This document summarizes key EPA guidance documents for environmental quality assurance programs. It discusses the purpose of quality assurance programs to ensure data is scientifically sound and legally defensible. A quality system provides a framework for planning, implementation, and assessment of work. It also describes the data quality objectives process which is a systematic planning tool to ensure data meets the needs of its intended use. EPA SW-846 provides standardized test methods for evaluating waste characteristics under the Resource Conservation and Recovery Act.

1. ENVIRONMENTAL QA
--A PRIMER--
By
Joel Hebdon, Principal
Vanilla Strategies

2. Environmental Quality Assurance
Program Requirements
•“Test Methods for Evaluating Solid Waste, Physical/Chemical Methods” (EPA/SW-846, as amended).
•“Guidance for the Data Quality Objectives Process” (EPA/600/R-96/055) (QA/G-4) 2000, as revised
•“EPA Requirements for Quality Assurance Project Plans” (EPA/240/B-01/0300) (EPA QA/R-5) March
2001, as revised.

3. What Is A Quality System?
A quality system is the means by which an organization manages its quality aspects in a systematic, organized
manner. It provides a framework for planning, implementing, and assessing work performed by an organization
And for carrying out required quality assurance (QA) and quality control (QC) activities. It encompasses a
Variety of technical and administrative elements, including:
• Policies and Objectives;
• Organizational Authorities;
• Responsibilities;
• Accountability, and
• Procedures and Practices

4. Quality Assurance In Region 10
EPA 910/R-88-100
1.
The goal of EPA’s QA program is to ensure that all data generated and used to make decisions
are scientifically sound, of known quality, thoroughly documented and legally defensible.
2.
An additional purpose is to obtain acceptable data at a reasonable cost.
3.
Although “quality” is built into the system, proper planning, audits or inspections, and
final report reviews are essential components of determining if the goals of EPA’s QA
program are being satisfied.
:

5. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
GENERAL
1.
Non-EPA organizations funded by EPA are required to document their quality system in a
Quality Management Plan (or equivalent document) through:
•
•
•
48 CFR 46, for contractors;
40 CFR 30, 31, and 35 for assistance agreement recipients; and
Other mechanisms, such as consent agreements in enforcement actions.
2.
The Quality Management Plan may be viewed as the “umbrella” document under which
individual projects are conducted.
3.
The Quality Management Plan is then supported by project specific QA Project Plans.
4.
In some cases, a QA Project Plan (R-5) and a Quality Management Plan (R-2) may be
combined into a single document that contains both organizational and project-specific elements.
:

6. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
GRADED APPROACH
1.
Implementation of the EPA Quality System is based on the principle of the “Graded Approach”.
2.
This principle recognizes that a “one size fits all” approach to quality requirements will not
work in an organization performing cleanup activities, so managerial controls are applied
according to the scope of the program and/or the intended use of the outputs from a process.
3.
Applying a Graded Approach means that:
Quality systems for different organizations and programs will vary according to the
specific objectives and needs of the organization.

7. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
CONTENT REQUIREMENTS
1.
The mission and quality policy of the organization;
2.
The specific (by name) roles, authorities, and responsibilities of management and staff
with respect to QA and QC activities;
3.
The means by which effective communications with personnel actually performing the work
are assured;
4.
The processes used to plan, implement, and assess the work performed;
5.
The process by which measures of effectiveness for QA and QC activities will be established
and how frequently effectiveness will be measured; and
6.
the continual improvement based on “lessons learned’ from previous experience.

8. EPA Requirements for QA Project Plans for Environmental Data Operations
EPA QA/R-5
QA PLANNING AND DATA LIFE CYCLE
PLANNING
Data Quality Objectives Process
Data Quality Objectives Process
Quality Assurance Project Plan Development
IMPLEMENTATION
Data
Quality
Objectives
Data
Quality
Design
Field Data Collection and Associated
Quality Assurance/Quality Control Activities
Quality Assurance Project Plan Development
ASSESSMENT
Data Validation
Data Quality Assessment
Quality
Assurance
Project
Plan (QAPP)

9. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
ELEMENTS TO BE ADDRESSED
Group A: Project Management
This group of QAPP elements covers the general areas of project management, project history and objectives, and roles
and responsibilities of the participants.
A1
A2
A3
A4
A5
A6
A7
A8
A9
Title and Approval Sheet
Table of Contents and Document Control Format
Distribution List
Project/Task Organization and Schedule
Problem Definition/Background
Project/Task Description
Quality Objectives and Criteria for Measurement Data
Special Training Requirements/Certification
Documentation and Records

10. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
ELEMENTS TO BE ADDRESSED
Group B: Measurement/Data Acquisition
This group of QAPP elements covers all of the aspects of measurement system design and implementation, ensuring
that appropriate methods for sampling, analysis, data handling, and QA are employed and will be thoroughly
documented:
B1 Sampling Process Design (Experimental Design)
B2 Sampling Methods Requirements
B3 Sample Handling and Custody Requirements
B4 Analytical Methods Requirements
B5 Quality Control Requirements
B6 Instrument/Equipment Testing, Inspection, and Maintenance Requirements
B7 Instrument Calibration and Frequency
B8 Inspection/Acceptance Requirements for Supplies and Consumables
B9 Data Acquisition Requirements (Non-Direct Measurements)
B10 Data Management

11. EPA Requirements for Quality Management Plans (QMP)
EPA QA/R-2
ELEMENTS TO BE ADDRESSED
Group C: Assessment/Oversight
The purpose of assessment is to ensure that the QAPP is implemented as prescribed. This group of QAPP elements
addresses the activities for assessing the effectiveness of the implementation of the project and the associated
QA/QC activities:
C1 Assessments and Response Actions
C2 Reports to Management
Group D: Data Validation and Usability
Implementation of Group D elements ensures that the individual data elements conform to the specified criteria, thus
enabling reconciliation with the project’s objectives. This group of elements covers the QA activities that occur after
the data collection phase of the project has been completed:
D1 Data Review, Validation, and Verification Requirements
D2 Validation and Verification Methods
D3 Reconciliation with Data Quality Objectives

12. Guidance for the Data Quality Objectives Process
EPA QA/G-4
OVERVIEW
1.
The DQO Process is a systematic planning process that is part of the Quality System.
2.
When data are being used to select between two alternative conditions (e.g., compliance or
non-compliance with a standard), the recommended systematic planning tool is the Data
Quality Objectives (DQO) Process.
3.
Organizations must ensure that data collected for the characterization of environmental processes
and conditions are of the appropriate type and quality for their intended use and that
environmental technologies are designed, constructed, and operated according to defined
expectations.
4.
ANSI/ASQC E4-1994, Specifications and Guidelines for Environmental Data Collection
and Environmental Technology Programs, recommends:
a.
a.
5.
First documenting each organization-wide quality system in a Quality Management Plan or
Quality Manual (to address requirements of Part A: Management Systems of the standard), and
Then documenting the applicability of the quality system to technical activity-specific efforts
In a Quality Assurance Project Plan or similar document (to address the requirements of
Part B: Collection and Evaluation of Environmental Data of the standard).
EPA QA/G4 addresses the requirements of Part B.

13. Guidance for the Data Quality Objectives Process
EPA QA/G-4
THE DQO PROCESS
Step 1: State the Problem
Define the problem; identify the planning team; examine budget, schedule.
Step 2: Identify the Decision
State decision; identify study question; define alternative actions.
Step 3: Identify the Inputs to the Decision
Identify information needed for the decision (information sources, basis for Action Level, sampling/analysis method).
Step 4: Define the Boundaries of the Study
Specify sample characteristics; define spatial/temporal limits, units of decision making.
Step 5: Develop a Decision Rule
Define statistical parameter (mean, median); specify Action Level; develop logic for action.
Step 6: Specify Tolerable Limits on Decision Errors
Set acceptable limits for decision errors relative to consequences (health effects, costs).
Step 7: Optimize the Design for Obtaining Data
Select resource-effective sampling and analysis plan that meets the performance criteria.

14. Guidance for the Data Quality Objectives Process
EPA SW-846
OVERVIEW
1.
Provides test procedures and guidance which are recommended for use in conducting the
evaluations and measurements needed to comply with the Resource Conservation and
Recovery Act (RCRA), Public Law 94-580, as amended.
2.
SW-846 presents the state-of-the-art in routine analytical testing adapted for the RCRA program.
3.
It contains procedures for field and laboratory quality control, sampling, determining hazardous
constituents in wastes, determining the hazardous characteristics of wastes (toxicity, ignitability,
reactivity, and corrosivity), and for determining physical properties of wastes.
4.
It also contains guidance on how to select appropriate methods.
5.
Several of the hazardous waste regulations under Subtitle C of RCRA require that specific testing
methods described in SW-846 be employed for certain applications. Refer to 40 CFR, Parts 260
through 270, for those specific requirements. Any reliable analytical method may be used to
meet other requirements under Subtitle C of RCRA.

15. Guidance for the Data Quality Objectives Process
EPA SW-846
OVERVIEW
Part I: Methods for Analytes and Properties
•
•
•
•
•
•
Quality Control
Choosing the Correct Procedure
Inorganic Analytes
Organic Analytes
Miscellaneous Test Methods
Properties
Part II: Characteristics
• Characteristics Introduction and Regulatory Definitions
• Methods for Determining Characteristics
Part III: Sampling
•
•
•
•
•
Sampling Plan
Sampling Methods
Ground Water Monitoring
Land Treatment Monitoring
Incineration