the Office of Environmental Information on all phases of system development, improvements, and updates. During the operational phases of information management systems, Region 3 will comply with requirements within CIO Policy 2100.0, Information Resources Management Policy Manual and CIO Policy 2121.1, System Life Cycle Management Policy (PDF) (9 pp, 181K). The goal of this process is to have a uniform approach and review of applications under consideration by Region 3. The process will determine if an application has management support, IRM support, is doable in the time frame needed, and is within the resource constraints identified. Compliance with the applicable information resource management standards will ensure that all hardware and software configurations are tested prior to use, to guarantee they perform as expected and meet user requirements.

For information technology contracts that involve applications development, the performance work statement will include, but not be limited to, requirements for system specification reviews; system development plans; data validation and transfer; acceptance testing, and report generation.

Top of page


E.4.c. Data Standards

All Federal agencies are required to adhere to Federally-mandated data standards and regulations. It is the policy of Region 3 to comply with all applicable regulations, guidance, executive orders, and internal policy documents concerning data standards. These include, but are not limited to:

Within EPA, adherence to data standards policy is accomplished through the direction of OEI. EPA's data-related policies apply to all EPA organizations and personnel, including contractors, Senior Environmental Employee (SEE) Program participants, and other personnel assigned to EPA who design, implement, and maintain information management systems for Region 3 and EPA. Additional information on secondary use of environmental information and/or data can be found in Section B.3.d.

Top of page


Appendices

Appendix A:   Quality Assurance Requirements for Grants and Cooperative Agreements

Region 3 Quality Assurance Requirements for
Grants and Cooperative Agreements
November 7, 2000
Quality Management Plan (QMP) Requirement

This QA requirement applies to all grants, cooperative agreements, contracts and interagency agreements that involve the use of environmental data. Environmental data is defined as direct measurements of environmental conditions or releases, such as sample collection and analysis. Environmental data also includes data collected from secondary sources of information, such as computer databases, computer models, literature files and historical databases. This data may be used for a variety of purposes, such as characterization of ecological effects, the health of human populations or the performance of environmental technology.

In accordance with 40 CFR 30.54 and 31.45, the recipient must develop and implement quality assurance policies and practices that are sufficient to produce data of adequate quality to meet program objectives. These policies and practices must be documented in a Quality Management Plan (QMP). The QMP should be prepared in accordance with EPA QA/R-2: EPA Requirements for Quality Management Plans. EPA QA/R-2 replaces EPA guidance document QAMS-004/80. The recipient's QMP should be reviewed and updated annually as needed.

Should there be multiple programs involved in a grant, cooperative agreement or interagency agreement, at the recipient's discretion, they may submit one of the following:

  1. A single QMP covering all of the programs in the grant or agreement or
  2. A separate QMP for each program receiving the grant or agreement funds.

For certain grants and agreements, the EPA Project Officer may allow the recipient to submit a combined Quality Management Plan/Quality Assurance Project Plan (QMP/QAPP). The minimum EPA requirements for a Quality Management Plan and a Quality Assurance Project Plan must be included in the combined QMP/QAPP.

The QMP or combined QMP/QAPP must be submitted to the EPA Project Officer at least 45 days prior to the initiation of data collection or data compilation. Prior to environmental data collection or data compilation, the QMP or combined QMP/QAPP must be approved by the EPA Regional Quality Assurance Manager.

Quality Assurance Project Plan (QAPP) Requirement

This QA requirement applies to all grants, cooperative agreements, contracts and interagency agreements that involve the use of environmental data. Environmental data is defined as direct measurements of environmental conditions or releases, such as sample collection and analysis. Environmental data also includes data collected from secondary sources of information, such as computer databases, computer models, literature files and historical databases. This data may be used for a variety of purposes, such as characterization of ecological effects, the health of human populations or the performance of environmental technology.

