Preparing a
Tribal
Environmental
Program Level
QAPP
EPA Region 4 has approved this instructional for use by Region 4 Tribes and intertribal
consortia. Information contained herein may be beneficial to Tribes outside or to non-Tribal
grantees, but should not be used to guide Quality Assurance Project Plan (QAPP)
development, submission or approval processes with prior approval. Please consult with your
project officer prior to utilizing this guide.
PROGRAM LEVEL QAPP INSTRUCTIONAL
Table of Contents
Introduction ................................................................................................................................................ 3
Why consider this approach? ............................................................................................................... 4
What is a QAPP? .................................................................................................................................... 4
General Process ...................................................................................................................................... 4
Foundation of the QAPP ........................................................................................................................... 7
Component 1: Project Management ................................................................................................... 8
Component 2: Measurement and Data Generation ....................................................................... 12
Component 3: Assessment and Oversight ...................................................................................... 16
Component 4: Data Evaluation ......................................................................................................... 17
Supplemental Information……………………………………………………….................…………..19
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Introduction
This instructional is meant to provide you with a starting
point to successfully develop a Tribal Environmental
Program Level Quality Assurance Project Plan (Program
In limited
Level QAPP) and Tribal Environmental Project/Sitecircumstances,
EPA
Specific QAPP for EPA funded projects involving
may
grant
collection and use of environmental data. Region 4 is
conditional approval
encouraging the use of a Program level QAPP and
of a QAPP to permit
Project/Site-Specific QAPP(s) as an alternative to
some work to begin
traditional QAPPs to eliminate redundancy, reduce costs,
while non-critical
and accelerate the approval process. A Tribe using funds
deficiencies in the
under a Performance Partnership Grant or separate EPA
QAPP are being
grants for multi-media data collection may prepare one
resolved.
Program Level QAPP and as many Project/Site-Specific
QAPPs as required. Grantees cannot collect, analyze, or
use data until Region 4 approves both the Program Level
and applicable Project/Site-Specific QAPPs. An attempt has been made to follow CIO 2105.0
and the Quality Assurance Handbook, http://www.epa.gov/quality/qa_docs.html, as well as
previous EPA requirements described in EPA Requirements for Quality Assurance Project
Plans, EPA QA/R-5, available at http://www.epa.gov/quality/qs-docs/r5-final.pdf. In addition,
the Northern Arizona University Institute for Tribal Environmental Professionals offers regular
workshops for Tribes to learn more about QAPPs, http://www4.nau.edu/itep/.
The information in this document is written mainly in a directive or in a “how to” format. The
information follows the same organization structure as the Templates for the Program Level
QAPP (Attachment A) and the Project/Site-Specific QAPP (Attachment B) including section
numbering systems and titles in EPA QA/R-5.
The concept of Program Level QAPPs and Project/Site-Specific QAPPs is an application of a
graded approach. Since content and level of detail in individual QAPPs will vary according to
the work being performed and the intended use of the data, the graded approach should be used
when preparing QAPPs. A graded approach is the process of establishing the project
requirements and level of effort according to the intended use of the results and the degree of
confidence needed in the quality of results. In other words, the degree of documentation, level of
effort and detail will vary based on the complexity and cost of the project. Appropriate and
objective consideration should be given to the significance of the environmental problems to be
investigated, the environmental decisions to be made, and the impact on human health and the
environment. Documentation will consist of concise explanation whenever a particular project
does not need to address a specific area. In addition, by cross referencing to approved Program
Level QAPPs, Project/Site-Specific QAPPs may need less detail in certain areas.
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Why consider this approach?
The QAPP lays out the background behind the environmental problem, the objectives for the
project, the tasks to be performed, and the design concepts behind the layout of the project or
field work. While QAPPs are project specific, some of the required elements apply to multiple
environmental projects, especially in small environmental programs. We encourage the use of a
streamlined Program Level QAPP and Project/Site-Specific QAPP(s) to eliminate redundancy,
reduce costs associated with development, and accelerate the review and approval process.
What is a QAPP?
A QAPP is “a formal document describing in detail the necessary quality assurance (QA) and
quality control (QC), and other technical activities that are implemented to ensure that the results
of the work performed will satisfy the stated performance criteria. A QAPP captures how and
why a project plan will be conducted, and assures the quality of the data for making
environmental decisions for the project. EPA is required to follow internal standards for projects
and entities outside of EPA are required external standards for projects to create a QAPP.
Many tribal programs undertake federally funded projects or programs that involve the collection
or creation of environmental data (examples: ambient monitoring, soil and water sampling, etc.).
