United States
Environmental Protection
Agency
Office of Air and Radiation
Office of Air Quality
Planning and Standards
Research Triangle Park, NC 27711
EPA-454/R-01-009
July 2001
P/EPA
Quality Management Plan
for the Fine Particle Speciation
Trends Monitoring Program
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Foreword
The following document is a Quality Management Plan (QMP) for the environmental data operations of
the Fine Particle - 2.5 micron (PM25) Speciation Trends Monitoring Program. The U.S. Environmental
Protection Agency (EPA) Office of Air Quality Planning and Standards (OAQPS) staff developed this
QMP to outline the roles of organizations involved in the Speciation Trends Network (STN). Please
review this document and forward your comments and suggestions to the person listed in the
Acknowledgment Section.
This QMP was generated using the EPA Quality Assurance (QA) regulations and guidance as described
in EPA QA/R-2, EPA Requirements for Quality Management Plans and the accompanying document,
EPA QA/G-2, Guidance for Developing, Reviewing and Implementing Quality Management Plans.
All pertinent elements of the QMP regulations and guidance are addressed in this plan.
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Acknowledgments
This QMP is the product of the EPA Office of Air Quality Planning and Standards. The following
individuals are acknowledged for their contributions.
Principle Authors
Dennis Mikel, OAQPS-EMAD-MQAG, Research Triangle Park, North Carolina
Reviewers
EPA Regions
Region
1 Marcus Kantz
5 Patricia Schraunagel
8 Kenneth Wang
Office of Radiation and Indoor Air
Michael Clark, NAREL- Montgomery, Alabama
Jewell Smiley, NAREL-Montgomery, Alabama
Mary Wisdom, NAREL-Montgomery, Alabama
Steve Taylor, NAREL-Montgomery, Alabama
Emilio Braganza, R&IE- Las Vegas, NV
Jed Harrison, R&IE-Las Vegas, NV
Scott Pallor, R&IE,-Las Vegas, NV
Office of Air Quality Planning and Standards
Jim Homolya, JoAnn Rice, Rich Scheffe, Michael Jones, Michael Papp
Office of Research and Development
Dr. Paul Solomon
State and Local Agencies
Comments and questions can be directed to:
Dennis Mikel, OAQPS-EMAD, Research Triangle Park, NC 27711 mikel.dennisk@epa.gov
m
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Acronyms and Abbreviations
AIRS
APTI
ASTM
CAA
CFR
CO
DQA
DQAO
DQOs
EDO
EMAD
EPA
EPM
FIPS
IMPROVE
LAN
LIMS
MQAG
MQOs
MSR
NAAQS
NAMS
NAREL
OAQPS
ORIA
PC
PE
QA/QC
QA
QAC
QAAR
QAO
QAPP
QMP
R&IE
SLAMS
SOP
SOW
STAG
STN
ISA
WAM
Aerometric Information Retrieval System
Air Pollution Training Institute
American Society for Testing and Materials
Clean Air Act
Code of Federal Regulations
contracting officer
data quality assessment
data quality assessment objective
data quality objectives
environmental data operation
Emissions, Monitoring, and Analysis Division
Environmental Protection Agency
environmental program management
Federal Information Processing Standards
Interagency Monitoring of Protected Visual Environments
local area network
Laboratory Information Management System
Monitoring and Quality Assurance Group
measurement quality objectives
management system review
National Ambient Air Quality Standards
national air monitoring station
National Air and Radiation Environmental Laboratory
Office of Air Quality Planning and Standards
Office of Radiation and Indoor Air
personal computer
performance evaluation
quality assurance/quality control
quality assurance
quality assurance coordinator
quality assurance annual report
quality assurance officer
quality assurance project plan
quality management plan
Radiation and Indoor Environment
state and local air monitoring stations
standard operating procedure
statement of work
state assistance grant
speciation trends network
technical system audit
work assignment manager
IV
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Pase No.
Tables
Number Description
2 i Assessments Performed in the STN
2 2 List of Analytes 1
3 1 Core Ambient Air Training Courses 4
9 i Assessments Schedule 2
1
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Figures
Number Description
1.1 Overview of the National Fine Particle Program
2.1 Description of the Speciation Trends Program
2.2 Data and Sample Flow Diagram
5.1 Hierarchy of Documents
10.1 Data Improvement Flow Diagram
Sectio
n
1.1
2.1
2.2
5.1
10.1
Page
VI
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Project: Speciation QMP
Revision No:2.1
Date: 7/18/01
Page 1 of 1
i>ugt 1 at I
Quality Manageuient Plan Identificntiun and Apprnval
The attac^ec QvlF ix>. the Fine Particle Sipeeia ion I'rwuU Fw^ca-'S'i is J-.ercby recommended "or
iipprovs! Mid coT;n;il£ Bfe rry.stsT-^1^ MIII! p^r^nnnnl hi Talksw tlic ^ih-moHs I|K^I:, ibfei witlissi.
Ulltce ot Air tjnaiity PluniaK and SlAiKlam*
Dj*.
^ ^^^'JSMil^J *~ *.._ I _/**(»,
Mr. I*-w Elti'ik, i '.I' 'PS L«jiit' As^.irjr*;.' Xtjiiiirt-T
I
Vtr. James Htimi i%fi, PTii^ruif r.l^iiai;** "** tHSt£rli"'orl trends Vctwork
*) Signal urc: _ ''~*"'-" Date:, ;/'* t^/'& ,'
vti. Dennis Mn- .' >n,il,,y .\,-.v -«i ;i .. < 'n-n! in. m lo- Speciali.MS Trends Network
Air "otic-al Hcmccs liratch
audlaJnor Enviraniuenta Nationxl La It-oral ory, I, MS V«g4«T ,Meva«Ia
Mr, Jed Hwricion, Plreetnr, Rt*-IPll^_,^
UIBce of Kwearcl^-and LJ«v«I»|>p»»t
DC. rail] Solomon, Scnicr Scientist. Las Vegas, K'v
U-atc.
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Table of Contents
Section
Foreword
Acknowledgments
Acronyms and Abbreviations
Tables
Figures
Title and Approval Page
Table of Contents
1. Project Task/Organization
1.1 Introduction
1.2 Roles and Responsibilities
1.2.1 OAQPS
1.2.2 Office of Research and Development
1.2.3 EPA Regional Offices
1.2.4NAREL
1.2.5R&IEL
1.2.6RTI
1.2.7 State and Local Air Monitoring Agencies
1.3 Key Personnel
1.4 References
2. Quality System and Description
2.1 Description of the Speciation Trends Network
2.2 Quality Assurance System
2.2.1 OAQPS-EMAD
2.2.2 NAREL
2.2.3 R&IEL
2.2.4 Regional Offices
2.3 Quality Documents
2.3.1 Quality Management Plan
2.3.2 Quality Assurance Plans
2.3.3 Assessments
2.3.4 Quality Assurance Annual Report
2.4 Description of the Monitoring System
2.4.1 Vendors
2.4.2 RTI
2.4.3 State and Local Agencies
2.4.4 OAQPS-AIRS
2.5 References
3. Personnel Qualifications and Training
3.1 Personal Qualification
3.2 Training
3.3 Certification
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Section
4. Extramural Agreements and Procurement of Items and Services
4.1 Sources of Funds
4.1.1 State Assistance Grants
4.1.2 OAQPS Internal Funds
4.2 Procurement of Items
4.3 Procurement of Services
4.3.1 Contracts
4.4 Assistance Agreements
4.5 EPA Exclusive Versus Discretionary Functions
4.5.1 Mandatory Quality Management Tasks and Descriptions
4.5.2 Non-Mandatory Quality Management Tasks and
Descriptions
5. Records and Documentation
5.1 Document Hierarchy and Process
5.1.1 Hierarchy
5. 1 .2 Document Creation and Review Process
5.2 Document Responsibility
5.2.1 EPA OAQPS/Regional Offices
5.2.2 NAREL
5.2.3 R&IEL
5.2.4 RTI
5.2.5 State and Local Agencies
5.3 Deposition and Storage of Documents and Records
5.4 Deposition of Reports
5.4.1 Annual Summary Reports
5.4.1Data Reporting Package/Archiving and Retrieval
6. Computer Software and Hardware
6.1 Computer Systems Description
6. 1.1 RTI
6.1.2EPA-OAQPS
6. 1.3 NAREL
6. 1.4 R&IEL
6.2 Roles and Responsibilities
6.2.1 EPA Systems
6.2.2 RTI
7. Planning
7.1 Project Goals and Objectives
7.2 Key Planning Personnel
7.2. 1 Monitoring and Quality Assurance Leader
7.2.2 Program Manager
7.2.3 DOPOs
7.2.4 Quality Assurance Coordinator
7.3 Other Planning Activities
7.3.1 Tele-communications
7. 3. 2 Internet
7.3.3 Data Analysis
7.4 References
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8. Implementation of Work
8.1 Implementation Roles
8.1.1 Program Manager
8.1.2 Quality Assurance Managers
9. Data Quality Assessments
9.1 Program Assessment Techniques
9.1.1 Technical Systems Audits
9.1.2 Network Reviews
9.1.3 Management Systems Reviews
9.1.4 Data Quality Assessments
9.2 Reports to Management
9.3 Planning, Training and Authority
9.3.1 Planning
9.3.2 Training
9.3.3 Authority
9.3.4 Disputes
10. Quality Improvement
10.1 Quality Improvement Process Flow
10.1.1 Assessments
10.1.2 Assessment Report
10.1.3 Response
10.1.4 Final Assessment Report
10.1.5 Review, Compilation and Analysis
10.1.6 Final QAAR
10.2 Quality Improvement Assurance
Glossary
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Appendix A - Procurement Policy Notice for Contracting Officer's
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Project: Speciation QMP
Element No: 1.0
Re vision No: 2.1
Date: 7/18/01
Page 1 of 9
1.0 Project/Task Organization
1.1 Introduction
The Clean Air Act (CAA) requires EPA to revise or update the air quality standards based on review
of the latest scientific information on known and potential human health effects associated with
Particulate Matter (PM) levels found in the ambient air. In fulfilling the obligation of the law, the EPA
recently reviewed the air quality criteria, National Ambient Air Quality Standards (NAAQS) for PM
and epidemiological evidence that shows an association between ambient concentrations of PM and a
range of serious health effects. Based on the results of its review, the EPA revised and promulgated
two new primary standards for the fine fraction of PM (i.e., particles with aerodynamic diameters less
than or equal to 2.5 m, referred to as PM2 5) and the regulatory requirements for monitoring the
chemical composition of these particles. In response to this promulgation, EPA has instituted a PM2 5
network. Please see Figure 1.1, which illustrates the overall national fine particle network. As can be
seen from the this figure, the second tier of the pyramid deals with the routine speciation. This QMP
deals strictly with
Overview:
if -50 Trends
(Massfi Components)
r -an sites
With
<- -200 sites (SIRS)
r -100 Improve. - -'
Routine
Speciation
Mass Sampling
r 4 -S Entianc ed Airsheds
,- : i sao Required
' -HJSQFmi
(Compare to
NAAQS)
- 200
Ccntimjcus
Figure 1.1 Overview of the National Fine Particle Network.
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Project: Speciation QMP
Element No: 1.0
Re vision No: 2.1
Date: 7/18/01
Page 2 of 9
54 trends sites that are a portion of the routine speciation program.
In meeting the requirements to monitor and gather data on the chemical makeup of fine particles, EPA
is establishing a Speciation Trends Network (STN). These STN samplers will be placed at various
national air monitoring stations (NAMS) and State and local air monitoring stations (SLAMS) across
the Nation. It is currently anticipated that 54 of these chemical speciation sites will be used to
determine, over a period of several years, trends in concentration levels of selected ions, metals,
carbon species, and organic compounds in PM2.5. Further breakdown on the location or placement of
the trends sites requires that approximately 20 of the monitoring sites be placed at existing
Photochemical Assessment Monitoring Stations (PAMS). The placement of the remaining trends sites
will be coordinated by EPA, the Regional Offices, and the state and local agencies. Locations will be
primarily in or near larger Metropolitan Statistical Areas (MSAs). The remaining chemical speciation
sites will be used to enhance the required trends network and to provide information for developing
effective State Implementation Plans (SIPs). This QMP focuses on management and communication
structure to assure data of adequate quality are produced by the 54 trends network sites.
As Figure 1 illustrates, the STN is a component of the National PM2 5 Monitoring Network. Although
the STN is intended to complement the activities of the much larger gravimetric PM2 5 measurements
network component (whose goal is to establish if NAAQS standards are being attained), STN data
will not be used for attainment or non-attainment decisions. The programmatic objectives of the STN
network are:
Annual and seasonal spatial characterization of aerosols;
Air quality trends analysis and tracking the progress of control programs;
Integration of chemical speciation data set with the data collected from the
IMPROVE network; and
Development of emission control strategies.
Stakeholders in the STN will be those at EPA and State and Local agency investigators who are
seeking to determine concentration trends of PM2 5 chemical species over a period of 3 or more years
and decision-makers at state and local levels who will use the data as input to models and for
development of emission control strategies and determination of their long-term effectiveness. Other
users will be public health officials and epidemiological researchers. However, expectations for data
sets from the STN must be put in context. A number of limitations are recognized, (for instance, the
24-hour integrated sample approach, taken every 3rd day, is not suitable for determination of diurnal
patterns and may have limited use to those who study health effects). EPA recognizes these data use
limitations and limitations on the sampling and analysis methodologies. Thus, EPA does not rule out
the possibility that objectives, requirements, and methods for speciation sampling may need to be
adjusted in the future.
