Classification No.: Approval Date: 5360 07/16/98 AGENCY LIBRARY 290411 1 COPY EPA QUALITY MANUAL FOR ENVIRONMENTAL PROGRAMS 1. PURPOSE. This Transmittal issues a new manual, 5360, EPA Quality Manual for Environmental Programs. 1. EXPLANATION. . The Office of Research and Development receives approval to issue a new manual, EPA Quality Manual for Environmental Programs, which provides program requirements for implementing the mandatory Quality System defined in EPA Order 5360.1 CHG 1. 3. FILING INSTRUCTIONS. File this Order in a three-ring binder established for the EPA Directives System. I Mei Chan, Central Directives Officer Organization and Management Consulting Services Originator EPA Form U15-12 (S-S6I Organization and Management Consulting Services Office of Administration and Resources Management ------- EPA QUALITY MANUAL FOR ENVIRONMENTAL PROGRAMS 5360 JULY 1998 United States Environmental Protection Agency Office of Research and Development National Center for Environmental Research and Quality Assurance Quality Assurance Division Washington, D.C. 20460 ------- EPA Quality Manual for Environmental Programs 5350 07/16/98 TABLE OF CONTENTS 1. QUALITY SYSTEM POLICY AND RATIONALE 1.1 Introduction 1.2 Scope 1.3 Applicability 1.3.1 Applicability to Environmental Programs 1.3.2 Applicability to Other EPA Programs .. . 1.4 Organizational Applicability 1.4.1 EPA Organizations 1.4.2 Extramural Agreements Page -1 -1 -2 -2 -2 -3 -4 -4 -4 1.5 Exemptions 1_4 2. QUALITY SYSTEM IMPLEMENTATION 2-1 2.1 Introduction 2-1 2.2 Implementation of Quality System Functions 2-1 2.2.1 Background 2-1 2 2.2 Mandatory' Quality Management Tasks and Descriptions 2-2 2.2.3 Non-Mandatory Quality Management Tasks and Descriptions 2-7 2.3 Reporting Requirements 2-9 2.3.1 Quality Management Plans 2-9 2.3.2 Quality Assurance Annual Report and Work Plan 2-9 2 4 Requirements for Extramural Agreements 2-9 2.4.1 Contracts 2-10 2.4.2 Assistance Agreements 2-10 2.4.3 Interagency Agreements 2-10 2.5 Requirements for Reporting Environmental Data 2-11 2.5.1 Technical Reports 2-11 2.5.2 Data Management and Storage 2-11 2.6 QA/QC Requirements and Guidance Documents 2-11 2.6.1 Agency-wide Requirements and Guidance Documents 2-11 2.6.2 Development of User-Specific QA/QC Guidance Documents 2-12 2.7 QA/QC Requirements in Regulations 2-13 2.8 Dispute Resolution 2-13 2.8.1 Technical Disputes 2-13 2.8.2 Management Systems Disputes 2-13 2.9 Performance Agreements 2-14 3. QUALITY MANAGEMENT PLANS 3-1 3.1 Introduction 3_1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 TABLE OF CONTENTS - Continued Page 3.2 Preparation, Submission, Review, and Approval 3-2 3.2.1 QMP Preparation Responsibility 3-2 3.2.2 Internal Submission and Approval 3-2 3.2.3 Agency Review and Approval of the QMP 3-3 3.2.4 QMP Revisions 3-3 3.3 Quality Management Plan Requirements 3-4 3.3.1 General Requirements 3-4 3.3.2 Management and Organization 3-4 3.3.3 Quality System and Description 3-5 3.3.4 Personnel Qualifications and Training 3-6 3.3.5 Procurement of Items and Services 3-6 3.3.6 Documents and Records 3-7 3.3.7 Computer Hardware and Software 3-8 3.3.8 Planning 3-8 3.3.9 Implementation of Work Processes 3-10 3.3.10 Assessment and Response 3-11 3.3.11 Quality Improvement 3-12 4. QUALITY ASSURANCE ANNUAL REPORT AND WORK PLAN 4-1 4.1 Background 4-1 4.2 Use of QAARWP Submissions 4-1 4.3 Requirements 4-1 4.3.1 QA Annual Report 4-2 4.3.2 Work Plan 4-5 5. QUALITY ASSURANCE PROJECT PLANS 5-1 5.1 Introduction 5-1 5.2 QAPP Responsibilities and Application 5-1 5.2.1 QAPP Preparation Responsibilities and Approvals 5-1 5.2.2 QAPP Implementation and Revision 5-2 5.2.3 Applicability of QAPPs 5-2 5.3 QAPP Elements and Requirements 5-3 5.3.1 General Content Requirements 5-3 5.3.2 Group A, Project Management 5-5 5.3.3 Group B,'Measurement/Data Acquisition 5-8 5.3.4 Group C, Assessment/Oversight 5-12 5.3.5 Group D, Data Validation and Usability 5-13 11 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 TABLE OF CONTENTS - Continued Page 6. QUALITY SYSTEM ASSESSMENT (RESERVED) 7. DESIGN, CONSTRUCTION, AND OPERATION OF ENVIRONMENTAL TECHNOLOGY (RESERVED) APPENDIX A. EPA ORDER 5360.1 CHG 1 A-l APPENDIX B. TERMS AND DEFINITIONS B-l APPENDIX C. REFERENCES C-l 111 ------- EPA Quality Manual for Environmental Programs 5350 07/16/98 CHAPTER 1 QUALITY SYSTEM POLICY AND RATIONALE 1.1 Introduction EPA Order 5360.1 CHG 1, Policy and Program Requirements for the Mandatory Agency-wide Quality System (Attachment A), provides requirements for the conduct of quality management practices, including quality assurance (QA) and quality control (QC), for all environmental data collection and environmental technology programs performed by or for this Agency. The primary goal of the Agency-wide Quality System is to ensure that environmental programs and decisions are supported by data of the type and quality needed and expected for their intended use, and that decisions involving the design, construction, and operation of environmental technology are supported by appropriate quality assured engineering standards and practices. The EPA Quality Manual for Environmental Programs provides program requirements for implementing the mandatory Quality System defined in EPA Order 5360 1 CHG l". All EPA organizational units conducting environmental programs shall comply with EPA Order 5360.1 CHG 1. Work performed on behalf of EPA through appropriate extramural agreements shall comply with the quality system requirements defined by EPA Order 5360.1 CHG 1 or applicable regulations, unilateral orders, and negotiated agreements. Environmental data are any measurements or information that describe environmental processes or conditions. or the performance of environmental technology. For EPA, environmental data include information collected directly from measurements, produced from models, and compiled from other sources such as data bases or the literature. Environmental technology includes treatment systems, pollution control systems and devices, and waste remediation and storage methods. In accordance with EPA Order 5360.1 CHG 1, EPA requires that environmental programs be supported by a quality system that complies with the American National Standard ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, incorporated herein by reference. ANSI/ASQC E4-1994 is a national consensus standard authorized by the American National Standards Institute (ANSI) and developed by the American Society for Quality (ASQ) that provides a basis for planning, implementing, documenting, and assessing an effective quality system for collecting and evaluating environmental data for decisions and for use in the design, construction, and operation of environmental technologies. Copies of the standard may be obtained from: ASQC Quality Press P.O. Box 3005 Milwaukee, WI 53201-3005 Phone:(800)248-1946 1-1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 By invoking this American National Standard as the basis for its internal Quality System, EPA recognizes that environmental programs are diverse and impact many constituencies, including Federal, State, local, and Tribal governments and industry. EPA realizes that a uniform, consistent set of quality management criteria are essential to assure effective environmental programs by Government and industry alike. ANSI/ASQC E4-1994 provides a stable foundation upon which quality systems supporting all environmental data and technology work across the Agency may be based. 1.2 Scope The scope of this Manual includes applicable environmental programs involving: the collection, evaluation, and use of environmental data by and for the Agency, and the design, construction, and operation of environmental technology by the Agency. Environmental data are critical inputs to decisions involving the protection of the public and the environment from the adverse effects of pollutants from natural and man-made sources. Decisions concerning environmental and human health protection often result in requiring the design, construction, and operation of pollution control or waste remediation systems. For example, environmental technologies are required to reduce contamination levels in the environment and to maintain the levels at concentrations that do not threaten the environment or human health and safety. 1.3 Applicability 1.3.1 Applicability to Environmental Programs This Manual contains the minimum specifications for quality management functions and activities necessary to support EPA environmental programs and satisfy the requirements of EPA Order 5360.1 CHG 1. Such programs may include activities encompassing the: characterization of environmental or ecological systems and the health of human. populations; characterization of ambient conditions in air, water, sediments, and soil in terms of physical, chemical, radiological, or biological characteristics; 1-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 characterization of radioactive, hazardous, toxic, and mixed wastes in the environment and their health and ecological effects; characterization and quantification of waste and effluent discharges to the environment from processes and operations (e.g., energy generation, metallurgical processes, chemicals production), during either normal or upset conditions (i.e., operating conditions that cause pollutant or contaminant discharges); performance assessment of environmental technology used for pollution prevention; pollution control; waste treatment, storage, and disposal; and waste remediation; demonstration of environmental technology (e.g.. treatability and pilot studies); investigation of chemical, biological, physical, or radioactive constituents in environmental and ecological systems, and their behavior and associated interfaces in those systems, including exposure assessment, transport, and fate; definition and evaluation of methods for use in the collection, analysis, and use of environmental data; development, evaluation, and use of computer or mathematical models (and their input data) that characterize environmental processes or conditions; 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; and collection and use of environmental data pertaining to the occupational health and safety of personnel in EPA facilities (e.g., indoor air quality measurements) and m the field (e.g., chemical dosimetry, radiation dosimetry). 1.3.2 Applicability to Other EPA Programs This Manual applies to the collection and use of medical testing data from Government . and non-Government personnel in EPA facilities for determination of substance abuse. 1-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 1.4 Organizational Applicability 1.4.1 EPA Organizations The Agency-wide Quality System requirements established in EPA Order 5360.1 CHG 1 shall apply to all EPA organizations and components thereof in which the environmental programs conducted involve the activities described in Section 1.2 above. 1.4.2 Extramural Agreements The Agency-wide Quality System requirements defined by Order 5360.1 CHG 1 shall apply to non-EPA organizations as defined by terms and conditions in EPA-funded extramural agreements. Compliance with the Agency-wide Quality System requirements may be specified in applicable regulations for these extramural agreements. In other cases, such requirements may be invoked as part of negotiated agreements such as memoranda of understanding. These extramural agreements include: Any organization or individual under direct contract to EPA to furnish services or items or perform work (i.e.. a contractor) under the authority of 48 CFR Chapter 15, Part 1546, (including applicable work assignments, delivery orders, and task orders); Institutions of higher education, hospitals, and other non-profit recipients of financial assistance (e.g., Grants and Cooperative Agreements) under the authority of 40 CFR Part 30; State, local, and Tribal governments receiving financial assistance under the authority of 40 CFR Part 31 and 35; and Other Government Agencies receiving assistance from EPA through interagency agreements. Extramural (non-EPA) quality systems that provide objective evidence (such as a Quality Management Plan, quality manual, or audit report acceptable to EPA) of complying fully with the specifications of ANSI/ASQC E4-1994 are in compliance with EPA policy. 1.5 Exemptions Statutory requirements for quality may supersede the specifications in this Manual or be more rigorous. In such cases, affected programs shall be exempt from the requirements of this 1-4 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Manual. EPA organizations conducting exempted activities shall comply with EPA Order 5360.1 CHG 1 in all other respects. The following exemptions from these requirements apply: The collection of environmental data under the authority of Good Laboratory Practices as defined by 40 CFR Part 792, for the Toxic Substances Control Act. The collection of environmental data under the authority of Good Laboratory Practices as defined by 40 CFR Part 160, for the Federal Insecticide, Fungicide, and Rodenticide Act. Requests for exemptions should be directed to the Quality Assurance Division (QAD). Exemptions shall be made by the Assistant Administrator for Research and Development. 1-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 CHAPTER 2 QUALITY SYSTEM IMPLEMENTATION 2.1 Introduction This chapter addresses the implementation of quality management activities to satisfy EPA Order 5360.1 CHG 1. including limitations on the use of extramural support to implement quality systems for programs involving environmental data operations; reporting requirements; requirements for extramural agreements; requirements for reporting results from applicable environmental programs; QA/QC requirements and guidance documents; user-specific QA/QC guidance; and dispute resolution. 2.2 Implementation of Quality System Functions 2.2.1 Background Many quality system activities involving environmental data operations are inherently governmental functions and must be performed only by EPA personnel or by personnel explicitly authorized by EPA based on statute, regulation, or by the terms of an extramural agreement. Such representatives may include other governmental personnel and with specific authorization. contractor personnel. When such quality management tasks are performed by a contractor, the contract must be appropriately managed and must remain under the control of the authorized EPA contracting representatives. EPA cannot use cooperative agreements or grants to provide quality management activities such as QA and QC services for EPA because it is an inappropriate use of financial assistance (Office of General Counsel memorandum, August 2, 1994). This section describes the quality management tasks necessary to comply with the Order and identifies those tasks that may be performed by non-government personnel under appropriate management controls. Two types of quality management functions are described: Exclusively EPA Functions - inherently governmental work which must be performed only by responsible EPA officials, including the QA Managers (QAMs), or authorized EPA representatives. Discretionary Functions - activities that may be performed either by EPA personnel or by non-EPA personnel under the specific technical direction of and performance monitoring by the QA Manager or other responsible EPA or 2-1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Government official under an approved contract, work assignment, delivery order, task order, etc. In the situations involving the other associated functions, there may be instances involving sensitive contracting services, advisory and assistance services, and vulnerable contracting practices as defined by the Federal Acquisition Regulations. Office of Federal Procurement Policy (OFPP), and the EPA Contracts Management Manual (EPA Order 1900). Such situations are identified by italicized text in the following sections. In addition, management approval of services contracts as defined by OFPP Letter 93-1 must be obtained for many of the associated tasks. Technical direction or other instructions to an extramural organization, relating to performance of an extramural agreement, shall be provided only by authorized EPA or other Government representatives in accordance with the terms of the applicable extramural agreement. Only authorized EPA or other Government representatives are to provide direction or instructions to an extramural organization providing quality systems support for environmental programs. This is to avoid such actions as: the providing of directions or instructions that are inconsistent with the terms of an extramural agreement, unauthorized access to confidential business information (CBI), or unauthorized access to information that may allow an extramural organization to gain an unfair competitive advantage. 212.2 Mandatory Quality Management Tasks and Descriptions This section describes the activities and tasks integral to an effective quality system. These tasks are required to implement EPA Order 5360.1 CHG 1. 2.2.2.1 Manage and Coordinate the Quality System Exclusively EPA functions that must be performed by EPA QA personnel include: managing the day-to-day implementation of the mandatory quality system. acting as liaison between the organization and the QAD on matters of QA policy. coordinating with senior management the development of and preparation of the organization's Quality Management Plan. 2-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 coordinating with senior management changes to the Quality System as needed to assure its continued effectiveness and assisting in reporting the results annually to management and to QAD in the QA Annual Rep.ort and Work Plan. managing organization resources designated for the quality system. maintaining records of pertinent quality system activities performed by the organization. 2.2.2.2 Review and Approve Procurement and Financial Assistance Documents for OA Requirements Exclusively EPA functions that must be performed by EPA QA personnel include: reviewing procurement and financial assistance documents (e.g., statements of work, scopes of work, applications for assistance, funding requests, and purchase requests) to confirm any need for QA requirements, providing any necessary special language or conditions for such QA requirements, and approving by signature the appropriate Quality Assurance Review Form. participating directly or indirectly in the solicitation or agreement review process to advise the Project Officer on the suitability of the offerer's quality system or quality assurance/quality control (QA/QC) approach for the particular project. reviewing work assignments, delivery orders, and task orders to certify that appropriate QA/QC requirements have been established and that the necessary instructions are being communicated to the contractor to carry out the required QA/QC tasks. Approving by signature appropriate Quality Assurance Review Form (EPA Order 1900, Chapter 2). 