Quality Management Plan: Grantees and Contractors
The version currently being displayed is the "Grantees and Contractors View" which is a customized version of Region 10's QMP with sections relevant to Grantees and Contractors expanded. Other views are listed on a separate web page and are accessible using the "Views" link in the left side bar or by clicking here.
Region 10 eQMP
Table of Contents: Main Sections
Section 1: Quality System Foundation
Section 2: Quality System Components
Section 3: Personnel Qualifications and Training
Section 4: Procurement of Items and Services
Section 5: Document and Records
Section 6: Computer Hardware and Software
Section 7: Quality Planning
Section 8: Implementation of Work Processes
Section 9: Assessment and Response
List of Figures
About this QMP
Effective date: January 2009
Section 1 of the Region 10 Quality Management Plan (QMP) contains the basic Introduction to the Region 10's Quality System (QS), which states the mission, policy underlying the QS, and the description of how the organizational structure of the Region supports the implementation of the QS, stressing the roles and responsibilities of groups and individuals within the Region. This section of the QMP, including the Mission and Scope, Quality Policy, and Quality System subsections, describes the Region's goals and policies related to the generation and use of environmental information. It also describes the system that is in place to make this all happen. It is closely linked with the Organizational Structure, which describes, among other things, how the large and small groups within the Region are organized and how the individuals within that structure work together to accomplish the mission described here.
Table of Contents: Section 1
1.2 Quality Assurance Policy
1.3 Regional Organization and QA Responsibilities
1.4 Quality System Roles, Responsibilities and Authorities
1.5 Resources to Support the Quality System (QS)
1.6 Independence of the Regional QA Manager
1.7 Dispute Resolution
EPA Region 10's mission is to protect human health and the environment of the Pacific Northwest and Alaska for present and future generations. To achieve this mission, the Region relies on its own environmental measurements and those collected by other Governmental agencies and regulated parties to make decisions affecting public health and the environment. Our environmental objectives are to:
- Protect diverse ecosystems and ensure healthy airsheds and watersheds
- Prevent pollution through source reduction
- Reduce the generation of land, air, and water pollutants
- Clean up contaminated sites
We will use sound science and wise decision-making to accomplish these objectives by:
- Maintaining an in-depth understanding of Region 10 and focusing our efforts on the greatest risks to human health and the environment
- Ensuring compliance with federal environmental laws within and across boundaries, while considering national consistency and local circumstances
- Working effectively with state and local governments, tribes, citizen groups, and industry to solve environmental problems
- Assisting state, local, and tribal governments to develop environmental programs
- Talking with the public about our actions and steps they can take to protect the environment
- Promoting faster and more efficient solutions to advance sustainable environmental quality
- Advocating regional needs and perspectives at the national level
We are accountable for achieving our mission. Our success as stewards of the public trust will be measured by meaningful and lasting environmental improvements.
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 E4-2004, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Program.
Region 10's Quality System is in compliance with the mandatory requirements set forth by the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12 pp, 94K) and the specifications of the EPA Quality Manual (CIO 2105-P-01-0 formerly Order 5360.A1)(PDF)(63 pp, 3694K) which when implemented provide 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. The QA policy also expands the applicability of QA and QC activities 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.
Region 10's QA Policy
- Environmental measures are derived from the collection of data of known and documented quality, of sufficient quantity, legally defensible and is suitable for its intended use.
- Environmental technologies utilized are supported by sound science to assure that performance will meet its intended use.
Section 2 of the Region 10 Quality Management Plan describes the different types of data collection activities that are performed by and for Region 10 and the Quality System components and planning tools that are required to meet the mandatory EPA Quality System requirements. It also highlights the general QA responsibilities of the regional staff responsible for the projects and sites conducting the environmental measurement activities.
Table of Contents: Section 2
The uniform and consistent application of Region 10's Quality System Processes and Quality Policy are required for the following products and services:
- Data and information and their resulting products and services produced for public use or access by partners, stakeholders or organizations outside the agency. Organizations must ensure the application and documentation of uniform and consistent quality practices on products and services intended for external dissemination which are subject to high level of scrutiny under the Information Quality Act.
- Data and information and their resulting products and services produced for cross-program business activities internal to the Agency. Products and services developed by one EPA organization for use by other Agency organizations are expected to utilize consistent quality practices and processes.
- Products and services produced by individuals or organizations outside of EPA that support aspects of EPA's mission. Products and services produced by individuals or organizations outside EPA are also subject to applicable EPA quality requirements under federal extramural agreements.
- Administrative or financial management systems, information technology applications or other technology-enabled systems developed for use by EPA offices and/or partners or stakeholders (including regulated parties) external to the Agency.
- Technology, systems or devices acquired or developed for use in environmental monitoring, characterization, remediation, control, research, energy development or use or other areas pertinent to EPA's mission.
To effectively manage and implement the Region's quality system, environmental monitoring activities, technologies and product development, systematic planning, routine review, peer review and approval of project specific QA planning documents and assessment of the quality of data generated are required. The following sections discuss the quality system tools used in planning, implementation and oversight of the Region's quality system:
Table of Contents: Section 2.1
All organizations conducting data collection activities for EPA's eventual use are required to have an EPA approved QMP. The QMP must address the QA elements specified in the “EPA Requirements for Quality Management Plans”, EPA QA/R-2, March 2001 (PDF)(30pp, 87K) or the most recent version. After the review and approval of the organization's QMPs, the authority to review the organization's site or project specific QAPPs and other QA planning document is delegated by the RQAM to the QA program of the organization. The approved QMPs must include a description of the preparation, review and approval process for specific QAPPs covered by the organization's grant. The approved QMPs shall be in effect for a period of no more than five years. Before the expiration date of the QMP, the organization shall revise their QMPs in accordance with EPA QA/R-2, March 2001 or the most recent version. Only two programs within the regional office have their own EPA approved program QMP, i.e., the EPA Manchester Environmental Laboratory and the Emergency Response Unit at the Office of Environmental Clean-up. Revisions and amendments to the approved QMP must be approved by the RQAM prior to implementation. The RQAM shall maintain a list and copies of the approved QMPs and their expiration dates.
