Environmental Technology Verification Water Quality Protection Center Quality Management Plan Revision 3 November 2004 Developed by: NSF International 789 Dixboro Road Ann Arbor, MI 48105 Authors and Contributors: Thomas Stevens Maren Roush WQPC QMP Page 1 of 32 Revision 3 - November 2004 ------- Environmental Technology Verification (ETV) Water Quality Protection Center (WQP) Quality Management Plan Revision 3 November 2004 Thomas Stevens Raymond Frederick NSF International U.S. Environmental Protection Agency WQP Center Project Manager WQP Center Project Officer Bruce DeMaine Carolyn Esposito NSF International U.S. Environmental Protection Agency WQP Center Quality Manager WQP Center Quality Manager WQPCQMP Page 2 of 32 Revision 3 - November 2004 ------- Contents Contents 3 Acronyms and Abbreviations 5 Introduction 6 Background 6 Environmental Technology Verification Program 6 Program Description 7 Operation of the Center 7 Program and Quality Management Documents 8 The ETV Quality Management Plan 8 WQP Center 8 WQP Center - Quality Management Plan 9 1. Management Systems 10 1.1. Management and Organization 10 1.1. WQP Center Quality Policy 10 1.2. Organization Structure 10 1.2.1. NSF Corporate Organization Structure 10 1.2.2. Center Structure - NSF Personnel 10 1.2.2.1. Vice President, Research 10 1.2.2.2. Project Manager, WQP Center 10 1.2.2.3. Project Coordinators, WQP Center 11 1.2.2.4. Secretary, Federal Programs 11 1.2.2.5. Director, Quality Assurance 11 1.2.3. Center Structure - EPA Personnel 12 1.2.4. WQP Center Stakeholder Advisory Groups 12 1.2.5. WQP Center Technology Panels 12 2. Quality System and Description 13 2.1. Corporate 13 2.2. Federal Programs 14 2.3. WQP Center 14 2.4. Laboratories 14 3. Assessments 15 3.1. Quality Management Systems Review 15 3.1.1. Assessment of Corporate Quality Assurance 15 3.1.2. Center Quality Systems Audits 15 3.1.2.1. Independent Assessment -EPA 15 3.1.2.2. Self Assessment-NSF 15 3.1.3. Other Assessments 15 4. Conformance to E4 16 4.1. Water Quality Protection Center QMP 16 4.2. Quality Management System (Part A of E4) 16 4.3. Collection and Evaluation of Data (Part B of E4) 16 5. Collection and Evaluation of Data 17 5.1. Planning and Design 17 5.2. Implementation 17 5.3. Reporting 17 5.4. Assessments 18 5.4.1. Technical Systems Audits 18 5.4.1.1. Independent - EPA 18 5.4.1.2. Self-NSF 18 5.4.2. Performance Evaluation Audits 18 5.4.2.1. Independent - EPA 18 5.4.2.2. Self-NSF 18 5.4.3. Audits of Data Quality 19 5.4.3.1. Independent - EPA 19 5.4.3.2. Self-NSF 19 6. Use of Existing Data 20 WQPCQMP Page 3 of 32 Revision 3 - November 2004 ------- Attachment A: Location of E4 Requirements in NSF Reference Documents 22 Appendix A: NSF Standard Operating Procedures Referenced in WQP QMP 33 WQPCQMP Page 4 of 32 Revision 3 - November 2004 ------- Acronyms and Abbreviations ANSI American National Standards Institute ASQC American Society for Quality Control CQAM Corporate Quality Assurance Manual E4 ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs EPA Environmental Protection Agency ETV Environmental Technology Verification Program GSA General Services Administration LQAM NSF Laboratory Quality Assurance Manual NERL National Exposure Research Laboratory NRMRL National Risk Management Research Laboratory NSF NSF International ORD EPA's Office of Research and Development QMP Quality Management Plan SOP Standard Operating Procedure WQPCQMP Page 5 of 32 Revision 3 - November 2004 ------- Introduction Background Environmental Technology Verification Program The following background information on the ETV Program is excerpted from the Environmental Protection Agency's Environmental Technology Verification Program Quality Management Plan (EPA Report No. EPA/600/R-03/021). The Environmental Technology Verification Program (ETV) was established by the Environmental Protection Agency (EPA) to evaluate the performance characteristics of innovative environmental technologies across all media and to report objective performance information to the permitters, buyers, and user of environmental technology. ETV evolved in response to the following mandates: • A 1995 Presidential directive to EPA in Bridge to a Sustainable Future, to "work with the private sector to establish a market-based verification process...which will be available nationally for all environmental technologies within three years." • Goals articulated in the Administration's Reinventing Government: A Performance Review, which directed EPA to begin a comprehensive environmental technology verification program no later than October 1995. • Congressional appropriation language contained in the FY96 and FY97 budgets, that the Agency fund technology verification activities at the $10 million level in each year. To comply with these directives, EPA's Office of Research and Development (ORD) established a five-year pilot program to evaluate alternative operating parameters and determine the overall feasibility of a technology verification program. ETV began the five-year pilot period in October 1995. At the conclusion of the pilot period, the Agency prepared a Report to Congress containing an evaluation of the results of the pilot program and recommendations for its future operation. Credible, high-quality performance information is one of the tenets of ETV. Therefore, the highest appropriate level of quality assurance is used throughout the program. EPA's Office of Research and Development, under which ETV operates, has implemented an Agency-wide quality system to assure that activities conducted in EPA research laboratories and other facilities or at facilities being operated on behalf of or in cooperation with the EPA are supported by data of known and acceptable quality for their intended use. Each of the ORD laboratories involved in ETV, the National Risk Management Research Laboratory (NRMRL) and the National Exposure Research Laboratory (NERL), operate under laboratory-specific quality management plans (QMPs). The ETV QMP is consistent with the policies expressed in the individual laboratory QMPs and is intended to provide an overarching uniform quality system for all aspects of the ETV program. WQPCQMP Page 6 of 32 Revision 3 - November 2004 ------- Program Description Developers of innovative environmental technology report numerous impediments to commercialization. Among those most frequently mentioned is the lack of acceptance of vendor performance claims. The success of the pilot program shows that objective, independently acquired, high-quality performance data and operational information on new technologies significantly facilitates the use, permitting, financing, export, purchase, and general marketplace acceptance of such technologies. ETV provides this data and information to the customer groups that require them to accelerate the real world implementation of improved technology. Improved technology more thoroughly, rapidly, and efficiently protects human health and the environment. It is important to stress that the product of ETV is high-quality data and information, not technology approval or endorsement. Although there is substantial EPA involvement in guiding and administering this program, ETV does not provide EPA endorsement or certification of commercial products. At the conclusion of the pilot period the Agency internally reviewed the performance and operation of the program to assess its future direction and scope. The ETV Director recommended consolidation of the program into six technology centers: • Advanced Monitoring Systems Center (AMS) • Air Pollution Control Technology Center (APCT) • Greenhouse Gas Technology Center (GHG) • Drinking Water Protection Center (DWS) • Water Quality Protection Center (WQP) • Pollution Prevention, Recycling and Waste Treatment Center (P2,R,WT) During 2000 and 2001 the first five centers above were established. The sixth center was not put in place due to a lack of adequate funding to support it. In addition, subsequent to the terrorist attacks of September 11th, 2001, the role of ETV in verifying homeland security type environmental technologies was brought to the forefront. As vulnerabilities in the Nation's critical infrastructure were identified, two areas of particular concern - drinking water supply systems, and the health and safety of the Nation's workforce in their places of employment - became a focus for EPA. ETV was called upon to support the Nation's homeland security efforts by adapting its testing and evaluation process for technologies for protecting and cleaning up drinking water systems