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 Chapter 1

 

Management and Organization

The National Risk Management Research Laboratory (NRMRL) has five divisions (three based in Cincinnati with one branch in Edison, NJ; one division each in RTP, NC, and Ada, OK). The organizational structure is depicted in Figure 1 below.


Figure 1. NRMRL Organization Chart Including QA Personnel

Figure 1. NRMRL Organization Chart Including QA Personnel

1.1 NRMRL Mission Statement

NRMRL's mission is to develop ways to prevent and reduce pollution of air, land, and water, and to restore ecosystems. NRMRL's staff of several hundred scientists and engineers shares the mission to solve a wide range of environmental challenges in seven research areas:

  • Drinking Water Protection
    • Remove contaminants from source water
    • Reduce sediments and disinfections byproducts from treated water

  • Air Pollution Control
    • Reduce emissions from industries, power plants, and incinerators
    • Improve the quality of indoor air
    • Understand the sources of greenhouse gases

  • Sustainable Technologies and Processes
    • Develop recycling, recovery and reuse of products
    • Promote "green chemistry" processes in industry
    • Promote sustainable development through an understanding of life-cycle impacts of products on the environment

  • Contaminated Media Contamination
    • Clean up hazardous waste sites, leaking underground storage tanks, oil spills, and sediments
    • Understand the transport and transformation of contaminants in soil and groundwater

  • Watershed Management and Protection
    • Understand the combined impacts to land, water, and air resources of watershed pollution
    • Develop good management practices for sediment reduction, stormwater management, and combined overflow sewer treatment and controls

  • Environmental Technology Verification
    • Provide credible performance data for commercial-ready environmental technologies in drinking water treatment, air pollution control, monitoring systems, recycling and waste treatment, and pollution prevention
    • Develop partnerships with private testing and evaluation laboratories to verify developer claims for innovative technologies
    • Create working relationships with environmental interest groups, government permitting agencies, developers and vendors, and private and public users of environmental technologies

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1.2 NRMRL Organizational Policy on Quality Assurance

The NRMRL policy on quality assurance (QA) is:

  • To ensure that NRMRL meets the US Environmental Protection Agency (EPA) QA requirements as defined in EPA Order CI02105.0 or the most recent change to the Order;
  • To ensure that NRMRL meets EPA's Information Quality Guidelines (IQG) and complies with EPA's Laboratory Competency Policy;
  • To ensure that NRMRL meets the Office of Research and Development (ORD) QA requirements as defined in the ORD Policies and Procedures Manual, Chapter 13, Quality Assurance;
  • To implement a quality system that guides QA planning for individual research projects and QA reviews of all research activities in NRMRL;
  • To ensure that continuous improvement is practiced in the implementation of the NRMRL quality system; and
  • To ensure that adequate resources (including full-time equivalents (FTE), contractor support, and travel funds) are provided to implement the NRMRL quality system across the Laboratory.

The purpose of this Quality Management Plan (QMP) is to describe the NRMRL quality system. This QMP describes the minimum requirements for the NRMRL quality system that must be implemented across all Divisions in a consistent manner. However, individual divisions may, at their discretion, implement additional QA requirements. These additional requirements may add to the NRMRL quality system requirements, but they shall not displace the NRMRL requirements with ones of a lower or less stringent nature.

The NRMRL quality system is designed to be usable and useful to project personnel, managers, and NRMRL QA staff. The quality system at NRMRL incorporates quality policy and lines of authority and responsibility for all personnel. NRMRL's management and quality staff work to ensure the following:

  • Standard policies and procedures are in place for the quality system elements described in the NRMRL quality system,
  • All environmental data collection, evaluation, and use are performed in accordance with an approved planning document, and
  • All NRMRL projects (both intramural and extramural) produce defensible data of defined quality.

To ensure consistent implementation of NRMRL's quality system across the Laboratory, NRMRL has instituted management controls to identify all research projects, list the QA category and Quality Assurance Project Plan (QAPP) requirements for these projects, identify the planned research products, and document the dates of QA approval for both QAPPs and research products. The consequences for not consistently implementing the QA system are also enumerated in these controls (see Appendix A). In addition, the NRMRL QA personnel attend a monthly conference call chaired by the NRMRL Director of Quality Assurance (DQA) to discuss issues with NRMRL's quality system or its implementation.