2.2.2.3 Review and Approve OA Planning Documents Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: reviewing Quality Assurance Project Plans (QAPPs) for all projects, work assignments, delivery orders, task orders, grants, cooperative agreements, and interagency agreements involving data acquisition, data generation, and/or measurement activities that are performed on behalf of EPA. 2-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 approving all QAPPs for implementation in all applicable projects, work assignments, delivery orders, task orders, grants, cooperative agreements, and interagency agreements performed on behalf of EPA. coordinating the correction of deficient QAPPs with the Project Officer and his/her management. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: reviewing, at the specific technical direction of the QAM, QA Project Plans and other QA-related planning documents, such as sampling and analysis plans. Data Quality Objectives (DOO) specifications, etc , and providing specific substantiated recommendations to the QAM on the adequacy of the OA approach in meeting the criteria provided by the QAM (The reviews should identify specific technical deficiencies in the planning documents) 2.2.2.4 Track and Report Quality System Deliverables Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: tracking critical quality system deliverables for the organization and make periodic reports to senior management on the status of reporting actions and deliverables. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: compiling/logging administrative and management information including turnaround times to correct deficient QAPPs, responses to audits (e.g., responses and corrective actions), and quality reviews of final reports. 2.2.2.5 Manage Contractor Support Work Assignments. Delivery Orders, and Task Orders Exclusively EPA functions that must be performed by EPA QA personnel include: serving as the Contracting Officer Representative (for example, Project Officer, Work Assignment Manager, or Delivery Order Project Officer) for specific QA support contracts, work assignments, delivery orders, and task orders. 2-4 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 2.2.2.6 Plan and Conduct Management Assessments Exclusively EPA functions that must be performed by EPA QA personnel include: planning, directing, and conducting assessments of the effectiveness of the quality system being applied to environmental data operations and reporting results to senior management. Such assessments may be conducted using the Management Systems Review (MSR) process. coordinating with senior management any revision of the quality system as necessary based on the findings of the assessment. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: providing technical support to the EPA QAM in the planning phase of managemer . issessments. (Such activities are limited to the assembly and compilation of background information and data, guidance documents, technical reports, etc.. available in the public domain, for use by EPA in designing the assessment goals and specifications.) 2.2.2.7 Plan and Conduct Technical Assessments Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: planning and directing with the responsible EPA project officials the implementation of periodic technical assessments of ongoing environmental data operations to provide information to management to assure that technical and quality objectives are being met and that the needs of the customer are being satisfied. Such assessments may include technical systems audits, surveillance, performance evaluations, and data quality assessments. determining conclusions and necessary corrective actions (if any) based on the findings of the assessments. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: performing technical assessments of environmental data producing activities, both intramural and extramural (on-site and off-site) according to a specific plan 2-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 approved by the QAM Preparations for such assessments may include the acquisition or development of audit materials and standards Results (findings) are summarized, substantiated, and presented to the QAM or authorized EPA representative. A determination of whether an authorized Agency representative should accompany a contractor's personnel should be made on a case-by-case basis only after coordination between the responsible organization and contracting officer Such coordination should include consideration of the purpose of the accompaniment and clear definition of the Agency representative 's role and responsibility during the contractor's performance of the audit or technical assessment to avoid the appearance of a personal services relationship 2.2.2.8 Prepare and Present OA Training Materials and Courses Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representa.^-e include: developing and presenting detailed guidance and training for QA/QC activities based on interpretation of Agency-wide requirements and guidance. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include. providing or coordinating quality-related training for the organization in special skill areas identified by the Agency and not generally available to the organization. providing allowable technical and/or logistical assistance in preparing and presenting quality-related technical training (within the Agency's implementation of special management and control measures and the constraints of potential for conflict of interest, of revealing confidential business information, or of appearing to be interpreting or representing Agency policy) 2.2.2.9 Review and Approve Final Reports for Quality Documentation Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: establishing criteria for the acceptability of quality documentation in the organization's published papers and reports; that is, defining what is required for 2-6 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 an adequate discussion of the quality of the project results and the usability of the information reported. approving for publication those papers and reports that meet the defined criteria. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: conducting a substantiated technical review of all reports produced by the organization using the qualitative and quantitative specifications obtained from the DOO process or other criteria provided by EPA This quality review complements the peer review process 2.2.3 Non-Mandatory Quality Management Tasks and Descriptions This section describes other activities and tasks integral to an effective quality system. They are not explicitly required to implement EPA Order 5360.1 CHG 1, but if implemented, they must be implemented as described below. 2.2.3.1 Review and Assist in the Development and Preparation of Environmental Data Collection Survey Designs Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: interpreting Agency policy and requirements pertaining to the development and preparation of environmental data collection survey/experimental design requirements. providing corrective action, technical assistance, and guidance to intramural and extramural personnel (in accordance with terms of the extramural agreement) conducting environmental data operations to enable them to produce in a timely manner satisfactory design documents. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: reviewing environmental data collection survey designs using criteria provided by the QAM and providing the QAM with a substantiated technical assessment of the strengths and weaknesses in the design. 2-7 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 2-2.3.2 Prepare and Present Quality Management Information in the Technical Literature and at Meetings/Symposia Exclusively EPA functions that must be performed by EPA QA personnel or their authorized EPA representative include: transferring information on EPA quality management subjects to other Agency, public, or scientific groups through participation in technical meetings and symposia, and papers or articles in the technical literature, including peer reviewed journal papers, oral presentations, and panel discussions. Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: transferring information on quality management subjects to other groups through participation in technical meetings and symposia and through the technical literature, with appropriate disclaimer that the information does not represent EPA policy or position. (NOTE. Only EPA personnel may represent the Agency in an official role.) 2.2.3.3 Research Relative to Quality Management Issues Discretionary functions that may be performed by either EPA personnel or non-EPA personnel include: providing information to the QAMs on the state-of-the-art in quality management. performing searches of the technical and quality management literature relative to specific QA/QC issues. This may include compiling summaries of alternative sampling and analytical methods, identifying QC reference materials, and availability of standard operating procedures for calibrating certain instrumentation. performing studies of quality management issues having a mathematical or statistical foundation with the objective of optimizing QA/QC protocols and procedures. 2-8 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 2.3 Reporting Requirements 2.3.1 Quality Management Plans All Agency organizational units governed by EPA Order 5360.1 CHG 1 shall document their quality system in a Quality Management Plan (QMP). The QMP is a policy statement describing how an EPA organization shall comply with the requirements of EPA Order 5360.1 CHG 1. Quality systems encompass the management and technical activities necessary to plan, implement, and assess the effectiveness of quality assurance (QA) and quality control (QC) operations applied to environmental programs. The QMP provides the blueprint for how an individual EPA Program Office. Region, and National Laboratory or Center will plan, implement, and assess its quality system for the environmental work to be performed as part of its mission. QMPs are reviewed and approved by ORD. Approval is valid for a period of up to five years. Specific QMP requirements are described in Chapter 3. 2.3.2 Quality Assurance Annual Report and Work Plan (QAARWP) All Agency organizations subject to the requirements of EPA Order 5360.1 CHG 1 must submit a Quality Assurance Annual Report and Work Plan (QAARWP) annually. The QAARWP shall summarize the results of having implemented the quality system the previous fiscal year and describe QA activities planned for the fiscal year beginning in October. The QAARWP may be used to identify limited changes or updates to the orgamzations's approved QMP. The QAARWP should provide helpful information to management by documenting the past fiscal year's activities and estimating the current year's workload based on the prior year and the expected activities in the current year. QAARWPs are described in Chapter 4 2:4 Requirements for Extramural Agreements All environmental data operations performed under extramural agreements shall comply with the Agency-wide Quality System requirements as defined by the relevant regulations. Accordingly, all acquisitions and assistance agreements must be reviewed by an authorized QA Manager, Officer, or Coordinator, as specified in the organization's Quality Management Plan, to determine if environmental data operations are to be performed and, if so. to ensure that appropriate QA/QC specifications are included or identified in the acquisition and assistance agreement solicitation package. Upon their receipt in response to the solicitation, proposals or applications must be reviewed by the QA approval authority to evaluate the adequacy with which the offerer or applicant addressed stated specification, as well as the adequacy of Quality Management Plans and QA Project Plans when submitted. 2-9 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 2.4.1 Contracts The requirements for QA/QC in contracts are given in 48 CFR 15, Part 1546 and in the Contract Management Manual, EPA Order 1900. The requirements and the specifications set forth in this Manual extend to all contract forms involving environmental programs, including work assignments, delivery orders, and task orders. The Quality Assurance Review Form (QARF) (EPA Order 1900, Chapter 2) provides confirmation to the Office of Acquisition Management (OAM) that appropriate QA/QC requirements have been determined. OAM officials shall then incorporate the necessary standard clauses or conditions to assure that the minimum specifications for compliance with EPA policy are included. The specific statement of work may include additional QA/QC specifications and requirements identified by the project officer in consultation with the organization's QAM. Approved QARFs are required for work assignments, delivery orders, and task orders. For level-of-effort and delivery order contracts, only general QA/QC requirements are specified in the contract. Since not all work assignments, delivery orders, and task orders issued involve data collection, QA/QC specifications may not be necessary. The QARF attached to the work assignment shall identify clearly those work assignments that need QA/QC specifications and shall identify the necessary requirements. 2.4.2 Assistance Agreements The regulatory requirements for QA/QC in assistance agreements are given in 40 CFR Part 30, for assistance to institutions of higher education, hospitals, and other non-profit organizations, and in 40 CFR Part 31, for assistance agreements to State, local, and Tribal governments. The requirements and the specifications set forth in this Manual extend to all assistance agreement forms involving environmental programs, including grants and cooperative agreements. 2.4.3 Interagency Agreements EPA cannot unilaterally require other Federal agencies to comply with Agency-wide Quality System requirements for interagency agreements funded by EPA. QA/QC specifications for interagency agreements must be negotiated between EPA and the other agency. When agreement is reached on the QA/QC specifications, the specifications must be included in the . interagency agreement. When EPA receives funding from another Agency through an interagency agreement, the EPA QA/QC requirements shall apply in addition to any specifications provided by the funding 2-10 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 organization. If the funding agency does not specify any requirements, EPA QA/QC requirements given by the Order and this Manual shall apply. 2.5 Requirements for Reporting Environmental Data 2.5.1 Technical Reports Published Agency reports containing environmental data shall be accompanied by a readily-identifiable section or appendix that discusses the quality of the data and any limitations on the use of the data with respect to their original intended application. Published EPA reports include those reports printed by the Government or distributed through publication services to the general public. This requirement does not apply to papers, journal articles, etc.. that undergo peer review processes external to EPA. Agency reports shall be reviewed by the QA manager (or other authorized official) before publication to ensure that an adequate discussion of QA/QC is enclosed. Adequacy is a subjective determination that should be based on the nature of the environmental data operations performed and the intended and likely use of the data by others, or on the objectives of the study. The purpose of the review is to ensure that sufficient information is provided to enable a knowledgeable reader to determine if the technical and quality goals were met for the intended use of the data. Reports should include applicable statements regarding the use of any environmental data presented as a caution about possible misuse of the data for other purposes. 2.5.2 Data Management and Storage Data management and electronic transfer and storage of environmental data shall conform with applicable Agency information resources management policies and procedures, or with applicable American National Standards. Agency policy requires that environmental data shall have their location reported and documented as well (2100, Chapter 13). Other applicable EPA Orders include 2180.1, 2180.2, 2180.3, and 7500.1 A. 2.6 OA/OC Requirements and Guidance Documents 2.6.1 Agency-wide Requirements and Guidance Documents QAD shall develop quality management practices and "tools" for use Agency-wide to enable effective planning, implementation, documentation, and assessment of individual quality systems. QAD produces the following types of documents for this purpose: 2-11 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Requirements Documents (OA/R-Sertes) Requirements Documents contain mandatory, minimum specifications or procedures for use by non-EPA organizations that must comply with Agency- wide Quality System requirements. These documents are usually invoked through regulations. Requirements Documents are designated the QA/R-series and are issued by the AA/ORD as Agency Policy documents following appropriate review and approval. Guidance Documents (QA/G-Series) Guidance Documents contain non-mandatory guidelines for use by EPA and non- EPA organizations in implementing quality management practices or QA/QC activities. Such documents often provide suggestions on how to meet specifications given in Requirements Documents. Guidance Documents are designated the QA/G-series and issued as Office of Research and Development reports following peer review and approval. All EPA quality-related Requirements Documents and Guidance Documents shall be valid for a period of five (5) years from the approval date. After five years, some action must be taken to reaffirm the document's validity, revise it, or delete it from the Agency-wide Quality System. Any changes to approved documents must comply with the procedures used for the original review and approval. ! 2.6.2 Development of User-Specific QA/QC Guidance Documents Additional user-specific QA/QC requirements and guidance that are tailored to a particular organization and its mission may be appropriate given the diversity of Agency programs. For the purposes of this Manual, "user-specific QA/QC guidance" includes but is not limited to written documents, computer software, and videos (if used to provide instructions). Such guidance shall be developed by the organization itself, consistent with Agency policy and the organization's QMP. Management shall ensure that all changes to the guidance documents are available to all personnel using that guidance, including active contractors and assistance agreement recipients (e.g., grantees, cooperative agreement holders). The changes do not become binding on contractors and assistance agreement holders until the Office of Acquisition Management or the Office of Grants and Debarmenfrevises the extramural agreement at the request of the EPA project officer. 