The QAARWP is a summary of specific activities within the Region's QS. The Region's implemented QA activities of the previous fiscal year and the planned QA activities for the upcoming fiscal year are summarized in the QAARWP. The QAARWP is prepared according to Chapter 4 of the most current version of the EPA Quality Manual CIO 2105-P-01-0 (formerly Order 5360.A1)(PDF)(63pp, 369K) by the RQAM, and/or the QAS with inputs from the QACs, CORs and the PMs and used to identify minor changes or updates to Region 10's QMP. The QAARWP is initially submitted electronically to the OEI Office Director (OEI-OD) at the end of each year (or other date as specified by the OEI-OD). The electronic submission is then followed by a hard copy of the QAARWP signature page signed by the RQAM, OD-OEA, RA/DRA.
Program assessments are conducted by performing a Quality System Review/Audit (QSR/QSA). QSR is a qualitative evaluation of a data collection operation and/or organization(s) to determine whether the current quality management structure, policies, practices, and procedures are adequate for ensuring that the type and quality of data needed are obtained. QSR is a tool used to determine the effectiveness of, and adherence to, the quality system and the adequacy of resources and personnel provided to achieve and ensure quality in all activities. The focus of these assessments is on the quality system process not on evaluating the quality of specific products -- not judging the quality of environmental data or the performance of personnel or programs.
Depending on the availability of resources, OEI Quality Staff performs an independent QSR of Region 10's Quality System once every three years. The Region 10 QSR Team comprised of the RQAM, QAS and/or technical specialists conduct QSRs of the USEPA Region 10 Manchester Environmental Laboratory every two years [as required by the Regional Science and Technology (RS&T) Directors]. QSRs of contractors, State, Tribes and other agencies are performed every three years following the “Quality System Assessment Guidance (PDF)(83pp, 555K)”, EPA QA/G3, March 2003.
Table of Contents: Section 2.1.4
126.96.36.199 Quality Assurance Project Plan (QAPP)
188.8.131.52 Generic QA Project Plans
184.108.40.206 Standard Operating Procedures (SOPs)
220.127.116.11 Data Quality Assessment
18.104.22.168 Data Verification and Validation
22.214.171.124 Technical System Review/Audit (TSR/TSA)
All environmental data collection activities conducted within the region must be covered by an EPA approved QAPP prepared in accordance with the Agency required Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) guidance www.epa.gov/fedfac/documents/qualityassurance.htm or the most current version of the EPA Requirements for Quality Assurance Project Plans, EPA QA/R5 March 2001 (PDF)(40pp, 121K). A QAPP is a technical planning document that defines the project's Data Quality Objectives (DQOs), project management and functional organization, sample collection and field methodologies, chemicals of potential concern (COPCs) and project reporting limits, laboratory and analytical methods, and the QA and QC associated with all field and laboratory activities. The QAPP must be submitted to the RQAM at least 30 days before the start of a project to allow sufficient time for review, revision and laboratory space coordination, if needed. All QAPPs must be reviewed and approved by the RQAM or designee prior to sample collection.
Generic QA Project Plans were prepared by the RQAM, maintained and updated by the QAS to assist and provide field personnel and inspectors from the Office of Waste and Chemical Management, Office of Environmental Assessment and Region 10 State Offices with basic guidelines for the collection of samples, proper sample documentation and the use of correct sampling and analytical methodologies in the collection of “samples of opportunity” to verify and determine facility compliance. Enforcement and inspection-related samples collected are usually to the USEPA Manchester Environmental Laboratory (MEL) located in Port Orchard, WA. These Generic QAPPs were prepared in compliance with the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K), and in accordance with the Agency required QA EPA/R-5 “EPA Requirements for Quality Assurance Project Plans, March 2001 (PDF)(40pp, 121K)," and the “QA EPA/G5 “EPA Guidance for Quality Assurance Project Plans, December 2002 (PDF)(111pp, 400K). The following generic QAPPs are available for download from this e-QMP (the Region 10 QA web site):
- Generic QAPP for RCRA Compliance Inspections
- Generic QAPP for Polychlorinated Biphenyl (PCB) Inspections
- Generic QAPP for the Concentrated Animal Feeding Operations (CAFO) Program
- Generic QAPP for Aquaculture NPDES Compliance Inspections
- Generic QAPP for Asbestos Inspection (AHERA, NESHAP & CERCLA)
- Generic QAPP for Underground Injection Control Compliance Inspections
- Generic QAPP for Stormwater Compliance Inspection
- Generic Facility QAPP for Motor Vehicle Waste Disposal Sites
- Generic QAPP for Seafood Processing Facility Inspections
Data collection and generation procedures are standardized and published as written protocols for inclusion by reference in QA Program Plans, QAPP, Sampling and Analysis Plans (SAPs), FSPs, contracts and similar documents, and for use as guidance and technical assistance documents. SOPs are prepared using the “Guidance for the Preparation of Standard Operating Procedures, EPA QA/G-6 (PDF)(60pp, 336K)”, April 2007. SOPs require RQAM review and approval and are generally integrated as addendums to the QAPP submitted for RQAM review and approval. Program Specific SOPs are prepared primarily by five groups: EPA Region 10, when performing the lead in an EDCA, IAG recipients (such as the U.S. Army Corps of Engineers, U.S. Geological Survey, or U.S. Department of Energy), grantees (such as States, Tribes, and Universities), PRPs, contractors and other government entities (i.e., Federal facilities). The responsibility for preparing, updating and approving SOPs rests with these parties, although the Region 10 RQAM may comment or require SOP revisions/modifications depending on the nature of the project. These groups are encouraged by the Region to develop program-specific SOPS for recurring activities. The RQAM and/or designated technical specialist may assist in the preparation of site-specific and program-specific sampling and analytical SOPs. To avoid duplication of effort, an SOP prepared by one program may be utilized by another program, when applicable. This will only be done with the permission of the originating party unless that party is under contract to EPA.
