**QUALITY MANAGEMENT PLAN**

**QMP**

for

**WED**

Western Ecology Division (WED)

National Health and Environmental Effects Research Laboratory (NHEERL)

United States Environmental Protection Agency (EPA)

Corvallis, OR 97333

Document Control No. QMP-NHEERL/WED/95-xx-002

August 2006

**Quality Management Plan**

Western Ecology Division (WED)

National Health and Environmental Effects Research Laboratory (NHEERL)

United States Environmental Protection Agency

Corvallis, OR 97333

![](media/image1.jpeg){width="6.295138888888889in"
height="4.624305555555556in"}

**FOREWORD**

![](media/image2.jpeg){width="6.294444444444444in"
height="5.414583333333334in"}

**NOTE:**

This document can be viewed on-line or downloaded from [WED's intranet
website](http://p2626xoray001/pages/QA/QApage.htm).

The blue highlighted areas are hyperlinks to the document indicated. For
those reading this from paper, a list of all web links is included at
the end.

[]{#Table_of_Contents .anchor}**TABLE OF CONTENTS**

INTRODUCTION [[6]{.underline}](#Introduction)

1\. ORGANIZATION and MANAGEMENT
[[6]{.underline}](#Organization_Management)

1.1 Organization [[6]{.underline}](#org_1)

1.2 Responsibilities for Quality Assurance [[7]{.underline}](#org_2)

2\. QUALITY SYSTEM and DESCRIPTION
...............\....[[9]{.underline}](#qmp)

2.1 Quality Management Plan [[9]{.underline}](#qmp)

2.2 Systematic Planning [[9]{.underline}](#Systematic_planning)

2.3 Graded Approach [[9]{.underline}](#graded)

2.4 Quality Assurance Project Plans [[10]{.underline}](#QAPPs)

2.5 Standard Operating Procedures [[11]{.underline}](#SOPs)

> 2.5.1 Standard Operating Procedures
> [[11]{.underline}](#ORD_wide_QA_policies_procedures)
>
> 2.6 Assessments [[11]{.underline}](#Assessnents)

2.7 Quality Assurance Annual Report and Work Plan
[[12]{.underline}](#QAARWP)

2.8 Review of Products [[12]{.underline}](#Products)

2.9 Requirements for Extramural Research [[12]{.underline}](#Extramural)

3\. PERSONNEL QUALIFICATIONS and TRAINING
[[12]{.underline}](#qualification_training)

4\. PROCUREMENT of ITEMS and SERVICES [[13]{.underline}](#Procurement)

4.1 Cooperative Agreement, Interagency Agreements, Contracts
[[13]{.underline}](#COOPs)

4.2 Work Assignments and Task Orders
[[14]{.underline}](#Work_Assignments)

5\. DOCUMENTATION and RECORDS [[14]{.underline}](#Documentation_Records)

5.1 Records Management [[14]{.underline}](#Records_Management)

5.2 Document Control [[15]{.underline}](#Document_Control)

6\. COMPUTER HARDWARE and SOFTWARE [[16]{.underline}](#Computer_stuff)

6.1 Hardware and Software [[16]{.underline}](#Hardware_Software)

6.2 Software Development [[16]{.underline}](#Software_Development)

7\. PLANNING [[17]{.underline}](#planning)

8\. IMPLEMENTATION of WORK PROCESSES [[17]{.underline}](#Implementation)

9\. ASSESSMENT and RESPONSE [[18]{.underline}](#Assessment_Response)

9.1 Project-level Quality Assurance Assessments
[[18]{.underline}](#Project_level)

9.1.1 Performance Evaluations [[19]{.underline}](#Performance_Evals)

9.2 Division-wide Quality Assurance Assessments
[[19]{.underline}](#Division_wide)

9.3 Assessment Reports [[19]{.underline}](#Assessment_Reports)

9.3.1 Project-level [[19]{.underline}](#Assess_reports_project_level)

9.3.2 Division-wide [[19]{.underline}](#Assess_reports_Division_wide)

10\. QUALITY IMPROVEMENT [[20]{.underline}](#quality_improvement)

**References:**

> World Wide Web URLs [[21]{.underline}](#Web_based_References)

**Appendices:**

> Appendix 1 Agency Policies Cited [[23]{.underline}](#Appendix_1)
>
> Appendix 2 Glossary [[25]{.underline}](#Glossary)
>
> Appendix 3 Instruction for Sample Collection Project QAPP Preparation
> [[28]{.underline}](#Appendix_3)
>
> Appendix 4 Instructions for Modeling Project QAPP
> [[40]{.underline}](#Appendix_4)
>
> Appendix 5 Instructions for SOP Preparation
> [[46]{.underline}](#Appendix_5)

**Forms:**

> Quality Assurance Review Form
> ([WED-26](http://p2626xoray001/pages/forms/qa/WED-26.doc)) [47](#QARF)
>
> ORD Clearance Form [(ORD-362
> (Rev.06/10/05))](http://wedcor.cor.epa.gov/pages/forms/Publications/ORD-362.doc)\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....[50](#Clearance_Form)
>
> Biennial SOP Review Form [51](#Biennial_review_form)

[]{#Introduction .anchor}**INTRODUCTION**

The U.S. Environmental Protection Agency (EPA) requires that all data
collected or used by or for the Agency comply with a series of steps to
assure the quality of the research. The basic policy is contained in
[[EPA ORDER 5360.1 A2 May 5,
2000]{.underline}](http://www.epa.gov/quality1/qs-docs/5360-1.pdf)
*POLICY AND PROGRAM REQUIREMENTS FOR THE MANDATORY AGENCY-WIDE QUALITY
SYSTEM* that follows the standards described in the [[ANSI/ASQC
E4-1994]{.underline}](http://qualitypress.asq.org/perl/catalog.cgi?item=T55):
*Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs*. The [[EPA
Quality Manual for Environmental
Programs]{.underline}](http://www.epa.gov/quality1/qs-docs/5360.pdf)
provides program requirements for implementing the order.

This Quality Management Plan (QMP) provides guidance to all persons
associated with or funded by WED. It defines Quality Assurance Program
goals, methods for attaining those goals, and explains basic and general
responsibilities.

[]{#Organization_Management .anchor}**1. ORGANIZATION and MANAGEMENT**

[]{#org_1 .anchor}**1.1 Organization**

**Western Ecology Division, NHEERL**

[go to Table of Contents](#Table_of_Contents)

[]{#org_2 .anchor}**1.2 Responsibilities for Quality Assurance**

> **Division Director** has ultimate responsibility for all research
> conducted, funded, or managed within the division. He/she approves the
> division QMP, Research Plans and the Quality Assurance Annual Report
> and Work Plan.
>
> **Associate Director for Science** oversees the division-wide quality
> assurance program to assure that all research supported or conducted
> by the division meets Agency quality assurance requirements.

**Performance Agreements** for senior managers and applicable staff
contain critical elements commensurate with the QA responsibilities
assigned them in this QMP and EPA Order 5360.1 A 2.

> **Branch Chiefs** are responsible for the quality of research
> conducted, funded, or managed within their branches**.** They annually
> review and report to management the [consistency of their projects
> with the Research
> Plans](http://wedcor.cor.epa.gov/pages/policy/Policy on Peer reviewed research plans 53003 joz-6-13.doc).
> They also approve Quality Assurance Project Plans (QAPPs) and
> manuscripts. They may delegate approval authority for approving
> Standard Operating Procedures (SOPs) to the program or project
> leaders.
>
> **Project Leaders (PLs)** manage and monitor all the work, including
> QA, within the project. They approve QAPPs, and all SOPs that pertain
> to their projects. Any of the following items can be
> [delegated]{.underline} to PIs or others for implementation, but the
> PL remains responsible for their establishment and execution.
>
> Key QA/QC responsibilities of Project Leaders:

-   Establish data quality objectives, specifications, and acceptance
    criteria for the project.

-   Establish [procedures](#QAPP_D1_Data_Review) to periodically verify
    and [document]{.underline} the acceptability of data generated by
    EPA and/or contract support staff. These procedures would include
    review of [project notebooks](#notebook_review) and prompt
    verification of contractor data reports and deliverables.

-   Prepare (in consultation with the QAM and PO) a [QA Review
    Form](http://p2626xoray001/pages/forms/qa/WED-26.doc) for
    solicitation packages for contracts, COOPs and IAGs in support of
    their project.

-   Ensure that an approved QAPP exists prior to start up of any
    research activity.

-   [Annually]{.underline} review and document implementation of their
    project's QAPP.

-   Identify the need for, and initiate, appropriate corrective actions.

-   Interact with the PIs regarding QA/QC.

-   Verify that adequate supportive QA/QC documentation is available for
    each research product and that EPA reports contain identifiable
    QA/QC and data usability sections.

-   Ensure that all outputs comply with the technical output [clearance
    process](#Clearance_Form).

> **Institution Project Manager** is the person at an extramural
> institution who is assigned to manage the project that is being done
> for or in cooperation with WED.
>
> **Principal Investigator** (**PI**) is the person charged with
> conducting or leading a research project or a part of a project
> (task). Depending on the project there may be one or several principal
> investigators and they may be either EPA employees or cooperators in
> extramural institutions. The
>
> PI is the person who generally conceives experiments, analyzes data,
> and writes research reports, and thus generally appears as the primary
> author. A PI may or may not be one of the following:

[go to Table of Contents](#Table_of_Contents)

> the Project Leader, Institution Project Manager, Program Leader,
> Branch Chief, etc. Duties of the PI are negotiated with the PL and are
> detailed in the QAPP.
>
> **Scientific Support Staff** (intramural or extramural) are
> responsible for conducting technical tasks and for ensuring the
> quality of the results generated.
>
> Key QA/QC responsibilities designated by the PI:

-   Participate in preparing the QAPP.

-   Document QC output(s).

-   Follow established procedures, such as SOPs, and document any
    deviations.

-   Perform and document preventive maintenance, as necessary.

-   Maintain up-to-date laboratory notebooks and/or other appropriate
    record-keeping systems.

-   Report to the PI all QA problems encountered and corrective actions
    taken.

> **Quality Assurance Manager** is a member of the Office of the
> Division Director. This administrative arrangement avoids potential
> conflicts with operational programs and provides **independent**
> **review** of QA matters. WED's QAM is also the Records Liaison
> Officer (RLO).
>
> The QAM/RLO is responsible for ensuring that all QA and [records
> related
> activities](http://www.epa.gov/records/policy/2100/2100-10.htm) are in
> compliance with agency policy and guidance. He reports to the
> Associate Division Director for Science.
>
> Key responsibilities of the QAM/RLO:

-   Certify that QAPPs and SOPs meet QA agency standards.

-   Review funding actions for extramural projects and certify
    compliance with quality policy.

-   Review all scientific outputs for compliance with Agency/WED
    research quality policies.

-   Prepare the QMP.

-   Review the QMP annually, and propose revisions as appropriate.

-   Prepare an annual status report describing activities that
    demonstrate compliance with policies for all research conducted or
    funded by the division. This is the Quality Assurance Annual Report
    and Work Plan that is submitted to the NHEERL Director of Quality
    Assurance.

-   Track the QA/QC status of WED projects.

-   Conduct assessments of QA procedures in WED projects.

-   Participate on WED's Science Council as a standing member.

-   Provide records management training for WED managers and staff.

-   Verify appropriate scheduling of records submitted for onsite
    archiving.

> **Delegation of Authority**: In the absence of the QAM, a senior
> member of the IO or the Associate Division Director for Science may
> sign in the QAM's stead.

[go to Table of Contents](#Table_of_Contents)

**2. QUALITY SYSTEM and DESCRIPTION**

[]{#qmp .anchor}**2.1 Quality Management Plan**

The QMP sets forth the basis for the division\'s quality assurance
program. It identifies roles and responsibilities of managers and
scientists regarding research quality.

The first page carries the signatures of those who have approved and
committed to follow the procedures that have been outlined. It provides
the basis for assessing the effectiveness of the WED Quality Assurance
Program. It provides the benchmark for periodic quality systems
assessments (QSA) conducted by NHEERL and EPA Quality Staff, and
Laboratory Competency audits These reviews are to assist WED in
complying with current EPA policy and procedures and assure the NHEERL
director that WED is in compliance with those policies. The QMP will be
reviewed annually by the QAM, and if needed, minor changes (approved by
the Division Director and Branch Chiefs) will be made by amendment. The
QMP is re-approved by the NHEERL Director of Quality Assurance (DQA)
every five years or sooner, if major revisions are needed.

[]{#Systematic_planning .anchor}**2.2 Systematic Planning**

WED's [Science
Council](http://wedcor.cor.epa.gov/pages/policy/wedscr&r 2006.doc)
provides the forum for discussion and development of solutions for
matters relating to planning and implementing the division's research
program. This council provides the leadership for WED's scientific
endeavors. Potential research projects are developed and evaluated
through interactions with the Science Council. [Research
Plans](http://wedcor.cor.epa.gov/pages/policy/Policy on Peer reviewed research plans 53003 joz-6-13.doc)
are developed and peer reviewed for those that address high priority
issues identified through the EPA and ORD planning process and that can
be completed with available resources. The steps outlined in WED's
Research Plans are similar to those in the [Data Quality Objective
process](http://www.epa.gov/quality/qs-docs/g4-final.pdf) Number range
CHAPTERthat identifies the clients and their needs, clarifies study
objectives, selects appropriate hypotheses, defines the appropriate type
of data, and specifies tolerable levels of potential errors.

[]{#graded .anchor}**2.3** **Graded Approach**

Since different research projects are associated with different levels
of public awareness and have different immediate applications, a graded
approach to project oversight is needed. Each project will be assigned a
category according to the criteria in Appendix D of the [[NHEERL
QMP]{.underline}](http://www.nheerl.epa.gov/administration/qa/files/qmp05_attachments.pdf):

> **Category 1:** Research that [directly]{.underline} and/or
> [immediately]{.underline} supports specific Agency rule-making,
> enforcement, regulatory, or policy decisions. This category may also
> include research of significant national interest, such as tasks that
> might be monitored by the Administrator. It may also include research
> conducted under a Cooperative Research and Development Agreement, more
> commonly known by the acronym CRADA, or other technology transfer
> project for which the data and/or the research conduct by which the
> data were obtained may be critical to the award of a patent or other
> important commercial or legal decision. Category I research tasks
> require the most detailed and rigorous QA and QC activities to ensure
> both legal and scientific defensibility.
>
> **Category 2:** Research of high programmatic relevance that, in
> conjunction with other ongoing or planned studies, is expected to
> provide complementary support of Agency rule-making, regulatory, or
> policy decisions.

**Category 3:** Demonstration or proof of concept projects; method
validation studies.

[go to Table of Contents](#Table_of_Contents)

> **Category 4:** Basic, exploratory, conceptual research to study basic
> phenomena or issues. Includes the characterization of health or
> ecological mechanisms and/or endpoints in order to improve the
> understanding of the interaction of environmental compounds,
> conditions, or processes with human and other life forms; and also
> includes development of assays or methods for detecting or estimating
> the influence of a particular environmental agent on a specified
> health or ecological endpoint.

The selection and justification of a research category is done in the
Research Plan for each project. All supporting extramural agreements
that are identified in project Research Plans assume the category of the
project. The choice of category has implications for review and approval
of project products, as well as, the retention of project records. At
WED, categories 1-2, would be scheduled as 501 or 507 (permanent
retention), while categories 3-4 would be scheduled as 503 with a 20
year retention. Through [periodic review of project
progress](http://wedcor.cor.epa.gov/pages/policy/Policy on Peer reviewed research plans 53003 joz-6-13.doc),
exploratory projects could be categorically elevated if preliminary
results show unexpected relevancy to the Agency or the public.

[]{#QAPPs .anchor}**2.4 Quality Assurance Project Plan (QAPP)**

**All** research is performed in compliance with an **approved**
**QAPP** ([[see EPA order 5360.1 A2 section
5.b.]{.underline}](http://www.epa.gov/quality1/qs-docs/5360-1.pdf)). The
types of research subject to this requirement include

1.  Characterization of environmental or ecological systems and the
    health of human populations;

2.  Direct measurement of environmental conditions or releases,
    including sample collection, analysis, evaluation, and reporting of
    environmental data;

3.  Development or evaluation of methods for use in the collection,
    analysis, and use of environmental data;

4.  Use of environmental data collected for other purposes or from other
    sources (also termed "secondary data"), including literature,
    industry surveys, compilations from computerized data bases and
    information systems, results from computerized or mathematical
    models of environmental processes and conditions;

5.  Mapping of environmental processes and conditions.

Any document that is supplemental (principally, SOPs) to the QAPP and
that defines or prescribes procedures that contribute to the quality of
data, is considered an integral part of the QAPP and therefore also
requires approval.

Since the implementation of the quality system is a management
responsibility, the appropriate research manager approves QA planning
documents. QAPPs are approved by branch chiefs and SOPs may be approved
by any manager designated by the branch chief. The QAM certifies that
the plans presented in the QAPP or SOP meet Agency standards.