The STN is included in the monitoring requirements and principles set forth by the Federal Register
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Project: Speciation QMP
Element No: 1.0
Re vision No: 2.1
Date: 7/18/01
Page 3 of 9
(62 FR 38763), promulgated as part of the P1VL.5 National Ambient Air Quality
Standard (NAAQS) review completed in 1997. At a minimum, the STN will quantify mass
concentrations and significant PMz.5 constituents which include trace elements, sulfate, nitrate, sodium,
potassium, ammonium, and carbon. This series of analytes is very similar to those measured within the
Interagency Monitoring of Protected Visual Environments (IMPROVE) program. In addition, several
STN monitors will be placed at IMPROVE locations (or visa versa) in order to ascertain whether
there are statistical and chemical links between these two national networks.
EPA anticipates that approximately 250 sites will comprise the full chemical speciation
network. In addition to the 54 sites for the trends network, another 200 sites will be implemented to
enhance the required network and provide information for developing effective State Implementation
Plans (SIPs). The non-trend sites will be allowed flexibility in terms of sampling frequency, site
selection, site mobility, and addition of target species to address regional and local issues as needed.
For example, some areas may choose to focus on specific episodes or seasons, such as a winter time
wood smoke problem. EPA does not believe that a single nationwide approach to speciation sampling
and analysis is the best approach for all locations. The EPA expects that most sites will follow a
sampling and analysis program similar to the core STNs for their non-trend sites; however, alternative
approaches will be considered on a case-by-case basis through negotiation by State agencies with
EPA Regional Offices and Headquarters. EPA encourages State and Local Agencies to consider
additional chemical analyses beyond the constituents specified for STN. For example, detailed analysis
for compounds comprising the organic carbon fraction could provide valuable insight into development
of more refined source-receptor relations, particularly in areas with significant carbon based aerosols.
EPA also encourages the use of continuous monitoring techniques to the extent possible. Recent
advances in measurement technologies have been proven reliable. This section of the QMP will focus
on the agencies involved with this program and their roles and responsibilities.
1.2 Roles and Responsibilities
1.2.1 Office of Air Quality Planning and Standards: OAQPS is the organization charged under
the authority of the Clean Air Act (CAA) to protect and enhance the quality of the nation's air
resources. OAQPS sets standards for pollutants considered harmful to public health or welfare and,
in cooperation with EPA's Regional Offices and the States, enforces compliance with the standards
through SIPs and regulations controlling emissions from stationary sources. The OAQPS evaluates
the need to regulate potential air pollutants, especially fine particles, and develops national standards.
Within OAQPS, the Emissions Monitoring and Analysis Division (EMAD), the Monitoring and Quality
Assurance Group (MQAG) will be responsible for the oversight of the STN. MQAG has the
following responsibilities for the STN:
ensuring that the methods and procedures used in making air pollution measurements are
adequate to meet the programs objectives and that the resulting data are of satisfactory quality;
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develop QMP and field Quality Assurance Project Plan (QAPP);
Overall coordination of the monitoring and QA aspects;
evaluating the performance, through mechanisms such as, technical systems audits,
performance evaluations and management systems reviews, of organizations making chemical
speciation measurements;
implementing satisfactory quality assurance programs over federally funded ambient air quality
monitoring networks;
ensuring that national and regional laboratories are available to support such programs;
ensuring that guidance pertaining to the quality assurance aspects of the fine particle speciation
program are written and revised as necessary;
rendering technical assistance to the EPA Regional Offices and air pollution monitoring
community concerning fine particle sampling and analysis.
1.2.2 Office of Research and Development: The office of Research and Development (ORD) is
charged with the research and development of the speciation sampler and technical oversight. ORD's
role in the STN will be:
oversee development and testing of new fine particle instrument designs;
work closely with OAQPS to determine that the STN instruments are being operated in
accordance to their design;
evaluate ambient data as it is collected and work with the research community to ascertain the
meaning of the results.
1.2.3 EPA Regional Office: EPA Regional Offices address environmental issues related to the
states within their jurisdiction and to administer and oversee regulatory and congressionally mandated
programs. The major quality assurance responsibilities of EPA's Regional Offices, in regards to the
STN, are the coordination of quality assurance matters at the Regional levels with the State and local
agencies. This is accomplished by the designation of EPA Regional Project Officers who are
responsible for the fiscal and technical aspects of the program including:
the Regional QA officer will be responsible for reviewing QAPPs for the EPA;
acting as a liaison by making available the technical and quality assurance information
developed by EPA Headquarters and the Region to the State and local agencies, and
making EPA Headquarters aware of the unmet quality assurance needs of the State and
local agencies.
performing a thorough review of the STN within their region every three years.
1.2.4 National Air and Radiation Environmental Laboratory: The National Air and Radiation
Environmental Laboratory (NAREL) in Montgomery, Alabama is one of two Office of Radiation and
Indoor Air (ORIA) laboratories that will have a major role in the quality assurance system for the
speciation program. NAREL will fill a specific and vital role in the quality assurance aspects of the
program. These are briefly listed below: Details can be seen in Reference 2.
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validation of chemical speciation analytical laboratory performance (contract and state
chemical speciation laboratories);
SOP and QAPP review;
Post Award PE Round Robin;
Post Award on-site audit;
Audit and PE Round Robin report to PO and OAQPS.
Ongoing QA oversight program to evaluate continuing performance through an
annual PE Round Robin study;
maintenance of a repository of PE samples that could be used as double blind PEs by states,
diagnostic tools by laboratories, etc.;
performance of on-site audits of contract and state laboratories.
Technical assistance to chemical speciation laboratories, states, DOPOs and PO regarding
data quality (technical assistance may range from telephone calls for assistance on
methodology to review of QC to determine data usability, to on-site performance audits).
1.2.5 Radiation and Indoor Environment National Laboratory The portion and Indoor
Environment National Laboratory (R&IEL) is the other ORIA laboratory that will have a major role
in the quality assurance system for the speciation program. The Las Vegas, Nevada office will fill
specific and vital roles in the quality assurance aspects of the program. This is briefly listed below:
R&IEL will provide the field QA for this program. This will consist of field TSAs, site visits
and setting up collocated QA samplers in the field;
provide observations of ongoing work to document conformance with specified field QAPPs;
examine data after collection and determine how well the system performed;
provide training for State and Local agencies on the operation of the STN samplers;
demonstration testing of newly developed STN instruments.
1.2.6 Research Triangle Institute (RTI): Research Triangle Institute is the main laboratory for all
speciation laboratory work. RTI will coordinate the pre-sampling, shipping, post-sampling activities.
Much of the QA activities will be performed by RTI internally. The QA activities are detailed in
RTFs Quality Assurance Project Plan1 Some of the QA activities are briefly listed below:
processing of all Quality Control (QC) filters;
analysis of all samples;
tracking and record keeping of all samples as they move through the speciation program;
participate in all TSAs, MSRs, and other audits;
analyze the PEs when received from the NAREL laboratory;
coordinate with sub-contractors and assure that the good laboratory practices and QA are
performed;
maintain adequate internal documentation and quality control;
development of a laboratory QAPP;
perform Level 0 and 1 validation on the data.
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Date: 7/18/01
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1.2.7 State and Local Air Monitoring Agencies: The state and local air monitoring agencies are
tasked in operating the speciation samplers in the field. The agencies will work closely with RTI on
shipping and receiving the speciation samples. Other activities include:
select monitors from the national contract;
write or adhere to a speciation field QAPP which must be approved by the EPA Regional QA
officer;
operate the samplers according to the accepted QAPP;
store un-exposed filters in the manner described by the QAPP;
Ship the exposed filters in a timely manner to RTI;
maintain records of sampler operation;
participate in any TSAs or Management Systems Reviews (MSRs)
notify OAQPS, ORD or the DOPOs of any problems with the operation or design of the
samplers;
perform Level 2 and 3 validation on the data.
1.2.8 Delivery Order Project Officers: The Delivery Order Project Officers are Regional Office
contacts who are liaisons between OAQPS, RTI and the State and Local agencies. The DOPOs
facilitate the financial and planning aspects of the STN. There will be three DOPOs for the entire
Nation: east, Midwest and west.
1.3 Key Personnel
Monitoring and Quality Assurance Group Leader Dr. Richard Scheffe
Dr. Scheffe has overall responsibility for managing the STN. The direct responsibility for assuring
data quality rests with management. Ultimately, the group leader is responsible for establishing QA
policy and for resolving QA issues identified through the QA program. Major QA related
responsibilities of the group leader include:
approving the budget and planning processes;
assuring that the program develops and maintains an adequate quality system.
The group leader delegates the responsibility of QA development and implementation in accordance
with the OAQPS policy to the program manager and QA coordinator.
Program Manager Mr. James Homolya
Mr. Homolya is the designated as the OAQPS program manager of the STN. He is responsible for the
OAQPS activities that are implemented as part of normal data collection activities. Responsibilities
include:
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ensuring the implementation of the STN;
communication with EPA Project Officers and EPA QA personnel on issues related to routine
sampling and QA activities;
understanding EPA monitoring and QA regulations and guidance, and ensuring all key personnel
understand and follow these regulations and guidance;
reviewing acquisition packages (contracts, grants, cooperative agreements, inter-agency
agreements) to determine the necessary QA requirements;
developing budgets and providing program costs necessary for EPA allocation activities;
ensuring that all personnel involved in environmental collection have access to any training or QA
information needed to be knowledgeable in QA requirements, protocols, and technology;
recommending required management-level corrective actions.
Quality Assurance Coordinator - Mr. Dennis Mikel
Mr. Mikel will oversee the quality assurance aspects of the speciation program, as such will be
designated the Quality Assurance Coordinator (QAC). His responsibilities include:
coordinating the input to the QA Annual Report (QAAR);
assisting in solving QA-related problems at any level of the program;
ensuring that an updated QAPP is in place for all environmental data operations associated with
the program;
ensuring that technical systems audits, audits of data quality, and data quality assessments occur
within the appropriate schedule and conducting or participating in these audits;
tracking and ensuring the timely implementation of corrective actions;
ensuring that a management system review occurs every 3 years;
coordinate with the ORIA activities.
The QAC has the authority to carry out these responsibilities and to bring to the attention of the
program manager or group leader any issues related to these responsibilities.
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NAREL - Montgomery, Alabama Team Leader - Mr. Michael Clark
This Team is responsible for overseeing laboratory QA activities of the STN. His responsibilities
include:
implementing and overseeing the laboratory STN QA policy within the team;
oversee analysis of the QA samples;
reporting the QA data to OAQPS staff;
oversee the preparing of QA samples for the RTI laboratory;
lead the MSRs and TSAs on the RTI laboratory.
R&IEL - Las Vegas, Nevada, Branch Manager - Mr. Emilio Braganza
The Las Vegas personnel are responsible for overseeing the field QA activities. His responsibilities
include:
participating in field training and certification activities;
participating in the development of data quality requirements (field) with the appropriate QA
staff;
performing field TSAs and MSRs;
oversee the verifying of all required field activities are performed and insure that measurement
quality standards are met as required in the QAPP.
RTI Laboratory Program Director - Dr. R. K. M. Jayanty
Laboratory personnel are responsible for carrying out a required task(s) and ensuring the data
quality results of the task(s) by adhering to guidance and protocol specified by the QAPP and
SOPs for the lab activities. His responsibilities include:
oversee participating in training and certification activities;
participating in the development of data quality requirements (laboratory) with the appropriate
QA staff;
overseeing the writing and modifying of standard operating procedures (SOPs) and good
laboratory practices (GLPs);
oversee the preparing and shipping of all samples to the State and Local agencies;
supervise the analysis of all samples;
oversee the performing and documenting of preventative maintenance on laboratory equipment;
overseeing the submission of final valid data to the Aerometric Information Retrieval System
(AIRS) database;
preparing and delivering reports to the OAQPS program manager and QA officer.
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1.4 References
1. Quality Assruance Project Plan Chemical Speciation of PM2.5 Filter Samples, Research Triangle
Park, NC, Document Number RTI/7565/00-02S
2. Quality Assurance Project Plan for the Quality Assurance Laboratory Role in the Particulate
Matter (PM2.5) Chemical Speciation Project, U.S. Environmental Protection Agency Office of
Radiation and Indoor Air, National Air And Radiation Environmental Laboratory, Draft 3, October
18,2000.
3. Speciation Trends Network Quality Assurance Project Plan, U.S. EPA Document EPA-454/R-
01-001
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2.0 Quality System Description
This chapter will describe the principle components comprising the quality system and how they are
used to implement the quality system. In addition, the latter part of this chapter will briefly discuss the
monitoring system and how samples and data flow through the system.
2.1 Description of the Speciation Trends Program
Figure 2.1 illustrates the systems in place that have oversight of the ST N.
PM. -STN Cbordmatinn
PM2.5
REBHial Off it r
Project Officers
East: M. Kant:
Midwest: P. EC h raufn agel
arnijp Leader
Prr^ect M an agtr
J. Hnimtlyj
-CASAC
-ORfi/MEIM-
t>. Common
V. PrminjJI
TVwidc Natv/ark Fiald Activiti
Field OA
JtetfttMenh
E. Braganza
-NJUEL
M. Clark
Figure 2.1 Description of the Speciation Trends Program
Figure 2.1 illustrates that there are two distinct systems in place for the STN: the QA system and
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Monitoring System. The following sections will highlight these.