and buildings. ORD realized the tremendous testing and evaluation capability that resided in the various technology verification organizations that have been and continue to operate each center, therefore, it was determined to be in the best interest of the Nation to utilize the existing technology verification organizations, where possible and practical, to execute this mission. Three of the existing verification organizations - Battelle, Research Triangle Institute, and NSF International - were enlisted to support the homeland security-related technology testing and evaluation needs. A new center operated by Battelle - the Building Decontamination Technology Center (BDT) - was established, as the existing verification organization funding agreements did not have this type technology verification within their scopes of work. The homeland security efforts fall into two categories: water security and safe buildings. The water security efforts are being accomplished through the existing cooperative agreements with the AMS, DWS, and WQP centers. The safe buildings efforts are being accomplished through General Services Administration (GSA) contract to two existing verification organizations, Battelle and Research Triangle Institute. Contracts through GSA were chosen in lieu of cooperative agreements because it was believed that for this area the Agency and federal government would have to be directive in many of the elements of the effort: the stakeholders, the test methods, deciding on the technologies to be tested, and possibly other aspects. This was in contrast to the water security effort in which the ETV management process consistent with cooperative agreements was to be followed. None of the contract funding will be commingled with cooperative agreement funding by the technology verification organizations. The ETV project officers have been trained in the distinctions between managing cooperative agreements and contracts. Operation of the Center The technology verification organizations are all not-for-profit entities that work with or for EPA through an extramural agreement (a cooperative agreement, an interagency agreement, or an existing General Services Administration (GSA) contract). EPA and the technology verification organization roles are identical to those established during the pilot period. Each agreement has oversight by an EPA project officer who may also be the EPA Center Manager. EPA provides substantial oversight through an active quality assurance program. Each technology verification organization is contractually required to fully implement EPA QA requirements for planning, auditing, and documenting the testing and reporting activities. Qualified peer reviewers are also utilized to review the technical aspects of the test plans and of the final reports. WQPCQMP Page 7 of 32 Revision 3 - November 2004 ------- Program and Quality Management Documents Several documents define the overall operation of the Program. The first to be published (February, 1997) was the Environmental Technology Verification Strategy. This document describes the goals, customer and key word definitions, basic operating principles, project selection criteria, and the programmatic and budgetary vision of the program. The Strategy is evaluated periodically for the need for modification and amplification. The second major program management document being used by ETV to guide its operation is the ETV Quality Management Plan (QMP). The ETV Quality Management Plan The ETV QMP uses the structure, policies, and standards established in the American National Standard Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs (E4)1. This document "...describes a basic set of mandatory specifications and non-mandatory guidelines by which a quality system for programs involving environmental data collection and environmental technology can be planned, implemented, and assessed." Based on the structure and standards of E4, the ETV QMP contains the definitions, procedures, processes, inter-organizational relationships, and outputs that assure the quality of both the data and the programmatic elements of ETV. Part A of the ETV QMP contains the specifications and guidelines that are applicable to common or routine quality management functions and activities necessary to support the ETV program. Part B contains the specifications and guidelines that apply to test-specific environmental technology testing activities involving the generation, collection, analysis, evaluation, and reporting of test data. The ETV QMP was also developed in accordance with EPA Requirements for Quality Management Systems2, a document that provides the development and content requirements for Quality Management Plans for organizations that conduct environmental data operations for EPA through contracts, assistance agreements, and interagency agreements; however, it may be used by EPA as well. The ETV QMP is designed to play a major role in clearly delineating the roles and responsibilities of all the diverse and important participants. The ETV Program is organizationally complex. Within EPA, the Program is coordinated though ORD's ETV Team, consisting of staff from eight branches located in three divisions in two laboratories, NRMRL and NERL, and one ORD center, the Homeland Security Research Center, including the quality assurance staff assigned to each organizational element. There are also numerous outside organizations involved through the stakeholder process, the technology verification organizations who bear most of the quality assurance responsibilities, and testing and consulting companies hired by technology verification organizations to conduct field and laboratory work. Finally, EPA program offices and regions are increasingly involved in outreach activities, as are other Federal agencies and states. WQP Center The U.S. Environmental Protection Agency's partner in the ETV Water Quality Protection (WQP) Center is NSF International (NSF), a not-for-profit, non-governmental organization that provides public health and safety-based risk management solutions and is dedicated to protection of the environment. The goal of the WQP Center is to verify commercial-ready environmental technologies that protect ground- and surface waters from contamination. Under the WQP Center, technologies are evaluated by a third party organization, following technically sound test procedures, appropriate QA/QC, and a managed process, to provide purchasers, specifiers and permitters with credible and relevant data. Verification protocols are developed for specific technology areas following an open process with broad-based stakeholder input. The protocols then serve as templates for developing test plans for the evaluation of individual technologies at specific locations. Verification reports detailing the results of the technology evaluations are made publicly available to assist in marketing, purchase and permitting of the technologies. Verification statements, executive summaries of each verification test, are also provided. 1 American Society for Quality (ASQ); American National Standard and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs: ASQ, Milwaukee, Wisconsin, 1994. (E4) 2 U.S. Environmental Protection Agency; EPA Requirements for Quality Management Systems. EPA/240/B-01/002; 2001 (available on the Internet at www.epa.gov/quality/qs-docs/r2-final.pdf). WQPC QMP Page 8 of 32 Revision 3 - November 2004 ------- WQP Center - Quality Management Plan As the Verification Organization for the WQP Center, NSF is required to maintain a center-specific QMP that adheres to the guidelines set forth in the American National Standard, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs (E4) and the ETV QMP. NSF has prepared a Water Quality Protection Center Quality Management Plan (WQP QMP) that outlines NSF's quality systems and demonstrates conformance with the relevant provisions of E4, EPA QMP Requirements, and the ETV QMP. Many of the provisions of E4 and the ETV QMP were already addressed in NSF's existing management and quality systems, as documented in the NSF Corporate Quality Assurance Manual, the NSF Laboratories Quality Assurance Manual, NSF Standard Operating Procedures (SOPs) and other NSF documents. The NSF documents that are relevant to the operation of the WQP Center are referenced herein. Other provisions of E4 and the ETV QMP (particularly Part B, Collection and Evaluation of Environmental Data) are addressed in the SOPs, Protocols, and Test Plans developed specifically for the WQP Center The