Many good and useful ideas regarding research are not envisioned
[prior]{.underline} to experimentation and are therefore not included
initially in QAPPs or SOPs. When such creative ideas are conceived,
authority to implement them is given by the Project Leader and if the
new activity alters the QA procedures, a written note will be forwarded
to the QAM. This note will constitute an amendment to the applicable
QAPP or SOP and will be reviewed and then added to the appropriate
document.

**Exceptions** from having a QAPP may be authorized by the Branch Chief
with the concurrence of the QAM for preliminary work. Exceptions are
authorized for a designated time (normally less than 6 months) and are
typically authorized to evaluate a procedure or concept prior to writing
a QAPP. Request for exemption is submitted in a memo from the Project
Leader, thru the Branch Chief, to the QAM. It contains an explanation of
the intended work, reasons for wanting an exemption, requested period,
and appropriate signatures. If needed, in a timely manner the QAM will
remind the PL of an impending, exception expiration.

[go to Table of Contents](#Table_of_Contents)

**Conditional approval** may be granted for research to begin on a
limited basis while non-critical deficiencies in the QAPP are being
resolved.

**Projects involving measurement** of environmental parameters are
organized according to Agency policy. The requirements are contained in
[[EPA Requirements for QA Project Plans
(QA/R-5)]{.underline}](http://www.epa.gov/quality1/qs-docs/r5-interim-final.pdf)
and guidance for writing in [[Guidance on Quality Assurance Project
Plans
(G-5)]{.underline}](http://www.epa.gov/quality1/qs-docs/g5-final.pdf).
Abbreviated guidance and some examples are contained in [[Appendix
3]{.underline}](#Appendix_3) of this QMP for writing QAPPs at WED.
Format is less important than the utility of a QAPP. If the suggested
format compromises the usefulness, each author can feel constrained by
the latter as long as all elements needed to specify quality are
included.

**Projects [not]{.underline} involving measurement** of environmental
parameters follow the same general format with modifications specific to
the type of activity. These, generally, modeling projects may be the
basis for important decisions and, although they do not generate new
data, attention to the origin and quality of data used in environmental
evaluation is vital. The QAPP directs the attention of scientists
towards explaining the limits or constraints of assumptions and the
inherent error associated with data transformations. Some models allow
error propagation while others may suggest sensitivity analysis as a
method of evaluating error. There is included a discussion of whether
the results are expected to be quantitative, comparative, or heuristic.
QAPP guidelines for model development can be found in [Guidance for
Quality Assurance Project Plans for Modeling (EPA
QA/G-5M)](http://www.epa.gov/quality/qs-docs/g5m-final.pdf) and an
outline of modeling project QAPP components are found in [Appendix
4](#Appendix_4).

[]{#SOPs .anchor}**2.5 Standard Operating Procedures**

These documents may be prepared at any time for any routine activity.
Branch management approval (may be delegated by the branch chief to the
project leader) and QAM certification is required for all procedures
that define activities that contribute to the quality of data. When
approved, the SOP can be referenced by any QAPP and thus functionally
becomes a part of that plan. Active SOPs are certified as being
implemented as written through the use of the [Biennial SOP Review
Form](#Biennial_review_form) by PLs/PIs/WACORs at the beginning of new
projects or work assignments. This form is also used for the biennial
review of SOPs used in ongoing projects.

The format for organizing a SOP includes the 12 section topics found in
[Appendix 5](#Appendix_5). SOPs are

written in sufficient detail to be used as a method by the persons
performing the procedure.

[]{#ORD_wide_QA_policies_procedures .anchor}**2.5.1 ORD-wide QA/QC
Policies and Procedures**

As these policies and procedures are
[developed](#ORD_Policies_Procedures_Manual), WED will adopt them to
ensure consistency across ORD in the implementation of best practices to
facilitate cross-organization cooperation. These may address topics such
as standardized procedures for the use of notebooks, qualification of
secondary data, minimum standards for measurement laboratory operations,
or others.

[]{#Assessnents .anchor}**2.6 Assessments**

[Technical systems assessments](#TSA) (TSAs) are the principle
assessment tool used at WED. TSAs document the degree to which the
procedures and processes specified in an approved QAPP are being
followed. Quality systems assessments (QSAs) are performed by the
Quality Staff of the Office of Environmental Information (OEI) to
document the adherence of WED personnel to this Quality Management Plan.
QSAs and that prescribed by the Agency Policy Directive, *Assuring the*

[go to Table of Contents](#Table_of_Contents)

*Competency of EPA Laboratories* are done triennially by individuals not
associated with NHEERL or WED. These and other assessments are more
fully addressed in [Section 9, Assessment and
Response](#Assessment_Response).

[]{#QAARWP .anchor}

**2.7 Quality Assurance Annual Report and Work Plan (QAARWP)**

This report to WED management from the QAM in October is about QA
activities for the current fiscal year, setting goals for the following
year and recommending revisions to the QMP that reflect current
practices. This management approved Division QAARWP is forwarded to the
NHEERL DQA for incorporation in the NHEERL QAARWP which is approved by
the NHEERL Deputy Director for Management before submission to the
Office of Environmental Information.

[]{#Products .anchor}

**2.8 Review of Products**

All products resulting from research at WED receive peer reviews
following the Agency's [Standard Operations Procedures for Technical
Information
Management](http://www.nheerl.epa.gov/administration/tim/tim_sop.pdf)
and [ORD Clearance Procedures (and
Form)](http://p2626xoray001/pages/forms/Publications/ORD-362.doc). In
addition to the responsibility to review EPA reports, the WED QAM,
because of his scientific background, provides a technical review of all
other products. Most manuscripts result from research described in an
approved QAPP. The relationship of the subject matter to the appropriate
QAPP is specified on the ORD Clearance form. If the manuscript is
unrelated to a QAPP or is disassociated from data (i.e., position paper,
editorial, etc.), an explanation is provided on the Clearance form.
Completed clearance forms accompany manuscripts when submitted to the
QAM for review.

Each WED Agency report (i.e., non-journal article) containing
environmental data contain a readily-identifiable section that discusses
data quality and any limitations on the use of the data with respect to
the original intent. The purpose of this section is to minimize the
possible misuse of data for other purposes. This requirement follows
from section 2.5.1 of the [EPA Quality Manual for Environmental
Programs.](http://www.epa.gov/quality1/qs-docs/5360.pdf)

[]{#Extramural .anchor}**2.9 Requirements for Extramural Research**

Contracts, cooperative agreements (COOPs) and interagency agreements
(IAGs) are exercised by WED to directly support or complement its
research goals. As with intramural research, COOPs and IAGs can only
commence sampling or working with environmental data with approved QAPPs
in place. Requirements for the documentation of extramural quality
systems can be found in the Higher-level Contract Quality Requirements
section of the [Contracts Management
Manual](http://epawww.epa.gov/oamintra/policy/cmm.pdf) (Chapter 46) and
various [Federal Acquisition
Regulations](#federal_acquisition_regulations). Specific quality system
requirements are identified in the Quality Assurance Review Form that is
filled out by each project officer (PO), work assignment contracting
officer representative (WACOR), or Task Order Project Officer (TOPO)
during the solicitation phase of these procurements. This form is
completed in consultation with the QAM. POs, WACORs and TOPOs receive
training specific to their QA responsibilities in managing these
extramural activities. Since one Federal agency can not impose its
requirements on another, the QA/QC controls for IAGs are negotiated
among the QA staff and PIs and POs of the agencies.

[go to Table of Contents](#Table_of_Contents)

[]{#qualification_training .anchor}**3. PERSONNEL QUALIFICATIONS and
TRAINING**

Branch Chiefs are responsible for assuring that each employee has the
necessary qualifications and job proficiency for assigned work. This
typically includes formal education in a scientific discipline,
on-the-job experience and off-site training by instrument vendors.

To assure that all division scientific management and staff have a
uniform knowledge of QA policies and procedures all newly hired
scientists will attend a presentation covering QA orientation,
recordkeeping, planning documents, operating procedures, and audits.
Every 3 years all scientific staff will attend a QA refresher session.

In addition to the training required to administer extramural projects,
POs, WACORs and TOPOS will be trained in the QA requirements of these
contracting roles and the use of the [Quality Assurance Review form
(QARF)
WED-26](http://wedcor.cor.epa.gov/pages/forms/qa/QARF_for_NHEERL.doc).
This form is used for contract, cooperative agreements and interagency
agreement solicitations, as well as contract amendments and incremental
funding actions.

The QAM at WED is required to be an experienced scientist who is trained
in subjects relating to environmental science. All scientists and
technical support staff are expected to be familiar with WED and Agency
QA policies in facilitating the research effort. Training at the project
and division levels is vigorously pursued as time and funds are
available.

[]{#Procurement .anchor}**4. PROCUREMENT of ITEMS and SERVICES**

[]{#COOPs .anchor}**4.1 Cooperative Agreements, Interagency Agreements,
Contracts**

Since **all** research is performed in compliance with an approved QAPP,
prospective applicants for WED assistance are sent a copy of the WED QMP
so they understand the extent of planning expected. A special condition
of any funding vehicle for research, analysis, or sample collection
includes a statement stipulating that no research can begin until a QAPP
has been approved.

At the discretion of the EPA PL/PO, a QAPP may be required as part of
the proposal or be required only from successful applicants. However, as
a minimum, [all]{.underline} proposals will include a QA capability
statement or institutional QMP following the *Respondent Requirements*
outline (page 3 of the
[QARF](http://wedcor.cor.epa.gov/pages/forms/qa/QARF_for_NHEERL.doc)).
In general, the QA capability statement is a qualitative statement of
the offeror\'s QA/QC capabilities, whereas the QAPP provides a
quantitative discussion. The Project Leaders specify the timing and
level of QA documentation in the QARF that is included in solicitation
and funding packages.

Following the Higher-Level [contracting requirements](#Higher_level) for
[all]{.underline} solicitations (contracts and COOPs) for which greater
that 15% of the expenditure is involved in the collection/use of
environmental data (i.e., most all of WED's extramural activities), WED
requires that QA/QC will be included among the technical evaluation
criteria. These criteria are listed in the RFP. The responding
organizations' QAPPs and/or QA capability statements/QMPs submitted with
their proposals will be the basis for the QA part of the evaluation.

Agency guidelines recommend that at least five (5) percent, and not more
than thirty (30) percent, of the total possible score be based on QA
criteria. The PLs/POs specify in the QARF the percent of evaluation
points applicable to QA.

[go to Table of Contents](#Table_of_Contents)

The PO, WACOR, or TOPO completes and submits a QARF with the request for
funding. Each Contract, COOP or IAG funding action package is reviewed
by the QAM to determine conformance with Division and Agency policy. For
continuation or incremental funding of ongoing projects, the QAM
evaluates evidence of compliance with an approved QAPP. The evidence
includes QA and assessments reports, notes from the project leaders or
project officers, manuscripts, performance evaluations, etc.

[]{#Work_Assignments .anchor}

**4.2 Work Assignments and Task Orders**

Technical support for WED research conducted by non-Student Services,
onsite contracts is directed by work assignments (WA), or task orders
(TO). Although the contracting organization must have a QMP that
describes their corporate commitment and policy regarding quality ([[EPA
ORDER 5360.1 A2 May 5,
2000]{.underline}](http://www.epa.gov/quality1/qs-docs/5360-1.pdf)),
authorization to conduct technical support activities is based on the
approved QAPPs. A WA or TO may assign work on one or many projects. The
[QARF](http://wedcor.cor.epa.gov/pages/forms/qa/QARF_for_NHEERL.doc) is
used to identify the projects involved and includes the WACOR or TOPO's
signature indicating that all QA/QC requirements are being met on all
projects involved. The QAM reviews the status of project approval,
required reports, manuscripts, and correction of any findings from
assessments and, if complete, certifies that the projects are in
compliance with QA requirements and work may begin.

[]{#Documentation_Records .anchor}**5. DOCUMENTATION and RECORDS**

[]{#Records_Management .anchor}**5.1 Records Management**

Records management policy is established by the Office of Environmental
Information and documented in the U.S. EPA Directive 2160 --- [Records
Management Manual](http://www.epa.gov/records/policy/2160/). This policy
applies to all records regardless of media (including paper, microform,
electronic, audiovisual, and record copies of Agency publications).
Number range CHAPTERFollowing this and other EPA Directives ensures
compliance with all statutory, contractual and assistance agreement
requirements for records from environmental programs and provides
adequate preservation of key records necessary to support the mission of
WED. The designated Records Liaison Officer at WED is the QAM.

To facilitate the minimum 20-year retention of these key records, WED
scientists will use uniquely numbered, case-bound notebooks with tables
of contents and pre-numbered archival quality pages to document their
project-specific research/laboratory activities. GSA "Green" record
books will continue to be used for various instrument logbooks, as will,
three-ring binders for pre-printed routine field and laboratory forms,
and instrument print outs. []{#notebook_review .anchor}Periodically the
project leaders will review the content of project notebooks for
legibility, accuracy and completeness, and will document the review in
each notebook's table of contents. A list of the owners of numbered
notebooks will be maintained by the QAM/RLO and will be available to PLs
for cross referencing.

Number range CHAPTERIt is WED's policy that all research projects
conducted or sponsored by WED will have adequate and proper
documentation in a manner that is consistent with the project file
contents specified in EPA [Records Disposition Schedules 501 and
503](http://www.epa.gov/records/policy/schedule/sched/501.htm). Project
files contain documentation related to the formulation and approval of
the research plan, the selection of the research methodology,
questionnaires, quality assurance project plans, [raw data]{.underline},
laboratory notebooks, project-related correspondence, copies of interim
reports showing data tabulation results and interpretations, copies of

[go to Table of Contents](#Table_of_Contents)

final reports/manuscripts, peer reviews, and quality assessments. This
documentation is intended to

ensure the defensibility of project results and facilitate the
reconstruction or reanalysis of underlying data. [Complete]{.underline}
project files from COOPs and IAGs are to be transferred to EPA at their
close.

WED maintains an on-site storage area for boxes of archived records that
are awaiting disposition. The content of these boxes is listed in a
Lotus Notes based database, "WED Archived Records" and is submitted to
the database by the record creator using form
[WED-24](http://wedcor.cor.epa.gov/pages/forms/OtherForms/WED-24Revision1-06.doc).

[]{#Document_Control .anchor}**5.2 Document Control**

QAPPs and SOPs are prepared and maintained under a document control
system that uniquely identifies documents and their versions. Following
NHEERL's identification convention the following sequence of codes will
be incorporated into all new QAPPs and SOPs:

SOP-NHEERL/WED/RCB/PI/05-02-001 3/20/2006

where:

SOP indicates the type of document

NHEERL/WED/RCB identifies the laboratory, division and branch

PI would be the initials of the principal author, generally a PI

05 indicates the year of the origin of this SOP

02 indicates that this was the second SOP authored by this individual in
2005

001 indicates that this is the first [revision]{.underline} (the
original would be 000)

March 20, 2006 is the date of this version

**Record copies** of QAPPs and SOPs, along with assessment reports,
progress reports, and communications regarding QA are kept by the
Project Leaders. These project records are to be in a project file that
contains documentation related to the formulation and approval of the
Research Plan, the QAPP, raw data (or lists of full paths to electronic
data files), correspondences, final reports, etc. These folders are
identified by the appropriate Records Schedules that correspond to the
type of research in them. For example, regulation supporting
([501](http://www.epa.gov/records/policy/schedule/sched/501.htm) ,
permanent retention), basic exploratory
([503](http://www.epa.gov/records/policy/schedule/sched/503.htm) , 20
years retention) and air and water criterion supporting
([507](http://www.epa.gov/records/policy/schedule/sched/507.htm) ,
permanent retention)

**Electronic copies** of WED's QA records are organized using a
Microsoft ACCESS database. Copies of approved Project Plans, QAPPs and
SOPs, assessment reports, manuscript reviews, and the approval of
funding packages are maintained in the database. The database provides
for creating and maintaining a record of receipt, assignment, decisions,
and return of each of the documents received. Database features provide
flagging various documents for follow-up such as the [biennial
review](#Biennial_review_form) of SOPs, or reminder to PI of a promised
document review. Read-only access to the database system is available to
anyone on the local area network. Access is provided to current and
previously used SOPs in the database through WED's [intranet
site](http://p2626xoray001/pages/QA/QApage.htm).

The database and the documents that it links to are located on a network
server. Both are backed-up daily to tapes that are kept off-site for 6
months. Monthly, the database and the linked documents are copied to
DVD. These procedures ensure WED's QA database and documents are
protected from permanent corruption and that if any computer problem
occurs, only work from the preceding day may be lost.

[go to Table of Contents](#Table_of_Contents)

Copies of finalized QA documents (QAPPs, SOPs) are requested in a
computer format, and signed approval pages are scanned and pasted into
the electronic versions maintained through the database.

WED quality management plans are kept as PDF files in the QA database
for 10 years following the approval of a more recent version (Records
Schedule 185). The current version will be available from WED's
[intranet site](http://p2626xoray001/pages/QA/QApage.htm).