2.2 Quality Assurance System
2.2.1 OAQPS-EMAD: At the top of the QA structure is the OAQPS-QAC. It is the QAC's
responsibility to oversee that QA is implemented into the program. The QAC will interact with a QA
Workgroup that has formed. This QA workgroup consists of EPA, State and local agency, Regional
Office, R&IEL and NAREL QA staff. They will meet periodically to discuss QA issues as they arise
throughout the program. The QAC will also work directly with the ORIA offices. Assessment
Reports will be given to the QAC on an annual basis. These will include the results of the assessments
listed in Table 2.1 performed during the previous year. The ORIA offices; NAREL and R&IEL will
have important roles in the QA system.. In addition, the MQAG may also perform MSR or TSAs on
any of the agencies in the QA or monitoring system.
2.2.2 NAREL-Montgomery, Alabama: NAREL will have QA oversight of the RTI laboratory
operations. As such, the laboratory will perform TSAs or MSRs on the RTI laboratory operation on
an annual basis. In addition, the NAREL will create laboratory audit samples Performance
Evaluations (PE) that will be forward to the RTI lab.
2.2.3 R&IEL - Las Vegas, Nevada: R&IEL will have QA oversight of the field operations. As
such, the laboratory will perform TSAs and performance audits at state and local agency monitoring
stations. At this time, the schedule and extent of the TSAs and performance audits are not known.
When the audits are completed, the QA reports will be forwarded to OAQPS for review. At some
time in the future, State Agencies and the Regional offices will be encouraged to perform these
functions.
2.2.4 Regional Offices: The EPA Regional Offices will provide Network Reviews of the STN on
each agency within their region once every three years.
Since EPA is providing funding for this program, the QA requirements fall under the auspices of EPA
Order 5360.1 July, 1998. In short, this EPA order states that all extramural activities funded by the
EPA must have minimum requirements in place at the beginning and carried through the project. In
order to fulfill this EPA Order, the EPA has put the following QA components in place.
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2.3 Quality Documents
The following are the documents, plans and guidelines by which the speciation trends program will be
implemented.
2.3.1 Quality Management Plan: This QMP (described herein) outlines the management structure
and how the QA system will be implemented. All entities listed in this QMP will adhere to these
guidelines.
2.3.2 Quality Assurance Plans: All entities will develop QAPPs for their programs. This includes,
RTI, R&IEL and NAREL. All state and local agencies will develop field QAPPs that will outline how
their QA system will be implemented. OAQPS has written a draft field QAPP that can be used by
the state and local agencies in drafting their individual QAPPs.
2.3.3 Assessments: There are several assessments tools that will be implemented by the QA system.
The following table illustrates the implementation of assessments. Each of these assessments will be
discussed in detail in Chapter 8.
Table 2.1 Assessments performed in the STN
Agency
NAREL
R&IEL
OAQPS-EMAD
OAQPS-EMAD
Regional Offices
Type of Assessment
ISA, MSRs and PEs
TSAs, Performance Audits
TSAs
MSRs
Network Reviews
Agency Assessed
RTI
State and local
agencies
RTI, NAREL, State
and Local
agencies, Regional
offices and R&IEL
RTI, NAREL, State
and Local
agencies, Regional
offices and R&IEL
State and local
agencies
Frequency
Annually
Annually*
As needed by
EMAD
determination
As needed by
EMAD
determination
Once every 3
years
* Not all instruments in the program will be audited every year. It is estimated that 25% of the instruments will be
audited annually.
Assessments will be performed as the program begins and on a periodic basis after January 2001.
2.3.4 Quality Assurance Annual Report: Quality Assurance Annual Report (QAAR) will be
provide to OAQPS-EMAD from R&IEL, NAREL and RTI. The QAARs will include the results
from the assessments described in Table 2.1 and will include all QA data collected by these entities
and summarized for a calendar year. These plans will also outline any assessments and corrective
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actions needed to correct any deficiencies in their operations.
2.4 Description of the Monitoring System
This section will outline the monitoring system as illustrated in Figure 2.1. Data will be collected on the
list of analytes below l.
Table 2.2 List of Analytes
Method
Constituents
Gravimetry
Ion Chromatography
X-Ray Fluorescence
Thermal Optical Analysis
nitrates, sulfates, ammonium, sodium ion and
potassium
aluminum, antimony, arsenic, barium
bromine, cadmium, calcium, cerium
chlorine, chromium, cobalt, copper
europium, gallium, gold, hafnium
indium, iridium, iron, lanthanum
lead, magnesium, manganese, mercury
molybdenum, nickel, niobium, phosphorus
potassium, rubidium, samarium,
scandium, selenium, silicon, silver
sodium, strontium, sulfur,tantalum
terbium, tin, titanium, vandium
wolfram, yttrium, zinc, zirconium
Elemental Carbon
Carbonates Carbon
Organic Carbon
Total Carbon
As can be seen from Table 2-2, there are a number of analytes on the list. The speciation program will
require two or three filter pack modules per instrument. Each of the modules will have a different filter
medium and therefore, a different analytical method.
This section will outline the monitoring system as diagramed in Figure 2.2 and discuss how quality will
be built into the overall speciation program process.
2.4.1 Vendor: The filter vendor will ship packaged filters to the RTI laboratory. These will be logged in
by the RTI shipping and receiving group and stored in a proper location.
2.4.2 RTI: The filters will be processed by RTI according to their QAPP and SOPs. These will be
stored until needed in the field. The filters will then be logged out and shipped to the appropriate State
and Local agency. Below is an outline of the RTI duties. Please note that these procedures will also be
performed on any QA samples received from NAREL.
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Pre-Sampling
Receiving filters from the vendors;
Checking sample integrity;
Conditioning filters;
Weighing filters;
Storing prior to field use;
Packaging filters for field use;
Associated QA/QC activities;
Maintaining microbalance and analytical equipment at specified environmental conditions;
Equipment maintenance and calibrations.
Shipping/Receiving
Receiving filters from the field and logging into database;
Storing filters;
Associated QA/QC activities.
Post-Sampling
Checking filter integrity;
Stabilizing/weighing filters;
analysis of elements by X-Ray Fluorescence;
thermal/optical analysis of quartz filters;
extraction of ions from Nylon filters;
Analysis of samples extracted;
Data downloads from field samplers;
Level 0 and 1 validation;
Data entry/upload to AIRS;
Storing filters/archiving;
Associated QA/QC activities.
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Pre arid Post
Samples
State and
Local Agencies
Eeports
Figure 2.2 Data and Sample Flow Diagram
2.4.3 State and Local Agencies: The State and Local Agencies will received the pre-sampling filters
from RTI. These will be stored until field use. After the sample run, the filters will be promptly shipped
to RTI for final analysis. Record keeping of sampler operation and forwarding this information to RTI
will be the responsibility of the State and Local Agencies.
2.4.4 OAQPS - AIRS: The EPA-OAQPS office will have the authority and responsibility for
oversight of this program. The agency has two separate roles: collection and storage of the data into
the AIRS database and oversight of the operation of the program. OAQPS will receive and review the
QA reports that will be generated by the two ORIA laboratories. In addition, it will provide technical
assistance to RTI, the State and Local Agencies and the ORIA laboratories.
2.5 References
1. Particulate Matter (PM2.5) Speciation Guidance Document, Final Draft, Edition 1, October 7,
1999, U.S. EPA document.
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3.0 Personal Qualifications and Training
This section will discuss the system and process put in place to provide training for the STN. This
chapter will outline the process involved and training available for air monitoring professionals.
The process of training personnel will be a three pronged approach. First, the agencies must select
persons who have the minimum qualifications to perform the duties. Second, the agencies must train the
individuals for the basics of air monitoring theory and technique. OAQPS provides numerous satellite
classes and on-your-own courses that are free to air monitoring individuals. All persons working on
this program are encouraged to take these courses. Lastly, OAQPS, in conjunction with R&IEL, is
currently conducting fine particle sampler courses that are "hands on." Training on the operation and
maintenance are taught at these classes.
3.1 Personnel Qualifications
OAQPS has the responsibility to provide training for this program. As such, OAQPS, in conjunction
with the R&IEL will make every effort to provide training to all who participate in this program.
Personnel assigned to the STN should meet the educational, work experience, responsibility, personal
attributes, and training requirements for their positions. Although OAQPS will provide training to all
agencies, it cannot require the state and local agencies or any contractors to send their staff to EPA
training courses. During MSRs, EPA and its contracts will review records on personnel qualifications
and training. All agencies should maintain these records in personnel files and have them accessible for
review during audit activities.
3.2 Training
Appropriate training will be made available to employees supporting the fine particle speciation
program, commensurate with their duties. Such training may consist of classroom lectures, workshops,
tele-conferences, and on-the-job training.
Over the last 2 years, a number of courses have been developed in cooperation with EPA for
personnel involved with ambient air monitoring and quality assurance aspects. Formal QA/QC training
is offered through the following organizations:
Air Pollution Training Institute (APTI) http://www.epa.gov/oar/oaq.apti.html
Air & Waste Management Association (AWMA) http://awma. org/epr.htm
American Society for Quality Control (ASQC) http://www.asqc.org/products/educat.html
EPA Institute
EPA Quality staff http://www.epa.gov/qualityl
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The above mentioned courses are open to all air monitoring personnel. EPA strongly encourages all
State and Local agencies and contractors to take these courses. Table 5.2 presents a sequence of core
ambient air monitoring and QA courses for ambient air monitoring staff, and QA managers. The
suggested course sequences assume little or no experience in QA/QC or air monitoring. Persons
having experience in the subject matter described in the courses would select courses according to their
appropriate experience level. Courses not included in the core sequence would be selected according
to individual responsibilities, preferences, and available resources.
Table 3.1 Core Ambient Air Training Courses
Sequence
1*
2*
3*
4*
5*
6*
7*
8*
9
10
11
*
*
*
*
*
Course Title (SI= self instructional)
Air Pollution Control Orientation Course (Revised), SL422
Principles and Practices of Air Pollution Control, 452
Orientation to Quality Assurance Management
Introduction to Ambient Air Monitoring (Under Revision), 81:434
General Quality Assurance Considerations for Ambient Air Monitoring
(Under Revision), SL471
Quality Assurance for Air Pollution Measurement Systems (Under
Revision), 470
Data Quality Objectives Workshop
Quality Assurance Project Plan
Atmospheric Sampling (Under Revision), 435
Analytical Methods for Air Quality Standards, 464
Chain-of-Custody Procedures for Samples and Data, SL443
Data Quality Assessment
Management Systems Review
Beginning Environmental Statistical Techniques (Revised), SL473A
Introduction to Environmental Statistics, SL473B
Statistics for Effective Decision Making
AIRS Training
Source
APTI
APTI
QAD
APTI
APTI
APTI
QAD
QAD
APTI
APTI
APTI
QS
QS
APTI
APTI
ASQC
OAQPS
Courses recommended for QA Managers
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3.3 Certification
OAQPS, in conjunction with ORIA - R&IEL have sponsored several "hands on" classes for State
and Local Agencies to get a first look at the speciation samplers. This course lasts two days and is
taught by the instrument vendors and EPA personnel. EPA issues training certifications for the
successful completion of field and sample custody and data management training. Certification is based
upon the qualitative and quantitative assessment of individuals adherence to the SOPs.
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4.0 Extramural Agreements and Procurement of Items and Services
OAQPS must ensure that the items and services it acquires are procured within EPA regulations, are
delivered in a timely fashion, and are within the required specifications. The following sections will
provide general information on OAQPS procurement procedures and provide personnel involved in the
Speciation Program with the a description of the requirements
4.1 Source of Funds
4.1.1 State Assistance Grants: Since implementation of the STN is a State and local responsibility,
the source of funds for the program are 103 and eventually 105 State Assistance Grants (STAG).
Every year funds will be allocated to the State and local air monitoring organizations to operate the
PM2 5 Speciation Program. The STAG allocation for the Speciation Program was based upon
estimates of setting up and implementing an ~ 200 sites network. The funds are allocated to the EPA
Regions who then allocate them to the State, local or Tribal agencies. These agencies then follow their
own procurement policies to get the Speciation monitoring accomplished.
A portion of the STAG funds are allocated back to OAQPS for two activities
1. National speciation monitor contract- OAQPS set up a national contract to facilitate the purchase
of speciation monitors
2. Analytical laboratory contract- OAQPS set up a national contract to perform all the filter
preparation and analyses and reporting activities.
Each year OAQPS will submit a request for the appropriate allocation of funds for these activities
based on the number of monitors being implemented (or planned) for that fiscal year. These allocations
or "taps" on the STAG funds are approved by the States.
4.1.2 OAQPS Internal funds: Each year OAQPS plans the activities it will pursue in the upcoming
fiscal year. The OAQPS speciation monitoring and QA leads will work with various work groups and
cooperators to prioritize the use of the environmental program management (EPM) funds. These funds
may be used to purchase capital equipment or for contracting.
OAQPS, through the Memorandum of Agreement with the ORIA labs (NAREL and R&IEL), will
provide contract funds to these labs. The use/ allocation of the funds will be negotiated during fiscal
year planning.
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4.2 Procurement of Items
Within EPA, only contracting officers (COs) are authorized to procure items and services, unless it is a
fund transaction approved by the CO prior to the originators purchase of the item. The Federal
Government is not bound by any commitments made by other than authorized personnel.
Requests for purchases begin at the yearly planning stages of the STN for the EPA or STAG funds.
Purchases by contractors must be identified in the project scope of work for such purchases. All items
should be identified and specifications that meet the STISTs minimum needs should be detailed. These
specifications will be referred to during the procurement process and will assure that the OAQPS
requestor receives the proper item and reduces the chances of purchase delays or incorrect purchases
because of inadequate product specifications. State and local funds are allocated through procurement
and should follow
state and local procurement policies.
