June 2008
Generic Verification Protocol for
Determination of Emissions from
Outdoor Wood-Fired Hydronic Heaters
Prepared by:
RTI International
3 040 Cornwall! s Road
Research Triangle Park, NC 27709
Under a Cooperative Agreement with:
U. S. Environmental Protection Agency
RTI Project No.: 0209309
EPA Cooperative Agreement No.: CR831911
HRTI
INTERNATIONAL
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Generic Verification Protocol for
Determination of Emissions from
Outdoor Wood-Fired Hydronic Heaters
EPA Cooperative Agreement No. CR831911 -01 -1
RTI Project No. 0209309
Prepared by:
RTI International
3 040 Cornwall! s Road
Research Triangle Park, NC 27709
Approved by:
APCT Center Director: Andrew Trenholm Signed by Andrew Trenholm February 19, 2008
APCT Center Quality Manager: W. Gary Eaton Signed by Andrew Trenholm February 19, 2008
EPA Project Manager: Michael Kosusko Signed by Michael Kosusko March 4, 2008
EPA Quality Manager: Paul Groff Signed by Paul Groff March 5, 2008
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Table of Contents
Section Page
1. Introduction 1
1.1 Environmental Technology Verification 1
1.2 Air Pollution Control Technology Verification Center 2
1.3 Quality Management 3
2. Objective and Scope 4
2.1 Objective 4
2.2 Scope 4
2.3 Relationship of ETV Program to EPA-OAQPS Voluntary OWHH Program 4
2.4 Data Quality Objectives 4
3. ETV Responsibilities 4
4. Application and Technology Description 5
4.1 Arranging Testing 5
4.2 Identification and Acquisition of OWHH 5
4.3 Confidential Business Information 6
5. ETV Testing 6
6. Reporting and Documentation 7
6.1 Reports 7
6.2 Data Reduction 8
7. Dissemination of ETV Reports and Statements 8
8. Applicant's Options Should a Technology Perform Below Expectations 8
9. Limitations on Testing and Reporting 8
10. Requirements for Test-QAPlan 9
10.1 Quality Management 9
10.2 Requirements for Participating Laboratories 9
10.3 Quality Assurance 10
11. Assessment and Response 11
11.1 Assessment Types 11
11.2 Assessment Frequency 12
11.3 Response to Assessment 12
12. Safety Measures 12
12.1 Safety Responsibilities 12
12.2 Safety Program 12
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List of Tables
Table Page
1. Overview of OWHH ETV Process and Participants' Responsibilities 1
11
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ANSI
APCT Center
ASQ
CBI
DQO
EPA
ETV
GVP
ISO
OAQPS
ORD
OWHH
PM
QA
QC
QMP
RTI
SOP
Abbreviations and Acronyms
American National Standards Institute
Air Pollution Control Technology Verification Center
American Society for Quality (formerly ASQC - American Society for Quality
Control)
confidential business information
data quality objective
U.S. Environmental Protection Agency
environmental technology verification
generic verification protocol
International Organization for Standardization
EPA Office of Air Quality Planning and Standards
EPA Office of Research and Development
outdoor wood hydronic heater
particulate matter
quality assurance
quality control
quality management plan
RTI International
standard operating procedure
in
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1.
INTRODUCTION
This protocol describes the Environmental Technology Verification (ETV) Program's
considerations and requirements for verification of emissions reduction provided by outdoor
wood-fired hydronic heaters (OWHHs). Outdoor wood-burning units provide heat and hot water
for homes and other buildings. Outdoor wood-fired hydronic heaters also are called outdoor
wood boilers, outdoor wood furnaces, or outdoor wood-fired heaters. The basis of the
verification will be the emissions and performance of these heaters under standardized test
conditions.
ETV provides verified emissions data for OWHH technologies. These data may be used as part
of an overall process that leads to a product's qualification in the U.S. Environmental Protection
Agency's (EPA) voluntary OWHH program. This protocol describes the ETV portions of that
process in detail. Table 1 provides an overview of OWHH ETV and its interface with the EPA
voluntary OWHH program. These data may also be used for state programs.
