CHAPTER ONE

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TABLE OF CONTENTS
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Section � Page

1.0 INTRODUCTION � 1
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1.1 � PLANNING 2
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1.2 � IMPLEMENTATION 9
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1.3 � ASSESSMENT 11
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1.4 � REFERENCES AND SOURCES FOR ADDITONAL INFORMATION ON 15
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PROJECT QUALITY ASSURANCE AND CONTROL
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1.5 � GLOSSARY 16
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Figure

1­1 PROJECT LEVEL EPA QA SYSTEM � 14

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Appendix A SUMMARY OF UPDATES/CHANGES IN CHAPTER 1 � 25
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 CHAPTER ONE

Project Quality Assurance and Quality Control

For a summary of changes in this version from the previously published Chapter One, please
see Appendix A at the end of this document.

1.0 INTRODUCTION

The goal of this chapter is to provide an understanding of environmental data and the need
for quality. EPA has developed numerous guidance documents on quality assurance. This
chapter is not intended to summarize the previously developed EPA guidance. Instead, this
chapter will provide familiarity with regulations and guidance relating to QA and where to find them.

Regulations promulgated under the Resource Conservation and Recovery Act (RCRA) of
1976, as amended; require the collection and use of environmental data by regulated entities. In
addition, organizations often collect and use environmental data for decision making. Given the
significant decisions to be made based on environmental data, it is critical that the data are of
sufficient quantity and quality for their intended use and can support decision­making based on
sound science.

In response to the need for quality data, it is recommended that all parties follow a structured
system of data quality assurance and quality control (QA/QC). In addition, some of the RCRA
regulations include specific requirements for ensuring data quality.

This chapter provides general guidance intended to ensure data are of sufficient quality for
their intended use. Its intended audience is any entity, government or private party that may be
collecting environmental data. It is designed to support the efforts of those responsible for
preparing and reviewing project planning documents such as Quality Assurance Project Plans
(QAPPs), those involved in implementing and assessing data collection and generation activities in
the field or laboratory, and those who use the data for decision­making.

Due to the diversity of data collection efforts, it is not possible to provide all details necessary
to meet the needs of all members of the intended audience. However, EPA has developed a
variety of detailed QA guidance documents that are incorporated into this Chapter by reference.
This series of quality systems documents can be accessed on the EPA's Quality web site at:
http://www.epa.gov/quality. These documents describe in detail EPA policies and procedures for
planning, implementing and assessing the effectiveness of quality systems.

EPA's quality system comprises three structural levels: policy, organization/program, and
project. This document addresses quality at the project level of the system, including technical
aspects of analytical method quality assurance (QA) and quality control (QC). Entities which
desire guidance on the other two structural levels (policy and organization/program levels) can
access such guidance at the aforementioned EPA quality web site.

A project's life cycle under EPA's quality system has three phases: planning, implementation,
and assessment. This chapter is organized into these three phases. Additionally, Figure 1 is
provided, and illustrates this process.

Additionally, this chapter contains general project QC guidance to be used with the
subsequent chapters and methods in this manual. It should be noted that several methods (e.g.,
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Method 8000) also contain general QC criteria and guidance that pertain to the individual methods
referenced therein (e.g., Methods 8081, 8082, 8260 and 8270). Individual methods may also
contain QC criteria specific only to that method. The QC criteria in the general methods take
precedence over chapter QC criteria. Method­specific QC criteria take precedence over general
method QC criteria.

1.1 PLANNING

Planning, the first phase of a project’s life cycle, involves the development of project
objectives and acceptance or performance criteria using a systematic process. Data quality
objectives (DQOs) and a sampling and analysis design are established to generate data of an
appropriate type, quality and quantity to meet project objectives. The final output of this phase is
a planning document, such as a QAPP, and/or a sampling and analysis plan (SAP) or a waste
analysis plan (WAP).

This section provides guidance on activities and concepts that EPA recommends to be used
or considered during the planning phase, when appropriate to a specific project.

1.1.1 Systematic Planning

Systematic planning is a process designed to ensure that the level of detail in planning is
commensurate with the importance and intended use of the work and the availability of resources
to accomplish it. The ultimate goal of systematic planning is to ensure collection of the
appropriate type, quantity, and quality of data to support decisions with acceptable confidence.
Following is a summary of EPA’s Agency­wide guidance on systematic planning. More detail can
be found in the EPA Quality Manual for Environmental Programs (CIO­2105­P­01­0).

The systematic planning process generally involves the following elements:

• Identification and involvement of data generators and users.

• Identification of project schedule, milestones, resources (including budget), and any

applicable requirements.

• Description of the project goals and objectives (i.e., what is trying to be accomplished
by performing this project)

• Identification of the type (e.g., individual data points to be used to estimate risk at a site,
multi­point composites to be used to evaluate the average concentration in a decision
unit), quantity and quality (e.g., screening for the presence/absence of an analyte,
definitive data supported by all method specific QC results) of data needed. Be specific
on what kind of analytical result will be needed to make a decision, whether the
collected results need to be comprehensive and meet well defined DQOs or are
merely for screening purposes to make a presence/absence decision?

• Specification of acceptance or performance criteria for ensuring the data collected

meets the needs of the project.

• Description of how, when, and where the data will be obtained, and identification of any
constraints on data collection.

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 • Specification of QA and QC activities needed to assess quality performance criteria
(e.g., QC samples for the field and laboratory, audits, technical assessments,
performance evaluations, etc.).

• Description of how acquired data will be analyzed (i.e., field and/or laboratory),
evaluated, and assessed against performance criteria. If statistical assumptions are
made as part of the planning process, the assessment must discuss how the
assumptions will be verified as accurate, and what actions will be taken if the statistical
assumptions are not supported by the data.

Planners should also recognize that existing data (i.e., secondary data) can be useful in supporting
decision making. Secondary data can provide valuable information to help design a plan for
collecting new data, while also lowering the cost of future data collection efforts. However, the
limitations on using any secondary data must be clearly understood and documented. For
example, secondary data must be examined to ensure that their quality is acceptable for a given
application. Combining secondary data with current data can be a complex operation and should
be undertaken with care. Sometimes, statistical expertise is necessary to evaluate both data sets
before they can be combined. If combining data sets, make sure historical data use is appropriate
in type and quality to the current project.

