Number range CHAPTER**EPA NEW ENGLAND**

**QUALITY ASSURANCE**

**PROJECT PLAN PROGRAM GUIDANCE**

![](media/image1.png)

**U.S. EPA NEW ENGLAND**

**Quality Assurance Unit**

**Office of Environmental Measurement and Evaluation**

Revision 1

April 1, 2008

Preface

> The EPA New England Quality Assurance Unit implements a Quality
> Assurance Project Plan (QAPP) Program in accordance with EPA Order
> 5360.1 A2, May 2000 (reclassified January 2008 as CIO 2105.0) and EPA
> New England QAPP Policy EQAPOL-QAPPOL2, February 2005. Among other
> requirements, the "QA Order" requires the development, review and
> approval of QAPPs for all environmental data operations performed by
> or for EPA. The term "environmental data operations" refers to
> activities involving the collection, generation, compilation,
> analysis, evaluation and use of environmental data. The *EPA New
> England Quality Assurance Project Plan Program Guidance* implements
> national QAPP requirements specified in *EPA Requirements for Quality
> Assurance Project Plans* (EPA QA/R-5), and the *EPA Quality Manual for
> Environmental Programs*, CIO 2105 --P-01-0 (formerly 5360 A1).
>
> As a regional implementation document, the *EPA New England Quality
> Assurance Project Plan Program Guidance*:

-   Outlines a regional planning process to ensure project quality
    objectives are systematically identified

-   Defines a minimum set of project QA/QC activities that must be
    described in a QAPP to ensure that data collected by or for EPA New
    England are of known and documented quality and can be used in
    environmental decision making

-   Describes the roles and responsibilities of project management and
    personnel

+---------------+------------------------------------------------------+
| **Program**   | **Guidance**                                         |
+---------------+------------------------------------------------------+
| **General**   | *EPA Guidance for Quality Assurance Project Plans*   |
|               | (EPA QA/G-5), December 2002, EPA/240/R-02/009,       |
|               | <http://www.epa.gov/quality/qa_docs.html>            |
+---------------+------------------------------------------------------+
| **Water       | Number range CHAPTER*The Volunteer Monitor's Guide   |
| Quality       | to Quality Assurance Project Plans,* September 1996, |
| Monitoring**  | EPA/841/B-96/003,                                    |
|               |                                                      |
|               | <http://                                             |
|               | epa.gov/owow/monitoring/volunteer/qapp/vol_qapp.pdf> |
|               |                                                      |
|               | Water Monitoring Quality Assurance Project Plan,:    |
|               | CD-ROM Tool for Tribes and Grantees                  |
|               |                                                      |
|               | <http://www.epa.gov/region6/6pd/qa/qatools.htm>      |
|               |                                                      |
|               | or contact Region 1 for a copy of the CD-ROM         |
+---------------+------------------------------------------------------+
| **Wadeable    | Number range CHAPTER*Generic Quality Assurance       |
| Streams and   | Project Plan Guidance for Programs Using Community   |
| Rivers**      | Level Biological Assessments in Wadeable Streams and |
|               | Rivers*,                                             |
|               | <http://www.epa.gov/bioindicators/html/qapp.html>    |
+---------------+------------------------------------------------------+
| **            | Number range CHAPTER*Quality Assurance Guidance for  |
| Brownfields** | Conducting Brownfields Site Assessments*, September  |
|               | 1998, EPA 540-R-98-038,                              |
|               |                                                      |
|               | <http://www.epa.gov/swerosps/bf/pdf/bfqag4.pdf>      |
+---------------+------------------------------------------------------+
| **Number      | Number range CHAPTER*Uniform Federal Policy for      |
| range         | Quality Assurance Project Plans*, July 2004, OSWER   |
| CHA           | Directive 9272.0-17                                  |
| PTERHazardous | [[http://www.epa.gov                                 |
| Waste**       | /fedfac/pdf/ufp_manualv1_july04.pdf]{.underline}](ht |
|               | tp://www.epa.gov/fedfac/pdf/ufp_manualv1_july04.pdf) |
| **(Federal    |                                                      |
| Facilities,   |                                                      |
| Superfund,    |                                                      |
| and RCRA)**   |                                                      |
+---------------+------------------------------------------------------+
| **Air**       | Ambient Monitoring Technology Information            |
|               | CenterNumber range CHAPTER                           |
|               | <http://www.epa.gov/ttn/amtic/>                      |
+---------------+------------------------------------------------------+
| *             | Number range CHAPTER*Guidance for Quality Assurance  |
| *Pesticides** | Project Plans-Development for EPA Funded Cooperative |
|               | Agreements with State and Tribal Agencies for the    |
|               | Conduct of FIFRA Pesticide Programs*, December 15,   |
|               | 2000                                                 |
|               |                                                      |
|               | <ht                                                  |
|               | tp://www.epa.gov/region9/qa/pdfs/finalqaappver9.pdf> |
+---------------+------------------------------------------------------+
| **TMDL        | *EPA New England Draft Generic Modeling Quality      |
| Modeling**    | Assurance Project Plan and Quality Assurance         |
|               | Checklist*                                           |
|               |                                                      |
|               | <http://epa.gov/ne/lab/qa/qamodeling.html>           |
+---------------+------------------------------------------------------+