4.3 Procurement of Services
Two types of mechanisms are primarily used to procure services, contracts and assistance agreements
(grants, cooperative agreements, etc.). As mentioned in section 4.1, COs are the only individuals who
can obligate funds.
When procuring services, one should follow the same basic procedure used for the procurement of
items. There are certain activities that are of a policy- and decision-making nature that should remain
the sole authority of EPA. The CMD should be contacted during the initial planning of the PR to
discuss specific requirements for the procurement.
The Project Officer (PO) states the service that will be delivered, measures the quality of the service,
and accepts the service. When a level-of-effort contract is the vehicle used in procuring services, the
work assignment manager (WAM) provides the technical expertise for the work assignment and
assumes responsibility for the QA requirements assigned to the PO. Two major tools to ensure that
adequate service is provided are a well-defined statement of work (SOW) and a QA Project Plan
(QAPP) that includes reviews (audits).
The QAC or DQAO assists in this activity by providing knowledge and guidance on the QA
requirements and aspects of any potential project. The QAC or DQAO will also approve the QA
review form that is discussed in the next section.
4.3.1 Contracts: Contracts are used when the government derives sole benefit from a particular
product or service. Contracts can be specific and can require a degree of lead time for development.
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Depending upon the scope of the service, QA attributes can be developed that must be adhered to
under the terms and agreements of the contract. Any EPA initiated contracts are required to use some
type of QA form to determine if the contract will require EDO and therefore requires a QMP and a
QAPP. After the form is completed it must be reviewed by the (WAM/PO) and a QAC. The form
must be kept in the official contract file.
The Federal Acquisition Regulations, Title 48 of the Code of Federal Regulations, was recently
amended to address contract quality systems requirements on a government-wide basis. The new FAR
clause at 52.246-11, Higher-Level Quality Requirement, allows a Federal agency to select a voluntary
consensus standard as the basis for its quality requirements for contracts and allows tailoring of the
standard to more effectively address specific needs or purposes. Based on this FAR clause, EPA has
selected ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs., as the basis for its environmental quality
requirements and has tailored this standard to ensure that contractors demonstrate conformance to this
national standard. The background and application of the new procurement policy as it relates to QA
is included in Appendix A.
Due to these changes, 48 CFR 1546, a quality regulation that applies only to EPA, will be removed
from the Code of Federal Regulations. The tailoring language allowed by 52 CFR 246-11 and
pertinent requirements in 48 CFR 1546 will be included in the EPA Directive 1900, Contracts
Management Manual. This procurement policy notice is being issued to ensure an orderly transition
from 48 CFR 1546 to EPA Directive 1900 and contains tailoring language allowed by 52 CFR 246-
11. It is in effect until the revisions to Directive 1900 are completed
Whenever the government enters into a contract, it is entitled to receive quality service. In order to
define and measure this quality, the WAM/PO must develop a SOW that will accurately define the
minimum acceptable requirements for the service. Methods used to determine quality (audits, quarterly
interviews, random inspections, etc.) should be explained prior to project implementation so that the
supplier will understand how quality will be assessed.
Part of the procurement process of certain types of large contracts include the use of a technical
evaluation panel (TEP). When this form of contracting mechanism is used to solicit contracts for the
STN, which a significant percent of the cost (> 25%) includes EDO, the TEP must include the QAC.
Part of the TEP responsibilities will include rating each potential contractor against a standard set of
criteria. A portion of this criteria can include various assessments such as on-site audits and the analysis
of performance evaluation materials. Prior to the solicitation for bid, it must be determined what
proportion of the TEP rating will be allocated to QA assessments. It is suggested that a minimum of
5% of the overall TEP rating be allocated to QA.
4.4 Assistance Agreements
Assistance agreements are used when both parties (EPA and the group providing the service) derive
benefit out of the service. This usually occurs with grants or cooperative agreements where universities
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or states derive benefits from participating in EDOs. QA requirements are developed for all assistance
agreements that include EDOs. OAQPS follows guidelines developed in the EPA Assistance
Administration Manual (EPA-5700). Assistance agreement SOWs are usually developed jointly.
However, once the SOW is completed, the parties must also agree on the quality standards for assuring
the product or service. It is the responsibility of the WAM/PO to be knowledgeable of the EPA QA
policy and to represent these standards during the development of the projects SOW. Special
conditions are usually included in assistance agreements. The PO will list the conditions to which
project participants must adhere. One of these conditions relates to QAPPs. Any assistance
agreement that includes EDOs must include the following statement:
A quality assurance project plan must be submitted within 90 days of this
agreement and/or 30 days prior to commencement of any EDOs.
Implementation dates will be adjusted based upon the above conditions. Costs
associated with data collection are not allowable costs until the quality
assurance project plan is submitted, nor will costs be reimbursed until the
quality assurance program plan is approved.
4.5 EPA Exclusive Versus Discretionary Functions
The following information comes directly from EPA Quality Manual for Environmental Programs
5360.
Many quality system activities involving EDOs are inherently governmental functions and must be
performed only by EPA personnel or by personnel explicitly authorized by EPA based on statute,
regulation, or by the terms of an extramural agreement. Such representatives may include other
governmental personnel and with specific authorization, contractor personnel. When such quality
management tasks are performed by a contractor, the contract must be appropriately managed and
must remain under the control of the authorized EPA contracting representatives. EPA cannot use
cooperative agreements or grants to provide quality management activities such as QA and QC
services for EPA because it is an inappropriate use of financial assistance (Office of General Counsel
memorandum, August 2, 1994).
This section describes the quality management tasks necessary to comply with the Order and identifies
those tasks that may be performed by non-government personnel under appropriate management
controls.
Two types of quality management functions are described:
Exclusively EPA Functions - inherently governmental work which must be performed only by
responsible EPA officials, including the QA Managers (QAMs), or authorized EPA
representatives.
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Discretionary Functions - activities that may be performed either by EPA personnel or by non-
EPA personnel under the specific technical direction of and performance monitoring by the
QA Manager or other responsible EPA or Government official under an approved contract,
work assignment, delivery order, task order, etc.
In the situations involving the other associated functions, there may be instances involving sensitive
contracting services, advisory and assistance services, and vulnerable contracting practices as defined
by the Federal Acquisition Regulations, Office of Federal Procurement Policy (OFPP), and the EPA
Contracts Management Manual (EPA Order 1900). Such situations are identified by italicized text in
the following sections. In addition, management approval of services contracts as defined by OFPP
Letter 93-1 must be obtained for many of the associated tasks.
Technical direction or other instructions to an extramural organization, relating to performance of an
extramural agreement, shall be provided only by authorized EPA or other Government representatives
in accordance with the terms of the applicable extramural agreement. Only authorized EPA or other
Government representatives are to provide direction or instructions to an extramural organization
providing quality systems support for environmental programs. This is to avoid such actions as:
the providing of directions or instructions that are inconsistent with the terms of an extramural
agreement,
unauthorized access to confidential business information (CBI), or
unauthorized access to information that may allow an extramural organization to gain an unfair
competitive advantage.
4.5.1 Mandatory Quality Management Tasks and Descriptions: This section describes the
activities and tasks integral to an effective quality system. These tasks are required to implement EPA
Order 5360.1 CHG1.
Manage and Coordinate the Quality System
Exclusively EPA functions that must be performed by EPA QA personnel include:
managing the day-to-day implementation of the mandatory quality system.
acting as liaison between the organization and the QS on matters of QA policy.
coordinating with senior management the development of and preparation of the organization's
Quality Management Plan.
coordinating with senior management changes to the Quality System as needed to assure its
continued effectiveness and assisting in reporting the results annually to management and to QS
in the QA Annual Report and Work Plan.
managing organization resources designated for the quality system.
maintaining records of pertinent quality system activities performed by the organization.
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Review and Approve Procurement and Financial Assistance Documents for OA Requirements
Exclusively EPA functions that must be performed by EPA QA personnel include:
reviewing procurement and financial assistance documents (e.g., statements of work, scopes of
work, applications for assistance, funding requests, and purchase requests) to confirm any
need for QA requirements, providing any necessary special language or conditions for such
QA requirements, and approving by signature the appropriate Quality Assurance Review
Form.
participating directly or indirectly in the solicitation or agreement review process to advise the
Project Officer on the suitability of the officer's quality system or quality assurance/quality
control (QA/QC) approach for the particular project.
reviewing work assignments, delivery orders, and task orders to certify that appropriate
QA/QC requirements have been established and that the necessary instructions are being
communicated to the contractor to carry out the required QA/QC tasks. Approving by
signature appropriate Quality Assurance Review Form (EPA Order 1900, Chapter 2).
Review and Approve OA Planning Documents
Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA
representative include:
reviewing Quality Assurance Project Plans (QAPPs) for all projects, work assignments,
delivery orders, task orders, grants, cooperative agreements, and interagency agreements
involving data acquisition, data generation, and/or measurement activities that are performed
on behalf of EPA.
approving all QAPPs for implementation in all applicable projects, work assignments, delivery
orders, task orders, grants, cooperative agreements, and interagency agreements performed
on behalf of EPA.
coordinating the correction of deficient QAPPs with the Project Officer and his/her
management.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
reviewing, at the specific technical direction of the QAM, QA Project Plans and other
QA-r-elatedplanning documents, such as sampling and analysis plans, Data Quality
Objectives (DQO) specifications, etc., and providing specific substantiated
recommendations to the QAM on the adequacy of the QA approach in meeting the
criteria provided by the QAM. (The reviews should identify specific technical
deficiencies in the planning documents.)
Track and Report Quality System Deliverables
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Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA
representative include:
tracking critical quality system deliverables for the organization and make periodic reports to
senior management on the status of reporting actions and deliverables.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
compiling/logging administrative and management information including turnaround times to
correct deficient QAPPs, responses to audits (e.g., responses and corrective actions), and
quality reviews of final reports.
Manage Contractor Support Work Assignments. Delivery Orders, and Task Orders
Exclusively EPA functions that must be performed by EPA QA personnel include:
serving as the Contracting Officer Representative (for example, Project Officer, Work
Assignment Manager, or Delivery Order Project Officer) for specific QA support contracts,
work assignments, delivery orders, and task orders.
Plan and Conduct Management Assessments
Exclusively EPA functions that must be performed by EPA QA personnel include:
planning, directing, and conducting assessments of the effectiveness of the quality system being
applied to environmental data operations and reporting results to senior management. Such
assessments may be conducted using the Management Systems Review (MSR) process.
coordinating with senior management any revision of the quality system as necessary based on
the findings of the assessment.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
providing technical support to the EPA QAM in the planning phase of management
assessments. (Such activities are limited to the assembly and compilation of background
information and data, guidance documents, technical reports, etc., available in the
public domain, for use by EPA in designing the assessment goals and specifications.)
Plan and Conduct Technical Assessments
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Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA
representative include:
planning and directing with the responsible EPA project officials the implementation of periodic
technical assessments of ongoing environmental data operations to provide information to
management to assure that technical and quality objectives are being met and that the needs of
the customer are being satisfied. Such assessments may include technical systems audits,
surveillance, performance evaluations, and data quality assessments.
determining conclusions and necessary corrective actions (if any) based on the findings of the
assessments.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
performing technical assessments of environmental data producing activities, both
intramural and extramural (on-site and off-site) according to a specific plan approved
by the QAM. Preparations for such assessments may include the acquisition or
development of audit materials and standards. Results (findings) are summarized,
substantiated, and presented to the QAM or authorized EPA representative.
A determination of whether an authorized Agency representative should accompany a
contractor's personnel should be made on a case-by-case basis only after coordination
between the responsible organization and contracting officer. Such coordination should
include consideration of the purpose of the accompaniment and clear definition of the
Agency representative 's role and responsibility during the contractor's performance of
the audit or technical assessment to avoid the appearance of a personal services
relationship.
Prepare and Present OA Training Materials and Courses
Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA
representative include:
developing and presenting detailed guidance and training for QA/QC activities based on
interpretation of Agency-wide requirements and guidance.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
providing or coordinating quality-related training for the organization in special skill
areas identified by the Agency and not generally available to the organization.
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providing allowable technical and/or logistical assistance in preparing and presenting
quality-related technical training (within the Agency's implementation of special
management and control measures and the constraints of potential for conflict of
interest, of revealing confidential business information, or of appearing to be
interpreting or representing Agency policy).
Review and Approve Final Reports for Quality Documentation
Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA
representative include:
establishing criteria for the acceptability of quality documentation in the organization's
published papers and reports; that is, defining what is required for an adequate discussion of
the quality of the project results and the usability of the information reported.
approving for publication those papers and reports that meet the defined criteria.
Discretionary functions that may be performed by either EPA personnel or non-EPA personnel
include:
conducting a substantiated technical review of all reports produced by the organization
using the qualitative and quantitative specifications obtained from the DQO process or
other criteria provided by EPA. This quality review complements the peer review
process.
4.5.2 Non-Mandatory Quality Management Tasks and Descriptions: This section describes
other activities and tasks integral to an effective quality system. They are not explicitly required to
implement EPA Order 5360.1 CHG 1, but if implemented, they must be implemented as described
below.