[]{#Computer_stuff .anchor}**6. COMPUTER HARDWARE and SOFTWARE**

The Information Technology (IT) Coordinator is responsible for ensuring
that WED's computer practices are in compliance with Federal Government
security protocols as well as Agency-wide IT policies, procedures, and
guidelines. This individual is the TOPO for the on-site IT contract.
Contractor performance is evaluated semi-annually on its adherence to
these Agency and Government procedures.

[]{#Hardware_Software .anchor}**6.1 Hardware and Software**

The division computing environment is comprised of over 300 Windows
based personal computers as well as Linux and UNIX workstations. These
computers are connected to various centralized file

servers and telecommunications devices to make up the division Local
Area Network (LAN) that is part of the EPA Enterprise Wide Area Network
(WAN).

The Enterprise Operations Center (EOC) is responsible for ensuring
strict adherence to agency standards for hardware and software. Agency
security protocols are also monitored by the EOC.

The following web sites provide more detailed information regarding
computer architecture, IT policy and security.

<http://intranet.epa.gov/architec/index.html>

<http://cfint.rtpnc.epa.gov/otop/policies/directives.cfm>

<http://intranet.epa.gov/itsecurity/>

While these policies do not address computers that operate in
conjunction with scientific instrumentation, some of WED's scientific
instruments are on the LAN and the data from those that are not are
routinely copied and archived to optical disks.

[]{#Software_Development .anchor}**6.2 Software Development**

Software (including SAS, VisualBasic, Access, and other procedures) that
is developed on-site by EPA staff and the IT contractor follow best
practices in quality control, such as [IEEE
standards](http://standards.ieee.org/software/) and [IBM Rational
Unified Process®](http://www-306.ibm.com/software/awdtools/rup/),
respectively. Implementation quality is ensured by the procedures used
during code development, such as using a version control system,
establishing procedures for bug tracking and resolution, verifying the
lab-wide file backup procedures, and by testing the models. Geospatial
databases developed at WED follow [Federal Geographic Data
Committee](http://www.fgdc.gov/) standards when applicable.

[go to Table of Contents](#Table_of_Contents)

[]{#planning .anchor}**7. PLANNING**

WED develops research projects that are aligned with the results of EPA
and ORD planning processes such as the multi-year plan. Two planning
documents are required for all projects before the collection of data or
research activity can begin. These are

> A peer reviewed **Research Plan** that documents the research
> activities to be performed and the resources needed to implement the
> plan. The form of this Research Plan can vary substantially depending
> on the type of research being conducted. ([WED policy
> 5300.2](http://wedcor.cor.epa.gov/pages/policy/Policy on Peer reviewed research plans 53003 joz-6-13.doc))
>
> A **Quality Assurance Project Plan** that documents the processes that
> assure data quality. (see [[Appendix 3]{.underline}](#Appendix_3) for
> content and format).

Research plans and QAPPs may be developed intramurally or by extramural
cooperators or contractors.

Scientific progress is regularly monitored by [division
management](http://wedcor.cor.epa.gov/pages/policy/peerreviewedresearchplans.htm)
and peer review.

When data are being used to select between two alternative conditions
(e.g., compliance or non-compliance with a standard), the Agency\'s
recommended systematic planning tool is the Data Quality Objectives
(DQO) Process. This system consists of the following steps and is
detailed in: [[Guidance for the Data Quality objectives Process E PA
QA/G-4]{.underline}](http://www.epa.gov/quality1/qs-docs/g4-final.pdf)

1)  State the problem

2)  Identify the decision

3)  Identify the inputs to the decision

4)  Define the boundaries of the study

5)  Develop a decision rule

6)  Specify tolerable limits on decision errors

7)  [Optimize the design for obtaining
    data](http://www.epa.gov/quality/qs-docs/g5s-final.pdf)

Most environmental research conducted at WED is associated with
identifying ecological concepts and patterns and describing ecosystem
relationships. Although the results of this research are critical to the
development of standards, regulations, and remediation policies, they
are rarely used to resolve a problem or define a level of action as may
be required at a hazardous waste or Superfund site. The steps outline in
the DQO process (G-4) are therefore not specifically required, however
the concepts discussed and the steps suggested to identify and clarify
goals and needed data quality are useful and are followed to the extent
applicable. The PI decides the data quality needed to adequately test
the proposed hypothesis. Consideration of available measurement
technology and costs often dictate the possibilities of data quality.

[]{#Implementation .anchor}**8. IMPLEMENTATION of WORK PROCESSES**

The Project Leader is responsible for ensuring adherence to all project
planning and procedural documents including the QAPP and supporting
SOPs. The QAPP includes a distribution list that identifies all who are
required to have a copy and who are expected to follow the procedures.
Copies of all SOPs identified in the QAPP are provided to those
implementing them. The Project Leader identifies new procedures that are
needed for the project and initiates the writing of new SOPs. The

[go to Table of Contents](#Table_of_Contents)

PL also initiates [biennial reviews](#Biennial_review_form) of SOPs to
verify that they are currently being applied as they are written. The PL
also reviews the QAPP annually to assess whether it reflects the current
practices and intent. If substantial differences are uncovered through
this process, revisions are submitted to the QAM for approval
concomitant with an incremental change in the version number and
effective date of the documents. The PL provides updated versions of
these revised documents to project personnel.

Through Performance Evaluations and other assessment tools, the PL can
obtain real-time feed back from project critical procedures through data
and assessment reports. These reports can identify short comings that
can be corrected early in the project, bringing the procedures into
compliance with the expectations delineated in the QAPP.

It is the Branch Chiefs' responsibility to ensure that all personnel
involved in the project are appropriately qualified, trained and
supervised. It is the PLs' responsibility to ensure that all project

personnel fully understand the project objectives, the technical and
QA/QC requirements of their part(s) of the project, and their roles and
responsibilities in the overall conduct of the project.

[]{#Assessment_Response .anchor}**9. ASSESSMENT and RESPONSE**

There are two principal means (Quality Assurance Assessments and the
Performance Evaluations) to determine compliance with a WED approved QA
program. These procedures are used to verify that

measurement systems are operating properly, to determine that data
quality is adequately documented, and to evaluate management of the QA
program.

[]{#Project_level .anchor}**9.1 Project-level Quality Assurance
Assessments**

These QA activities consist of a thorough on-site evaluation of a
research activity. Assessments can be used to evaluate the existence and
adequacy of all equipment, facilities, supplies, personnel, and
procedures that are either used directly for, or in support of, the
collection and interpretation of data. In addition, assessments are used
to evaluate the documentation associated with data quality indicators.
Assessments will be planned by the QAM with assistance from the Project
Leader. The

QAM has the lead responsibility for carrying out assessments.
Assessments are designed to complement the peer review process by
assuring that any QA issues that may affect the scientific credibility
of the data are brought to the investigator\'s attention. The QAM may
delegate this responsibility to project-independent EPA staff with
specialized expertise not held by the QAM.

Assessment scheduling depends on the size of the project, the project
duration, and the specified quality of the data. Projects in QA
Categories I and II will be assessed at least every two years and other
projects every three years. A Project Leader may request an assessment
based on information presented in project progress reports, results of
prior assessments, performance evaluations or other situations where
there is concern for the quality of data.

The following []{#Assessments_general .anchor}assessment tools are used
at WED:

> **Readiness reviews** are conducted before specific technical
> activities (e.g., sample collection, field work, and laboratory
> analysis) are initiated to assess whether procedures, personnel,
> equipment, and facilities are ready for environmental data to be
> collected according to the QAPP and identified SOPs.

[go to Table of Contents](#Table_of_Contents)

> []{#surveillance-1 .anchor}**Surveillance** is used to continuously or
> periodically assess the implementation of an activity or activities to
> determine conformance to established protocols or SOPs.
>
> []{#TSA .anchor}**Technical systems assessments** (TSAs) qualitatively
> document the degree to which the procedures and processes specified in
> the approved QAPP are being implemented.
>
> **Assessments of data quality** are conducted on previously verified
> data to determine how well the measurement system performed with
> respect to the data quality indicators and acceptance criteria
> specified in the QAPP.

[]{#Performance_Evals .anchor}

**9.1.1** []{#PE .anchor}**Performance Evaluations (PEs)**

This assessment tool is used by WED Project Leaders to test the ability
of a measurement system to obtain acceptable results. These are often
used for specific chemical analyses and use certified

reference materials, or may be interlaboratory proficiency testing
studies. They may be part of a pre-award evaluation or used throughout
the course of a project with results included in data reports.
Implementation and assessment of Performance Evaluations are the
responsibilities of the Project Leader. This assessment is based on the
comparison of PE sample results with control limits established in the
QAPP DQO statements to identify compliance or out-of-control conditions.

[]{#Division_wide .anchor}**9.2 Division-wide Quality Assurance
Assessments**

Implementation of the WED Quality Management Plan is evaluated every 3-4
years by OEI Quality Staff and every 3 years through Laboratory
Competency assessments performed by non-EPA personnel. Yearly, the
NHEERL DQA assesses adherence to the QMP through review of WED's QAAWRP,
Laboratory Competency and Quality Staff audit reports, and periodic
QSAs.

[]{#Assessment_Reports .anchor}**9.3 Assessment Reports**

[]{#Assess_reports_project_level .anchor}**9.3.1 Project-level**

These reports are submitted by the QAM to the EPA Project Leader,
through a Branch Chief. Written assessment reports will contain a
summary of the areas evaluated during the assessment, statement on novel
or good QA practices followed, and identification of problem areas.

When significant concerns are identified in the assessment report, the
Project Leader develop an action plan to correct any significant
deficiencies including a time frame in which to accomplish these
actions. A copy of the plan will be forwarded to the QAM, who will
monitor the corrective actions.

[Performance evaluation](#PE) reports by the Project Leaders summarize
results with a list of conclusions and recommended corrective actions.
These ongoing reports are kept by the Project Leader who follows up with
the analyst to address the identified corrections. Copies of these
reports are sent to the QAM.

[]{#Assess_reports_Division_wide .anchor}**9.3.2 Division-wide**

Upon completion of these assessments, written reports are prepared and
submitted to the Associate Director for Science of WED. Corrective
actions and recommendations are identified and the QAM oversees their
implementation.

[go to Table of Contents](#Table_of_Contents)

[]{#quality_improvement .anchor}**10. QUALITY IMPORVEMENT**

Even the most thoroughly thought out and reviewed projects are not
static, and the most well intentioned scientists and support staff may
be implementing their parts of a project incorrectly. It is through
periodic review of project plans and their QAPPs that Project Leaders
are able to redirect their research activities to respond to unexpected
findings and changes in priorities. Similarly, QSAs and the annual
review of WED's quality system and QMP through the QAARWP provide
mechanisms for identifying areas for improvement.

It is through the timely use of the various [assessment
tools](#Assessments_general) that WED Project Leaders and Principal
Investigators are able to detect procedural, implementation, and
training deficiencies. Through prompt responses to the reported findings
of these assessments the projects can be brought back on track.

[[]{#Web_based_References .anchor}go to Table of
Contents](#Table_of_Contents)

**REFERENCES**

**List of web addresses appearing in QMP**:

EPA ORDER 5360.1 A2 May 5, 2000 Policy and Program Requirements for the
Mandatory Agency-wide Quality System
[[http://www.epa.gov/quality1/qs-docs/5360-1.pdf]{.underline}](http://www.epa.gov/quality1/qs-docs/5360-1.pdf)

ANSI/ASQC E4-1994
[[http://qualitypress.asq.org/perl/catalog.cgi?item=T55]{.underline}](http://qualitypress.asq.org/perl/catalog.cgi?item=T55)

EPA Quality Manual for Environmental Programs
[[http://www.epa.gov/quality1/qs-docs/5360.pdf]{.underline}](http://www.epa.gov/quality1/qs-docs/5360.pdf)

[]{#ORD_Policies_Procedures_Manual .anchor}ORD Policies and Procedures
Manual, Chapter
13\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
[http://dcordhqapps1.epa.gov:9876/orma/policies.nsf/f536fba05d681a598525702600653e9c/bbe0316b92a235b38525710f0070e73f/\$FILE/13.1%20QA%20SOP.doc](http://dcordhqapps1.epa.gov:9876/orma/policies.nsf/f536fba05d681a598525702600653e9c/bbe0316b92a235b38525710f0070e73f/$FILE/13.1 QA SOP.doc)

EPA Guidance for the Data Quality Objectives Process E PA (QA/G4)
[[http://www.epa.gov/quality1/qs-docs/g4-final.pdf]{.underline}](http://www.epa.gov/quality1/qs-docs/g4-final.pdf)

EPA Requirements for QA Project Plans (QA/R-5)
<http://www.epa.gov/quality/qs-docs/r5-final.pdf>

EPA Guidance on Quality Assurance Project Plans (QA/G-5)
[[http://www.epa.gov/quality1/qs-docs/g5-final.pdf]{.underline}](http://www.epa.gov/quality1/qs-docs/g5-final.pdf)

NHEERL Quality Management Plan (QMP)
<http://www.nheerl.epa.gov/administration/qa/files/qmp05.pdf>

ORD Clearance form (EPA 362)......................
<http://p2626xoray001/pages/forms/Publications/ORD-362.doc>

Publication Review and Clearance Procedures.........
<http://www.nheerl.epa.gov/administration/tim/tim_sop.pdf>

Quality Assurance Review Quality form
(WED-26)\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
<http://wedcor.cor.epa.gov/pages/forms/qa/QARF_for_NHEERL.doc>

Institute of Electrical and Electronics Engineers
<http://standards.ieee.org/software/>

IBM Rational Unified Process for programming projects
<http://www-306.ibm.com/software/awdtools/rup/>

Federal Geographic Data Committee <http://www.fgdc.gov/>

[**Requirements for Extramural Research in sections of the Federal
Acquisition
Regulations:**](http://www.epa.gov/quality/exmural.html#fed-regs)

[]{#federal_acquisition_regulations
.anchor}(http://www.epa.gov/quality/exmural.html#fed-regs)

> **Universities, hospitals and other non-profit
> organizations**........................ [40 CFR Part
> 30](http://www.epa.gov/quality/qa_cfrs.html#40PART30)
> (http://www.epa.gov/quality/qa_cfrs.html#40PART30
>
> **Admin. Reqirem'ts for Grants and COOPs to State and Local
> Gov'ts**\...\...\...\...[40 CFR Part
> 31](http://www.epa.gov/quality/qa_cfrs.html#40PART30)
> (http://www.epa.gov/quality/qa_cfrs.html#40PART31)
>
> **State and Local
> Assistance**.............................................\...\...\...\...\...\........[40
> CFR Part 35](http://www.epa.gov/quality/qa_cfrs.html#40PART35)
>
> (http://www.epa.gov/quality/qa_cfrs.html#40PART35)

[]{#Higher_level .anchor}**Higher-level contract quality
requirements**\...\...\...\...\...\...\...\...\...\...\...\.....[FAR 48
CFR part
46.202-4](http://acquisition.gov/far/current/html/Subpart 46_2.html#wp1069847)
(http://acquisition.gov/far/current/html/Subpart%2046_2.html#wp1069847)

**Contracts Management
Manual**\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....[Chapter
46-QA](http://epawww.epa.gov/oamintra/policy/cmm.pdf)

http://epawww.epa.gov/oamintra/policy/cmm.pdf

[go to Table of Contents](#Table_of_Contents) **App**[]{#Appendix_1
.anchor}**endix 1**

**QA POLICY**

[[EPA Quality System Documents Requirements for EPA
Organizations]{.underline}](http://www.epa.gov/quality1/qa_docs.html#EPArqts):
(http://www.epa.gov/quality1/qa_docs.html#EPArqts)

This web address provides a list and current status of EPA requirement
and guidance documents. It also provides links to the current versions.

[[EPA Order 5360.1 A2 (May 5,
2000)]{.underline}](http://www.epa.gov/quality1/qs-docs/5360-1.pdf)

(http://www.epa.gov/quality1/qs-docs/5360-1.pdf)

Policy and Program Requirements for the Mandatory Agency-Wide Quality
System. This is the primary instruction upon which all EPA QA programs
are based.

[[EPA Manual 5360 A1 (May
2000)]{.underline}](http://www.epa.gov/quality1/qs-docs/5360.pdf)

(http://www.epa.gov/quality1/qs-docs/5360.pdf)

EPA Quality Manual for Environmental Programs defines program
requirements for EPA organizations in implementing the mandatory Quality
System defined in 5360.1 A2. Equivalent specifications are defined in
Requirements Documents for organizations receiving financial assistance
from EPA through extramural agreements.

[[Requirements for non-EPA
Organizations]{.underline}](http://www.epa.gov/quality1/qa_docs.html#noneparqt):
(follow this link to all requirement documents listed below)

(http://www.epa.gov/quality1/qa_docs.html#noneparqt)

Quality requirements for non-EPA organizations are defined in the Code
of Federal Regulations and the Quality Staff in OEI have issued
documents to provide information on satisfying the Federal Regulations.
These documents contain policy statements that identify and discuss
mandatory elements of the Agency\'s Quality System for organizations
receiving financial assistance from EPA through extramural agreements
(e.g., contracts, grants, cooperative agreements, and interagency
agreements). These documents may be used by EPA organizations as well.