**Table of Contents**

[1.0 INTRODUCTION 5](#__RefHeading___Toc100027029)

[2.0 SCOPE 6](#__RefHeading___Toc100027031)

[3.0 REQUIRED QAPP ELEMENTS 6](#__RefHeading___Toc100027032)

[4.0 ROLES AND RESPONSIBILITIES 8](#__RefHeading___Toc100027034)

[5.0 QAPP REVIEW AND APPROVAL 10](#__RefHeading___Toc100027035)

[6.0 IMPLEMENTATION OF APPROVED QAPP 10](#__RefHeading___Toc100027038)

[7.0 REVISION AND MODIFICATION OF APPROVED QAPP
10](#__RefHeading___Toc100027039)

[8.0 QAPP ARCHIVAL 11](#__RefHeading___Toc100027042)

[9.0 REFERENCES 12](#__RefHeading___Toc100027043)

# 

# EPA NEW ENGLAND

**QUALITY ASSURANCE PROJECT PLAN PROGRAM GUIDANCE**

[]{#__RefHeading___Toc100027029 .anchor}**1.0 INTRODUCTION**

A quality assurance project plan (QAPP) is a required planning document
that provides a "blueprint" for obtaining the type, quantity and quality
of data needed to support environmental decision making. The QAPP
documents all quality assurance (QA), quality control (QC) and technical
activities and procedures associated with planning, implementing,
documenting and assessing environmental data operations.

EPA New England (EPA NE) recognizes the following two types of QAPPs:

1.  **Project-specific QAPP:** Provides a QA blueprint specific to one
    project or task. Project-specific QAPPs are used when projects are
    limited in scope and time and, in general, can be considered the
    sampling and analysis plan/workplan for the project.

2.  **Generic program QAPP:** Provides an overarching plan that
    describes a program\'s quality objectives and documents a
    comprehensive set of sampling, analysis, QA/QC, data review, and
    assessment procedures specific to one program or long-term project.
    In contrast to the project-specific QAPP, the generic program QAPP
    serves as an umbrella under which multiple data collect activities
    may be conducted over an extended period of time. Project or
    task-specific information, not covered by the umbrella, is
    documented in detailed sampling and analysis plans/workplans/addenda
    that use the generic program QAPP as an informational reference. EPA
    may authorize the Lead organization to approve site-specific and
    project-specific addenda contingent upon a review and approval
    process that is fully documented in the approved generic program
    QAPP.

EPA Order CIO 2105.0 (formerly 5360.1 A2) requires that a QAPP be
prepared and approved for all environmental data operations performed by
or for EPA prior to the initiation of those data operations. In addition
to the QAPP requirement, the Order mandates that quality systems be in
place to support the development, review, approval, implementation and
assessment of data operations and to ensure that environmental
technologies are designed, constructed, and operated according to
defined expectations.

