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Frequent Questions - Quality Management Plans (QMPs)
- What is a Quality Management Plan?
- How do I develop a Quality Management Plan if
my organization doesn't have a quality system?
- What organizations are required to have a QMP?
- Where are the specifications for QMPs established?
- 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 Quality Staff review and
approval, what do I submit?
- If my QMP is subject to Quality Staff review and
approval, is an "informal" review possible?
- How long does it take for a QMP to be reviewed
and approved by the Quality Staff?
- What criteria does the Quality Staff use to review
a QMP?
- My EPA organization is developing a QMP for Quality
Staff review and approval - what assistance is available?
- Will the Quality Staff notify me when my organization's
QMP is going to expire?
- When do I need to resubmit my QMP for Quality
Staff approval?
- 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.
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) (PDF 114pp, 569K About PDF). The system developed using this guidance can then be documented in a Quality Management Plan.
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, and in response to statutory or regulatory requirements and 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; and
- 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).
Where are the specifications for QMPs established?
- Non-EPA organizations: The need to have a Quality System,
and to document this system in a QMP, is established through Federal
Regulations. See Doing Business with EPA: Quality
Requirements for non-EPA Organizations for more information.
- EPA organizations: The need to have a Quality System,
and to document this system in a QMP, is established in EPA
Order
CIO 2105.0 (PDF
12pp, 94K About
PDF), Policy and Program
Requirements for the Mandatory Agency-wide Quality System. The
required contents of the QMP are specified in EPA
CIO
2105-P-01-0 (PDF
62pp, 169K About
PDF).
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 (PDF 14pp, 37K About PDF) to verify that all applicable specifications are satisfied. EPA organizations should also consult Chapter 3 of EPA Manual CIO 2105-P-01-0 (PDF 62pp, 169K About PDF) 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) (PDF 114pp, 569K About PDF).
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.
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).
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 (PDF 14pp, 37K About PDF) was submitted. Submitting an electronic copy of the QMP would also facilitate the review.
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.
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.
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 (PDF 14pp, 37K About PDF). 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.
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.
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.
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 (PDF 62pp, 169K About PDF) 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. |
Where can I find more information on QMPs? For more information on QMPs, see Quality Management Tools - Quality Management Plans.