SOP revisions are prompted when the following situations occur and should be reviewed yearly:
- Significant update/revision of procedures to improve method efficiency or changes due to instrument up-grades or new technologies
- Modification of methods or previously approved SOPS to address project or site-specific needs (e.g., need a lower detection limit for an analytical method)
- Promulgation of new regulations or their revisions requiring the addition of new or revisions of existing SOPS due to more stringent and higher environmental standards
- Change of contract awardees
SOPs affected by these criteria will need to be updated during the year of the change. The one year rule for revision and update may be waived on a case-by-case basis due to resource constraints or where the change is so minor that the quality of the data generated are unaffected. In these cases the minimum frequency for update will be every three years. When significant changes occur in the contract or organization, SOPs are revised and submitted to RQAM or the QACs for review and approval as addendums to the QA planning documents. These significant changes are included in the planning documents submitted by the contractor or EPA PM. In addition, periodic field and laboratory visits are performed by the QA team to ensure that activities are conducted in accordance with the SOPs. Revisions to Region 10 program SOPs must be submitted to the RQAM for review and approval.
Data Quality Assessment is used to assess the type, quantity, and quality of data generated in order to verify that the planning and project objectives, Quality Assurance Project Plan components, and sample collection and analytical procedures were satisfied and that the data are suitable for its intended purpose. It is the responsibility of the PO to evaluate, statistically and scientifically, the project data, both during the project and after completion. Project Managers who select to use the formal DQO process and subsequent statistical approach to determine whether the data collected meet project objectives should refer to Data Quality Assessment: A Reviewer's Guide (QA/G-9R) and Data Quality Assessment: Statistical Tools for Practitioners (QA/G-9S), both available at http://www.epa.gov/quality1/qa_docs.html. The PM/PO/COR must ensure that this information is specifically discussed in the QAPP.
The following data assessments tools are also available for Region 10 to use for the CLP generated environmental data sets: Contract Compliance Screening for CLP organic analyses, for laboratory deliverables through the Electronic Data Exchange and Evaluation System (EXES). EXES include a self-inspection tool for CLP laboratories that provide an Electronic Data Deliverable (EDD) in the Staged Electronic Data Deliverable (SEDD) format. Using the EXES web-based system, laboratories upload their EDD and receive an e-mailed report outlining any compliance issues found in the EDD. This allows CLP laboratories to inspect the contractual completeness and compliance of their EDD prior to delivery to EPA, resulting in a more compliant deliverable for CLP customers. In addition, electronic data reviews of the SEDDs are conducted by ASB during EXES process and provides validated results based on Stage 2A EDD deliverables to the regions. SEDD electronic data validation checks 100% of the calculations. To access EXES, visit the SMO Customer Service Web site.
For CLP inorganic analyses, ASB uses the Web-based Contract Compliance Screening (WebCCS) system to provide contract compliance screening to laboratories. WebCCS is able to determine the contractual compliance and completeness of data submitted by the laboratories, prior to delivery to EPA. Following these evaluations, a defect report is generated and emailed to the laboratory. For more information visit the WebCCS software Web site.
Data verification and validation is used to evaluate whether data has been generated according to specifications, satisfy acceptance criteria, and are appropriate and consistent with their intended use. Data verification is a systematic process for evaluating performance and compliance of a set of data when compared to a set of standards to ascertain its completeness, correctness, and consistency using the methods and criteria defined in the project documentation. Data validation follows the data verification process and uses information from the project documentation to ascertain the usability of the data in light of its measurement quality objectives and to ensure that results obtained are scientifically defensible. The analytical laboratory usually performs data verification prior to the release of analytical results to clients. Data validation determines the bias, usability limitations of the generated data based on meeting the project goals and QAPP specifications. Region 10 uses a graded approach when conducting data verification and validation. The validation levels depend largely on project needs and public visibility and are defined in the QA document “Draft Guidance for Labeling Externally Validated Laboratory Analytical Data for Superfund Use”, OSWER No. 9200.1-85, EPA 540-R-08-005, November, 2008. Region 10 has no contract support for data validation. The RQAM and QAS are responsible for providing data validation support to the programs, and partners, when needed. Region 10 QA program also works with OSWER's Analytical Services Branch (ASB) and use ASB's data assessment tools to evaluate contract compliance and electronically validate the analytical data generated by the Superfund Contract Laboratory Program. For data verification and data validation, Region 10 follows the QA and technical specifications of the QAPP and analytical methods, the procedures set forth in the Guidance for Data Verification and Data Validation (G8), applicable National Functional Guidelines for Organic and inorganic Analyses and Region 10 Data Validation Guidelines.
A technical audit or assessment is a systematic and objective examination of an intramural or extramural project to determine whether (a) environmental data collection activities and related results comply with the project's QA Project Plan, (b) procedures defined by the QA Project Plan are implemented effectively, and (c) sufficient and adequate data and QC activities are obtained to achieve the QA Project Plan's data quality goals. Proper use of technical reviews and assessments provides important information to management to help ensure that collected environmental data are defensible. It can uncover deficiencies in physical facilities, equipment, project planning, training, operating procedures, technical operations, custody procedures, documentation of QA and QC activities as well as quality system aspects applying to more than one project. Technical system reviews can be performed before, during, and after environmental data collection.
TSRs of Superfund contractors like Remedial Action Contract (RACs), Environmental Services Assistance Team (ESAT), Superfund Technical Assessment & Response Team (START) and PRP contractors are coordinated, scheduled and conducted by the RQAM, QAS and/or designated technical specialists and the POs/RPMs on as per request basis, such as before the project starts or when problems are identified through data validation. Laboratory TSRs are performed on Superfund's CLP laboratories located within the Region at least once per year. State, Tribal and Territory drinking water laboratories certification and TSRs are conducted every three years by the Regions Certified SDWA Auditors. The RQAM and/or designated technical specialists also perform TSRs of commercial laboratories contracted by the PRPs, Federal facilities, RCRA owner/operators, National Pollution Discharge Elimination System (NPDES) dischargers and the Underground Injection Control Program upon request or as needed by the POs/RPMs. TSRs of internal programs and external organizations will be conducted by the TSR. Technical System Audits are performed following the Technical System Audit Guidance (PDF)(101pp, 255K), January 2000.