EPA NE designates those organizations performing work for or on behalf
of EPA as "Lead Organizations." Lead Organizations include organizations
performing work under financial assistance agreements and in response to
voluntary, consentual or unilateral enforcement agreements, decrees and
orders. Lead Organizations are required to develop, operate and document
their quality system in quality management plans (QMPs) to ensure that
environmental data collected and used by the Agency are of known and
documented quality and are suitable for their intended use.

Guidance for developing quality systems is provided in *Quality Systems
for Environmental Data and Technology Programs - Requirements with
Guidance for Use*, American National Standard, (ANSI/ASQ E4 - 2004)
February 2004; *EPA Requirements for Quality Management Plans*, EPA
QA/R-2, http://www.epa.gov/quality/qs-docs/r2-final.pdf ; and *EPA
Quality Manual for Environmental Programs*,
<http://www.epa.gov/quality/qs-docs/>

**2.**[]{#__RefHeading___Toc100027031 .anchor}**0 SCOPE**

The *EPA New England Quality Assurance Project Plan Program Guidance*
(hereafter referred to as the *EPA NE QAPP Program*) is based on Agency
requirements as outlined in *EPA Requirements for Quality Assurance
Project Plans*, EPA QA/R-5. The *EPA NE QAPP Program* provides the
framework for all project-specific and generic program QAPPs. It is
companion guidance to other documents written by the EPA NE Quality
Assurance Unit which are available at
<http://epa.gov/ne/lab/qa/qualsys.html> . These documents form the basis
of the EPA NE quality system that supports the generation, collection
and use of scientifically defensible data. Program-specific QAPP
guidance documents, listed on page 3, should be used when so directed by
the environmental program office. General QAPP guidance is provided in
*EPA Guidance for Quality Assurance Project Plans,* EPA QA/G-5.

Since the content and level of detail in individual QAPPs will vary
according to the work being performed and the intended use of the data,
EPA NE supports a "graded approach" when preparing QAPPs. In other
words, the amount of documentation and level of detail will vary based
upon the complexity and cost of the project. Appropriate consideration
should be given to the significance of the environmental problem to be
investigated, the environmental decision to be made, and the impact on
human health and the environment.

[]{#__RefHeading___Toc100027032 .anchor}**3.0 REQUIRED QAPP ELEMENTS**

In accordance with EPA QA/R-5, there are four basic element groups
(refer to Figure 1) that must be addressed in all QAPPs. Planning is
central to the success of environmental activities and may be
accomplished through meetings, conference calls, e-mail coordination,
etc. A systematic planning process, similar to the one outlined in
Figure 2, should be used to determine project objectives and tasks and
to select technical and QA/QC activities.

![](media/image2.jpeg){width="4.072222222222222in"
height="3.0659722222222223in"}

**Figure 1. Required QAPP Element Groups**

Specific requirements for each element group are detailed in
program-specific QAPP guidance documents listed on page 3. If some or
all of the required QAPP elements are incorporated into other planning
documents (i.e., Sampling and Analysis Plans \[SAPs\], Field Sampling
Plans \[FSPs\], Field Operations Plans \[FOPs\], Project Operations
Plans \[POPs\] or general Project Workplans \[WPs\]), then a
cross-reference table should be provided to identify where the required
QAPP elements are located. The referenced SAP, FSP, etc., should be
identified with the document title, date, section number, and page
numbers. []{#__RefHeading___Toc100027034 .anchor}

**4.0 ROLES AND RESPONSIBILITIES**

**Lead Organization**

The Lead Organization is responsible and accountable for all phases of
the project. The Lead Organization may perform the project work directly
or contract for field sampling, analytical, data validation, data
usability assessment, and/or oversight assessment services.

The Lead Organization is responsible for ensuring that there is an
approved QAPP in place prior to beginning any environmental data
operation. Also, the Lead Organization is responsible for ensuring that
organization personnel, contractors and/or subcontractors perform
project work as prescribed in the approved QAPP. To that end, Lead
Organizations should plan and conduct oversight assessments, such as
technical system audits (TSAs), of project activities.