While there is some flexibility in the EPA Regional Offices regarding how this requirement is
implemented, in general, Tribes must have an EPA approved QAPP to assure the quality of data
being collected or created prior to beginning the project or program that involves data collection.
Funding for costs incurred to collect data without an EPA approved QAPP may be disallowed1.
The development and revisions of a QAPP may be added as a task to the project workplan.
General Process
First, a Program Level QAPP must be developed. The Program Level QAPP consists of all
routine processes and procedures or what some refer to as “Boiler Plate” for EPA projects.
These consist of routine field, lab and criteria that you readily have available and should be
presented in the Tribal Environmental Program Level QAPP.
Second, a Project/Site-Specific QAPP must be developed after the EPA approves the Program
Level QAPP. A Project/Site-Specific QAPP is the project plan for the site or project work to be
performed at a particular site (e.g. information similar to a site sampling plan). When a site or
project is identified and approved by EPA, a Project/Site-Specific QAPP is developed and is
linked to the approved Program Level QAPP.
There are two concepts for working with Project/Site-Specific QAPP on a site or project: the
initial Project/Site-Specific QAPP, and any follow-up Project/Site-Specific QAPP. The initial
Project/Site-Specific QAPP is the first and most comprehensive plan for the site. Follow-up
Project/Site-Specific QAPPs or addenda are used to document any additional site or project work
(or an update) that may be needed to complete the investigation. The Tribe should use the
sequential number system for Project/Site-Specific QAPP to retain the context and flow of a site
1
40 CFR 31.45
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PROGRAM LEVEL QAPP INSTRUCTIONAL
or project work. For example, the initial Project/Site-Specific QAPP for a site or project will be
1.A. Follow-up Project/Site-Specific QAPP Addenda for site 1 would continue the sequence with
1.B, 1.C, etc. As additional sites are proposed for sampling the second one (site 2) would start
with 2.A and so forth. Refer to Figure 1 below.
Figure 1, Flow Chart Indicating Process for Multiple Sites or Projects
Program Level QAPP
Project or Site 1
Project/Site-Specific
QAPP 1A
Project or Site 2
Project/Site-Specific
QAPP 2A
Project or Site 1
Project/Site-Specific
QAPP 1B
Project or Site 3
Project/Site-Specific
QAPP 3A
Project or Site 3
Project/Site-Specific
QAPP 3B
Project or Site 1
Project/Site-Specific
QAPP 1C
Case Study: Applying the Program Level and Project/Site-Specific
QAPP Process to a Tribal Environmental Program
Tribe ABC has a growing environmental program. In addition to a GAP grant for capacity
building, the Tribe has water and air monitoring programs, and is assessing contamination at a
former gas station for proposed reuse as a community park. The Tribe has had a CWA 106
grant for 3 years, and recently adopted new testing protocols for Memorial Lake.
Tribe ABC has an EPA approved Program Level QAPP that addresses the routine components
of the Tribe’s quality assurance system. The Tribe has also developed Project/Site-Specific
QAPPs for the Roaring River location and the Memorial Lake location. The Tribe has
submitted a revised Project/Site-Specific QAPP providing new testing protocols for Memorial
Lake.
The Tribe has air monitoring sites at the Tribal Administration Building and at Old Town. PM
2.5 and ozone is monitored at both locations. Based on EPA guidance, the Tribe has developed
pollutant specific QAPPS for ozone and PM 2.5. Each pollutant-specific Project/Site-Specific
QAPP includes both monitoring locations.
The Tribe’s Program Level QAPP and Project/Site-Specific QAPPs are shown in Figure 2.
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Tribe Environmental
Program Level QAPP
(Water, Air and Land)
Project/Site
Specific QAPP(s)
Project/Site
Specific QAPP(s)
Project/Site
Specific QAPP(s)
CWA 106
CAA 103/105
Brownfields
Roaring
River 1A
Memorial
Lake 2A
(site specific)
(site specific)
Ozone 1A
(pollutant specific)
PM 2.5 2A
(pollutant
specific)
Memorial Lake 2B
Figure 2, Case Study Program Level QAPP and Project/Site-Specific QAPP
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New Town
Park 1A
(site specific)
PROGRAM LEVEL QAPP INSTRUCTIONAL
Foundation of the QAPP
The Program Level QAPP and Project/Site-Specific QAPP can be broken down into four parts to
help you plan and document certain aspects of your site/project:
1) Project Management – how you will organize and run the project;
2) Measurement and Data Acquisition – how you will collect and report data;
3) Assessment and Oversight – how you will check that all activities are completed correctly;
and
4) Data Evaluation – how you will review and interpret the data.
