Published on February 5, 2014
ENVIRONMENTAL QA --A PRIMER-- By Joel Hebdon, Principal Vanilla Strategies
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.
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
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. :
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. :
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.
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.
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)
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
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
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
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.
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.
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.
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
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