Frequent Questions about EPA's Quality Program
On this page:
- EPA's Quality Program
- Systematic Planning
- EPA Methods
- EPA Standards
- Examples and Templates
- Training
- Information Quality Guidelines
- Citizen Science QAPP
- Other Related Topics of Interest
EPA's Quality Program
- What are the goals of EPA's Quality Program?
- What are the benefits of EPA's Quality Program?
- What activities does the EPA Quality Program cover?
- What is the relationship between the EPA Quality Program and EPA's Information Quality Guidelines?
- Who is responsible for the EPA Quality Program?
- What are the roles and responsibilities of the Enterprise Quality Management Division?
- What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel?
- What are the main components of the EPA Quality Program?
- How is a 'graded approach' applied to EPA's Quality Program?
General Quality Program Questions
- What is a quality program?
- Does a quality program ensure that information collected is 'good'?
- What is the difference between a quality program, quality assurance and quality control?
- What is the difference between a Quality Management Plan and a Quality Assurance Project Plan?
- Which EPA documents do I use to implement and manage my quality program?
- Must a Quality Management Plan be called a Quality Management Plan, and similarly, must a Quality Assurance Project Plan be called a Quality Assurance Project Plan?
EPA Organizations and Personnel
- What EPA organizations are covered by the EPA Quality Program?
- What Quality Program specifications apply to my organization?
- What EPA Quality Program specifications apply to me?
- Who is my Quality Assurance Manager?
- Where can I get a copy of my Organization's Quality Management Plan?
- Where can I find more information for EPA organizations?
EPA's Quality Program Contacts
- Where do I find a list of QAMs responsible for EPA's Quality Program?
- Where do I find specific information by EPA Region?
- Where can I find National Program Manager guidance?
EPA's Quality Program
What are the goals of EPA's Quality Program?
The goals of the Agency-wide Quality Program are to ensure that environmental programs and decisions are supported by information of the type and quality needed and expected for their intended use and that decisions involving environmental technology are supported by appropriate quality-assured engineering standards and practices.
What are the benefits of EPA's Quality Program?
Successful implementation of the EPA Quality Program leads to:
- Scientific Data Integrity - EPA will produce information of known and documented quality based on sound scientific principles.
- Reduced or Justifiable Resource Expenditures - Resource expenditures can be reduced if EPA's information needs are more closely matched to the information collection. Through proper planning, only the correct type, amount, and quality of information will be collected for EPA use.
- Proper Evaluation of Internal and External Activities - The EPA Quality Program provides documentation of activities and improved oversight for evaluation purposes. This reduces the potential for waste and abuse.
- Reliable and Defensible Decisions - When the quality of information is known, it is possible to determine whether the information can be used for a specific decision. This reduces challenges to regulations, permit appeals, etc.
- Burden Reduction - As EPA better defines the information needed for a specific application. The burden is on organizations who are required to collect, produce, evaluate or use information that is reported to EPA.
Overall, implementation of the EPA Quality Program will reduce the Agency's vulnerabilities and increase EPA ability to make reliable, cost-effective, and defensible decisions.
What activities does the EPA Quality Program cover?
The EPA Quality Program covers the collection, production, evaluation or use of environmental information by and for the Agency, and the design, construction and operation of environmental technology by the Agency. This includes environmental programs such as the:
- demonstration of environmental technology
- investigation of chemical, biological, physical or radioactive constituents
- development, evaluation, and use of computer or mathematical models
- use of information collected for other purposes or from other sources
- the collection and use of information pertaining to the occupational health and safety of personnel in EPA facilities
A list of some example activities are contained in Example Activities.
What is the relationship between the EPA Quality Program and EPA's Information Quality Guidelines?
EPA's Environmental Information Quality Policy includes procedures for developing and implementing program-specific quality-related activities. These activities then serve as a framework for information product developers to ensure that information products meet the specifications of the Information Quality Guidelines (IQG). For more information, see EPA's Information Quality Guidelines.
Who is responsible for the EPA Quality Program?
The EPA Quality Program is decentralized so each EPA organization designs, implements, and manages its own quality program through their Quality Management Plan. The Chief Information Officer (CIO) and Deputy Assistant Administrator (DAA) for Information Technology/Information Management (IT/IM) serves as the Senior Quality Management Official for the Agency. This responsibility is delegated from the EPA Administrator and is stated in Environmental Information Quality Policy. The Enterprise Quality Management Division (EQMD), Office of Records, Administrative Systems and eDiscovery (ORASE), supports the CIO/DAA for IT/IM and is responsible for the development of Agency-wide policy and procedures and for the oversight of implementation of the Quality Program.