2-12 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 2.7 OA/OC Requirements in Regulations EPA regulations often require the regulated community to. collect and submit environmental data to EPA or the State as part of compliance or enforcement actions. Some regulations include specific QA/QC requirements while others are less specific. Because critical decisions are often made based on data collected from the regulated community, the adequacy of those data are very important, both to EPA and to the regulated community. The inclusion of appropriate QA/QC requirements in EPA regulations helps to assure that data of the type and quality needed for a particular decision are obtained. The authoring organization shall ensure that appropriate and effective specifications for QA/QC are included in proposed regulations. 2.8 Dispute Resolution Oversight responsibilities for QA/QC may sometimes result in disagreements between the oversight group and the program reviewed regarding the results of the activity. Such disputes may occur in situations involving technical issues (e.g.. audits, surveillance, data quality assessments) and management issues (e.g., QMP reviews, management systems reviews). This section discusses the process for resolving such disputes. 2.8.1 Technical Disputes For those situations in which technical issues regarding QA/QC are in dispute, resolution should be sought at the lowest management level practicable All parties should make every effort to resolve disputes through discussion and negotiation. If unsuccessful, final resolution should be made by the senior manager for the organization. It is recommended that an organization's QMP include a process for dispute resolution within that organization. While the process described below (Section 2.8.2) may be used for technical disputes, an organization may develop a process that meets its particular needs. 2.8.2 Management Systems Disputes Implementation of the Agency-wide Quality System may create disagreements arising from the results of the review and approval of Quality Management Plans (QMPs) and from the performance of management assessments using Management Systems Reviews (MSRs). The dispute resolution process should only be used when parties cannot achieve mutual resolution of. their disagreement at the lowest possible administrative level. The dispute resolution process is terminated at any point where resolution is achieved and the issue resolved. Disagreements should be resolved at the lowest administrative level possible. The dispute resolution officials for management systems issues are as follows: 2-13 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Within the National Center for Environmental Research and Quality Assurance (NCERQA) - the Director, NCERQA. Within the components of the Office of Research and Development (ORD) - the Assistant Administrator for Research and Development (AA/ORD). Between ORD and the National Program Offices or Regional Offices - the AA/ORD and the respective National Program Office Assistant Administrator (AA) or Regional Administrator (RA). Should agreement not be reached at this level, the issue shall be resolved by the Deputy Administrator. The dispute resolution process has the following steps: (1) The process begins when either disagreeing party declares an issue to be unresolvable and sends a memorandum to the other party invoking this dispute resolution process, defining the disputed issue, and presenting supporting arguments for the first party's position on the issue. (2) Within 30 days, the second party must send a draft dispute resolution package to the first party. As soon as possible after this, the two parties, working together, must submit a dispute resolution package to the dispute resolution official. This package would contain both party's arguments, both party's rebuttals, and any supporting materials. (3) The dispute resolution official shall schedule a meeting for resolving the dispute within 30 to 60 days from receipt of the dispute resolution package, and for notifying both parties of this date. Both parties are invited to attend the resolution meeting to present arguments and answer questions. The dispute resolution official may get advice from third parties. The decision of the dispute resolution official shall be binding on both parties. 2.9 Performance Agreements Successful implementation of the Agency-wide Quality System requires that EPA managers and staff perform specific quality management functions. Performance agreements for senior managers, supervisors, and applicable staff shall contain critical element(s) to commensurate with the quality management responsibilities assigned by EPA Order 5360.1 CHG 1, this Manual, and the organization's Quality Management Plan. 2-14 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 CHAPTER 3 QUALITY MANAGEMENT PLANS 3.1 Introduction All Agency organizational units governed by EPA Order 5360.1 CHG 1 shall document their quality system in a Quality Management Plan (QMP). The QMP is a policy statement describing how an EPA organization shall comply with the requirements of EPA Order 5360.1 CHG 1. Quality systems encompass the management and technical activities necessary to plan, implement, document, and assess the effectiveness of quality assurance (QA) and quality control (QC) operations applied to environmental programs. The QMP provides the blueprint for how an individual EPA Program Office, Region, and National Laboratory or Center will plan. implement, document, and assess its quality system for the environmental work to be performed as part of its mission. The QMP defines an organization's QA-related: policies and procedures. criteria for and areas of application, and roles, responsibilities, and authorities. The QMP. therefore, is a management tool that should be appropriately tailored to the needs of the organization. The QMP must be sufficiently inclusive, explicit, and readable to enable managers and supervisors to understand the priority that senior management places on QA, the established QA policies and procedures, and their respective QA roles. The QMP must be constructed and written so that an assessment of its effectiveness following implementation can be made. This enables managers to determine whether or not the quality system is being implemented in a way that ensures successful results from environmental programs. The QMP should focus on the processes used to plan, implement, document, and assess the programs to which it is applied. The level of detail should be based on a common sense, graded approach that establishes QA and QC requirements commensurate with the importance of the work, the available resources, and the unique needs of the organization. QMPs shall be tailored to individual requirements and modified as the requirements change. This chapter describes the quality management practices which are normally considered to be critical to an effective quality system. Each Agency organization shall evaluate these key elements to see if they are applicable to its quality system. Where a particular element is not relevant, a brief explanation of why it is not relevant shall be provided in the QMP. If the QMP 3-1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 preparer determines that additional quality management elements are useful or necessary for an adequate quality system, these elements shall be developed and discussed in the QMP. 3.2 Preparation. Submission. Review, and Approval 3.2.1 QMP Preparation Responsibility The senior manager for each EPA organization is responsible for the preparation of a QMP that covers all environmental programs for which the manager is accountable. A senior manager is a manager who is responsible and accountable for mission accomplishment and overall operations. Senior management shall ensure that the quality system documented in the QMP complies with the requirements in this Manual. If desired by an organization's management, a draft of the QMP may be submitted to QAD one time for informal comment prior to the formal review and approval process. However. an informal review by QAD shall not be used to replace a thorough review of the quality system and the proposed QMP by the management of the organization preparing the plan. 3.2.2 Internal Submission and Approval The QMP must be approved and signed by the senior manager of the organization preparing the QMP. The senior manager shall indicate his/her approval of the QMP on the signature page of the document. The senior managers are designated as follows- Organization Preparing the OMP Senior Manager Headquarters Office Office Director Headquarters Field Component Office Director Laboratory/Center/Office Laboratory/Center/Office Director Regional Office Regional Administrator The QMP must also be approved and signed by the QA manager of the organization, the QAD Director, and the ORD\NCERQA Director. The senior manager may require the concurrence on the QMP by appropriate subordinate line managers to encourage the acceptance and implementation of the quality system. Subordinate line managers may include Division Directors, Branch Chiefs, and other supervisory personnel as defined for a particular organization. 3-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 3.2.3 Agency Review and Approval of the QMP The QMP must be submitted to ORD\NCERQA for review and approval. Each QMP will be reviewed to determine compliance with Agency-wide Quality System requirements. The review of the QMP shall focus on the substance of the group's QA management process and not on format or technical details. QMPs that address all mandatory program elements and include acceptable QA policies, procedures, administrative criteria, and management systems for key QA elements including systematic planning processes, QA Project Plans, other QMPs, Standard Operating Procedures, assessments, and oversight of delegated programs shall be approved. QMP approval shall be valid for a period not to exceed five years. 3.2.4 QMP Revisions Although the QMP approval by the Agency is valid for up to five years, all Agency quality systems must be reviewed at least annually by their organizations to reconfirm the effectiveness of the approved quality management practices. This assessment must include an evaluation of the effectiveness of the QMP. The process of developing and annually updating the QMP provides an opportunity for management and staff to review and clarify roles and responsibilities, to address problem areas, and to acknowledge successes Having an accurate QMP at all times is an essential element in every quality system. Changes in QA policy and procedures shall be documented in a timely fashion by QMP revisions. In general, a copy of any QMP revision(s) made during the year should be submitted to QAD as an attachment to or as part of the QA Annual Report and Work Plan (see Chapter 4). A revised QMP may be submitted at any time, but is required under certain conditions including: expiration of the five-year life of the approved QMP, a major reorganization that requires "Directive Clearance" review (EPA, 1995), a significant change in the organization's mission, such as may occur in the reauthorization or revision of enabling environmental legislation, or any major change to the organization's quality system. All appropriate personnel performing work for the organization, including active contractors and assistance agreement holders, shall be notified of all changes to the quality system and the QMP that may affect their work for EPA and to keep them apprised of the current requirements. 3-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 3.3 Quality Management Plan Requirements 3.3.1 General Requirements The QMP describes the processes by which the organization plans, implements, documents, and determines the effectiveness of quality management practices, including QA/QC activities, to help management to obtain results of its technical work that are of the type and quality needed for their intended use. Specifically, the QMP must discuss: the mission and quality policy of the organization. the specific roles and responsibilities of management and staff with respect to QA/QC activities, the means and structure by which effective communications are assured, the process(es) used to plan, implement, and assess the work performed, the process(es) by which measures of effectiveness for QA/QC will be established and how frequently effectiveness will be measured, and the process for continual improvement of the organization's quality system. The QMP should reflect the organization's commitment to quality management principles and practices, tailored by senior management to meet the organization's needs. To reduce duplication between QMPs and QAPPs. the QMP shall include discussion of those activities, policies, and procedures that are common to all projects. Such discussions provide an "umbrella" under which individual project activities may be performed. There are ten elements contained in a QMP. If an element is not applicable to an organization's quality system, then the QMP must state why this is the case. Specific requirements for each of the elements follow (Sections 3.3.2 - 3.3.11). 3.3.2 Management and Organization Provide or address the following management and organizational items: a statement of the organization's policy on QA, including the importance of quality in its products to the organization and its mission, and why; the general 3-4 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 objectives/goals of the quality system; and the policy for resource allocation for the quality system, including personnel, extramural funding, and travel funding; an organization chart that identifies all of the components of the organization and, in particular, the organizational position and lines of reporting for the QA Manager (and any QA staff) that confirms and documents the independence of the QA Manager from groups generating, compiling, and evaluating environmental data; a discussion of the responsibilities and authorities of the QA Manager and any other QA staff; a brief discussion of the technical activities or programs that are supported by the quality system and to which it applies; that is. the specific programs that require extensive quality management controls; where oversight of delegated, contracted, or other extramural programs is needed to assure data quality; and where internal coordination of QA and QC among the group's organizational units needs to occur; a discussion of the QA/QC roles and responsibilities of line management, technical staff, and any other staff, and how these roles and responsibilities are incorporated into performance standards; a discussion of the organization's process for resolving disputes regarding quality system requirements, QA/QC procedures, assessments, or corrective actions; a discussion of how management shall assure that applicable elements of the quality system are understood and implemented in all environmental programs; and an approval page for the signatures of the senior manager, senior line management (as appropriate), the QA manager of the organization, the QAD Director, and the NCERQA Director. This approval page may be part of a title page or a separate sheet following the title page. Approving officials whose signatures must be contained on the approval page are described in section 3.2.2. 3.3.3 Quality System and Description Discuss the principal components (or "tools") comprising the quality system and how they are used to implement the quality system. These components include, but are not limited to QMPs, management assessments (self and independent), systematic planning processes, QA 3-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Project Plans, Standard Operating Procedures, technical assessments (self and independent), and Data Quality Assessments. This discussion shall also identify how and when the components of the quality system are to be applied to individual projects and tasks. 3.3.4 Personnel Qualifications and Training State the organization's policy regarding training for management and staff. Describe the processes and the management and/or staff responsible for: identifying statutory, regulatory, or professional certifications that may be required to perform certain operations; and identifying, designing, performing, and documenting technical, quality, and project management training. Describe how staff proficiency in critical technical disciplines is maintained and documented. 3.3.5 Procurement of Items and Services Describe and discuss the organization's process for ensuring that all appropriate extramural agreements, including grants, cooperative agreements, and contracted and subcontracted activities, involving or affecting environmental programs shall: contain appropriate QA/QC requirements in all applicable documents; receive the same review and approval for changes as for the original documents; address satisfactorily all QA/QC requirements in applicable responses to solicitations and include QA as an integral criterion in the evaluation criteria; provide objective evidence of quality furnished by suppliers and subcontractors for applicable items and services, including source selection, source inspections, supplier audits, and examination of deliverables; and provide evidence of the suppliers capability to satisfy EPA QA/QC requirements. as defined in the extramural agreement or applicable regulation (e.g., 40 CFR Part 30, 40 CFR Part 31,48 CFR Chapter 15, Part 1546). Describe how procurement documents or financial assistance agreements shall require suppliers (i.e., contractors, subcontractors, or financial assistance recipients) to have a quality 3-6 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 system consistent with EPA requirements. This requirement applies only to those suppliers who provide services or items that directly affect the quality of results or products from environmental programs. 3.3.6 Documents and Records Describe or provide a reference to the process: for identifying quality-related documents and records requiring control; for handling documents and records to assure their accessibility, protection from damage and deterioration, and means of retention, including discussion of the roles and responsibilities for management and staff; by which all technical guidance documents are prepared, reviewed, approved, issued, used, and revised; and by which all planning documents (e.g., QA Project Plans, Sampling and Analysis Plans) are prepared, reviewed, approved, issued, used, and revised; and that ensures compliance with all statutory, contractual, and assistance agreement requirements for records from environmental programs and that provides adequate preservation of key records necessary to support the mission of the organization. Documents and records, including revisions, must be reviewed for conformance with the quality system requirements and approved by authorized personnel before general use. Describe or provide a reference to the management process that ensures that records accurately reflect completed work and/or fulfill statutory and contractual requirements, including any specific record keeping requirements defined in EPA Order 2160 and EPA Directive 2100, Chapter 10. The maintenance of records includes defining requirements and responsibilities for record transmittal, distribution, retention, protection, preservation, traceability, disposition, and retrievability. Identify how the disposition of records, in accordance with regulatory requirements, schedules, or directives from senior management, is accomplished. 