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1.2.1 EPA Order 5360.1 A2, May 5 2000, Policy and Program Requirements for the Mandatory Agency-wide Quality System

Since 1979, Agency policy has required participation in an Agency-wide Quality System by all EPA organizations (office, region, national center or laboratory) supporting environmental programs and by non-EPA organizations performing work on behalf of EPA through extramural agreements. This policy was affirmed in EPA Order 5360.1 in April 1984 and is reaffirmed in this Order. The initial order addressed environmental measurements. Later reaffirmations of this order extended the Quality Systems to activities such as modeling, the use of secondary data, and the design, construction, and operation of environmental technologies so that all information used to support environmental decisions were brought under this order. It is EPA policy that all environmental programs performed by EPA or directly for EPA through EPA-funded extramural agreements shall be supported by individual quality systems that comply fully with the American National Standard ANSI/ASQ E4-2004, Quality Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use. Currently, a workgroup has been assembled to revise this order to include other business processes/areas to ensure that all business areas are covered by appropriate quality procedures. At this time, it is too early to tell what impact the revised policy will have on NRMRL's QMP.

1.2.2 Information Quality Guidelines

EPA's Information Quality Guidelines (IQGs) (Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection, [EPA260R-02-008], October 2002) contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information disseminated by EPA, and complements EPA's Quality System for ensuring the quality of EPA's product and information. "Information" generally includes any communication or representation of knowledge or position/policy such as facts or data, in any medium or form. This includes "preliminary" information that EPA has endorsed or adopted, and also conclusions or facts drawn from or based upon other, existing information (secondary uses of information).

Information that is adopted, endorsed, or used by EPA to support an Agency decision or position is generally considered "information" for the purposes of the IQG and is subject to pre-dissemination review. The pre-dissemination review procedures are intended to provide assurance that quality has been built into the information disseminated. EPA's IQGs were developed in response to the Data Quality Act mandated by the Office of Management and Budget (OMB). These Guidelines were published in the Federal Register Volume 67, No. 36, on Friday February 22, 2002, pages 8452–8460.

EPA in developing their IQGs relied on their existing Policies and Procedures including Quality System, Peer Review Policy, Action Development Process, Integrated Error Correction Process, Information Resources Management Manual, and Risk Characterization Policy and Handbook, etc. EPA has established an Agency-wide correction process and request for reconsideration panel to provide a centralized point of access for all affected parties to seek and obtain the correction of disseminated information that they believe does not conform to these Guidelines or the OMB guidelines. Also, scientific research conducted by Federally employed scientists or Federal grantees who publish and communicate their research findings in the same manner as their academic colleagues is not covered by these guidelines unless the agency represents the information as, or uses the information in support of, an official position of the agency.

1.2.3 Laboratory Competency Policy

On February 23, 2004, the EPA's Science Policy Council issued a new Agency Policy Directive, Assuring the Competency of Environmental Protection Agency Laboratories. To ensure data quality, all the laboratories operated by EPA, including Agency-owned, contractor-operated facilities, will need to maintain a documented Quality System that at a minimum complies with the requirements of the EPA Quality System as defined by EPA Order 5360.1 A2 May 2000, Policy and Program Requirements for the Mandatory Agency-wide Quality System and contains the specific items listed in the Laboratory Quality System Components section of the Policy Directive which are staff training, initial and continuing demonstrations of laboratory capability, demonstration of individual staff capability and competency, active internal quality assurance system including periodic internal audits, periodic management reviews, validation/verification of method performance, documentation of procedures used and results obtained, systematic planning of work, correction of deficiencies found during audits, and controls on subcontracting to ensure data quality. All laboratories will document adherence to their quality system through periodic independent assessments and by participation in inter-laboratory comparisons. In addition, where appropriate accreditation programs are available for one or more components of a given laboratory's operations (i.e., environmental sample analysis, animal husbandry, microbiology), the laboratory will seek accreditation for those components. The Office of Environmental Information (OEI) will provide oversight of policy implementation through the existing Quality Assurance Annual Report and Work Plan, and Quality Management Plan review processes. OEI will report annually to the Forum on Environmental Measurement (FEM), the Science Policy Council (SPC), and the Quality Information Council (QIC) on the results of their oversight. Implementation of this policy is intended to protect the Agency against any challenges to the data that it generates.

1.2.4 ORD Policies for Quality Assurance

In April of 2006, the quality assurance personnel in ORD had the first ORD-wide policy on QA approved for the "Development of Quality Assurance (QA)/Quality Control (QC) Policies and Procedures for ORD Research Activities." The purpose of this policy is to establish a process by which common and consistent QA and QC policies and procedures can be developed, implemented and maintained for those ORD research activities covered by EPA Order 5360.1A2.