purpose of the WQP QMP is to provide the definitions, procedures, processes, inter-organizational relationships, and outputs that assure the quality of both the data and programmatic elements of the WQP Center. Sections 1 through 4 of the WQP QMP contain the specifications and guidelines that are applicable to common or routine quality management functions and administrative activities necessary to support the WQP Center. These sections also detail the organizational structure of both NSF and the WQP Center Sections 5 through 6 of the WQP QMP contain the specifications and guidelines that apply to test-specific environmental activities involving the generation, collection, analysis, evaluation, and reporting of data. WQPCQMP Page 9 of 32 Revision 3 - November 2004 ------- 1. Management Systems 1.1. Management and Organization 1.1. WQP Center Quality Policy The quality system for the WQP Center seeks to be consistent with that of the ETV Program, EPA QMP Requirements, and industry consensus standards. To that purpose, the quality system for the WQP Center conforms to the relevant provisions of the ETV QMP, EPA QMP Requirements, and E4. Attachment A is a table that lists the requirements of E4 and the NSF Reference Documents (SOPs) that fulfill them. In addition, all SOPs referenced herein are included in Appendix A. Each verification test shall be performed according to planned, documented, and approved test/QA plans, which are developed by NSF International or a subcontractor in accordance with NSF SOP AA-394-0002. All technical statements in ETV verification reports shall be supported by the appropriate data. The quality management system for NSF International is described in the NSF Corporate Quality Assurance Manual (CQAM), NSF Document Control No. AF-700-0002, which is included in Appendix A. The CQAM documents NSF's Corporate Mission, Corporate Values, Quality Policy and Objectives, Quality System Document Structure, and General and Administrative Structure. In addition, the CQAM describes the quality systems in place for all of NSF's operations. 1.2. Organization Structure 1.2.1. NSF Corporate Organization Structure The NSF corporate organization structure is described in Section 4 of the CQAM. 1.2.2. Center Structure - NSF Personnel The WQP Center is one of two ETV Centers operated under separate cooperative agreements between NSF and EPA. The NSF ETV Centers are overseen by the Vice President, Research. Training records of NSF staff are available from NSF's Human Resources Department for review by EPA, upon request. Listed below are the general functional responsibilities of the NSF personnel associated with the WQP Center. 1.2.2.1. Vice President, Research Gordon Bellen, 734-827-6840 Responsibilities include: • providing leadership on Center initiatives and long-term goals; • overseeing outreach activities, including those that impact multiple ETV Centers or other NSF Programs; and • communicating with NSF Chief Executive Officer, Corporate Officers, and Senior Management regarding ETV activities. 1.2.2.2. Project Manager, WQP Center Thomas Stevens, 734-769-5347 Responsibilities include: • reporting to Vice President, Research; • establishing, attending, and conducting meetings of stakeholders; • maintaining communication with EPA, including the ETV director, ETV team, EPA center manager and the EPA center quality manager, to assure mutual understanding and conformance with EPA quality procedures and expectations and ETV policies and procedures; • managing the oversight and conduct of verification activities; • assuring that quality procedures are incorporated into all aspects of the each ETV project; • overseeing the development of verification protocols and test plans; WQPC QMP Page 10 of 32 Revision 3 - November 2004 ------- • overseeing the development and implementation of the WQP Center Quality Management Plan; • overseeing the development of ETV verification reports for technology evaluations; • overseeing the development of an ETV verification statement at the completion of each technology verification; • approving contractual agreements with external parties such as protocol developers, peer-reviewers, and testing organizations; and • identifying, conducting, and managing Center outreach activities including paper presentations, trade shows, agency visits, etc. 1.2.2.3. Project Coordinators, WQP Center Patrick Davison, 734-913-5719 MarenRoush, 734-827-6821 Responsibilities include: • reporting to Project Manager, WQP Center; • establishing contact with interested stakeholders and soliciting their participation on Stakeholder Advisory Groups and Technology Panels and with peer-review activities; • preparing agendas, meeting materials, presentations, and summaries for meetings of Stakeholder Advisory Groups and Technology Panels; • soliciting vendor applications for verification testing; • coordinating verification protocol/test plan development; • soliciting potential field testing organizations/sites for verification activities; • reviewing qualifications of potential field testing organizations/sites and making recommendations to the Project Manager as to their suitability for conducting testing and preparing reports; • conducting audits and inspections of verification tests; • reviewing verification reports and supporting data for completeness and conformance with QA provisions in the verification protocol and test plan; • preparing and updating the WQP Center Quality Management Plan; • preparing and maintaining the WQP Center web pages on the NSF web sites and forwarding content to EPA for inclusion on its web sites; and • ensuring that Center documents are distributed to the proper ETV Program personnel. 12.2A. Secretary, Federal Programs Pat Wilkie, 734-913-5740 Responsibilities include: maintaining mailing lists for the Stakeholder Advisory Groups, Technology Panels, Contract organizations, and other stakeholders; providing administrative support for Center activities such as mailings and faxes; and making necessary arrangements for on-site and off-site meetings and conference calls. 1.2.2.5. Director, Quality Assurance Bruce DeMaine, 734-769-5143 Responsibilities include: ensuring that quality procedures are incorporated into all aspects of the Center; ensuring that quality assurance reviews have been performed on all verification protocols, product- and site-specific test plans and verification reports, and that feedback for improvement has been provided and addressed; reviewing and approving the WQP QMP; and conducting annual audits of the WQP Center for conformance with the WQP QMP. WQPC QMP Page 11 of 32 Revision 3 - November 2004 ------- 1.2.3. Center Structure - EPA Personnel The WQP Center is one of seven centers operating under the EPA's ETV Program. Section 1.2 of the ETV QMP, "Organization Structure", lists the general functional responsibilities of the EPA personnel associated with the ETV program, including the EPA center manager. 1.2.4. WQP Center Stakeholder Advisory Groups The WQP Center Stakeholder Advisory Groups are comprised of individuals representing organizations concerned with water quality protection. Five Stakeholder Advisory Groups were formed by the WQP Center to address the following technology areas: Ballast Water Treatment, Decentralized Wastewater Treatment, Infrastructure Rehabilitation, Watershed Protection, and Wet Weather Flow. Stakeholder Advisory Group members are selected by NSF and EPA and include users of technologies, technology vendors, consultants, financial institutions, state and local permitters and regulators, EPA regional personnel, and federal agency officials. Many members represent professional and trade organizations in addition to their specific employer. Members of a Stakeholder Advisory Group: • assist in prioritizing the types of technologies to be verified; • assist in the development and review of verification protocols, as requested; • review verification reports and statements, as requested; • assist in definition and conduct of outreach activities appropriate to the technology area and customer groups; • exchange information with the organizations represented; and • provide general guidance to Center, especially with respect to Center policies and procedures. For more information on the roles and responsibilities of WQP Center Stakeholder Advisory Groups, refer to NSF SOP No. AA- 394-0001, which is included in Appendix A. 7.2.5. WQP Center Technology Panels Technology Panels consist of individuals who have expertise in a particular technology area. Whereas Stakeholder