Lead Organizations may include the following:

 EPA NE

 Other Federal agencies under interagency agreements, Federal facility
agreements, and memoranda of understanding (MOUs) with EPA NE

 States, tribes and local governments under financial assistance
agreements with EPA, including grants and cooperative agreements

 Non-profit organizations under financial assistance agreements with
EPA NE, including institutions of higher education, hospitals, volunteer
organizations, and interstate associations

 Regulated facilities (e.g., potentially responsible parties) under
voluntary or enforcement consent decrees, agreements and orders with EPA
NE

**Project Manager**

The project manager is responsible for directing, coordinating, and
overseeing all project activities for the Lead Organization. He/she is
responsible for submitting the QAPP, QAPP amendments, revisions and
annual review letters to appropriate personnel, with sufficient lead
time, for review and approval. QAPPs should be submitted to EPA NE for
review and approval no less than 30 days in advance of the scheduled
environmental data operation. The project manager ensures that all
technical issues identified during QA review are satisfactorily
addressed and documented prior to beginning of field work. Refer to
Figure 3 for an outline of the life cycle of a QAPP developed by or for
EPA NE.

**Project Team**

The project manager assembles a project team consisting of technical
personnel including data generators, QA scientists, and data users to
plan the project. The size of the project team should reflect the
complexity of the project. For example, small volunteer monitoring
projects may have project teams comprised of only two or three people.

Planning (scoping) meetings are convened to identify the project
objectives; environmental decisions that will be made with the collected
data; project action limits; type and quantity of data; and, how
\"good\" the data must be (the data quality) to support the decisions
that will be made. The project team defines the quality of the data by
setting acceptability limits for the project, otherwise known as
measurement performance criteria. Once the measurement performance
criteria have been decided upon, the project team can select sampling
and analytical methods that have appropriate quantitation limits and
quality control limits to achieve project objectives.

The project team is responsible for compiling project information as
defined in the program-specific QAPP guidance (page 3) and for resolving
all technical issues prior to the preparation of the QAPP document.
**Ultimately, it is the responsibility of the project team, and not the
QAPP preparer alone, to design a QA "blueprint" that meets project
objectives.**

The QAPP should be written by members of the project team experienced in
many aspects of environmental science including chemistry, engineering,
hydrogeology and risk assessment. In addition, they should be familiar
with the sample collection procedures, analytical methods and data
review and assessment procedures that will be used for the project.

**Project Personnel**

An organizational chart, or detailed discussion, should clearly indicate
the reporting relationships between EPA NE and project personnel,
including contractors and subcontractors. All project personnel are
responsible for reading and understanding the QAPP before beginning
field work, and for implementing the QAPP as prescribed.

**EPA NE QA Unit**

The EPA NE QA Unit is responsible for reviewing and approving all
intramural and extramural QAPPs, except in the case where the review and
approval authority has been delegated by the EPA NE regional quality
assurance manager (RQAM) in accordance with Section 5.2.

Members of the QA Unit are available to provide assistance and QA/QC
guidance during the planning and implementation of environmental
projects. In addition, they perform technical system audits and data
review activities.

The QA Unit is also responsible for identifying the QA/QC training needs
for the region, including project planning and QAPP training, and for
conducting assessments of environmental programs.

[]{#__RefHeading___Toc100027035 .anchor}**5.0 QAPP REVIEW AND APPROVAL**

**5.1 Internal Review and Approval**

The Lead Organization is responsible for ensuring that the QAPP includes
all required QAPP elements and information and that project quality
objectives (PQOs), technical activities and supporting QA/QC will result
in data of known and documented quality that can be used in
environmental decision making. To that end, the Lead Organization should
review the QAPP and require that all project personnel, contractors, and
subcontractors review applicable sections of the QAPP to ensure
technical accuracy [prior]{.underline} to submitting the QAPP to EPA NE
for approval.