Figure 3 shows the four components and breakdown of all the QAPP elements that need be
covered in the main body of a Program Level QAPP and Project/Site-Specific QAPP.
ELEMENT
PROGRAM-LEVEL PROJECT/SITE-SPECIFIC QAPP
PROJECT MANAGEMENT
In Project/Site
Specific
Title and Approval Page / Table of Contents/ Distribution List
In Program Level
A4
Project /Task Organization
In Program Level
A5
Problem Definition / Background
In Project/Site
Specific
A6
Project/Task Description
In Project/Site
Specific
A7
Special Training and Certification
In Program Level
A8
Documentation and Records
In Program Level
A1, 2, 3
MEASUREMENT DATA ACQUISITION
B1
Sampling Design and Site Figures
In Project/Site
Specific
B2
Sampling and Analytical Methods Requirements
In Project/Site
Specific
B3
Sample Handling & Custody Requirements (usually in an SOP)
In Program Level
B4
Analytical Methods Requirements (usually in an SOP)
In Program Level
B5
Field Quality Control Requirements (usually in an SOP)
In Program Level
B6
Laboratory Quality Control Requirements (usually in an SOP)
In Program Level
B7
Field Equipment Calibration and Corrective Action (usually in an SOP)
In Program Level
B8
Laboratory Equipment Calibration and Corrective Action (usually in an SOP)
In Program Level
B9
Analytical Sensitivity and Project Criteria (usually in an SOP)
In Program Level
B10
Data Management and Documentation
In Program Level
C1
Assessments and Response Actions
In Program Level
C2
Reports
In Program Level
ASSESSMENT/OVERSIGHT
DATA EVALUATION
D1
In Program Level
Data Review, Validation and Verification
February 2013- Barbara Caprita, EPA Region 4, RCRA Division Brownfields and Underground Storage Tank QA Coordinator
Figure 3 – The Four Components and Elements
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Component 1: Project Management
This section of the QAPP answers:
How you will organize and run the project?
Who will be involved with the project or site?
What is the environmental problem? What is the background history of the problem? How will
the data be used and what decisions will be made with the data?
A1. Title and Approval Page (In Program Level and Project/Site-Specific
QAPP)
The purpose of this section is to identify the project title and name of organization conducting
the project, as well as to document approval of the QAPP.






Ensure this element includes:
Title of project and/or Program Level QAPP
Name of organization conducting the work
(e.g., ABC Tribe Environmental Department)
and their mailing address
Preparation date of QAPP and version
number
Signature/date line for all key parties who
must approve the QA Project Plan followed
by a printed line including their name,
organization, and title (Note: Approving
officials may include if applicable, the Tribal
Project Manager, Tribal QA Manager, the
Tribal Environmental Director, the Tribal
Chairperson/Chief or Tribal Council
Members, consultant staff, contract laboratory
director, the EPA Project Officer, the
Regional EPA QA/QC Manager or project
representative)
Assistance agreement(s), Cooperative
Agreement(s), Grant(s) and/or contract
number(s) funding the activity and knowledge
of what program is funding the work (e.g.,
Clean Water Act 106 Program, Brownfields
Program, Drinking Water Program, etc.)
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Many Tribes balance QA/QC
requirements with the demands of
running an environmental program,
often with limited staff; therefore, a
dedicated QA/QC Manager may not be
feasible. To address QA/QC oversight
requirements, a Tribe may choose to
share QA/QC Manager responsibilities.
For example, if a staff of two are both
collecting data samples, they may
review one another's work. EPA’s
definition of a QA/QC Manager is “the
individual designated as the principal
manager within the organization having
management oversight and
responsibilities for planning,
documenting, coordinating, and
assessing the effectiveness of the quality
system for the organization”.
PROGRAM LEVEL QAPP INSTRUCTIONAL
A2. Table of Contents (In Program Level and Project/Site-Specific QAPP)
The purpose of this section is to allow the reader of the QA Project Plan to locate the different
information sections. Provide a list of the various QA Project Plan sections and subsections,
tables, figures, references, appendices, etc. Include the section number, section title, and
associated page where the information will be found. It is recommended to include a header on
each page (typically, in the upper right corner) of the QA Project Plan denoting the project name,
revision number and/or date of version, and page number.
A3. Distribution List (In Program Level and Project/Site-Specific QAPP)
The purpose of this section is to present a list of all individuals who should receive a copy of the
EPA approved QA Project Plan, as well as any subsequent revisions/updates.