Table 1. Overview of OWHH ETV Process and Participants' Responsibilities
Step in Process
Preparation of preliminary
application (without ETV data)
Preliminary test dialog
Test/quality assurance (QA) plan
Acceptance of ETV test-QA
plan, and terms and payment
Conduct ETV test
Prepare test report
Publish ETV report & statement
Applicant
Primary
Participate
Review
Primary
Access
Access
Review
ETV
APCT
Center
None
Organize
&
participate
Testing
Org.
None
Participate
Shared preparation,
APCT Center approve
Advise
Audit
Review
Primary
Advise
Primary
Primary
Review
EPA-
OAQPS
Advise
Participate
Review
Access
Access
Access
Access
EPA-ORD
Access
Access
Review &
approve
Access
Audit
Access
Review &
approve
1.1 Environmental Technology Verification
EPA through its Office of Research and Development (ORD) has instituted the ETV Program to
verify the performance of innovative and improved technical solutions to problems that threaten
human health or the environment. EPA created the ETV Program to accelerate the entrance of
new and improved environmental technologies into the marketplace. It is a voluntary,
nonregulatory program. Its goal is to verify the environmental performance characteristics of
commercially available technologies through the evaluation of objective and quality-assured data
so that potential purchasers and permitters are provided with an independent and credible
assessment of what they are buying and permitting.
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The ETV Program does not conduct technology research or development. ETV test results are
always publicly available, and the applicants are strongly encouraged to ensure that they are
satisfied with the performance of their technologies prior to beginning an ETV test. Within the
ETV Program, this state of development is characterized as "commercially available" (i.e., the
technology will be available for sale as tested).
The provision of high-quality performance data on a commercially available technology
encourages more rapid implementation of that technology and consequent protection of the
environment with better and less expensive approaches. The ETV Program is conducted by
multiple ETV centers that span the breadth of environmental technologies.
1.2 Air Pollution Control Technology Verification Center
EPA's partner in the Air Pollution Control Technology Verification Center (APCT Center) is
RTI International,1 a nonprofit contract research organization with headquarters in Research
Triangle Park, NC. The APCT Center verifies the performance of commercially available
technologies used to control air pollutant emissions. The emphasis of the APCT Center is
currently on technologies for controlling particulate matter (PM), volatile organic compounds,
nitrogen oxides, and hazardous air pollutants from both mobile and stationary sources. The
activities of the APCT Center are conducted with the assistance of stakeholders from various
interested parties. Overall, APCT Center guidance is provided by the Stakeholders Advisory
Committee, whereas the detailed development of individual technology ETV protocols is
conducted with input from stakeholders focused on each technology area.
The APCT Center develops generic verification protocols and specific test/quality assurance
(QA) plans, conducts independent testing of technologies, and prepares ETV test reports and
statements for broad dissemination. Testing costs are ultimately borne by the technology
applicants.
This generic verification protocol (GVP) provides the requirements for APCT Center's
verification of the emissions performance of OWHH. The APCT Center reserves the right to
evaluate each technology submitted for verification and to determine the applicability of this
protocol to that specific technology. The critical data quality objectives (DQOs) in this document
were based on emissions measurements necessary to support the vendor's application for
OAQPS voluntary program and to provide data of interest to state programs. Regulatory
authorities, including EPA through its Office of Air Quality Planning and Standards (OAQPS)
and state agencies, may have additional requirements.
This protocol was developed and based on input from EPA and a broad group of stakeholders
who have expertise in OWHH and come from the vendor, user, and regulatory spheres.
The tests will be conducted at an independent, third-party testing organization that has been
qualified and audited by the APCT Center. The data quality requirements of this GVP will be
applied at approved testing organizations through the preparation of a laboratory-specific test-
QA plan. Other application- or technology-specific information may also need to be addressed in
:RTI International is a trade name of Research Triangle Institute.
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the test-QA plan, which is described in Section 10.0. Test results will be presented as ETV
reports and statements.