3-7 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 3.3.7 Computer Hardware and Software Describe or discuss: how applicable EPA requirements for information resources management are addressed (EPA Directive 2100) including Year 2000 compliance, security, and privacy requirements (Chapters 5. 8, and 11 of EPA Directive 2100, respectively); the process for ensuring that computer hardware used in environmental programs meets technical requirements and quality expectations (i.e., configuration testing); how changes to hardware shall be controlled to assess the impact of the change on performance; the process for developing computer software, for validating, verifying, and documenting the software for its use. and for assuring that the software meets the requirements of the user (EPA Directive 2182); how purchased software is evaluated to meet user requirements and to comply with applicable contractual requirements and standards; and the process for ensuring that data and information produced from or collected by computers meet applicable EPA information resources management requirements and standards (EPA Directive 2100). These discussions shall include the roles and responsibilities assigned to management and staff. The QMP shall document how the organization manages its computer hardware and software operations that directly impact the quality of the results of environmental programs. Computer programs covered by this Manual include, but are not limited to. design, design analysis, data handling, data analysis, modeling of environmental processes and conditions, operations or process control, and data bases. 3.3.8 Planning 3.3.8.1 Systematic Planning Environmental data operations shall be planned using a systematic planning process that is based on the scientific method. The planning process shall be based on a common sense, graded approach to ensure that the level of detail in planning is commensurate with the importance and intended use of the work and the available resources. Elements of a systematic planning approach that shall be documented include: 3-8 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Identification and involvement of the project manager, sponsoring organization and responsible official, project personnel, stakeholders, scientific experts, etc. (e.g., all customers and suppliers); Description of the project goal, objectives, and questions and issues to be addressed; Identification of project schedule, resources (including budget), milestones, and any applicable requirements (e.g., regulatory requirements, contractual requirements); Identification of the type of data needed and how the data will be used to support the project's objectives: Determination of the quantity of data needed and specification of performance criteria for measuring quality; Description of how. when, and where the data will be obtained (including existing data) and identification of any constraints on data collection. Specification of needed QA/QC activities to assess the quality performance criteria (e.g.. QC samples for both the field and laboratory, audits, technical assessments, performance evaluations, etc.). Description of how the acquired data will be analyzed (either in the field or the laboratory)- evaluated (i.e.. QA review, validation, verification), and assessed against its intended use and the quality performance criteria A systematic planning process shall ensure that all organizations and/or parties who contribute to the quality of the environmental program or use the results are identified and that they participate in this process. The planning process shall also provide for direct communication between the customer and the supplier to ensure that there is a clear understanding by all participants of the needs and expectations of the customer and the product or results to be provided by the supplier. EPA has developed a systematic planning process called the Data Quality Objectives Process (EPA, 1994). While not mandatory, this process is the recommended planning approach for many EPA data collection activities. Describe the process for planning environmental programs, including identification of who is responsible and how general project planning is documented. Describe who uses the 3-9 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 planning "tools" (as defined in the Quality System Description section of the QMP) and the roles and responsibilities of all management and staff involved in planning. 3.3.8.2 Quality Assurance Project Plans Discuss how the results of planning for environmental data operations shall be documented in a Quality Assurance Project Plan (QAPP) (see Chapter 5) and approved by authorized personnel for implementation. The process for developing, reviewing, approving, implementing, and revising a QAPP, must be described in this section of the QMP. Identify the staff who is authorized to approve QAPPs. Describe or discuss how data obtained from sources outside EPA that did not use an EPA-approved QAPP (or equivalent planning document) for data collection shall be evaluated and qualified for use. Discuss the process for qualifying such data, including the application of any statistical methods used. 3.3.9 Implementation of Work Processes Describe the process of how and by whom work shall be implemented within the organization for: ensuring that work is performed according to plan; development and implementation of procedures for. <- propnate routine, standardized, special, or critical operations, including those that address, but are not limited to: identification of operations needing procedures; preparation of procedures, including form, content, and applicability, and review and approval of procedures; and use of QA/QC '"tools" such as standard operating procedures (SOPs). Describe how appropriate measures for controlling the release, change, and use of planned procedures are implemented. These measures provide for the necessary approvals, specific times and points for implementing changes, removal of obsolete documentation from work areas, and verification that the changes are made as prescribed. To help to assure consistency in common procedures, SOPs are encouraged for appropriate routine, standardized, or special/critical operations. The QMP shall contain the organization's process for identifying the need for SOPs, the process for developing SOPs, and 3-10 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 the policy for using SOPs. The QMP shall also describe the process by which SOPs are reviewed for initial and subsequent use. 3.3.10 Assessment and Response Describe how and by whom assessments of environmental programs are planned, conducted, and evaluated. Describe the process by which management chooses a particular assessment tool, and the expected frequency of their application to environmental programs. Available assessment tools include audits, data quality assessments, management systems reviews, peer reviews and technical reviews, performance evaluations, readiness reviews, technical systems audits, and surveillances. Senior management shall assess (at least annually) the adequacy of the quality system. Discuss or address the following items pertaining to management and technical assessments: how the process for the planning, scheduling, and implementation of assessments works, as well as how the organization shall respond to needed changes; r esponsibilities. levels of participation, and authorities for all management and staff participating in the assessment process, and how. when, and by whom actions shall be taken in response to the findings of the assessment, and how the effectiveness of the response shall be determined. Describe how the level of competence, experience, and training necessary to ensure the capability of personnel conducting assessments are determined. Personnel conducting assessments shall be qualified, based on project-specific requirements, to perform the assigned assessment. Management is responsible for choosing the assessors, defining acceptance criteria. approving audit procedures and check lists, and identifying goals prior to initiation of an assessment. Assessors shall be technically knowledgeable with no real or perceived conflict of interest. If the assessors are chosen from within the organization, they must have no direct involvement or responsibility for the work being assessed, except for self-assessments. Describe how personnel conducting assessments shall have sufficient authority, access to programs and managers, access to documents and records, and organizational freedom to: identify quality problems; identify and cite noteworthy practices that may be shared with others to improve the quality of their operations and products; 3-11 ------- EPA Quality Manual for Environmental Programs . 5360 07/16/98 propose recommendations for resolving quality problems; and independently confirm implementation and effectiveness of solutions. The QMP shall also discuss conditions under which a "stop work" order may be needed and when and how authority for such decisions shall be made. Describe how assessment results shall be documented, reported to, and reviewed by management. Describe how management shall respond to the results (or findings) and recommendations from assessments in a timely manner. When conditions needing corrective action are identified, the appropriate response must be made promptly. Indicate how follow-up action shall be taken and documented to confirm the implementation and effectiveness of the response action. Describe how disputes, if encountered, as a result of assessments are addressed and by whom. 3.3.11 Quality Improvement Describe how the organization shall detect and prevent quality problems. Describe the organization's process for ensuring continual quality improvement, including the management process for determining, planning, implementing, and evaluating the effectiveness of quality improvement activities; who (organizationally) is responsible for quality improvement: and the corrective action program to ensure that conditions adverse to quality are identified promptly and corrected as soon as practical. Corrective actions shall include the identification of root causes of problems, the determination of whether the problem is unique or has more generic implications, and a recommendation of procedures to prevent recurrence. The QMP shall describe how staff at all levels are encouraged to identify and establish communications among customers and suppliers, identify process improvement opportunities. identify problems, and offer solutions to those problems. 3-12 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 CHAPTER 4 QUALITY ASSURANCE ANNUAL REPORT AND WORK PLAN 4.1 Background Careful annual planning is necessary to the success of the Agency-wide Quality System. In order for management to budget adequate resources to implement the quality system for an organization, estimates of the quality system workload are needed. Moreover, management must give priority to quality system resource needs with respect to other mission requirements. All Agency organizations subject to the requirements of EPA Order 5360.1 CHG 1 shall submit a Quality Assurance Annual Report and Work Plan (QAARWP) annually. The QAARWP shall summarize the results of having implemented the quality system the previous fiscal year and describe QA activities planned for the fiscal year beginning in October. The QAARWP may be used to identify limited changes or updates to the organizations^ approved Quality Management Plan (QMP) (see Chapter 3). The QAARWP should provide helpful information to management by documenting the past fiscal year's activities and estimating the current year's workload based on the prior year and the expected activities in the current year. 4.2 Use of OAARWP Submissions The contents of the QAARWPs shall be used by QAD to evaluate the overall effectiveness of the Agency-wide Quality System. As problems related to QA are identified by EPA organizations. QAD shall use the QAARWP information to id/ -tify systemic or Agency- wide problems and shall initiate plans to address such problems. The QAARWPs shall not be approved as are QMPs. 4.3 Requirements The QAARWP must be submitted under the signature of the senior manager for the organization to the AA/ORD. Organization is defined here as an ORD Center. Laboratory, or Office; individual Program Office one level under an AA-ship, or Region. In order to simplify the submittal, the QAARWP and its attachments may be submitted electronically to the QAD Director along with a copy of the original signature page. The QAARWP has two parts, the annual report for the previous fiscal year and the proposed work plan for the new fiscal year. Specifications for the QAARWP are contained in Sections 4.3 1 - 4.3.2. 4-1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 4.3.1 QA Annual Report 4.3.1.1 Quality Management Resources Resources provided here may be estimated if not strictly accounted for by position or expense tracking. For example, if 10% of the time of all project officers is spent on quality assurance activities, then an estimate can be made by multiplying 10% times the number of project officers. If such an estimate is made, the algorithm should be provided to clarify the response. Provide a current estimate of the organization's filled FTE positions. State the total EPA (and other Federal) FTE (to the nearest tenth of an FTE) involved in the management of QA/QC activities. Examples of these activities include providing input to management on the need for and use of QA resources. disseminating Agency QA policy, developing and ensuring the implementation of the organization's QMP (including document tracking, auditing, and training), and acting as a liaison with QAD. Vacancies should be listed separately. State the total EPA (and other Federal) FTE involved in QA/QC support activities. Examples of these activities include writing and reviewing QAPPs and Standard Operating Procedures (SOPs) and validating data. If your organization uses contractor support to impkvient the quality system, state the total contractor FTEs involved in QA/QC support activities. Include the technical QA/QC support of Senior Environmental Employment Program (SEEP) grantees or other grantees. State the total FTEs involved in other non-technical QA/QC support activities. This category would include the non-technical SEEP employees and clerical staff. State the total dollar amounts (rounded to nearest $K) of other QA supporting funds, not including travel funds or training. State the total dollar amounts of travel funds used for QA activities such as oversight, surveillance, and audits/assessments State the total dollar amount of funds used for QA/QC training, including travel for training, and the total number of people who attended the training. Include training for QA staff. 4-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Discuss the adequacy of the above listed resources in relation to their impact on your quality system, including the ability to implement last year's work plan. 4.3.1.2 Training Briefly describe the method used to assess the organization's QA training needs and the results of the assessment; i.e., what needs were identified. Discuss separately any needs assessment made of other organizations participating in your quality system (i.e., States, Tribes, Regions). List courses and name the supplier(s) for QA/QC courses given to your organization and other non-EPA organizations participating in your quality system. The courses attended by the QA staff, while critically important for educating new QA staff members, are not the primary concern of QAD. For example, contract administration and field/lab equipment techniques are not considered QA courses. Statistics courses, however, are considered related to QA in terms of project planning and data analysis. List the attendance for each course. If course attendees included persons from outside your organization, identify the total attendance by each organization represented. For each course, indicate whether the course goals were achieved; that is. were the training needs fulfilled? If not, please indicate why and what you believe needs to be done to satisfy the remaining needs 4.'3 1.3 Management Accomplishments Discuss any innovative quality management practices you have developed and used in planning, implementing, or assessing your quality system. Include any proposed revisions to your Quality Management Plan reflecting changes to your operating practices for QA/QC. Summarize the technical assessments that were performed by your organization on itself and others participating in your quality system. For each assessment. identify the type of assessment performed, the organization and project which were the subject of the assessment, when the assessment was performed, and who did the assessment. Also provide a general statement of the assessment results and any corrective actions. For example, the QA staff members performed technical systems audits of these projects: (list). Note, if this information is 4-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 indicated on an attached quality system tracking program output, give the totals here. . Summarize the technical assessments that were performed on your organization by others. For each assessment, identify the type of assessment performed, the organization and project which were the subject of the assessment, when the assessment was performed, and who did the assessment. Also provide a general statement of the assessment results and any corrective actions. Summarize technical assistance given on planning, data review, etc. For QAPPs, the numbers of QAPPs reviewed (or re-reviewed) and an indication of average turnaround time is sufficient. Note, if tracking program outputs are attached, give totals for intramural and extramural projects. Include QA assistance given by the organization or individuals to non-EPA organizations, including states, private industry, and foreign countries. Organizations participating in your quality system that have QMPs reviewed and approved by you should also be listed. List any new or revised QA guidance developed by your organization. It is not necessary to list SOPs written and revised during the past year. The numbers of both new and revised SOPs is sufficient. List any publications and presentations concerning QA/QC practices and results by your organization. QA guidance listed above need not be repeated. Internet or other electronic document forms should be included. List any awards or recognition related to QA given to your organization or to individual staff members. 