In accordance with 40 CFR 30.54 and 31.45, the recipient must develop and implement quality assurance and quality control procedures, specifications and documentation that are sufficient to produce data of adequate quality to meet project objectives. The Quality Assurance Project Plan (QAPP) is the document that provides comprehensive details about the quality assurance/quality control requirements and technical activities that must be implemented to ensure that project objectives are met. The QAPP should be prepared in accordance with EPA QA/R-5: EPA Requirements for Quality Assurance Project Plans. EPA QA/R-5 replaces EPA QAMS 005/80.

The QAPP must be submitted to the EPA Project Officer at least 30 days prior to the initiation of data collection or data compilation.

Prior to environmental data collection or data compilation, the QAPP must be approved by the EPA Project Officer. When the recipient is delegating the responsibility for an environmental data collection or data compilation activity to another organization, the EPA Regional Quality Assurance Manager may allow the recipient to review and approve that organization's QAPP.

QA Requirement for Lead Grants (Combined QMP/QAPP)

For lead grants, the recipient must develop a combined QMP/QAPP that meets the requirements found in the Region 3 Lead Program Quality Assurance Project Plan Guidance. A copy of this guidance document can be obtained from the Region 3 Hotline. The hotline number is 1 (800) 438-2474. The combined QMP/QAPP must be submitted to the EPA Project Officer at least 30 days prior to the initiation of data collection or data compilation. Prior to environmental data collection or data compilation, the combined Lead QMP/QAPP must be approved by the EPA Project Officer and the Land and Chemicals Division (formerly the Waste and Chemicals Management Division) QA Coordinator.

QA Requirement for Brownfields Cooperative Agreements (Combined QMP/QAPP)

For cooperative agreements awarded for Brownfields' projects, the recipient must develop QA documents that meet the requirements found in 40 CFR Part 30, Subpart O and the US EPA Quality Assurance Guidance for Conducting Brownfields Site Assessments (PDF) (72 pp, 1.4MB).

In accordance with 40 CFR Part 30, Subpart O, the recipient must develop and implement quality assurance policies and practices that are sufficient to produce data of adequate quality to meet program objectives. Phase I environmental site assessments are non-intrusive, desktop studies which must be conducted in accordance with the most recent version of the American Society for Testing and Materials (ASTM) Practice E1527 (Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process). E1527 identifies the practices that constitute all appropriate inquiry into the previous ownership and uses of the property consistent with good commercial or customary practice. Upon completion of the Phase I assessment, the recipient must submit a copy of the Phase I Report to the EPA Brownfields Project Officer or designated EPA Brownfields Project Representative.

If the EPA Brownfields Project Officer or designated EPA Brownfields Project Representative authorizes the initiation of a Phase II assessment, the recipient must prepare a combined QMP/QAPP. This combined QMP/QAPP must be prepared in accordance with the U.S. EPA Region 3 Generic Quality Assurance Project Plan (QAPP) Template. A copy of the US EPA Region 3 Generic Quality Assurance Project Plan Template can be obtained from the EPA Brownfields Project Officer, designated EPA Brownfields Project Representative or the Regional Quality Assurance Manager. At least 30 days before the initiation of the Phase II assessment, the recipient must submit the generic QAPP to the EPA Brownfields Project Officer or designated EPA Brownfields Project Representative. The EPA Brownfields Project Officer or designated EPA Brownfields Project Representative must approve the recipient's generic QAPP before the Phase II assessment begins.

In addition, at least 30 days before the initiation of any site sampling and analysis investigation, the recipient must submit a site-specific Sampling and Analysis Plan. This site-specific Sampling and Analysis Plan must meet the requirements found in the U.S. EPA Region 3 Site-Specific Sampling and Analysis Plan Template. A copy of the US EPA Region 3 Site-Specific Sampling and Analysis Plan Template can be obtained from the EPA Brownfields Project Officer, designated EPA Brownfields Project Representative or the Regional Quality Assurance Manager. Before sampling and analysis begins, the site-specific Sampling and Analysis Plan must be approved by the EPA Brownfields Project Officer or designated EPA Brownfields Project Representative.