EPA's Information Quality Guidelines (IQGs) contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information the Agency disseminate. They are interrelated to the Regional Quality System for assuring the quality of EPA's data products and information. "Information" generally includes any communication or representation of knowledge or position/policy such as facts or data in any medium or form. This includes "preliminary" information that EPA has endorsed or adopted and also conclusions or facts drawn from or based upon other existing information. This QMP incorporates by reference all definitions, principles, policies and procedures found in EPA's IQGs (http://www.epa.gov/quality/informationguidelines). EPA Region 10 is using a multi-faceted approach to implement EPA's Information Quality Guidelines and conduct Pre-Dissemination Reviews (PDRs). The key components of the Regional PDR implementation plan include:
- Identifying information products
- Implementing office review procedures, including the roles of authors, managers, and reviewers
- Utilizing existing Region-wide mechanisms that ensure quality, including:
- Regional QA Review conducted by the Office of Environmental Assessment
- Regional Product Review conducted by the Office of Ecosystems, Tribal and Public Affairs
- Regional Peer review coordinated by the Office of Environmental Assessment
- Regional Executive Team and supervisor briefings
- Distributing non-EPA information and the use of disclaimers
- Providing Regional contacts for IQG and PDR
Table of Contents: Section 2.2
2.2.1 R10 Office Review Procedures
2.2.2 Types of IQG Review Processes, Roles, and Responsibilities
2.2.3 Other Regional Review Processes that Are Considered Equivalent to PDR
2.2.5 Distributing Non-EPA Information and Use of Disclaimers
Region 10 Offices utilize various review processes to ensure that the quality of information products is adequate for the intended use and that the content of the information product has objectivity, utility, and integrity as defined in EPA's Information Quality Guidelines. Staff and management have roles and responsibilities, described below, to ensure that pre-dissemination review procedures are successfully implemented and that the quality of information is known and documented prior to its use. Unless impracticable, information products should be reviewed by at least one person in addition to the author. Here's a link to the PDR checklist.
Whenever possible, existing review procedures will be used for IQG pre-dissemination reviews. The Region is incorporating and integrating the IQG quality components of objectivity, utility and integrity into existing review procedures. The following describes the menu of various review processes, roles, and responsibilities for staff and management to implement IQG pre-dissemination reviews. One or more review types may be appropriate depending upon the nature and importance of the information or product. Authors and supervisors who are developing an information product subject to Pre-dissemination Review should use best judgment in determining which of the review procedures listed below are most appropriate.
The author is considered a person or persons preparing an information product for dissemination. The primary author has the main responsibility to ensure that the informational content of a product is technically sound, meets the project's objectives, and fulfills the objectivity, utility, and integrity criteria of EPA's Information Quality Guidelines.
In some cases, the primary author may have had others (i.e. GIS or risk assessment staff) to prepare all or part of the material required to generate an information product. These technical support staff also have a role to ensure that the tools used to do the analysis are appropriate for meeting the primary author's stated purpose, that the data sources used are as defined in the project plan, and that the output produced has provided a reliable rendering of the analysis. The supervisor of technical support staff is responsible for the quality of their work.
The direct supervisor is the person or persons who supervise the author or authors of an information or product for dissemination. The direct supervisor of the author is responsible for the quality of all documents and products (including documents and products not subject to EPA's IQG) generated within his/her Unit.
Direct supervisors should review all disseminated information products that:
- have significant policy implications
- set an important precedent
- involve important emerging issues
- are significantly controversial
- have major cross-organizational impacts
- represent a significant investment of Agency resources
They should also review other documents and products that sound professional judgment dictates.
Direct supervisors can delegate to appropriate staff the review of documents, especially those documents that do not meet the circumstances described above.
The direct supervisor is also responsible for conformance of information products to applicable EPA policy. The direct supervisor's review of disseminated information products includes the responsibility to ensure that the quality of such products is adequate for their intended use; that the content of the information product has objectivity, utility, and integrity as defined in EPA's Information Quality Guidelines; and that the product is aligned with applicable program policies.
EPA Region 10 periodically solicits reviews of documents and information products from qualified individuals who are external to the region. External review is principally to ensure that the product is technically sound. Examples of external reviewers include experts from:
- other EPA offices, regions, laboratories, or Headquarters
- states or tribes
- interstate organizations
- Colleges or universities
A manager or designated senior staff person has the responsibility to coordinate and oversee all external reviews. Although a formal review charge is not required, Regional personnel have a responsibility to ensure that external reviewers are aware of any specific issues that should be a focus of attention and that reviewers understand their overall responsibilities. Products that are reviewed for technical quality by external reviewers also need PDR by qualified EPA personnel.
Formal peer reviews are conducted and documented in accordance with the Agency's Peer Review Handbook and Peer Review Policy. Historically, only a few Regional products rise to the level of peer review on an annual basis. By definition, these reviews include a charge to the reviewers that identifies their responsibilities, content areas, and specific documentation procedures.
Formal peer review is generally considered to be the highest level of technical quality review. The Office Director determines which products shall undergo formal peer review as well as what type of peer review mechanism shall be utilized (e.g. internal or external, individual or panel, etc.). Supervisors are responsible to identify to their Office Director disseminated information products that may be subject to formal peer review.
Peer review is recognized as a component of pre-dissemination review that complements and enhances the objectivity and utility of information products. Scientific and technical products that are peer reviewed also need PDR by qualified EPA Regional personnel to ensure all IQG are fully met.
The EPA Region 10 Quality Assurance Staff provide direct scientific and technical assistance on quality assurance matters. This assistance is provided by reviews and assessments of documents, data, and quality systems. Reviews and assessments are considered integral procedures for pre-dissemination review. Products resulting from these reviews and assessments are used in the development of other information products that may be disseminated. The products resulting from Quality Assurance reviews and assessments will contain language attesting to satisfying some of the IQG performance goals. Information products that rely upon Quality Assurance reviews and assessments can use this documentation as evidence for a quality assurance pre-dissemination review.
The objective of the Product Review Process is to assist staff in producing quality products that are targeted at the right audience, utilize effective graphics and layout, and deliver a message which will achieve the desired result, while reducing the potential of redundant products.