1.1.2 DQOs

The DQO process, discussed in detail in the Guidance on Systematic Planning Using the 

Data Quality Objectives Process, EPA QA/G­4, is designed to produce scientific and
resource­effective data collection designs that will support decision making with a defined level of
confidence.

The DQO process can be applied to any study, regardless of its size. While there is no
regulatory obligation to use the DQO process, it is the recommended planning approach for most
EPA data collection activities. The depth and detail of DQO development will depend on the study
objectives. The DQO process is particularly applicable to a study in which multiple decisions must
be reached. By using the DQO process, the planning team can clearly separate and delineate
data requirements for each decision to be made or question to be answered. It consists of seven
planning steps that are summarized below.

1.1.2.1 Step 1: State the Problem

The purpose of Step 1 is to clearly define the problem that has created the need for
the study. In describing the problem, especially for more complex sites, it is often useful to
include a conceptual site model (CSM). The CSM is a three­dimensional "picture" of site
conditions at a discrete point in time that conveys what is known or suspected about the
facility, including releases, release mechanisms, contaminant fate and transport, exposure
pathways, potential receptors, and risks.

1.1.2.2 Step 2: Identify the Goals of the Study

The purpose of Step 2 of the DQO process is to identify the key questions that need
to be answered in order to resolve the problem(s) identified in Step 1. Step 2 should also
identify any actions that may be taken based on study results. The goals of the study and
the alternative actions are then combined to form decision statement(s) that will resolve the
problem. A decision statement defines which of the identified alternative actions will be
pursued depending on the outcomes of the study.

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 1.1.2.3 Step 3: Identify the Information Inputs

The purpose of Step 3 of the DQO process is to identify the information needed to
resolve the decision statement. This may include, but is not limited to:

• Primary data, including sampling and analysis methods

• Secondary data, including the necessary information to ensure the data is of
known and documented quality (e.g., sampling and analysis methods used as
well as sufficient information to evaluate the quality of the data)
• Action limits to be considered
• Background information about the site or process, including known or
anticipated variability of the study parameters that may help the planning team
identify critical sampling locations

1.1.2.4 Step 4: Define the Boundaries of the Study

The purpose of Step 4 of the DQO process is to define the spatial and temporal
boundaries for the data collection design, including where samples will be collected. Spatial
boundaries describe the physical area (i.e., horizontal and vertical boundaries) of the study.
They can include geographic area or volume of material. Temporal boundaries include both
the period of time the data collection effort will represent and the timeframe to which the
decision will apply.

1.1.2.5 Step 5: Develop the Analytic Approach

The purpose of Step 5 of the DQO process is to consider the outputs from Steps 1­
4 and develop “If..., then... else” decision rules that unambiguously state which of the
alternative actions identified in Step 2 will be pursued. These if/then/else decisions should
be formulated to be dependent on how the results of the study compare to an established
action level.

1.1.2.6 Step 6: Specify Performance or Acceptance Criteria

The purpose of Step 6 of the DQO process is to set limits on decision errors, and to
document those limits. For judgmental and random samples, Step 6 should examine
consequences of making incorrect decisions, and place acceptable limits on the likelihood of
making decision errors. For random samples, Step 6 should specify any statistical
hypothesis to be considered and all applicable statistical tests that will be used to assess the
data.

1.1.2.7 Step 7: Develop the Plan for Obtaining Data

The purpose of Step 7 of the DQO process is to develop the data collection plan that
will satisfy the objectives presented in Steps 1 through 6. RCRA Waste Sampling Draft 
Technical Guidance, dated August 2002, provides guidance that may be used during
sampling design development. EPA also developed a guidance document called Guidance 
for Choosing a Sampling Design for Environmental Data Collection (QA/G­5S), to specifically
provide the information needed to carry out step 7 and develop a sampling design.

The proposed plan should be the most resource­effective data collection design that
meets the previously identified performance or acceptance criteria. The plan for obtaining
data is documented in detail by developing a project QAPP as per EPA Requirements for 

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 Quality Assurance Project Plans (QA/R­5), which presents the requirements for QAPPs, and
its companion document, EPA Guidance for Quality Assurance Project Plans (QA/G­5).

1.1.3 Development of QAPPs, Waste Analysis Plans (WAPs) and Sampling and Analysis
Plans (SAPs) 
 
Documentation of planning processes and outcomes are critical to the:

• effective communication of planned activities to all participants in the process,

• reconstruction of completed events, and
• reconciliation of the analytical data with the project plans.

Two types of planning documents are discussed in this section. Section 1.1.3.1 discusses
QAPPs, which are a key output of the systematic planning process. Section 1.1.3.2 discusses
WAPs and SAPs.

1.1.3.1 QAPPs

All environmental data collection efforts performed by or funded by EPA (e.g.,

through an EPA contractor) must be supported by an approved QAPP. EPA also
recommends the use of QAPPs for environmental data collection efforts by other entities
(e.g., by other regulated entities in compliance with the RCRA regulations). EPA has issued
several documents to aid in preparing QAPPs, including the documents noted in Section
1.1.2.7. These documents provide suggestions for both EPA and non­EPA organizations
on preparing, reviewing, and implementing QAPPs.

The primary purpose of the QAPP is to present the data collection activities to be
implemented, including all necessary QA and QC, to ensure that all data produced are of
known and documented quality, and that the data will satisfy the stated performance criteria.

QAPPs, and any accompanying WAPs or SAPs, should be accessible to all

participants throughout the life of the project. They should provide understandable
instructions to those who must implement the QAPP, such as the field sampling team, the
analytical laboratory, modelers, and the data reviewers.

When preparing a QAPP, a graded approach should be used to determine the level of
detail needed. This will ensure that the level of information presented is consistent with the
intended use of the results and the degree of confidence needed in the quality of the results.
The QAPP should be detailed enough to provide a clear description of every aspect of the
project, from site history through assessment of the planned data collection. At a minimum,
the QAPP should provide sufficient detail to demonstrate that:

• the project technical and quality objectives are identified and agreed upon;

• the intended measurements and data generation or data acquisition methods

are appropriate for achieving project objectives;

• assessment procedures are sufficient for confirming that data of the type and
quality needed and expected are obtained; and

• any limitations on the use of the data can be identified and documented.

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 As described in QA/R­5 and QA/G­5, the QAPP should be composed of standardized,
recognizable elements covering the entire project from planning through assessment.
These elements may be divided into the following four general groups:

• Project Management ­ The elements in this group address project organization

and management; site background and history; and project objectives. These
elements ensure that project goals are clearly defined, that the participants
understand the goals and the approach to be used, and that the planning
process is documented.