What are the roles and responsibilities of the Enterprise Quality Management Division?
EQMD is responsible for coordinating the implementation of the Agency Quality Program, developing Agency policies and procedures on quality, and providing training on quality issues. EQMD accomplishes these activities by:
- developing Agency guidance and policy
- providing training and training aids for quality assurance procedures
- reviewing Quality Management Plans and recommending Agency approval
- assessing implementation of established Quality Management Plans
- facilitating communication among members of EPA's quality assurance community
- providing general outreach and consulting services to the EPA quality assurance community
For more information on the policies and procedures for EQMD, see Policies and Procedures for EPA Organizations: Agency-wide Oversight.
What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel?
EPA Quality Assurance Managers (QAMs) are tasked with reporting on quality issues to their senior management, providing independent oversight, and assuring the implementation of the organization's quality program. This individual must function independently of direct environmental information generation, model development, or technology development responsibility. The Quality Policy also defines the responsibilities of the QAM and other quality management personnel to include:
- facilitating the development and maintain the organization's Quality Management Plan
- representing the organization on matters pertaining to quality management
- providing expert assistance to project personnel on quality assurance and quality control issues
- developing and implementing a Quality Assurance Training Program
- reviewing and/or approving quality management documentation
- providing quality management support to project personnel
- overseeing and assessing the organization's quality program
In addition to these general responsibilities, each EPA organization's Quality Management Plan defines specific responsibilities for its QAM and other quality management personnel.
What are the main components of the EPA Quality Program?
The main components of the EPA Quality Program are described below. Each EPA organizations consider these components when developing their individual Quality Program.
Quality Program Policies - Policies for EPA and Non-EPA organizations are contained in internal policy documents. See Specifications for EPA and Non-EPA Organizations for more information about these policy documents.
Quality Program Documentation - Documentation that describes the authorities, policies, and procedures specific to an organization's quality. EPA organizations are required to develop a Quality Management Plan as documentation.
Annual Reviews and Planning - A yearly review of the activities within, and changes to, an organization's quality program; work accomplished; and future projects requiring quality management attention. EPA organizations are required to submit a Quality Assurance Annual Report and Work Plan to document this review.
Management Assessments - Assessments of a program and/or organization to determine the conformance of the quality program to policies, compliance with regulations, and conformance to the organization's quality program documentation. EPA uses Quality Program Assessments and other management assessments to assess EPA organizations and some supporting organizations.
Training - Methods and techniques to ensure that all personnel having responsibility within the quality program for management and information collection activities have the skills and knowledge to complete their tasks in accordance with their quality program's policies and procedures. EPA organizations are required to document their Training Program in their Quality Management Plan.
Project Planning - Systematic planning (for example, the Data Quality Objective Process) is used to develop performance criteria for the data (i.e., the type, quantity, and quality of data needed to serve their needs) or technology design, to develop a plan to satisfy these criteria, and to determine the level of oversight and quality control activities needed to ensure the criteria are satisfied. The results from the systematic planning are documented in a Quality Assurance Project Plan.
Project Implementation - Information is collected and environmental technology is implemented according to the methods and procedures documented in the approved Quality Assurance Project Plan, Standard Operating Procedures, and design documentation. During information collection, oversight may be performed using technical audits that are conducted to assess whether or not information is being collected as stated in the Quality Assurance Project Plan.
Project Assessment - Analysts use technical knowledge and statistical methods to determine whether or not the collected information meet the user's needs. The information is formally verified and validated to ensure that the measured values are free of gross errors due to procedural or technical problems and then are analyzed to determine if they meet the performance criteria documented in the Quality Assurance Project Plan (data quality assessment) or other design documentation.
How is a 'graded approach' applied to EPA's Quality Program?
Because of the diversity of work conducted by the Agency, EPA recognizes that a "one size fits all" approach to quality specifications will not work. Therefore, the implementation of the EPA Quality Program is based on a graded approach. Applying a graded approach means that quality programs for different organizations will vary according to the specific objectives and needs of the organization. For example, the quality controls of a fundamental research program are different from that of a regulatory compliance program because the purpose or intended use of the information is different. Once a graded approach has been applied to the components of a quality program, a graded approach is then applied to the documentation.