Top of page


Appendix B:   References

Quality System Documents

Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs (ANSI/ASQ E4-1994)Exit Disclaimer; American Society for Quality Control (ASQC), 1994.

Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs (ANSI/ASQC E4-2004) Exit Disclaimer; American Society for Quality Control (ASQC), 2004.

Policy and Program Requirements for the Mandatory Agency-wide Quality System (PDF) (12 pp, 94K); EPA Order 5360.1 A2 (CIO Policy 2105.0); U.S. Environmental Protection Agency; Washington, DC, 2000.

EPA Quality Manual for Environmental Programs (PDF) (62 pp, 196K); EPA Order 5360 A1 (CIO Procedure 2105-P-01); U.S. Environmental Protection Agency, Washington, DC, 2000.

EPA Requirements for Quality Management Plans (R-2) (PDF) (30 pp, 87K); EPA/240/B-01/002; U.S. Environmental Protection Agency, Washington, DC, 2001.

Guidance on Assessing Quality Systems (G-3) (PDF) (83 pp, 556K); EPA/240/R-03/002; U.S. Environmental Protection Agency, Washington, DC, 2003.

EPA Requirements for QA Project Plans (R-5) (PDF) (40 pp, 120K); EPA/240/B-01/003; U.S. Environmental Protection Agency, Washington, DC, 2001.

Guidance on Systematic Planning using the Data Quality Objectives Process (G-4) (PDF) (121 pp, 1.6MB); EPA/240/B-06/001; U.S. Environmental Protection Agency, Washington, DC, 2006.

Guidance on Quality Assurance Project Plans (G-5) (PDF) (111 pp, 410K); EPA/600/R-02/009; U.S. Environmental Protection Agency, Washington, DC, 2002.

Guidance for Geospatial Data Quality Assurance Project Plans (G-5G) (PDF) (106 pp, 1.5MB); EPA/240/R-03/003; U.S. Environmental Protection Agency, Washington, DC, 2003.

Guidance for Preparing Standard Operating Procedures (G-6) (PDF) (60 pp, 336K); EPA/600/B-07/001; U.S. Environmental Protection Agency, Washington, DC, 2007.

Guidance on Technical Audits and Related Assessments for Environmental Data Operations (G-7) (PDF) (101 pp, 254K); EPA/600/R-99/080; U.S. Environmental Protection Agency, Washington, DC, 2000.

Guidance on Environmental Data Verification and Data Validation (G-8) (PDF) (96 pp, 387K);EPA/240/R-02/004; U.S. Environmental Protection Agency, Washington, DC, 2002.

Data Quality Assessment: A Reviewer's Guide (G-9R) (PDF) (61 pp, 255K); EPA/240/B-06/002; U.S. Environmental Protection Agency, Washington, DC, 2006.

Data Quality Assessment: Statistical Tools for Practitioners (G-9S) (PDF) (198 pp, 2.4MB); EPA/240/B-06/003; U.S. Environmental Protection Agency, Washington, DC, 2006.

Guidance for Developing a Training Program for Quality Systems (G-10) (PDF) (58 pp, 190K), EPA/240/B-00/004; U.S. Environmental Protection Agency, Washington, DC, 2000.

Guidance on Quality Assurance for Environmental Technology Design, Construction and Operation (G-11) (PDF) (86 pp, 401K); EPA/240/B-05/001; U.S. Environmental Protection Agency, Washington, DC, 2005.

Peer Review Handbook, 3rd Edition (PDF) (190pp, 1.1MB), EPA/100/B-06/002, U.S. Environmental Protection Agency, Washington, DC, 2001.

Information Management

Chemical Abstract Service Registry Number Data Standard, EPA Order 2180.1, U.S. Environmental Protection Agency, Office of Environmental Information, Office of Technology Operations and Planning, Information Technology Policy and Planning Division; Washington, DC, 1987 (PDF) (3 pp, 175K).

