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Frequent Questions about EPA's Quality System

EPA's Quality System

  1. What are the goals of EPA's Quality System?
  2. What are the benefits of EPA's Quality System?
  3. What activities does the EPA Quality System cover?
  4. What is the relationship between the EPA Quality System and EPA's Information Quality Guidelines?
  5. Who is responsible for the EPA Quality System?
  6. What are the roles and responsibilities of the Quality Staff?
  7. What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel?
  8. What are the main components of the EPA Quality System?
  9. How is a 'graded approach' applied to EPA's Quality System?
  10. Is there a document that contains the above information?

What are the goals of EPA's Quality System?

The goals of the Agency-wide Quality System are to ensure that environmental programs and decisions are supported by data of the type and quality needed and expected for their intended use and that decisions involving environmental technology are supported by appropriate quality-assured engineering standards and practices.

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What are the benefits of EPA's Quality System?

Successful implementation of the EPA Quality System leads to:

  • Scientific Data Integrity - EPA will produce data 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 data will be collected for EPA use.
  • Proper Evaluation of Internal and External Activities - The EPA Quality System 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 data is known, it is possible to determine whether the data can be used for a specific decision. This reduces embarrassing surprises and challenges to regulations, permit appeals, etc.
  • Burden Reduction - As EPA better defines the data needed for a specific application, the burden on other organizations who are required to collect and/or report data to EPA may be reduced.

Overall, implementation of the EPA Quality System will reduce the Agency's vulnerabilities and increase EPA ability to make reliable, cost-effective, and defensible decisions.

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What activities does the EPA Quality System cover?

The EPA Quality System covers the collection, evaluation and use of environmental data by and for the Agency, and the design, construction and operation of environmental technology by the Agency. This includes environmental programs such as the:

A list of some example activities are contained in Example Activities.

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What is the relationship between the EPA Quality System and EPA's Information Quality Guidelines?

EPA's quality system 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.

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Who is responsible for the EPA Quality System?

The EPA Quality System is decentralized so each EPA organization designs, implements, and manages its own quality system. The Assistant Administrator for Environmental Information is the Senior Quality Management Official for the Agency as stated in EPA Order CIO 2105.0 (formerly 5360.1) and is responsible for the assessment and approval of each EPA organization's quality system. The Quality Staff, Office of Environmental Information, supports the Assistant Administrator and is responsible for the development of Agency-wide policy and procedures and for the oversight of implementation of the EPA Quality System. The EPA Assistant Administrators, Associate Administrators, and Regional Administrators have official quality responsibilities and are responsible for the success of their quality system. Line managers within each organization are responsible for the quality of data collected or used by their programs.

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What are the roles and responsibilities of the Quality Staff?

The Quality Staff is responsible for coordinating the implementation of the Agency Quality System, developing Agency policies and procedures on quality, and providing training on quality issues. The Quality Staff accomplishes these activities by:

  • demonstration of environmental technology
  • investigation of chemical, biological, physical or radioactive constituents
  • development, evaluation, and use of computer or mathematical models
  • use of data collected for other purposes or from other sources (also termed "secondary data")
  • the collection and use of data pertaining to the occupational health and safety of personnel in EPA facilities
    • 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 the Quality Staff, see Policies and Procedures for EPA Organizations: Agency-wide Oversight.

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    What are the roles and responsibilities of an EPA Quality Assurance Manager and quality management support personnel?

    EPA Quality Assurance Managers are tasked with reporting on quality issues to their senior management, providing independent oversight, and assuring the implementation of the organization's quality system. This individual must function independently of direct environmental data generation, model development, or technology development responsibility. The Order also defines the responsibilities of the Quality Assurance Manager 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 system

    In addition to these general responsibilities, each EPA organization's Quality Management Plan defines specific responsibilities for its Quality Assurance Manager and other quality management personnel.

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    What are the main components of the EPA Quality System?

    The main components of the EPA Quality System are described below. Each EPA organizations consider these components when developing their individual Quality System.

    Quality System Policies - Policies for EPA organizations are contained in internal policy documents. See Policies and Procedures for EPA Organizations for more information about these policy documents. Policies for non-EPA organizations are contained in the Federal Acquisition Regulations. See Quality Specifications for non-EPA Organizations for more information on these Federal Regulations.

    Quality System 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 system; 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 system to policies, compliance with regulations, and conformance to the organization's quality system documentation. EPA uses Quality Systems Assessments and Audits 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 system for management and data collection activities have the skills and knowledge to complete their tasks in accordance with their quality system'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 - Data are 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 data collection, oversight may be performed using technical audits that are conducted to assess whether or not data are 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 data meet the user's needs. The data are 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.

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    How is a 'graded approach' applied to EPA's Quality System?

    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 System is based on a graded approach. Applying a graded approach means that quality systems for different organizations and programs will vary according to the specific objectives and needs of the organization. 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 data is different. Once a graded approach has been applied to the components of a quality system, a graded approach is then applied to the documentation required by that system.