Advisory Group members provide policy-related input to the Center and assist with prioritization of technology areas to be addressed by the Center, Technology Panels are formed, as needed, to assist with the development and review/revision of Verification Protocols and Test Plans for specific technologies or technology areas. For more information on the roles and responsibilities of WQP Center Technology Panels, refer to NSF SOP No. AA-394-0001, which is included in Appendix A. All stakeholders in the WQP Center, in addition to those serving on Stakeholder Advisory Groups and Technology Panels, are encouraged to participate in Center activities, including meetings and review of documents that have been released for public comment. WQPC QMP Page 12 of 32 Revision 3 - November 2004 ------- 2. Quality System and Description 2.1. Corporate NSF has a company-wide quality system to assure that the NSF quality policy is upheld and the NSF quality objectives are achieved. The quality system is described in the CQAM and related standard operating procedures (SOPs). Corporate quality systems are reviewed and their description updated annually to reflect changes in the organization and in policy. Table 2-1 highlights the key elements of the NSF quality system and identifies the NSF Document, by Document Control Number and Title, in which the element is addressed. The procedures and policies contained in the referenced NSF document apply to the Federal Programs area of the Engineering and Research Services Department and the WQP Center. Table 2-1. NSF Quality System Summary and References to Control Documents Key Elements of the NSF Quality System Established quality policy and objectives focused on meeting customer and stakeholder needs applicable to all of NSF' s operations Training of NSF personnel Documentation of procedures, policies and processes used in NSF's operations Process to control the distribution and dissemination of documents such as processes, procedures and contracts for all operations Addressing customer feed back and comments Internal and external audits and inspections of operations Record retention Control Document Reference AF-700-0002: SECTIONS 2.0 AND 2. 1 IN CQAM AA-700-0188: CONTINUOUS IMPROVEMENT REPORT AC-700-0007: CONTINUOUS IMPROVEMENT REPORT FORM AF -700-0003: CORPORATE TRAINING MANUAL AF -700-0001: HUMAN RESOURSES HANDBOOK AA-700-0001: PERFORMANCE APPRAISALS SEE THE LIST OF CONTROL DOCUMENTS WHICH BEGIN WITH THE LETTERS "AA". THESE LETTERS SIGNIFY THAT THE DOCUMENT IS A PROCEDURE. OTHER LETTER DESIGNATIONS INCLUDE FORMS (AC), ETC. AA-759-0006: SUBMITTAL AND ISSUANCE OF CONTROLLED DOCUMENTS AA-700-0008: PROCEDURAL MODIFICATION DOCUMENTATION AA-700-0 191: CLIENT FEEDBACK MANAGEMENT SYSTEM AF-700-0002: SECTION 13 IN CQAM AF-700-0002: SECTION 14 IN CQAM AA-700-0 187: CORPORATE QUALITY ASSURANCE AUDITS AF-700-0002: SECTION 15 IN CQAM WQPC QMP Revision 3 - November 2004 Page 13 of 32 ------- 2.2. Federal Programs The Engineering and Research Services (ERS) Department consists of two main groups of staff: Federal Programs employees, who are ETV personnel (NSF staff who work for the Drinking Water Systems Center and the Water Quality Protection Center) and other Engineering and Research Services personnel. The ERS staff typically respond to and manage research projects, one- time evaluations and special studies. The highly qualified and credentialed members of the ERS Department have years of experience in developing and performing test protocols for "non-routine" commercial, municipal, and government projects of all sizes. In addition to operating under the company-wide quality system outlined in Table 2-1, the ERS Department develops, documents and implements procedures as needed for its specific operations. SOPs for ERS operations, including those specific to the Federal Programs personnel, are maintained in the NSF Document Control System. 2.3. WQP Center In order to achieve the technical and quality goals of the WQP Center and the ETV Program, the WQP Center operates in accordance with written procedures and guidelines. The procedures and guidelines specific to the Center include the following documents: AA-394-0001 Procedures for the Formation, Maintenance, and Role of Stakeholder Advisory Groups and Technology Panels AA-394-0002 Verification Protocol, Test Plan, and Verification Report Development Procedures AK-394-0001 Guidelines for the Conduct of Meetings of the Stakeholder Advisory Groups and Technology Panels 2.4. Laboratories NSF operates several laboratories for the purpose of conducting chemical, engineering, and microbiological assessments. NSF's laboratories are accredited by more than 20 organizations at the state, national, and international levels. The laboratories operate in accordance with the corporate quality system as described in the CQAM, and in accordance with the laboratories' quality system, as described in the NSF Laboratories Quality Assurance Manual (LQAM), Document Control #AF-840-0001. Analyses performed on behalf of the ETV Program are done in accordance with the QA/QC procedures established in the LQAM and the relevant Test Plan(s). WQPCQMP Page 14 of 32 Revision 3 - November 2004 ------- 3. Assessments 3.1. Quality Management Systems Review Periodic reviews of NSF Corporate and WQP Center quality systems are necessary to establish that the Center's quality management structure, policies, practices and procedures are adequate for ensuring the quality of results demanded by its customers. 3.1.1. Assessment of Corporate Quality Assurance An independent audit of the NSF Corporate Quality Assurance Systems is conducted annually as prescribed in Section 14 of the CQAM. Independent accreditation bodies periodically audit NSF's Quality Assurance Systems. This is done as necessary to obtain and maintain NSF's multiple accreditations. 3.1.2. Center Quality Systems Audits 3.1.2.1. Independent Assessment - EPA The EPA Center Quality Manager will perform a quality systems audit of the WQP Center, using the WQP QMP as a basis, to assess the quality management practices of the WQP Center. The quality systems audit will take place once in the first year after approval of the WQP QMP, and thereafter as requested. The quality systems audit follows the guidelines presented in Part A: Section 2.7 and Table 9.1 of the ETV QMP. The audit report will be forwarded for review to the EPA Director of Quality Assurance, EPA Center Manager, the appropriate Project Manager(s) (NSF), and the ETV Director. 3.1.2.2. Self Assessment-NSF The NSF Director, Quality Assurance, will perform a quality systems audit of the WQP Center, using the WQP QMP as a basis, as specified in Part A: Section 2.7 and Table 9.1 of the ETV QMP. The quality systems audit will take place once in the first year after approval of the WQP QMP, and thereafter as requested. The audit report will be forwarded to the Project Manager of the WQP Center for review and final copies of the report will be distributed to the EPA Center Manager. 3.1.3. Other Assessments NSF is also responsible for conducting quality assessments related to the collection and evaluation of data under the WQP Center. Additional required assessments include Technical Systems Audits, Performance Evaluation Audits, and Audits of Data Quality, the purpose and frequency of which are described in 5.4. WQPC QMP Page 15 of 32 Revision 3 - November 2004 ------- 4. Conformance to E4 The ETV Water Quality Protection Center is committed to conforming to the relevant provisions of E4 and EPA QMP Requirements. 4.1. Water Quality Protection Center QMP The WQP QMP is organized so that it can be compared to E4 and EPA QMP Requirements. Attachment A addresses NSF's quality management system (Part A of E4) and the Center's processes for collecting and evaluating environmental data (Part B of E4). 