• Data Generation and Acquisition ­ The elements in this group address all
aspects of project design and implementation, including the numbers, types,
and locations of all samples to be collected; the rationale for why the proposed
data collection effort will be sufficient to address the study objectives; all
sampling, subsampling and analytical procedures to be followed (i.e., both
sample preparation as well as determinative procedures); QC requirements for
all applicable field and laboratory procedures including the data quality
indicators (DQIs) discussed below in Section 1.1.4; instrument calibration and
maintenance for both field and laboratory equipment; use of secondary data;
and data management. Implementation of these elements ensures that
appropriate methods for sampling, analysis, data handling, and QC activities
are employed and properly documented.

• Assessment and Oversight ­ The elements in this group address the activities
for assessing the effectiveness of project implementation and associated QA
and QC activities. The purpose of assessment is to ensure that the QA Project
Plan is properly implemented as prescribed.

• Data Validation and Usability ­ The elements in this group address the QA
activities that occur after data collection or generation is completed. These
elements address how data will be reviewed, verified and validated as well as
how data will be assessed and reconciled with the project objectives.

While most QAPPs will describe project­ or task­ specific activities, there may be occasions
when a generic QAPP may be more appropriate. A generic QAPP addresses the general,
common activities of a program that are to be conducted at multiple locations or over a long
period of time. For example, a generic QAPP may be useful for a large monitoring program
that uses the same methodology at different locations. A generic QAPP describes, in a
single document, the information that is not site or time­specific but applies throughout the
program. Application­specific information is then added to the approved QAPP, either in the
form of a site­specific QAPP, QAPP Addendum, or SAP.

1.1.3.2 WAPs and SAPs

In certain cases, WAPs or SAPs are required by a RCRA regulation. For example,
WAPs are required as part of a permit application. Where WAPs or SAPs are required by
regulation, the applicable regulations should be reviewed to ensure that the content and
format requirements for the WAP or SAP are understood. Additionally, it should be noted
that EPA has prepared various guidance documents to assist in preparing WAPs and SAPs
that meet various regulatory requirements. Examples of these guidance documents include
the following:

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 • EPA guidance on the preparation of WAPs can be found in the document
entitled Waste Analysis at Facilities that Generate, Treat, Store and Dispose of 
Hazardous Wastes (ECDIC 2002­011), dated April 1994.
• EPA guidance on SAPs for delisting petitions can be found in the document
entitled EPA RCRA Delisting Program Guidance Manual for the Petitioner,
dated March 2000.
• General SAP guidance can be found in EPA’s RCRA Waste Sampling Draft 
Technical Guidance, dated August 2002.
• Chapter 9 of this document (Test Methods for Evaluating Solid Waste, 
Physical/Chemical Methods ­ SW­846) presents additional discussion on
sampling plans.

A QAPP may also be prepared, and required, as a supplement to any WAP or SAP. It
should also be noted that if a WAP or SAP is not required by regulation, QAPPs can be
prepared such that they present sufficient detail to cover both the QAPP and WAP or SAP in
a single document. If a WAP or SAP is prepared along with a QAPP, it is common for these
documents to reference one another for necessary information. To enhance the usability of
QAPPs and WAPs/SAPs, references between the documents should be specific, providing
the full document name, section number, subsection, and page number.

1.1.4 Data Quality Indicators

As part of systematic planning, measurement performance criteria for DQIs must be

established and documented for each data collection effort. DQIs apply to both laboratory and
field activities. At a minimum, DQIs should include precision, accuracy, representativeness,
comparability, and completeness (PARCC). The following presents a discussion of PARCC and
other DQIs.

1.1.4.1 Precision

Precision measures the agreement among a set of replicate measurements. Field

precision is assessed through the collection and analysis of field duplicates. Analytical
precision is estimated by duplicate/replicate analyses, usually on laboratory control samples,
spiked samples and/or field samples. The most commonly used estimates of precision are
the relative standard deviation (RSD) and, when only two samples are available, the relative
percent difference (RPD).

1.1.4.2 Accuracy

Accuracy is the closeness of a measured result to an accepted reference value.

Accuracy is usually measured as a percent recovery. QC analyses used to measure
accuracy include standard recoveries, laboratory control samples, spiked samples, and
surrogates.

1.1.4.3 Representativeness

Sample representativeness expresses the degree to which data accurately and

precisely represents a characteristic of a population, parameter variations at a sampling
point, a process condition, or an environmental condition. It is dependent on the proper
design of the sampling program and will be satisfied by ensuring the approved plans were
followed during sampling and analysis.

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 1.1.4.4 Comparability

Comparability expresses the degree of confidence with which one data set can be
compared to another. It is dependent upon the proper design of the sampling program and
will be satisfied by ensuring that the approved plans are followed and that proper sampling
and analysis techniques are applied. Further, when assessing comparability, data sets
should be of known and documented quality.

1.1.4.5 Completeness

Completeness is a measure of the amount of valid data collected compared to the

amount planned. Measurements are considered to be valid if they are unqualified or
qualified as estimated data during validation. Field completeness is a measure of the
number of samples collected versus the number of samples planned. Laboratory
completeness is a measure of the number of valid measurements compared to the total
number of measurements planned.

1.1.4.6 Bias

Bias is the systematic or persistent distortion of a measurement process that causes

error in one direction (e.g., the sample measurement is consistently lower than the sample’s
true value). Bias can be introduced during sampling, analysis, and data evaluation.
Sampling bias is best addressed through the proper selection and use of sampling tools,
uses of correct sampling and subsampling procedures to limit preferential selection or loss of
sample media, use of random sampling designs, and use of sample handling procedures that
limit the loss or gain of constituents to the sample media. Analytical bias refers to deviation
in one direction (i.e., high, low or unknown) of the measured value from a known spiked
amount. Analytical bias can be assessed by comparing a measured value in a sample of
known concentration to an accepted reference value or by determining the recovery of a
known amount of contaminant spiked into a sample (matrix spike). The planning team
should specify qualitative criteria for sampling bias and quantitative criteria for analytical bias,
typically expressed as "percent recovery."