Provide a list of all key personnel that will receive original and updated copies of the QA Project
Plan, along with their respective organization and contact information (i.e., telephone number,
email address, and/or mailing address). These individuals may include:









Project Manager for Tribe
Field team leader for Tribe
QA/QC Manager for Tribe
QA Project Plan preparer for Tribe
Laboratory manager
Data reviewers
Any essential contractor personnel
Project Officer for EPA
QA/QC Manager for EPA
Paper copies need not be provided to individuals if equivalent electronic information systems can
be used.
A4. Project/ Task Organization (In Program Level and Project/Site-Specific
QAPP)
The purpose of this section is to identify the roles and responsibilities of those individuals
involved in the project and their respective organizations.
Identify the individuals and organizations participating in the project and discuss their specific
roles and responsibilities. Depending on your Tribe, these individuals and organizations may
include:


Local Community Elder(s)
Program or project manager
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PROGRAM LEVEL QAPP INSTRUCTIONAL





Program or project staff conducting the various project activities
Tribal person responsible for QA/QC (activities may include: ensuring sampling,
shipment, and lab analysis incorporate adequate QC components; reviewing QC results;
recommending corrective action, when necessary; and evaluating data for inclusion in
reports) – whenever possible, ensure this individual is independent of the staff generating
the data
Point(s) of contact and associated organization for any consultants and/or contractors and
their specific project responsibilities
Contract laboratory, if applicable, as well as associated name(s) of points(s) of contact
and QA Manager
Any other key personnel or organizations involved in project or program activities
Include contact information (i.e., telephone numbers, email addresses, and mailing addresses) of
all program or project staff, consultants and/or contractors, laboratory contacts and QA/QC
Manager, etc. responsible for the project and the QA Project Plan.
Provide an organization chart showing lines of authority/communication (i.e., who reports to
whom) for all referenced people or organizations.
A5. Problem Definition/Background (In Project/Site-Specific QAPP)
The purpose of this section is to describe the specific issue or problem to be investigated with the
current project, along with any pertinent background information.
Data Quality Objectives (DQO) Process is EPA’s recommended planning process when
environmental data are used to select between two alternatives or derive an estimate of
contamination. The document, Guidance on Systematic Planning Using the Data Quality
Objectives Process (EPA QA/G-4) http://www.epa.gov/quality/qs-docs/g4-final.pdf, provides a
standard working tool for to develop DQO for determining the type, quantity, and quality of data
needed to reach defensible decisions or make credible estimates. Use a table for your DQOs.
Provide information on why the investigation needs to take place. This might include knowledge
about tribal concerns, reasons for conducting baseline monitoring, any background on why a
problem exists or may exist, knowledge of any data gaps that need to be filled, or anything else
that supports the need for the project effort. (NOTE: This information may have been
included in your work plan submittal. If so, this information could be reiterated in this
section.)
Identify the principal data users/decision makers (i.e., the individual(s) who will use the data to
make decisions).
Provide a brief summary of existing information (including previously collected field and/or
laboratory data related to the project or monitoring effort) to provide a historical, scientific,
and/or regulatory perspective for the current project. This information may include:
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PROGRAM LEVEL QAPP INSTRUCTIONAL



Information regarding where and how historical data were obtained;
Source of the data such as State, Tribe, Federal Agency, county, city, volunteer, permits,
university, or other sources;
Summary of data gaps indicating what information is not known.
A6. Project/Task Description (In Project/Site-Specific QAPP)
The purpose of this section is to provide an overview or summary of the work. Demonstrate an
understanding of what the project hopes to accomplish, by providing a summary of:




Work to be performed - This discussion should be as specific as possible and may include
answering questions such as: What locations will be sampled for what parameters? How
many samples are being collected? What analyses will take place for each measurement?
Products to be generated, including reports to be written
Schedule for implementation - This information is often presented as a timeline
bracketing the targeted dates for each key project task such as: development and approval
of QA Project Plan, sample collection dates, laboratory analysis and reporting, data
validation/evaluation, other project milestones, project report development and due date.
Provide maps or tables to show geographic locations of field tasks.
This discussion does not have to be lengthy or overly detailed, but should give an overall picture
of how it will help the issue or problem or question described in A5.
A7. Special Training and Certification (In Program Level QAPP)
The purpose of this section is to describe any special or non-routine training or certifications
necessary to successfully complete the project.
Identify any special training or certifications needed by personnel to conduct project activities.