General Quality Program Questions
What is a quality program?
A quality program is the means by which an organization manages its quality aspects in a systematic, organized manner and provides a framework for planning, implementing, and assessing work performed by an organization and for carrying out required quality assurance and quality control activities. It encompasses a variety of technical and administrative elements, including:
- policies and objectives,
- organizational authority,
- responsibilities,
- accountability, and
- procedures and practices.
Does a quality program ensure that information collected is 'good'?
No. Information is neither 'good' or 'bad' but rather information is either useful for its intended purpose or not useful for its intended purpose. One must know in what context the information is to be used to judge whether or not the information is adequate.
What is the difference between quality program, quality assurance and quality control?
A Quality Program is the totality of management controls, processes, and documentation in EPA’s planning, implementation, and assessment for ensuring the quality of Agency environmental information operations products and services.
Quality assurance is the management of an integrated system of activities involving planning, implementation, documentation, assessment, reporting, and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the organization.
Quality control is the overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements; operational techniques and activities that are used to fulfill requirements for quality.
What is the difference between a Quality Management Plan and a Quality Assurance Project Plan?
A Quality Management Plan is a formal document that describes a Quality Program in terms of the organizational structure, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, and assessing all activities conducted.
A Quality Assurance Project Plan is a planning document related to a project or program that describes in comprehensive detail the necessary QA/QC requirements and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance and acceptance criteria.
Which EPA documents do I use to implement and manage my quality program?
Refer to the Quality Directives Table to determine which Directives are applicable to your organization.
Must a Quality Management Plan be called a Quality Management Plan, and similarly, must a Quality Assurance Project Plan be called a Quality Assurance Project Plan?
Yes. Refer to the Quality Management Plan Standard and the Quality Assurance Project Plan Standard.
EPA Organizations and Personnel
What EPA organizations are covered by the EPA Quality Program?
All EPA organizations that collect, produce, evaluate, or use environmental information or design, construct, or operate environmental technology are covered by the EPA Quality Program. EPA organizations that maintain quality programs include EPA Regions, National Program Offices, and the Office of Research and Development.
What Quality Program specifications apply to my organization?
EPA organizations must develop, implement, and maintain a quality program that is consistent with the requirements included in ASQ/ANSI E4.
Specific specifications for EPA organizations are defined in Environmental Information Quality Policy. Supplemental information is contained in Environmental Information Quality Procedure.
What EPA Quality Program specifications apply to me?
Depending on your job function, different quality specifications apply to you. Responsibilities for EPA Senior Managers, quality management personnel, EPA managers and staff are all described in Environmental Information Quality Policy. Program-specific responsibilities are described in your organization's Quality Management Plan.
However, all EPA employees must ensure that all applicable intramural programs and activities comply with Environmental Information Quality Policy; ensure all applicable extramural environmental programs comply fully with the Code of Federal Regulations; and assure that the results of environmental programs are of sufficient quantity and adequate quality for their intended use.
Who is my Quality Assurance Manager?
A list of EPA Quality Assurance Managers (QAMs) is provided at Quality Assurance Managers (QAMs). If your organization does not appear, please contact EQMD at [email protected] to determine your Quality Assurance Manager.
Where can I get a copy of my Organization's Quality Management Plan?
Contact your supervisor or QAM for the most recent version of your organization's Quality Management Plan.
Where can I find more information for EPA organizations?
For more information for EPA organizations, see Specifications for EPA and Non-EPA Organizations.
EPA's Quality Program Contacts
Where do I find a list of QAMs responsible for EPA's Quality Program?
To view a list of the QAMs responsible for EPA's Quality Program, see Quality Assurance Managers (QAMs).
Where do I find specific information by EPA Region?
To find specific information by EPA region, see Regional Offices.
Where can I find National Program Manager Guidance?
National operational framework used by the regions, states, and tribes to implement programmatic activities.
Systematic Planning
- What is systematic planning?
- Why systematically plan projects?
- What are the elements of systematic planning?
- Do I need to systematically plan my projects?
- How do I systematically plan my projects?
- What are some examples of systematic planning processes?
- How do I document my systematic planning?
What is systematic planning?
Systematic planning is a methodical, or ordered, approach to planning. EPA uses systematic planning to plan projects and link goals, cost and schedule and quality criteria with the final outputs.
Why systematically plan projects?