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    Is there a document that contains the above information?

    The above information is documented in the the Overview of the EPA Quality System for Environmental Data and Technology.

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General Quality System Questions

  1. What is a quality system?
  2. Does a quality system ensure that data collected are 'good' data?
  3. What is the difference between quality assurance and a quality system?
  4. What is the difference between quality assurance and quality control?
  5. What is the difference between a Quality Management Plan and a Quality Assurance Project Plan?
  6. Which EPA documents do I use to implement and manage my quality system?
  7. 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?

What is a quality system?

A quality system 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.

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Does a quality system ensure that data collected are 'good' data?

No. Data are neither 'good' or 'bad' but rather data are either useful for their intended purpose or not useful for their intended purpose. One must know in what context data are to be used to judge whether or not the data are adequate.

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What is the difference between quality assurance and a quality system?

Quality assurance is a system of management activities to ensure that a process, item, or service is of the type and quality needed by the user. Thus, quality assurance is just one part of a quality system. A quality system provides the framework for developing quality assurance policy and management controls.

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What is the difference between quality assurance and quality control?

Quality assurance is a management or oversight function; it deals with setting policy and running an administrative system of management controls that cover planning, implementation, and review of data collection activities and the use of data in decision making. Quality control is a technical function that includes all the scientific precautions, such as calibrations and duplications, that are needed to acquire data of known and adequate quality.

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What is the difference between a Quality Management Plan and a Quality Assurance Project Plan?

A Quality Management Plan is a document that describes a quality system in terms of the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. A Quality Assurance Project Plan is a document that describes the necessary quality assurance, quality control, and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria. A Quality Management Plan documents the overall organization/program whereas a Quality Assurance Project Plan documents project-specific information. Usually you document your quality system once (and update it on a regular basis) but need to document the quality assurance activities for each project.

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Which EPA documents do I use to implement and manage my quality system?

If you are not an EPA employee, use:

If you are an EPA employee, use:

Note: EPA may also use EPA Requirements for Quality Management Plans (QA/R-2) and EPA Requirements for Quality Assurance Project Plans (QA/R-5) since these documents contain the equivalent specifications as Chapters 3 and 5 of EPA Manual 2105-P-1-0, respectively.

For copies of guidance produced by the EPA Quality Staff see Agency-wide Quality System Documents.

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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?

No. As long as all the required information is provided, the title of the documentation does not matter.

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EPA Organizations and Personnel

  1. What EPA organizations are covered by the EPA Quality System?
  2. What Quality System specifications apply to my organization?
  3. What EPA Quality System specifications apply to me?
  4. Who is my Quality Assurance Manager?
  5. Where can I get a copy of my Organization's Quality Management Plan? 
  6. Where can I find more information for EPA organizations?

What EPA organizations are covered by the EPA Quality System?

All EPA organizations that collect, evaluate, or use environmental data or design, construct, or operate environmental technology are covered by the EPA Quality System. Overall, there are more than 40 EPA organizations that maintain quality systems including the EPA Regions, National Program Offices, and the Office of Research and Development's National Research Centers and Laboratories. Specialized, highly-visible programs also may have their own quality systems. Typically, such programs cut across organizational lines and have their own organizational infrastructure.

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What Quality System specifications apply to my organization?

Specific specifications for EPA organizations are defined in EPA Order CIO 2105.0 . Supplemental information is contained in CIO 2105-P-01-0.

Basically, EPA organizations must develop, implement, and maintain a quality system that demonstrates conformance to the minimum specifications of ANSI/ASQC E4-1994 and:

  1. Identify a quality assurance manager who reports on quality issues to the senior manager for the organization.
  2. Develop and implement a Quality Management Plan, which documents the organization's quality policy, describes its quality system, and identifies the environmental programs to which the quality system applies.
  3. Provide sufficient resources to implement the quality system.
  4. Assess the quality system at least annually and make improvements based on these assessments.
  5. Submit a yearly Quality Assurance Annual Report and Work Plan.
  6. Use a systematic planning approach to develop acceptance or performance criteria for all environmental data collection and use.
  7. Have EPA approved Quality Assurance Project Plans for all applicable projects and tasks involving environmental data prior to any data gathering.
  8. Assess existing data to verify that they are of sufficient quantity and adequate quality for their intended use.
  9. Implement Agency-wide Quality System specifications in all applicable EPA-funded extramural agreements.
  10. Provide appropriate training, for all levels of management and staff, on quality management responsibilities and specifications.

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What EPA Quality System 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 EPA Order CIO 2105.0. 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 EPA Order 2105-0; 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.

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Who is my Quality Assurance Manager?

A list of EPA Quality Assurance Managers is given in Quality System Contacts. If your organization does not appear, please contact the Quality Staff (quality@epa.gov) to determine your Quality Assurance Manager.

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Where can I get a copy of my Organization's Quality Management Plan?

Contact your supervisor or Quality Assurance Manager for the most recent version of your organization's Quality Management Plan.