This generic protocol will be revised as necessary. Changes to the protocol will not affect
products that already have been verified. However, such changes will be reflected in test-QA
plans not yet finalized regardless of the applicant's application status. Test-QA plans that are
being carried out when a protocol change is enacted will be examined by the APCT Center to
determine whether any modifications must be made.
1.3 Quality Management
Management and testing in the APCT Center program are performed in accordance with
procedures and protocols defined by the following:
• U.S. EPA. 2008. Environmental Technology Verification Program Quality Management
Plan, EPA/600/R-08/009, U.S. EPA, Cincinnati, OH;
• RTI (Research Triangle Institute). 2005. Quality Management Plan for Verification
Testing of Air Pollution Control Technology, Revision 2.2, Research Triangle Park, NC;
• Generic Verification Protocol for Determination of Emissions from Outdoor Wood-fired
Hydronic Heaters (this document);
• Test-QA plan prepared for each test organization; and
• Test-QA plan addendum prepared for each OWHH model.
EPA's ETV Quality Management Plan (QMP) lays out the definitions, procedures, processes,
inter-organizational relationships, and outputs that ensure the quality of both the data and the
programmatic elements of the ETV Program. Part A of the ETV QMP contains the specifications
and guidelines that are applicable to common or routine quality management functions and
activities necessary to support the ETV Program. Part B of the ETV QMP contains the
specifications and guidelines that apply to test-specific environmental activities involving the
generation, collection, analysis, evaluation, and reporting of test data.
The APCT Center QMP describes the quality systems in place for the overall APCT Center. It
was prepared by RTI and approved by EPA. Among other quality management items, it defines
what must be covered in the GVPs and test-QA plans for technologies undergoing ETV testing.
Generic verification protocols are prepared to describe the general procedures to be used for
testing a type of technology and to define the critical DQOs.
A test-QA plan is prepared by each test organization. The test-QA plan describes, in detail, how
the testing organization will implement and meet the requirements of the GVP. The test-QA plan
also sets DQOs for any planned measurements that were not set in the GVP for a particular
technology. The test-QA plan addresses issues such as the testing organization's management
structure, the test schedule, test procedures and documentation, analytical methods,
recordkeeping requirements, and instrument calibration and traceability. It also specifies the QA
and quality control (QC) requirements for obtaining ETV data of sufficient quantity and quality
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to satisfy the DQOs of the GVP. Testing organizations will be audited by the APCT Center
against the approved GVP and test-QA plan they are expected to follow. Section 10 of this GVP
addresses requirements for the test-QA plan.
2. OBJECTIVE AND SCOPE
2.1 Objective
The objective of this GVP is to establish the parameters within which OWHH will be tested to
verify their emissions control performance with uniform and consistent methods.
2.2 Scope
This protocol describes the considerations and requirements for ETV of emissions from OWHH.
Before an OWHH technology can be accepted for verification, several criteria must be met:
• The controlling interests in each technology must be in agreement to pursue ETV;
• The applicant must be a single organization with authority to pay for the applicant's cost;
and
• The applicant must show that the technology has a credible impact on emissions.
Emissions testing under this protocol is based on EPA Test Method 28 OWHH for Measurement
of Particulate Emissions and Heating Efficiency of Outdoor Wood-Fired Hydronic Heating
Appliances and American Society for Testing Materials International Standard Test Method for
Determination of Particulate Matter Emissions Collected by a Dilution Tunnel (E2515-07). EPA
Test Method 28 OWHH also includes energy efficiency. Additional testing may be specified in
the Test-QA plan addendum to match data needs of state or other agencies.
2.3 Relationship of ETV Program to EPA-OAQPS Voluntary OWHH Program
EPA-OAQPS has initiated a voluntary program for OWHH. The test results EPA-OAQPS will
use to evaluate a technology should be generated following the ETV process, with the ETV
report and verification statement submitted by the vendor as the data package to EPA-OAQPS.
The Voluntary OWHH Program is described and appropriate contacts are identified at
http://www.epa.gov/woodheaters.
2.4 Data Quality Objectives
The data of primary interest for verification of OWHH technologies are the emissions of
parti culate matter. The DQOs of this GVP are the QC requirements of the test methods
referenced in Section 2.2. The test-QA plan will address the DQOs.