Systematic planning ensures that all participants understand the needs and expectations of the customer and the product or results to be provided by the supplier. It also results in:
- a project's logical development
- efficient use of resources
- transparency of intent and direction
- defensibility of project results
- appropriate documentation
Planning a project before resources are expended reduces waste and rework.
What are the elements of systematic planning?
EPA's elements of systematic planning are stated in Section 5 of the Environmental Information Quality Procedure and include:
- Identification and involvement of the project manager, sponsoring organization and responsible official, project personnel, stakeholders, scientific experts, etc.;
- Description of the project goal, objectives, and questions and issues to be addressed;
- dentification of project schedule, resources (including budget), milestones, and any applicable requirements (e.g., regulatory requirements, contractual requirements);
- Identification of the type of information needed and how the information will be used to support the project’s objectives;
- Determination of the quantity of information needed and specification of performance criteria for measuring quality;
- Description of how, when, and where the information will be obtained (including existing information) and identification of any constraints on information collection;
- Specification of needed QA and QC activities to assess the quality performance criteria (e.g., QC samples for both the field and laboratory, audits, technical assessments, performance evaluations, sensitivity analysis of models, etc.);
- Description of how the acquired information will be analyzed, evaluated (i.e., QA review, validation, verification), and assessed against its intended use and the quality performance criteria.
Do I need to systematically plan my projects?
The Environmental Information Quality Policy states that all EPA organizations shall use a systematic planning process to develop acceptance or performance criteria for the collection, production, evaluation, or use of environmental information.
How do I systematically plan my projects?
Your organization's Quality Management Plan may specify a process for you to use. Program-specific guidance may also be available to help you (for example, the Multi-Agency Radiation Survey and Site Investigation Manual provides information on planning, conducting, evaluating and documenting environmental radiological surveys of surface soil and building surfaces for demonstrating compliance with regulations.) Review applicable regulations to ensure the appropriate planning elements. If you need additional information refer to the Elements of Systematic Planning.
What are some examples of systematic planning processes?
The scientific method and the observational method are both examples of systematic planning processes. Processes have been created for specific applications include:
- The Data Quality Objectives (DQO) Process - EPA's recommended systematic planning tool. For resources on the Data Quality Process, see Elements of Systematic Planning.
- The Triad Approach - EPA's planning process for the Agency's hazardous waste remediation programs.
How do I document my systematic planning?
The results of systematic planning are documented in a Quality Assurance Project Plan (QAPP) or an equivalent document. QAPP requirements are listed in the Quality Assurance Project Plan (QAPP) Standard . Consult your organization's Quality Assurance Manager or your Quality Management Plan for documentation specifics.
EPA Methods
Where can I find out information regarding EPA methods?
Approved methods for measuring the concentration of a substance or pollutant.
EPA Standards
- Where can I find information regarding EPA water quality standards?
- Where can I find information regarding EPA air quality standards?
- Where can I find information regarding EPA data standards?
- Where can I find information regarding the EPA IM/IT directives? (including their associated policies, procedures, standards and guidance)
- Where can I find information on laboratory competency?
Where can I find information regarding EPA water quality standards?
Water quality standards: regulations and resources.
Where can I find information regarding EPA air quality standards?
Clean Air Act, primary and secondary standards.
Where can I find information regarding EPA data standards?
Data standards adopted by EPA for use by Agency programs.
Where can I find information regarding the EPA IM/IT directives? (including their associated policies, procedures, standards and guidance)
Current information directives.
Where can I find information on laboratory competency?
Information on laboratory competency.
Examples and Templates
Quality Assurance Project Plans (QAPP)
- Where can I find more information on QA Project Plans?
- What is a QA Project Plan?
- Why do I have to write a QA Project Plan?
- How do I develop a QA Project Plan?
- Where can I find some tools and templates to help me prepare a QA Project Plan?
- Where are content specifications for QA Project Plans defined?
- I have a Quality Management Plan, do I still need a QA Project Plan?
- Who is responsible for implementing the QA Project Plan?
- Whom do I contact if I have questions?
- Where can I find more information on SOPs?
- What is a SOP?
- How should a SOP be organized?
- How much detail needs to be included in a SOP?
- Who should write a SOP?
- What is the benefit of having a SOP?
- I am following a published method. Do I have to have a SOP?
- Where can I find more information on QMPs?
- What is a Quality Management Plan?
- What organizations are required to have a QMP?