4.3.1.4 Management Assessment of the Approved Quality System Summarize the management assessments (i.e. management systems reviews) that were performed bv your organization on itself and others participating in your quality system. Include the part of the implemented program that was examined and what was learned (including positive findings). If corrective actions were indicated, summarize the response actions taken, and discuss progress toward their implementation. Report on their effectiveness, if known. Summarize the management assessments that were performed bv others (including QAD) on your quality system. Include the part of the implemented program that was examined and what was learned. If corrective actions were indicated, briefly summarize the response actions taken, and discuss progress 4-4 ------- EPA Quality Manual for Environmental Programs 5350 07/16/98 toward their implementation. In particular, highlight any incomplete corrective actions resulting from QAD's assessments. Report on the effectiveness of the corrective actions, if known. 4.3.2 Work Plan 4.3.2.1 Quality Management Resources State the total EPA (and other Federal) FTE (to the nearest tenth of an FTE) proposed for supporting quality management activities in your organization. Examples of these activities include providing input to management on the need for and use of QA resources, disseminating Agency QA policy, developing and ensuring the implementation of the organization's QMP (including document tracking, auditing, and training), and acting as a liaison with QAD. Vacancies should be listed separately. State the total EPA (and other Federal) FTE proposed for QA/QC support activities. Examples of these activities include writing and reviewing QAPPs and SOPs and validating data. If your organization uses contractor support to implement the quality system, state the total contractor FTEs proposed for the QA/QC support activities. State the total FTEs proposed for other non-technical QA/QC support activities. This category would include Senior Environmental Employment Program employees, other grantees, and clerical staff State the total dollar amounts (rounded to nearest $K) of proposed QA/QC support funds, not including travel funds or training. State the total dollar amounts of proposed travel funds for QA activities such as oversight, surveillance, and audits. State the total dollar amounts of proposed funds for training, including travel. 4.3.2.2 Activities List and briefly describe anticipated major QA/QC activities expected during the year including QA/QC-related training to be given, taken, or developed, guidance to be developed or revised, technical and management assessments of your 4-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 organization and others participating in your quality system, and implementation of corrective actions from prior MSRs of your quality system. 4-6 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 CHAPTER 5 QUALITY ASSURANCE PROJECT PLANS 5.1 Introduction EPA policy requires that all work performed by or on behalf of EPA involving the collection of environmental data shall be implemented in accordance with an Agency-approved Quality Assurance Project Plan (QAPP). The QAPP defines and documents how specific data collection activities shall be planned, implemented, and assessed during a particular project. This chapter presents detailed specifications on the information that must be addressed in a QAPP for environmental data operations performed by or on behalf of EPA and on the procedures for its review and approval. Guidance on developing QAPPs, including examples of QAPP elements, may be found in EPA QA/G-5, Guidance on Qualify Assurance Project Plans. The QAPP is a critical planning document for any environmental data operation since it documents how environmental data operations are planned, implemented, documented, and assessed during the life cycle of a program, project, or task. The ultimate success of an environmental program or project depends on the adequacy and sufficiency of the quality of the environmental data collected and used in decision-making This may depend significantly on the adequacy of the QAPP and its effective implementation. Quality planning (Section 3.3.8.1) is an absolutely essential component of project management and the QAPP provides the mechanism for documenting the results of the planning process. This planning must include the "stakeholders" (i.e., the data users, data producers, decision makers, etc.) to ensure that all needs are defined adequately at the outset and that the planning for quality addresses the specific needs defined. In the sections to follow, the elements of the QAPP are discussed in detail. These elements represent the information generally required for most data operations involving the characterization of environmental processes and conditions Because of the diversity of Agency programs, some elements described in this chapter may not be applicable to all programs The final decision on the applicability or use of any or all of these elements for QAPPs shall be made by individual EPA organizations. EPA organizations may tailor these requirements in their own implementation documents to better fit their specific needs. 5.2 OAPP Responsibilities and Application 5.2.1 QAPP Preparation Responsibilities and Approvals The EPA organization's Quality Management Plan (QMP) establishes how, when, and by whom development, review, approval, and effective oversight of QAPPs occurs, including situations in which QAPPs are prepared by extramural (non-EPA) organizations. In some cases, 5-1 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 it may be necessary to add special requirements to the QAPP. The EPA organization sponsoring the work shall define any specific requirements beyond those listed in this manual. * No environmental data collection work shall be started until the QAPP has been approved and distributed to project personnel except under circumstances requiring immediate action to protect human health and the environment or operations conducted under police powers. Some non-data collection activities such as equipment procurement, instrument calibration, etc., may be conducted prior to the approval of the QAPP. In limited circumstances, EPA may grant conditional approval to a QAPP to permit some work to begin while non-critical deficiencies in the QAPP are being resolved. 5.2.2 QAPP Implementation and Revision All QAPPs shall be implemented as approved by EPA. The organization performing the work shall implement the approved QAPP and ensure that all personnel involved in the work have copies of the approved QAPP and all other necessary documents. Personnel implementing the approved QAPP should understand the requirements prior to the start of data generation activities. Because of the complex and diverse nature of environmental data operations, changes to original plans are often needed. The EPA Project Manager, with the assistance of the QA Manager as appropriate, must determine the impact of such changes on the technical and qual'ity objectives of the project. When a substantive change is warranted, the originator of the QAPP shall modify the QAPP to document the change and submit the revision for approval by the same authorities that performed the original review Only after the revision has been approved and received (at least verbally with written follow-up) by project personnel, shall the change be implemented. It is essential that the QAPP be kept current and that all personnel involved in the work have easy access to a current version of the QAPP. For programs or projects of long duration, such as multi-year monitoring programs, the QAPPs shall be reviewed at least annually by the Project Manager. If revisions are necessary to reflect current needs, the QAPP must be revised and resubmitted for review and approval. 5.2.3 Applicability of QAPPs The QAPP requirements in this chapter apply to all (intramural and extramural) environmental data operations that acquire, generate, or compile environmentally-related data and that are performed by or on behalf of EPA. Extramural data operations may include contracts and work assignments, deliver)' orders, task orders, cooperative agreements. interagency agreements, State-EPA agreements, State, local, and Tribal Financial 5-2 ------- EPA Quality Manual for Environmental Programs . 5360 07/16/98 Assistance/Grants, Research Grants, and responses to statutory or regulatory requirements and to consent agreements negotiated as part of enforcement actions. QA/QC requirements shall be negotiated into applicable interagency agreements, including sub-agreements since EPA cannot unilaterally impose its QA/QC requirements in these agreements. Where specific Federal regulations require QA/QC, QAPPs shall be prepared, reviewed, and approved in accordance with the specifications contained in this document for the data collection activity unless superseded by the regulation. 5.3 OAPP Elements and Requirements Environmental data operations encompass diverse and complex activities, including rule making, compliance with regulations, and research. As a result, some environmental data operations may only require a qualitative discussion of the experimental process and its objectives while others may require extensive documentation in order to adequately describe a complex environmental program. The content and level of detail in each QAPP may vary according to the nature of the work being performed and the intended use of the data. The final decision on QAPP content and level of detail belongs to the EPA organization responsible for the work to be done, consistent with the approved QMP. 5.3.1 General Content Requirements The QAPP must provide sufficient detail to demonstrate that: the project technical and quality objectives (e g., Data Quality Objectives) are identified; the intended measurements 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. Most environmental data operations require the coordinated efforts of many individuals, possibly including managers, engineers, scientists, statisticians, and others. The QAPP must integrate the contributions and requirements of everyone involved into a clear, concise statement of what needs to be accomplished, how it shall be done, and by whom. It must provide understandable instructions to those who must implement the QAPP, including the field sampling team, the analytical laboratory, and the data reviewers. The use of standard operating procedures and national standards and practices is encouraged in all aspects of the QAPP. 5-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 In order to be effective, the QAPP must specify the level or degree of QA/QC needed for the particular environmental data operations. The QA/QC technical requirements of a project should commensurate with: « the purpose of the environmental data collection (e.g., enforcement action, research and development), the type of work to be done (e.g., monitoring, site characterization, bench level proof of concept), and how the results shall be used (e.g., regulatory enforcement, permit approval). The QAPP must be composed of standardized, recognizable elements covering the entire project from planning, through implementation, to assessment. The QAPP elements that follow are presented in that order and have been arranged for convenience into four general groups. The four groups of elements and their intent are summarized as follows: A. Project Management - These elements cover the basic area of project management, including the project history, project objectives, and roles and responsibilities of the participants. These elements document that the project has a defined goal and that the participants understand the goal and the approach to be used. B. Measurement/Data Acquisition - These elements cover all aspects of measurement systems design and implementation, ensuring that appropriate methods for sampling, analysis, data handling, and QC are employed and are properly documented. C. Assessment/Oversight - These elements address the activities for assessing the effectiveness of the implementation of the project and associated QA/QC. The purpose of assessment is to ensure that the QAPP is implemented as prescribed. D. Data Validation and Usability - These elements cover the QA activities that occur after the data collection phase of the project is completed. Implementation of these elements ensures that the data conform to the specified criteria, thus achieving the project objectives. All applicable elements defined by the EPA organization sponsoring the work must be addressed in the QAPP. Documentation, such as an approved Work Plan, Standard Operating Procedures (SOPs), etc., may be referenced in response to a particular required QAPP element to reduce the size of the QAPP and the time required for preparation and review. All referenced 5-4 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 documents must be attached to the QAPP itself or be placed on file with the appropriate EPA office and available for routine referencing when needed. Such references must be kept current by the submitter. The QAPP shall also address related QA planning documentation (e.g., Quality Management Plans) from subcontractors or suppliers of services critical to the technical and quality objectives of the project or task. 5.3.2 Group A, Project Management This group of QAPP elements covers the basic area of project management, including: Al Title and Approval Sheet A2 Table of Contents A3 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 5.3.2.1 A1. Title and Approval Sheet Include the title of the plan, name of the organization(s) implementing the project, and names, titles, signatures of appropriate approving officials and their - ^proval dates. Approving officials include the Organization's Project Manager, Organization's Quality Assurance Manager. EPA Project Manager, and EPA Quality Assurance Manager, as appropriate. Other officials, as needed, may include the field operations manager, laboratory manager. State officials, and other Federal Agency officials. 5.3.2.2 A2. Table of Contents List the sections, figures, tables, references, and appendices. Document control format may be required at the option of the Project Manager and QA Manager. When required, use a document control format on each page following the Title and Approval Sheet. For example, the following may be placed on the upper right hand comer of each page: Section No. Revision No. Date Page of 5-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 5.3.2.3 A3. Distribution List List the individuals and their organizations who shall receive copies of the approved QAPP and any subsequent revisions. Include all persons responsible for implementation (including managers), the QA managers, and representatives of all groups involved. 5.3.2.4 A4. Project/Task Organization Identify the individuals or organizations participating in the project and discuss their specific roles and responsibilities. Include the principal data users, the decision-makers, the project QA manager, and all persons responsible for implementation. The project quality assurance manager must be independent of the unit generating the data. (This does not include being independent of senior officials, such as corporate managers or agency administrators, who are nominally, but not functionally, involved in data generation, data use. or decision-making.) If someone other than the project manager is responsible for approving and accepting final products and deliverables, then that individual shall be identified. The individual responsible for maintaining the official, approved QAPP shall also be identified. Provide a concise organization chart showing the relationships and the lines of communication among all project participants. Include other data users who are outside of the organization generating the data, but for whom the data are nevertheless intended; e.g., modelers, risk assessors, design engineers, lexicologists, etc. The organization chart must also identify any subcontractor relationships relevant to environmental data operations. Where direct contact among project managers and data users does not occur, such as a S^v-rfund Potentially Responsible Party and the EPA Risk Assessment staff, the organization chart should show the pathway by which information is exchanged. 5.3.2.5 A5 Problem Definition/Background State the specific problem to be addressed or decision to be made. Include sufficient background information to provide the historical perspective for the project. 5.3.2.6 A6. Project/Task Description Provide a description of the work to be performed and schedule for implementation. This discussion may not need to be lengthy or overly detailed, but it should give an overall picture of how the project shall resolve the problem or question described in A5. Describe in general terms the following, as needed: Measurements that will be made during the course of the project. 5-6 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Applicable technical, regulatory, or program-specific quality standards, criteria, or objectives. % Any special personnel and equipment requirements. The assessment tools needed (i.e., program technical reviews, surveillances, and technical audits as needed by the project or specified by the QMP) for the project. A schedule for the work to be performed. Project and QA/QC records required, including the types of reports needed. 5.3.2.7 A7. Quality Objectives and Criteria for Measurement Data Provide a statement of the project quality goals or objectives and measurement performance criteria. EPA requires the use of a systematic planning process and prefers that most project planning be accomplished using the DQO Process. For details on the DQO Process and when it may be used, see the Guidance for the Data Quality Objectives Process (EPA 1994). 5.3.2.8 A8. Special Training Requirements/Certification Identify and describe any specialized training or certification requirements needed by personnel in order to successfully complete the project or task. Discuss how such training shall be provided and how the necessary skills shall be assured and documented. 