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Where can I find more information for EPA organizations?

For more information for non-EPA organizations, see Policies and Procedures for EPA Organizations.

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Non-EPA Organizations

  1. Since I receive funding from EPA, what EPA Quality System specifications apply to me?
  2. What has EPA done to minimize the impact of its Quality System specifications on small businesses?
  3. What are R-2 and R-5 and when do I use them?
  4. Are there other documents besides R-2 and R-5 that are required?
  5. Who do I contact if I have questions?
  6. Where can I find more information for non-EPA Organizations?

Since I receive funding from EPA, what EPA Quality System specifications apply to me?

EPA specifications for non-EPA organizations are defined in the Code of Federal Regulations. The basic regulations are described in Quality Specifications for non-EPA Organizations. In general, EPA requires that compliance with the American National Standard ANSI/ASQC E4-1994, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs." To demonstrate conformance to this standard, EPA requires two forms of documentation:

  1. Documentation of the organization's quality system (usually called a Quality Management Plan)
  2. Documentation of the application of quality assurance and quality control activities to an activity-specific effort (usually called a Quality Assurance Project Plan).

EPA may also specify in a Solicitation or Request for Proposals that the use of existing quality system documentation, such as documentation that a company is ISO 9001 certified, may be an acceptable alternative.

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What has EPA done to minimize the impact of its Quality System specifications on small businesses?

EPA has tried to reduce the impact of its Quality System requirements on small entities by applying a graded approach to the implementation of these quality specifications and the documents needed. This means that managerial quality controls are applied according to the scope of the work and/or the intended use of the outputs from the work. While large projects may require an organization to develop comprehensive quality system documentation, smaller projects with relatively less significant impacts generally only require limited documentation. Thus, small entities will normally only provide limited quality-related documentation to EPA.

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What are R-2 and R-5 and when do I use them?

R-2, or EPA Requirements for Quality Management Plans is a document specifically for non-EPA organizations that defines EPA specifications for documentation of the organization's quality system. R-5, or EPA Requirements for Quality Assurance Project Plans is a document that defines EPA specifications for documenting of the application of quality assurance and quality control activities to an activity-specific effort. Usually you document the quality system once using R-2 (with scheduled updates) and you document the quality assurance activities for each project using R-5.

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Are there other documents besides R-2 and R-5 that are required?

No. Other documents, such as EPA Order CIO 2105.0, are internal EPA policy documents and do not apply to you. However, EPA has issued guidance documents (see Agency-wide Quality System Documents) to assist you in satisfying EPA specifications. The use of these documents is not mandatory.

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Who do I contact if I have questions?

If you have a Quality System related question, you should contact either the Project Officer for your agreement or the EPA Quality Assurance Manager of the organization sponsoring the work. A list of EPA Quality Assurance Managers is given in Quality System Contacts.

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Where can I find more information for non-EPA organizations?

For more information for non-EPA organizations, see <a href="/quality/quality-specifications-non-epa-organizations-do-business-epa%3EDoing%20Business%20with%20EPA%3A%20Quality%20Specifications%20for%20non-EPA%20Organizations.%3C/p%3E____%3Cp%20class%3D"pagetop">Top of Page

Resources and Help

  1. What procedures and tools are available to help me implement the EPA Quality System?
  2. What training does EPA provide?
  3. Who do I contact at EPA if I have quality system-related questions?

What procedures and tools are available to help me implement the EPA Quality System?

EPA has a comprehensive system of protocols or tools for assuring the quality of its data collection and use activities. Management tools include Quality Management Plans and Quality System Audits. Technical tools include the:

  • Data Quality Objectives Process
  • Quality Assurance Project Plans
  • Standard Operating Procedures
  • Technical Assessments
  • Data Quality Assessment

EPA has developed guidance on the majority of these tools. For more information and links to relevant guidance, see Quality Management Tools.

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What training does EPA provide?

On an Agency-wide basis, the Quality Staff provides training courses - traditional lecture instruction. The training courses can be tailored by an organization to fit its specific training requirements. For information on Agency-wide training, see the Quality Staff Training Program. In addition, many EPA organizations offer program-specific training. Contact the Quality Assurance Manager for your organization for information on these resources.

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Who do I contact at EPA if I have quality system-related questions?

If you have questions about an individual program, contact the Quality Assurance Manager for that program. A current list of these individuals are listed at Quality System Contacts. If you have questions that concern Agency-wide Quality System specifications, contact the Quality Staff (quality@epa.gov).

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Systematic Planning

  1. What is systematic planning?
  2. Why systematically plan projects?
  3. What are the elements of systematic planning?
  4. Do I need to systematically plan my projects?
  5. How do I systematically plan my projects?
  6. What are some examples of systematic planning processes?
  7. How do I document my systematic planning?

What is systematic planning?

Systematic planning is simply using 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.

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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

Of course, planning a project before resources are expended reduces waste and rework.

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What are the elements of systematic planning?