- Where are the specifications for QMPs established?
- How often do organizations review their QMP?
- What documents will help me prepare my QMP?
- Who reviews and approves QMPs?
- How long does approval of a QMP last?
- If my QMP is subject to EQMD review and OMS approval, is an "informal" review possible?
- If my QMP is subject to EQMD review and OMS approval, what do I submit for a "formal" review?
- How long does it take EQMD to review a "formal" QMP submission?
- What criteria does EQMD use to review a QMP during informal and formal review?
- My EPA organization is developing a QMP for EQMD review and approval - what assistance is available?
- Will EQMD notify me when my organization's QMP is going to expire?
- When do I need to resubmit my QMP for EQMD approval?
Quality Assurance Project Plans
Where can I find more information on QA Project Plans?
For more information on QA Project Plans, see Quality Assurance Project Plan (QAPP)Standard.
What is a QA Project Plan?
A QA Project Plan is a planning document related to a project that describes in comprehensive detail the necessary Quality Assurance/Quality Control requirements and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance and acceptance criteria.
Why do I have to write a QA Project Plan?
EPA requires approved QA Project Plans (or equivalent documents) for all applicable projects and tasks involving environmental information to ensure the project and task is documented and reviewed before the work is started. The need to write a QA Project Plan applies is defined in Environmental Information Quality Policy when EPA conducts a project directly, or in the applicable Federal Regulations (see Specifications for EPA and Non-EPA Organizations) when EPA is funding the project under a grant, contract, or other agreement.
How do I develop a QA Project Plan?
Development of a QA Project Plan should be a multi-step process involving a number of people. The following is a brief summary of the process:
- Assemble a project team and "systematically plan" what needs to be done.
- Write the QA Project Plan using the results of that planning process.
- Submit the QA Project Plan for review and approval.
- Once approved, distribute the QA Project Plan to all pertinent individuals involved with the project or program.
- Begin work, but remember to:
- document any changes in QA Project Plan; and if necessary, get re-approval and distribute the update version to all persons
- review the QA Project Plan on a systematic basis to ensure that it remains up-to-date.
Where can I find some tools and templates to help me prepare a QA Project Plan?
National programs and regions have developed many helpful tools and templates, below are some examples:
- Secondary Data Use template, and information for QAPP preparation provided by Region 3.
- Surface or groundwater monitoring and/or collection and analysis of water samples Quality Assurance (QA) Project Plan tool from the Office of Water.
- Design and Implementation of New Tools for Quality Assurance in Modeling developed by Region 1, New England.
- Total Maximum Daily Load (TMDL) program design and implementation of new tools for Quality Assurance in Modeling from Region 1, New England.
- Streamlined QAPP tables/templates that may be included in a QAPP to summarize information, supplement and simplify the text or to create a useful list provided by Region 1, New England.
- Tribal from Region 6:
- Sampling and analysis plan from Region 6:
Where are content specifications for QA Project Plans defined?
Specifications for those receiving EPA funds for environmental activities are defined in the Quality Assurance Project Plan (QAPP) Standard. For EPA personnel, content specifications are defined in Chapter 5 of the Environmental Information Quality Policy. Because the 'Requirements' document is clearer, more user-friendly and less repetitive, EPA recommends that EPA personnel use this document in lieu of the Manual.
I have a Quality Management Plan, do I still need a QA Project Plan?
Yes. A Quality Management Plan describes the organization's quality program, that is, its management structure for quality, while the QA Project Plan describes the necessary quality assurance, quality control and other technical activities that must be implemented for a specific project. For small programs, grants and contracts, these two documents may be combined into a single document, with permission of the EPA QA Manager of the organization sponsoring the work. The combined document will need to address all the elements defined by the EPA QA Manager and include documentation of both the organization's quality program and the application of this system to the work to be performed.
Who is responsible for implementing the QA Project Plan?
The organization performing the work is responsible for ensuring that the QA Project Plan is approved prior to the commencement of any work and that it is implemented as written. All project personnel should understand the specifications prior to the start of information generation activities and ensure that the plan is implemented as written and that all changes are documented and approved prior to their being made.
Whom do I contact if I have questions?
For recipients of EPA funds, the QA Manager of the funding EPA office should be contacted. For internal EPA projects, the QA Manager of that organization should be contacted. A list of all EPA QA Managers is available at Quality Program Contacts.
