Frequent Questions - Non-EPA Organizations
- Since I receive funding from EPA, what EPA
Quality System specifications apply to me?
- What has EPA done to minimize the impact
of its Quality System specifications on small businesses?
- What are R-2 and R-5 and when do I use them?
- Are there other documents besides R-2 and
R-5 that are required?
- Who do I contact if I have questions?
- 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:
- Documentation of the organization's quality system (usually called a Quality Management Plan), and
- 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.
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.
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.
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.
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.
Where can I find more information for non-EPA organizations? For more information for non-EPA organizations, see Doing Business with EPA: Quality Specifications for non-EPA Organizations.