Chesapeake Information Management System Major Project 14 Point Development Protocol; U.S. Environmental Protection Agency, Region III, Chesapeake Bay Program Office, Annapolis, MD, 1999.

Data Standards Policy (PDF) (7 pp, 544K); EPA CIO 2133.0; U.S. Environmental Protection Agency; Office of Environmental Information; Washington, DC; 2007.

Federal Information Processing Standards; National Institute of Standards and Technology; Gaithersburg, MD, 2008.

Information Resources Management Policy Manual, CIO Policy 2100.0, U.S. Environmental Protection Agency, Office of Environmental Information, Washington, DC, 1987.

Site Location Identification Policy and Responsibilities; Region III Order 5361.5; U.S. Environmental Protection Agency, Region III; Philadelphia, PA, 1988.

System Life Cycle Management (SLCM) Policy (PDF) (9 pp, 181K); CIO Policy 2121.1; U.S. Environmental Protection Agency, Office of Environmental Information, Washington, DC, 2012.

Program Documents

Chesapeake Bay Program, Grant and Cooperative Agreement Guidance; U.S. Environmental Protection Agency, Chesapeake Bay Program Office; Annapolis, MD, 2010.

EPCRA Section 313 Data Quality Inspection Manual; 68-C8-0066, 68-DO-0020; U.S. Environmental Protection Agency, Office of Water; Washington, DC, 1992.

Generic Quality Assurance Project Plan Guidance for Programs Using Community Level Biological Assessment in Wadable Streams and Rivers; EPA 841-B-95-004; U.S. Environmental Protection Agency, Office of Water; Washington, DC, 1995.

Graves, J., Metadata Tools Manual for EPA Region III (Draft); U.S. Environmental Protection Agency, Office of Environmental Data; Philadelphia, PA, 2001.

Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by EPA; EPA/260R/02-008; U.S. Environmental Protection Agency, Office of Environmental Information, Washington, DC, 2002.

Manual for the Certification of Laboratories Analyzing Drinking Water (PDF) (109 pp, 4MB); EPA 815-R-05-004; U.S. Environmental Protection Agency, Office of Water; Washington, DC, 2005.

NPDES Compliance Inspection Manual (PDF) (802 pp, 9.8MB), EPA 305-X-03-004; U.S. Environmental Protection Agency, Office of Enforcement and Compliance Assistance; Washington, DC, 2004.

NPDES Self-Monitoring Data and Data Inspections DAIs; EPA-903-R-94-043; U.S. Environmental Protection Agency, Office of Wastewater Management; Washington, DC, 1994.

On-Site Inspection of Superfund PRP Monitoring Procedures; U.S. Environmental Protection Agency, Region III, Philadelphia, PA, 2000.

RCRA Inspection Manual; EC-G-1999-001; U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response; Washington, DC, 1998.

Uniform Federal Policy for Implementing Environmental Quality Systems, Final, Version 2 (PDF) (126 pp, 988MB); Intergovernmental Data Quality Task Force; 2005.

Uniform Federal Policy for Quality Assurance Project Plans, UFP-QAPP Manual, Final, Version 1 (PDF) (177 pp, 1.63MB); Intergovernmental Data Quality Task Force; 2005.

Volunteer Monitor's Guide to Quality Assurance Project Plans (PDF) (67 pp, 5.6MB); U.S. Environmental Protection Agency, Office of Wetlands, Oceans and Watersheds; Washington, DC, 1996.

Quality Management Plans/Quality Manuals

Air Protection Division Quality Management Plan (PDF) (22 pp, 3.2MB); U.S. Environmental Protection Agency; Air Protection Division; Philadelphia, PA, January 2014.

Chesapeake Bay Program Office Quality Management Plan; U.S. Environmental Protection Agency, Chesapeake Bay Program Office; Annapolis, MD, June 2005.