Standard Operating Procedures
Where can I find more information on SOPs?
For more information on SOPs, see Quality Management Tools - Standard Operating Procedures.
What is a SOP?
A SOP is a set of written instructions that document a routine or repetitive activity. SOPs describe both technical and administrative operational elements.
How should a SOP be organized?
A SOP should be organized to ensure ease and efficiency in use and to be specific to the organization which develops it. There is no one 'correct' format for writing a SOP.
How much detail needs to be included in a SOP?
A SOP should be written with sufficient detail so that someone with a basic understanding of the activity, can successfully repeat the activity.
Who should write a SOP?
SOPs should be written by individuals knowledgeable with the activity. These individuals are essentially subject-matter experts who actually perform the work or use the process. A team approach can also be followed, especially for multi-tasked processes where the experiences of a number of individuals are critical.
What is the benefit of having a SOP?
The development and use of SOPs is an integral part of a successful quality program. It provides individuals with the information to perform a job properly and facilitates consistency. When historical information is being evaluated for current use, SOPs can be valuable for reconstructing project activities. In addition, SOPs are frequently used as checklists by inspectors when auditing procedures. Ultimately, the benefits of a SOP is knowledge transfer.
I am following a published method. Do I have to have a SOP?
Yes. SOPs are needed even when published methods are being utilized because cited published methods may not contain pertinent information for conducting the procedure in-house. For example, if the SOP is written for a standard analytical method, the SOP should specify the procedures to be followed in greater detail than appear in the published method, detailing how, if at all, the SOP differs from the standard method and any options, changes or adjustments that the organization follows.
Quality Management Plans
Where can I find more information on QMPs?
For more information on QMPs, see Quality Management Plan Standard.
What is a Quality Management Plan?
A formal document that describes a Quality Program in terms of the organizational structure, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, and assessing all activities conducted.
What organizations are required to have a QMP?
All EPA and non-EPA organizations conducting environmental information operations on behalf of EPA are required to establish and implement a quality program. This includes work performed in support of EPA's mission or national priorities as defined by and in accordance with:
- federal laws and legal requirements including administrative orders/enforcement actions,
- regulations,
- extramural agreements, or
- performing work on a voluntary basis under agreement with EPA.
Non-EPA organizations include but are not limited to:
- contractors,
- regulated parties,
- cooperative agreement holders,
- grantees,
- states, tribes, localities, intergovernmental agencies,
- educational institutions, hospitals, non-profits,
- other federal governmental agencies, and parties to Memoranda of Agreement or Understanding,
- volunteer organizations, and
- other environmental information providers.
Since non-EPA organizations may participate in more than one extramural agreement with EPA, the organization’s QMP may contain common management information that may be applied to more than one agreement.
Where are the specifications for QMPs established?
- EPA organizations: The need to have a Quality Program is documented in a QMP, and established in the Environmental Information Quality Policy and Environmental Information Quality Procedure. The required contents of the QMP are specified in the QMP Standard.
- Non-EPA organizations: The need to have a Quality Program, and to document this Program in a QMP, is established through Federal Regulations. For more information, refer to Specifications for EPA and Non-EPA Organizations and contact the QA Manager of the organization sponsoring the work.
How often do organizations review their QMP?
Annually, as defined in the Quality Management Plan Standard.
What documents will help me prepare my QMP?
When preparing a QMP, you should follow the Quality Management Plan Standard and use the EPA Checklist for Reviewing Quality Management Plans to verify that applicable requirements are included. EPA organizations should also consult Section 5 B of Environmental Information Quality Procedure which contains equivalent specifications to this 'Requirements' document.
Who reviews and approves QMPs?
- EPA Organizations: The Office of Records, Administrative Systems and eDiscovery (ORASE) Enterprise Quality Management Division (EQMD) is responsible for reviewing Agency QMPs required by Environmental Information Quality Policy and the CIO/DAA for IT/IM approves these QMPs. EPA Organizations with approved QMPs are responsible for the review and approval of QMPs from their supporting organizations. Procedures for review and approval of supporting QMPs are defined in the organization's approved QMP.
- Non-EPA Organizations: When a QMP is required either by statute, contractual requirement, or assistance agreement, the QMP must be submitted for review and approval to the EPA official responsible for the work. The EPA official may include the contracting officer's representative (such as the project officer, work assignment manager, or delivery order project officer), the award official, or the EPA QA Manager. For example, a State QMP that has been submitted as part of a request for an assistance agreement may be reviewed and approved by the QA Manager of the Regional Office awarding the assistance agreement.