3. ETV RESPONSIBILITIES
Table 1 (see page 1) provides an overview of OWHH ETV and its interface with the EPA
voluntary OWHH program and lists primary responsibilities for each organization involved in
the OWHH ETV verification program.
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The technology applicant provides the complete product for ETV testing, and logistical and
technical support, as required, during the ETV testing. The applicant's responsibilities are
defined by a contract with the APCT Center. The preliminary application (Table 1, Row 1)
provides relevant background data and technology information to facilitate test-QA plan
development. The applicant must pay the verification cost required at the time its contractual
relationship with the APCT Center begins.
In addition to the items in Table 1, the APCT Center prepares the GVP (this document);
qualifies, approves, and audits the testing organization; approves test-QA plans; prepares the
ETV reports and statements from the laboratory test reports; and, jointly with EPA-ORD,
reviews and approves the ETV reports and statements. Qualified testing organizations prepare
the test-QA plan for their organization and conduct ETV verifications under contract to the
APCT Center. The order of activities in Table 1 is mandatory, with the test-QA plan being
prepared and approved before testing. The testing organization also conducts internal QA on test
results and reports.
4. APPLICATION AND TECHNOLOGY DESCRIPTION
The ETV applicant is the basic source of information regarding its technology, information
which is provided to the APCT Center. This information is used by the testing organization and
APCT Center to prepare and review a test-QA plan addendum that meets the requirements of the
applicant. An applicant may conduct privately sponsored tests at a testing organization for
development purposes prior to conducting verification tests. Such pre-testing is understood to be
common and important to ensure the technology is properly adjusted and tuned to the
application.
4.1 Arranging Testing
Manufacturers wishing to have their products tested under this protocol will notify the APCT
Center and contact one of the approved testing laboratories to arrange for testing. All
participating test laboratories that have met the requirements of Section 11.0 will be eligible to
perform the testing. On request, the APCT Center will provide the names of testing laboratories
that meet the requirements given in Section 11.0 and that are participating in the ETV program.
4.2 Identification and Acquisition of OWHH
OWHH will be selected by the manufacturers and shipped to a testing facility that has been
qualified and audited by the APCT Center. The OWHH unit will be supplied directly from the
manufacturer with a letter signed by the manufacturer's chief executive officer, president, or
other responsible corporate representative, attesting that the heater is representative of what will
be available to the commercial market. Included in the signed letter will be the full name and
description of the product and a description of how the unit was selected.
Information describing the product must include the following.
• The model name and number, serial number, date of manufacture and the thermal output
rating, in Btu/h;
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• Four color photographs of the unit showing the front, back and both sides;
• A copy of the operation and maintenance instructions; and
• Engineering drawings and specifications for each of the following components:
- firebox, including a secondary combustion chamber,
- air induction systems,
- baffles,
- refractory and insulation materials,
- catalysts,
- flue gas exit,
- door and catalyst bypass gaskets,
- outer shielding and coverings,
- fuel feed system, and
- blower motors and fan blade size.
For purposes of product identification (for example, by the test laboratory, auditors, end-users,
and local inspectors), the manufacturer must attach information to the unit in a reasonably
permanent manner to show the name of the manufacturer, all applicable model numbers, and
date (year and month) of manufacture. If this information is not present, the test laboratory will
reject the heater for testing. All products that the manufacturer claims to be covered by the ETV
verification test report and statement must be consistent with this information or they are not
covered by the verification test report and statement. Anytime a manufacturer changes a product
(e.g., firebox dimensions, airflow rates, airflow direction, heat output, pressure differential
through the OWHH) the ETV Verification Statement is no longer valid and a new verification
test is required if verification of the product is desired.