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5. 0 Records and Documentation
The responsibility of record keeping will fall upon OAQPS, NAREL, R&IEL, State and Local
agencies and RTI. For the STN, there are number of documents and records that need to be
retained. A document, from a records management perspective, is a volume that contains information
which describes, defines, specifies, reports, certifies, or provides data or results pertaining to
environmental programs. As defined in the Federal Records Act of 1950 and the Paperwork
Reduction Act of 1995 (now 44 U.S.C. 3101-3107), records are: "...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 of data in them..." EPA-OAQPS, NAREL, and R&IEL will adhere to this
guideline. RTI will be strongly encouraged to adhere to this guideline as well. Section 5.1 will
illustrates the process that will be implemented for storing documents and records. Since many
agencies are involved, their documentation storage capabilities and processes will differ; however,
there is one thing to which must to adhered, all documents and records for this program will be
securely stored. For more information on document control and storage, please see the individual
agency QAPPs.
5.1 Document Hierarchy and Process
This section will outline the hierarchy of the documentation and illustrate the review process for the
major documents created for this program. Please See Figure 5.1 for an illustration of the documents
that govern the STN program.
5.1.1 Hierarchy: The Clean Air Act (CAA) and EPA Order 5360.1, July 1998 are the the
overarching documents for this program. As such, all authority to create programs and allocate funds
is given in these documents. EPA Order 5360.1 gives the EPA authority to require all agencies that
accept federal funds to create QMPs, QAPPs and Network Plans. For the STN, OAQPS has the
authority to require, review, comment and withhold funds if these requirements are not met. The order
of hierarchy follows:
1. The Code of Federal Regulation, through the CAA and Order 5360.1 are the overarching
authority.
2. The QMP encompasses the entire program. All agencies, R&IEL, NAREL, OAQPS, RTI
and the state and local agencies will adhere to the requirements and guidelines in the QMP.
The QMP discusses the roles of each agency.
3. The QAPPs for individual agencies will govern that agency. The agency must adhere to the
statements made in their QAPP.
4. The Network Plan will outline how the network will be implemented and document the
location of each sampler with all ancillary data.
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5.1.2 Document Creation and Review Process: Please see Figure 5.1 for structure of the
documentation in this STN program.
QMP - The QMP for this program was generated by OAQPS-EMAD-MQAG. It has the
overarching authority over all QAPPs, Network Plan and all other ancillary documents. This
document will undergo thorough review by OAQPS, ORD, NAREL, R&IEL, and RTI. It will be
made available for comments to the state and local agencies as well. Since changes may be made
in this program, any revisions must be reviewed by all agencies.
QAPPs - The QAPPs written by the individual agencies to describe their process of assuring the
quality of the data. OAQPS delegates the authority to review these individual QAPPs to the
Regional QA officers.
Network Plan - OAQPS requests that all agencies that will operate a STN sampler will take
electronic photographs of each site in the cardinal directions. These will be forwarded to OAQPS
with all other siting data. OAQPS will create an database which will include the following:
Electronic photo of the sampler in place;
Electronic photos of the area in all cardinal directions;
Maps of the area showing local sources (if known);
All information required for the AMP 380 report;
Coordinates of the location generated by Geographic Positioning Systems.
This data will be compiled and placed in a database. Since this data will also be entered in to the
Aerometric Information Retrieval System (AIRS), the OAQPS database will be updated
periodically. All of this data will be placed on Compact Disk (CD) and distributed and stored by
OAQPS. Any parties that wish to review the network will be able to obtain this data
expeditiously.
Other Documents - The responsibility of all other documents is detailed in the next section.
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fli)
Slate/Local (MIT R&IE QAPP
Network Plan on CD
TJOM *
Order 5360.1
RTI QAFF
k Plan
Figure 5.1 Hierarchy of Documents
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5.2 Documentation Responsibilities
5.2.1 EPA OAQPS/Regional Offices: This division has oversight of the STN. As such, the
documents that must be control and stored are under the jurisdiction of the DOPOs, the program
manager and the QA coordinators are listed below.
DOPOs - The DOPOs has the responsibility of storing and archiving all records that pertain to the
requisition and deposition of contracts and equipment to contractors, State and local agencies, or
Regional offices. The DOPOs will store these documents as specified in this QMP.
Program Manager - The program manager is responsible for the overall operation and technical
guidance for the program. The documents and records for under his/her jurisdiction, are reports
to management, summaries of discussion and conference calls, technical guidance documents and
any other data shared with all agencies involved.
QA coordinator - The QAC is responsible for the QA aspects of this program. As such, he is
responsible for the QA documents related to QA conference calls The QAC is also responsible
for the oversight and review of the STN QMP and all QAPPs created by the RTI, NAREL and
R&IEL.
Regional QA Officers- The EPA Regional QA officers are responsible for the QA documentation
related their individual QAPPs. In addition, these officers are responsible for the storage of the
maintenance and operation documentation required to run a local program.
5.2.2 NAREL - Montgomery Alabama:
Project Manager - The project manager is responsible for the oversight of the laboratory QA at
NAREL. As such, he/she is responsible for the storage of all records and documents generated
by this lab. The NAREL approach uses bound notebooks to enter data on any stock solutions,
working calibration or dilutions that are generated. It is the project managers responsibility to
assure that all personnel under his jurisdiction keep these secured when not in use or overnight.
Quality Assurance Chemist - The QA chemist is responsible for the QA oversight of this
laboratory. Any records created that pertains to duplicates, spikes or other QA samples will be
under the QA chemist's jurisdiction.
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5.2.3 R&IEL -Las Vegas, Nevada: The R&IEL approach uses bound notebooks to enter data on
any flow rate or field performance evaluations. Standard TSA forms will be filled out in the field
situation. The data will then be entered into spreadsheets/word processing programs on laptop.
Project Manager - The project manager, in cooperation with the QAC, is responsible for the
oversight of the field QA. As such, he/she is responsible for the storage of all records and documents
generated by field TSA or performance audits. The project managers responsibility to assure that all
personnel under his jurisdiction keep the handwritten and electronic field reports locked when not in
use or overnight.
Field Auditors - The field auditors are responsible for the collection of QA data at the monitoring
locations during TSAs or field performance evaluations. Any records created on paper or in on
laptop computer must be in the auditors presence when traveling or be in his/her locked room.
5.2.4 RTI -Research Triangle Park, North Carolina: The RTI will handle the bulk of the
documentation and records for this program since the beginning and final deposition of all samples will
be with RTI. RTI has fully documented their system in their QAPP. Below are responsible parties
for documentation control.
Technical Area Supervisors - RTI has a two tiered level of management. The first tier has the
program services manager, who is overall responsible lab operations and the QA Manager. The
second tier is the Technical Area Supervisors. There are 7 Technical Areas, each with its own
supervisor. Each is responsible for maintaining, quality handling, storage and retrieval of their area
records.
5.2.5 State and Local Agencies: Each agency will retain copies of their documents and records
pertaining to the operation, storage or handling of samples. These records must be made available for
inspection and review by EPA or its designee.
5.3 Deposition and Storage of Documents and Records
This section will address the deposition, storage accessibility, protection, of documents and records. It
is noted that the persons filling the roles mentioned above are responsible for the documents and
record that they generate. These agencies will take full responsibility for the deposition of these
records. Please note that all records and documents will be made available for review and scrutiny
upon request for up to 5 years after the data were generated.
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Field notebooks- Notebooks will be utilized for recording results of field audits. Dates, times, field
conditions, temperature, pressure and flow rates will be recorded. These will be archived
along with the data generated by the field laptops in Las Vegas, Nevada. Please see the R&IEL
QAPP and SOPs.
Lab Notebooks- Notebooks will also be issued for the laboratory. These notebooks will be uniquely
numbered and associated with the speciation program. One notebook will be available for general
comments/notes; others will be associated with, the temperature and humidity recording instruments,
the refrigerator, calibration equipment/standards, and the analytical
balances and instruments used for this program. RTI and NAREL will both be generating laboratory
data. Therefore, they must maintain all records for at least 5 years after the data are generated.
Chain of Custody Forms- Original Chain of Custody forms must be retained by RTI and copies must
be kept by the state or local agency.
Other Documents- All other documents must be stored according to their QAPP.
Electronic data collection- In order to reduce the potential for data entry errors, automated systems
will be utilized where appropriate and will record the same information that is found on data entry
forms. In order to provide a back-up, a hardcopy of automated data collection information will be
stored for the appropriate time frame in project files.
5.3 Deposition of Reports
5.3.1 Annual Summary Reports: The annual reports will ensure that work performed by the
agencies is accurately performed and that the statutory and contractual requirements are met.
RTI- RTI shall submit to EPA-OAQPS an annual summary report of all the speciation data
collected within that calender year. The report will be submitted by April 1 of each year for
the data collected from January 1 to December 31 of the previous year. The report will
contain the following information:
Site and Monitoring Information.
City name;
county name and street address of site location;
AIRS-AQS site code;
AIRS-AQS monitoring method code.
Summary Data
Annual arithmetic mean, and
Sampling schedule used as once every 3-day schedule.
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NAREL- NAREL shall submit to EPA-OAQPS an annual summary report of all the QA
speciation data collected within that calender year. The report will be submitted by
April 1 of each year for the data collected from January 1 to December 31 of the previous
year. This report will include analysis of all PE samples and results of any MSRs or TSAs
performed.
R&IEL- R&IEL shall submit to EPA-OAQPS an annual summary report of all the field
performance evaluations and TSAs for data collected within that calender year. The
report will be submitted by April 1 of each year for the data collected from January 1 to
December 31 of the previous year.
5.4.2 Data Reporting Package/Archiving and Retrieval: All the information, electronic and
written, will be retained for 5 years from the date the grantee submits its final expenditure report unless
otherwise noted in the funding agreement. However, if any litigation, claim, negotiation, audit or other
action involving the records has been started before the expiration of the 5-year period, the records
will be retained until completion of the action and resolution of all issues which arise from it, or until the
end of the regular 5-year period, whichever is later. For example, any data collected in calendar
year 2001 (1/1/01 -12/31/01) will be retained until, at a minimum, January 1, 2006, unless the
information is used for litigation purposes.
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6.0 Computer Software and Hardware
There is an increasing dependence upon computers and computer related hardware in the collection of
environmental data. Indeed, most environmental programs within and outside of the EPA use
computers extensively to collect, store, validate and analyze environmental data. This section will
outline briefly what computer systems will be employed throughout the STN. This chapter will also
describe the roles and responsibilities for system hardware and software.
6.1 Computer System Descriptions
6.1.1 RTI: RTI will have the most extensive computer system for this operation. The pre-sampling,
post sampling filter data and sample run information will be housed in the RTI Oracle data base.
6.1.2 EPA-OAQPS: Once the data has been validated by RTI and reviewed by the State and Local
agencies, the data will be delivered to the AIRS database. The AIRS database is a long term data
storage main-frame computer. It is housed at the EPA facility in Research Triangle Park, North
Carolina.
6.1.3 NAREL: The NAREL will have a database system that will house the QA sample information
analyzed by NAREL. The QA database will be on Local Access Network (LAN) that is maintained
by the NAREL computer group.
6.1.4 R&IEL: The ORIA Las Vegas data will mostly consist of audit reports and TSA reports. As
audit reports are written, they will be download to PC hardrive of the auditors.
6.2 Roles and Responsibilities
6.2.1 EPA Systems: All EPA databases are governed by EPA directive 2100 including the Year
2000 compliance, security and privacy requirements. Each of the EPA agencies have their own LAN
(R&IEL, NAREL and OAQPS). These are password protected and maintained by the System
Administrators (SA) for each agency. The EPA's SA have the responsibility of ensuring that the
computer hardware used for this program meets the technical requirements. These include:
quality expectations (i.e., configuration testing);
control to changes to hardware;
the SA's follow their QMP for developing, validating, verifying software so that it meets EPA
Directive 2182;
evaluate purchased software before it is utilized by EPA scientists;
ensure that data and information produced by the EPA are collected and archived in a safe and
secure manner.
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6.2.2 RTI: RTI is currently developing a Data Base Management System (DBMS) based on
Microsoft SQL server. This system will be utilized by RTI to manage, store analyze the database as
the data are collected. The final database will be tested and follow the guidelines set down by EPA
Directive 2182. The RTI has a data base Technical Supervisor who is tasked to perform the following
duties:
quality expectations (i.e., configuration testing);
control to changes to hardware;
follow their QAPP for developing, validating, verifying software so that it meets EPA Directive
2182;
evaluate purchased software before it is utilized by RTI scientists;
ensure that data and information produced for the EPA are collected and archived in a safe and
secure manner.
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7.0 Planning
This section will outline planning and implementation procedures that will be employed in the STN.
This program has several diverse agencies that are will be interacting at several levels. Therefore, to
ensure that the work is being performed and that the quality of the data is acceptable, clear
communication must be employed for this program. The following sections will outline how this will be
accomplished.
7.1 Project Goals and Objectives
As stated in Section 1, the STN is a component of the National PM2 5 Monitoring Network. The
programmatic objectives of the STN network are:
Annual and seasonal spatial characterization of aerosols;
Air quality trends analysis and tracking the progress of control programs;
Integration of chemical speciation data set with the data collected from the
IMPROVE network; and
Development of emission control strategies.
It has been decided that PM2.5 chemical species over a period of 3 or more years would be sufficient
for statistical analysis of the data. This data will be utilized as input to models and for development of
emission control strategies and determination of their long-term effectiveness. Public health officials
and epidemiological researchers will also use the data to test health based research.
In the early stages of this program, an expert panel met on May 18-19, 1998 in Las Vegas, NV, to
review the EPA's revised guidance document on the speciation network. Members of the panel were:
Drs. Tom Cahill, Phil Hopke, Lara Gundel, John Ondov, and Petros Koutrakis. Mr. Robert Stevens,
who is also a panel member, did not attend the meeting, but he submitted his comments in writing.