(This might be associated with activities such as: collecting samples, performing field
measurements, handling of hazardous waste, reviewing data, drilling soil borings or installing
groundwater monitoring well.). Discuss plans for providing any necessary training, as well as
how training records will be documented, where this information will be stored, and how the
effectiveness of the training will be determined.
A8. Documentation and Records (In Program Level QAPP)
The purpose of this section is to provide information concerning the management of project
documents and records, including this QAPP.
List all the records and documents that will be created during the project and describe which
ones will be kept, how long they will be kept, and where they will be kept. Itemize the contents
of the laboratory report package. It should include: field samples results, QC samples results
(blanks, duplicates, etc.), description of data qualifiers that laboratory applies to sample results,
narrative describing issues and problem, resolution during analysis, chain-of-custody records raw
data, copies of logbook information to name a few. Note: A table may be useful.
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Indicate where all project documents and records will be stored and how long, including
procedures for removing and destroying obsolete documents and records. Include any backup
procedures for electronic data.
Describe plans or requirements for reporting data to EPA or other report recipients. Identify what
final reports will be generated, what the report will include, and how the data will be stored (e.g.,
in a database, an Excel spreadsheet, a file cabinet, etc.).
Component 2: Measurement and Data Generation
The elements in this group answer
the following questions:
What are the sampling design and the
rationale behind it? What sample collection
methods will be used and what quality control
will be used to assure that representative samples are collected? What measurement procedures,
field techniques and laboratories will be used and what quality control will be used to assure
accurate, precise and sensitive data are collected? How will sample data be managed? Note: A
good reference is EPA Region 4, SESD, Athens, GA, “Field Branches Quality System and
Technical Procedures”. Website: http://www.epa.gov/region4/sesd/fbqstp/index.html
B1. Sampling Design and Site Figures -- (In Project/Site-Specific QAPP)
The purpose of this element is to describe the overall design of the project data collection
activities and the rationale supporting the design. This element should describe how you plan to
collect representative samples. Statistical sampling designs can be used to help ensure
representative samples are collected. However, statistically based sampling designs may be
beyond the extent of the project.
Explain why the sampling locations, environmental parameters/analytical methods and matrices
were chosen. Describe the sampling design for the project including: sampling locations and
directions to them, frequency of sampling at each location, matrices to be sampled,
environmental parameters/analytical methods of interest in each matrix, any design assumptions
(e.g. storm event defined as “X” inches of rain after “Y” number of dry days). Include maps that
detail sample locations.
Some things to consider in developing your sampling design: What are the standards or action levels
against which the data will be compared? Example, do you need to determine whether water quality
criteria are exceeded? Do you care about average contamination levels, hot spots, or the proportion of a
site contaminated? Will composite samples or grab samples be used? Are you looking for trends over
time? Will there be a reference site? Are you collecting background samples? For guidance on selecting
the appropriate design, refer to “Guidance for Choosing a Sampling Design for Environmental Data
Collection” (QA/G-5S) http://epa.gov/quality/qs.docs/g5s-final.pdf
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PROGRAM LEVEL QAPP INSTRUCTIONAL
It is recommended to create a table that includes sample
matrix, environmental parameters and/or analytical
methods, sampling collection method, analytical method
reference, number of field samples, type and number of
field QC samples for each matrix and parameter, and
include acceptance criteria for blanks, matrix spike/matrix
spike duplicates, and field duplicate samples.
B2. Sampling and Analytical Methods
Requirements (In Project/Site-Specific QAPP)
Each sampling procedure should describe in detail each
step of the procedure, the equipment, materials, supplies,
sample preservation techniques, sample holding times,
decontamination procedures, disposal of decontamination
by-products, sample containers and volumes, quality
control acceptance limits and corrective actions that will
be used.
Describe procedures, or include written SOPs as electronic
attachments, or on a CD, if preferred, to the QAPP for
sample collection, including preparation of sample
containers, sample volumes, preservation and holding
times; sample packaging, labeling and shipping; equipment
preparation; decontamination and disposal of waste byproducts; Describe how problems (lost samples, broken
equipment, inaccessible sampling locations, etc.) will be
resolved and documented.
If written SOPs are used, create a table listing all field
sampling SOPs that will be used. Include: Title of SOP,
Date, Revision number and Organization that wrote the
SOP.
Provide another table that includes: Parameter, sample
container, sample volume, preservation, holding times for
each parameter and matrix. Describe any modifications to
the SOPs that are necessary for your project. Also, if there
are any method or equipment options within the SOP,
indicate which ones will be used. Indicate how these
modifications and option choices will be relayed to the
samplers.