4.3 Confidential Business Information
The ETV program is intended to provide independent and quality-assured performance data to
potential users of technologies through a documented public process. ETV documents (protocol,
test-QA plans, reports, and verification statements) are publicly available. When necessary to
conduct verification, confidential business information (CBI) can be submitted to the APCT
Center. CBI should be submitted under separate cover, not in the application form, to the APCT
Center along with an explanation of why the applicant believes that the submission of CBI is
required and why the information is confidential. The applicant can provide CBI design
information directly to the test laboratory with written permission to forward the CBI to the
APCT Center with the test results. The applicant should also provide written permission to share
the CBI with the EPA or state OWHH programs as appropriate.
5. ETV TESTING
The test requirements for verification of OWHH are contained in two methods. They are:
• EPA Test Method 28 OWHH for Measurement of Particulate Emissions and Heating
Efficiency of Outdoor Wood-Fired Hydronic Heating Appliances; and
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• ASTM Standard Test Method for Determination of Particulate Matter Emissions
Collected by a Dilution Tunnel (E2515-07).
The test laboratory will confirm that the tested unit conforms to descriptive and design
information submitted by the applicant. Any deviation from these methods must be documented
in the approved test-QA plan addendum. ETV verification reports must report all data collected
and use all valid data as specified by the methods to calculate verification results.
6. REPORTING AND DOCUMENTATION
This section addresses reporting data in the verification report and verification statement. The
specifics of what data must be included and the format in which the data must be included shall
be covered in a test-QA plan for the test organization (e.g., QA/QC summary forms, raw data
collected, and photographs/slides/video tapes). All data collected during ETV tests will be
retained by the test organization and reported to the APCT Center, including invalid test results.
All data that meet the QA requirements of the test-QA plan are considered valid and will be used
to compute emissions reductions for ETV purposes. The emissions will be reported as specified
in EPA Method 28 OWHH including units of Ib/MM Btu heat input and output and g/hr.
The verification report for each technology will include near the beginning a verification
statement that summarizes the verification test and its results. The verification report, including
the verification statement, will be written by the APCT Center based on the test report submitted
to the APCT Center by the testing organization. The verification report and verification
statement will be reviewed by the APCT Center and the technology applicant before being
submitted to the EPA for review and approval as specified in the ETV QMP.
6.1 Reports
Based on the test data and report from the laboratory, the APCT Center will prepare the draft
verification report, which includes the following topics:
• Verification statement;
• Introduction;
• Description and identification of product tested;
• Procedures and methods used in testing;
• Documentation of test conditions;
• Summary and discussion of results as required to support the verification statement and
explain and document necessary deviations from the test plan; and
• References
The verification statement will be signed and will include the following:
• Technology applicant's name and technology's descriptive information,
• Summary of ETV test program,
• Results of the ETV test,
• Any limitations related to the ETV results, and
• Brief QA statement.
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The report will contain a statement that the test was performed according to EPA Method 28
OWHH. Review and approval of the draft ETV report and statement are described in Section 1.0,
Table 1.
6.2 Data Reduction
Data from measurements made as part of the ETV test will be reported as specified in EPA
Method 28 OWHH. Data reduction will be according to this method (or by reference, the ASTM
PM test method) or will be documented in the test-QA plan for the test organization.
7. DISSEMINATION OF ETV REPORTS AND STATEMENTS
After an OWHH technology has been tested and the draft verification report and verification
statement prepared by the APCT Center, the APCT Center will send a draft of both to the
applicant for review. This gives the applicant the opportunity to review the results, test
methodology, and report terminology while the drafts remain working documents. The applicant
may submit comments and revisions on the draft statement and report to the APCT Center for
consideration.
After the APCT Center incorporates appropriate revisions, the draft final verification report and
verification statement will be submitted to EPA for review and approval. When complete, four
original verification statements with EPA and APCT Center signatures will be produced. One
will be filed and retained by the APCT Center, two provided to EPA ETV staff, and one to the
applicant. Further distribution of the ETV report, if desired, is at the applicant's and EPA's
discretion and responsibility. However, approved verification statements and verification reports
will be posted on the ETV web site (www.epa.gov/etv) site for public access without restriction.
Full documentation of the verification test will not be posted on the web site, but will be publicly
available from the APCT Center.