1.1.4.7 Reproducibility

Analytical reproducibility is a quantitative indicator that is used when referring to the

uncertainty associated with the use of multiple laboratories for a specific study. The ability
of multiple laboratories to generate the same result for splits of the same sample can be
expressed as a measure of interlaboratory precision and bias. Specific indicators of
precision and bias (such as range or variance) are generated using data from replicate
samples sent to multiple laboratories.

1.1.4.8 Repeatability

Repeatability is a quantitative indicator that in used within a single laboratory (i.e.,

intralaboratory precision). It is determined when the laboratory, analyst, test method and
equipment remain constant and random aliquots of the same sample are analyzed within a
short period of time.

1.1.4.9 Sensitivity

Sensitivity is an instrument’s or method’s minimum concentration that can be reliably

measured or reported (i.e., or lower limit of quantitation [LLOQ]).

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 Please note the glossary section to this chapter includes further discussion of the
DQIs.

1.2 IMPLEMENTATION

Implementation is the second phase of the project life cycle. The implementation phase includes
the following steps:

1.2.1 Standard Operating Procedures (SOPs)

SOPs are written documents that describe, in detail, the routine procedures to be followed for
a specific operation, analysis, or action. Please note, in most cases, referencing a given method
or method number is not sufficient, unless the method is performed exactly as written (e.g., a
method­defined parameter). Laboratories must have an SOP to demonstrate that their procedure
meets the conditions of the referenced method. Information on how to prepare SOPs can be
found in EPA’s Guidance for the Preparation of Standard Operating Procedures (QA/G­6), dated
April 2007.

SOPs enable tasks to be accomplished reproducibly, even if there are changes in the
personnel performing them. Consistent use of an approved SOP ensures conformance with
organizational practices, reduction in the frequency of errors, and improved data comparability and
defensibility. SOPs also serve as resources for training and for ready reference and
documentation of proper procedures.

The SOPs, and/or procedures described in the QAPP, must be followed for all project
activities from sample collection to validation. If project­specific modifications to SOPs are
needed, they must also be presented in the QAPP. Field and laboratory SOPs should be
provided for the areas discussed below, as applicable:

• Sample Custody SOPs that describe sample receipt and handling; sample storage;
sample security and tracking; and holding times
• Sample collection
• Analytical Method SOPs, including subsampling, sample preparation/clean­up,
calibration, QC, and analysis
• Reagent/Standard Preparation and Traceability SOPs
• Equipment Calibration and Maintenance SOPs
• Corrective Action SOPs
• Data Reduction SOPs
• Data Reporting SOPs
• Records Management SOPs
• Waste Disposal SOPs

As indicated above, the QC associated with each method may be provided in appropriate SOPs.
The types of QC parameters to include in the SOPs and QAPP are defined in the glossary of this
chapter. Since the QC acceptance limits are frequently adjusted more often than SOPs are
revised, it may be impractical to update SOPs as these limits change. Therefore, field and
laboratory QC limits may need to be presented in QAPP tables rather than SOPs.

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 1.2.2 Conducting the Study/Experiment

The data collection effort is performed in accordance with approved plans (e.g., QAPP).
The QAPP will present all proposed methods (i.e., including sampling, subsampling, preservation,
preparation, clean­up and determinative methods), as well as a rationale for why the proposed
methods are sufficient to meet the project DQOs.

The QAPP should also indicate whether the proposed analyses include method­defined
parameters and/or whether the flexible approach to methods will be utilized. For the flexible
approach, the QAPP must also demonstrate that the proposed methods are adequate to reach the
study goals outlined in the DQOs.

1.2.2.1 Method­defined parameters

Method­defined parameters (MDP), such as the Toxicity Characteristic Leaching

Procedure (TCLP), have been written into regulations, the methods should be followed
without deviation, and should not to be modified on a project basis. For a list of
method­defined parameters, see Vol 40 CFR 260.11 references or the Methods Innovation
Rule (MIR), in Volume 70, Number 113 of the Federal Register (70 FR 34537 Table 3). Some
method­defined parameters are discussed in Chapter 8 of this manual.

1.2.2.2 Flexible Approach to Environmental Measurements

The Flexible Approach to Environmental Measurement was finalized in 2008 as

EPA’s preferred approach for environmental monitoring except in cases where methods are
required by regulation.

The goals of the flexible approach are to:

• Provide method users flexibility when choosing sampling and analytical

approaches to meet regulatory requirements for measurements
• Develop processes for validation to confirm measurements meeting quality
requirements
• Increase collaboration with stakeholders to develop validation processes for
new measurement technology
• Ensure timely assessment of new or modified technologies, methods, and
procedures.

Chapter Two of this manual entitled, "Choosing the Correct Procedure” provides additional
guidance regarding the selection of appropriate methods and method flexibility.

1.2.3 � Technical Assessments

Technical Assessments (otherwise known as audits) are systematic and objective

examinations of a program or project to determine whether environmental data generation
activities and related results comply with planning documents. Technical assessments can be
performed to evaluate all phases of a project including field sampling, laboratory analysis,
validation and data handling/management.

The QAPP should identify all personnel responsible for performing technical assessments,
the authority of the auditor (e.g., do they have the authority to stop work if significant deviations
from planning documents are found), and the planned audit frequency. Additionally, if technical
assessments are planned or required as part of a project, the QAPP should provide the applicable

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technical assessment checklists. These checklists establish and document the scope of all
proposed technical assessments. The development of these technical assessment checklists
should overseen by an independent party (i.e., someone not involved in the day to day operations
of a project), such as the organization’s QA personnel. Further, the QAPP should establish a
process for correcting technical assessment findings and confirming implementation of any
corrective actions taken as a result of the findings.

While most technical assessments will be scheduled in advance with an organization, there
may be occasions when unannounced technical assessments are needed. However, an
unannounced audit may not reveal a representative picture of project activities if it occurs when the
project is not active, or activities that are not within the scope of the technical assessment are
occurring.

Technical assessments may be planned as part of the pre­award activities, or throughout the
life of a project. For example, pre­award audits, including performance evaluation (PE) samples,
are useful tools in determining the ability of a laboratory to perform the proposed analytical work.
Additionally, technical assessments may also be used as an investigative tool where problems
may be suspected. The EPA document Guidance on Technical Audits and Related Assessments
for Environmental Data Operations (QA/G­7), dated January 2000, provides detailed information
on various types of technical audits and includes an example checklist for a technical systems
audit of a laboratory measurement system.