**5.2 EPA NE Review and Approval**

As specified in EPA Order CIO 2105.0 (formerly 5360.1 A2), EPA NE must
review and approve all intramural and extramural QAPPs before
environmental data operations can begin. To that end, a technical review
is performed by the QA Unit and the project officer/project manager to
ensure that project quality objectives, technical tasks, and supporting
QA/QC activities will result in data of known and documented quality
that can be used in making environmental decisions. All comments
provided by EPA NE must be acceptably addressed in writing before
environmental data operations can begin. The response document (either a
revised QAPP or letter responding to specific deficiencies) should
provide identifying information, as it is presented on the "title and
approval page" of the original QAPP.

In accordance with the QA Order and as documented in the EPA NE QMP, the
RQAM has delegated QAPP approval authority to the Superfund and RCRA
Corrective Action Programs. As a condition of this delegated authority,
the program is required to provide to the QA Unit a copy of the "title
and approval page" for each approved QAPP.

The RQAM in concurrence with the EPA NE environmental program(s) may
delegate QAPP approval authority to non-EPA organizations. Delegation of
this approval authority is contingent upon having an EPA-approved QMP
and an effectively implemented quality system.

[]{#__RefHeading___Toc100027038 .anchor}**6.0 IMPLEMENTATION OF APPROVED
QAPP**

The approved QAPP must be implemented as prescribed; however, the QAPP
may be modified at any time after undergoing the proper approval
process, to ensure project objectives are met.

[]{#__RefHeading___Toc100027039 .anchor}**7.0 REVISION AND MODIFICATION
OF APPROVED QAPP**

QAPPs are approved for a fixed period of time specific to the
environmental data operation. They must be kept current and revised
whenever necessary and when so directed by EPA NE or national program
office.

**7.1 Modification of Approved QAPP**

When procedures or project activities need to be modified to achieve
project quality objectives, the QAPP must be amended (e.g., change of
sampling locations, methods, matrices, QC samples). This amendment must
be reviewed and approved in the same manner as the original QAPP. The
amendment should contain complete identifying information, as presented
on the original QAPP title and approval page, with updated signatures
and dates. Amendments should be approved before changes are implemented.

Verbal approval of modifications may be obtained to expedite project
work. Descriptions of modifications and verbal approvals must be
documented in telephone logs or emails which are retained in the project
file. Subsequently, this verbally approved modification must be
documented in an amendment to the QAPP and submitted to EPA NE within
seven working days, or on a mutually agreed upon date, for formal
signature approval.

Note that when "minor" changes are made to a QAPP (e.g., extending the
monitoring period, adding a sampling station), approved amendments are
not required. Instead, EPA should be notified by email of all changes
and a letter documenting the changes or revised QAPP pages should be
sent as a follow up.

**7.2 Annual Review of Approved QAPP**

Approved QAPPs must be reviewed annually by the Lead Organization, and
this annual review should be documented in a letter to the EPA NE RQAM.
The annual review letter should describe all changes to the QAPP and/or
include revised QAPP pages. If extensive revisions are necessary,
greater than ten pages, then a revised QAPP document should be
submitted.

[]{#__RefHeading___Toc100027042 .anchor}**8.0 QAPP ARCHIVAL**

All QAPPs, reviewers\' comments, and responses to reviewers\' comments
(revised QAPPs, QAPP amendments, and response letters addressing
specific issues) must be archived in the appropriate project/program
file according to the procedures specified by the Lead Organization in
the QAPP and/or their QMP.

Project files must be retained for the period of time specified in the
interagency agreement, MOU, cooperative agreement, financial assistance
agreement, contract, or voluntary or enforcement consent decree,
agreement or order. In addition, project files must be maintained in
accordance with program-specific retention schedules.

EPA NE retains the authority to request project/program files for any
extramural project/program during the period of performance of the
extramural agreement.