8. APPLICANT'S OPTIONS SHOULD A TECHNOLOGY PERFORM BELOW
EXPECTATIONS
ETV is not a technology research and development program; technologies submitted to ETV are
to be commercially available, with well-understood performance. Tests that meet the ETV data
quality requirements are considered valid and suitable for publishing; however, a technology
may fail to meet the applicant's expectations. In this case, the applicant may request that a
verification statement not be issued. However, ETV reports are always in the public domain and
will be posted on the ETV web site. Verification reports will be written and will be available
from EPA for review by the public regardless of a request not to issue a verification statement.
The applicant may improve the product and resubmit it under a new model identification for
ETV testing. ETV reports and statements for acceptable tests of the new product will be issued
as they are processed by the APCT Center and EPA.
9. LIMITATIONS ON TESTING AND REPORTING
To avoid having multiple ETV reports for the same product and to maintain the ETV testing as
independent and a cooperative effort with the applicant, the following restrictions apply to ETV
testing under this protocol:
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• Applicants may submit only products they own or whose distribution they control.
Applicants may not submit for ETV testing products whose use is not in their control,
except with the written agreement of the manufacturer or vendor.
• Verifications are valid for a given product (e.g., brand, model, design) as tested. Only one
ETV report and statement will be issued for any single application and verification test.
• Test organizations that generate data for verifications must be independent of the
applicant.
10. REQUIREMENTS FOR TEST-QA PLAN
10.1 Quality Management
All testing organizations participating in this ETV Program must meet the QA/QC requirements
defined below and have an adequate quality system to manage the quality of work performed.
Documentation and records management must be performed according to the ETV and APCT
Center QMPs or their superseding documents. Testing organizations must also perform
assessments and allow audits by the APCT Center (headed by the APCT Center QA officer) and
EPA corresponding to those in Section 11.
10.2 Requirements for Participating Laboratories
The APCT Center ETV Program is open to multiple test laboratories. All participating
laboratories, domestic and international, must register their laboratories with the APCT Center,
meet the ETV program's QA requirements, and accept on-site audits by the APCT Center, EPA,
or its representatives. The audits may include technical system audits, performance evaluations,
assessments of the test laboratory's quality system, and audits of data quality. In order to qualify,
a test laboratory must take the following actions:
• Have American National Standards Institute / American Society for Quality Control
(ANSI/ASQC) E4 or International Organization for Standardization (ISO) 9000 quality
management systems in place;
• Possess the equipment and facilities required to perform the tests identified in Section 5.0
of this protocol;
• Be an independent organization (e.g., not be a manufacturer's or end user's in-house
laboratory or subsidiary);
• Have an EPA-compliant QA system;
• Allow on-site audits by APCT Center staff, EPA, or their representatives;
• Have an EPA and APCT Center approved test-QA plan as described in Section 10.0 of
this protocol;
• Provide written health and safety procedures for ETV testing; and
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• Comply with APCT Center reporting requirements.
In addition, a test laboratory must be accredited for the woodstove new source performance
standard (see 40 CFR 60.535) and have participated on at least one American Society for Testing
and Materials technical subcommittee for residential wood heating appliances. Other
independent laboratories with similar qualifications will be considered on a case-by-case basis.
10.3 Quality Assurance
All ETV testing will be done following an approved test-QA plan that meets EPA Requirements
for Quality Assurance Project Plans (U.S. EPA, 2001c) and Part B, Section 2.2.2 of EPA's ETV
QMP. These documents establish the requirements for test-QA plans and the common guidance
document, Guidance for Quality Assurance Project Plans, provides guidance on how to meet
these requirements. The APCT Center Quality Management Plan implements this guidance for
the APCT Center.
The test-QA plan must describe in adequate detail how the test methods are implemented by the
testing organization. Internal standard operating procedures (SOPs) may be referenced provided
they are available for audit review. (SOPs need not be incorporated into the test-QA plan except
by reference. If considered proprietary to the testing organization, they should be clearly
marked.) Steps the testing organization will take to ensure acceptable data quality in the test
results are also identified in the test-QA plan. Detailed reference to SOPs or other available
documents is encouraged. Any needed SOPs will be developed in accordance with EPA's
Guidance for Preparing Standard Operating Procedures (SOPs).