1.3 ASSESSMENT

Following planning (Sec. 1.1) and implementation (Sec. 1.2), assessment is the third and
final phase of the project data generation life cycle. The purpose of this phase is to evaluate
whether the data are of the type, quantity and quality needed to meet project DQOs. Assessment
can involve many different complex activities, including the use of statistical tools. This section
provides an introduction and overview of these data assessment activities.

1.3.1 Data Verification and Validation

Data verification and/or validation is the first step in the assessment process. Validation and
verification are defined in the EPA Guidance on Environmental Data Verification and Data
Validation (QA/G­8), dated November 2002. According to QA/G­8, verification is the process of
evaluating the completeness, correctness, and conformance/compliance of a data set against a
specified set of requirements. QA/G­8 defines validation as an analyte and sample specific
process that extends the evaluation of data beyond data verification to determine its analytical
quality. For the purposes of this chapter, it should be noted that the meaning of verification and
validation is often program, organization and/or system specific. Further, these terms are used
interchangeably at times, and in other cases have very different meanings. Therefore, it is critical
that the procedures for verification and/or validation be clearly documented in the approved QAPP.

In general, data verification/validation involves the examination and review of project data
(e.g., field and laboratory data for all applicable QC measurements) to confirm that the sampling
and analysis protocols specified in the QAPP (and any other planning or contractual documents)
were followed. Data verification/validation also involves examining whether the data met the
method performance and acceptance criteria established in the project QAPP. When these
criteria are not met, data verification/validation procedures should include qualification of the data
(e.g., the J qualifier is commonly used to indicate estimated data and the R qualifier is commonly
used to indicate rejected data). The reasons for any failure to meet performance criteria also

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need to be documented during this phase of assessment (e.g., in a data verification/validation
report).

In addition to QA/G­8, EPA has published several references which provide more detailed
information on what should be included in data verification and validation procedures. These
include EPA regional and programmatic validation guidance documents that may apply to
particular projects. It is also common for EPA guidance from one program or region to be
modified for use in another area. While this may be acceptable, any modifications or changes to
the established validation procedures should be included in the approved QAPP.

Data verification/validation may be performed at various phases throughout a project. As

such, the procedures for verifying and/or validating data may need to be described in laboratory
SOPs and/or QA Plans, in addition to the project documents like the QAPP. Corrective action
based on verification/validation findings may also need to be described in these documents.

Data verification/validation activities may be performed internally (e.g., when the laboratory
or data collector review their own data), or externally by an independent entity (i.e., a party that is
not associated with the data collection effort). Internal and external data verification/validation
procedures should be defined in the QAPP or other project documents.

A data verification/validation report should be generated to document the procedures

followed as well as the findings and qualifications applied during data verification/validation. The
report should include a list of the samples collected, field information about how the samples were
collected, the analyses performed on the samples, the results of the analysis and the quality of the
reported data, at a minimum. The usability of this report can be enhanced by listing the samples
and analytes affected by each QC criteria exceedance, as well as the extent of the exceedance,
and any qualifiers applied. Any other observations noted by the data reviewer that may impact
the usability of the data should also be documented.

1.3.2 Data Quality Assessment

Data quality assessment (DQA) is the second step in the assessment process. DQA is
often needed because data verification/validation alone is generally not sufficient to determine
whether a data set can be used for its intended purpose. Typically, the DQA follows the data
verification and/or validation step.

In general, the DQA should include an evaluation of overall trends or biases in the data and
associated QC results, as well as how the data may be affected. For random data sets, the DQA
should evaluate the validity of any statistical assumptions made during the planning phase. If the
statistical assumptions made during the planning phase are not supported by the data,
recommendations for corrective action should be presented. All DQA findings should be
summarized in a report.

Guidance documents available from EPA that discuss the DQA process include Data Quality 
Assessment: A Reviewer’s Guide (QA/G­9R), dated February 2006, and Data Quality 
Assessment: Statistical Tools for Practitioners (QA/G­9S), dated February 2006.

The DQA process described in this guidance is a five­step process.

Step 1: Review the Data Quality Objectives and Sampling Design

Step 2: Conduct a Preliminary Data Review
Step 3: Select the Statistical Method
Step 4: Verify the Assumptions of the Statistical Method

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 Step 5: Draw Conclusions from the Data

It is recommended that the data user refer to these guidance documents, because they
provide extensive information about DQA and the statistical tools that can be employed.

Although the DQA process described in QA/G-9R and QA/G-9S includes a significant
amount of statistical procedures, it should be noted that the DQA process is not only applicable to
random data sets, where statistics can be used to assess the data. A DQA should also be
performed on judgmental, or biased, data sets. The process for how any data set will be
assessed should be determined during the planning phase, and documented in the QAPP or other
site documents.

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 FIGURE 1-1

PROJECT LEVEL EPA QA SYSTEM

Systematic Planning
(e.g., DQO Process)

QA
Project Plan

Technical
Assessments

Conduct Study/
Experiment Standard
Operating
Procedures

Data Verification
& Validation
Planning Implementation

Assessment

Data Quality
Assessment

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1.4. REFERENCES AND SOURCES FOR ADDITIONAL QA/QC INFORMATION

1. USEPA. Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA
QA/G-4. Quality Staff, Office of Environmental Information, United States Environmental
Protection Agency, Washington, D.C. February 2006.

2. USEPA. EPA Quality Manual for Environmental Programs CIO 2105-P-01-0. Office of
Environmental Information Quality Staff, United States Environmental Protection Agency,
Washington, D.C. May 5, 2000.

3. USEPA. Guidance on Choosing a Sampling Design for Environmental Data Collection, EPA
QA/G-5S. Quality Staff, Office of Environmental Information, United States Environmental
Protection Agency, Washington, D.C. December 2002.

4. USEPA. Guidance on Environmental Data Verification and Data Validation, EPA QA/G-8.
Quality Staff, Office of Environmental Information, United States Environmental Protection
Agency, Washington, D.C. November 2002.

5. USEPA. Data Quality Assessment: A Reviewer’s Guide, QA/G-9R. Quality Staff, Office
of Environmental Information, United States Environmental Protection Agency, Washington,
D.C. February 2006.

6. USEPA. Data Quality Assessment: Statistical Tools for Practitioners, QA/G-9S. Quality
Staff, Office of Environmental Information, United States Environmental Protection Agency,
Washington, D.C. February 2006.