> EPA Requirements for Quality Management Plans (QA/R-2)
>
> EPA Requirements for QA Project Plans (QA/R-5

[[Guidance for Implementing
Requirements:]{.underline}](http://www.epa.gov/quality1/qa_docs.html#guidance)
(follow this link to all guidance documents listed below)

(http://www.epa.gov/quality1/qa_docs.html#guidance)

The Quality Staff also issues documents to assist in the development and
implementation of a suitable Quality System for both EPA and non-EPA
organizations.

> Guidance for the Data Quality Objectives Process (G-4)
>
> Decision Error Feasibility Trials (DEFT) Software (G-4D)
>
> Guidance for the Data Quality Objectives Process for Hazardous Waste
> Sites (G-4HW)
>
> Guidance on Quality Assurance Project Plans (G-5)
>
> Guidance on Sampling Designs to Support QA Project Plans (G-5S)
>
> Geospatial Data Quality Assurance Projects (G-5g)
>
> [go to Table of Contents](#Table_of_Contents)
>
> Guidance on QA Project Plans for Modeling (G-5m)
>
> Guidance for the Preparation of Standard Operating Procedures (G-6)
>
> Guidance on Technical and Related Assessments (G-7)
>
> Guidance for Data Quality Assessment: Practical Methods for Data
> Analysis (G-9)
>
> Data Quality Assessment Statistical Toolbox - DataQUEST (G-9D)
>
> Guidance for Developing a Quality Assurance Training Program (G-10)

[[]{#Glossary .anchor}go to Table of Contents](#Table_of_Contents)
**Appendix 2**

**GLOSSARY**

The definitions listed below represent standard language to the extent
it is applicable. Exceptions are for the terms accuracy, completeness
and precision. Definitions found in other sources are generally
identical, but suggest that a mathematical presentation for the reverse
concept. In example consider the definition for precision that is
typically unambiguous and described by words similar to those presented
below. However, as a final sentence in the definition there is often a
statement requiring that the values of precision reflect standard
deviation expressed as the coefficient of variation (CV). Clearly the CV
describes the imprecision, not precision. We prefer to express the words
and values with similar connotations. The terms of accuracy and
completeness follow similar arguments.

[]{#accuracy .anchor}**Accuracy** - An indication of how close measured
values are to the true value. One manner of expressing this is as 100%
minus the % deviation (absolute value) from the true value.

> Accuracy
> $(\text{\%}) = (1\text{.}0 - (\frac{\sum_{}^{}{(|V_{t} - V_{m}|)}}{n}\frac{)}{V_{t}}) \ast \text{100}$
>
> where:
>
> *V~t~* is the true or standard value
>
> *V~m\ ~*is the measured value
>
> n is the number of measured values

Other mathematical expressions are also valid and are acceptable. Use of
the above absolute (based on %) scale hides the aspect of bias that may
be important information. Removal of the absolute signs will yield +
or - values that reveals bias as well as accuracy. If this practice is
used, interpretation of values greater than 100% is understood to be
less than accurate since, by definition, no value can be more than
perfectly accurate (i.e. 100%).

**Bias** - the systematic or persistent distortion of a measurement
process that causes errors in one direction (i.e., the expected sample
measurement is different from the sample\'s true value).

[]{#calibration .anchor}**Calibration** - To make adjustment (as in
adjusting an instrument to present the correct response to some
measurement). A calibration curve is often created by measuring
different known concentrations and plotting the known values against the
machine response. By applying the slope of such a curve to machine
outputs, the measurements are adjusted to yield calibrated values. Note
the difference between calibrating (making an adjustment) and making a
measurement and comparing the value with the know quantity of the
standard.

[]{#comparability .anchor}**Comparability** - The degree of confidence
with which two or more sets of data may be compared. Data comparability
is dependent upon consistency in sampling conditions, selection of
sampling procedures, sample preservation methods, analytical methods,
and data reporting units, throughout the project, and with the previous
projects with which these results will be compared. All these factors
are qualitative and hard to measure. Comparability of data is generally
best described in a narrative statement that references the items listed
above.

[]{#completeness .anchor}**Completeness** - During experimentation or
monitoring, some samples may be impossible to secure, some measurements
may become lost, or be inaccurate because of malfunctioning equipment,
among

[go to Table of Contents](#Table_of_Contents)

other reasons. Completeness is the % of values available for evaluation.
The number of missing values influences the usefulness of the
statistical evaluation of the information and too many missing values
will, at some point, become unacceptable for the desired goals.

> Completeness (%) =
> $1\text{.}0 - (N_{e} - N_{o}\frac{)}{N_{e}}) \ast \text{100}$
>
> where:
>
> $N_{e}$ is the expected number of measurements for the study.
>
> $N_{o}$ is the number of measurements obtained.

[]{#precision .anchor}**Precision** - an indication of the similarity of
repeated analyses or sampling. A useful method of expression is as 100%
minus the coefficient of variation of repeated measurements.

> Precision
> $(\text{\%}) = (1\text{.}0 - \frac{\text{SD}}{\overline{X}}) \ast \text{100}$(%)
>
> where:
>
> *SD* is the standard deviation
>
> $\overline{X}$ is the mean
>
> Alternately, the coefficient of variation, CV,
> ($\frac{\text{SD}}{\overline{X}}$) may be used.
>
> The exact nature of the precision index is specified to eliminate
> possible confusion. For example, when the CV is used, smaller values
> are associated with greater precision and the index is therefore
> intuitively reversed.

When duplicate determinations are made, the relative percent difference
(RPD) may be calculated as:

> RPD
> $= |V_{1} - V_{2}\frac{|}{(}V_{1} + V_{2}\frac{)}{2}) \ast \text{100}$
>
> were:
>
> *V~1~* and *V~2\ ~*are the two values of a measurement.

**Quality Assurance (QA) -** an integrated system of management
activities involving planning, implementation,
[assessment](#Assessments_general), reporting, and quality improvement
to ensure that a process, item, or service is of the type and quality
needed and expected by the client.

**Quality Control (QC) -** the overall system of technical activities
that measures the attributes and performance of a process, item, or
service against defined standards to verify that they meet the stated
requirements established by the client.

[]{#representativeness .anchor}**Representativeness** - a measure of the
degree to which the data accurately and precisely represent a
characteristic of a population parameter, variation of a property, a
process characteristic, or an operational condition.

[]{#validation .anchor}**Validation** - confirmation by examination and
provision of objective evidence that the particular requirements for a
specific intended use are fulfilled. In environmental studies,
validation might include checking to determine if the samples within the
expected range of

[go to Table of Contents](#Table_of_Contents)

concentrations or behaviors. In design and development, validation
concerns the process of examining a product or result to determine
conformance to user needs.

[]{#verification .anchor}**Verification** - confirmation by examination
and provision of objective evidence that specified

requirements have been fulfilled. In analytical processes this would
include results from various QC operations, such as, blanks, sample
replicates, certified reference materials, etc. In design and
development, verification concerns the process of examining a result of
a given activity to determine conformance to the stated requirements for
that activity.

For more definitions see:

> [[EPA Quality Manual for Environmental Programs. May
> 2000.]{.underline}](http://www.epa.gov/quality1/qs-docs/5360.pdf)
> Appendix A, Terms and Definitions.

[[]{#Appendix_3 .anchor}go to Table of Contents](#Table_of_Contents)
**Appendix 3**

**PREPARING QUALITY ASSURANCE PROJECT PLANS**

Agency policy regarding QAPP development will be followed at WED as
contained in: [[EPA Requirements for QA Project Plans
(QA/R-5)]{.underline}](http://www.epa.gov/quality1/qs-docs/r5-interim-final.pdf)
and guidance for writing is in: [[Guidance on Quality Assurance Project
Plans
(G-5)]{.underline}](http://www.epa.gov/quality1/qs-docs/g5-final.pdf).
An abbreviated guidance with suggested outline is contained below:

**[Graded Approach](#graded):** WED recognizes that a "one size fits
all"approach to quality requirements for research does not work. The
level of detail in the QAPP will vary according to the nature of the
work being performed and the intended use of the data.

Each project will be assigned a category according to the criteria
listed in Section 2.3.

**Exemptions:** It is recognized that under some circumstances it is
necessary to conduct preliminary experiments or range finding tests to
facilitate appropriate experimental design that will form the basis of a
QAPP. It is also obvious that for some low cost purchase orders or
COOPs, the cost of developing a QAPP is disproportionate to the task.
Other projects that consist entirely of developing a policy or reviewing
an area of science may make writing a QAPP useless. Request for
exemption are submitted in a memo from the project leader, thru the
branch chief, to the QAM. It contains:

1.  explanation of the intended work

2.  reasons for wanting an exemption

3.  requested period

4.  appropriate signatures.

**Inclusions:** Any document that is supplemental to the QAPP and that
defines or prescribes procedures that contribute to the quality of data,
is considered an integral part of the QAPP and therefore requires the
same management and QA approval as for the QAPP. This typically includes
SOPs, and amendments and alterations to the QAPP.

**Format:** The same format is used for all (in-house, extramural,
experimental, analytical, modeling, data manipulation, etc.) projects
sponsored by WED. It is obvious that not all sections apply equally to
all types of projects. Thus, when a section is irrelevant, a simple note
is included that indicates that it is not applicable with a simple
explanation.

The recommended format presented in this Appendix allows different
approaches to the development of QAPPs. For a simple project, the QAPP
may contain the entire set of instructions needed to complete a project.
For a complicated, extensive project, the QAPP may be composed of a
summary of goals, management, organization, and any other portion that
lends itself to a general treatment, with reference to associated SOPs
in [Appendix 5](#Appendix_5) that detail the procedures for various
tasks. The advantage of the latter approach is that the QAPP is
conveniently divided into manageable portions, that can be added or
amended as different tasks are added.

The development or application of **mathematical models** and the use of
**pre-existing data** garnered from the literature, databases, or
archived files, presents unusual problems in describing the procedures
for quality assurance. [Appendix 5](#Model_QAPP) shows an outline of the
types of modeling activities that are appropriate for the generic QAPP
elements that must be

[go to Table of Contents](#Table_of_Contents)

addressed. Again, if a particular activity is not used, don't include
it, but do consider them all, as this list comes from the Agency's
guidance document for modeling project QAPPs: [Guidance on QA Project
Plans for Modeling (EPA/QA G-5m) (EPA, 2002e) and Guidance on Geospatial
Data Quality Assurance Projects (EPA/QA G-5g) (EPA,
2002d).](http://www.epa.gov/quality1/qa_docs.html)

**QAPP Format and Content**

The QAPP must be composed of the following four standardized,
recognizable elements covering the entire project from planning, through
implementation, to assessment. **Sub-element s may be combined, or not
addressed by stating: "Not Applicable because...."**.

A.  **Project Management**

B.  **Measurement/Data Acquisition**

C.  **Assessment/Oversight**

D.  **Data Validation and Usability**

**Document control:**

Each page will have a footer containing:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Short Title** **Page 1 of xx**

**QAPP-NHEERL/WED/RCB/LW/05-02-001 3/20/06**

This is the first revision (original=000) as of March 20, 2006 of the
second (02) QAPP written in 2005 by Lidia Watrud in the Risk
Characterization Branch.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**A. PROJECT MANAGEMENT**

This group of QAPP elements covers the basic area of project management,
including:

> A1 [Title and Approval Sheet](#QAPP_title_page)
>
> A2 [Table of Contents](#QAPP_table_of_Contents)
>
> A3 [Distribution List](#QAPP_distribution_list)
>
> A4 Project/Task Organization
>
> A5 Problem Definition/Background
>
> A6 Project/Task Description
>
> A7 Quality Objectives and Criteria for Measurement Data
>
> A8 Special Training Requirements/Certification
>
> A9 Documentation and Records

[go to Table of Contents](#Table_of_Contents)

**A4. PROJECT ORGANIZATION:** Present a brief introduction describing
the need for the research, how this work relates to previous work, and
the context of the project in relation to accepted knowledge and
practice (literature review). An extensive introduction presumably
already exists in the proposal or Research Plan that was intended to
convince the reader of the need and worthiness of this project. Please
don't copy that introduction, but rather make this brief, but sufficient
for the reader to understand why the work is important.

> **Goals:** List the goals of the project. This section is also not
> intended to be a treatise of the research, nor a justification for
> work, but a simple statement of goals so that the reader can
> understand how the methods match the intended results. Project
> deliverables and a schedule for their completion should be agreed upon
> between the Principal Pnvestigator and the Project Leader and stated
> in this section.
>
> **Organization:** Explain the QA organization of the project. Identify
> all project participants (especially the PI(s)) and their roles and
> responsibilities for all planned tasks. Identify lines of project
> responsibility for each task or group of measures. Subcontractors are
> included in the description. A flow chart may be a useful way of
> presenting the lines of responsibility.

**A7. DATA QUALITY OBJECTIVES:** DQOs establish the data user's
requirements for [precision](#precision), [accuracy](#accuracy),
[completeness](#completeness),
[representativeness](#representativeness), and
[comparability](#comparability). There are two forms for developing
DQOs: the first is primarily for research and the second is a more
formal process for monitoring or research done specifically to support
an EPA regulatory decision. WED research falls mainly within the first
type and this outline presents only the short form for research. The
formal DQO process is presented in the EPA guidance document [[(Guidance
for the Data Quality Objectives Process
(G-4)]{.underline}](http://www.epa.gov/quality1/qs-docs/g4-final.pdf)
and includes a description of when it should be used.

> One method to determine the required data quality objectives (DQOs) is
> to make a list of all measurements needed to answer the questions
> posed in the research. Determine the level of precision, accuracy, and
> completeness needed to accomplish your goals. This can often be
> presented in a table format (example [Table 1](#Table_1)). It is
> important to remember that the values presented as your data quality
> objectives will be the standards for evaluating the data collected.
> Make sure that the DQOs reflect the needs of the project and are not
> too restrictive or too lax. Remember that the DQOs may be changed if
> in the course of the project you have been too optimistic regarding
> your measurement ability or that your analysis requires greater
> precision, accuracy or completeness.

**B. MEASUREMENT / DATA ACQUISITION**

This group of QAPP elements covers all aspects of measurement systems
design and

implementation, including:

> B1 Sampling Process Design (Experimental Design)
>
> B2 Sampling Methods Requirements
>
> B3 Sample Handling and Custody Requirements
>
> B4 Analytical Methods Requirements

[go to Table of Contents](#Table_of_Contents)

> B5 Quality Control Requirements
>
> B6 Instrument/Equipment Testing, Inspection, and Maintenance
> Requirements
>
> B7 Instrument [Calibration](#calibration) and Frequency
>
> B8 Inspection/Acceptance Requirements for Supplies and Consumables
>
> B9 Data Acquisition Requirements (Non-direct Measurements)
>
> B10 Data Management

**B1. STATISTICAL RESEARCH DESIGN:** The selection of an appropriate
research design for specific objectives is a crucial step in optimizing
available resources and in determining the success and applicability of
a study, whether data are developed or existing data are used. The
number and kind of factors controlled or observed, the pattern of
randomization, and the extent of sample and analytical replication in a
study determine what hypotheses are testable, whether relationships can
be fit, the precision of estimates, and the range of conditions over
which inferences may be made. A statistical research design focuses on
specific objectives, but in so doing, may limit the application of the
results. No research design has universal application.

Projects designated as \"range finding\" will follow the same tenets.
However, range finding projects may require deviations that must be
documented in writing and caveated appropriately during the planning
phase.

**B2. SAMPLING:** For each sample type, describe sampling methods and
analytical procedures. Many procedures lend themselves to description as
standard operating procedures, a practice recommended when it will
clarify and compartmentalize description of specific tasks. When an SOP
is used, reference in this section should direct the reader to its
location. Help in sampling design will be available in the near future
as an EPA document: [[Guidance on Sampling Designs to Support QA Project
Plans (G-5S).]{.underline}](http://www.epa.gov/quality1/qa_docs.html)

Methods

Describe procedures for selecting, collecting and handling samples. Many
of these items can be most effectively presented in tables (example
table 2) or lists, other items need a more detailed presentation. Make
certain that sufficient information is presented to clarify the
procedure and allow judgment of appropriateness and completeness. Some
of the items that should be considered are listed below:

-   What rules are used to select sampling points and frequencies?

-   What procedures are to be used in collecting samples? This may
    include decontamination of sampling implements, identification of
    temporal and spatial conditions of the sample, corollary information
    (weather conditions, slope, etc.) that identify the sample in a
    manner meaningful to the goal of the experiment.

-   Preparation of sample containers

-   Specification of sample volumes

-   Preservation methods, maximum holding times.

-   Record keeping procedures. Attach field sampling data sheets, sample
    inventory forms, shipping forms, and any other forms used in this
    process.