The testing organization must prepare a test-QA plan and submit it for approval by the APCT
Center. The test-QA plan must also be approved by EPA before the testing organization can
begin ETV testing. A test-QA plan contains the 24 elements listed below, the contents of which
may be stand-alone or include references to widely distributed and publicly available sources.
Group A Elements: Project Management
Al Title and Approval Sheet
A2 Table of Contents
A3 Distribution List
A4 Project/Task Organization
A5 Problem Definition/Background
A6 Project/Task Description
A7 Quality Objectives and Criteria
A8 Special Training/Certifications
A9 Documentation and Records
Group B Elements: Data Generation and Acquisition
Bl Sampling Process Design (Experimental Design)
B2 Sampling Methods
B3 Sample Handling and Custody
10
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B4 Analytical Methods
B5 Quality Control
B6 Instrument/Equipment Testing, Inspection, and Maintenance
B7 Instrument/Equipment Calibration and Frequency
B8 Inspection/Acceptance of Supplies and Consumables
B9 Non-direct Measurements
BIO Data Management
Group C Elements: Assessment and Oversight
Cl Assessments and Response Actions
C2 Reports to Management
Group D Elements: Data Validation and Usability
Dl Data Review, Verification, and Validation
D2 Verification and Validation Methods
D3 Reconciliation with User Requirements
11. ASSESSMENT AND RESPONSE
Each independent testing organization must conduct internal assessments of its quality and
technical systems and must allow external assessments of these systems by APCT Center QA
personnel and by EPA QA personnel. After an assessment, the testing organization will be
responsible for developing and implementing corrective actions in response to the assessment's
findings.
As appropriate, the APCT Center, EPA, or both will conduct assessments to determine the
testing organization's compliance with its test-QA plan. The requirement to conduct assessments
is specified in EPA's ETV QMP, and in RTFs APCT Center QMP. EPA will assess RTFs
compliance with APCT Center's test-QA plans. The APCT Center will assess the compliance of
other organizations with their test-QA plans. The assessments will be conducted according to
EPA's Guidance on Technical Audits and Related Assessments for Environmental Data
Operations and Guidance on Assessing Quality Systems.
11.1 Assessment Types
Quality system assessment—Qualitative assessment of a particular quality system to establish
whether the prevailing quality management structure, policies, practices, and procedures meet
EPA requirements and are adequate for ensuring that the type and quality of measurements
needed are obtained.
Technical systems audit—Qualitative on-site audit of the physical setup of the test. The
auditors determine the compliance of testing personnel with the test-QA plan.
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Performance evaluation audit—Quantitative audit in which measurement data are
independently obtained and compared with routinely obtained data to evaluate the accuracy (bias
and precision) of a measurement system.
Audit of data quality—Qualitative and quantitative audit in which data and data handling are
reviewed and data quality and data usability are assessed.
11.2 Assessment Frequency
Activities performed during verification testing that affect the quality of the data will be assessed
regularly and the findings reported to management to ensure that the requirements stated in the
generic verification protocols and the test-QA plans are being implemented as prescribed. The
types and minimum frequency of assessments for the ETV Program are listed in Part A Section
9.0ofEPA'sETVQMP.
11.3 Response to Assessment
When needed, appropriate corrective actions shall be taken and their adequacy verified and
documented in response to the findings of the assessments. The impact and the action taken shall
be documented. Assessments are conducted according to procedures contained in the APCT
Center QMP. Findings are provided in audit reports. Responses by the testing organization to
adverse findings are required within 10 working days of receiving the audit report. Follow-up by
the auditors and documentation of responses are required.
12. SAFETY MEASURES
12.1 Safety Responsibilities
The testing organization's project leader is responsible for ensuring compliance with all
applicable occupational health and safety requirements. Each individual staff member is
expected to follow the requirements and identify personnel who deviate from them and report
such action to their supervisor.
12.2 Safety Program
The testing organization must maintain a comprehensive safety program and ensure that all test
personnel are familiar with and follow it.
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