7. USEPA. Guidance for Preparing Standard Operating Procedures, EPA QA/G-6. Quality
Staff, Office of Environmental Information, United States Environmental Protection Agency,
Washington, D.C. April 2007.

8. USEPA. RCRA Waste Sampling Draft Technical Guidance. Office of Solid Waste, United
States Environmental Protection Agency, Washington, D.C. August 2002.

9. USPEA. Guidance for Quality Assurance Project Plans, EPA QA/G-5. Quality Staff, Office
of Environmental Information, United States Environmental Protection Agency, Washington,
D.C. December 2002.

10. USEPA. EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5. Quality
Staff, Office of Environmental Information. United States Environmental Protection Agency,
Washington, D.C. March 2001.

11. USEPA. RCRA Delisting Program Guidance Manual for the Petitioner. United States
Environmental Protection Agency, March 23, 2000.

12. USEPA. Waste Analysis at Facilities That Generate, Treat, Store and Dispose of
Hazardous Wastes, ECDIC 2002-011. Office of Waste Programs Enforcement, United
States Environmental Protection Agency. April 1994.

13. USEPA. Guidance on Technical Audits and Related Assessments for Environmental Data
Operations, QA/G-7. Quality Staff, Office of Environmental Information, United States
Environmental Protection Agency, Washington, D.C. January 2000.

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1.5. GLOSSARY

Also see the following for a glossary of quality-related terms developed by EPA:

http://www.epa.gov/fem/pdfs/Env_Measurement_Glossary_Final_Jan_2010.pdf

ACCURACY The degree of agreement between an observed value and an accepted

reference value. When applied to a set of observed values, accuracy
includes a combination of a random error (precision) and systematic
error (bias) components.

ANALYTICAL BATCH A group of samples, including quality control samples, which are
processed together using the same method, the same lots of reagents,
and at the same time or in continuous, sequential time periods.
Samples in each batch should be of similar composition and share
common internal quality control standards. For QC purposes, if the
number of samples in a batch is limited to 20; laboratory QC samples
are not included in the batch count.

Each batch should be uniquely identified within the laboratory for

tracking purposes. Samples collected from the same site would
normally be grouped together for batching purposes within the
constraints imposed by the method holding times and batch size.
Samples prepared in the same batch would normally be analyzed
together on a single instrument. However, laboratories may find it
necessary to group multiple clients’ samples into a single batch. Under
these circumstances, additional matrix QC samples (i.e., duplicates,
matrix spikes) may be needed to evaluate the effect of the matrix from
each site on method performance.

BIAS The constant or systematic distortion of a measurement process,

different from random error, which manifests itself as a persistent
positive or negative deviation from the known or true value. This can
result from improper data collection, poorly calibrated analytical or
sampling equipment, or limitations or errors in analytical methods and
techniques.

Bias can be assessed by comparing a measured value to an accepted

reference value in a sample of known concentration or by determining
the recovery of a known amount of contaminant spiked into a sample
(matrix spike). Thus, the bias (B) due to matrix effects based on a
matrix spike is calculated as:

B = (xs - xu ) - K
where:

xs = measured value for spiked sample,

xu = measured value for unspiked sample, and
K = known value of the spike in the sample.

Using the following equation yields the percent recovery (%R).

%R = 100 (xs - xu)/ K

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BLANK Blanks are generally considered to be acceptable if target analyte
concentrations are less than ½ the LLOQ or are less than
project-specific requirements. Blanks may contain analyte
concentrations greater than acceptance limits if the associated
samples in the batch are unaffected (i.e. targets are not present in
samples or sample concentrations are ≥10X the blank). Other criteria
may be used depending on the needs of the project. For method
specific details see methods 6010, 6020 for inorganics and Method
8000 for organics).

See also Calibration Blank, Equipment Blank, Method Blank, Reagent

Blank and Trip Blank.

CALIBRATION BLANK A calibration blank is a sample of analyte-free media that can be used
along with prepared standards to calibrate the instrument. A
calibration blank may also be used to verify absence of instrument
contamination (e.g., initial calibration blank and continuing calibration
blank).

CALIBRATION CHECKS Calibration check analyses are used to assess calibration drift and
memory effects over time for each analytical system. These analyses
may include zero, span (low and high) to cover the full calibration
range, and mid-range checks, depending on the method.

CALIBRATION CURVE A plot of instrument response to an analyte versus known

concentrations or amounts of analyte standards. Calibration
standards are prepared by successively diluting a standard solution to
produce working standards which cover the working range of the
instrument. Standards should be prepared at the frequency specified
in the appropriate method. The calibration standards should be
prepared using the same type of acid or solvent and at the same
concentration as the samples following sample preparation. This is
applicable to organic and inorganic chemical analyses.

CO-LOCATED A type of field duplicate where independent samples are collected as

SAMPLES close as possible to the same point in space and time. They are two
separate samples taken from the same source, stored in separate
containers, and analyzed independently by the same method and
laboratory. These duplicates are useful in documenting the precision
of the sampling process.

COMPARABILITY The degree to which different methods or data agree or can be

represented as similar. Comparability describes the confidence that
two data sets can contribute to a common analysis and interpolation.

COMPLETENESS A measure of the amount of valid data obtained from a measurement

system compared with the amount that was expected to be obtained
under correct, normal conditions. Percent completeness is calculated
as:
x
% Completeness = x 100
y
where:
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 x = amount of valid data obtained
y = amount of data expected to be obtained

DATA QUALITY The quantitative statistics and qualitative descriptors that are used to
INDICATORS (DQIs) interpret the degree of acceptability or utility of data to the user. The
principal indicators of data quality are precision, bias, accuracy,
representativeness, comparability, completeness, and sensitivity.

DATA QUALITY Qualitative and quantitative statements derived from the DQO Planning
OBJECTIVES (DQOs) Process that clarify the purpose of the study, define the most
appropriate type of information to collect, determine the most
appropriate conditions from which to collect that information, and
specify tolerable levels of potential decision errors.

DATA VALIDATION The process of evaluating the available data against the project DQOs
to make sure that the objectives are met. Data validation may be very
rigorous, or cursory, depending on project DQOs. The available data
reviewed will include analytical results, field QC data, laboratory QC
data, and may also include field records.

DUPLICATE See Co-located Samples, Laboratory Duplicate, Field Duplicate, Field

Split Samples, and Matrix Spike Duplicate.