-   Sample labeling

-   Sample handling, transportation and custody. This instruction is
    particularly important for monitoring studies that may become the
    basis for litigation or if samples will be analyzed by

[go to Table of Contents](#Table_of_Contents)

> different subcontractors or shipped. Discuss an approach for verifying
> sample receipt and evaluation of sample condition upon receipt,
> security within sample storage areas, and sample archiving (location,
> labeling). Identify how long samples are required to be stored after
> analysis and if samples should be stored after holding times are
> exceeded.

**B4. ANALYTICAL METHODS:** Describe the analytical procedures used for
each sample. If standard methods (i.e. methods described by American
Society of Testing Materials (ASTM) or American Public Health
Association (APHA), etc.) are used, provide a copy of the procedure as
an appendix. Analysis often depends on an instrument that measures some
parameter of the sample. A useful presentation can often be organized by
instrument although in some systems other approaches may be easier to
understand. When measurements don't depend on an instrument (i.e. bird
census determined by identifying bird songs along a prescribed transect)
use this heading to describe the process of measurement. Some of the
items that should be considered are listed below:

Instruments: Make a list of the instruments, the parameters measured,
and the inferences to be made. This list will clarify the measurement
procedure and be useful for the person making the measurements and the
person reviewing the plan. This may be presented in a table (example
table 3), a list or in paragraph format.

**B5. QUALITY CONTROL (QC)**: Describe the procedures used to evaluate
the instrument and the quality (precision and accuracy) of data being
collected. In most analytical systems, accuracy is determined by routine
and periodic measurement of standards and blanks. Describe the
procedures for introduction and evaluation of standards and blanks.
These procedures will differ between instruments and will vary from the
simple measurement of standard weights before and after each measurement
session to the insertion of blanks, blind replicates of samples, and
standard chemical preparations into a GC sample train. Describe how this
process will be accomplished and how the data will be compared to DQOs
and what rules will govern the acceptance, modification or rejection of
data. This presentation can often be facilitated by displaying some
information in tables (example table 5). These procedures should be
completed as quality control (QC) samples are analyzed. QA/QC data
should be stored in a format associated with the coincident data. An
easy way to accomplish this is to create an additional column (in a
spread sheet) or file (in a relational database) that will naturally
accompany the data collected from the session covered by the standard
measurements. Analytical precision is a considerably different thing
than sampling precision. Both should be known to evaluate an
environmental condition.

**B7. INSTRUMENT [CALIBRATION](#calibration):** The intent of this
section is to identify the needs and procedures for calibration.
Describe how and when the instrument will be calibrated (example table
4). Describe the traceability of the calibration standard to some
authenticated system and describe the procedure for maintaining
standards. It is important to distinguish the difference between
calibrating and checking accuracy. To calibrate an instrument is to
adjust the output so that the reading is accurate. For a balance, this
may be accomplished by adjusting the tension on a spring or adjusting a
potentiometer. For a spectrophotometer this may be accomplished by
making a standard curve of a dilution series and applying the
mathematical fit (calibration curve) to the measurements of unknown
samples. Some instruments need calibration frequently (i.e. a pH meter
is calibrated each time it is used), while others need calibration
rarely (i.e. a balance). Some instruments require calibration at several
concentrations. Often instrument detection limits determine the accuracy
of measurements at the extremes of instrument sensitivity. Although
values may be recorded by some instruments, those

[go to Table of Contents](#Table_of_Contents)

values may have no meaning if they fall outside detection limits. For
those measurement systems with either high or low limitations a
description of how to deal with values that fall outside acceptable
limits must be described *a priori*..

**B8. CONSUMABLES:** Where consumable items, such as solvents, standard
gasses, reagents, etc. are involved, discuss acceptability rules and
procedures used to inspect and evaluate.

**B10. DATA MANAGEMENT:** Trace data from collection to the final
report. This may include various steps such as: entry into field
notebook, transcription into computer spread sheet or database,
[verification](#verification), proof reading, outlier identification,
editing, analysis, report writing. Include identification of units, when
they change and how such changes are accomplished, (i.e., original data
may be captured as peak height from some detector, changed to quantity
based on a standard, changed to concentration by dividing by amount
injected into detector, changed into concentration of tissue by dividing
by mass of tissue in the sample, changed to concentration on area basis
by a regression of mass to area, and finally reported on the basis of
amount per hectare by another regression). The issue for QA is to
specifically identify each data transformation and justify the use of
auxiliary information when it is used to alter the values or the form of
presentation. Some modifications introduce additional error, such as the
error in measuring a second variable like area or mass. It is important
to propagate all errors associated with any data generated in the
laboratory or obtained from the literature.

Provide information on your computer system, method and frequency of
file back-up. Discuss how long sample data should be stored, by whom and
where.

**C. ASSESSMENT / OVERSIGHT**

This group of QAPP elements addresses the activities for assessing the
effectiveness of the

implementation of the project and associated QA and QC activities,
including:

> C1 Assessments and Response Actions
>
> C2 Reports to Management

**C1. ASSESSMENTS AND RESPONSE ACTIONS:** Identify the frequency, and
type of assessment activities for this project. Assessments include, but
are not limited to the following:

• [surveillance](#surveillance-1)

• peer review

• [performance evaluation](#PE)

• [assessments](#Assessments_general)

Describe the procedures that best serve this project and provide an
outline to implement the assessment activity. Explain how the project
will be internally reviewed and state how the results of your review
will be acted upon and documented.

The QAM has the responsibility to perform assessments of all projects
(except Performance Evaluations that are the Project Leader's). The
goals are to: (1) evaluate the implementation of the QAPP, and (2)
provide assistance regarding QA procedures. Assessments are often useful
prior to or

[go to Table of Contents](#Table_of_Contents)

at the commencement of sampling or analysis. Regular assessments should
be performed every two years or more frequently at the request of the
Project Leader. Include a proposed assessment schedule with
consideration of sampling and analytical periods and times when an
assessment would be disruptive (i.e. test week or vacation times). The
proposed schedule is intended only as a guide and assessment times will
be arranged by the mutual consent of the Project Leader and the QAM.

**C2. REPORTS TO MANAGEMENT:** This section should specify the frequency
of progress reports to EPA and define an approach to address project
QA/QC in the final deliverables. The QA portion of the progress reports
should address:

-   A summary of precision, accuracy and completeness for all samples
    analyzed.

-   Any problems that could affect the quality of the data collected,
    the project schedule or the completion of the project;

-   A summary of any corrective actions implemented and the result;

-   Changes in the project\'s experimental design, objectives, or
    staffing;

-   The need for additional equipment to achieve project objectives.

-   Identify any problems with equipment.

-   A summary of data quality evaluation (especially for modeling or
    data review projects).

**D. DATA VALIDATION AND USABILITY**

This group of QAPP elements covers the QA activities that occur after
the data collection

phase of the project is completed, including:

> D1 Data Review, Validation, and Verification Requirements
>
> D2 [Validation](#validation) and [Verification](#verification) Methods
>
> D3 Reconciliation with User Requirements

**D1.** []{#QAPP_D1_Data_Review .anchor}**DATA REVIEW, VALIDATION, AND
VERIFICATION REQUIREMENTS:** Describe procedures to periodically verify
and [document]{.underline} the acceptability of data generated by EPA
and/or contract support staff. These procedures would include review of
[project notebooks](#notebook_review) and prompt verification of
contractor data reports and deliverables. The frequency of these
activities would be highest during the initial implementation of
procedures and for those that produce project-critical data. State the
criteria used to review and validate data.

Provide examples of any forms or checklists to be used.

Identify any project-specific calculations required.

**UPDATES AND REVISIONS**

Many good and useful ideas regarding research are not conceived prior to
experimentation and are therefore not included in QAPPs or SOPs. Also,
because research is complex, changes to original QAPPs are sometimes
needed. The Project Leader is responsible to determine if an anticipated
change will impact the quality of the project. If a change is desirable,
the change should be submitted for approval through the same channel as
the original.

[go to Table of Contents](#Table_of_Contents) []{#QAPP_title_page
.anchor}**QAPP**

**FOR**

**PROJECT TITLE**

Assistance agreement number (extramural projects)

Project Leader:

Principal Investigator:

Institution:

**Project TITLE**

**Management Approvals:**

> Signature indicates that this QAPP is approved and will be implemented
> in conducting the research of this project.

Name\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
(Branch name) Branch Chief *Signature Date*

Name
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Project Leader and/or Officer *Signature Date*

Extramural **Project Managers and/or Principal Investigators**:[^1]

Signature indicates commitment to follow the procedures in this QAPP.

Name
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Principal Investigator *Signature Date*

**Quality Assurance:**

> Signature indicates that this QAPP meets the quality requirements of
> WED.

Bob Ozretich
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_­\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Quality Assurance Manager *Signature Date*

[[]{#QAPP_distribution_list .anchor}go to Table of
Contents](#Table_of_Contents) **Distribution List**

List the individuals and their organizations who will receive copies of
the approved QAPP and any subsequent revisions. Include all managers who
are responsible for implementing the plan, as well as the QA managers
and representatives of all groups involved.

[]{#QAPP_table_of_Contents .anchor}**TABLE of CONTENTS**

Cover Page i

Approval Page ii

Distribution List iii

Table of Contents iv

A. PROJECT MANAGEMENT 1

INTRODUCTION 2

Goals 2

Organization 3

DATA QUALITY OBJECTIVES 3

B. MEASUREMENT / DATA ACQUISITION 5

EXPERIMENTAL DESIGN 5

SAMPLING 5

Methods (list SOPs used) 5

ANALYSES 6

Instruments: (list SOPs used) 6

Quality Control 7

Consumables 7

Precision, accuracy, and completeness: 7

Corrective actions 7

Preventive maintenance 7

> DATA MANAGEMENT 8

C. ASSESSMENT/OVERSIGHT 8

ASSESSMENTS 8

Types, frequency and evaluation criteria used 8

OVERSIGHT 8

Expectations for corrective actions 8

D. DATA VALIDATION and USABILITY 9

Data review, verification and validation requirements 9

Verification and validation methods used 9

REFERENCES 10

[go to Table of Contents](#Table_of_Contents)

The following tables are presented as examples of one way to organize
and present some of the information in a QAPP. These tables should not
be regarded as a prescribed format since the appropriate format
necessarily varies with the type of research described.

[]{#Table_1 .anchor}Table 1. Data quality objectives

+--------------+----------+------------+--------+---------+----------+
| Parameter    | Mea      | Expected   | Ac     | Pr      | Comp     |
|              | surement | range      | curacy | ecision | leteness |
|              |          |            |        |         |          |
|              | units    | (units^1^) | (%)    | (%)     | (%)      |
+--------------+----------+------------+--------+---------+----------+
| Leaf mass    | g        | 0.5 - 2.0  | 98     | 98      | 95       |
| (dry)        |          |            |        |         |          |
+--------------+----------+------------+--------+---------+----------+
| Benzene      | g/ml    | 10 - 500   | 95     | 90      | 95       |
| c            |          |            |        |         |          |
| oncentration |          |            |        |         |          |
+--------------+----------+------------+--------+---------+----------+
| Soil         | C        | -20 to 40  | 95     | 95      | 100      |
| Temperature  |          |            |        |         |          |
+--------------+----------+------------+--------+---------+----------+

^1.^ Expressed in the same units as measured.

Table 2. Summary of sample collection, handling, and preservation
activities

  ---------------------------------------------------------------------------------
  Sample      Parameter(s)    Sample        Minimum    Preservation     Maximum
  Type^a^     Measured        Container     Sample     Method/Storage   Holding
                                            Size                        Time
  ----------- --------------- ------------- ---------- ---------------- -----------
  Stream      pH              syringe       50 ml      Store on ice     4 hours
  H~2~O                                                                 

  Soil        Pesticide       plastic, 1-L  50 g       Store on ice     28 days
              concentration   HDPE^b^ or                                
                              glass                                     

  Leachate    N, TKN^c^       1-L HDPE^b^   500 ml     H~2~SO~4~ \< 2   28 days
  collected                                            pH Store on ice  
  from                                                                  
  lysimeter                                                             

  Leaves      dry mass (g)    paper bag     25 g       dry at 100C for  6 months
                                                       24 hrs.          

  Audio       bird songs      audio         3          NA               1 year
  recording                   cassette                                  
  ---------------------------------------------------------------------------------

a For example - air, soil, through-fall, lysimeter, stream, lake,
tissue, blood, plant tissue

b High density polyethylene

c Total Kjeldahl Nitrogen

[go to Table of Contents](#Table_of_Contents)

Table 3. Instrument Calibration

  --------------- ---------------------------------------------- -----------
  Instrument      Calibration procedure                          Frequency

  Mettler balance Calibrated by factory service technician (if   yearly
  PM3000          needed) during annual maintenance              

  Gas             Calibration curve determined by injecting      each
  Chromatograph   concentration standards covering expected      session
                  range injected.                                

  pH meter        Adjust meter using standard buffers.           each
                                                                 session

  Lambda PAR      Returned to manufacturer for spectrum          yearly
  sensor          verification and intensity calibration         
  --------------- ---------------------------------------------- -----------

Table 4. Quality control checks for instruments

+----------+-------------+--------+--------+---------+---------------+
| Ins      | Q.C. Check  | Fre    | Data   | Acc     | Action if     |
| truments |             | quency | s      | eptance | values are    |
|          |             |        | ummary | c       | unacceptable  |
|          |             |        |        | riteria |               |
+----------+-------------+--------+--------+---------+---------------+
| Mettler  | Record      | before | cal    | greater | Re-weigh all  |
| balance  | readings    | and    | culate | than    | samples on    |
| PM3000   | for NIST    | after  | ac     | DQO     | another       |
|          | traceable   | each   | curacy |         | balance.      |
|          | standard    | s      |        |         | Clean, adjust |
|          | weights     | ession |        |         | or send       |
|          | that cover  |        |        |         | balance for   |
|          | the range   |        |        |         | repair.       |
|          | of expected |        |        |         |               |
|          | values      |        |        |         |               |
+----------+-------------+--------+--------+---------+---------------+
| Oxford   | determine   | before | Single | Within  | Clean,        |
| and      | mass of     | each   | measur |  1% of | adjust,       |
| E        | dispensed   | s      | e-ment | e       | replace       |
| ppendorf | volume      | ession |        | xpected | pipette. Send |
| pipettes |             |        |        | volume  | defective     |
|          |             |        |        |         | pipette to    |
|          |             |        |        |         | supplier for  |
|          |             |        |        |         | maintenance.  |
+----------+-------------+--------+--------+---------+---------------+
| Gas      | Co          | before | Plot   | linear  | repeat        |
| Chrom    | ncentration | each   | dose / | re      | standards     |
| atograph | standards   | s      |        | sponse, | injection     |
|          | covering    | ession | re     | R^2^ \> | until linear  |
|          | expected    |        | sponse | .95     | response.     |
|          | range       |        | curve. |         | Clean         |
|          | injected.   |        |        |         | detector, or  |
|          |             |        |        |         | otherwise     |
|          |             |        |        |         | repair        |
|          |             |        |        |         | instrument.   |
+----------+-------------+--------+--------+---------+---------------+
| Trained  | Test        | yearly | S      | a       | Retrain and   |
| o        | observers   |        | pecies | ccuracy | re-test.      |
| bservers | against     |        | count  | \> 80%  |               |
| (bird    | experts     |        |        |         |               |
| songs)   | using audio |        |        |         |               |
|          | tapes or    |        |        |         |               |
|          | field       |        |        |         |               |
|          | trials.     |        |        |         |               |
+----------+-------------+--------+--------+---------+---------------+

[go to Table of Contents](#Table_of_Contents)

Table 5. Preventive maintenance

  ------------------- ------------------------- -------------------------
  Instrument          Frequency                 Preventive Maintenance

  Mettler balance     yearly                    Contract service
  PM3000                                        

  Gas Chromatograph   yearly or when column is  detector cleaned,
                      changed                   diagnostic self test

  Oxford and          yearly or when QC checks  replace gaskets,
  Eppendorf pipettes  are unsatisfactory        lubricate, clean, use
                                                contract maintenance
                                                service.
  ------------------- ------------------------- -------------------------

[go to Table of Contents](#Table_of_Contents) []{#Appendix_4
.anchor}**Appendix 4**

**QA PROJECT PLAN ELEMENTS FOR MODELING**

[**http://www.epa.gov/quality1/qs-docs/g5m-final.pdf**](http://www.epa.gov/quality1/qs-docs/g5m-final.pdf)

**Document control:**

Each page will have a footer containing:

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**Short Title** **1 of xx**

**QAPP-NHEERL/WED/RCB/NS/05-02-001 3/20/06**

This is the first revision (original=000) as of March 20, 2006 of the
second (02) QAPP written in 2005 by Nathan Schumaker in the Risk
Characterization Branch.