Members of the speciation group, which consists of EPA staff and representatives from several states,
also participated in this meeting. Below is a summary of the expert panel recommendations1.
Identification of types of data: Speciation data will be required in three major categories; ions,
semi-volatile organics and metals;
these data will be used to support SIP implementation and source characterization;
the sampling frequency should be increased from once every 6th day to once every 3rd day;
there should be at least 3 years of data collected.
the number of sites can be supported with no more than 55 sites;
there should be a phased in approach to the program; and
the data should be collected around the nation.
The expert panel meets from time to time to assess the progress of the STN program. Milestones we
set by the expert panel by which EPA would adhere. The following is a description of the milestones;
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1. First Year. Network Design and Objectives: During the first year, the EPA staff focused its
efforts on the design of the speciation network. In 1998, at the Seattle meeting, the expert
panel had the opportunity to review the objectives of the network and the list of measurement
parameters.
2. Second Year. Sampler Intercomparison Field Studies: Since the Seattle meeting, a series of
field studies have been conducted to evaluate the performance of the candidate sampling
devices. In addition, the EPA staff has initiated the process of contracting the laboratories
designated to perform the sampler preparation and chemical analysis.
3. Third Year. Intercomparison Completion and Implementation of the First Ten Sites: The focus
should be on the completion of the sampler tests, completion of the sampling and analysis
protocols, and start-up of the first ten sampling sites. An effort should be made to develop an
implementation plan for the speciation network and to set up a managerial structure. It is
important to present a structured plan outlining the responsibilities and duties of the
participating groups.
4. Fourth Year. Development of State Expertise in Particulate Data Interpretation: Research
scientists have a tremendous experience in particle sampling and to, some extent, in chemical
analysis methods; however, the state scientists have little experience in analyzing particulate
data. Therefore, before the end of the fourth year, a plan should be presented to provide
training to state scientists in source apportionment methodologies and their interpretation.
The EPA has accepted these recommendations and have begun to implement them on this
abovementioned schedule. Below is a list of the key personnel and their responsibilities.
7.2 Key Planning Personnel
7.2.1 Monitoring and Quality Assurance Group Leader: The group leader has the responsibility
to make the final decision on the implementation of the program. He/she has the following
responsibilities:
1. meet with the expert panel or/or CAS AC to review the progress of the program;
2. direct OAQPS personnel listed below;
3. review the progress of the program and assure that it is moving forward as recommended by
the expert panel.
7.2.2 Program Manager: The program manager is the person who performs the following planning
activities:
1. identify program schedules;
2. writes the level of effort proposals;
3. oversees the implementation of program from a technical perspective.
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7.2.3 Delivery Order Project Officer: The DOPOs are responsible for the following planning
activities;
1. identify program schedule, in terms of deliverable goods;
2. work with the program manager on the level of effort;
3. oversee the financial implementation of the program.
7.2.4 Quality Assurance Coordinator: The QAC is responsible for the QA planning for the
program. He/she is responsible for:
1. overseeing the overall QA for the program;
2. making sure that proper QA is being performed;
3. meet with other QA members via meetings and tele-conferences
4. assess any data obtained from sources outside of the EPA that did not use approved QAPPs;
7.3 Other Planning Activities
The following activities will facilitate the success of the program.
OAQPS must assure that each agency within the program receives the proper training, equipment,
goods, services and technical knowledge to perform their duties. In addition, all parties must be made
aware of events and deadlines. Part of this is clear communication amongst all agencies. The
following methods will be used to impart information to ensure proper planning.
7.3.1 Tele-communications: Tele-conferencing is an extremely useful tool to impart information and
ensure that the planning process is moving forward. For the past 12 months, Mr. James Homolya has
led tele-conference working group for the speciation program. The working group has consisted of
OAQPS, Regional EPA and State and Local Agency staff. Mr. Homolya has guided this working
group by informing the group concerning the development of the speciation samplers, discussion of the
laboratory operations and the time lines of implementation of the samplers into the field.
Recently, a new working group has been formed to bring together the quality system for the speciation
program. This QA working group will be led by Mr. Dennis Mikel, who has been designated as the
STN-QA coordinator. The QA workgroup consists of OAQPS and ORIA
staff.
7.3.2 Internet: EPA supports and maintains a web site on the Word Wide Web. Guidance
documents, special announcements and related documents are posted on the website. These
documents can be downloaded from the File Transfer Protocol (FTP) areas of the web site. In
addition, the EPA and all of the agencies involved in this program have electronic mail (email)
capabilities, by which information can be transmitted and all affected parties can be informed of
meetings and special events. Any persons interested in the program may find information at the
following location: http://www.epa.gov/ttn/amtic/amticpm.html.
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Re vision No: 2.1
Date: 7/18/01
Page 4 of 4
7.3.3 Data Analysis: Preliminary data analysis will be performed by RTI as described in their
QAPP2. However, it is OAQPS technical staff will also review and analyze the data sets. Results and
summaries will be presented a various seminars and technical workshops.
7.4 References:
1. Koutrakis, Petros, Chair, Speciation Expert Panel. Recommendations of the 1999 Expert Panel
on the EPA Speciation Network, Final Summary-08/03/99
2. Quality Assruance Project Plan Chemical Speciation of PM2.5 Filter Samples, Research Triangle
Park, NC, Document Number RTI/7565/00-02S
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Project: Speciation QMP
Element No:.8.0
Re vision No: 2.1
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Page 1 of 1
8.0 Implementation of Work
Each organization involved in this program will develop a QAPP that will describe the process and
work performed for their program. The state and local agencies' QAPPs will be submitted to EPA
Regional Offices, which will review, provide comments and finally approve their QAPPs. On the
other hand, RTFs, NAREL's and R&IEL's QAPPs will be submitted to OAQPS for review,
comments and final approval. Since each agency/laboratory has developed their own QAPPs,
ultimately each agency is responsible for the implementation of the program in their county, state or
laboratory. This section will outline the individuals in each agency that will be required to implement the
work.
8.1 Implementation Roles
8.1.1 Program Manager: The program managers are responsible for overall work to be performed.
These include:
ensuring that work is being performed according the agency QAPP;
development and implementation of procedures;
standardization of techniques;
development of special or "critical" techniques that might deviate from the normal good
laboratory practices;
8.1.2 Quality Assurance Managers: The QA managers oversee through internal TSAs and review
of data that procedures are being followed as specified by the agency QAPP. In addition, the QA
managers must also:
identify operations needing procedures;
help prepare the procedures by writing and revising the QAPP;
review and approve procedures before they are implemented;
provide new tools to the monitoring or laboratory staff that may enhance or increase the
productivity of the operation;
control the release, change and use of planned procedures;
work with the program manager in approving changes to procedures;
revise the QAPP to remove obsolete techniques and keep up-to-date procedures available to
field and laboratory staff;
verify that changes made in the field, through TSAs, as performed as prescribed in the QAPP.
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9. Data Quality Assessments
This section describes the quality-related activities necessary to support the speciation network
operations and the associated data acquisition, validation, assessment, and reporting.
Important benefits of regular DQAs include the opportunity to alert the management of data quality
problems, to propose viable solutions to problems, and to procure necessary additional resources.
Management should not rely entirely upon the MSRs and TSAs for their assessment of the data. The
MSR and TSA only occur annually. Quality assessment, including the evaluation of the technical
systems, the measurement of performance, and the assessment of data, is conducted to help insure that
measurement results meet program objectives and to insure that necessary corrective actions are taken
early, when they will be most effective.
9.1 Program Assessment Techniques
Assessment is an all-inclusive term used to denote any of the following: :TSAs, performance evaluation
audits, management systems review, data quality assessments(DQAs). Definitions for each of these
activities can be found in the Glossary. Table 10.1 provides information on the parties implementing
the assessment and their frequency.
Table 9.1 Assessment Schedule
Agency
NAREL
R&IEL
OAQPS-EMAD
OAQPS-EMAD
Regional Offices
Type of Assessment
TSA, MSRs and PEs
TSAs, Performance Audits
TSAs
MSRs
Network Reviews
Agency Assessed
RTI
State and local
agencies
RTI, NAREL, State
and Local
agencies, Regional
offices and R&IEL
RTI, NAREL, State
and Local
agencies, Regional
offices and R&IEL
State and local
agencies
Frequency
Annually
Annually*
As needed by
EMAD
determination
As needed by
EMAD
determination
Once every 3
years
* Not all instruments in the program will be audited every year. It is estimated that 10% of the instruments will be
audited annually.
9.1.1 Technical System Audit: Initially, the TSAs will be performed by the ORIA laboratories. The
results of the TSAs will be included in the QAAR reports that will be submitted to OAQPS. Other
agencies will submit their reports to OAQPS as well. Information on how these will be conducted can
be found in EPA QA/R- 5 document.
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9.1.2 Network Reviews: Network Reviews will be performed by EPA Regional staff on each State
and Local Agency once every three years. Network Reviews for criteria pollutants are performed
once every three years. The EPA Regional offices will be tasked to review the speciation network at
the same time as the criteria pollutant Network Review. The Regional offices will notify OAQPS of
any anomalies in the network.
9.1.3 Management System Review: Management System Review will be conducted by the EPA-
EMAD- MQAG staff. The MSR will be performed annually. The RTI laboratory and selected EPA
Regional office will be reviewed annually.
9.1.4 Data Quality Assessments: The EPA-EMAD-MQAG will produce a Data Quality
Assessment report during the first year and every three years thereafter. This assessment will be
performed using standard statistical tests to ascertain the uncertainty of the data.
9. 2 Reports to Management
The NAREL and R&IEL laboratories will submit assessments and reports performed by the
organization, in particular, the QAARs. The NAREL QAAR will report on the TSAs, QA sample data
and the effectiveness of the quality system. The R&IEL QAAR will focus on the TSAs and field audits
that have been performed throughout the year.
Network Review performed by the Regional Offices should be forwarded to OAQPS for inclusion in
the QAAR.
9.3 Planning, Training and Authority
The following sections will discuss process of planning, training and the authority of those whom will be
performing assessments.
9.3.1 Planning: The QMP is the first step towards having an effective planning process. This QMP
will outline how assessors for this program will plan, schedule and implement assessments. At the
beginning of the year, those who have been assigned to perform assessments will set out their tentative
schedule for assessments. This schedule will first be submitted to management, who can modify the
schedule. After management approval, the schedule is submitted in writing (or email) to the agencies
that will be assessed. Usually, one month before the assessment, the agency to be assessed is notified
by telephone of the exact dates and times. At this time, the assessment form (TSA or MSR forms) are
submitted to the agency to be assessed(in writing or via email). This allows the agency the time to
review the forms and gather the information needed to be presented to the assessors. This has a two-
fold objective: it allows those to be assessed knowledge of what will be required and it can minimize the
time that assessors are in the field and that managers and scientists are away from their other duties.
9.3.2 Training: Training is essential to assessors in two ways: the assessor needs to understand the
process by which data are generated, without this knowledge the assessment may be inadequate, and in
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order to communicate clearly with the agency that is being assessed, the assessor must be competent.
Training fill these needs. A part of training that is not seen or documented is the fact that those chosen
for assessment should have experience in the field in which they are assessing. Although most QA
criteria and theory are universal, understanding the process by being experienced in working in that field
is essential. Below is a list of assessment training that will be provided in this program.
OAQPS will continue to offer satellite course on QA and QC, as well as programs that update the
state and local agencies on the STN.
NAREL, R&IEL will continue to offer training classes to the personnel that will be performing
assessment to the STN.
9.3.3 Authority: All personnel that are chosen to conduct assessments to this program have the
authority to do so through the EPA. OAQPS has the overall responsibility and authority over this
program. It delegates this authority to perform assessments to all agencies that perform such duties.
All personnel in this capacity have the right and responsibility to:
identify problems;
Identify and cite noteworthy practices that may be shared with others to improve the quality of their
operations;
propose recommendations for resolving quality problems;
independently confirm implementation and effectiveness of solutions;
report these finding to the EPA Regional Offices or directly to OAQPS.
Reports of assessments are discussed in section 9.2.
9.3.4 Disputes: Occasionally, findings in an assessment report may be disputed by the agency
assessed. Any disputes that are announced by an agency should first be handled by the Regional
Offices. If this fails to satisfy the situation, then OAQPS has the final authority to make a decision
concerning a dispute. In the case of assessments made by NAREL and R&IEL, OAQPS has the
authority to discuss and satisfy disputes.
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Project: Speciation QMP
Element No:. 10
Re vision No: 2.1
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Page 1 of 3
10.0 Quality Improvement
This section will outline planning and implementation procedures that will be employed for improving the
quality of the program. OAQPS has the responsibility to improve the quality of the program over an
unspecified period of time. There can be no set dates on when this improvement can or will occur,
however, OAQPS will make every effort to improve the system over a period of many years. The
following figures illustrates the quality improvement process that OAQPS will institute for this program.
Final
t
Compilation and
Figure 10.1 Data Improvement Flow Diagram
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Project: Speciation QMP
Element No:. 10
Re vision No: 2.1
Date: 7/18/01
Page 2 of 3
10.1 Quality Improvement Process Flow
This section will outline the process flow of the quality improvement paradigm as diagramed in figure
10.1.
10.1.1 Assessment: The assessments that are planned for the STN are detailed in section 9 of this
QMP. Once the assessment agency has completed the assessment, a report will be sent to the
assessed agency.
10.1.2 Assessment Report: The assessment report will state the who, what, where and when of the
assessment. The report will highlight the findings of the assessment and allow the assessed agency the
ability to respond to all assessment findings (usually 45 days).