EPA's elements of systematic planning are stated in Chapter 3 of the EPA Quality Manual for Environmental Programs and include:

  • Identification and involvement of the:
    • project manager
    • sponsoring organization and responsible official
    • project personnel
    • stakeholders
    • scientific experts
    • others (e.g., all customers and suppliers)
  • Description of the project goal, objectives and questions and issues to be addressed
  • Identification of project schedule, resources (including budget), milestones and any applicable requirements (e.g., regulatory requirements, contractual requirements)
  • Identification of the type of data needed and how the data will be used to support the project's objectives
  • Determination of the quantity of data needed and specification of performance criteria for measuring quality
  • Description of how, when and where the data will be obtained (including existing data) and identification of any constraints on data collection
  • Specification of needed QA and QC activities to assess the quality performance criteria, for example:
    • QC samples for both the field and laboratory
    • audits
    • technical assessments
    • performance evaluations
  • Description of how the acquired data will be analyzed (either in the field or the laboratory), evaluated (i.e., QA review, validation, verification) and assessed against its intended use and the quality performance criteria.

See Elements of Systematic Planning for more information.

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Do I need to systematically plan my projects?

It is EPA policy, per CIO 2105.0, that all EPA organizations use a systematic planning process to develop acceptance or performance criteria for the collection, evaluation, or use of environmental data or information.

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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.) Also, some regulations specify many of the elements that would need to be planned, so review applicable regulations carefully. Finally, if no resource exists, use the elements defined in Elements of Systematic Planning.

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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 Systematic Planning - Examples.
     
  • The Triad Approach (www.triadcentral.org/) - EPA's planning process for the Agency's hazardous waste remediation programs.

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How do I document my systematic planning?

The results of systematic planning are documented in a QA Project Plan or an equivalent document. All elements should be documented, but the extent of documentation should be based on the project needs and objectives. Consult your organization's Quality Management Plan for documentation specifics.

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Quality Assurance Project Plans

  1. Why do I have to write a QA Project Plan?
  2. How do I develop a QA Project Plan?
  3. Where are content specifications for QA Project Plans defined?
  4. I have a Quality Management Plan, do I still need a QA Project Plan?
  5. Who is responsible for implementing the QA Project Plan?
  6. Whom do I contact if I have questions?
  7. Where can I find more information on QA Project Plans?

What is a QA Project Plan?

A QA Project Plan is a written document that describes the quality assurance procedures, quality control specifications and other technical activities that must be implemented to ensure that the results of the project or task to be performed will meet project specifications. Primary data collection, secondary data usage and data processing (such as modeling) project activities funded by EPA are described and documented in QA Project Plans.

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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 data 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 CIO 2105.0 when EPA conducts a project directly, or in the applicable Federal Regulations (see Quality Specifications for Non-EPA Organizations) when EPA is funding the project under a grant, contract, or other agreement.

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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:

  1. Assemble a project team and "systematically plan" what needs to be done.
  2. Write the QA Project Plan using the results of that planning process.
  3. Submit the QA Project Plan for review and approval.
  4. Once approved, distribute the QA Project Plan to all pertinent individuals involved with the project or program.
  5. 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.

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Where are content specifications for QA Project Plans defined?

Specifications for those receiving EPA funds for environmental activities are defined in EPA Requirements for QA Project Plans. For EPA personnel, content specifications are defined in Chapter 5 of the CIO 2105.0. 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.

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I have a Quality Management Plan, do I still need a QA Project Plan?

Yes. A Quality Management Plan describes the organization's quality system, 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 system and the application of this system to the work to be performed.

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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 data generation activities and ensure that the plan is implemented as written and that all changes are documented and approved prior to their being made.

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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 System Contacts.

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Where can I find more information on QA Project Plans?

For more information on QA Project Plans, see Quality Management

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Standard Operating Procedures

  1. What is a SOP?
  2. How should a SOP be organized?
  3. How much detail needs to be included in a SOP?
  4. Who should write a SOP?
  5. What is the benefit of having a SOP?
  6. I am following a published method. Do I have to have a SOP?
  7. Where can I find more information on SOPs?

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 of an organization that would be managed under a Quality Assurance Project Plan and under an organization's Quality Management Plan.

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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; and internal formatting will vary with each organization and with the type of SOP being written. See Guidance for Preparing Standard Operating Procedures for format suggestions and examples of both technical and administrative SOPs.

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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 field, can successfully reproduce the activity or procedure when unsupervised.

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Who should write a SOP?

SOPs should be written by individuals knowledgeable with the activity and the organization's internal structure. 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.

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What is the benefit of having a SOP?

The development and use of SOPs is an integral part of a successful quality system. It provides individuals with the information to perform a job properly and facilitates consistency in the quality and integrity of a product or end-result through consistent implementation of a process or procedure within the organization. SOPs can also be used as a part of a personnel training program, since they should provide detailed work instructions. When historical data are 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 valid SOP are reduced work effort, along with improved data comparability, credibility and legal defensibility.

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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.

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Where can I find more information on SOPs?