4.2. Quality Management System (Part A of E4) The requirements in Part A of E4 for a quality management system are met by two NSF documents: • AF-700-0002: Corporate Quality Assurance Manual • AF-840-0001: Laboratory Quality Assurance Manual The locations of the specific E4 requirements in these NSF documents are shown in Attachment A. The two referenced documents are attached to this QMP. 4.3. Collection and Evaluation of Data (Part B of E4) The requirements in Part B of E4 for the collection and evaluation of test data are met by the following NSF documents: • AA-394-0002: Verification Protocol, Test Plan, and Verification Report Development Procedures • Individual protocols and test plans developed for technology evaluations under the ETV Water Quality Protection Center WQPC QMP Page 16 of 32 Revision 3 - November 2004 ------- 5. Collection and Evaluation of Data 5.1. Planning and Design Verification Protocols have been and will continue to be developed for various categories of water quality protection technologies identified as priorities by NSF, EPA, and the relevant Stakeholder Advisory Groups. Verification Protocols outline the scope, data quality objectives, and the generic experimental design for verification. These protocols are developed in accordance with NSF Document AA-3 94-0002, Verification Protocol, Test Plan, and Verification Report Development Procedures, which conforms to the guidelines established in the ETV QMP Part B: Section 2.0 Design of Technology Verification Tests. The Verification Protocols provide the framework for the development of Test Plans, which are also addressed in NSF Document AA- 394-0002. Test Plans describe the procedures to be followed when evaluating vendor-specific technologies at site-specific locations. Each Verification Protocol contains a QA/QC section that provides guidelines for the quality assurance elements to be included in the technology- and site-specific Test Plans. The QA/QC section of the Verification Protocol addresses QA responsibilities, data quality indicators, QC checks, data handling, corrective action plans, and other items necessary to verify the quality and consistency of the work. Each Test Plan contains a Quality Assurance Project Plan that describes the specific QA/QC methods and procedures to be followed during all phases of equipment operation, sample collection, handling and analysis, instrument calibration, and data handling. The Quality Assurance Project Plans contain written procedures for planning and conducting audits. 5.2. Implementation Most verification tests are conducted at off-site facilities by organizations under contract with NSF. Procedures for NSF subcontracting are explained in NSF SOP AA-840-0001. The subcontract testing organization, if any, is responsible for conducting the testing in accordance with the approved Verification Protocol and Test Plan(s). The subcontract organization must demonstrate its ability to implement the Verification Protocol and Test Plan(s) as written and operate in accordance with the WQP QMP. If the subcontract organization is to draft the test plan and/or verification report, it must also demonstrate its ability to meet the requirements outlined in AA-394-0002 Verification Protocol, Test Plan, and Verification Report Development Procedures. Due to unforeseen occurrences it is sometimes necessary for a subcontract testing organization to propose deletions, additions, or modifications to an approved Test Plan in order to complete the verification testing. Any changes or additions to the Test Plan deemed necessary by the contract testing organization shall be documented and approved in advance by the Verification Organization 5.3. Reporting NSF and EPA are responsible for the issuance of all ETV Verification Reports and ETV Verification Statements developed under the WQP Center. NSF oversees the development of ETV Verification Reports in accordance with AA-394-0002 Verification Protocol, Test Plan, and Verification Report Development Procedures prior to their submission to EPA. The Project Manager (NSF) or designated Project Coordinator is responsible for overseeing the preparation of each verification report. Verification reports are reviewed by the EPA Center Quality Manager, the NSF Director, Quality Assurance, peer-reviewers, and the vendor. The Center Quality Manager and NSF Director, Quality Assurance, are ultimately responsible for the QA review of each verification report, but may choose to designate other staff to perform the review, as needed to expedite the process. The reviewers' comments are considered and the verification report is updated as appropriate. Following the required reviews of the verification report, the Project Manager (NSF) forwards the reviewed reports to the EPA Center Manager for approval, as specified in the ETV QMP. Final verification reports are distributed to the ETV Director and are provided to the ETV Webmaster to post on the Internet. NSF oversees the development of ETV verification statements in accordance with AA-394-0002 Verification Protocol, Test Plan, and Verification Report Development Procedures. A verification statement is included as an "executive summary" of the verification test at the beginning of each verification report, and may also be used as a standalone document. The Project Manager (NSF) is responsible for the preparation of each verification statement. Each verification statement is reviewed by the EPA Center Manager, the EPA Center Quality Manager, the NSF Director, Quality Assurance, peer-reviewers, the vendor and the WQPC QMP Page 17 of 32 Revision 3 - November 2004 ------- ETV Director. The Center Quality Manager and the NSF Director, Quality Assurance, are ultimately responsible for the QA review of each verification statement, but may choose to designate other staff to perform the review, as needed to expedite the process. The reviewers' comments are considered and the verification statement is updated as appropriate. Following the required reviews of the verification statement, the revised verification statements are forwarded to the EPA laboratory directors for approval, as specified in the ETV QMP. Final verification statements are distributed to the ETV Webmaster. 5.4. Assessments 5.4.1. Technical Systems Audits 5.4.1.1. Independent - EPA The EPA Center Quality Manager will perform a technical systems audit at least once per year, as applicable, in accordance with Part B: Section 4.1.2 of the ETV QMP. The purpose of the technical systems audit is to assess the technical systems of verification tests, including all facilities, maintenance, calibration procedures, reporting requirements, sampling and analytical activities, and quality control procedures, and to ensure their conformance to the approved test plans. Audit reports will be forwarded to the appropriate EPA Center Manager for review. 5.4.1.2. Self-NSF The Project Manager (NSF), Project Coordinator, Director, Quality Assurance, or other qualified NSF designee will conduct a technical systems audit at least once during the verification testing period for each technology evaluated through the WQP Center. The purpose of the technical systems audit is to assess the technical systems of verification tests, including all facilities, maintenance, calibration procedures, reporting requirements, sampling and analytical activities, and quality control procedures, and to ensure their conformance to the approved test plans. Technical systems audits are most useful when conducted early in the life cycle of a project, when corrective actions (if necessary) can be performed that will minimize the loss of data. Audit reports will be forwarded to the appropriate Project Manager (NSF), the EPA Center Quality Manager, and the Testing Organization for review. Subcontract testing organizations will conduct serf-assessments of technical systems at a frequency specified in the relevant Test Plan. 5.4.2. Performance Evaluation Audits 5.4.2.1. Independent - EPA The EPA Center Quality Manager will conduct a performance evaluation audit of the measurement systems used in testing, as applicable, according to Part A: Table 9.1 and Part B: Section 4.1.4 of the ETV QMP. Although each measurement in a test program could be subjected to a performance evaluation, the critical measurements (designated in the test/QA plan) are more commonly evaluated. An evaluation of a measurement system usually involves the measurement or analysis of a reference material of known value or composition. The value or composition of reference material must be certified or verified prior to use, and the certification or verification must be adequately documented. Ideally, the identity of the reference material is disguised so that the operator or analyst will treat the material no differently than a test program sample. The audit report will be forwarded to the EPA Center Manager for review. 