10.1.3 Response: The assessed agency has the right to respond in writing, or email. All responses will
be reviewed by the assessment agency and will respond in kind. If any disputes arise from the
assessment this will be dealt as detailed in section 9.3.4 of this QMP. In addition, the EPA and all of
the agencies involved in this program have electronic mail (email) capabilities, by which information can
be transmitted and all affected parties can be informed of meetings and special events.
10.1.4 Final Assessment Report: The final assessment report will be sent to OAQPS and the
assessed agency. This report will highlight the findings of the assessment and recommendations.
10.1.5 Review, Compilation and Analysis: Once OAQPS has received the final assessment reports,
the agency will review the findings, compile the information and analyze the data. Any disputes
concerning the assessments will be finalized at that time.
10.1.6 Final QAAR: The final QAAR will be the final report for a given calendar year. This report,
created by OAQPS, will highlight the major findings of the assessment and recommendations will be
made in this report. This report will then be sent to all Regional Offices, RTI, NAREL, R&IEL,
CASAC and the expert panel. Any other parties that wish to obtain this report must contact the person
listed in the forward of this QMP. Regional offices will be required to forward this report to the state
and local agencies.
10.2 Quality Improvement Assurance
The QAAR and the assessment reports will ensure that quality will continually improve by allowing the
assessed agencies the ability to participate, review and have input into the final reports. Once the
assessment reports are issued, the assessment agencies will note where improvement needs to be
addressed. When the next assessment is performed, the previous deficiency will be noted and brought
to the assessed agency's attention. At that time, the assessed agency must provide proof that the
previous year's assessment deficiencies were addressed between the assessments. Any deficiencies
that were not addressed will be documented in the next assessment report. Deficiencies that are not
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addressed over a one year period will be noted by OAQPS. OAQPS will request that the Regional
Offices contact the management of the assessed agency and take action as needed. This assures that
OAQPS management will have resolution to deficiencies and that these deficiencies do not remain un-
addressed. This above mentioned process will allow OAQPS and all stakeholders the ability to
evaluate planning, implementation of programs, and evaluate the effectiveness of the program.
In the case of action items that threaten the quality of the data, the assessment team will identify who
(organizationally) is responsible for improvements. If immediate action is needed, EPA-OAQPS gives
the authority to the assessment agency to follow-up (within two weeks) to ensure that corrective action
are taken and adverse conditions to quality are remedied as soon as practical
Staff members at all agencies are encouraged to identify and establish communications between all
agencies. This includes state and local agencies to OAQPS and from any assessment agency to the
state and local agencies. Staff members are encouraged to bring any improvements to the assessment
agencies during the assessments and to discuss the most practical and cost effective remedies for any
problem.
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Project: Speciation QMP
Glossary
Re vision No: 1.0
Date: 7/18/01
Page 1 of 4
GLOSSARY OF QUALITY ASSURANCE AND RELATED TERMS
Activity An all-inclusive term describing a specific set of operations of related tasks to be performed,
either serially or in parallel (e.g., research and development, field sampling, analytical operations,
equipment fabrication), that, in total, result in a product or service.
Assessment The evaluation process used to measure the performance or effectiveness of a system
and its elements. As used here, assessment is an all-inclusive term used to denote any of the following:
audit, performance evaluation (PE), management systems review (MSR), peer review, inspection, or
surveillance.
Audit (quality) A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are implemented
effectively and are suitable to achieve objectives.
Audit of Data Quality (ADQ) A qualitative and quantitative evaluation of the documentation and
procedures associated with environmental measurements to verify that the resulting data are of
acceptable quality.
Authenticate The act of establishing an item as genuine, valid, or authoritative.
Certification The process of testing and evaluation against specifications designed to document,
verify, and recognize the competence of a person, organization, or other entity to perform a function or
service, usually for a specified time.
Collocated samples Two or more portions collected at the same point in time and space so as to be
considered identical. These samples are also known as field replicates and should be identified as such.
Computer program A sequence of instructions suitable for processing by a computer. Processing
may include the use of an assembler, a compiler, an interpreter, or a translator to prepare the program for
execution. A computer program may be stored on magnetic media and referred to as "software," or it
may be stored permanently on computer chips, referred to as "firmware." Computer programs covered
in a QAPP are those used for design analysis, data acquisition, data reduction, data storage (databases),
operation or control, and database or document control registers when used as the controlled source of
quality information.
Configuration The functional, physical, and procedural characteristics of an item, experiment, or
document.
Corrective action Any measures taken to rectify conditions adverse to quality and, where possible, to
preclude their recurrence.
Data Quality Assessment (DQA) The scientific and statistical evaluation of data to determine if
data obtained from environmental operations are of the right type, quality, and quantity to support their
intended use. The five steps of the DQA Process include: 1) reviewing the DQOs and sampling design,
2) conducting a preliminary data review, 3) selecting the statistical test, 4) verifying the assumptions of the
statistical test, and 5) drawing conclusions from the data.
Data Quality Objectives (DQOs) The qualitative and quantitative statements derived from the
DQO Process that clarify study's technical and quality objectives, define the appropriate type of data, and
specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality
and quantity of data needed to support decisions.
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Glossary
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Page 2 of 4
Data reduction The process of transforming the number of data items by arithmetic or statistical
calculations, standard curves, and concentration factors, and collating them into a more useful form. Data
reduction is irreversible and generally results in a reduced data set and an associated loss of detail.
Design The specifications, drawings, design criteria, and performance requirements. Also, the result
of deliberate planning, analysis, mathematical manipulations, and design processes.
Document Any written or pictorial information describing, defining, specifying, reporting, or certifying
activities, requirements, procedures, or results.
Document control The policies and procedures used by an organization to ensure that its documents
and their revisions are proposed, reviewed, approved for release, inventoried, distributed, archived, stored,
and retrieved in accordance with the organization's requirements.
Environmental data Any parameters or pieces of information collected or produced from
measurements, analyses, or models of environmental processes, conditions, and effects of pollutants on
human health and the ecology, including results from laboratory analyses or from experimental systems
representing such processes and conditions.
Financial assistance The process by which funds are provided by one organization (usually
governmental) to another organization for the purpose of performing work or furnishing services or items.
Financial assistance mechanisms include grants, cooperative agreements, and governmental interagency
agreements.
Finding An assessment conclusion that identifies a condition having a significant effect on an item or
activity. An assessment finding may be positive or negative, and is normally accompanied by specific
examples of the observed condition.
Independent assessment An assessment performed by a qualified individual, group, or organization
that is not a part of the organization directly performing and accountable for the work being assessed.
Inspection The examination or measurement of an item or activity to verify conformance to specific
requirements.
Management Those individuals directly responsible and accountable for planning, implementing, and
assessing work.
Management system A structured, nontechnical system describing the policies, objectives, principles,
organizational authority, responsibilities, accountability, and implementation plan of an organization for
conducting work and producing items and services.
Management Systems Review (MSR) The qualitative assessment of a data collection operation
and/or organization(s) to establish whether the prevailing quality management structure, policies, practices,
and procedures are adequate for ensuring that the type and quality of data needed are obtained.
Organization A company, corporation, firm, enterprise, or institution, or part thereof, whether
incorporated or not, public or private, that has its own functions and administration.
Organization structure The responsibilities, authorities, and relationships, arranged in a pattern,
through which an organization performs its functions.
Procedure A specified way to perform an activity.
Process A set of interrelated resources and activities that transforms inputs into outputs. Examples of
processes include analysis, design, data collection, operation, fabrication, and calculation.
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Glossary
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Page 3 of 4
Project An organized set of activities within a program.
Quality The totality of features and characteristics of a product or service that bears on its ability to
meet the stated or implied needs and expectations of the user.
Quality Assurance (QA) An integrated system of management activities involving planning,
implementation, assessment, reporting, and quality improvement to ensure that a process, item, or service
is of the type and quality needed and expected by the client.
Quality Assurance Project Plan (QAPP) A formal document describing in comprehensive detail the
necessary quality assurance (QA), quality control (QC), and other technical activities that must be
implemented to ensure that the results of the work performed will satisfy the stated performance criteria.
The QAPP components are divided into four classes: 1) Project Management, 2) Measurement/Data
Acquisition, 3) Assessment/Oversight, and 4) Data Validation and Usability. Guidance and requirements
on preparation of QAPPs can be found in EPA QA/R-5 and QA/G-5.
Quality Control (QC) The overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the stated
requirements established by the customer; operational techniques and activities that are used to fulfill
requirements for quality. The system of activities and checks used to ensure that measurement systems
are maintained within prescribed limits, providing protection against "out of control" conditions and
ensuring the results are of acceptable quality.
Quality improvement A management program for improving the quality of operations. Such
management programs generally entail a formal mechanism for encouraging worker recommendations
with timely management evaluation and feedback or implementation.
Quality management That aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning, allocation
of resources, and other systematic activities (e.g., planning, implementation, and assessment) pertaining to
the quality system.
Quality Management Plan (QMP) A formal document that describes the quality system in terms of
the organization's structure, the functional responsibilities of management and staff, the lines of authority,
and the required interfaces for those planning, implementing, and assessing all activities conducted.
Quality system A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of an
organization for ensuring quality in its work processes, products (items), and services. The quality system
provides the framework for planning, implementing, and assessing work performed by the organization
and for carrying out required quality assurance (QA) and quality control (QC).
Requirement A formal statement of a need and the expected manner in which it is to be met.
Round-robin study A method validation study involving a predetermined number of laboratories or
analysts, all analyzing the same sample(s) by the same method. In a round-robin study, all results are
compared and used to develop summary statistics such as interlaboratory precision and method bias or
recovery efficiency.
Self-assessment The assessments of work conducted by individuals, groups, or organizations directly
responsible for overseeing and/or performing the work.
Specification A document stating requirements and referring to or including drawings or other
relevant documents. Specifications should indicate the means and criteria for determining conformance.
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Page 4 of 4
Standard Operating Procedure (SOP) A written document that details the method for an operation,
analysis, or action with thoroughly prescribed techniques and steps and that is officially approved as the
method for performing certain routine or repetitive tasks.
Technical review A documented critical review of work that has been performed within the state of
the art. The review is accomplished by one or more qualified reviewers who are independent of those
who performed the work but are collectively equivalent in technical expertise to those who performed the
original work. The review is an in-depth analysis and evaluation of documents, activities, material, data,
or items that require technical verification or validation for applicability, correctness, adequacy,
completeness, and assurance that established requirements have been satisfied.
Technical Systems Audit (TSA) A thorough, systematic, on-site qualitative audit of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management, and
reporting aspects of a system.
Vendor Any individual or organization furnishing items or services or performing work according to a
procurement document or a financial assistance agreement. An all-inclusive term used in place of any of
the following: seller, contractor, subcontractor, fabricator, or consultant.
Verification Confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled. In design and development, verification concerns the process of
examining a result of a given activity to determine conformance to the stated requirements for that
activity.
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Project: Speciation QMP
Contact List
Re vision No: 1.0
Date: 7/18/01
Page 1 of 1
Contact List
The following list is a compilation of contacts for the Fine Particle Speciation Program.
Contact
Rich Scheffe
James Homolya
Dennis Mikel
Joann Rice
Michael Papp
Michael Clark
Steve Taylor
Jewell Smiley
Mary Wisdom
Jed Harrison
Emilio Braganza
Dick Siscanaw
R.K.M. Jayanty
Paul Solomon
Marc Pitchford
Scott Faller
Vickie Presnell
Kenneth Wang
Pat Schraufnagel
Marcus Kantz
Agency
OAQPS-EMAD-MQAG
OAQPS-EMAD-MQAG
OAQPS-EMAD-MQAG
OAQPS-EMAD-MQAG
OAQPS-EMAD-MQAG
NAREL
NAREL
NAREL
NAREL
R&IEL
R&IEL
EPA Region 1
Research Triangle Institute
ORD-Las Vegas
ORD-Las Vegas
R&IEL
OAQPS-EMAD
Region 8
Region 5
Region 1
Phone Number
919-541-4650
919-541-4039
919-541-5511
919-541-3372
919-541-2408
334-270-7069
334-270-7072
334-270-7073
334-270-3476
702-798-2476
702-798-2430
781-860-4327
919-541-6483
702-798-2280
702-895-0432
702-798-2323
919-541-7620
303-312-6738
312-886-5955
732-321-6690
Email
scheffe.rich@epa.gov
homolya.james@epa.gov
mikel.dennis@epa.gov
rice.joann@epa.gov
papp.michael@epa.gov
clark.michael@epa.gov
taylor-jr. steve@epa.gov
smiley j ewell@epa. go v
wisdom.mary@epa.gov
harrison.jed@epa.gov
braganza.emilio@epa.gov
siscanaw.dick@epa.gov
rkmj@rti.org
solomon.paul@epa.gov
marcp@snsc.dri.edu
fallen scott@epa.gov
presnell.vickie@epa.gov
wang.kenneth@epa.gov
schraufnagel.pat@epa.gov
kantz .marcus@epa. go v
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Project: Speciation QMP
Appendix A
Re vision No: 1.0
Date: 7/18/01
Page 1 oflO
Appendix A
Procurement Policy Notice
for Contracting Officer's Representatives
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Project: Speciation QMP
Appendix A
Re vision No: 1.0
Date: 7/18/01
Page 2 oH 0
Procurement Policy Notice
for Contracting Officer's Representatives
1. Background
The Federal Acquisition Regulations, Title 48 of the Code of Federal Regulations, was recently
amended to address contract quality systems requirements on a government-wide basis. The new FAR
clause at 52.246-11, Higher-Level Quality Requirement, allows a Federal agency to select a voluntary
consensus standard as the basis for its quality requirements for contracts and allows tailoring of the
standard to more effectively address specific needs or purposes. Based on this FAR clause, EPA has
selected ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs., as the basis for its environmental quality
requirements and has tailored this standard to ensure that contractors demonstrate conformance to this
national standard.