**GROUP A: PROJECT MANAGEMENT**

**A1. Title and Approval Sheet**

Contents this element [will]{.underline} contain:

-   Title of QA Project Plan

-   Revision number of QA Project Plan

-   Effective date of QA Project Plan revision

-   Names of all organizations involved in modeling project

-   Names of all key project officials responsible for the work, with
    space for dated signatures

**A2. Table of Contents and Document Control Format**

Contents this element [will]{.underline} contain:

-   Title of all sections, including subsections, tables, figures,
    references, appendices

-   Page numbers for each section

-   Section for each QA Project Plan element

-   Document control box

**A3. Distribution List**

Contents this element [will]{.underline} contain:

-   List of all individuals (and their role on the project) who will be
    provided copies of the approved QA Project Plan, including all
    persons responsible for implementation, including project managers,
    QA Manager(s), and representatives of all groups involved.

**A4. Project/Task Organization**

Contents this element [will]{.underline} contain:

-   Concise organizational chart showing the relationships and lines of
    communication among all

-   project participants, other data users, and any subcontractors
    relevant to environmental data operations

[go to Table of Contents](#Table_of_Contents)

-   Project name and organizations involved, and a description of their
    respective responsibilities

**A5. Problem Definition/Background**

Contents this element may contain:

-   Goals and objectives of this project that will address this problem

-   Definition of the population the problem targets and what measures
    within this population the problem addresses

-   Reason the project includes a modeling approach to address the
    problem (is it a new predictive tool?)

-   Types of decisions that may be made as a result of this project

-   Names of those responsible for making these decisions

-   Any other types of problems that the project may address

-   Background information on the problem

-   Reasons the project is important, how it supports other existing
    research, programs, or regulations

-   Conflicts or uncertainties that will be resolved by this project

-   Reasons one model is determined to be better than another for this
    application

**A6. Project/Task Description and Schedule**

Contents this element may contain:

-   Summary of all work to be performed, products to be produced, and
    the schedule for

-   implementation

-   List of products, deliverables, and milestones to be completed in
    the various stages of the project

-   Schedule of anticipated start and completion dates for the
    milestones and deliverables, and persons responsible for each

**A7. Quality Objectives and Criteria for Model Inputs/Outputs**

Contents this element may contain:

-   Project data quality objectives (DQOs), performance criteria, and
    acceptance criteria

-   Description of task that needs to be addressed and the intended uses
    of the output of the modeling project to achieve the task

-   List of requirements associated with the hardware/software
    configuration for those studies involving software evaluation

**A8. Special Training Requirements/Certification**

Contents this element may contain:

-   Types of required training and certification needed by the project
    team

-   Plan for obtaining training and/or certification

-   Documentation of training and/or certification

**A9. Documentation and Records**

Contents this element may contain:

-   Description of information to be included in reports

-   Proper document control and distribution procedures

[go to Table of Contents](#Table_of_Contents)

-   Details on document storage

-   Backup plan for records stored electronically

-   Description of the change control process (who approves changes,
    etc.)

-   Length of retention periods for each record

-   Data assessment reports, interim project progress reports

-   Model science formulation report, peer review reports

-   Model assessment reports, interim project progress reports

-   Code standards, code auditing and testing reports, interim project
    progress reports

-   Model calibration report

-   Model evaluation records (How well does the model report variability
    and uncertainty in its output?)

-   User's manual

-   Configuration management (after production version) and code
    maintenance manuals (e.g., or software, internal documentation of
    logic and structure)

**GROUP B: MEASUREMENT AND DATA ACQUISITION**

**B7. Calibration**

Contents this element may contain:

-   Objectives of model calibration activities, including acceptance
    criteria

-   Frequency of model calibration activities

-   Details on the model calibration procedure

-   Method(s) of acquiring input data

-   Types of output generated by the model calibration

-   Approach to characterize uncertainty (e.g., sensitivity analysis)

-   Corrective action to be taken if criteria are not met

-   Resources and responsibilities for calibrating the model

-   Analysis of model output relative to acceptance criteria

**B9. Non-direct Measurements (Data Acquisition Requirements)**

Contents this element may contain:

-   Types of data needed for implementing a project that are obtained
    from non-measurement sources such as databases, literature files

-   Need for non-direct measurements, intended use of data

-   Method(s) of identifying and acquiring data

-   Method of determining the underlying quality of the data

-   SOPs and field or lab-specific deviations associated with these
    procedures

-   Acceptance criteria for non-direct measurements: such as
    completeness, [representativeness](#representativeness), bias,
    precision, qualifying data

**B10. Data Management and Hardware/Software Configuration**

-   Contents this element may contain:

-   Information on the project data management process (field, office,
    and lab)

-   Record-keeping procedures, document control system, audit trails

[go to Table of Contents](#Table_of_Contents)

-   Control mechanism for detecting and correcting errors, preventing
    loss of data

-   Procedures for assuring applicable Agency resource management
    requirements are satisfied

-   Required computer hardware/software and any specific performance
    requirements

**Data Management**

-   Any data forms, checklists, on-line interactive screens used in the
    modeling process

-   Any graphics developed to document the data management process
    (process flow diagrams, modeling flow charts, etc.)

-   Documentation of internal checks used during data entry

-   Data calculations and analyses that should to be highlighted in the
    QA Project Plan

-   Plans for characterization of uncertainty and variability in the
    model results (e.g., summary

-   statistics, frequency distributions, goodness-of-fit tests)

**Hardware/Software Configuration**

-   List of equipment, hardware, and software that will be used on the
    project

-   Description of performance requirements

-   Decisions regarding security issues

-   Decision regarding communication issues

-   Decisions regarding software installation issues

-   Decisions regarding response time issues

-   Plans for requirements documentation

-   Coding standards

-   Testing plans

-   Plans for data dictionary (may not need to be a separate document)

-   Plans for a user's manual

-   Plans for a maintenance manual (explaining software logic and
    organization)

-   Plans for source code for the ultimate user of the model or model
    framework

-   Configuration management plan (procedures to control
    software/hardware configuration during development of the original
    model version)

**GROUP C: ASSESSMENTS AND OVERSIGHT**

**C1. Assessment and Response Actions**

Contents this element may contain:

-   Assessment/oversight strategies and schedule of assessment
    activities, order of events

-   Organizations and individuals expected to participate in
    assessments, including peer reviews

-   Information expected, success criteria

-   Scope of authority of assessors to recommend or direct changes to
    the model (corrective actions)

-   Qualitative and quantitative assessments

[go to Table of Contents](#Table_of_Contents)

-   Internal assessments (internal QA officer's review of input data,
    code [verification](#verification), calibration, benchmarking) and
    external assessments (peer review of model theory or mathematical
    structure)

-   [Surveillance activities](#surveillance-1) (continued monitoring of
    status and progress of the project, tracking project milestones and
    budgets)

-   Plans for model performance evaluations

-   Plans for sensitivity analysis

-   Plans for uncertainty analysis

-   Plans for data quality assessment

-   Plans for code testing

**Hardware/Software Assessments**

-   Plans for hardware and software configuration testing, if
    appropriate

-   Plans for code [verification](#verification) tests

-   Plans for internal and external peer reviews

-   Plans for checking for programming errors

-   Plans for checking for correct insertion of model equations

-   Plans for checking for code's linkage to analysis of uncertainty

**Hardware/Software Configuration Tests**

-   Plans for software code development inspections

-   Plans for software code performance testing

-   Plans for a test of the model framework

-   Plans for integration tests (check computational and transfer
    interfaces between modules)

-   Plans for regression tests

-   Plans for stress testing of complex models (to ensure that maximum
    load during peak usage does not exceed limits of the system)

-   Plans for acceptance testing (contractually-required testing needed
    before a new model or model application is accepted by the customer
    and final payment is made)

-   Plans for beta testing of pre-release hardware/software, recording
    of anomalies

-   Plans for checking for programming errors

**Plans for science and product peer review**

-   Theoretical basis for the model

-   Mathematical model structure

```{=html}
<!-- -->
```
-   Model algorithms

-   Model predictions

-   Model calibration

-   Plans for data quality assessment

-   Plans for peer review of final technical product

[go to Table of Contents](#Table_of_Contents)

**C2. Reports to Management**

-   Contents this element may contain: plans for documentation of:

-   Project reporting schedule

-   Frequency, content, and distribution of reports

-   Deviations from approved QA Project Plan

-   Need for response actions to correct deviations

-   Potential uncertainties in decisions based on input data and model
    limitations

-   Data Quality Assessment findings

**GROUP D: DATA VALIDATION AND USABILITY**

**D1. Departures from Validation Criteria**

Contents this element may contain:

-   Criteria used to review and validate (accept, reject, or qualify)
    model components such as theory, mathematical procedures, code, and
    calibration (convergence criteria, etc.)

-   Criteria used to review and validate input data

-   Criteria used to test model performance

-   Criteria used to review or validate model outputs

**D2. [Validation](#validation) Methods**

Contents this element may contain:

-   Methods for review of model components such as theory, mathematical
    procedures, code, and calibration (peer review, etc.)

-   Methods for review of input data

-   Methods for review of model performance tests

-   Methods for assessment of model output and usability

**D3. Reconciliation with User Requirements**

Contents this element may contain:

-   Discussion of project or task results

-   List of departures from assumptions set in the planning phase of the
    model

-   Report on limitations on use of output data for decision makers or
    users

[[]{#Appendix_5 .anchor}go to Table of Contents](#Table_of_Contents)
**Appendix 5**

**WED Standard Operating Procedure Format**

Condensed from the document entitled: [[Guidance for the Preparation of
Standard Operating Procedures (SOPs) for Qualtiy Related Documents, EPA
QA/G-6]{.underline}](http://www.epa.gov/quality1/qs-docs/g6-final.pdf)

http://www.epa.gov/quality/qs‑docs/g6‑final.pdf

**Document control:**

Each page will have a footer containing:

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Short Title/ID \# 1 of xx**

**SOP-NHEERL/WED/PCEB/BB/05-02-001 3/20/06**

This is the first revision (original=000) as of March 20, 2006 of the
second (02) SOP authored in 2005 by Bruce Boese of the Pacific Coast
Ecology Branch.

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}**

**WED SOPs will consist of the following 12 sections:**

[(For activities such as field work, a separate SOP is not required for
each procedure. All the procedures can be included under a single SOP
title. If sections are not applicable or relevant, their entries should
be NA with a brief explanation)]{.underline}

**Title-Signature Page** (outline same as QAPP, SOP author, first line
management, QAM)

**Table of Contents**

1\. **Scope & Applicability** (describing the purpose of the process or
procedure and any organizational or regulatory requirements)

2\. **Summary of Method** (briefly summarizing the procedure)

3\. **Definitions** (identifying any acronyms, abbreviations, or
specialized terms used)

4\. **Health & Safety Warnings** (indicating operations that could
result in personal injury or loss of life and explaining what will
happen if the procedure is not followed or is followed incorrectly;
listed here and at the critical steps in the procedure)

5\. **Cautions** (indicating activities that could result in equipment
damage, degradation of sample, or possible invalidation of results;
listed here and at the critical steps in the procedure)

[go to Table of Contents](#Table_of_Contents)

6\. **Interferences** (describing any component of the process that may
interfere with the accuracy of the final product)

7\. **Personnel Qualifications** (denoting the minimal experience the
SOP follower should have to complete the task satisfactorily, and citing
any applicable requirements, like certification or Ainherently
governmental function@)

8\. **Equipment and Supplies** (listing and specifying, where necessary,
equipment, materials, reagents, chemical standards, and biological
specimens)

9\. **Procedure** (identifying all pertinent steps, in order, and
materials need to accomplish the procedure such as:

\$ Instrument or Method Calibration and Standardization

\$ Sample Collection

\$ Sample Handling and Preservation

> \$ Sample Preparation and Analysis (such as extraction, digestion,
> analysis, identification, and counting procedures)

\$ Troubleshooting

> \$ Data Acquisition, Calculations & Data Reduction Requirements(such
> as listing any mathematical steps to be followed)
>
> \$ Computer Hardware & Software (used to store field sampling records,
> manipulate analytical results, and/or report data)

10\. **Data and Records Management** (e.g.,
transcription/[verification](#verification)/authentication
documentation, identifying any forms to be used (attach as Appendices),
storage location hard and electronic versions, and archiving
information).

11\. **Quality Control and Quality Assurance Section** - QC activities
are designed to allow self-verification of the quality and consistency
of the work. Describe here the preparation of appropriate QC procedures
(self-checks, such as calibrations, recounting, re-identification,
control charts) and QC material (such as trip, field, or method blanks;
positive and negative controls; replicates; splits; spikes; performance
evaluation samples, SRMs) that are required to demonstrate successful
performance of the method. Specific criteria for each should be
included. Describe the frequency of required calibration and QC checks
and discuss the rationale for decisions. Describe the limits/criteria
for QC data/results and actions required when QC data exceed QC limits
or appear in the warning zone. Describe the procedures for reporting QC
data and results.

12\. **Reference Section** - Documents or procedures that interface with
the SOP should be fully referenced (including version), such as related
SOPs, published literature, or methods manuals. Citations cannot
substitute for the description of the method being followed in the
organization. Attach any that are not readily available.

[[]{#QARF .anchor}go to Table of Contents](#Table_of_Contents) **U.S.
EPA / NHEERL**

[Number range CHAPTER**QUALITY ASSURANCE REVIEW
FORM**](http://wedcor.cor.epa.gov/pages/forms/qa/WED-26.doc)