Product review covers new or significantly revised materials that have policy implications and are targeted to specific audiences (e.g. industry groups, community organizations, educators, consumers, public officials) or general public sectors, and all web pages. Product review does not cover editorial updates; fact sheets, newsletters, and leaflets; previously approved documents posted on the Internet as Adobe Acrobat (PDF) files; Legal documents, notices, and testimony; Technical material; Reports; Materials produced entirely by partners under grants, Memoranda of Agreement, and Cooperative Agreements.
Those items subject to product review are first proposed at the Concept Stage to the Product Review Officer (PRO) in ETPA with supervisor approval. If approved by the PRO, the project is added to the PROTRAC database (print products only) which notifies HQ Office of Public Affairs of the concept. The product originator will then proceed to the Draft Product Stage, and submit the draft to the PRO. Upon approval, the product originator proceeds to the Final Product Stage, and submits the final for approval.
For formal peer review, the documentation requirements outlined in the Agency's Peer Review Handbook shall be followed. For internal management and staff information product reviews and informal external reviews, there are no additional pre-dissemination review documentation requirements beyond those documentation practices that are currently being employed by each program office. At management's discretion, on a case-by-case basis, additional documentation requirements may be established. In all cases, Agency record retention requirements are to be met.
In view of EPA IQG and PDR guidance, Regional personnel are encouraged to develop sound documentation practices to be able to retrieve review documentation. For example, creating an electronic folder to file electronic records or a hard copy file to maintain hard copy review records is advised.
As necessary, the Region may utilize the upcoming Enterprise Content Management System (ECMS) to manage PDR documentation records.
EPA sometimes provides a service to the public and regulated community by distributing information from non-EPA sources. If EPA endorses or appears to endorse the information, the IQG and PDR apply. However, if through the use of disclaimers, EPA makes it clear to recipients that the information is not EPA's information, that we are only facilitating its distribution as a public service, and do not endorse or vouch for its quality, then the IQG and PDR may not apply. This is especially important for non-EPA information that we distribute via the web.
If EPA is using non-EPA information to support an Agency position or action, or if EPA is otherwise endorsing the information, EPA is responsible for the quality of the information and the IQG and PDR apply.
Section 4 of Region 10's Quality Management Plan describes the procedures followed for obtaining services and/or items involving environmental measurements. It especially focuses on the RQAM's, CO's and COR's responsibilities in ensuring that sufficient QA/QC activities are incorporated on different levels of contracts, grants and procurement activities involving environmental measurements.
Table of Contents: Section 4
Region 10 has no Contracting Office or Procurement Office. However, each program office is allowed to purchase items or services < $3,000.00 obtained through the use of Government Purchase Cards. Only purchases > $3,000.00 require Purchase Requisition (PR) Forms (1900-8) that are prepared and approved by the regional Program Managers with program funds committed to by the Funding Control Officers (FCOs). These PRs are approved and processed by Region 7 Contracting Officer(s).
All EPA purchases must meet established administrative and QA requirements. The Office of Personnel Management (OPM) is responsible for ensuring that all procured items and services meet established requirements and perform as specified. Procurement documents or financial assistance agreements require suppliers to have a Quality System, consistent with EPA QA requirements, if the supplier is providing services or items that directly affect the quality of results or products for environmental programs. Contractors, suppliers and financial assistance recipients are responsible for the quality of work performed or items and services provided by their subcontractors and suppliers.
During the contract pre-award phase, the originating program office through the project Contract Officer Representative (CORs) shall notify the RQAM of all contracts involving environmental data collection. Normally, the types of contracts which will require the generation of quality assurance documentation are those in which services are procured. Examples of these types of service contracts include contractor analytical operations, sampling/field measurements, data assessment, site investigations, etc. The QA requirements in the Federal Acquisition Regulations (FAR) 46.202-4 and FAR 52.246-11 (Higher-Level Contract Quality Requirement, Feb 1999) apply to regional contracts involving the collection and use of environmental data. The appropriate project and contracting officer (PO and CO) are responsible for ensuring that all solicitations for work involving environmentally-related measurements meet the Higher Level Quality Requirements specified in FAR 52.246-11. The COR shall ensure that a QA Review Form has been completed in accordance with EPA Order 1900, the Contracts Management Manual. The COR is also responsible for including the RQAM as a technical evaluation panel member on those contracts with a value of $500,000 or greater, if the contracts involve environmental measurements or technology.
It is the responsibility of the project COR and program office to ensure that QA Review (QAR) Forms, for each procurement request/order, except for incremental funding actions, when the acquisition is in excess of $25,000, with appropriate signatures, are included in every solicitation package. The QAR Form will specify if environmentally-related measurements are required under the contract's scope of work, and if so, which type of quality documentation is required under the contract. The default submissions for contracts requiring environmental measurements are a Quality Management Plan (QMP) before award and a Quality Assurance Project Plan (QAPP) for each applicable project after award. The QMP and QAPP may be combined into a single quality assurance document if agreed to before contract award by the contract PO and the RQAM. Prior to contract award, the program office shall ensure that QMPs and QAPPs are reviewed and approved by the RQAM for those contracts requiring environmental measurements or technology.
Details on QA requirements for contracts and solicitations involving measurement activities can be found in the following Contract Quality Requirements webpage.
Region 10, as do most Regions, provides financial assistance to States, Tribes, Locals and non-profit organizations who assist the Agency in carrying out its mission. For projects involving environmental programs, EPA assistance agreement recipients must implement or have implemented a quality system conforming to the American National Standard ANSI/ASQC E4-1994, “Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs.” This quality system shall be applied to all environmental programs within the scope of the assistance agreement. Environmental programs include direct measurements or data generation, environmental modeling, compilation of data from literature or electronic media, and data supporting the design, construction, and operation of environmental technology. This requirement is consistent with and for all environmental programs operating under the EPA Quality System.