For more information on SOPs, see Quality Management Tools - Standard Operating Procedures.

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Quality Assurance Annual Report and Work Plans

General Questions

  1. Why should my organization prepare a QAARWP?
  2. Does my organization need to submit a QAARWP?
  3. Why must I submit a QAARWP to EPA Headquarters?
  4. Does the Quality Staff compare the resources for my organization directly compared to other organizations?
  5. When are the QAARWPs due?
  6. Where do I send my QAARWP?
  7. Can I submit my QAARWP electronically?

Content Questions

  1. What information must be contained in a QAARWP?
  2. Can my QAARWP contain information not required by EPA Manual CIO 2105.0
  3. Can I submit QAARWPs from sub-organizations and not summarize them for the primary organization?
  4. What are the most frequent problems with QAARWPs?
  5. Who must sign my organization's QAARWP?
  6. Why does the QAARWP ask about activities instead of processes?
  7. What are quality management activities as opposed to technical activities?
  8. Should quality-related activities from non-QA Staff be included in the QAARWP?
  9. What does "assessments of a Quality System" include?
  10. If I report changes to my organization's Quality Management Plan in the QAARWP, do I need to resubmit my Quality Management Plan for Agency approval?
  11. Where can I get more information and answers to other questions about QAARWPs?

General Questions

Why should my organization prepare a QAARWP?

The activities and vulnerabilities of an organization's quality system should be reviewed annually. The QAARWP documents this review and identifies the proposed activities for the coming year. It provides a vehicle for the organization's management to determine the implementation status of their Quality System.

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Does my organization need to submit a QAARWP?

If you have a Quality Management Plan (QMP) subject to approval by the Office of Environmental Information under the EPA policy CIO 2106.0 you must submit a QAARWP.

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Why must I submit a QAARWP to EPA Headquarters?

EPA Order CIO 2106.0 requires that organizations covered by the EPA Quality System submit a QAARWP to the Quality Staff, Office of Environmental Information. The QAARWPs are required so that the Quality Staff can assess the status of the implementation of the Agency-wide Quality System for the EPA Administrator. QAARWPs from approximately 45 organizations are summarized across EPA. This summary, along with other information collected during the year, is then used to identify trends and gaps in the Agency-wide Quality System and plan Agency-level activities. This information is then reported to the EPA Administrator so that she can determine the implementation status of the Agency-wide Quality System.

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Does the Quality Staff compare the resources for my organization to other organizations?

No, EPA organizations all make different environmental decisions based on different sources of environmental information with different resources. The graded approach is used by management to determine the appropriate level of quality assurance within budget constraints. However, where types of environmental decisions are similar within EPA, large differences in resources and/or activities reported can signal the need for more information about how a program is operating its quality system.

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When are the QAARWPs due?

QAARWP submissions are timed to coincide with the Federal Managers' Financial Integrity Act reporting, usually in December. The Assistant Administrator for the Office of Environmental Information will issue a "Call Memo" to each Assistant Administrator and Regional Administrator with the exact due date, at least one month before it is due. Everyone in EPA's QA community receives a copy of the memorandum.

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Where do I send my QAARWP?

The QAARWPs should be submitted directly to the Office of Environmental Information's Quality Staff, as directed in the call memo.

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Can I submit my QAARWP electronically?

The Quality Staff prefers to receive QAARWPs electronically, either in MS Word (with signature page faxed to 202/565-2441) or in Adobe Acrobat (signature page scanned) to quality@epa.gov.

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Content Questions

 

What information must be contained in a QAARWP?

The content specifications for a QAARWP are defined in Chapter 4 of EPA CIO 2105.0. These specifications do not change. The Quality Staff has developed a QARRWP Microsoft Word template (DOC) (8 pp, 98 K) that parallels these specifications to assist in writing your QAARWP.

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Can my QAARWP contain information not required by EPA CIO 2105-P-01-0?

Yes. The QAARWPs are used to examine Agency-wide trends but can also be used to brief an organization's management on their quality system. Any information that is useful to an organization's management or quality personnel can (and should) be included. For example, some EPA organizations may include a status table of State QMPs in their QAARWP; others may wish to including a summary of data assessments by number of samples instead of events, etc.

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Can I submit QAARWPs from sub-organizations and not summarize them for the primary organization?

No. The purpose of the QAARWP is to review the status of implementation of the organization's quality system. This means that information for supporting QAARWPs needs to be integrated and analyzed so that an assessment can be performed for the entire organization (not for each sub-organization) where trends and issues organization-wide are identified. Attaching individual QAARWPs without developing a QAARWP for the overall organization does not meet the requirement for an annual assessment required in Section 6.a.4 of CIO 2105.0.

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What are the most frequent problems with QAARWPs?

Information is sometimes omitted and reported in inconsistent ways. Also, the compilation of information from many sources sometimes leads to loss of explanation. In addition, signature pages are often missing - the signature documents the review and approval of the organization's senior manager.

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Who must sign my organization's QAARWP?