**FOR EXTRAMURAL ACTIONS**

+--------------+---+---------------------+---+-----------+--------------+
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|              | [ |                     |   |           |              |
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|              | n |                     |   |           |              |
|              | d |                     |   |           |              |
|              | e |                     |   |           |              |
|              | r |                     |   |           |              |
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|              | n |                     |   |           |              |
|              | e |                     |   |           |              |
|              | } |                     |   |           |              |
|              |   |                     |   |           |              |
|              | I |                     |   |           |              |
|              | n |                     |   |           |              |
|              | c |                     |   |           |              |
|              | r |                     |   |           |              |
|              | e |                     |   |           |              |
|              | m |                     |   |           |              |
|              | e |                     |   |           |              |
|              | n |                     |   |           |              |
|              | t |                     |   |           |              |
|              | a |                     |   |           |              |
|              | l |                     |   |           |              |
|              | F |                     |   |           |              |
|              | u |                     |   |           |              |
|              | n |                     |   |           |              |
|              | d |                     |   |           |              |
|              | i |                     |   |           |              |
|              | n |                     |   |           |              |
|              | g |                     |   |           |              |
|              |   |                     |   |           |              |
|              | O |                     |   |           |              |
|              | t |                     |   |           |              |
|              | h |                     |   |           |              |
|              | e |                     |   |           |              |
|              | r |                     |   |           |              |
|              | : |                     |   |           |              |
|              |   |                     |   |           |              |
|              |   |                     |   |           |              |
|              |   |                     |   |           |              |
|              |   |                     |   |           |              |
|              |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| *\*If you    |   |                     |   |           |              |
| are          |   |                     |   |           |              |
| processing   |   |                     |   |           |              |
| an **IAG**   |   |                     |   |           |              |
| or           |   |                     |   |           |              |
| **CRADA**,   |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| re           |   |                     |   |           |              |
| sponsibility |   |                     |   |           |              |
| for QA must  |   |                     |   |           |              |
| be           |   |                     |   |           |              |
| negotiated   |   |                     |   |           |              |
| within the   |   |                     |   |           |              |
| agreement.   |   |                     |   |           |              |
| The Project  |   |                     |   |           |              |
| Officers     |   |                     |   |           |              |
| (POs) in     |   |                     |   |           |              |
| consultation |   |                     |   |           |              |
| with the     |   |                     |   |           |              |
| QAMs in the  |   |                     |   |           |              |
| various      |   |                     |   |           |              |
| o            |   |                     |   |           |              |
| rganizations |   |                     |   |           |              |
| must agree   |   |                     |   |           |              |
| on, and      |   |                     |   |           |              |
| document     |   |                     |   |           |              |
| which        |   |                     |   |           |              |
| organization |   |                     |   |           |              |
| will take    |   |                     |   |           |              |
| the lead for |   |                     |   |           |              |
| QA, the      |   |                     |   |           |              |
| names of the |   |                     |   |           |              |
| QAM and PO   |   |                     |   |           |              |
| from each    |   |                     |   |           |              |
| o            |   |                     |   |           |              |
| rganization, |   |                     |   |           |              |
| and the QA   |   |                     |   |           |              |
| requirements |   |                     |   |           |              |
| which will   |   |                     |   |           |              |
| be adhered   |   |                     |   |           |              |
| to during    |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| agreement.   |   |                     |   |           |              |
| Include this |   |                     |   |           |              |
| information  |   |                     |   |           |              |
| in the       |   |                     |   |           |              |
| IAG/CRADA    |   |                     |   |           |              |
| package*.    |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **C.         |   | **D. QA Category:** |   |           |              |
| Branch:**    |   |                     |   |           |              |
|              |   | >  1. Research      |   |           |              |
|              |   | > directly and      |   |           |              |
|              |   | > immediately       |   |           |              |
|              |   | > supporting        |   |           |              |
|              |   | > regulations or    |   |           |              |
|              |   | > congressional or  |   |           |              |
|              |   | > presidential      |   |           |              |
|              |   | > mandates, etc.    |   |           |              |
|              |   | >                   |   |           |              |
|              |   | > 2. Research of    |   |           |              |
|              |   | > high programmatic |   |           |              |
|              |   | > relevance, etc.   |   |           |              |
|              |   | >                   |   |           |              |
|              |   | > 3. Research       |   |           |              |
|              |   | > demonstrating     |   |           |              |
|              |   | > proof of concept; |   |           |              |
|              |   | > method validation |   |           |              |
|              |   | > studies           |   |           |              |
|              |   |                     |   |           |              |
|              |   | 4. Basic            |   |           |              |
|              |   | exploratory         |   |           |              |
|              |   | research to study   |   |           |              |
|              |   | mechanisms,         |   |           |              |
|              |   | conditions, etc.    |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **II. Scope  |   |                     |   |           |              |
| of Work**    |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **A.**Number |   |                     |   |           | Yes No       |
| range        |   |                     |   |           |              |
| CHAPTER Does |   |                     |   |           |              |
| this         |   |                     |   |           |              |
| extramural   |   |                     |   |           |              |
| action       |   |                     |   |           |              |
| involve the  |   |                     |   |           |              |
| collection,  |   |                     |   |           |              |
| generation,  |   |                     |   |           |              |
| use, and/or  |   |                     |   |           |              |
| reporting of |   |                     |   |           |              |
| e            |   |                     |   |           |              |
| nvironmental |   |                     |   |           |              |
| data;        |   |                     |   |           |              |
|              |   |                     |   |           |              |
| > or         |   |                     |   |           |              |
| >            |   |                     |   |           |              |
|  development |   |                     |   |           |              |
| > of         |   |                     |   |           |              |
| > software   |   |                     |   |           |              |
| > and/or     |   |                     |   |           |              |
| > models, or |   |                     |   |           |              |
| > methods?   |   |                     |   |           |              |
| > *(**If     |   |                     |   |           |              |
| > "No", skip |   |                     |   |           |              |
| > to Section |   |                     |   |           |              |
| > IV, and    |   |                     |   |           |              |
| > sign the   |   |                     |   |           |              |
| > form.**)*  |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **B.** For   |   |                     |   |           | Yes No \*N/A |
| so           |   |                     |   |           |              |
| licitations, |   |                     |   |           |              |
| will the     |   |                     |   |           |              |
| activities   |   |                     |   |           |              |
| in Section   |   |                     |   |           |              |
| IIA account  |   |                     |   |           |              |
| for greater  |   |                     |   |           |              |
| than 15% of  |   |                     |   |           |              |
| the cost or  |   |                     |   |           |              |
| effort? If   |   |                     |   |           |              |
| so, the QA   |   |                     |   |           |              |
| d            |   |                     |   |           |              |
| ocumentation |   |                     |   |           |              |
| specified in |   |                     |   |           |              |
| the RFP or   |   |                     |   |           |              |
| SOW and/or   |   |                     |   |           |              |
| provided for |   |                     |   |           |              |
| in Section   |   |                     |   |           |              |
| III1or III2  |   |                     |   |           |              |
| shall be     |   |                     |   |           |              |
| included in  |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| technical    |   |                     |   |           |              |
| evaluation   |   |                     |   |           |              |
| at a weight  |   |                     |   |           |              |
| of 10-20%,   |   |                     |   |           |              |
| or           |   |                     |   |           |              |
| pass/fail.   |   |                     |   |           |              |
| ***(\*check  |   |                     |   |           |              |
| N/A for      |   |                     |   |           |              |
| existing     |   |                     |   |           |              |
| vehicle      |   |                     |   |           |              |
| actions)***  |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **C**.       |   |                     |   |           | Yes No       |
| Number range |   |                     |   |           |              |
| CHAPTERWill  |   |                     |   |           |              |
| the SOW or   |   |                     |   |           |              |
| any          |   |                     |   |           |              |
| subsequent   |   |                     |   |           |              |
| work         |   |                     |   |           |              |
| assignments  |   |                     |   |           |              |
| or task      |   |                     |   |           |              |
| orders, or   |   |                     |   |           |              |
| COOP, or IAG |   |                     |   |           |              |
| involve any  |   |                     |   |           |              |
| c            |   |                     |   |           |              |
| ross-federal |   |                     |   |           |              |
| or           |   |                     |   |           |              |
| ganizational |   |                     |   |           |              |
| efforts? If  |   |                     |   |           |              |
| so, which    |   |                     |   |           |              |
| organization |   |                     |   |           |              |
| will take    |   |                     |   |           |              |
| the lead for |   |                     |   |           |              |
| QA?          |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **D.** Has a |   |                     |   |           | Yes No       |
| QAPP already |   |                     |   |           |              |
| been         |   |                     |   |           |              |
| approved for |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| activities   |   |                     |   |           |              |
| specified in |   |                     |   |           |              |
| the SOW or   |   |                     |   |           |              |
| RFP?         |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| 1\. Provide  |   |                     |   |           |              |
| the title,   |   |                     |   |           |              |
| date or      |   |                     |   |           |              |
| revision     |   |                     |   |           |              |
| number, and  |   |                     |   |           |              |
| date of QA   |   |                     |   |           |              |
| approval:    |   |                     |   |           |              |
|              |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| 2\. Does the |   |                     |   |           | Yes No \*N/A |
| QAPP require |   |                     |   |           |              |
| *any*        |   |                     |   |           |              |
| revision by  |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| contractor   |   |                     |   |           |              |
| or           |   |                     |   |           |              |
| cooperator?  |   |                     |   |           |              |
| ***(\*If IID |   |                     |   |           |              |
| is "No",     |   |                     |   |           |              |
| check        |   |                     |   |           |              |
| N/A)***      |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **E.** Is an |   |                     |   |           | Yes No \*N/A |
| applicable   |   |                     |   |           |              |
| QAPP in the  |   |                     |   |           |              |
| process of   |   |                     |   |           |              |
| being        |   |                     |   |           |              |
| prepared or  |   |                     |   |           |              |
| revised by   |   |                     |   |           |              |
| EPA, the     |   |                     |   |           |              |
| contractor,  |   |                     |   |           |              |
| or           |   |                     |   |           |              |
| grantee      |   |                     |   |           |              |
| /cooperator? |   |                     |   |           |              |
| (*QAPP must  |   |                     |   |           |              |
| be approved  |   |                     |   |           |              |
| by EPA       |   |                     |   |           |              |
| [before]     |   |                     |   |           |              |
| {.underline} |   |                     |   |           |              |
| the          |   |                     |   |           |              |
| collection   |   |                     |   |           |              |
| or use of    |   |                     |   |           |              |
| e            |   |                     |   |           |              |
| nvironmental |   |                     |   |           |              |
| data.*)      |   |                     |   |           |              |
| ***(\*If IID |   |                     |   |           |              |
| is "No",     |   |                     |   |           |              |
| check        |   |                     |   |           |              |
| N/A)***      |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| 1\. Provide  |   |                     |   |           |              |
| the expected |   |                     |   |           |              |
| title and    |   |                     |   |           |              |
| approximate  |   |                     |   |           |              |
| date for     |   |                     |   |           |              |
| submission   |   |                     |   |           |              |
| to QA staff  |   |                     |   |           |              |
| for          |   |                     |   |           |              |
| approval:    |   |                     |   |           |              |
|              |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **III.**     |   |                     |   |           |              |
| **Qua        |   |                     |   |           |              |
| lity-Related |   |                     |   |           |              |
| Re           |   |                     |   |           |              |
| quirements** |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **A. Quality |   |                     |   |           |              |
| System       |   |                     |   |           |              |
| Documents    |   |                     |   |           |              |
| (Specif      |   |                     |   |           |              |
| ications):** |   |                     |   |           |              |
| In Section   |   |                     |   |           |              |
| III.B.,      |   |                     |   |           |              |
| "R-2" refers |   |                     |   |           |              |
| to [EPA      |   |                     |   |           |              |
| Requirements |   |                     |   |           |              |
| for Quality  |   |                     |   |           |              |
| Management   |   |                     |   |           |              |
| Plans        |   |                     |   |           |              |
| (QA/R-2)]    |   |                     |   |           |              |
| {.underline} |   |                     |   |           |              |
| (EPA/2       |   |                     |   |           |              |
| 40/B-01/002, |   |                     |   |           |              |
| 03/20/01)    |   |                     |   |           |              |
| and "R-5"    |   |                     |   |           |              |
| refers to    |   |                     |   |           |              |
| Number range |   |                     |   |           |              |
| CHAPTER [EPA |   |                     |   |           |              |
| Requirements |   |                     |   |           |              |
| for Quality  |   |                     |   |           |              |
| Assurance    |   |                     |   |           |              |
| Project      |   |                     |   |           |              |
| Plans        |   |                     |   |           |              |
| (QA/R-5)]    |   |                     |   |           |              |
| {.underline} |   |                     |   |           |              |
| (EPA/2       |   |                     |   |           |              |
| 40/B-01/003, |   |                     |   |           |              |
| 03/20/01).   |   |                     |   |           |              |
| Copies of    |   |                     |   |           |              |
| these        |   |                     |   |           |              |
| documents    |   |                     |   |           |              |
| are          |   |                     |   |           |              |
| available at |   |                     |   |           |              |
| [            |   |                     |   |           |              |
| [http://www. |   |                     |   |           |              |
| epa.gov/qual |   |                     |   |           |              |
| ity/.]{.unde |   |                     |   |           |              |
| rline}](http |   |                     |   |           |              |
| ://www.epa.g |   |                     |   |           |              |
| ov/quality/) |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **B.Number   |   |                     |   |           |              |
| range        |   |                     |   |           |              |
| CHAPTERQA    |   |                     |   |           |              |
| D            |   |                     |   |           |              |
| ocumentation |   |                     |   |           |              |
| Options:**   |   |                     |   |           |              |
| *\[For       |   |                     |   |           |              |
| so           |   |                     |   |           |              |
| licitations, |   |                     |   |           |              |
| complete     |   |                     |   |           |              |
| items 1-4;   |   |                     |   |           |              |
| for all      |   |                     |   |           |              |
| actions      |   |                     |   |           |              |
| other than   |   |                     |   |           |              |
| so           |   |                     |   |           |              |
| licitations, |   |                     |   |           |              |
| complete     |   |                     |   |           |              |
| items 3-4.   |   |                     |   |           |              |
| All          |   |                     |   |           |              |
| d            |   |                     |   |           |              |
| ocumentation |   |                     |   |           |              |
| specified    |   |                     |   |           |              |
| under        |   |                     |   |           |              |
| "Other" must |   |                     |   |           |              |
| be defined   |   |                     |   |           |              |
| in the       |   |                     |   |           |              |
| NHEERL       |   |                     |   |           |              |
| Quality      |   |                     |   |           |              |
| Management   |   |                     |   |           |              |
| Plan or      |   |                     |   |           |              |
| individual   |   |                     |   |           |              |
| Division     |   |                     |   |           |              |
| QMPs and be  |   |                     |   |           |              |
| consistent   |   |                     |   |           |              |
| with         |   |                     |   |           |              |
| requirements |   |                     |   |           |              |
| defined in   |   |                     |   |           |              |
| EPA Order    |   |                     |   |           |              |
| 5360 A1. For |   |                     |   |           |              |
| all items    |   |                     |   |           |              |
| checked      |   |                     |   |           |              |
| below, there |   |                     |   |           |              |
| must be      |   |                     |   |           |              |
| adequate     |   |                     |   |           |              |
| information  |   |                     |   |           |              |
| in the SOW   |   |                     |   |           |              |
| (or its      |   |                     |   |           |              |
| appendices)  |   |                     |   |           |              |
| for the      |   |                     |   |           |              |
| offeror to   |   |                     |   |           |              |
| develop this |   |                     |   |           |              |
| do           |   |                     |   |           |              |
| cumentation. |   |                     |   |           |              |
| Where        |   |                     |   |           |              |
| applicable,  |   |                     |   |           |              |
| reference a  |   |                     |   |           |              |
| specific     |   |                     |   |           |              |
| section of   |   |                     |   |           |              |
| the SOW.\]*  |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| **Before     |   |                     |   |           |              |
| Award        |   |                     |   |           |              |
| Doc          |   |                     |   |           |              |
| umentation** |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| 1.Number     |   |                     |   | QMP       |              |
| range        |   |                     |   | developed |              |
| CHAPTERa.    |   |                     |   | in        |              |
| D            |   |                     |   | a         |              |
| ocumentation |   |                     |   | ccordance |              |
| of an        |   |                     |   | with R2   |              |
| or           |   |                     |   | or        |              |
| ganization's |   |                     |   |           |              |
| Quality      |   |                     |   | Other:    |              |
| System:      |   |                     |   | "R        |              |
| Either       |   |                     |   | espondent |              |
|              |   |                     |   | Req       |              |
|              |   |                     |   | uirements |              |
|              |   |                     |   | Demo      |              |
|              |   |                     |   | nstrating |              |
|              |   |                     |   | Their     |              |
|              |   |                     |   | Organ     |              |
|              |   |                     |   | ization's |              |
|              |   |                     |   | Quality   |              |
|              |   |                     |   | Assurance |              |
|              |   |                     |   | and       |              |
|              |   |                     |   | Quality   |              |
|              |   |                     |   | Control   |              |
|              |   |                     |   | System"   |              |
|              |   |                     |   | attached  |              |
|              |   |                     |   | to, and   |              |
|              |   |                     |   | r         |              |
|              |   |                     |   | eferenced |              |
|              |   |                     |   | from      |              |
|              |   |                     |   | within    |              |
|              |   |                     |   | the SOW   |              |
|              |   |                     |   | or RFP    |              |
|              |   |                     |   | (found on |              |
|              |   |                     |   | page 3 of |              |
|              |   |                     |   | this      |              |
|              |   |                     |   | document) |              |
+--------------+---+---------------------+---+-----------+--------------+
| b\. Combined |   |                     |   | R-2       |              |
| d            |   |                     |   | [and]{.u  |              |
| ocumentation |   |                     |   | nderline} |              |
| of an        |   |                     |   | R-5 or    |              |
| or           |   |                     |   |           |              |
| ganization's |   |                     |   | Other:    |              |
| Quality      |   |                     |   |           |              |
| System and   |   |                     |   |           |              |
| application  |   |                     |   |           |              |
| of QA and QC |   |                     |   |           |              |
| to the       |   |                     |   |           |              |
| single       |   |                     |   |           |              |
| project      |   |                     |   |           |              |
| covered by   |   |                     |   |           |              |
| contract:    |   |                     |   |           |              |
| Either       |   |                     |   |           |              |
| developed in |   |                     |   |           |              |
| accordance   |   |                     |   |           |              |
| with         |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| 2\. a.       |   |                     |   | R-5 or    |              |
| Programmatic |   |                     |   |           |              |
| QA Project   |   |                     |   | Other:    |              |
| Plan: Either |   |                     |   |           |              |
| developed in |   |                     |   |           |              |
| accordance   |   |                     |   |           |              |
| with         |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| b\.          |   |                     |   | QA        |              |
| Application  |   |                     |   | Project   |              |
| of QA and QC |   |                     |   | Plan      |              |
| activities   |   |                     |   | developed |              |
| to the       |   |                     |   | in        |              |
| single       |   |                     |   | a         |              |
| project      |   |                     |   | ccordance |              |
| covered by   |   |                     |   | with R-5  |              |
| contract:    |   |                     |   | or        |              |
| Either       |   |                     |   |           |              |
|              |   |                     |   | Other:    |              |
|              |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+
| c\. Not      |   |                     |   |           |              |
| applicable.  |   |                     |   |           |              |
+--------------+---+---------------------+---+-----------+--------------+

[go to Table of Contents](#Table_of_Contents)

