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Frequent Questions - Quality Assurance Annual Report and Work Plans (QAARWPs)
General Questions
- Why should my organization prepare a QAARWP?
- Does my organization need to submit a QAARWP?
- Why must I submit a QAARWP to EPA Headquarters?
- Does the Quality Staff compare the resources for
my organization directly compared to other organizations?
- When are the QAARWPs due?
- Where do I send my QAARWP?
- Can I submit my QAARWP electronically?
Content Questions
- What information must be contained in a QAARWP?
- Can my QAARWP contain information not required
by EPA Manual CIO
2105-P-01-0 ?
- Can I submit QAARWPs from sub-organizations and not summarize them for the primary organization?
- What are the most frequent problems with QAARWPs?
- Who must sign my organization's QAARWP?
- Why does the QAARWP ask about activities instead
of processes?
- What are quality management activities as opposed to technical activities?
- What should I do if I can't determine resources
numbers?
- Should quality-related activities from non-QA Staff
be included in the QAARWP?
- What does "assessments of a Quality System"
include?
- 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?
- Where can I get more information and answers to other questions about QAARWPs?
Why should my organization prepare a QAARWP? The resources, activities, and vulnerabilities of an organization's quality system should be reviewed annually. The QAARWP documents this review and identifies the proposed resources and activities for the coming year. It provides a vehicle for the organization's management to determine the implementation status of their Quality System and whether sufficient resources are available to implement the necessary activities for the next year.
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 2105.0 (PDF 12pp, 94K About PDF) you must submit a QAARWP.
Why must I submit a QAARWP to EPA Headquarters? EPA Order CIO 2105.0 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 he/she can determine the implementation status of the Agency-wide Quality System and whether sufficient resources are available to implement the necessary activities for the next year.
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.
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.
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.
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.
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-P-01-0 (PDF 62pp, 169K About PDF). These specifications do not change. The Quality Staff has developed a Microsoft Word template (DOC 8pp, 98K) that parallels these specifications to assist in writing your QAARWP.
Can my QAARWP contain information not required by EPA Manual 5360? 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.
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 (PDF 12pp, 94K About PDF).
What are the most frequent problems with QAARWPs? Some information, like the total size of the organization (in FTE) is often omitted. Also, the compilation of resource information from many sources sometimes leads to loss of the explanation of whether the resources were adequate. This is crucial information for both the senior management of the organization and the Quality Staff in reporting on the condition of the Agency's quality system. In addition, signature pages are often missing - the signature documents the review and approval of the organization's senior manager.
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.
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.
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.
What should I do if I can't determine resources numbers? Estimating staff time spent on these duties is expected, and the algorithm used for the estimate should be provided.
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.
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.
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 Manual CIO
2105-P-01-0
(PDF 62pp, 169K About
PDF) 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 |
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 at quality@epa.gov or call 202-564-6830 if you have additional questions.