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A word about Standard Operating
Procedures (SOPs): Written SOPs describe
an organization’s procedure for doing a
specific task. Unlike published methods,
SOPs are specific to one organization. EPA
R-4 Programs encourage the use of SOPs
because they provide consistency from one
user to the next and can be used by the
organization for multiple projects. SOPs
should be submitted electronically, or on a
CD, if preferred, and submitted with the
Program Level and Project/Site-Specific
QAPP(s). You may also reference the SOP
in the applicable document(s). When
referencing SOPs, always cite the title,
revision date and/or number, author,
organization, and indicate if, and how, the
SOP will be modified for the project (if
necessary). In general, SOPs should
include the following sections:
1. Title and Approval Page/Table of
Contents
2. Scope and Applicability
3. Summary of Procedure
4. Definitions
5. Health and
Safety/Cautions/Interferences
6. Personnel Qualifications
Equipment, materials and supplies
(sample containers)
7. Sample Collection (Sequential steps
and sample volumes)
8. Sample Handling, Preservation and
Holding Times (shipment, chain-ofcustody)
9. Sample Analysis (detailed steps
including sample preparation)
10. Troubleshooting
11. Decontamination procedures for both
sampling and analysis and disposal of
decontamination by-products
12. Data Records and Management (field
notes, calculations and data sheets)
13. QA/QC including QC acceptance limits
and corrective actions that will be used
when limits are exceeded.
14. References
A good reference is, “Guidance for
Preparing Standard Operating Procedures
(SOPs)”, EPA QA-G/6 Website:
http://www.epa.gov/quality/qa_docs.html
PROGRAM LEVEL QAPP INSTRUCTIONAL
B3. Sample Handling and Custody Requirements (In Program Level QAPP)
This element describes how you will maintain sample integrity (samples will not get corrupted or
mixed up). Indicate how samples will be handled, transported, and then held in the laboratory.
Describe how samples will be handled in the field, during transport and in the lab. Identify
responsible persons. Specify chain-of-custody (C-O-C) procedures that will be used to ensure
samples don’t get lost, mixed up, or tampered. Provide examples of a sample label, C-O-C
forms and other documentation. Describe sample numbering/identification system for field
samples and laboratory. Attach applicable SOPs.
B4. Analytical Methods Requirements (In Program Level QAPP)
This element identifies the analytical methods that will be used in the field and in the laboratory.
These methods need to be sensitive enough to characterize the environmental conditions.
Describe sample preparation and analytical procedures for field techniques and laboratory
methods. Reference standard methods and attach SOPs. Detail any project-specific
modifications to analytical methods and SOPs. List laboratory quantitation limits (reporting
limits) to ensure project sensitivity requirements will be
Some things to consider when
met. Include the Laboratory QA Manual attached as
reviewing QC sample results:
SOP(s). Describe how problems (lost samples,
What will you do if
quantitation limits, holding time exceedances, etc.) will
contaminants are found in a
be resolved and documented
“blank” sample?
What will you do with sample
results that do not compare with
previously collected data and
appear to be incorrect?
What will you do with sample
results if the instrument was not
calibrated correctly?
What will you do when
duplicate sample results aren’t
comparable?
What will you consider the
range of comparable results to
be?
What will you do with sample
results when a spiked
compound is not recovered? Or
when the results of a
performance evaluation sample
are inaccurate?
B5. & B6. Field/Laboratory Quality Control
Requirements (In Program Level QAPP)
This element should list all the QC checks you are going
to perform to characterize the quality of the data.
Quality Control – Field: This element should list all the
QC checks you are going to perform to characterize the
quality of the data. Provide a table listing the QC
samples for each sampling matrix (e.g., water, soil) and
environmental parameter (pH, phosphorus, etc.). The
table should include: Type of QC sample (field
duplicates, Performance Evaluation Samples, and trip,
equipment and cooler temperature blanks); Frequency;
Acceptance criteria (control limits); matrix spike/matrix
spike duplicate samples; and Corrective actions that will
be done when acceptance criteria are exceeded. Include
procedures and formulas for calculating QC data.
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PROGRAM LEVEL QAPP INSTRUCTIONAL
Quality Control - Field Measurement/Laboratory: Provide a table listing the QC samples for each
analytical method, for each matrix and for each
measurement parameter. The table should include:
SOPs should be submitted




Types of QC sample (lab duplicates, matrix
spikes, method blanks, etc.)