Environmental Assessment and Innovation Division Quality Management Plan; U.S. Environmental Protection Agency; Environmental Assessment and Innovation Division; Philadelphia, PA, June 2006.

Hazardous Site Cleanup Division Quality Management Plan; U.S. Environmental Protection Agency; Hazardous Site Cleanup Division; Philadelphia, PA, July 2005.

Office of Analytical Services and Quality Assurance (OASQA) Laboratory Quality Manual, Laboratory Branch, Freshwater Biology Team, Associate Director's Immediate Office, Version 6; U.S. Environmental Protection Agency; Environmental Services Division, Office of Analytical Services and Quality Assurance; Fort Meade, MD, August 6, 2007.

Quality Management Plan for Ocean Dumping Program; U.S. Environmental Protection Agency; Environmental Assistance and Innovation Division; Philadelphia, PA, 2001.

Waste and Chemicals Management Division Quality Management Plan; U.S. Environmental Protection Agency; Waste and Chemicals Management Division; Philadelphia, PA, March 2005.

Water Protection Division Quality Management Plan; U.S. Environmental Protection Agency; Water Protection Division; Philadelphia, PA, July 2007.

Records Management

A User Guide for Getting Started in ECMS E-mail Records [Intranet], ECMS, U.S. Environmental Protection Agency, Washington, DC, 2007.

Disposition of Federal Records: A Records Management Handbook, NARA Personal Papers of Executive Branch Officials: A Management Guide (Management Guide Series), 2000 (PDF) (168 pp, 2.2MB).

Federal Records Management Laws and Regulations, NARA.

Managing Cartographic and Architectural Records (Instructional Guide Series), National Archives and Records Administration (NARA).

Managing Electronic Records (Instructional Guide Series), NARA.

OMB Circular A-130, Management of Federal Information Resources; 36 CFR Chapter XII, Subchapter B.

Records Disposition Schedules, U.S. Environmental Protection Agency.

Records Management Manual; U. S. Environmental Protection Agency; National Records Management Program, Washington, DC.

Interim Records Management Policy (PDF) (9 pp, 167K); CIO Directive 2155.2; U.S. Environmental Protection Agency, Office of Environmental Information, Office of Technology Operations and Planning, Information Technology Policy and Planning Division; Washington, DC, 2013.

Sampling and Analysis

CLP National Functional Guidelines (Series); U.S. Environmental Protection Agency, Washington, DC.

General Requirements for the Competence of Testing and Calibration Laboratories Exit EPA Click for disclaimer; ISO/IEC 17025; International Organization for Standardization and the International Electro-technical Commission; 2005.

National Environmental Laboratory Accreditation Conference (NELAC) Standards; EPA/600/R-04/003; The NELAC Institute, 2003.

National Environmental Methods Index; National Water Quality Monitoring Council; Washington, DC.

Quality Management and Quality System Elements for Laboratories - Guidelines; ANSI/ASQC Q2-1991; American National Standards Institute, Washington, DC 1991.

Recommended Guidelines for Sampling and Analyses in the Chesapeake Bay Monitoring Program, EPA 903-R-96-006; U.S. Environmental Protection Agency, Region III, Chesapeake Bay Program Office; Annapolis, MD, 1996.

Region III Office of Analytical Services and Quality Assurance (OASQA) Sample Submission Guidelines, Revision 11.0; U.S. Environmental Protection Agency, Region III, Environmental Services Division, Office of Analytical Services and Quality Assurance; Fort Meade, MD, 2002.

Contracts Management

EPA Contracts Management Manual [Entering intranet] ; U.S. Environmental Protection Agency, Washington, DC 2008.

Federal Acquisitions Regulations (FAR) Part 46 - Quality Assurance.


Appendix C:   Information Quality Guidelines Pre-Dissemination Review

EPA Region 3
Information Quality Guidelines Pre-Dissemination Review
Overview

EPA issued its Information Quality Guidelines (IQG) in October 2002 in response to guidelines issued by OMB pursuant to the 2001 Information Quality Act.