5.4.2.2. Self-NSF As applicable, NSF's Director, Quality Assurance, or another qualified NSF designee, will conduct a performance evaluation audit of the measurement systems used in testing at least once during the verification testing period for each technology evaluated under the WQP Center, as specified in Part A: Table 9.1 and Part B: Section 4.1.4 of the ETV QMP. Although each measurement in a test program could be subjected to a performance evaluation, the critical measurements (designated in the test/QA plan) are more commonly evaluated. An evaluation of a measurement system usually involves the measurement or analysis of a reference material of known value or composition. The value or composition of reference material must be certified or verified prior to use, and the certification or verification must be adequately documented. Ideally, the identity of the reference material is disguised so that the operator or analyst will treat the material no differently than a test program sample. Audit reports will be forwarded to the Project Manager (NSF) and the EPA Center Quality Manager for review. Contract testing organizations will conduct serf- assessments of measurements performance at a frequency specified in the relevant Test Plan. Laboratories conducting sample analyses for the WQP Center shall be accredited by: WQPC QMP Page 18 of 32 Revision 3 - November 2004 ------- • The state in which the laboratory operates, if an accreditation program is offered; • The American Association for Laboratory Accreditation; • NSF International (according to the LQAM); or • An equivalent program deemed acceptable by NSF. Subcontract laboratories shall have documented quality control procedures that include participation in approved, independent performance audits. 5.4.3. Audits of Data Quality 5.4.3.1. Independent - EPA To determine the accuracy and usability of data calculations and reporting, the EPA Center Quality Manager will conduct an audit of data quality for the WQP Center, as applicable. The audit of data quality will be performed on raw data and summary data. Findings will be documented in a data quality audit report, which will be provided to the EPA Center Manager for review. 5.4.3.2. Self-NSF To determine the accuracy and usability of data calculations and reporting, NSF's Director, Quality Assurance, or another qualified NSF designee, will conduct an audit of data quality for each verification test conducted under the WQP Center using raw data and summary data. Audits of Data Quality are performed on at least 10% of the test data ("10% of the test data" means a random selection of 10% of the data from all of the measured parameters") that have already been 100% verified by project personnel, as possible (i.e. it may not be feasible to verify every data point generated by a monitor that measures flow every five seconds over the course of a verification test). Findings are documented in a data quality audit report, which is signed by NSF's Director, Quality Assurance, and is provided to the appropriate NSF Project Manager and to the EPA Center Quality Manager for review. Data quality audit reports will document that NSF's Quality Assurance Department reviewed the data associated with the verification test for the data quality indicators and that they were found to be acceptable. The data quality audit report will outline any deficiencies in 1) the data set and 2) the way in which the data were presented in the draft verification report. The data quality report will note any data quality deficiencies, along with corrective actions taken. WQPC QMP Page 19 of 32 Revision 3 - November 2004 ------- 6. Use of Existing Data The use of existing data (i.e., data collected outside of the ETV Program) toward the ETV Verification of a water quality protection technology is considered in accordance with the guidelines established in the ETV QMP Appendix C - Environmental Technology Verification Program Existing Data: Policy and Process. WQPC QMP Page 20 of 32 Revision 3 - November 2004 ------- Attachment A: Location of E4 Requirements in NSF Reference Documents E4: PART A ITEM 001 002 003 004 005 006 007 008 009 010 Oil 012 013 014 015 016 017 018 019 020 021 022 023 024 E4 REFEREN CE NO. 2.01.1.001 2.01.1.002 2.01.1.003 2.01.1.004 2.01.1.005 2.01.1.006 2.01.1.007 2.01.1.008 2.01.1.009 2.01.1.010 2.01.1.011 2.02.1.001 2.02.1.002 2.02.1.003 2.02.1.004 2.02.1.005 2.02.1.006 2.02.1.007 2.02.1.008 2.02.1.009.0 0 2.02.1.009.0 1 2.02.1.009.0 2 2.02.1.009.0 o 6 2.02.1.010 E4 SECTIO N mgt mgt mgt mgt mgt mgt mgt mgt mgt mgt mgt Qsyst Qsys Qsys Qsys Qsys Qsys Qsys Qsys Qsys Qsys Qsys Qsys Qsys SPECIFICATION quality policy quality system resp. authority, mgt appr ID of customers and suppliers ID their needs/expectations, est. work objectives negotiation for quality when problems/constraints ensure E4 understood and implemented provide adequate resources stop unsafe work or delegate authority assess and document adequacy of Q system define assessment objectives, determine Q system, impl. meas. determine response actions, implement in a timely manner Qsys plan, established, documented, implemented, and assessed include as org, policy, requi., guidance necessary shall ensure product/results of type needed no initiation of work until Qsys approved Qsys in QMP approved by mgt for implementation controls for projects and how projects are plan/impl/assess address all applicable part of E4 general descr. items/prog/activities Qsys applies to ID/document activities affecting Q mgt. resp. technic. act. resp. required interfaces Qsys update, at least annual NSF REFERENCE DOCUMENT AND SECTION 2.0-2.1 in CQ AM 4.0-4.3 in CQAM 2.0-2.1 in CQAM, Protocols 3.0-3.4 in CQAM, Protocols 3.0-3.4 in CQAM, AA 700-0191 5. 1.1 in CQAM 1.2 in CQAM Technology-Specific Test Plans 3.0-3.4 and 14.0-14.4 in CQAM 3.0-3.4 and 14.0-14.4 in CQAM 3.0-3.4 and 14.0-14.4 in CQAM 3. 0-3. 5 in CQAM 3. 0-3. 5 and 4 in CQAM 3. 0-3. 5 in CQAM 3.0-3.5 and 5.1.1 in CQAM 3. 5 and 14.4 in CQAM 3. 0-3. 5 in CQAM 3.0-3.5 and 5.11 in CQAM 3. 0-3. 5 in CQAM 3. 0-3. 5 in CQAM 4.0-4.3 in CQAM 4.0-4.3 in CQAM 3. 2 and 4.0-4.3 in CQAM 3. 5 and 14.0 in CQAM WQPC QMP Revision 3 - November 2004 Page 21 of 32 ------- ITEM 025 026 027 028 029 030 031 032 033 034 035 036 037 038 039 040 041 042 043 044 045 046 047 048 049 E4 REFEREN CE NO. 2.03.1.001 2.03.1.002 2.03.1.003 2.03.1.004 2.03.1.005 2.03.1.006 2.04.1.001 2.04.1.002 2.04.1.003 2.04.1.004 2.04.1.005 2.04.1.006 2.04.1.007 2.05.1.001 2.05.1.002 2.05.1.003 2.05.1.004 2.05.1.005 2.05.1.006 2.05.1.007 2.05.1.008 2.05.1.009 2.05.1.010 2.05.1.011 2.05.1.012 E4 SECTIO N Per/Tr Per/Tr Per/Tr Per/Tr Per/Tr Per/Tr Procur Procur Procur Procur Procur Procur Procur Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec Doc/Rec SPECIFICATION trained for project before starting the work need for training evaluated and impl. documentation of training ensure training when job reqs change doc/maintain evidence of job proficiency training resources planned/controlled/documented to meet client needs docs describe item/service needed & associated technical reqs/crit. specify parts of E4 supplier resp. for docs reviewed for accuracy before release changes to docs subject to same review procedures to ensure procured items meet requirements if stated, demonstrated capability needed from suppliers records mgt. procedures required must be applicable to all, including electronic media ID need for control of any specified documents must be reviewed for conformance before release by authoriz. if used for work, must be kept current ensure all users understand docs ID obsolete/superseded docs/ remove from workplace maintain docs to show quality of work or conformance to regs. maintenance to include retention/prot/pres/trac/retr if evid. records, COC for records and confidentiality proc. retention times based on contract/stat requirements storage, protection from damage, loss, deterioration NSF REFERENCE DOCUMENT AND SECTION 8.0-8.3 in CQAM, AF- 700-0003, AA-759-0006 8.0-8.3 in CQAM, AF- 700-0003 8.0-8.3 in CQAM, AF- 700-0003, AA-700-0001 8.0-8.3 in CQAM, AA- 759-0006 8.0-8.3 in CQAM, AA- 700-0001 8.0-8.3 in CQAM, AF- 700-0003 CQAM 9.0-9.3, LQAM 5.11-5.13 CQAM 9.0-9.3, LQAM 5.11-5.13;AA-840-0001 NA CQAM 9.0-9.3, LQAM 5.11-5.13 CQAM 9.0-9.3, LQAM 5.11-5.13 CQAM 9.0-9.3, LQAM 5.11-5.13;AA-840-0001 CQAM 9.0-9.3, LQAM 5.11-5.13; AA-840-0001 10.0-10.5 in CQAM, AF- 700-0002 NA 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM, AF- 700-0002, AA-759-0006 10.0-10.5 in CQAM WQPC QMP Revision 3 - November 2004 Page 22 of 32 ------- ITEM 050 051 052 053 054 056 057 058 059 060 061 062 063 064 065 066 067 068 069 070 071 072 073 074 075 E4 REFEREN CE NO. 2.06.1.001 2.06.1.002 2.06.1.003.0 0 2.06.1.003.0 1 2.06.1.003.0 2 2.06.1.004 2.06.1.005 2.06.1.006 2.06.1.007.0 0 2.06.1.007.0 1 2.06.1.007.0 2 2.06.1.007.0 3 2.06.1.007.0 4 2.06.1.007.0 5 2.07.1.001.0 0 2.07.1.001.0 1 2.07.1.001.0 2 2.07.1.001.0 3 2.07.1.001.0 