How long does approval of a QMP last?
- EPA Organizations: Approval is valid for five years unless there is a major reorganization or mission change that affects the Quality functions and structures in the organization. If an assessment of the organization's Quality Program determines that the existing QMP is not being implemented as written, then the organization must either implement the Quality Program as approved or revise the QMP to reflect its operations.
- Non-EPA Organizations: Approval is valid for no more than five years for State, local and Tribal governments or the length of the extramural agreement for all other extramural agreement holders unless there is a major reorganization or mission change that affects the Quality functions and structures in the organization. The period for which a QMP is valid is defined in the QMP of the EPA organization sponsoring the work.
If my QMP is subject to EQMD review and OMS approval, is an "informal" review possible?
Yes. EQMD will review an organization's draft, unsigned QMP. EQMD will inform the organization after they complete their review and identify if additional changes are needed or if the organization may proceed with obtaining signatures.
If my QMP is subject to EQMD review and OMS approval, what do I submit for a "formal" review?
The senior manager, in coordination with the QAM, should submit the signed QMP, a completed copy of the EPA Checklist for Reviewing Quality Management Plans, and all referenced attachments to EQMD. The QMP must be signed by the organization's senior managers and QAM.
How long does it take EQMD to review a "formal" QMP submission?
EQMD's total review time goal is 45 working days.
What criteria does EQMD use to review a QMP during informal and formal review?
A QMP review verifies the identified requirements listed in the EPA Checklist for Reviewing Quality Management Plans. If a required element is not addressed, the reviewer must verify that this element is not applicable for that specific organization. In addition, any required corrective actions from quality program assessments must also be identified and verified as resolved.
Will EQMD notify my organization prior to my QMP's sunset date?
EQMD notifies the organization's QA Manager six months prior to the sunset date.
When do I need to resubmit my QMP for EQMD review?
You should submit your QMP 60 days prior to the sunset date. Use the table below to determine when a QMP should be resubmitted.
Reason for Updating QMP | Action Needed to Maintain Agency-Approval |
---|---|
Minor updates | Report in your QAARWP. |
Reorganization | Current QMP sunset date is 6 months from effective date of reorganization. Submit revised QMP for review and approval. |
Mission Change | Current QMP sunset date is 6 months from effective date of mission change. Submit revised QMP for review and approval. |
Update due to 5-year approval sunset | Submit revised QMP for review and approval. |
EQMD assessment required revision as a corrective action | Submit revised QMP for review and approval. Current approval sunset date will be identified in final report. |
EQMD assessment recommended revision (not as a corrective action) | Report status in your QAARWP. |
Training
What training does EPA provide?
EQMD provides train-the-trainer courses based on the Quality Program Directives to EPA QAMs. This training may be tailored by an organization to meet their specific needs. Also, Agency training is available and you may contact the appropriate QAM of an EPA organization for additional QA training.
Information Quality Guidelines
- What is a Request for Correction under the Information Quality Guidelines?
- How do I submit a Request for Correction?
- How does EPA expect to respond to my request?
- What if my request concerns information on which EPA has sought public comment?
- What if I disagree with EPA's decision regarding my Request for Correction?
- How does EPA intend to process my Request for Reconsideration?
What is a Request for Correction under the Information Quality Guidelines?
EPA developed their Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by the Environmental Protection Agency to comply with the Office of Management and Budget Guidelines (67 FR 8451, February 22, 2002) (PDF). Section 515 of the "Treasury and General Government Appropriations Act for FY 2001 (Public Law 106-554)" directed OMB to issue government-wide guidelines that "provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility and integrity of information, including statistical information, disseminated by Federal Agencies."
The guidelines create a mechanism that enables the public to seek and obtain, where appropriate, correction of information disseminated by the Agency that does not comply with EPA or OMB Information Quality Guidelines (IQG). If you believe that information disseminated by EPA may not comply with the Guidelines, we encourage you to consult informally with the contact person listed in the information product before submitting a request for correction.
How do I submit a Request for Correction?
Once you have determined that filing a Request for Correction (RFC) is appropriate, you should provide a request to the EPA that includes:
- Contact Information:
- Contact name
- Organization
- Phone number
- Physical address
- E-mail address
- A description of the information you believe does not comply with the Office of Management and Budget Guidelines (PDF) or EPA Information Quality Guidelines, including specific citations to the information and to the IQG.