EQUIPMENT BLANK A sample of analyte-free media which has been used to rinse the
sampling equipment. It is collected after completion of
decontamination and prior to sampling at a location. This blank is
useful in documenting adequate decontamination of sampling
equipment.

EQUIPMENT RINSATE See Equipment Blank.

FIELD BLANK Field blanks include any sample submitted from the field that is
identified as a blank. These include trip blanks, rinsates, equipment
blanks, etc.

Field blanks may also be obtained by the sampling organization to

measure ambient contamination in the field. If this type of field blank is
requested, a container of reagent water or a solid blank material is
opened in the field for a predefined period of time. The sample is then
sent to the laboratory for analysis.

FIELD DUPLICATES Field duplicates are useful in documenting the precision of the
sampling process. Field duplicates are used to assess improper
homogenization of the samples in the field; reproducibility of sample
preparation and analysis; and, heterogeneity of the matrix.

See also Co-located Samples and Field Split Samples.

FIELD SPLIT SAMPLES A type of field duplicate where the sample is homogenized and then
divided into two or more aliquots so that variability can be evaluated,
(i.e., often between laboratories or methods). Homogenization may
have an impact on sample integrity for some sample types (e.g., VOCs

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 in soil), and in these cases co-located samples may be more
appropriate.

INITIAL Prior to the analysis of samples an initial demonstration of method

DEMONSTRATION of proficiency is accomplished through the successful calibration of
PROFICIENCY (IDP) method-specific instruments according to project requirements and
criteria set forth in the applicable analytical methodology. This initial
demonstration should be performed prior to independently running an
analytical method, and should be repeated if other changes occur (e.g.,
instrument repair, significant change in procedure).

Please see individual methods for additional guidance on IDP.

INTERNAL STANDARD Internal standards may be spiked into prepared field samples and QC
samples (or sample extracts). Their recovery is generally used to
demonstrate the lack of severe matrix effect in the instrumental
analysis by setting criteria for the internal standard response in
comparison to a response in a sample with a known lack of matrix
effect (i.e., a standard). Internal standards are also used to account
for matrix effects and/or variability in instrument response by
normalizing the response of the target analytes and surrogates,
thereby decreasing measurement bias to the extent that their behavior
mimics that of the target analytes.

LABORATORY The Laboratory Control Sample (LCS) is analyzed to assess general

CONTROL method performance based on the ability of the laboratory to
SAMPLE successfully recover target analytes from a control matrix. The LCS is
similar in composition to the method blank in that it is an aliquot of
analyte-free water or analyte-free solid (e.g., Ottawa sand, anhydrous
sodium sulfate, or other purified solid) to which known amounts of the
method analytes are added. LCS analyses help determine if the
system is running properly (i.e., within pre-defined limits). Although
the frequency of LCS analysis should be determined by the needs of a
project, typically one LCS is prepared and analyzed for every analytical
batch. The LCS sample is prepared and analyzed in the same
analytical batch and in exactly the same manner as the other routine
samples. The recovery of the target analytes in the LCS analysis
demonstrates whether the methodology is in control and the laboratory
is capable of making unbiased measurements. The results of the LCS
are evaluated in conjunction with other QC information to determine the
acceptability of the data generated for that batch of samples.
Acceptance criteria for LCS recovery are calculated based on
statistical treatment of historical LCS recovery data through the use of
control charts.

LABORATORY The analysis or measurements of the variable of interest performed

DUPLICATE identically on two sub-samples of the same sample, usually taken from
the same container. The results from duplicate analyses are used to
evaluate analytical or measurement precision and include variability
associated with sub-sampling and the matrix, but not the precision of
field sampling, preservation, or storage internal to the laboratory.

Laboratory duplicate analysis entails removing two aliquots from the

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 same sample and taking them through the same preparative and
analytical procedures to evaluate analytical precision. Laboratory
duplicates are more commonly used to assess precision for inorganic
and radiological constituents, while precision for organic analyses is
usually assessed by determining the RPD between matrix spike and
matrix spike duplicates. The frequency of laboratory duplicate
analysis will depend on project requirements.

LOWER LIMIT OF The lowest point of quantitation which, in most cases, is the lowest
QUANTITATION (LLOQ) concentration in the calibration curve. The LLOQ is initially verified by
spiking a clean control material (e.g., reagent water, method blanks,
Ottawa sand, diatomaceous earth, etc.) at the LLOQ and processing
through all preparation and determinative steps of the method.
Laboratory-specific recovery limits should be established when
sufficient data points exist. Individual methods may recommend
procedures for verifying the LLOQ and acceptance limits for use until
the laboratory has sufficient data to determine acceptance limits.
LLOQs should be determined at a frequency established by the
method, laboratory’s quality system, or project.

Please see individual methods for additional guidance on implementing

LLOQ (e.g., 8000, 6020).

MATRIX The material of which the sample is composed or the substrate

containing the analyte of interest, such as waste water, storm water
and biosolids. Also called medium or media.

MATRIX SPIKE Matrix spikes are aliquots of environmental samples to which known
concentrations of certain target analytes have been added before
sample preparation, cleanup, and determinative procedures have been
implemented. Matrix spike analysis would normally be included with
each preparation batch of samples processed. Under ideal
circumstances, the original, unspiked, field sample will be analyzed
first, to determine the concentration in the unspiked sample.
However, if this approach is not practical, the samples may be spiked
at the midpoint of the calibration range or at the same level as the LCS.

The matrix spike analysis is used to assess the performance of the

method by measuring the effects of interferences caused by the
sample matrix and reflects the bias of the method for the particular
matrix in question.

MATRIX SPIKE Matrix spike duplicates are additional replicates of matrix spike
DUPLICATES samples that are subjected to the sample preparation and analytical
scheme as the original sample. A matrix spike duplicate sample
would normally be included with each preparation batch of samples
processed. Analysis of spiked duplicate samples ensures a positive
value, allowing for estimation of analytical precision.

Matrix spike duplicates are used to document the precision as well as

bias of a method in a given sample matrix. When critical decisions are
based on the matrix spike and matrix spike duplicate recoveries, the
laboratory should maintain control charts for these samples to monitor

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 precision and bias for each particular matrix.