It is the Grant's Office and PO's responsibility to ensure that QA Review (QAR) Forms with appropriate signatures are included in each grant application packet involving data collection activities. The grantee, the PO and the RQAM work together to determine when the preparation of QA Planning documents are required. These QA documents are submitted by the grantee to the PO. The PO is responsible for ensuring that the QA planning documents submitted are adequate in meeting the Program goals and objectives. The document is then forwarded to the RQAM for QA review and approval/disapproval. Once the RQAM completes the review and approval of the planning document, immediate oversight responsibilities are transferred with the PO, Task Monitor or the WAM. For a more detailed information regarding QA requirements for EPA grants please refer to the Grants and Debarment webpage.
Please refer to section 1.4.4 of this QMP.
Note: These responsibilities apply to QA Managers, QA Coordinators, QA Directors, and other authorized representatives. Authorizations are documented in each organization's Agency-approved Quality Management Plan.
- For all solicitations, the QA Manager must review the Statement of Work and the completed QA Review Form to ensure that quality-related requirements are appropriately addressed and are consistent with the organization's Quality Management Plan, and then sign the QA Review Form.
- If quality-related documentation or activities are
required for a solicitation or a Statement of Work under a
multiple award contract, and (a) the potential value of the
procurement exceeds $500,000, or (b) the estimate of the
percentage of costs or level-of-effort allocated to activities
requiring quality requirements exceeds 15%, or (c) procedures
defined in the Agency-approved Quality Management Plan of the
organization sponsoring the work apply, then the QA Manager must:
- Assist the COR with the development of the Technical Evaluation Criteria, and any associated technical instructions, for the Request for Proposal, and
- Serve as a member of the Technical Evaluation Panel (when convened) for the purpose of evaluating the QA aspects of the technical proposals.
- After award of the contract, the QA Manager must review each subsequent Statement of Work under the contract and the completed QA Review Form to ensure that quality-related requirements are addressed and are consistent with the organization's Quality Management Plan.
- Both before and after award of the contract, the QA Manager must perform any additional responsibilities defined in his or her organization's Quality Management Plan (such as reviewing and approving quality documentation or ensuring that the organization's QMP is being implemented).
Section 5 of the Region 10 Quality Management Plan describes the procedures in handling and management of both paper and electronic documents and records generated during environmental measurement activities and the staff that are responsible for their upkeep, maintenance, retention and eventual transfer to the Federal Record Center and the required documentation for each process. It also describes the different types of in-house databases used by the Region for environmental monitoring and work tracking purposes.
Table of Contents: Section 5
5.1 Quality Related Documents and Records
5.2 Region 10 QA Tracking System
5.3 RSCC Electronic Tracking System
5.4 QA Document Review Tracking System
5.5 ASB CLP Tracking Systems
5.6 Sample Documentation
The Federal Records Act of 1950, as amended, requires all federal agencies to make and preserve records containing adequate and proper documentation of their organization, function, policies, decisions, procedures, and essential transactions. These records are public property and must be managed according to applicable laws and regulations.
All records and documents used in administering this Quality Management Plan and conducting environmental data operations and environmental technologies must be managed according to federal laws and regulations and EPA policy and guidance. Records are managed as an Agency asset throughout their life cycle, which consists of three basic stages: creation, active maintenance and use, and disposition. The records life cycle is initiated by the creation, collection, or receipt of records in the form of data or documents in the course of carrying out EPA's administrative and programmatic responsibilities. The life cycle continues through the processing and active use of the information in the record, until the record is determined to be inactive. The final step in the life cycles is disposition which frequently includes transfer to inactive storage, followed by transfer to the National Archives or destruction.
Maintenance of documents and records (both printed and electronic) associated with the mission of a given program or project is the responsibility of the Office which has the primary responsibility for that program or project. Each Office is responsible for establishing and implementing procedures for identifying and managing records throughout their life cycle.
The Region 10 Records Management Program intranet site for EPA staff provides a records management manual, standard operating procedures, training modules, framework, retention schedules and program contacts to provide records storage and timely retrieval, secure storage and preservation of sensitive records, minimize potential loss or damage to records, and provide cost effective use of available storage space. It is also linked to the new Enterprise Content Management System (ECMS), an electronic standardized recordkeeping system that will improve records management at EPA and make records retrieval and information sharing easier and less time consuming. ECMS is scheduled for roll-out in 2009.
QA-related records and documentation are comprised of the products generated from the following QA activities and document: Management System Reviews, Technical System Audits, Data Audits, QAPPs, SOPs, QMPs, Data Review and Validation Reports and Superfund CLP Laboratory Data and Data Assessment results.
Each Program Office is the custodian of its own quality-related documents and records pertaining to environmental data operations. OEA's QA Records Management Procedures SOP identifies the policies and procedures for implementing OEA's management of quality system documents. This SOP is available from the RQAM on request. All quality system documents are maintained in accordance with EPA's Records Schedules.
While undergoing data validation process, all original hard copy of the CLP- generated data and courtesy copies of QA documents submitted by the programs for review and approval are filed and stored in locked file cabinets on the 9th floor (which is accessible by employees/contractors with key card access to the floor) for a period of up to 6 months or until the site specific project had been completed. After the project has been completed, and program authorization has been obtained, the CLP-generated analytical data and review documents are transferred to the Superfund Records Center for filing and then eventually transferred to the Federal Records Center (FRC). The establishment and routine use of filing systems and security procedures for the programs are the responsibility of the Regional Program Offices. The documents are maintained in a manner ensuring compliance with all applicable statutory, regulatory and EPA requirements for documents and records, i.e., EPA Order 2160 (EPA 1984) and the EPA Directive 2100, Chapter 10 (EPA 1998) by the QA staff and the RQAM. Detailed SOPs on requesting record for review, retention and transfer of records to the Superfund Records Center and/or Federal Record Center can be found in the Superfund Records Center web page.
The QA program uses three tracking systems in monitoring and maintaining electronic data files and information regarding sample analysis requests, QA workload and receipt of data deliverables from the laboratories. The sample analysis and submitted deliverables database is located in the QA user share drive and maintained by Region 10 RSCC, the sample analysis request database, the SDG tracking system (password protected site), was created and maintained by the Sample Management Office (SMO) in ASB and the QA workload tracking (password protected site) is maintained by the RQAM and the QAS.