Frequency
Acceptance criteria (control limits)
Corrective actions that will be done when
acceptance criteria are exceeded.
electronically, or on a CD, if preferred,
and submitted with the Program Level
and Project/Site-Specific QAPP(s). You
may also reference the SOP in the
applicable document(s).
Describe procedures and formulas for calculating QC data.
The answers to these questions should be addressed in the discussion of how you will review and
qualify your data. Remember: QC data are only worthwhile generating if they are used to
review and evaluate your data.
B7. & B8. Field/Laboratory Equipment Calibration and Corrective Action
(In Program Level QAPP)
The information in this element should describe how you will keep instruments and equipment
properly operational during the project. Identify equipment and instrumentation (both field and
laboratory) requiring calibration and periodic maintenance, inspection and testing. Describe how
often the instrument needs to be calibrated and maintained, who will perform and document
tasks. Describe the calibration and testing procedures and acceptance criteria (control limits) for
operation. This information can be found in the equipment manual or on the manufacturer’s
website. List the spare parts needed to be kept on hand to keep the instrument operational.
Describe how problems (e.g., instrument doesn’t hold calibration) will be resolved and
documented. All instrumentation/equipment must be calibrated according to a schedule specified
by the method and instrument/equipment manual or SOPs.
B9. Analytical Sensitivity and Project Criteria (In Program Level QAPP)
Provide an analytical method sensitivity and project criteria table for the analytical methods that
will be routinely performed on Tribal projects. This table is important for both planning the
project and evaluating the resulting data. The table should include: Laboratory providing data;
Analytical Method reference (e.g., VOCs 8260B); Matrix (soil, groundwater, air, etc.);
Analyte/compound list; Method Detection Limit (MDL); and Quantitation/reporting limit
(QL/RL)
B10. Data Management and Documentation (In Program Level QAPP)
The information contained in this element describes managing project data. It also describes
procedures for maintaining data so that they will not be lost or corrupted. Data can be lost
during data reduction, data reporting, data entry onto forms, reports, databases, and even in
storage. Indicate how computerized information will be maintained and stored and how data loss
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will be mitigated. Any forms or checklists to be
used can be attached.
For additional information refer to
“Guidance on Technical Audits and
Related Assessments for
Environmental Data Operations”,
G-7
Website:
http://www.epa.gov/quality/qa_docs.
html
Describe how data (both hard-copy and electronic)
will be managed from the time they are generated
in the field to final report and storage, and how
long data will be retained. Describe how data (both
hard-copy and electronic) will be managed from
the time they are generated in the field to final
report and storage. Discuss methods and
equipment for detecting/correcting errors, and
preventing data loss. Describe how computer
outputs will be checked. Identify who is responsible for these tasks. Attach applicable SOPs.
Note: Include SOPs on a CD and include in the appropriate document (either Program Level or
the Project/Site-Specific).
Discuss methods and equipment for detecting/correcting errors, and preventing data loss.
Describe how computer outputs will be checked. Identify who’s responsible for these tasks.
Attach applicable SOPs. Include SOPs electronically or on a CD and include in the appropriate
document (either the Program Level or the Project/Site-Specific QAPP).
Component 3: Assessment and Oversight
The elements in this group
answer the following questions:
How will you check to make sure that the project is being conducted as described in the QAPP?
For example: Are field personnel collecting samples at the correct locations? Is the laboratory
generating accurate data?
What interim and final reports will be generated? Assessment findings should be documented in
a report with recommendations for corrective actions, if it applies.
Include a list of the document and reports required by EPA as listed in Award Programmatic
Conditions.
C1. Assessments and Response Actions (In Program Level QAPP)
Discuss how you plan to ensure that the project will be conducted as described in the QAPP.
Describe any oversight activities and/or assessments that will be performed, approximate
timeframe, and person responsible. Identify who will receive a report of the findings and who
will be responsible for corrective actions and follow up. Minimally, the Tribe’s Project Manager
should schedule one review of field activities at the beginning of the project to ensure that all
personnel are trained and the right equipment is in place. A Corrective Action Flow Chart is
extremely useful.
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If laboratories are required to maintain certification/accreditation, discuss this here. Most
accredited / certified laboratories are routinely audited by certifying/accrediting bodies as part of
the certification / accreditation process. Clients should request a copy of the laboratory’s
accreditation certificate to retain on file. ISO, NELAC, A2LA are examples of accrediting /
certifying bodies.
C2. Reports (In Program Level QAPP)
The QAPP should clearly state the type of information that will be included in the final project
report.