The senior manager responsible for your organization's quality system must sign the QAARWP. This means that the Assistant Administrator or Regional Administrator must sign a National Program Office or Regional QAARWP. If an individual office submits a QAARWP, that organization's senior manager must sign it.

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Why does the QAARWP ask about activities instead of processes?

Processes and policies are defined in an organization's Quality Management Plan. The QAARWP is used to assess implementation of these processes and what activities are being performed within an organization and then across the Agency. Each individual organization should use their QAARWP to ensure that the number and type of activities being performed are appropriate for an organization and to identify any gaps in implementation.

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What are quality management activities as opposed to technical activities?

Management activities are system-wide activities needed to implement an organization's quality system, i.e., the activities that relate to the system as a whole. Examples include developing a Quality Management Plan, providing training about the quality system and its activities and performing assessments on a quality system. Technical activities are project-specific activities needed to successfully implement an individual project. Examples include reviewing Quality Assurance Project Plans and Quality Management Plans for delegated programs. So, developing a process to review and approve QA Project Plans is a management activity; implementing this process for an individual project is a technical activity. Developing a training program and providing this training are management activities; project planning and oversight are technical activities. An organization's quality personnel usually perform both management and technical activities, depending on the program.

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Should quality-related activities from non-QA Staff be included in the QAARWP?

The QAARWP discusses application of a Quality System for an entire organization not the performance of the QA Staff. Therefore, all quality activities and resources should be reported, regardless of whether they are performed by the QA staff or by other personnel within an organization.

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What does "assessments of a Quality System" include?

The phrase "assessments of a Quality System" refers to any type of assessment performed on the overall Quality System, not an individual project(s). The 'name' of the assessment (such as management systems review, quality system audit, etc.) does not matter.

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If I report changes to my organization's Quality Management Plan in the QAARWP, do I need to resubmit my Quality Management Plan for Agency approval?

In general, minor updates to your Quality Management Plan do not need to be submitted for Agency approval. However, there are special cases where Agency-approval is required. Use the table below to determine where to report changes to your organization's Quality Management Plan in the QAARWP and whether the QMP needs to be submitted for Agency approval or consult Section 3.2.4 of EPA CIO 2105-P-01-0 for more information.

Reason for Updating QMP QAARWP Reporting
Minor updates Report in Section 1.3.2
Organization-wide Reorganization Report in Section 1.3.2. Current QMP expires 6 months from effective date of reorganization and must be submitted for Agency-approval.
Reorganization of the quality management function Report in Section 1.3.2. Current QMP valid expires 6 months from effective date of reorganization and must be submitted for Agency-approval.
Update due to 5-year approval expiring Report in Section 1.3.2 and submit revised QMP for Agency-approval.
Quality Staff management assessment required revision as a corrective action Report in Sections 1.3.2 and 1.3.4 and submit revised QMP for Agency-approval by expire on date identified in final report.
Quality Staff management assessment recommended revision (not as a corrective action) Report in Sections 1.3.2 and 1.3.4

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Where can I get more information and answers to other questions about QAARWPs?

Examples and other resources are available at Quality Management Tools - QA Annual Reports and Work Plans. You can also e-mail the Quality Staff (quality@epa.gov) or call 202-564-6830 if you have additional questions.

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Quality Management Plans

  1. What is a Quality Management Plan?
  2. How do I develop a Quality Management Plan if my organization doesn't have a quality system?
  3. What organizations are required to have a QMP?
  4. Where are the specifications for QMPs established?
  5. What documents will help me prepare my QMP?
  6. Who reviews and approves QMPs?
  7. How long does approval of a QMP last?
  8. If my QMP is subject to Quality Staff review and approval, what do I submit?
  9. If my QMP is subject to Quality Staff review and approval, is an "informal" review possible?
  10. How long does it take for a QMP to be reviewed and approved by the Quality Staff?
  11. What criteria does the Quality Staff use to review a QMP?
  12. My EPA organization is developing a QMP for Quality Staff review and approval - what assistance is available?
  13. Will the Quality Staff notify me when my organization's QMP is going to expire?
  14. When do I need to resubmit my QMP for Quality Staff approval?
  15. Where can I find more information on QMPs?

What is a Quality Management Plan?

A Quality Management Plan (QMP) is a document that describes an organization's quality system. It identifies the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority and its processes for planning, implementing, documenting and assessing all activities conducted under the organization's quality system.

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How do I develop a Quality Management Plan if my organization doesn't have a quality system?

EPA has developed guidance to help you in developing a quality system: Guidance for Developing Quality Systems for Environmental Programs (QA/G-1). The system developed using this guidance can then be documented in a Quality Management Plan.

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What organizations are required to have a QMP?