The RSCC electronic data tracking system is a relational ACCESS database system created, maintained and modified, as needed, by the RSCC. The system is stored under the RSCC subdirectory of the QA directory. This system is purely a tracking system for CLP data packages received in the region and summary information for samples scheduled for analysis with the EPA Region 10 Laboratory or for subcontracting. The system does not contain environmental data.
For tracking QA documents submitted to the RQAM for review and approval, the RQAM utilizes the QA Workload tracking system. The project requests are logged-in by the RQAM or assigned staff with the expected deliverables, estimated level of effort (man-hours) and the estimated date of completion. At the end of each fiscal year, the number of QAPPs reviewed and the data validations completed are summed up using the tracking system. These numbers are reported in the QAARWP.
ASB has the following tracking databases that are also used by regions to keep track of their Superfund analytical services requests and data packages. The tracking systems are: (1) Analytical Services Tracking System (ANSETS) is a web-based database that keeps track of each Region's Superfund analytical services that were sub-contracted to commercial laboratories, (2) Superfund Project Request System (SUPRS) is a web-based database that allows users to manage the sample request and scheduling process based on their roles, responsibilities, and assigned user privileges. SUPRS allows user to perform the following tasks (users who perform the task are indicated in the parentheses): create, update, and submit requests for analytical services (Regions); assign and notify laboratories and regional personnel of a laboratory's assignment (SMO); verify the accuracy of site data (SMO and Regions); and confirm acceptance of an assignment to perform analytical services (laboratories), (3) Sample Delivery Group (SDG) Tracking System (STS) (password protected site) is also a web0based tracking system that keeps the Regional POs, RSCCs, and the other CLP community of the status of the submission of the analytical data from the CLP laboratories, and (4) Web-based Invoicing System (WIS) was designed to permit authorized CLP laboratories to generate and submit invoices via the Internet. This Internet-based solution has minimum startup costs for the laboratories, requiring only a low-end computer, Internet access, and a Web browser. Encryption and authentication techniques have been incorporated to ensure secure transmission of confidential and sensitive invoice information over the Internet.
Table of Contents: Section 5.6
EPA CLP sample numbers are issued by SMO to the RSCC after the laboratory has been assigned to the project. The RSCC supplies the laboratory assignment, address, lab contact person, sample shipment instructions and sample numbers to the EPA Project Manager and the field sample collection PM. For in-house tracking, the RSCC also issues and keeps tract of the Region 10 sample tracking numbers issued in increments of 50 samples per project starting with the year as the first two number and the weeks of sample for the third and fourth number and then the four digit sample numbers. Sample collection team may use the Forms II Lite or the Region 10 MEL traffic report/chain of custody form during sampling.
All samples that are scheduled for analysis via the Superfund CLP laboratories are required to use the Field Operations and Records Management System (FORMS) II Lite software for chain-of custody (COCs). The FORMS II Lite software is a flexible and easy-to-use, stand-alone, Windows-based application that simplifies and accelerates the sample documentation process. FORMS II Lite reduces the generation of hand written documents by nearly 70 percent. Specifically, FORMS II Lite: generates sample labels, bottle tags, and Chain of Custody (COC) forms; tracks samples from the field to the laboratory; facilitates electronic capture of sample information into databases; and exports data electronically as .xml, .dbf, or .txt files. Here's the link to the FORMS II Lite website.
The Region 10 personnel collecting samples for measurement activities have the option to use the FORMS II Lite or the MEL TR/COC Form to keep track of the samples and sampling information both of which could be obtained from the RSCC. In the absence of the FORMS II Lite and the MEL TR/COC forms, the samplers may use the COC provided by the laboratory where the samples will be sent for analysis. This usually happens when the samples are scheduled to be sub-contracted to a commercial lab.
Unless the samples collected are for enforcement, sample tags are no longer required for each sample container collected. This will minimize mistakes in the field and will allow the field crew to focus on the maintenance of the COCs and reconciliation of sample bottles with the sample collection documentation. When needed, sample tags can be obtained from the RSCC prior to mobilization to the site. The use of custody seals are still required by the region. Due to the latest developments in security and sample processing at the laboratory, custody seals per sample are no longer required. Custody seals are usually affixed on the lid and sides of the coolers to monitor cooler custody tampering during sample shipment.
QA guidance documents are developed for Regional use by the RQAM and technical specialists in the absence of Agency-wide guidance, or when detailed Regional processes need to be documented. Examples include Regional Guidance for Data Deliverables for CLP and non-CLP laboratory data packages, Region 10 Data Review Guidelines and Generic QAPP for Program Compliance Inspections, Filed and Laboratory Standard Operating Procedures (SOPs) and Modified Analysis Statement of Work (MA SOWs) for Organic and Inorganic Analyses for the CLP Lab. The regional guidance is readily accessible at the Region 10 QA web site.
Section 8 of Region 10's Quality Management Plan describes the QA workflow processes.
Table of Contents: Section 8
The Regional Project Officers/Regional Project Managers in Region 10 shall follow the following workflow process when requesting technical support for the review and approval of QA documents:
- The need for QA support is identified by the program and the designated Project Officer or Project Manager (referred to as the “requester”).
- A formal request for a need for technical QA support is made by the requester to the Environmental Services Unit Manager and cc the RQAM using the OEA tech support tracking system. If the QA staff supporting the site, project, or program is known or has been previously designated (referred to as “designated QA staff”), that person will be copied with the formal request. If available in electronic format, the documents for review are also attached by the requester to the formal request. The work request will specify the following:
- Name of the site or project
- Site account number or regional office/program being supported
- Type of QA support needed
- Completion due date
- Level of effort required
- Depending on the designated staff's current workload and commitments, the designated staff will respond to the requester, discuss due dates and deliverables with copies sent to the RQAM and his/her Unit Manager. Once an agreement has been reached between the designated staff and the requester, the QA staff's manager will formally accept the work request in the OEA tracking data base. The designated QA staff designated staff will enter the work request into the in-house web-based QA workload tracking system.
- If the site or project is new and the QA document is not available in electronic format the requester will submit the hard copy document to the RQAM.