Due to these changes, 48 CFR 1546, a quality regulation that applies only to EPA, will be removed
from the Code of Federal Regulations. The tailoring language allowed by 52 CFR 246-11 and
pertinent requirements in 48 CFR 1546 will be included in the EPA Directive 1900, Contracts
Management Manual. This procurement policy notice is being issued to ensure an orderly transition
from 48 CFR 1546 to EPA Directive 1900 and contains tailoring language allowed by 52 CFR 246-
11. It is in effect until the revisions to Directive 1900 are completed.
2. Application
This procurement policy notice applies to all Contracting Officer's Representatives, that is, all
Project Officers, Deputy Project Officers, Regional Project Officers, Zone Project Officers, Delivery
Order Project Officers, Work Assignment Managers, and Task Order Managers.
This procurement policy notice applies to all solicitations, task orders, work assignments, and other
statements of work for contracts (including simplified procurement acquisitions) that involve
environmentally-related measurements (i.e., the collection and use of environmental data1 and the
design, construction, and operation of environmental technologies). Examples of environmentally-
related measurements are contained in Attachment 1.
3. General Requirements
Although this procurement policy notice applies solely to contracts, EPA requires that all recipients
of funds (i.e., contractors, grantees, etc.) for work involving environmentally-related measurements
comply with the American National Standard ANSI/ASQC E4-1994, Specifications and Guidelines
for Quality Systems for Environmental Data Collection and Environmental Technology
Programs. To demonstrate conformance to this standard, EPA requires all recipients submit two types
of documentation:
1. Documentation of the organization quality system (usually called a Quality Management Plan),
and/or
2. Documentation of the application of quality assurance (QA) and quality control activities to a
project-specific effort (usually called a Quality Assurance Project Plan).
Environmental data are 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, environmental data include information collected directly from measurements,
produced from models, and compiled from other sources such as data bases or the literature.
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Use of existing quality system documentation, such as documentation that a company is ISO 9000
certified, may be acceptable alternatives.
For small contracts, these two documents may be combined into a single document that describes
the organization's quality system and the application of this system to the work performed under the
contract. This can only be done with permission of the EPA QA Manager who will identify which
elements should be addressed in this combined document.
Some contracts may cover activities of a program that are to be conducted at multiple locations or
over a long period of time; for example, a large monitoring program that uses the same methodology at
different locations. In this case, a Programmatic Quality Assurance Project Plan may be used to
describe, in a single document, the general, common activities that are not site- or time-specific but are
applied throughout the program. Project-specific information is then added to the approved
Programmatic Quality Assurance Project Plan on an project-specific basis.
4. Directions for Pre-Award and Post-Award Activities
STEP 1. After consultation with the QA Manager (or the appropriate QA personnel2), complete
the QA Review Form (as described in Section 2.5 of the Contracts Management
Manual) and obtain the concurrence signature of the QA Manager.
If QA requirements are not applicable to the procurement (indicated on the QA Review Form),
the remaining Steps do not apply.
STEP 2. With the assistance of the QA Manager, determine what quality standards apply.
Generally, ANSI/ASQC E4-1994 applies to the majority of EPA's work; however,
standards other than ANSI/ASQC E4-1994 may also apply.
STEP 3. If ANSI/ASQC E4-1994 applies, identify (with the assistance of the Q A Manager)
whether the contract work will consist of:
A. a single project,
B. multiple projects with different activities, or
C. multiple proj ects with similar activities.
A. If the contract work consists of a single project, you must require one of the
following:
1. Before Award: A Quality Management Plan
After Award: A Quality Assurance Proj ect Plan for the contract
(Note: These are the default requirements.)
2. Before Award: Q A Manager-specified documentation3
After Award: A Quality Management Plan and a Quality
Assurance Project Plan for the contract
3. Before Award: QA Manager-specified documentation3
Appropriate QA personnel are defined in each EPA organization's Agency-approved Quality Management
Plan. For simplicity, the use of the term QA Manager will refer to both the QA Manager and other approved QA
personnel.
QA Manager-specified documentation is defined in an EPA organization's Agency approved Quality
Management Plan. This documentation must be consistent with Agency requirements defined in EPA Order 5360
(May 2000).
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Project: Speciation QMP
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Re vision No: 1.0
Date: 7/18/01
Page 4 oH 0
After Award: A Joint Quality Management Plan/Quality
Assurance Project Plan for the contract
4. Before Award: A Joint Quality Management Plan/Quality
Assurance Project Plan for the contract
After Award: None
B. Jf the contract work consists of multiple projects with different activities,
you must require one of the following:
1. Before Award: A Quality Management Plan
After Award: A Quality Assurance Proj ect Plan for each
applicable project
(Note: These are the default requirements.)
2. Before Award: QA Manager-specified documentation3
After Award: A Quality Management Plan and a Quality
Assurance Project Plan for each applicable project
C. Jf the contract work consists of multiple projects with similar activities,
you must require one of the following:
1. Before Award: A Quality Management Plan
After Award: A Quality Assurance Project Plan for each
applicable project
(Note: These are the default requirements.)
2. Before Award: A Quality Management Plan
After Award: A Programmatic Quality Assurance Proj ect Plan
for the program (contract) and a project-specific
supplement to the Programmatic Quality Assurance
Project Plan for each applicable project
3. Before Award: A Quality Management Plan and a Programmatic
Quality Assurance Project Plan for the program
(contract)
After Award: A project-specific supplement to the Programmatic
Quality Assurance Project Plan for each applicable
project
For each of the three cases (single project, multiple projects with different activities, or
multiple projects with similar activities), the default requirements are listed as the first
option (1). These requirements should be used unless the QA Manager concurs
otherwise.
STEP 4. For each type of documentation identified in STEP 4, identify (with the assistance of the
QA Manager) whether the documentation should be prepared in accordance with the
standard EPA requirements [i.e., EPA Requirements for Quality Management Plans
(QA/R-2) and EPA Requirements for Quality Assurance Project Plans (QA/R-5)]
or whether other EPA-approved equivalent requirements will be used. The standard
EPA requirements should be used unless the QA Manager concurs otherwise.
STEP 5. Jf additional standards apply besides ANSI/ASQC E4-1994, identify (with the
assistance of the QA Manager) what documentation is required to determine
conformance to these standards.
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Project: Speciation QMP
Appendix A
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Date: 7/18/01
Page 5 oflO
STEP 6. Provide the Contracting Officer with a list of documentation required before and after
award (from cases A, B, and C in STEP 3) and if applicable, a list of any equivalent
requirements to be used (STEP 4), and the Title, Numbering, Date, and any
documentation required to demonstrate conformance for any additional standards
(STEP 5).
The information that must be submitted to the Contracting Officer is contained in
Attachment 2. It is recommended that you complete this form and provide it to the
Contracting Officer with the QA Review Form (STEP 1).
STEP 7. After award of the contract, if the work consists of multiple projects (cases B and C in
STEP 3), complete a QA Review Form and Section 3 of Attachment 2 for each
statement of work (e.g., work assignment, delivery order, task order).
Include in each applicable statement of work the requirement to submit the quality
documentation needed after contract award. For example, if a project-specific
supplement to the Programmatic Quality Assurance Project Plan is required for the
project described in the statement of work, you must incorporate the requirement to
develop this document into the statement of work.
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Appendix A
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Attachment 1
Example of Activities involving Environmentally-Related Measurements
The following are some examples that involve environmentally-related measurements:
Activities that collect data to establish/determine the states/conditions of environmental
or ecological systems and the health of human populations;
Activities that collect data to establish the ambient conditions in air, water, sediments,
and soil in terms of physical, chemical, radiological, or biological characteristics;
Activities that collect data to establish/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;
Activities that monitor and quantify 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);
Activities that use environmental data to develop environmental technology for pollution
prevention, pollution control, waste treatment, storage, and disposal, and waste
remediation;
Activities that use environmental data in mapping environmental process and conditions,
and/or human health risk data, etc. (e.g., geological information system);
Activities that generate data from the evaluation of environmental technology used for
pollution prevention; pollution control; waste treatment, storage, and disposal; and
waste remediation;
Activities that generate/collect data to support enforcement and/or compliance
monitoring efforts;
Activities that collect/generate data for the evaluation and/or demonstration of
environmental technology (e.g., treatability and pilot studies);
Activities that investigate and collect data to determine 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;
Activities that collect and/or generate data from the development and evaluation of
methods for use in the collection, analysis, and use of environmental data;
Activities that involve the development, evaluation, and use of computers or
mathematical models (and their input data) to characterize environmental processes or
conditions;
Activities that use secondary data (i.e., environmental data that were collected for other
purposes or obtained from other sources, including literature, industry surveys,
compilations from computerized data bases and information systems) for the
development and/or evaluation of computerized or mathematical models of
environmental processes and conditions, and collect/generate data from the process;
and
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Appendix A
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Date: 7/18/01
PaseVoflO
Activities that collect and/or use environmental data for monitoring/addressing concerns
over the occupational health and safety of personnel in EPA facilities (e.g., indoor air
quality measurements) and in the field (e.g., chemical dosimetry, radiation dosimetry).
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Appendix A
Re vision No: 1.0
Date: 7/18/01
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Attachment 2
Contracts Clause and Tailoring Language Form
Use this form to provide direction to the Contracting Officer on the quality assurance activities that are
required in your solicitation and contract.
1.
List any additional quality standards besides Specifications and Guidelines for Quality
Systems for Environmental Data Collection and Environmental Technology Programs
(ANSI/ASQC E-4)
Title:
Numbering:
Date:
Documentation required to determine conformance:
2. a. Check all required documentation required before award of contract:
Documentation
Quality Management Plan
Joint Quality Management
Plan/Quality Assurance Project
Plan
Programmatic Quality
Assurance Project Plan
Other Equivalent:
Specifications
EPA Requirements for Quality Management Plans
(OA/R-2) [dated I4
EPA Requirements for Oualitv Manasement Plans
(OA/R-2) [dated ] and EPA Requirements
for Oualitv Assurance Project Plans fOA/R-5^
[dated ]
EPA Requirements for Oualitv Manasement Plans
rOA/R-2^ [dated ] and EPA Requirements
for Oualitv Assurance Project Plans fOA/R-5")
[dated ]
[Insert specification]
If the standard specifications do not apply, identify equivalent specifications:
TSTote: we will fill in this date once the Federal Register Notice is published.
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Page 9 oH 0
3.
Select all documentation required after award of contract either at time of award or
upon issuance of a statement of work:
Documentation
Quality Management Plan
Joint Quality Management
Plan/Quality Assurance
Project Plan
Contract Quality Assurance
Project Plan
Programmatic Quality
Assurance Project Plan
Quality Assurance Project
Plan for each applicable
project
A J
Project-specific supplement
to Programmatic Quality
Assurance Project Plan
J
Other Equivalent:
Specifications
EPA Requirements for Quality
Management Plans (OA/R-2)
[dated ]
EPA Requirements for Quality
Management Plans (OA/R-2)
[dated ] and EPA
Requirements for Oualitv Assurance
Project Plans (OA/R-5Y [dated
EPA Requirements for Quality
Assurance Project Plans fOA/R-5")
[dated ]
L J
EPA Requirements for Quality
Management Plans (OA/R-2)
[dated ] and EPA
Requirements for Oualitv Assurance
Project Plans rOA/R-5^) [dated
_]
EPA Requirements for Quality
Assurance Project Plans COA/R-5")
[dated ]
L J
EPA Requirements for Quality
Assurance Project Plans fOA/R-5^
[dated ]
[Insert specification]
Due After
Award of
contract
Award of
contract
Award of
contract
Award of
contract
Issuance of
statement of
work
Issuance of
statement of
work
[Select one]
award of
contract
issuance of
statement of
work
If the standard specifications do not apply, identify equivalent specifications:
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TECHNICAL REPORT DATA
(Please read Instructions on reverse before completing)
1. REPORT NO.
EPA-354/RO1-009
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
Quality Management Plan for the Fine Particle Speciation
Trends Monitoring Program
5. REPORT DATE
07/01
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
Dennis Mikel
8. PERFORMING ORGANIZATION REPORT NO
9. PERFORMING ORGANIZATION NAME AND ADDRESS
U.S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Research Triangle Park, NC 27711
10. PROGRAM ELEMENT NO.
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
Director
Office of Air Quality Planning and Standards
Office of Air and Radiation
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
13. TYPE OF REPORT AND PERIOD COVERED
14. SPONSORING AGENCY CODE
EPA/200/04
15. SUPPLEMENTARY NOTES
16. ABSTRACT
The Quality Management Plan that outlines the management structure for the Fine Particle Speciation
Trends Network (STN) Monitoring Program. The guidance document gives details on how the
STN Program will be implemented. The STN program is a multi-year program that draws upon
EPA OAQPS, Office of Indoor Air (ORIA), Regional offices and State and Local Air Pollution
Agencies. This Plan outlines each agency's responsibilities and authority.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b. IDENTIFIERS/OPEN ENDED TERMS
c. COSATI
Field/Group
Air Quality Monitoring
Quality Assurance
Air Pollution Control
18. DISTRIBUTION STATEMENT
Release Unlimited
19. SECURITY CLASS (Report)
Unclassified
21. NO. OF PAGES
20. SECURITY CLASS (Page)
Unclassified
22. PRICE
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