All EPA and non-EPA organizations conducting environmental programs on behalf of EPA which acquire, generate, compile or use environmental data and technology are required to establish and implement a quality system. This includes work performed:

  • internally
  • under contracts
  • cooperative agreements
  • interagency agreements
  • State-EPA agreements
  • State, local and Tribal financial assistants/grants (including Performance Partnership Grants and Agreements)
  • research grants
  • in response to statutory or regulatory requirements
  • consent agreements

The specification for a QMP is also negotiated into interagency agreements, including sub-agreements and may be included in enforcement consent agreements and orders.

Specifically, organizations that perform any of the following activities on behalf of EPA must have an EPA-approved QMP:

  • characterization of environmental or ecological systems and/or the health of human populations
  • direct measurements of environmental conditions or releases, including sample collection, analysis, evaluation and reporting of environmental data
  • use of environmental data collected for other purposes or from other sources (also termed "secondary data"), such as published literature, industry surveys, compilations from computerized data bases and information systems or results from computerized or mathematical models of environmental processes and conditions
  • collection and use of environmental data pertaining to the occupational health and safety of personnel in EPA facilities (e.g., indoor air quality measurements) and in the field (e.g., chemical dosimetry, radiation dosimetry)

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Where are the specifications for QMPs established?

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What documents will help me prepare my QMP?

When preparing a QMP, you should follow the specifications defined in EPA Requirements for Quality Management Plans (R-2) and use the EPA Checklist for Reviewing Quality Management Plans (DOCX)(13 pp, 46 K) to verify that all applicable specifications are satisfied. EPA organizations should also consult Chapter 3 of EPA Manual CIO 2105-P-01-0 which contains equivalent specifications to this 'Requirements' document. Since the 'requirements' document noted above is clearer, more user-friendly, and less repetitive, it is recommended that EPA organizations use this document instead of EPA Manual CIO 2105-P-01-0 for the contents of the QMP. (However, the preparation, submission, review and approval procedures for EPA organizations defined in Section 3.2 of EPA Manual 2105-P-01-0 are not replaced by this 'requirements' document.)

If your organization needs to develop a quality system (before documenting the system in a Quality Management Plan), use the Guidance for Developing Quality Systems for Environmental Programs (QA/G-1).

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Who reviews and approves QMPs?

  • Non-EPA Organizations: When a QMP is required either by statute, contractual requirement, or assistance agreement condition, 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.
     
  • EPA Organizations: The Office of Environmental Information's Quality Staff is responsible for reviewing and approving Agency QMPs required by EPA policy 2105.0. EPA Organizations with approved QMPs under EPA policy 2105.0 that require QMPs from their supporting organizations are responsible for reviewing and approving those supporting QMPs. Procedures for review and approval of supporting QMPs are defined in the organization's QMP approved under EPA Order CIO 2105.0.

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How long does approval of a QMP last?

  • 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 program reorganization 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.
     
  • EPA Organizations: Approval is valid for five years unless there is a major program reorganization that affects the Quality functions and structures in the organization. In that case, the QMP is invalidated and must be revised within six months of the reorganization. In addition, if an assessment of the organization's Quality System determines that the existing QMP is not being implemented as written, then the organization must either implement the Quality System as approved or revise the QMP to reflect its operations (and still comply with Agency policy).

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If my QMP is subject to Quality Staff review and approval, what do I submit?

The senior manager (e.g., Office Director, ORD Laboratory or Center Director, Regional Administrator) should submit the signed QMP and all referenced attachments to the OEI Quality Staff. The QMP must be signed by the organization's senior managers and QA Manager. The review process would be greatly expedited if a completed copy of the EPA Checklist for Reviewing Quality Management Plans was submitted. Submitting an electronic copy of the QMP would also facilitate the review.

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If my QMP is subject to Quality Staff review and approval, is an "informal" review possible?

A draft QMP may be submitted to the OEI Quality Staff for informal comment prior to the formal review and approval process. Every effort will be made to review these submissions in a timely manner.

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How long does it take for a QMP to be reviewed and approved by the Quality Staff?

The Quality Staff's goal is to complete the review in less than 60 days, but workload has a significant impact on the turnaround time. If the Plan has been reviewed before and minor changes were made, an electronic comparison of the documents to determine the changes may be done to simplify the review process.

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What criteria does the Quality Staff use to review a QMP?

A QMP review verifies 73 items before approval; these are identified 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 systems assessments must also be identified and verified as having been resolved.

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My EPA organization is developing a QMP for Quality Staff review and approval - what assistance is available?

Upon request, the Quality Staff will help facilitate the development process by consulting on questions and issues that may arise.

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Will the Quality Staff notify me when my organization's QMP is going to expire?

The Quality Staff will notify an organization QA Manager six months prior to the expiration date. However, it is the responsibility of an organization to determine the status of their Quality System and documentation.

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When do I need to resubmit my QMP for Quality Staff approval?

To ensure that your approval status does not expire, you should submit your QMP 60 days prior to expiration. In general, minor updates to a QMP do not need to be submitted for Quality Staff approval; these can be reported in your QA Annual Report and Work Plan (QAARWP). However, there are special cases where approval is required. Use the table below to determine when a QMP should be submitted for approval or consult Section 3.2.4 of EPA Manual CIO 2105-P-01-0 for more information.