ORD QA staff was prompted to look for opportunities to simplify the work environment of the ORD researcher due to the increasing number of research projects that cross ORD organizations. Establishment of ORD QA/QC policies and procedures creates a research process that can rely on best practices and minimize inconsistencies that may impede cross-organizational scientific collaboration.

ORD QA/QC policies and procedures will be used to describe QA/QC best practices in a number of areas such as scientific record keeping, QA/QC for cross-ORD scientific collaborations, minimum standards for measurement laboratories, and qualification of secondary data.

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1.3 QA Organization in NRMRL

The QA organization in NRMRL is shown in Figure 1. The QA Managers (QAMs) of the Sustainable Technology Division (STD), the Land Remediation and Pollution Control Division (LRPCD), the Water Supply and Water Resources Division (WSWRD), and the Ground Water and Ecosystems Restoration Division (GWERD) report directly to the Division Director. The QA Manager (QAM) is assigned to a branch within the division. The Technical Services Branch of APPCD is a support function, not a research group; therefore, the required independence of the QA function is maintained. In all Divisions, the QAMs meet regularly with the Division Director to discuss QA issues relating to the implementation of the NRMRL quality system.

NRMRL's DQA is assigned to the Laboratory Support and Accountability Staff (LSAS), which reports to the Deputy Director for Management. The DQA meets regularly with the Chief of the LSAS to update him/her on specific activities relating to the duties of the DQA. In addition, the DQA meets quarterly, at a minimum, with the Deputy Director to report on the status of quality system implementation and identify any QA issues that require resolution. Finally, if deemed necessary by the DQA and Deputy Director, meetings are held with the Laboratory Director to discuss resolution of specific QA issues. Also, the Laboratory Director may schedule additional meetings with the DQA to review specific aspects of the NRMRL quality system (e.g., project tracking lists).

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1.4 QA Roles and Responsibilities

The NRMRL Laboratory Director is responsible for:

  • Ensuring that the EPA quality policy and ORD QA requirements are implemented at NRMRL by including quality responsibilities as described in this QMP in the performance standards of all NRMRL Division Directors (DD), Branch Chiefs (BC), QA personnel, and Technical Lead Persons (TLP);
  • Reviewing and assessing the project tracking lists and discussing them with the DQA as required in the management controls (see Appendix A);
  • Promoting (by words, actions, and involvement) the establishment of a quality culture at NRMRL;
  • Promoting (by words, actions, and involvement) continuous quality improvement within NRMRL;
  • Providing facilities that are conducive to the production of data of appropriate quality to meet the needs of the research being conducted;
  • Providing adequate resources (including FTEs, contractor support, and travel) for the operation of the NRMRL quality system;
  • Reviewing and approving the NRMRL QMP; and
  • Approving the nomination of a primary QA person for specifically identified programs, and issuing a memorandum to identify this person's responsibilities.

The NRMRL Deputy Director has been designated by the NRMRL Laboratory Director as the senior management designee for ensuring the NRMRL quality system is implemented NRMRL wide.

The NRMRL Deputy Director is responsible for:

  • Meeting quarterly with the DQA to discuss status of quality system implementation and identify any QA issues that require resolution; and
  • Reviewing and approving the NRMRL QMP.

The NRMRL Staff Chief of the LSAS is responsible for:

  • Informing the Deputy Director for Management about DQA activities and QA program developments;
  • Reviewing and recommending approval of the NRMRL QMP;
  • Selecting the NRMRL Director of Quality Assurance (DQA), in consultation with the Deputy Director; and
  • Overseeing the activities of the DQA.

The NRMRL Director of Quality Assurance is responsible for:

  • Reporting all unresolved EPA/Office of Research and Development (ORD) and NRMRL specific QA issues and information to the LSAS Staff Chief, the Deputy Director for Management, and the Laboratory Director, as needed;
  • Leading the NRMRL Quality Team [consisting of all NRMRL Quality Assurance Managers (QAMs)], chairing the NRMRL monthly QA conference call, and serving as the facilitator for resolving quality issues between divisions;
  • Coordinating the preparation and updating, as necessary, of the NRMRL QMP and the QA sections on NRMRL's intranet and internet sites;
  • Serving as the NRMRL liaison to the Agency's Office of Environmental Information's (OEI) Quality Staff (QS);
  • Assisting QS in the review of policy and concept documents;
  • Coordinating the preparation of the NRMRL QA Annual Report and Work Plan (QAARWP) and submitting it to and discussing it with the NRMRL Laboratory Director;
  • Receiving and compiling the project tracking lists received from the divisions (see Appendix A);
  • Initiating discussions with the Laboratory Director to correct quality problems as needed;
  • Coordinating and monitoring NRMRL's Laboratory Competency Implementation Plan;
  • Serving as the decision maker on the quality issues within NRMRL that are not resolved at the division level (This was delegated to the DQA by the Laboratory Director in the Management Controls implemented on August 30, 2006);
  • Identifying NRMRL quality training needs and assisting in the development and presentation of QA training courses; and
  • Leading continuous quality improvement efforts within NRMRL.