[]{#__RefHeading___Toc100027043 .anchor}**9.0 REFERENCES**

1\. *Quality Systems for Environmental Data and Technology Programs -
Requirements with Guidance for Use*, American National Standard,
(ANSI/ASQ E4 -2004), February 2004

2\. *EPA Requirements for Quality Management Plans*, March 2001, (EPA
QA/R-2) EPA/240/B-01/002,
[[http://www.epa.gov/quality/qs-docs/r2-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/r2-final.pdf)

3\. *Overview of the EPA Quality System for Environmental Data and
Technology*, November 2002, EPA/240/R-02/003,
[[http://www.epa.gov/quality/qs-docs/overview-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/overview-final.pdf)

4.  March 2, 1999 Memorandum From Norine E. Noonan (AA) to Assistant
    Administrators and Regional Administrators Re: Clarification of
    Terminology for the EPA Quality System with attachments

5\. *EPA Requirements for Quality Assurance Project Plans,* March 2001,
(EPA QA/R-5), EPA/240/B-01/003,
[[http://www.epa.gov/quality/qs-docs/r5-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/r5-final.pdf)

6\. *EPA Guidance for Quality Assurance Project Plans,* December 2002,
(EPA QA/G-5), EPA/240/R-02/009,
[[http://www.epa.gov/quality/qs-docs/g5-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/g5-final.pdf)

7 *Guidance for the Data Quality Objective Process*, EPA/600/R-98/018,
February 1998, (EPA QA/G-4), EPA/600/R-96/055,
[[http://www.epa.gov/quality/qs-docs/g4-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/g4-final.pdf)

8.  *EPA New England Quality Management Plan*, May 5, 2005
    [<http://epa.gov/ne/lab/qa/qualsys.html>]{.underline}

9.  *Region 1, EPA-NE Data Validation Functional Guidelines for
    Evaluating Environmental Analyses*, December 1996,
    [[http://epa.gov/ne/lab/qa/qualsys.html]{.underline}](http://epa.gov/ne/lab/qa/qualsys.html)

10. *Region 1, EPA NE Assessment Program,* February 2002.

11. *Guidance for the Preparation of Standard Operating Procedures for
    Quality-Related Operations*, November 1995, (EPA QA/G-6),
    EPA/600/R-96/027,
    [[http://www.epa.gov/quality/qs-docs/g6-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/g6-final.pdf)

12. *Guidance for Data Quality Assessment: Practical Methods for Data
    Analysis*, July 2000 (EPA QA/G-9), EPA/600/R-96/084,
    [[http://www.epa.gov/quality/qs-docs/g9-final.pdf]{.underline}](http://www.epa.gov/quality/qs-docs/g9-final.pdf)

13. *National Enforcement Investigations Center (NEIC) Policies and
    Procedures,*

> EPA-330/9-78-001-R, May 1978, Rev. December 1981 NTIS: 1-800-553-6847

14. *Implementation of Quality Assurance Requirements for Organizations
    Receiving EPA Financial Assistance*
    [[http://www.epa.gov/ogd/qa.htm]{.underline}](http://www.epa.gov/ogd/qa.htm)

15. EPA New England Quality Assurance Project Plan Policy,
    EQAPOL-QAPPOL2

![](media/image1.wmf)![](media/image1.wmf)![](media/image1.wmf)

**Figure 3. Life Cycle of a QA Project Plan within EPA New England**

![](media/image2.wmf)

Assign project manager, assemble project team

![](media/image3.wmf)

Schedule and conduct planning meetings

![](media/image4.wmf)

Plan project, determine project objectives and tasks, and select methods

![](media/image5.wmf)

Prepare project-specific or generic program QAPP

![](media/image6.wmf)

Perform internal review, and submit QAPP for EPA approval

![](media/image7.wmf)

Revise QAPP as required

![](media/image8.wmf)

![](media/image9.wmf)

Implement QAPP as written

![](media/image10.wmf)

Amend QAPP as needed, and submit amendments for EPA approval

![](media/image11.wmf)

Review QAPP annually, and submit review letter to EPA

Revise QAPP as necessary, when directed by region or national program
office

![](media/image12.wmf)

Archive QAPP in accordance with records retention policy