<table>
<colgroup>
<col style="width: 40%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 3%" />
<col style="width: 7%" />
<col style="width: 10%" />
<col style="width: 19%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><strong>After Award Documentation</strong></td>
</tr>
<tr class="even">
<td colspan="7">3. a. Documentation of an organization’s Quality System:
Either</td>
<td colspan="3"><p> QMP developed in accordance with R-2 or</p>
<p> Other: “Respondent Requirements Demonstrating Their Organization’s
Quality Assurance and Quality Control System” attached to, and
referenced from within the SOW or RFP (found on page 3 of this
document)</p></td>
</tr>
<tr class="odd">
<td colspan="7">b. Combined documentation of an organization’s Quality
System and application of QA and QC to the single project covered by the
contract: Developed in accordance with</td>
<td colspan="3"><p> R-2 <u>and</u> R-5 or</p>
<p> Other:      </p></td>
</tr>
<tr class="even">
<td colspan="10">c. Not applicable.</td>
</tr>
<tr class="odd">
<td colspan="3">4. a. Documentation of the application of QA and QC
activities to applicable project(s): Either developed in accordance
with</td>
<td colspan="7"><p> R-5;</p>
<p> A supplement to the following Programmatic QA Project Plan
<u>     </u> ; or</p>
<p> Other:      </p></td>
</tr>
<tr class="even">
<td colspan="10">b. Programmatic QA Project Plan with supplements for
each specific project: Developed in accordance with:      </td>
</tr>
<tr class="odd">
<td colspan="5">c. Existing documentation of the application of QA and
QC activities will be used: Either</td>
<td colspan="5"><p> Documentation developed pre-award;</p>
<p> Documentation will be identified in individual SOW or RFP, or</p>
<p> Documentation identified in Section <u>     </u> of the SOW or
RFP</p></td>
</tr>
<tr class="even">
<td colspan="10"><p><strong>C. Reports:</strong> Are quality reports or
reports containing quality assurance information (for example, status of
quality system implementation, review of a quality system, quality
control data, etc.) required? <strong>Yes</strong>
<strong>No</strong></p>
<p>If yes, identify the required reports and the time frame for
submission:      </p></td>
</tr>
<tr class="odd">
<td colspan="2"><p><strong>D. Assessments:</strong> Select all quality
assessments that will be</p>
<p>performed post-award by EPA staff:</p></td>
<td colspan="6"><p> Readiness reviews;</p>
<p> PE samples;</p>
<p> Technical systems audits;</p></td>
<td colspan="2"><p> Surveillance audits;</p>
<p> These and/or others are specified in the SOW/QAPP at some
frequency.</p></td>
</tr>
<tr class="even">
<td colspan="10"></td>
</tr>
<tr class="odd">
<td colspan="10">Number range CHAPTER<strong>IV.
Signatures**</strong></td>
</tr>
<tr class="even">
<td colspan="10">The signatures below verify that the Statement of Work
or Request for Proposal has been reviewed to ascertain the necessary QA
and QC activities required to comply with EPA Order 5360.1 A2, that the
Contracting Officer’s Representative (COR), Technical Lead (TL) and/or
Project Officer (PO) understands these requirements, and that the
COR/TL/PO will ensure that the quality requirements indicated on the
pages of this form are incorporated into all necessary sections of the
SOW or RFP. <em>(Sign/date below, obtain a concurrence signature from
the QA Staff, and submit the form along with the other extramural action
documentation.)</em></td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td>NHEERL COR, TL / PO</td>
<td colspan="3">Date</td>
<td colspan="2"></td>
<td colspan="3">NHEERL QA Staff Member</td>
<td>Date</td>
</tr>
<tr class="odd">
<td></td>
<td colspan="3"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td>NHEERL TL (when needed, if COR or PO is not the TL)</td>
<td colspan="3">Date</td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
</tr>
</tbody>
</table>

\*\*If this form accompanies an incremental funding action, the
signature of the Project Officer acknowledges that the assistance
recipient has fulfilled any QA requirements identified in the initial
funding decision memo and is current with any periodic QA/QC reports
that are identified in the project's QAPP as specified in Section IIIC,
above.

**Respondent Requirements**

**Demonstrating Their Organization's**

**Quality Assurance and Quality Control System**

Number range CHAPTERIn accordance with EPA Order 5360.1 A2, conformance
to ANSI/ASQC E4 must be demonstrated by each solicitation respondent.
Providing responses to the list of topics provided below are sufficient
to demonstrate this conformance. Responding to the topics listed below
provides a description of each respondent's Quality System that sets
forth its capabilities in providing products (such as those described in
the Statement of Work or Request for Proposals) of known and verifiable
quality. Each respondent, as a separate and identifiable part of its
technical proposal, shall submit its responses to these topics. The
Quality System documentation of the respondent will become part of the
evaluation. For more information on these requirements visit:
<http://www.epa.gov/QUALITY/faq4.html>

For the successful respondent, the Quality System documentation will be
reviewed by the EPA Quality Assurance Manager and approved following an
acceptable response to his requested revisions. In addition, a
project-specific Quality Assurance Project Plan (QAPP) (following
directions in the Quality Management Plan of the originating NHEERL
Division) shall be submitted to the Government at least thirty (30) days
prior to the beginning of any environmental data gathering or generation
activity in order to allow sufficient time for review and revisions to
be completed. After the Government has approved the quality
documentation, the successful respondent shall also implement it as
written and approved by the Government.

**Topics to be addressed in demonstrating an organization's Quality
System**

\(a\) A statement of policy concerning the organization\'s commitment to
implement a Quality Control/Quality Assurance program to assure
generation of data of adequate quality to meet the requirements of the
Request for Proposals (RFP) or Statement of Work (SOW).

\(b\) An organizational chart showing the position of a QA function or
person within the organization. It is highly desirable that the QA
function or person be independent of the functional groups which
generate measurement data.

\(c\) A delineation of the authority and responsibilities of the QA
function or person.

\(d\) The type and degree of experience in developing and applying
Quality Control/Quality Assurance procedures to the proposed methods
needed for performance of the SOW or RFP.

\(e\) The background and experience of the proposed personnel who will
be assigned to the project.

\(f\) The responder\'s general approach for accomplishing the QA
specifications within the scope of the SOW or RFP, or their specific
approach that would provide results of known and verifiable quality.

**The respondents shall be aware of the following nonexclusive list of
words and phrases that may indicate the need for a discussion of QA
activities as they describe the various (a thru f) features of the
particular application of their organization's Quality System to this
SOW or RFP.**

> **validation verification hardware/software evaluation**
>
> **audit procedures positive/negative controls matrix spikes**
>
> **system evaluation configuration management change control**
>
> **Standard Reference Materials acceptance or QA/QC testing**
>
> **Standard Operating Procedures surrogates documenting software code**

  -------------------------------------------------------------------------
  [[]{#Clearance_Form .anchor}go to Table of Contents](#Table_of_Contents)
  [**ORD CLEARANCE
  FORM**](http://wedcor.cor.epa.gov/pages/forms/Publications/ORD-362.doc)

  -------------------------------------------------------------------------

  ---------------- ------------------------------- ----------------------
  **1**. **EPA     **2. Laboratory/Center/Office   **3. Copyright
  Pub. No.** (if   Tracking Number**               Permission**
  applicable)                                      

                   WED-                            Yes (attached) No (not
                                                   applicable)

  **4. Title**                                     

                                                   

  **5. Author(s),                                  
  Affiliation, and                                 
  Address:**                                       
  Include either                                   
  Telephone Number                                 
  or Email Address                                 
  (required) to                                    
  provide unique                                   
  identifiers for                                  
  non-EPA authors.                                 

                                                   

  **6. Internet                                    
  Address** (If                                    
  the product is                                   
  posted on a                                      
  website, provide                                 
  the URL for                                      
  linking to the                                   
  publication.)                                    

                                                   

  A PDF file of                                    
  the final                                        
  publication and                                  
  a WordPerfect or                                 
  Word file of the                                 
  product abstract                                 
  (approximately                                   
  200 words) must                                  
  be submitted                                     
  with the final                                   
  package for                                      
  uploading to the                                 
  Technical                                        
  Information                                      
  Management                                       
  (TIMS) Database.                                 
  ---------------- ------------------------------- ----------------------

  ---------------- ------------------------------------------------------
  **7. Enter these **8. Project Officer/Principal Investigator Name and
  numbers:**       Telephone Number**

  OMIS Task #           

  APG FY & \#      
                   

  APM FY & #       **9. Cooperative Agreement, Contract, Grant,
                   Interagency Agreement Number**

  Multi-Year Plan       
  (MYP)            

  Past             
  Research         
  ---------------- ------------------------------------------------------

+------------------+------------------+--------------+----------------+
| **10 . Product   |                  |              |                |
| Type**           |                  |              |                |
+------------------+------------------+--------------+----------------+
| Assessment       | EPA Published    | Newsletter   | IRIS           |
| Document         | Proceedings      |              | Assessment     |
+------------------+------------------+--------------+----------------+
| Book             | Paper in EPA     | Newsletter   | ETV Document   |
|                  | Proceedings      | Article      |                |
+------------------+------------------+--------------+----------------+
| Book Chapter     |                  | Risk         |                |
|                  |                  | Assessment   |                |
|                  |                  | Guidelines   |                |
+------------------+------------------+--------------+----------------+
| Criteria         | Non‑EPA          | Summary      |                |
| Document         | Published        |              |                |
|                  | Proceedings      |              |                |
+------------------+------------------+--------------+----------------+
| Internal Report  | Paper in Non‑EPA | Unpublished  |                |
|                  | Proceedings      | Report       |                |
+------------------+------------------+--------------+----------------+
| **10a. Product   | **10b. Product   |              |                |
| Types having     | Subtypes**       |              |                |
| Subtypes**       |                  |              |                |
+------------------+------------------+--------------+----------------+
| Communication    | Announcement     |              |                |
| Product          | Brochure         |              |                |
|                  | External Fact    |              |                |
|                  | Sheet Flyer      |              |                |
|                  | General Public   |              |                |
|                  | Videotape        |              |                |
+------------------+------------------+--------------+----------------+
| Data             | Database Map     |              |                |
|                  | Model Scientific |              |                |
|                  | Data Software    |              |                |
|                  | Spreadsheet      |              |                |
+------------------+------------------+--------------+----------------+
| Extramural       | Contract         |              |                |
| Document         | Cooperative      |              |                |
|                  | Agreement Grant  |              |                |
|                  | Interagency      |              |                |
|                  | Agreement        |              |                |
+------------------+------------------+--------------+----------------+
| Journal          | Non‑Peer         |              |                |
|                  | Reviewed Peer    |              |                |
|                  | Reviewed         |              |                |
+------------------+------------------+--------------+----------------+
| Presentation     | Abstract Exhibit |              |                |
|                  | Extended         |              |                |
|                  | Abstract Paper   |              |                |
|                  | Poster Slide     |              |                |
+------------------+------------------+--------------+----------------+
| Published Report | Guidance         |              |                |
|                  | Document         |              |                |
|                  | Handbook Issue   |              |                |
|                  | Paper Manual     |              |                |
|                  | Methodology      |              |                |
|                  | Report (default) |              |                |
|                  |                  |              |                |
|                  | Technology       |              |                |
|                  | Transfer User\'s |              |                |
|                  | Guide            |              |                |
+------------------+------------------+--------------+----------------+
| SITE Document    | Bulletin         |              |                |
|                  | Capstone Doc     |              |                |
|                  | Capsule Report   |              |                |
|                  | Summary          |              |                |
+------------------+------------------+--------------+----------------+

+---+---------------+-----------------+-----------------+---+---------------+
| * |               |                 |                 |   |               |
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|   |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
|   |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| * |               |                 | **15a. Peer     |   |               |
| * |               |                 | Review          |   |               |
| 1 |               |                 | Categories**    |   |               |
| 4 |               |                 |                 |   |               |
| . |               |                 |                 |   |               |
| C |               |                 |                 |   |               |
| o |               |                 |                 |   |               |
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| t |               |                 |                 |   |               |
| s |               |                 |                 |   |               |
| * |               |                 |                 |   |               |
| * |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
|   |               |                 | 1 Major Agency  |   |               |
|   |               |                 | Scientific or   |   |               |
|   |               |                 | Technical Work  |   |               |
|   |               |                 | Product         |   |               |
|   |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
|   |               |                 | 2 Important,    |   |               |
|   |               |                 | Highly Visible  |   |               |
|   |               |                 | Scientific      |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
|   |               |                 | 3 General       |   |               |
|   |               |                 | Scientific or   |   |               |
|   |               |                 | Technical Work  |   |               |
|   |               |                 | Product         |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
|   |               |                 | 4 Non-major     |   |               |
|   |               |                 | Scientific or   |   |               |
|   |               |                 | Technical Work  |   |               |
|   |               |                 | Product         |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| * |               |                 | **15b.          |   |               |
| * |               |                 | C               |   |               |
| 1 |               |                 | ontact/location |   |               |
| 6 |               |                 | for peer review |   |               |
| a |               |                 | comments**      |   |               |
| . |               |                 |                 |   |               |
| H |               |                 |                 |   |               |
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+---+---------------+-----------------+-----------------+---+---------------+
| 1 |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| 2 |               |                 | **17. This      |   |               |
|   |               |                 | Product         |   |               |
|   |               |                 | enunciates new  |   |               |
|   |               |                 | policy or       |   |               |
|   |               |                 | affects         |   |               |
|   |               |                 | existing        |   |               |
|   |               |                 | policy:**       |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| 3 |               |                 | Yes No          |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| * |               |                 |                 |   |               |
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+---+---------------+-----------------+-----------------+---+---------------+
| * |               |                 |                 |   |               |
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| 1 |               |                 |                 |   |               |
| 8 |               |                 |                 |   |               |
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| d |               |                 |                 |   |               |
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|   |               |                 |                 |   |               |
|   |               |                 |                 |   |               |
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|   |               |                 |                 |   |               |
|   |               |                 |                 |   |               |
|   |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+
| S |               |                 |                 |   | Date          |
| i |               |                 |                 |   |               |
| g |               |                 |                 |   |               |
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| a |               |                 |                 |   |               |
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| r |               |                 |                 |   |               |
| e |               |                 |                 |   |               |
+---+---------------+-----------------+-----------------+---+---------------+

ORD-362 (Rev. 06/10/05)

> **19. Impact Statement Attached (Required for most products other than
> abstracts)**
>
> **Yes** **No**
>
> **20. This manuscript reports research performed under the
> following:**
>
> **Research Plan Title:      **
>
> **QAPP Title (if different):      **
>
> **If not applicable, explain**:

ORD-362 (Rev. 06/10/05

[go to Table of Contents](#Table_of_Contents)

+--------+-------------------------------------------------------------+
| [      |                                                             |
| []{#Bi |                                                             |
| ennial |                                                             |
| _revie |                                                             |
| w_form |                                                             |
| .anc   |                                                             |
| hor}Bi |                                                             |
| ennial |                                                             |
| Review |                                                             |
| Form   |                                                             |
| ](http |                                                             |
| ://wed |                                                             |
| cor.co |                                                             |
| r.epa. |                                                             |
| gov/pa |                                                             |
| ges/fo |                                                             |
| rms/qa |                                                             |
| /SOP_b |                                                             |
| iennia |                                                             |
| l_revi |                                                             |
| ew_for |                                                             |
| m.doc) |                                                             |
|        |                                                             |
| **SOP  |                                                             |
| Ti     |                                                             |
| tle**: |                                                             |
|        |                                                             |
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| *Origi |                                                             |
| nating |                                                             |
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| ranch, |                                                             |
| pr     |                                                             |
| oject, |                                                             |
| or     |                                                             |
| group  |                                                             |
| and    |                                                             |
| num    |                                                             |
| ber**: |                                                             |
| **Vers |                                                             |
| ion**: |                                                             |
|        |                                                             |
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| g.TERA |                                                             |
| 1.1,   |                                                             |
| WRS    |                                                             |
| 14A,   |                                                             |
| S      |                                                             |
| OP-WED |                                                             |
| /RCB/B |                                                             |
| B/06-0 |                                                             |
| 1-000* |                                                             |
| )      |                                                             |
|        |                                                             |
| **Or   |                                                             |
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| Prepa  |                                                             |
| rer**: |                                                             |
|        |                                                             |
| **QA   |                                                             |
| c      |                                                             |
| ertifi |                                                             |
| cation |                                                             |
| date   |                                                             |
| of     |                                                             |
| this   |                                                             |
| vers   |                                                             |
| ion**: |                                                             |
+--------+-------------------------------------------------------------+
| **BI   |                                                             |
| ENNIAL |                                                             |
| R      |                                                             |
| EVIEWS |                                                             |
| ^a^**  |                                                             |
+--------+-------------------------------------------------------------+
| Date   | **EPA Reviewer (signature/title: PI, or project leader, or  |
|        | WACOR w/ WA#)**                                             |
+--------+-------------------------------------------------------------+
|        |                                                             |
+--------+-------------------------------------------------------------+
|        |                                                             |
+--------+-------------------------------------------------------------+
|        |                                                             |
+--------+-------------------------------------------------------------+
|        |                                                             |
+--------+-------------------------------------------------------------+
| **^a^  |                                                             |
| Sig    |                                                             |
| nature |                                                             |
| doc    |                                                             |
| uments |                                                             |
| the    |                                                             |
| bi     |                                                             |
| ennial |                                                             |
| review |                                                             |
| when   |                                                             |
| no     |                                                             |
| rev    |                                                             |
| isions |                                                             |
| are    |                                                             |
| deemed |                                                             |
| necess |                                                             |
| ary.** |                                                             |
|        |                                                             |
| **If a |                                                             |
| mo     |                                                             |
| dified |                                                             |
| v      |                                                             |
| ersion |                                                             |
| of     |                                                             |
| this   |                                                             |
| SOP is |                                                             |
| being  |                                                             |
| fo     |                                                             |
| llowed |                                                             |
| these  |                                                             |
| rev    |                                                             |
| isions |                                                             |
| should |                                                             |
| be     |                                                             |
| sub    |                                                             |
| mitted |                                                             |
| for    |                                                             |
| review |                                                             |
| and    |                                                             |
| appro  |                                                             |
| val.** |                                                             |
+--------+-------------------------------------------------------------+

[^1]: A chain of responsible persons should be established where
    signatures are required for each independent PI or manager.
    Subordinates do not need to sign the approval page.