NRMRL Division Directors are responsible for:

  • Ensuring that the NRMRL QA system is implemented across the Division by including quality responsibilities as described in this QMP in the performance standards of all Branch Chiefs, QA personnel, and Technical Lead Persons in the division;
  • Promoting (by words, actions, and involvement) the NRMRL quality system;
  • Promoting (by words, actions, and involvement) continuous quality improvement within their Divisions;
  • Submitting the project tracking list of all projects in the division to the Laboratory Director (see Appendix A);
  • Providing adequate resources (including FTEs, contractor support, and travel funds) to implement the NRMRL QMP across the Division;
  • Providing facilities that are conducive to the production of data of known and appropriate quality to meet the needs of the research being conducted;
  • Reviewing, approving, and subsequently ensuring that the NRMRL QMP is implemented by the division and providing written review comments regarding the QMP to the DQA;
  • Ensuring that the division QAM attends division planning meetings when proposed, new, and/or current research activities (any activity that generates or collects environmental data or uses secondary data for situations related to the environment ) are discussed;
  • Ensuring that the QAM is aware of all research activities in the division;
  • Resolving disagreements within the division if possible (e.g., appropriate corrective action to an audit, QAPP, or final product review finding) before elevating them to the DQA; and
  • Preparing responses to findings of Quality System Audits (QSAs) of the Division and submitting the responses to the DQA to ensure that all unresolved QA issues are adequately addressed. (While this responsibility may be delegated, it is the DD's responsibility to ensure that this requirement is met.)

NRMRL Branch Chiefs are responsible for:

  • Ensuring that the NRMRL QA system is implemented by researchers by including quality responsibilities as described in this QMP in the performance standards of all QA personnel and Technical Lead Persons in the branch;
  • Ensuring that the division QAM is aware of all research activities being conducted in the branch;
  • Promoting (by words, actions, and involvement) the NRMRL quality system;
  • Compiling the project tracking list by TLP for all projects being conducted in the branch and submitting it to the division director (see Appendix A);
  • Ensuring that quality planning documents [QAPPs, Standard Operating Procedures (SOPs), etc.] are developed and implemented as appropriate for all research activities occurring within their branches, i.e., for all intramural and extramural projects. Assigning branch personnel the responsibility for developing project-specific QAPPs and SOPs (QAPPs need to be prepared and approved for research activities as soon as a TLP is prepared to collect data/information to support Agency decisions or for inclusion in research products (e.g., published reports [both paper and electronic], journal articles, symposium/conference papers, extended abstracts, computer products/software/models/databases, or scientific data). Signing the approval form for QAPPs to show concurrence with the QAMs approval of the document;
  • Keeping their Division Directors informed of Branch QA issues;
  • Participating in and ensuring branch personnel participate in QA training sessions as appropriate;
  • Ensuring that research products (i.e., published reports [both paper and electronic], journal articles, symposium/conference papers, extended abstracts, computer products/software/models/databases, or scientific data) are reviewed by the QAM and approved prior to publication (research products shall be subjected to QA review prior to being distributed outside of NRMRL);
  • Resolving technical or administrative issues relating to quality within the branch if possible (e.g., appropriate corrective action to an audit, QAPP, or final product review finding) before elevating them to the division level;
  • Ensuring implementation of corrective actions; and
  • Preparing responses to any internal branch/laboratory audits and submitting responses to the QAM to ensure that all unresolved QA issues are addressed. (While this responsibility may be delegated, it is the BC's responsibility to meet this requirement.)

NRMRL Technical Lead Persons (TLP) (The TLP is the person who is technically responsible for the project. For extramural contract work, the TLP is typically the contracting officer's representative [COR]; for intramural work, the TLP is typically the principal investigator [PI].) are responsible for:

  • Ensuring that all extramural agreements (contracts, cooperative agreements, grants, interagency agreements) and intramural projects include appropriate QA requirements (QA category and QAPP requirements) and that the requirements are met for their projects;
  • Obtaining the concurrence of the QAM for the QA Category and QAPP requirements before preparing a QAPP for an intramural project;
  • Obtaining the concurrence of the QAM for the QA Category and QAPP requirements before submitting a funding package for an extramural project;
  • Ensuring development of a planning document consistent with NRMRL policy for all intramural and extramural projects that involve the collection, generation or use of primary and/or secondary data (environmental data collected from other sources, by or for EPA, that are used for purposes other than those originally intended);
  • Ensuring that all project participants agree to the project objectives and planned experimental approach before the QAPP is submitted for QA review;
  • Ensuring that all environmental data collection, evaluation, and use do not proceed until there is an approved QAPP;
  • Ensuring that the approved QAPP is implemented and that significant changes (those that may or do affect the quality of data, the scope of the project, or the successful completion of the project) to the approved QAPP are documented and approved before the change is implemented;
  • Ensuring for long term projects that the QAPP is reviewed and revised (if necessary) every twelve (12) months;
  • Ensuring that research products (i.e., published reports [both paper and electronic], journal articles, symposium/conference papers, extended abstracts, computer products/software/models/databases, or scientific data) are reviewed by the Division's QAM and approved prior to publication (research products shall be subjected to QA review prior to being distributed outside of NRMRL);
  • Ensuring that corrective action procedures are initiated in a timely manner and issuing documentation to QA Manager of all corrective actions;
  • Requesting or cooperating with any project-specific audits as required in Section 2.3.5; and
  • Preparing responses to audit or review (QAPP or product) findings.

NRMRL Division QA Managers are responsible for (while the QAMs are responsible for the following items, they may be delegated with oversight from the division QAM):

  • Reviewing and approving QAPPs, SOPs, published reports [both paper and electronic], journal articles, symposium/conference papers, and extended abstracts, computer products/software/models/databases, or scientific data;
  • Reviewing the project tracking list for the division and discussing any oversights, omissions, or missing information with the division director;
  • Reviewing and signing the QA Review Form for funding packages and in-house projects;
  • Entering quality document tracking information into the QA tracking system;
  • Managing QA support contracts;
  • Attending division research project planning meetings when proposed, new, and/or current research activities are discussed;
  • Compiling division information for the QAARWP and submitting it to the NRMRL DQA;
  • Negotiating whenever there is disagreement to the proposed resolution to an audit or review (QAPP, final report, journal article, symposium paper, extended abstract, etc.) finding (if agreement cannot be reached, negotiations will be elevated by the QAM to the BC or DD);
  • Reporting issues regarding NRMRL QA system noncompliance to the DQA for further action when resolution cannot be made at the division level;
  • Performing audits as listed in Section 2.3.5 of support laboratories and projects and preparing audit reports for submission to the TLP and BC;
  • Participating in the QSAs and/or internal audits of the division;
  • Assisting in the development of QA guidance;
  • Serving as a QA consultant for Division projects;
  • Assisting in the preparation of the NRMRL QMP or any revisions to the NRMRL QMP by providing information to NRMRL DQA;
  • Providing QA training to Division personnel;
  • Assisting in the development and revision of NRMRL quality system forms as needed;
  • Assisting in the development of NRMRL QA system SOPs;
  • Tracking corrective action as required at project level;
  • Assisting other QAMs in support of the overall NRMRL quality system;
  • Assisting in the review of the NRMRL QA program as needed;
  • Serving as Quality Control (QC) Coordinator for in-house research projects when requested. (This may include assisting the TLP in the development of the QAPP; establishing appropriate project objectives, experimental design, analytical methods, sampling points, etc.; performing audits to ensure implementation of QAPP; performing some level of data validation; and reviewing the final report.); and
  • Leading continuous quality improvement efforts within their Divisions. (Some Divisions use a quality committee for assistance [advice] in this area.)

NRMRL Program QA Managers
NRMRL sometimes achieves mission-specific goals by establishing well-defined programs. To insure consistent implementation of the quality system, a QA Manager may be designated to have overall responsibility for QA activities associated with a program.

NRMRL Program QA Managers are responsible for:

  • Assisting in the preparation of a Program-specific QMP, when requested by the Technical Program Manager;
  • Assessing implementation of the programmatic QMP; and
  • Reporting non-compliances to the Technical Program Manager and to the NRMRL DQA or the Director of TTSD when the DQA is the program's QAM.
The definition of whether a work effort is defined as a "Program" is the responsibility of management. Generally, a NRMRL Program is defined by the following guidelines:

  • The work is of sufficient size and scope to be viewed as a high-visibility effort (e.g., congressional mandates, etc.);
  • The work is typically multi-year, multi-project level of effort;
  • The work often crosses Laboratory, Center or Division boundaries; and
  • There is a discrete program management structure, distinct from NRMRL Branch/Division line management.

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