4 2.07.1.001.0 5 2.07.1.002 2.07.1.003 2.08.1.001 2.08.1.002 2.08.1.003 E4 SECTIO N Comput Comput Comput Comput Comput Comput Comput Comput Comput Comput Comput Comput Comput Comput Planning Planning Planning Planning Planning Planning Planning Planning Impleme nt Impleme nt Impleme nt SPECIFICATION all aspects to meets user reqs & conform to appl. cone. stds. test hardware/software before use further testing of configs not req. unless: software usage scope changes mods to hard/software configs. assess changes to configs re: impact on technical & Qobj. change components (& config), must retest program changes, check (& test) config as needed configs covered include: experimental design design analysis environmental modeling process control systems (LIMS, auto data acquisition, etc.) environmental data bases establ./imple/control/ and docu planning process to: ID customers, needs, work results expected ID tech and Q goals to meet needs translate goals to tech. specs. address cost/schedule constraints ID acceptance criteria for results plan, docs approved by authorized person. Before work starts plan doc include work plans, schedules, and QAPPs work accord, to plans and other docs, in the correct order mgt. oversight commensurate to work importance SOPs for standard, critical operations NSF REFERENCE DOCUMENT AND SECTION CQAM 7.0-7.3, LQAM 5.8 CQAM 7.0-7.3, LQAM 5.8 NA NA NA NA NA NA NA NA NA NA NA NA 5. 0-5. 6 in CQAM 5.0-5.6 in CQAM, Protocols 5.0-5.6 in CQAM, Protocols 5.0-5.6 in CQAM, Test Plans 5.0-5.6 in CQAM, Protocols and Test Plans 5.0-5.6 in CQAM, Protocols and Test Plans 5.0-5.6 in CQAM, Protocols and Test Plans 5.0-5.6 in CQAM, Test Plans 3.0-3.4 in CQAM, Protocols 3.0-3.4 in CQAM, Protocols 3. 0-3. 4 in CQAM WQPC QMP Revision 3 - November 2004 Page 23 of 32 ------- ITEM 078 079 080 081 082 083 084 085 086 087 088 089 090 091 092 093 094 095 096 097 098 099 100 101 102 E4 REFEREN CE NO. 2.08.1.004 2.08.1.005.0 0 2.08.1.005.0 1 2.08.1.005.0 2 2.08.1.005.0 o 5 2.08.1.006 2.08.1.007 2.08.1.008 2.08.1.009 2.09.1.001 2.09.1.002.0 0 2.09.1.002.0 1 2.09.1.002.0 2 2.09.1.002.0 3 2.09.1.002.0 4 2.09.1.003 2.09.1.004 2.09.1.005 2.09.1.006 2.09.1.007 2.09.1.008 2.09.1.009.0 0 2.09.1.009.0 0 2.09.1.009.0 0 2.09.1.009.0 0 E4 SECTIO N Impleme nt Impleme nt Impleme nt Impleme nt Impleme nt Impleme nt Impleme nt Impleme nt Impleme nt Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp SPECIFICATION SOPS in good format, sufficient detail following addressed at minimum: ID of operations needing SOPs prep process for SOPs- form, content, applicability review/approval for SOPs tech SOPs reviewed/approved by qualified personnel Impl. to include measurement of performance to tech. Q specs. monitor work proc. independence of monitor. personnel commensurate with work assess, to be plan/sche/periodically cond. four types of assessment: mgt. self-assessment mgt. ind.-assessment tech. self-assessment tech. ind.-assessment ass. type selected in planning stage of project must address tech requirement (not just procedural) ass. performed according to a described process ass. documented, reported to mgt, reviewed by mgt. assessors must be qualified respo. and authority for ass. must be documented/stop work authority must include: ID and document problems ID lessons learned and share them propose recommendations NSF REFERENCE DOCUMENT AND SECTION 3.0-3.4 in CQAM, AA- 759-0006 3. 4 in CQAM 3. 4 in CQAM 3. 4 in CQAM 3. 4 in CQAM 3. 4 in CQAM 3. 0-3. 4 in CQAM 3. 0-3. 4 in CQAM 3. 0-3. 4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM, AA- 700-0187 14.0-14.4 in CQAM 14.0-14.4 in CQAM; WQPQMP 14.0-14.4 in CQAM; WQPQMP 14.0-14.4 in CQAM, WQPQMP, Test Plans 14.0-14.4 in CQAM, WQPQMP 5.0 and 14.0-14.4 in CQAM, WQP QMP 14.0-14.4 in CQAM, WQPQMP 14.0-14.4 in CQAM, WQPQMP 14.0-14.4 in CQAM, WQPQMP 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM WQPC QMP Revision 3 - November 2004 Page 24 of 32 ------- ITEM 103 104 105 106 107 108 109 110 111 112 E4 REFEREN CE NO. 2.09.1.009.0 0 2.09.1.009.0 0 2.09.1.010 2.09.1.011 2.09.1.012 2.10.1.001 2.10.1.002 2.10.1.003 2.10.1.004 2.10.1.005 E4 SECTIO N Ass/Resp Ass/Resp Ass/Resp Ass/Resp Ass/Resp Improv. Improv. Improv. Improv. Improv. SPECIFICATION independently confirm corrective action document to mgt, monitoring of work where problems resp. to adverse conclusions must be timely condition, needing corrective action ID and responded timely follow-up required to confirm response process to be est. / implemented process to detect and correct problems in all phases if big problems, ID cause & effect and root causes ID root causes before permanent prev. measures plan/doc/imple. appro responses, timely NSF REFERENCE DOCUMENT AND SECTION 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM 14.0-14.4 in CQAM, AA- 700-0188 14.0-14.4 in CQAM, AA- 700-0188 14.0-14.4 in CQAM, AA- 700-0188 14.0-14.4 in CQAM, AA- 700-0188 WQPC QMP Revision 3 - November 2004 Page 25 of 32 ------- Referenced NSF Documents: CQAM: Corporate Quality Assurance Manual, Issue No. 2 (AF-700-0002) LQAM: NSF International Laboratories Quality Assurance Manual (AF-840-0001) WQP QMP: Water Quality Protection Center Quality Management Plan (AA-394-003) AA-700-0001: Performance Appraisals AA-700-0008: Procedural Modification Documentation AA-700-0187: Corporate Quality Assurance Audits AA-700-0188: Continuous Improvement Report AA-759-0006: Submittal and Issuance of Controlled Documents AA-840-0001: Qualifying a Subcontract Laboratory AF-700-0001: Human Resources Handbook AF-700-0003: Corporate Training Manual Water Quality Protection Center Verification Protocols and Test Plans (available at www.epa.gov/etv and www.nsf.org/etv WQPC QMP Page 26 of 32 Revision 3 - November 2004 ------- E4 - PART B ITEM 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 E4 REFERENCE NO. 3.01.1.001 3.01.1.002 3.01.1.003 3.01.1.004 3.01.1.005.00 3.01.1.005.01 3.01.1.005.02 3.01.1.005.03 3.01.1.005.04.0 0 3.01.1.005.04.0 1 3.01.1.005.04.0 2 3.01.1.005.04.0 o 5 3.01.1.005.05 3.01.1.005.06 3.01.1.005.07 3.01.1.005.08 3.01.1.005.09 E4 SECTION Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope Plan/Scope SPECIFICATION all work (involving generation, acquisition, & use of environ, data) planned and documented type & qual. of environ, data, ID and documented using a systematic planning process proj. spec, planning involves key users, customers of data,& tech. staff results of planning activities subject to review for conformance to tech. and qual. expectations proj. planning coordinated among participating orgs. & include: definition of proj. /task scope & objs. & desired action or result from the work ID of orgs. (e.g., sampling groups & anal. labs) that need to participate in proj. & their role in planning/imp/ass . activities ID of environ, data required to achieve desired action or result ID of QA/QC requirements to establish qual. of data collected or produced including: data qual. indicator (e.g., precision, bias) goals acceptable level of confidence (or statistical uncertainty) level of data valid. & verif . needed ID of documentation to describe qual. of results ID of personnel, their skills & required equipment. ID of applicable regulatory requirements & other constraints (e.g., time & budget) ID of conditions under which suspension of work is necessary determination of assessment tools (e.g., prog. tech. reviews, peer reviews, surveillances, readiness reviews, & tech. audits) NSF REFERENCE DOCUMENT AND SECTION AA-3 94-0002 / Verification Protocols / Test Plans ibid. AA-3 94-0001 / AA-3 94-0002 / Verification Protocols / Test Plans ibid. AA-3 94-0001 / AA-3 94-0002 / AK-3 94-0001 AA-3 94-0002 AA-3 94-0001 AA-3 94-0002 AA-3 94-0002 / Verification Protocols / Test Plans ibid. ibid. ibid. ibid. WQPQMP AA-3 94-0002 AA-3 94-0002 AA-3 94-0002 / Verification Protocols / Test Plans WQPC QMP Revision 3 - November 2004 Page 27 of 32 ------- ITEM 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 E4 REFERENCE NO. 3.01.1.005.10 3.01.1.005.11 3.02.1.001 3.02.1.002 3.02.1.003.00 3.02.1.003.01 3.02.1.003.02 3.02.1.003.03 3.02.1.003.04 3.02.1.003.05 3.02.1.003.06 3.02.1.003.07 3.02.1.003.08 3.02.1.003.09 3.02.1.003.10 3.02.1.003.11 3.02.1.003.12 3.02.1.003.13 E4 SECTION Plan/Scope Plan/Scope Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops SPECIFICATION ID of methods/procedures for storing, retrieving, analyzing, & reporting data produced ID of possible methods/procedures (including waste minimization objs) for char. & disp. of cont. sample material accumulated during the