The QAPP should clearly state the types of reports that will be developed and identify
information to be included. This may include reports to the Tribal Government as well as reports
identified in the Programmatic Conditions of the award.
Describe the type and number of reports that will be generated for the project. Identify who is
responsible for preparing the reports and the recipients for each report. Minimally, a final
project report should be written and provided to the EPA Project Officer. This report should
analyze and interpret data, present observations, draw conclusions, identify data gaps, and
describe any limitations in the way the data should be used.
Include a list of the type of information included in hardcopy and electronic analytical data
reports.
Component 4: Data Evaluation
D1. Data Review, Validation and Verification (In Program Level QAPP)
This section describes how the data will be evaluated to determine whether they can be used to
address project objectives. This group of elements answers the following questions: How will
you check that individual data collection tasks were completed correctly? How will you
determine that individual sample results are acceptable or unacceptable based on QC data? How
will you assess the entire set of project data to determine whether the data are “good” enough to
use in making project decisions and conclusions?
All data validation, review, verification SOPs should be included in an appendix to the QAPP.
Also include a list of the data qualifier flags (along with their definitions). Specify how the data
review, validation and verification process will be documented.
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These elements are simplified into 3 steps for the purpose of this section.
Step 1: Verification
Describe how data will be checked to ensure that they are complete and were generated
according to the methods and procedures specified in the QAPP.
Describe steps taken by the laboratory to qualify sample results. Include qualifiers that the
laboratory will apply when data do not meet laboratory QC acceptance limits.
Discuss how issues will be resolved, documented and reported and the personnel responsible for
these tasks. Attach any forms and checklists used to perform completeness checks. For
example, is there a procedure to check that the samples were correctly preserved? Is there a
procedure to check that laboratory data packages are complete (contain all required
information)?
Laboratories generally apply flags to reported sample results that do not meet Lab QC limits.
For example, if a lab contaminant is present in a method blank, that contaminant would be
flagged on the sample report form. Other items to check include: incubation temperatures, media
preparation and sample holding times.
Step 2: Validation Procedures
Describe how sample results will be accepted, rejected or estimated based on quality control
acceptance criteria. Define the data qualifiers that will be applied to the data (e.g., U=not
detected, J=estimated, R=rejected). Attach or refer to written data validation procedures, if
used. Identify the individuals who will review data, and resolve and document data quality
problems.
Also known as the reconciliation
process for reconciling the data to
the project specific DQOs which
is normally a step wise process
(rarely statistical) for determining
whether the sample were
collected and preserved properly,
sample were collected at the
appropriate sampling location, the
sample were handled properly,
the appropriate extraction /
digestion / analytical method was
employed, etc.
Validation is a review of sample results by an individual
who is independent of the generation of the data. That
means that the laboratory reporting the data wouldn’t
perform data validation. Instead, the laboratory generally
performs an internal verification (QC check) of the data
that it generates. Data validators use mathematical and/or
statistical procedures to assess the overall ability of the
data to meet the project-specific data quality objectives.
For additional guidance in data usability assessment refer to these EPA Documents: “Data Quality
Assessment: A Reviewer’s Guide, (QA/G-9R)”and the companion document “Data Quality Assessment:
Statistical Tools for Practitioners, (QA/G-9S).
Website: http://www.epa.gov/quality/qa_docs.html
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Step 3: Evaluating Data in Terms of User Needs
This step describes how you intend to objectively decide whether the data you collected are good
enough for the data user to use.
Describe how the results of the study will be analyzed and evaluated to determine whether the
needs of your project were met and then reported. Include mathematical and statistical formulae
that will be used to calculate precision, accuracy/bias, completeness, comparability of the project
data. Describe what will happen if data are unusable. Remember, anything that compromises
data representativeness ultimately impacts data quality.
Supplemental Information
This section is to include any additional information that is supportive of your QAPP documents,
such as abbreviations, a glossary, references, etc.
Abbreviations – Provide a list of abbreviations and full name (example, QAPP - Quality
Assurance Project Plan).
References - The use of references provides supporting documentation to the QAPP text.
Include a list of all pertinent references.
Attachments – Figures, Tables and Appendices – These provide supporting information to the
QAPP text.
 Maps and Figures - Include maps and figures that don’t easily fit within the QAPP text as
an appendix or attachment.
 Tables - Include large tables that don’t easily fit within the QAPP text as an appendix or
attachment.
 Appendices – On CD - Include items such as: field equipment manuals, laboratory
contracts and/or QA Manuals, field, laboratory and other SOPs, example documentation
(i.e., field forms, chain-of-custody forms, sample labels), etc.
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