METHOD BLANK Method blanks are analyzed to assess background interference or

contamination that exists in the analytical system that might lead to the
reporting of elevated concentration levels or false positive data. The
method blank is defined as an interference-free blank matrix, similar to
the sample matrix, to which all reagents are added in the same
volumes or proportions as used in sample preparation and carried
through the complete sample preparation, cleanup, and determinative
procedures. For aqueous analyses, analyte-free reagent water would
typically be used. For soil analyses, a purified solid matrix (e.g., sand)
would typically be used, except for metals analyses. Method blank
results are evaluated in conjunction with other QC information to
determine the acceptability of the data generated for that batch of
samples. The method blank results should be below the LLOQ for the
target analytes being tested; otherwise, corrective action should be
taken. A method blank is included with the analysis of every analytical
batch of 20 samples or less or as stated in the QAPP or method,
whichever is more frequent.

ORGANIC-FREE All references to water in the methods refer to water in which an

REAGENT WATER interferant is not observed at the LLOQ for the compounds of interest.
Preparation of organic-free reagent water may depend on the types
of interferants of concern for the analysis and may include boiling,
sparging with an inert gas, reverse osmosis purification, distillation,
particle filtration, activated carbon filtration, ion exchange filtration,
etc.

POST-DIGESTION Post-digestion spike samples are typically prepared for inorganic

SPIKES analyses when pre-digestion/pre-distillation matrix spike recoveries
are outside the required control limits. They are prepared by spiking
a known amount of standard to the sample digestate. The recovery
data from the post digestion spike analyses are used to further assess
if matrix effects may be a source of measurement bias in sample
quantitation.

PRECISION The agreement among a set of replicate measurements without

assumption of knowledge of the true value. Precision is estimated by
means of duplicate/replicate analyses of separate aliquots of the same
sample (not multiple runs of a single digestion/extraction). These
samples should contain concentrations of analyte at or above the
LLOQ, and may involve the use of matrix spikes. The most commonly
used estimates of precision are:

Relative standard deviation (RSD), also known as the coefficient of

variation (CV):
_
RSD = CV = (100)*(S/x)

where:
_
x = the arithmetic mean of the i measurements, and
S = the square root of the variance of i measurements; and,

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 Relative percent difference (RPD) when only two results are compared:

| −  |

 = ∗ 100
 + 


2

where: x1 and x2 are measurements of independently prepared aliquots

of the same sample or replicate samples.

PROJECT Single or multiple data collection activities that are related through the
same planning sequence.

QUALITY CONTROL A sample made from standards or matrix and used to verify
SAMPLE acceptability of the results from preparation and/or analysis of a batch
of samples. Examples of laboratory quality control samples are
method blanks, laboratory duplicates, and laboratory control samples;
field quality control samples are field blanks, trip blanks, field
duplicates, and matrix spikes.

QUALITY ASSURANCE A formal document describing in comprehensive detail the necessary

PROJECT PLAN quality assurance, quality control, and other technical activities that
(QAPP) should be implemented to ensure that the results of the work
performed will satisfy the stated performance criteria.

REAGENT BLANK Reagent blanks are analyzed to assess background interference or

contamination that exists in the analytical system that might lead to the
reporting of elevated concentration levels or false positive data. The
reagent blank is defined as an interference-free blank matrix, to which
all reagents are added in the same volumes or proportions as used in
sample preparation but are NOT carried through the complete sample
preparation, cleanup, and determinative procedures. The purpose of
a reagent blank is to gauge contamination from chemical inputs and
instrumental factors only. A reagent blank is NOT run as part of a
digestion or preparation method.

REAGENT GRADE Analytical reagent (AR) grade, ACS reagent grade, and reagent grade
are synonymous terms for reagents which conform to the current
specifications of the Committee on Analytical Reagents of the
American Chemical Society.

REAGENT WATER Water that has been generated by any method which would achieve
the performance specifications for ASTM Type II water. For organic
analyses, see the definition of organic-free reagent water.

REFERENCE A material containing known quantities of target analytes in solution or

MATERIAL in a homogeneous matrix. It is used to document the bias of the
analytical process.

REPEATABILITY The degree of agreement between mutually independent test results

produced by the same analyst using the same test method and
equipment on random aliquots of the same sample within a short

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 period of time.
REPRESENTATIVE-
NESS A measure of the degree to which data accurately represent a
characteristic of a population, a parameter variation at a sampling
point, a process condition, or an environmental condition.

REPRODUCIBILITY Reproducibility is defined as the closeness of the agreement between

the results of measurements of the same analyte carried out under
variable conditions of measurement.

STANDARD ADDITION The addition of a known amount of analyte to the sample in order to
determine the relative response of the detector to an analyte within the
sample matrix. The relative response is then used to assess either an
operative matrix effect or the sample analyte concentration.

SURROGATE Surrogates are most commonly used to monitor the performance of

organic analyses using methods such as high performance liquid
chromatography (HPLC), gas chromatography (GC), and gas
chromatography/mass spectrometry (GC/MS). Surrogate spikes are
added to field samples and QC samples for organic analyses at known
amounts, and their recoveries are used to assess matrix effects and, to
some extent, verify proper processing and instrument performance for
each sample. The analytes used as surrogates mimic the behavior of
the target analyte(s) throughout sample preparation and instrument
determination. Surrogates are organic compounds which are similar
to the target analytes in chemical composition and behavior in the
analytical process, but are not normally found in the environmental
samples. Surrogates added to LCS samples and blanks are used to
assess recovery in a matrix known to be free from interference. This
information can be used to determine the magnitude of matrix
interference effects on environmental sample results.

TRIP BLANK A sample of analyte-free media taken from the laboratory to the
sampling site and returned to the laboratory unopened. Trip blanks
should be prepared at a frequency of one per day of sampling during
which samples are collected for volatile organic constituents (VOCs).
Trip blanks are prepared prior to the site visit at the time sample
containers are shipped to the site. The trip blank should accompany
the sampling kits throughout all the sample collection and transport
operations. This blank will not be opened during the sampling
activities and will be used to assess sample VOC contamination
originating from sample transport, shipping, or site conditions. A trip
blank is used to document contamination attributable to shipping and
field handling procedures.

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 APPENDIX A
SUMMARY OF UPDATES/CHANGES IN CHAPTER 1

1. The entire Chapter has been rewritten and reorganized to reflect changes in the EPA data
quality system approach.
2. The revision number was changed to two and the date published to July 2014.
3. This appendix was added to document changes made during the editorial process.
4. The document was updated to match the current SW-846 style guidelines.
5. Figure 1 was added based on information in EPA QA/G-8, November 2002, Figure 1.

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