proj. Define, control, verify, & document the design of data collection operation ID all relevant activities pertaining to environ, data operations, establish performance specs, ID appropriate ctrls design process includes detailed specs for: assessments during proj. (e.g., surveillance, audits, performance evaluations). data reporting requirements. data validation & verification methods integrating cost or schedule constraints into design protection of health & safety of workers & the public readiness reviews prior to data collection reqs. for calibration & perf. eval. samples for anal. methods requirements for data (and data base) security, archival, & retention requirements for field & lab QA/QC activities requirements & qualifications for sampling & analysis personnel sample handling, packaging, shipping & custody requirements selection of analytical methods & their quality performance expectations selection of analytical facility or lab NSF REFERENCE DOCUMENT AND SECTION AA-3 94-0002 / Verification Protocols / Test Plans Verification Protocols / Test Plans AA-3 94-0002 AA-3 94-0002 4inWQPQMP/ AA-3 94-0002 / Verification Protocols AA-3 94-0002 / Verification Protocols Verification Protocols AA-3 94-0002 / Verification Protocols Verification Protocols AA-3 94-0002 / Test Plans Verification Protocols / Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans AA-394-0003 /Test Plans WQPC QMP Revision 3 - November 2004 Page 28 of 32 ------- ITEM 148 149 150 151 152 153 154 155 156 157 158 159 160 E4 REFERENCE NO. 3.02.1.003.14 3.02.1.003.15 3.02.1.003.16 3.02.1.004 3.02.1.005 3.02.1.006 3.02.1.007 3.02.1.008 3.02.1.009 3.02.1.010 3.02.1.011 3.02.1.012 3.02.1.013 E4 SECTION Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops Design Ops SPECIFICATION selection of field sampling or testing methodology (specific sampling or field analytical instrumentation & other analytical testing requirements) techniques for assessing limitations on data use disp. or min. proc. for wastes prod, during sampling & analy. operations ID & control (accord, specs determined during design) key variables that det. or directly affect qual. of results ensure that data are traceable to the proc. (incl. revisios) used to produce data & to the persons generating or coll. data deter. & document data transfer, red., verif. , and valid, reqs deter. & spec, in the design data interpretation and analysis needs, such as the use of specific statist. methods ID & doc. reports to manag. re: work status, interim work results, & ass. results ID & state restrictions on using interim results (and data) - defines restriction & the specific data to which it applies (if the data are stored in magnetic media) Encode restrictions with the data and report in accompanying documentation document results of the environ, data collection design process in QAPP & other plan docs according to reqs. of QA system & line mgmt review/approve QAPP &/or other plann documents by designated persons - tech. capable of eval. the proj. organizations qual. system ID who must review & approve proj. -specific QAPP & explain process for conducting the review NSF REFERENCE DOCUMENT AND SECTION Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans WQPC QMP Revision 3 - November 2004 Page 29 of 32 ------- ITEM 161 162 163 164 165 166 167 168 169 170 171 172 173 E4 REFERENCE NO. 3.02.1.014 3.03.1.001 3.03.1.002 3.03.1.003 3.03.1.004 3.03.1.005 3.03.1.006 3.03.1.007 3.03.1.008 3.03.1.009 3.03.1.010 3.03.1.011 3.03.1.012 E4 SECTION Design Ops Implement Implement Implement Implement Implement Implement Implement Implement Implement Implement Implement Implement SPECIFICATION changes to data collection designs or procedures (including field changes) subject to same review/approval protocols as the original document environ, data operations implemented according to approved planning docs - by qual. persons Doc. and report deviations to mgmt. determine impact & significance of the deviation on planned operations & make adjustments to such operations make approved changes to planning documents, operating guides & manuals and distribute to proj. personnel data collected during impl. shall be traceable to plans used & persons collecting data use qual. and accepted services/items in environ. data operations. Accept, shall be ID on the items &/or in docs traceable to the items. perform inspections/accept, test, of samp, meas., anal, instr. (or other meas. systems) and their components to confirm intended use of items when accept, criteria are not met, defic. resolved & re-inspection performed Ctrl tools, gauges, instruments, & other sampling, measuring, & testing equipment for activites affecting qual. as required & at specified intervals, calibrated to maintain accuracy within specified limits. ID unsuitable equipment eval. the valid, of measure./ tests performed with out-of-calibr. equipment - measurements and tests will be repeated document basis for the calib. Maintain docs of calibr. - shall be traceable to the equipment perform periodic preventive and corrective maint. of meas./test equipment - ensure avail, and satisfactory perf. of the systems re-calibrate all equipment subj. to maintenance or repair, before the equipment is used NSF REFERENCE DOCUMENT AND SECTION AA-3 94-0002 / Verification Protocols /Test Plans 4.3.2inWQP QMP/ Verification Protocols /Test Plans 4.3.2inWQP QMP/ Verification Protocols /Test Plans 4.3.2inWQP QMP/ Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols / Test Plans Verification Protocols / Test Plans Verification Protocols / Test Plans Verification Protocols / Test Plans AA-3 94-0002 / Verification Protocols / Test Plans Verification Protocols / Test Plans WQPC QMP Revision 3 - November 2004 Page 30 of 32 ------- ITEM 174 175 176 177 178 179 180 181 182 183 E4 REFERENCE NO. 3.03.1.013 3.03.1.014 3.04.1.001 3.04.1.002 3.04.1.003 3.05.1.001 3.05.1.002 3.05.1.003 3.05.1.004 3.05.1.005 E4 SECTION Implement Implement Ass/Resp Ass/Resp Ass/Resp Ass/Verif Ass/Verif Ass/Verif Ass/Verif Ass/Verif SPECIFICATION perform hand., stor, cleaning, pack., ship., and pres. of field and lab samples accord, to req. specs, protocols, or proc. to prevent damage, loss, deter., artifacts, or interfer. Track and document sample chain of custody perform data or info, mgmt, incl. trans., storage, valid., assess., process., & retrieval, accord, to approved instr., methods, procs. assess activities perf. during environ, data ops. that affect the qual. of the data & the find, reported to mgmt. to ensure that the reqs stated in planni docss (e.g., QAPPs, work & sampling plans) are being implemented take appropriate corr. actions and verify/ document the ass. findings eval. data obtained prev. from a method or instrument found to be nonconforming to specs to determine impact of a nonconform. on qual. of data. Doc. impact and the approp. action taken assess, verify, and qualify data obtained from environ, data operations according to their intended use express limitations on this intended data use (quantitatively) and doc. reporting of the data in print or electronically assess data obtained from sources that did not use a qual. system equiv. to this Standard according to approved/documented proc. independ. review of proj. reports w/ data, OR report results of environ, data ops to confirm that data/r results are presented correctly. reports shall be approved by mgmt. prior to release, publ., or dist. NSF REFERENCE DOCUMENT AND SECTION Verification Protocols / Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans AA-3 94-0002 / Verification Protocols /Test Plans Verification Protocols /Test Plans Verification Protocols /Test Plans AA-3 94-0002 3.5inWQPQMP AA-3 94-0002 AA-3 94-0002 Referenced NSF Documents: WQP QMP: Water Quality Protection Center Quality Management Plan (AA-394-003) AA-394-0001: Procedures for the Formation, Maintenance, and Roles of Stakeholder Advisory Groups and Technology Panels AA-394-0002: Verification Protocol, Test Plan, and Verification Report Developmental Procedures AK-394-0001: Guidelines for the Conduct of Meetings of the Stakeholder Advisory Groups and Technology Panels WQPC QMP Revision 3 - November 2004 Page 31 of 32 ------- Appendix A: NSF International SOPs NSF considers all Controlled Documents, including SOPs, forms or laboratory manuals as Proprietary Business Information. Therefore, NSF will provide EPA any Controlled Documents referenced in this QMP upon request. NSF requests that EPA refrain from sharing these documents with any other party. WQPCQMP Page 32 of 32 Revision 3 - November 2004 ------- |