Reason for Updating QMP Action Needed to Maintain Agency-Approval
Minor updates Report them in Section 1.3.2 of your QAARWP.
Organization-wide Reorganization Current QMP expires 6 months from effective date of reorganization. Submit revised QMP for approval.
Reorganization of the quality management function Current QMP expires 6 months from effective date of reorganization. Submit revised QMP for approval.
Update due to 5-year approval expiration Submit revised QMP for approval.
Quality Staff management assessment required revision as a corrective action Submit revised QMP for approval. Current approval will expire on date identified in final report.
Quality Staff management assessment recommended revision (not as a corrective action) Report status in Section 1.3.2 of your QAARWP.

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Where can I find more information on QMPs?

For more information on QMPs, see Quality Management Tools - Quality Management Plans.

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Information Quality Guidelines

  1. What is a Request for Correction under the Information Quality Guidelines?
  2. What if I just want to notify the Agency regarding a data error?
  3. How do I submit a Request for Correction?
  4. How does EPA expect to respond to my request?
  5. What if my request concerns information on which EPA has sought public comment?
  6. What if I disagree with EPA's decision regarding my Request for Correction?
  7. How does EPA intend to process my Request for Reconsideration?
  8. What happened to the e-mail address quality.guidelines@epa.gov and can I still use it?

What is a Request for Correction under the Information Quality Guidelines?

EPA's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by the Environmental Protection Agency were developed by EPA 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. 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.

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What if I just want to notify the Agency regarding a data error?

If you simply want to report a data error on the EPA Web site, you are encouraged to use the EPA Integrated Error Correction Process. As part of EPA's ongoing efforts to improve the quality of the data it provides to the public, this process enables those outside of the Agency to directly notify EPA of a data error. The Integrated Error Correction Process involves routing the error notification to the appropriate person who has the authority to make corrections. To notify us about a data error found on the EPA Web site, visit EPA's "Contact Us" page.

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How do I submit a Request for Correction?

Once you have determined that filing a request for correction is appropriate, you should provide a request to the EPA that includes:

  • Contact Information:
    • Contact name
    • Organization
    • Phone number
    • Physical address
    • Any other contact information (e.g., fax number or e-mail address if available)
       
  • 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 guidelines, if applicable.
  • An explanation of how the information does not comply with the Information Quality Guidelines.
  • 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 Requests for Correction and Requests for Reconsideration 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.

Requests for correction may be submitted to EPA using any of the following methods:

  • E-mail: Quality Staff (quality@epa.gov)
  • Mail:

    Information Quality Guidelines Staff
    USEPA Headquarters
    1200 Pennsylvania Ave., NW
    Mail Code 2811A
    Washington, DC 20460

  • Delivery:

    William Jefferson Clinton North
    Information Quality Guidelines Staff
    1200 Pennsylvania Ave., NW
    OEI Quality Staff, Suite 5315
    Washington, DC 20004

View previously submitted Requests for Correction (RFC) or Requests for Reconsideration (RFR)

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How does EPA expect to respond to my request?

EPA's goal is to respond to your request within 90 days of receipt, by providing either a decision on the request or an estimate of the time for decision. 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 intend to provide you with a notice of the decision.

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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 requests for correction 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 Information Quality Guidelines, provides an opportunity for correction of any information that does not comply with the Guidelines and does not duplicate or interfere with the orderly conduct of the action.

EPA generally will not consider a request for correction that could have been submitted during the comment period of a rulemaking or other action. If EPA cannot respond to a request for correction 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 germane to the action), EPA will consider whether a separate response is appropriate.

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What if I disagree with EPA's decision regarding my Request for Correction?

If you are dissatisfied with EPA's decision on your request for correction, you may submit a request for reconsideration. EPA recommends this request be submitted within 90 days of the date of EPA's decision. To submit a Request for Reconsideration (RFR) you should have already submitted a Request for Correction (RFC) to EPA and received a response to that request. 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 decision
  • A specific recommendation for corrective action.
You may submit an RFR via any one of the methods listed here:
  • Mail:

    Information Quality Guidelines Staff
    USEPA Headquarters
    1200 Pennsylvania Ave., NW
    Mail Code 2811A
    Washington, DC 20460

  • Delivery:

    William Jefferson Clinton North
    Information Quality Guidelines Staff
    1200 Pennsylvania Ave., NW
    OEI Quality Staff, Suite 5315
    Washington, DC 20004

Note: EPA policy is that Requests for Correction and Requests for Reconsideration 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.

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How does EPA intend to process my Request for Reconsideration?

An executive panel would make EPA's final decision on the request for reconsideration. 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, you will be notified of the final decision.

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What happened to the e-mail address quality.guidelines@epa.gov and can I still use it?

As of October 18, 2004, the quality.guidelines@epa.gov is no longer a working e-mail box. All e-mail correspondence should be sent to the Quality Staff (quality@epa.gov).

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