EPA's IQG contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information it disseminates. The EPA IQG provide definitions for "information," "dissemination," "utility," "objectivity," "integrity" and others and should be referred to for detailed information. The EPA IQG document is available on the IQG public web site at http://www.epa.gov/quality/informationguidelines/index.html. Additional IQG documents and training materials for EPA staff are available on the IQG intranet site at http://intranet.epa.gov/quality/informationguidelines/ [Intranet].

A Pre-Dissemination review as defined in section 7 of the IQG is intended to insure that information EPA disseminates is of the highest quality possible and meets standards for objectivity, utility and integrity. Any disseminated information not meeting these standards can be subject to a "request for correction" (RFC) and its appeal, a "request for reconsideration" (RFR) by any person. OEI has a formal process in place for the administration of RFCs and RFRs. Past and current RFCs and RFRs can be viewed on the EPA website.

EPA issued its Pre-Dissemination Review Guidelines in 2006 to assist offices and regions in implementing their own pre-dissemination review procedures. This document therefore serves as a basis for Region 3's procedure for conducting pre-dissemination reviews. Region 3 offices may expand upon the review procedure presented here.

Please note that EPA's pre-dissemination review guidelines provide non-binding internal policy and procedural guidance intended solely for EPA management and staff (EPA Final Pre-Dissemination Review Guidelines, September 2006).

Pre-Dissemination Review

One of the most important things to remember about conducting a pre-dissemination review is that it is not intended to consist solely of a final review in the development of a product. Rather, it should be conducted throughout a product's development life cycle. The Information Quality Guidelines Pre-Dissemination Review Checklist (PDF) (1 pg, 102K) can be used to document the results of pre-dissemination review during development.

Determine Eligibility
  • Determine if you need to conduct a pre-dissemination review using the IQG definitions of "information" and "dissemination" (Steps 2 and 3 below and IQG Section 5.3). The Region 3 IQG officer can be consulted should you have questions about whether the IQG apply (and thus a review is needed). Examples of non-applicability of the IQG are given in IQG Section 5.4.

  • Determine whether the product to be reviewed is information. "Information" generally includes any communication or representation of knowledge such as facts or data, in any medium or form.

  • Determine whether the product will be disseminated by EPA. EPA disseminates information to the public when EPA initiates or sponsors the distribution of information to the public.

  • If neither step 2 or 3 applies then no PDR is necessary at this time. Otherwise continue to step 5. Note that under certain circumstances a product may become eligible for a review (e.g. EPA decides it would like to disseminate a report that had been only available within EPA).
Determine whether quality is maximized and IQG quality criteria are met
  • Determine whether the product to be disseminated has maximized quality and has met the IQG criteria for utility, objectivity and integrity. "Utility" refers to the usefulness of the information to the intended users. "Objectivity" focuses on whether the disseminated information is being presented in an accurate, clear, complete, and unbiased manner, and as a matter of substance, is accurate, reliable, and unbiased. "Integrity" refers to security, such as the protection of information from unauthorized access or revision, to ensure that the information is not compromised through corruption or falsification. (See IQG, Sections 5.1 and 6.1).

  • Determine whether the product is influential. "Influential," when used in the phrase "influential scientific, financial, or statistical information," means that the Agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact (i.e., potential change or effect) on important public policies or private sector decisions. If the product is influential then a higher degree of transparency for data and methods will be required. Consult IQG Section 6.3 on transparency requirements.
Approval of information prior to dissemination
  • Obtain approval for the information to be disseminated from the appropriate program director. Approval can include other types of reviews such as legal reviews, peer reviews, programmatic reviews, scientific and technical review clearance processes, stakeholder reviews, and product review in accordance with the Office of Public Affairs guidelines.
Records management

Top of page


Local Navigation


Jump to main content.