5:3.2.9 A9 Documentation and Records Describe the process and responsibilities for ensuring that the most current approved version of the QAPP is available. Itemize the information and records which must be included in a data report package and specify the desired reporting format. Documentation can include raw data, field logs, instrument printouts, and results of calibration and QC checks. Specify the level of detail of the field sampling and/or laboratory analysis narrative needed to provide a complete description of any difficulties encountered during sampling or analysis. The narrative refers to an annotated summary of the analytical work performed by a laboratory that describes in narrative form what activities were performed and identifies any problems encountered that provides additional information to users in interpreting the data received. 5-7 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Specify any requirements for the final disposition of records and documents from the project, including location and length of retention period. 5.3.3 Group B, Measurement/Data Acquisition This group of QAPP elements covers all aspects of measurement systems design and implementation, including: Bl 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 5-3.3.1 Bl. Sampling Process Design (Experimental Design) Describe the experimental design or data collection design for the project, including as appropriate the types and numbers of samples required, the design of the sampling network, sampling locations and frequencies, sample matrices, measurement parameters of interest, and the rationale for the design. Classify each measurement as critical (i.e., required to achieve project objectives) or non-critical (informational purposes only). 5.3.3.2 B2. Sampling Methods Requirements Describe the procedures for collecting samples and identify the sampling methods and equipment, including any implementation requirements, sample preservation requirements. decontamination procedures, and materials needed. Identifying sampling methods by number, date, and regulatory citation (as appropriate) is often sufficient. If a method allows the user to select from various options, then the method citations should state exactly which options are being selected. Describe specific performance requirements for the method. For each sampling method, identify any support facilities needed. The discussion should also address what to do when a failure in the sampling or measurement system occurs and who is responsible for corrective action and how the effectiveness of the corrective action shall be determined and documented. 5-8 ------- EPA Quality Manual for Environmental Programs 5350 07/16/98 Describe the process for the preparation and decontamination of sampling equipment, including the disposal of decontamination by-products; the selection and preparation of sample containers, sample volumes, preservation methods, and maximum holding times to sample extraction and/or analysis. 5.3.3.3 B3. Sample Handling and Custody Requirements Describe the requirements and provisions for sample handling and custody in the field, laboratory, and transport, taking into account the nature of the samples, the maximum allowable sample holding times before extraction or analysis, and available shipping options and schedules. Sample handling includes preservation, packaging, shipment from the site, and storage at the laboratory. Examples of sample labels, custody forms, and sample custody logs should be included. 5.3.3.4 B4. Analytical Methods Requirements Identify the analytical methods and equipment required, including subsampling or extraction methods, laboratory decontamination procedures and materials (such as in the case of hazardous or radioactive samples), waste disposal requirements (if any), and any specific performance requirements for the method. Address what to do when a failure in the analytical system occurs and who is responsible for corrective action and how the effectiveness of the corrective action shall be determined and documented. Identifying analytical methods by number, date, and regulatory citation (as appropriate) is often sufficient. If a method allows the user to select from various options, then the method citations should state exactly which options are being selected. For non-standard methods, such as- unusual sample matrices and situations, appropriate method performance study information is needed to confirm the performance of the method for the particular matrix. If previous performance studies are not available, they must be developed during the project and included as part of the project results. 5.3.3.5 B5 Quality Control Requirements Identify QC procedures needed for each sampling, analysis, or measurement technique. For projects at or beyond the "proof-of-concept" stage and projects employing well-characterized methods, this section should list each required QC procedure, along with the associated acceptance criteria and corrective action. Because standard methods are often vague or incomplete in specifying QC requirements, simply relying on the cited method to provide this information is usually insufficient. 5-9 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Identify required measurement QC checks for both the field and the laboratory; for example, blanks, duplicates, matrix spikes, laboratory control samples, surrogates, or second column confirmation. State the frequency of analysis for each type of QC check, and the spike compounds sources and levels. State or reference the required control limits for each QC check and corrective action required when control limits are exceeded and how the effectiveness of the corrective action shall be determined and documented. Describe or reference the procedures to be used to calculate each of the QC statistics, including the QC checks described in the preceding paragraph as well as precision and bias. Copies of the formulas are acceptable as long as the accompanying narrative or explanation specifies clearly how the calculations will address difficult situations such as missing data values and "less than" or "greater than" values. 5.3.3.6 B6. Instrument/Equipment Testing. Inspection, and Maintenance Requirements Describe how inspections and acceptance testing of environmental sampling and measurement systems and their components shall be performed and documented to assure their intended use as specified by the design. Identify and discuss the procedure by which final acceptance shall be performed by independent personnel (e.g.. personnel other than those performing the data collection work) and/or by the EPA Project Officer. Describe how deficiencies are to be resolved, and when re-inspection shall be performed and how the effectiveness of the corrective action shall be determined and documented. Identify the equipment and/or systems requiring periodic maintenance. Describe or reference how periodic preventive and corrective maintenance of measurement or test equipment shall be performed to ensure availability and satisfactory performance of the systems. Discuss how the availability of critical spare parts, identified in the operating guidance and/or design specifications of the systems, shall be ensured and maintained. 5.3.3.7 B7. Instrument Calibration and Frequency Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment used for data collection activities affecting quality that must be controlled and, at specified periods, calibrated to maintain performance within specified limits. Describe or reference how calibration shall be conducted using certified equipment and/or standards with known valid relationships to nationally recognized performance standards. If no such nationally recognized standards exist, document the basis for the calibration. Identify the certified equipment and/or standards used for calibration. Indicate how records of calibration shall be maintained and be traceable to the instrument. 5-10 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 5.3.3.8 B8. Inspection/Acceptance Requirements for Supplies and Consumables Describe how and by whom supplies and consumables sjiall be inspected and accepted for use in the project. State acceptance criteria for such supplies and consumables. They include, but are not limited to: sample bottles, calibration gases, reagents, hoses, materials for decontamination of sampling equipment, deionized water, and potable water. 5.3.3.9 B9. Data Acquisition Requirements (Non-direct Measurements') Identify any types of data needed for project implementation or decision making that are obtained from non-measurement sources such as computer data bases, spreadsheets, programs, and literature files. Define acceptance criteria for the use of such data in the project. Discuss any limitations on the use of the data resulting from uncertainty in its quality and from the impact of adding more error to the results. 5.3.3.10 BIO. Data Management Describe the project data management scheme, tracing the path of the data from their generation in the field or laboratory to their final use or storage. Describe or reference the standard record-keeping procedures, document control system, and the approach used for data storage and retrieval on electronic media Discuss the control mechanism for detecting and correcting errors and for preventing loss of data during data reduction (i.e., calculations), data reporting, and data entry to forms, reports, and databases. Provide examples of any forms or checklists to be used. Identify and describe all data handling equipment and procedures to process, compile. ahd analyze the data including procedures for addressing data generated as part of the project as well as data from other sources. Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used. Describe the procedures that shall be followed to demonstrate acceptability of the hardware/software configuration required Describe the process for assuring that applicable Agency information resource management requirements (EPA Directive 2100) are satisfied. Agency policy requires that locational data be collected and reported with environmental data. If other Agency data management requirements are applicable, such as the Chemical Abstract Service Registry Number Data Standard (EPA Order 2180.1). Data Standards for the Electronic Transmission of Laboratory Measurement Results (EPA Order 2180.2), or the Minimum Set of Data Elements for Ground-Water Quality (EPA Order 7500.1 A), discuss how these requirements are addressed. 5-11 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 5.3.4 Group C, Assessment/Oversight This group of QAPP elements addresses the activities for assessing the effectiveness of the implementation of the project and associated QA/QC, including: C1 Assessments and Response Actions C2 Reports to Management 5.3.4.1 C1. Assessments and Response Actions Identify the number, frequency, and type of assessment activities needed for this project. Assessments include, but are not limited to surveillance, management systems review, readiness review, technical systems audit, performance evaluation, audit of data quality, and data quality assessment. List and describe the assessments to be used in the project. Discuss the information expected and the success criteria (i.e.. goals, performance objectives, acceptance criteria specifications, etc.) for each assessment proposed. List the approximate schedule of activities. For any planned self-assessments (utilizing personnel from within the project groups), identify potential participants and their exact relationship within the project organization. For independent assessments, identify the organization and person(s) that shall perform the assessments if this information is available. Describe how and to whom the results of the assessments shall be reported. Define the scope of authority of the assessors, including stop work orders. Define explicitly the unsatisfactory conditions under which the assessors are authorized to act and provide an approximate schedule for the assessments to be performed. Discuss how response actions to non-conforming conditions shall be addressed and by whom. Identify who is responsible for implementing the response action. Describe how response actions shall be verified, validated, and documented. 5.3.4.2 C2. Reports to Management Identify the frequency and distribution of reports issued to inform management of the status of the project, results of performance evaluations and system audits; results of periodic data quality assessments; and significant quality assurance problems and recommended solutions. Identify the preparer and the recipients of the reports. 5-12 ------- EPA Quality Manual for Environmental Programs 5350 07/16/98 5.3.5 Group 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 : Dl Data Review, Validation, and Verification Requirements D2 Validation and Verification Methods D3 Reconciliation with User Requirements 5.3.5.1 Dl. Data Review. Validation, and Verification Requirements State the criteria used to review and validate - that is, accept, reject, or qualify - data, in an objective and consistent manner. Provide examples of any forms or checklists to be used. Identify any project-specific calculations required. 5.3.5.2 D2. Validation and Verification Methods Describe the process to be used for validating and verifying data, including the chain of custody for data throughout the life cycle of the project or task. Discuss how issues shall be resolved and the authorities for resolving such issues. Describe how the results are conveyed to data users. 5.3.5.3 D3. Reconciliation with User Requirements Describe how the results obtained from the project or task shall be reconciled with the requirements defined by the user. Describe how issues shall be resolved. Discuss how limitations on the use of the data shall be reported to decision makers 5-13 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 APPENDIX A EPA ORDER 5360.1 CHG 1 POLICY AND PROGRAM REQUIREMENTS FOR THE MANDATORY AGENCY-WIDE QUALITY SYSTEM 1. PURPOSE. This Order re-affirms the policy defined by EPA Order 5360.1, April 1984, and expands that policy to accommodate the current and evolving needs of the Agency. The Order establishes policy and program requirements for the preparation and implementation of organizational or programmatic management systems pertaining to quality and contains the minimum requirements for the mandatory Agency-wide Quality System. 2. BASIS. AUTHORITY. AND REQUIREMENTS. a. Since 1979. Agency policy has required participation in an Agency-wide Quality System by all EPA organizations (office, region, national center or laboratory) supporting environmental programs and by non-EPA organizations performing work in behalf of EPA through extramural agreements This policy was affirmed in EPA Order 5360.1 in April 1984 and is reaffirmed in this Order. b. It is EPA policy that all environmental programs performed by EPA or directly for EPA through EPA-funded extramural agreements shall be supported by individual quality systems that comply fully with the American National Standard ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology'Programs, incorporated herein by reference. ANSI/ASQC E4-1994 is a national consensus standard authorized by the American National Standards Institute (ANSI) and developed by the American Society for Quality Control (ASQC) that will provide a basis for the planning, implementation, documentation, and assessment of the Agency-wide Quality System. Adoption of this standard is consistent with the statutory authority of the National Technology Transfer and Advancement Act of 1995 and the implementation authority of Office of Management and Budget (OMB) Circular A-l 19, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. c Under Delegation of Authority-I-41, "Mandatory Quality Assurance Program,'' the Office of Research and Development (ORD) is the focal point in the Agency for Quality System policy. ORD is responsible for developing quality assurance and quality control (QA/QC) requirements and for overseeing implementation of the Agency-wide Quality System. The Assistant Administrator for Research and Development (AA/ORD) is designated as the Agency Senior Management Official for Quality. The Quality Assurance Division (QAD) is designated by the AA/ORD to serve as the central management authority for this program. A-l ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 d. Each EPA Headquarters Office, National Program Office, Region, and components thereof, that conducts activities described by ANSI/ASQC E4-1994 shall develop and implement a quality system that complies with the requirements of this Ord.er. 3. BACKGROUND a. The Agency-wide Quality System is a management system that provides the necessary elements to plan, implement, document, and assess the effectiveness of QA/QC activities applied to environmental programs conducted by or for EPA. This system embraces many functions including: establishing quality management policies and guidelines for the development of organization- and project-specific quality plans; establishing criteria and guidelines for planning, implementing, documenting, and assessing activities to obtain sufficient and adequate data quality, providing an information focal point on QA/QC concepts and practices: performing management and technical assessments to ascertain effectiveness of QA/QC implementation; and identifying and developing training programs related to QA/QC implementation. In addition, this Order expands the applicability of QA/QC to the design, construction, and operation by EPA organizations of environmental technology such as pollution control and abatement systems; treatment, storage, and disposal systems; and remediation systems b. A consistent. Agency-wide Quality System will provide, when implemented, the needed management and technical practices to assure that environmental data used to support Agency decisions are of adequate quality and usability for their intended purpose. Since most EPA decisions rest on environmental data, a management system is needed that provides for: (1) identification of environmental programs for which QA/QC is needed. (2) specification of the quality of the data required from environmental programs, and (3) provision of sufficient resources to assure that an adequate level of QA/QC is performed. 4. REFERENCES. The following documents contain provisions which, through reference in this text, constitute provisions of this Order. At the time of the issuance of this Order, the editions were valid. Since policy documents and standards are subject to periodic revision, users of this Order should apply the most recent editions of the documents indicated below. a. 40 CFR Pan 30, "Grants and Agreements With Institutions of Higher Education. Hospitals, and Other Non-Profit Organizations." A-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 b. 40 CFR Part 31, "Uniform Administrative Requirements for Grants and Cooperative Agreement to State and Local Governments." c. 40 CFR Part 35, "State and Local Assistance." d. 48 CFR Chapter 15, Subpart 1546.2, "Contract Quality Requirements." e. ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, American National Standard, January 1995. f. Circular A-l 19, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, Office of Management and Budget, February 1998. g. Delegation of Authority 1-41, "Mandatory Quality Assurance Program,'' U.S. Environmental Protection Agency, Washington, DC, April 1981. h. EPA Order 5360. EPA Quality Manual for Environmental Programs. 1998. i. National Technology Transfer and Advancement Act of 1995. PL 104-113. March 1996 5 SCOPE AND FIELD OF APPLICATION. a. Scope. This Order defines the minimum requirements for quality systems supporting EPA environmental programs that encompass: (1) the collection, evaluation, and use of environmental data by or for EPA. and (2) the design, construction, and operation of environmental technology by EPA. b- Applicability to Environmental Programs. This Order applies to (but is not limited to) the following environmental programs: (1) the characterization of environmental or ecological systems and the health of human populations; (2) the direct measurement of environmental conditions or releases, including sample collection, analysis, evaluation, and reporting of environmental data, A-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 (3) the 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; and % (4) the collection and use of environmental data pertaining to the occupational health and safety of personnel in EPA facilities (e.g., indoor air quality measurements) and in the field (e.g., chemical dosimetry, radiation dosimetry). c. Applicability to Other EPA Programs. This order applies to the collection and use of medical testing data from Government and non-Government personnel in EPA facilities for determination of substance abuse. d. Organizational Applicability. (1) EPA Organizations. The Agency-wide Quality System requirements defined by this Order apply to all EPA organizations, and components thereof, in which the environmental programs conducted involve the scope of activities described in Section 5.a above. The authority of this Order applies only to EPA organizations except as addressed by Section 5.d(2) below. (2) Extramural Agreements. Agency-wide Quality System requirements may also apply to non-EPA organizations. These requirements are defined in the applicable regulations governing extramural agreements. Agency-wide Quality System requirements may also be invoked as part of negotiated agreements such as memoranda of understanding. Non- EPA organizations that may be subject to quality system requirements include: (a) Any organization or individual under direct contract to EPA to furnish services or items or perform work (i.e., a contractor) under the authority of 48 CFR Chapter 15, Part 1546. (including applicable work assignments, delivery orders, and task orders); (b) Institutions of higher education, hospitals, and other non-profit recipients of financial assistance (e.g.. Grants and Cooperative Agreements) under the authority of 40 CFR Part 30; (c) State, local, and Tribal governments receiving financial assistance under the authority of 40 CFR Part 31 and 35; and (d) Other Government Agencies receiving assistance from EPA through interagency agreements. A-4 ------- EPA Quality Manual for Environmental Programs . 5360 07/16/98 6. QUALITY SYSTEM REQUIREMENTS AND IMPLEMENTATION. a. Quality System Requirements. EPA organizations cqvered by the scope of this Order shall develop, implement, and maintain a quality system that demonstrates conformance to the minimum specifications of ANSI/ASQC E4-1994 and that additionally provides for the following: (1) A quality assurance manager (QAM), or person assigned to an equivalent position, who functions independently of direct environmental data generation, model development, or technology development responsibility; who reports on quality issues to the senior manager having executive leadership authority for the organization; and who has sufficient technical and management expertise and authority to conduct independent oversight of and assure the implementation of the organization's quality system in the environmental programs of the organization. (2) A Quality Management Plan (QMP), which documents the organization's quality policy, describes its quality system, identifies the environmental programs to which the quality system applies, and which is implemented following approval by the organization's executive leadership and the AA/ORD. (3) Sufficient resources to implement the quality system defined in the approved QMP. (4) Assessments of the effectiveness of the quality system at least annually. . (5) Submittal to the AA/ORD of the Quality Assurance Annual Report and Work Plan (QAARWP) for the organization that summarizes the previous year's QA/QC activities and outlines the work proposed for the current year. (6) Use of a systematic planning approach to develop acceptance or performance criteria for all work covered by this Order. (See Section 3.3.8 of the EPA Quality Manual for Environmental Programs, 1998.) (7) Approved Quality Assurance Project Plans (QAPPs), or equivalent documents defined by the QMP, for all applicable projects and tasks involving environmental data with review and approval having been made by the EPA QAM (or authorized representative defined in the QMP). QAPPs must be approved prior to any data gathering work or use, except under circumstances requiring immediate action to protect human health and the environment or operations conducted under police powers. A-5 ------- EPA Quality Manual for Environmental Programs . 5360 07/16/98 (8) Assessment of existing data, when used to support Agency decisions or other secondary purposes, to verify that they are of sufficient quantity and adequate quality for their intended use. (9) Implementation of Agency-wide Quality System requirements in all applicable EPA-funded extramural agreements (see Section 5.d(2)). (10) Implementation of corrective actions based on assessment results. (11) Appropriate training, for all levels of management and staff, to assure that QA/QC responsibilities and requirements are understood at every stage of project implementation. b. Quality System Implementation. (1) EPA Organizations. Mandatory requirements for implementing this Order are contained in the EPA Quality Manual for Environmental Programs, hereafter referred to as the EPA Quality Manual. Additional non-mandatory guidance for implementing the requirements are provided in EPA Guidance Documents which may be applied to intramural environmental programs, as appropriate. (2) Extramural Agreements. (a) Mandatory requirements for implementing this Order are defined in applicable EPA regulations. EPA Requirements Documents provide specifications for satisfying the requirements of these regulations. The EPA Requirements Documents provide the equivalent information to the EPA Quality Manual, except they have been written especially for the extramural user. Non-mandatory guidance for implementing the requirements are provided in EPA Guidance Documents which may be applied to extramural environmental programs, as appropriate. (b) Extramural organizations that provide objective evidence (such as a QMP or quality manual) of conforming to the specifications of the American National Standard ANS1/ASQC E4-1994 are in compliance with this Order. A-6 ------- EPA Quality Manual for Environmental Programs 07/16/98 7- GENERAL REQUIREMENTS FOR MANAGERS AND STAFF a' Assistant Administrator for Research and Development and ORQ Senior Manaperg (1) The AA/ORD, as the Agency Senior Management Official for Quality, shall: (a) Establish, document, and periodically revise Agency policies and procedures for planning, implementing, and assessing the effectiveness of the mandatory Agency-wide Quality System. (b) Review and approve QMPs from Agency components conducting environmental programs for implementation for up to five years. (c) Perform periodic management assessments of all EPA organizations conducting environmental programs to determine the effectiveness of their mandatory quality systems and recommend corrective actions. , (d) Develop generic training programs, for all levels of EPA management and stati, so that quality management responsibilities and requirements are understood at every stage of project implementation. (2) The AA/ORD and ORD senior managers shall: (a) Designate a representative for quality management and QA/QC to advise and assist the AA in the planning, implementation, documentation, and assessment of the quality systems for organizations under the AA's responsibility. (b) Ensure that all ORD components and applicable programs comply fully with the requirements of this Order. (c) Ensure that quality management is an identified activity with associated resources adequate to accomplish its program goals and is implemented as prescribed in approved QMPs. (<0 Ensure that all ORD-funded environmental programs implemented through extramural agreements comply fully with applicable QA/QC requirements. (e) Ensure that environmental data from research and development programs are of sufficient quantity and adequate quality for their intended use and are used consistent with such intentions. A-7 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 (f) Perform periodic assessments of ORD organizations conducting environmental programs to determine the conformance of their mandatory quality systems to their approved QMPs and the effectiveness of their implementation. (g) Ensure that deficiencies highlighted in the assessments of ORD organizations are appropriately addressed. (h) Identify program-specific QA/QC training needs for all levels of management and staff and provide for this training. (i) Ensure that performance plans for supervisors, senior managers, and appropriate staff contain critical element(s) that are commensurate with the quality management responsibilities assigned by this Order and the organization's QMP. b. National Program Office Assistant Administrators and Senior Managers. (1) Each National Program Office (NPO) Assistant Administrator shall designate a representative for quality management and QA/QC to advise and assist the AA in the planning. implementation, documentation, and assessment of the quality systems for organizations under the AA's responsibility. (2) The National Program Office (NPO) Assistant Administrators and senior managers shall: (a) Ensure that all NPO components and applicable programs comply fully with the requirements of this Order. (b) Ensure that quality management is an identified activity with associated resources adequate to accomplish its program goals and is implemented as prescribed in the organization's approved QMP. (c) Ensure that all environmental programs implemented through extramural agreements comply fully with applicable QA/QC requirements. (d) Ensure that environmental data from the parts of National Programs implemented by the Regions or delegated to State, local, and Tribal governments are of sufficient quantity and adequate quality for their intended use and are used consistent with such intentions. (e) Ensure that all proposed and final regulations needing environmental data during their development or implementation include the application of sufficient and adequate QA/QC during the collection and use of such data. A-8 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 (0 Perform periodic assessments of NPO organizations conducting environmental programs to determine the conformance of their mandatory quality systems to their approved QMPs and the effectiveness of their implementation. (g) Ensure that deficiencies highlighted in the assessments are appropriately addressed. (h) Identify program-specific QA/QC training needs for all levels of management and staff and provide for this training. (i) Ensure that performance plans for supervisors, senior managers, and appropriate staff contain critical element(s) that are commensurate with the quality management responsibilities assigned by this Order and the organization's QMP. c- Regional Administrators and Senior Managers. Regional Administrators and senior managers shall: (1) Ensure that all Regional components and programs comply fully with the requirements of this Order. (2) Ensure that quality management is an identified activity with associated resources adequate to accomplish its program goals and is implemented as prescribed in the organization's approved QMP. (3) Ensure that all environmental programs implemented through extramural agreements comply fully with applicable QA/QC requirements. (4) Ensure that the environmental data from environmental programs delegated to State, local, and Tribal governments are of sufficient quantity and adequate quality for their intended use and are used consistent with such intentions. (5) Ensure that training is available for State, local, and Tribal governments performing environmental programs for EPA in the fundamental concepts and practices of quality management and QA/QC that they may be expected by EPA to perform. (6) Perform periodic assessments of Regional organizations conducting environmental programs to determine the conformance of their mandatory quality systems to their approved QMPs and the effectiveness of their implementation. (7) Ensure that deficiencies highlighted in the assessments are appropriately addressed. A-9 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 (8) Identify QA/QC training needs for all levels of management and staff and provide for this training. (9) Ensure that performance plans for supervisors, senior managers, and appropriate staff contain critical element(s) that are commensurate with the quality management responsibilities assigned by this Order and the organization's QMP. d. Quality Management Personnel. Quality management personnel, including the QAM, refers to individuals within the organization who are assigned specific quality management duties and are delegated authority for quality management as defined in the organization's QMP. The functions of the quality management personnel may be totally related to quality system activities or be in conjunction with other functions and responsibilities within the organization. If these personnel have other functions to perform, there should be no conflict of interest. Specific duties and responsibilities of all quality management personnel shall be documented in the organization's QMP. Specific responsibilities shall include: (1) facilitating QMP development and approval by the organization and preparing updates to the approved QMP; (2) representing the organization to QAD and other groups on matters pertaining to quality management and QA/QC, (3) providing expert assistance to the staff in the organization on QA/QC policies, requirements, and procedures applicable to procurement an- technical activities; (4) reviewing and approving QMPs and QAPPs submitted by intramural programs and by holders of extramural agreements as defined in the organization's QMP; (5) identifying QA/QC training needs for the organization; (6) providing oversight of QA/QC implementation in the environmental programs conducted by or for the organization; and (7) performing assessments of environmental programs and confirming the effectiveness of corrective actions. A-10 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 e. Agency Managers and Staff. (1) Managers at all levels shall: (a) Ensure that quality management is an identified activity with associated resources adequate to accomplish its program quality goals. (b) Ensure that all organizational components and programs comply fully with the requirements of this Order. (c) Ensure that all applicable environmental programs for which management is responsible comply fully with the requirements of this Order. (d) Perform all other quality management roles and responsibilities assigned to them in their organization's QMPs. (2) Managers and staff shall: (a) Ensure that all applicable intramural programs and activities comply fully with the requirements of this Order. (b) Ensure that all applicable extramural environmental which the manager or staff member is responsible comply fully with the requir Order. programs for requirements of this (c) Assure that the results of environmental programs are of sufficient qnantity and adequate quality for their intended use. (d) Perform all other quality management roles and responsibilities assigned to them in their organization's QMPs. 8. DEFINITIONS. The following terms have special meanings in relation to this Order. a. assessment - the evaluation process used to measure the performance or effectiveness of a system and its elements. As used here, assessment is an all-inclusive term used to denote any of the following: audit, performance evaluation, management review, peer review. inspection, or surveillance. b. environmental data - any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology. For EPA, environmental data include information A-ll ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 collected directly from measurements, produced from models, and compiled from other sources such as data bases or the literature. c. environmental programs - work or activities involving the environment, including but not limited to: characterization of environmental processes and conditions; environmental monitoring; environmental research and development; the design, construction, and operation of environmental technologies; and laboratory operations on environmental samples. d. environmental technology - an all-inclusive term used to describe pollution control devices and systems, waste treatment processes and storage facilities, and site remediation technologies and their components that may be utilized to remove pollutants or contaminants from or prevent them from entering the environment. Examples include wet scrubbers (air), soil washing (soil), granulated activated carbon unit (water), and filtration (air, water). Usually, this term applies to hardware-based systems; however, it also applies to methods or techniques used for pollution prevention, pollutant reduction, or containment of contamination to prevent further movement of the contaminants, such as capping, solidification or vitrification, and biological treatment. e. extramural agreement - a legal agreement between EPA and an organization outside EPA for items or services to be provided. Such agreements include contracts, work assignments. delivery orders, task orders, cooperative agreements, research grants, state and local grants, and EPA-funded interagency agreements. f. management system - a structured non-technical system describing the policies. objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for conducting work and producing items and services. g. organization - a company, corporation, firm, enterprise, or institution, or part thereof. whether incorporated or not. public or private, that has its own functions and administration. In the context of this Order, an EPA organization is an office, region, national center or laboratory. h. process - a set of interrelated resources and activities which transforms inputs into outputs. Examples of processes include analysis, design, data collection, operation, fabrication. and calculation. i. quality - the totality of features and characteristics of a product or service that bear on its ability to meet the stated or implied needs and expectations of the user. j. quality assurance (QA) - an integrated system of management activities involving planning, implementation, documentation, assessment, reporting, and quality improvement to A-12 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 ensure that a process, item, or service is of the type and quality needed and expected by the customer. k. quality assurance manager (QAM) - the individual designated as the principal manager within the organization having management oversight and responsibilities for planning, documenting, coordinating, and assessing the effectiveness of the quality system for the organization. 