- The RQAM checks with the appropriate Unit Manager regarding the availability of the requested expertise, the presence of any conflicts of interest, and the current workload of the affected staff/Unit. If the staff's workload capacity is full, the RQAM, requesting official, and Unit Manager will re-prioritize the work request and re-assign the request to the appropriate Unit staff.
- If the site or project is highly sensitive, requiring fast turnaround completion time and high level of effort, the requester shall meet with the RQAM and the corresponding Unit Manager to discuss the details of the work that is requested and the rationale for the level of effort and fast turn around time.
- For new sites or projects with regular turn around times (3-4 weeks), the RQAM enters the work request into the QA tracking system as unassigned work and communicates with the Units for the need for technical support. Once the work request has been entered in the QA workload tracking system, a tracking number or File ID is assigned automatically. It is incumbent upon the staff to check the status of the unassigned work request and check for availability of support. The RQAM meets regularly with the technical QA staff and keeps them informed of the workload status.
- The staff member accepting the work becomes the designated staff and goes to the QA tracking system entering their name as the expert assigned and changes the status of the work request.
- If no unresolved problems are encountered and the work is completed by the due date, the product is submitted to the requester with a copy sent to the RQAM and the work status changed in the QA tracking system as “closed” by the designated staff. The RQAM or the RQAM designee approves the product and returns the work product to the requestor. If the document is not approvable, the designated staff sends his/her comments and/or recommendations to the requester. The designated QA staff and the requester continually work together during review and revision process until the document has been finally approved.
- If problems occur that will prevent the designated staff from completing the work by the required due date, the requestor will be informed by the designated staff or the RQAM to establish a new due date.
If an agreement on the new due date can not be reached, the requester will consult with the designated staff's Unit Manager for resolution. The Unit Manager and RQAM will either re-assign the work request to another technical staff member or change the priorities of the designated staff to meet the new due date. The work request entry to the OEA tech support tracking system is revised as necessary to reflect the new work request, work assignment, and due date. A Schematic Diagram for the QA Workflow and Tracking is in Appendix A of this QMP.
A QAPP is a required planning document for all projects that involve the generation and/or use of environmental information - generally called environmental data. These environmental information projects are mostly traditional sampling and analysis projects. However, many other types of work are considered environmental information projects and require QAPPs and they are:
Secondary Use of data requires the development of a QAPP, or needs to be included in a QAPP for a project that includes other data generation or use as well. The only exception is if you can verify that the data were generated for the same purpose for which you will use them. The various guidance documents explain how to treat the Secondary Use of Data in your QAPP, and in your project and in the UFP QAPP Guidance - Subsection 2.7 at http://www.epa.gov/fedfac/pdf/ufp_qapp_v1_0305.pdf (PDF)(177pp, 1.6 MB) page 74).
Modeling Projects, some projects utilize models or mathematical algorithms for inferring or predicting an environmental condition. In general, modeling projects need to be covered by a QAPP. However, the QAPP may not necessarily need to be developed for the specific project at hand. There are a number of guidance documents available (i.e. G-5M http://www.epa.gov/quality/qs-docs/g5m-final.pdf (PDF)(121pp, 615K) and the November 2003 Council for Regulatory Environmental Monitoring [CREM] "Draft Guidance on the Development, Evaluation, and Application of Regulatory Environmental Models" found at http://cfpub.epa.gov/crem/cremlib.cfm#whitepapers) that provide assistance in determining whether a new QAPP is needed, and how it should be developed. Region 10 has modeling experts and technical specialists that handle the review of modeling QAPPs.
GIS Projects, there are a number of different types of projects that utilize Geographic Information Systems (GIS, a collection of computer hardware, software, and geographic data designed to capture, store, update, manipulate, analyze, and display geographically referenced data). Some projects involve the development of new techniques and/or underlying spatial data to answer a specific question. Some of these GIS projects utilize only existing data, while others utilize only new data collected as part of the same project, or a combination of old and new data. In general projects that simply involve use of existing data and established procedures do not require a QAPP. Projects that involve field collection of new spatial data or development of new procedures to support environmental decisions generally should be covered by a QAPP. Refer to "EPA Guidance for Geospatial-related Quality Assurance Projects Plans" found at http://www.epa.gov/esd/gqc/pdf/g5g-final.pdf (PDF)(106pp, 1.4 MB) for guidance in determining whether a new QAPP is needed, and if so, how it should be developed. Anyone starting a new GIS project should consult with a member of the QA Staff or the Region 10 GIS Team.
The QAPP integrates all technical and quality aspects of a project, including planning, implementation, and assessment. The function of the QAPP is to document planning results for environmental data operations and to provide a project-specific “blueprint” for obtaining the type and quality of environmental data needed for a specific decision or use.
The QAPP shall be prepared in accordance with the (UFP-QAPP) guidance www.epa.gov/fedfac/documents/qualityassurance.htm for regulated or clean-up facilities or the most current version of the EPA Requirements for Quality Assurance Project Plans (PDF)(40pp, 87K), EPA QA/R5 March 2001.
It is the PO's, PM's or COR's responsibility to submit the QAPP to the RQAM for review and approval. For reviews that will entail more than 8 hours estimated level of effort, the work request is entered by the PM/PO/COR into the OEA tracking database. For timekeeping and accounting purposes, the work request is routed to the PM/PO/COR's immediate supervisor for approval. The RQAM initially reviews the document needing a review and confers with the QAS' and technical specialist's immediate supervisor for FTE availability. Once a turn around time has been agreed upon by all parties, i.e., the requestor, the program supervisors, the assigned QAS/technical specialist and the RQAM, the review process then commence. Only the RQAM is authorized to approve QMPs. The QAS has the RQAM delegated authority to approve QAPPs. The PM/PO/COR and the RQAM or the designated QAS are the approving authorities for QAPPs. No environmental measurement activity could occur in the region without an EPA approved QAPP. A detailed schematic diagram of the QAPP/QMP review process is in Appendix A.
- Figure 1 - Region 10's Organizational Chart (staff and phone listing)
- Figure 2 - OEA Organizational Chart
- Figure 3 - RQAM Workflow and Tracking Processes
- Figure 4 - QA Document Review Process