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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
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 (12 pp, 94 KB) 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
(http://www.epa.gov/irmpoli8/ciopolicy/2105-0.pdf)
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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