- A recommendation for corrective action.
- An explanation of how the alleged error affects or how a correction would benefit you.
Note: EPA policy is that RFCs and Request for Reconsideration (RFR) will generally be made available for public viewing on the Internet. Any personal information you choose to include in your request may be publicly disclosed on the Internet or otherwise as required by law.
RFCs may be submitted to EPA using any of the following methods:
- E-mail: Enterprise Quality Management Division at [email protected]
- Mail:
Enterprise Quality Management Division
USEPA Headquarters
1200 Pennsylvania Ave., NW
Mail Code 2821T
Washington, DC 20460 - Delivery:
William Jefferson Clinton West Building
Enterprise Quality Management Division
1301 Constitution Ave., NW
Room 6408A
Washington, DC 20004
View previously submitted Request for Correction and Reconsideration
How does EPA expect to respond to my request?
EPA's goal is to respond to your request within 120 days of receipt, by providing either a decision on the request or an estimate of the time for decision that is agreeable to you. If your request is approved, EPA would determine what type of corrective action is appropriate. Whether or not EPA determines that corrective action is appropriate, we will provide you with a notice of the decision.
What if my request concerns information on which EPA has sought public comment?
Where EPA has provided a structured opportunity for public comment on information in a draft or proposed document, EPA generally expects to treat RFCs procedurally like other public comments, addressing them in the response to comments rather than through a separate response mechanism. EPA believes that the thorough consideration provided by the public comment process serves the purposes of the IQG, provides an opportunity for correction of any information that does not comply with the IQG and does not duplicate or interfere with the orderly conduct of the action.
EPA generally will not consider a RFC that could have been submitted during the comment period of a rulemaking or other action. If EPA cannot respond to a RFC in the response to comments for the action (for example, because the request/comment is submitted too late to be considered and could not have been timely submitted, or because the request is not applicable to the action), EPA will consider whether a separate response is appropriate.
What if I disagree with EPA's decision regarding my Request for Correction?
If you disagree with EPA's decision on your RFC, you may submit a Request for Reconsideration (RFR). EPA recommends this request be submitted within 90 days of the date of EPA's decision on the RFC. Your request should be identified as an RFR by including "Request for Reconsideration" in the subject or title. The request should include the following information:
- RFC number provided in the EPA response
- Date of the original submission of the RFC
- Date of EPA's decision on the RFC
- Name and contact information. Organizations submitting an RFR should identify an individual as a contact
- An explanation of why the person disagrees with the EPA RFC's decision
- A specific recommendation for corrective action
You may submit an RFR via any one of the methods below:
- E-mail: Enterprise Quality Management Division at [email protected]
- Mail:
Enterprise Quality Management Division
USEPA Headquarters
1200 Pennsylvania Ave., NW
Mail Code 2821T
Washington, DC 20460 - Delivery:
William Jefferson Clinton West Building
Enterprise Quality Management Division
1301 Constitution Ave., NW
Room 6408A
Washington, DC 20004
Note: EPA policy is that RFC and RFR will generally be made available for public viewing on the Internet. Any personal information you choose to include in your request may be publicly disclosed on the Internet or otherwise as required by law.
How does EPA intend to process my Request for Reconsideration?
An Executive Panel makes EPA's final decision on the RFR. If your request is approved, EPA will determine what type of corrective action is appropriate. Whether or not EPA determines that corrective action is appropriate, you will be notified of the final decision.
Citizen Science QAPP
Where can I find out information regarding a Citizen Science QAPP?
Click here for the link to the Handbook for Citizen Science Quality Assurance and Documentation.
Other Related Topics of Interest
- How do I report a data error on the website to the Agency?
- Where can I find and review quality specifications for Non-EPA Organizations?
How do I report a data error on the website to the Agency?
Use the EPA Integrated Error Correction Process to report a data error on the EPA Website. This process enables the public to notify EPA of a data error. The Integrated Error Correction Process involves routing the error notification to the appropriate office who has the authority to make corrections. To notify EPA about a data error found on the EPA Web site, visit EPA's Integrated Error Correction Process Notification page.
Where can I find and review quality specifications for Non-EPA Organizations?
The Specifications for EPA and Non-EPA Organizations provides requirements for Non-EPA Organizations. Additional information can be found under FAQs for Examples and Templates.