1. quality assurance project plan (QAPP) - a document describing in comprehensive detail the necessary QA/QC and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria. m. 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 customer; operational techniques and activities that are used to fulfill requirements for quality. n. quality management - that aspect of the overall management system of the organization that determines and implements the quality policy. Quality management includes strategic planning, allocation of resources, and other systematic activities (e.g., planning, implementation, documentation, and assessment) pertaining to the quality system. o quality management plan (QMP) - a document that describes a quality system in terms of the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. p. quality system - a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, documenting, and assessing work performed by the organization and for carrying out required QA/QC. q. user - an organization, group, or individual that utilizes the results or products from environmental programs or the customer for whom the results or products were collected or created. A-13 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 9. SUPERSESSION. This Order replaces EPA Order 5360.1, dated April 1984, in its entirety. /s/ David J. O'Connor Director Office of Human Resources and Organizational Services A-14 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 APPENDIX B TERMS AND DEFINITIONS assessment - the evaluation process used to measure the performance or effectiveness of a system and its elements. As used here, assessment is an all-inclusive term used to denote any of the following: audit, performance evaluation, management systems review, peer review, inspection, or surveillance. audit (quality) - a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. bias - the systematic or persistent distortion of a measurement process which causes errors in one direction (i.e., the expected sample measurement is different from the sample's true value). calibration - comparison of a measurement standard, instrument, or item with a standard or instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those inaccuracies by adjustments. data quality assessment (DQA) - a statistical and scientific evaluation of the data set to determine the validity and performance of the data collection design and statistical test, and to determine the adequacy of the data set for its intended use. data quality objectives (DQOs) - qualitative and quantitative statements derived from the DQO Process that clarify study objectives, define the appropriate type of data, and specify tolerable levels of potential decision errors that will be used as the basis for establishing the quality and quantity of data needed to support decisions. data quality objectives process - a systematic planning tool to facilitate the planning of environmental data collection activities. Data quality objectives are the qualitative and quantitative outputs from the DQO Process. design - specifications, drawings, design criteria, and performance requirements. Also the result of deliberate planning, analysis, mathematical manipulations, and design processes. document - any compilation of information which describes, defines, specifies, reports, certifies. requires, or provides data or results pertaining to environmental programs. environmental conditions - the description of a physical medium (e.g., air. water, soil, sediment) or biological system expressed in terms of its physical, chemical, radiological, or biological characteristics. B-l ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 environmental data -any measurements or information that describe environmental processes, location, or conditions; ecological or health effects and consequences; or the performance of environmental technology. For EPA, environmental data include information collected directly from measurements, produced from models, and compiled from other sources such as data bases or the literature. environmental data operations - work performed to obtain, use, or report information pertaining to environmental processes and conditions. environmental processes - manufactured or natural processes that produce discharges to, or that impact, the ambient environment. environmental programs - work or activities involving the environment, including but not limited to: characterization of environmental processes and conditions; environmental monitoring; environmental research and development; and the design, construction, and operation of environmental technologies; and laboratory operations on environmental samples environmental technology - an all-inclusive term used to describe pollution control devices and systems, waste treatment processes and storage facilities, and site remediation technologies and their components that may be utilized to remove pollutants or contaminants from or prevent them from entering the environment Examples include wet scrubbers (air), soil washing (soil). granulated activated carbon unit (water), and filtration (air. water) Usually, this term applies to hardware-based systems: however, it also applies to methods or techniques used for pollution prevention, pollutant reduction, or containment of contamination to» prevent further movement of the contaminants, such as capping, solidification or vitrification, and biological treatment. extramural agreement - a legal agreement between EPA and an organization outside EPA for items or services to be provided Such agreements include contracts, work assignments, delivery orders, task orders, cooperative agreements, research grants, state and local grants, and EPA- funded interagency agreements. financial assistance - the process by which funds are provided by one organization (usually government) to another organization for the purpose of performing work or furnishing services or items. Financial assistance mechanisms include grants, cooperative agreements, and government interagency agreements. graded approach - the process of basing the level of application of managerial controls applied to an item or work according to the intended use of the results and the degree of confidence needed in the quality of the results. B-2 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 independent assessment - an assessment performed by a qualified individual, group, or organization that is not a part of the organization directly performing and accountable for the work being assessed. management - those individuals directly responsible and accountable for planning, implementing, and assessing work. management assessment - the qualitative assessment of a particular program operation and/or organization(s) to establish whether the prevailing quality management structure, policies. practices, and procedures are adequate for ensuring that the type and quality of results needed are obtained. A management assessment may either be performed by those immediately responsible for overseeing and/or performing the work (i.e., a management self-assessment) or by someone other that the group performing the work (i.e., a management independent assessment). management system - a structured non-technical system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for conducting work and producing items and services. management systems review (MSR) - the qualitative assessment of a data collection operation and/or organization(s) to establish whether the prevailing quality management structure, policies. practices, and procedures are adequate for ensuring that the type and quality of data needed are obtained. measurement and testing equipment - tools, gauges, instruments* sampling devices or systems used to calibrate, measure, test, or inspect in order to control or acquire data to verify conformance to specified requirements. . method - a body of procedures and techniques for performing an activity (e.g., sampling. chemical analysis, quantification) systematically presented in the order in which they are to be executed. observation - an assessment conclusion that identifies a condition (either positive or negative) which does not represent a significant impact on an item or activity. An observation may identify a condition which does not yet cause a degradation of quality. organization - a company, corporation, firm, enterprise, or institution, or part thereof, whether incorporated or not. public or private, that has its own functions and administration. In the context of this Manual, an EPA organization is an office, region, national center or laboratory. peer review - a documented critical review of work by qualified individuals (or organizations) who are independent of those who performed the work, but are collectively equivalent in B-3 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 technical expertise. A peer review is conducted to ensure that activities are technically adequate, competently performed, properly documented, and satisfy established technical and quality requirements. The peer review is an in-depth assessment of ^assumptions, calculations, extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions pertaining to specific work and of the documentation that supports them. performance evaluation (PE) - a type of audit in which the quantitative data generated in a measurement system are obtained independently and compared with routinely obtained data to evaluate the proficiency of an analyst or laboratory. precision - a measure of mutual agreement among individual measurements of the same property, usually under prescribed similar conditions, expressed generally in terms of the standard deviation. process - a set of interrelated resources and activities which transforms inputs into outputs. Examples of processes include analysis, design, data collection, operation, fabrication, and calculation. quality - the totality of features and characteristics of a product or service that bear on its ability to meet the stated or implied needs and expectations of the user. quality assurance (QA) - an integrated system of management activities involving planning, implementation, documentation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the customer. quality assurance manager (QAM) - the individual designated as the principal manager within the organization having management oversight and responsibilities for planning, documenting. coordinating, and assessing the effectiveness of the quality system for the organization. quality assurance project plan (QAPP) - a document describing in comprehensive detail the necessary QA. QC, and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria. 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 customer; operational techniques and activities that are used to fulfill requirements for quality. quality' improvement - a management program for improving the quality of operations. Such management programs generally entail a formal mechanism for encouraging worker recommendations with timely management evaluation and feedback or implementation. B-4 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 quality management - that aspect of the overall management system of the organization that determines and implements the quality policy. Quality management includes strategic planning, allocation of resources, and other systematic activities (e.g., planning, implementation, documentation, and assessment) pertaining to the quality system. ii quality management plan (QMP) - a document that describes a quality system in terms of the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. quality system - a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, documenting, and assessing work performed by the organization and for carrying out required QA and QC. readiness review - a systematic, documented review of the readiness for the start-up or continued use of a facility, process, or activity. Readiness reviews are typically conducted before proceeding beyond project milestones and prior to initiation of a major phase of work. record - a completed document that provides objective evidence of an item or process. Records may include photographs, drawings, magnetic tape, and other data recording media scientific method - the principles and processes regarded as necessary for scientific investigation, including rules for concept or hypothesis formulation, conduct of experiments, and validation of hypotheses by analysis of observations. self-assessment - assessments of work conducted by individuals, groups, or organizations directly responsible for overseeing and/or performing the work. standard operating procedure (SOP) - a written document that details the method for an operation, analysis, or action with thoroughly prescribed techniques and steps, and that is officially approved as the method for performing certain routine or repetitive tasks. supplier - any individual or organization furnishing items or services or performing work according to a procurement document or financial assistance agreement. This is an all-inclusive term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, or consultant. B-5 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 surveillance (quality) - continual or frequent monitoring and verification of the status of an entity and the analysis of records to ensure that specified requirements are being fulfilled. « technical assessment - the evaluation process used to measure the performance or effectiveness of a technical system and its elements with respect to documented specifications and objectives. Such assessments may include qualitative and quantitative evaluations. A technical assessment may either be performed by those immediately responsible for overseeing and/or performing the work (i.e., a technical self-assessment) or by someone other that the group performing the work (i.e., a technical independent assessment). technical review - a documented critical review of work that has been performed within the state of the art. The review is accomplished by one or more qualified reviewers who are independent of those who performed the work, but are collectively equivalent in technical expertise to those who performed the original work. The review is an in-depth analysis and evaluation of documents, activities, material, data, or items that require technical verification or validation for applicability, correctness, adequacy, completeness, and assurance that established requirements are satisfied. technical systems audit (TSA) - a thorough, systematic, on-site. qualitative audit of facilities. equipment, personnel, training, procedures, record keeping, data validation, data management. and reporting aspects of a system. user - an organization, group, or individual that utilizes the results or products from environmental programs or a customer for whom the results or products were collected or created. validation - confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. In design and development, validation concerns the process of examining a product or result to determine conformance to user needs verification - confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 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. B-6 ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 APPENDIX C REFERENCES Title 40, Part 30, Code of Federal Regulations, "Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations." Title 40, Part 31, Code of Federal Regulations, "Uniform Administrative Requirements for Grants and Cooperative Agreement to State and Local Governments." Title 40, Part 160, Code of Federal Regulations, "Good Laboratory Practices (Pesticides)." Title 40, Part 792, Code of Federal Regulations, "Good Laboratory Practices (Toxic Substances Control Act)." Title 48, Pan 1546, Code of Federal Regulations, "Contract Quality Requirements." ANSI/ASQC E4-1994. Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology' Programs, American National Standard. January 1995. EPA Directive 2100. Information Resources Management Policy Manual. 1998 EPA Directive 2182. EPA System Design and Development Guidance, December 1996 EPA Order 1900, Contracts Management Manual. February 1998. EPA Order 1900.1 A, Use of Contractor Services to Avoid Improper Contractor Relationship* April 1994. EPA Order 2160, Records Management Manual, July 1984. EPA Order 2180.1, Chemical Abstract Service Registry Number Data Standard. June 1987. EPA Order 2180.2, Data Standards for the Electronic Transmission of Laboratory Measurement Results, December 1988. EPA Order 2180.3, Facility Identifications Standard, April 1990. EPA Order 7500.1 A, Minimum Set of Data Elements for Ground-Water Quality, October 1992. C-l ------- EPA Quality Manual for Environmental Programs 5360 07/16/98 Office of Federal Procurement Policy, 1992. OFPP Policy Letter 92-1, "Inherently Governmental Functions," 57 FR 45096, Washington, DC. Office of Federal Procurement Policy, 1993. OFPP Policy Letter 93-1, "Management Oversight of Service Contracting," 58 FR 63593, Washington, DC. U.S. Environmental Protection Agency, 1998. Guidance for Quality Assurance Project Plans (QA/G-5), EPA/600/R-98/018, Office of Research and Development. U.S. Environmental Protection Agency, 1996. Guidance for the Data Quality Assessment Process Practical Methods for Data Analysis (QA/G-9). EPA/600/R-96/084, Office of Research and Development. U.S. Environmental Protection Agency, 1995. The Directives Clearance Process - What It Is and How It Works, EPA/200/F-95/001, Office of Administration and Resource Management. U.S. Environmental Protection Agency, 1994. Guidance for the Data Quality Objectives Process (QA/G-4). EPA/600/R-96/055, Office of Research and Development U.S. Environmental Protection Agency. 1994. Memorandum from Ray E Spears, Associate General Council, to H. Matthew Bills. Director for Modeling, Monitoring Systems and Quality Assurance, "Use of Extramural Support to Implement Quality Systems for Environmental Programs Involving Environmental Data Operations." C-2 ------- |