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U.S. Department of Health and Human Services

About FDA

Quality Assurance Program (Phase I)

Description: Strengthen the quality assurance program for OBRR by developing a formal quality framework and developing written standard operating procedures according to a prioritized timeline.

Accomplishment: In September 2009, OBRR established a Quality Assurance Program whose purpose was to strengthen a culture of quality for the office and mirror the requirements that are levied on CBER stakeholders. The program included implementation and training of the OBRR Quality Manual and Quality Assurance Plan. OBRR continues to develop over 45 standard operating procedures as part of the Quality Assurance Program. OBRR anticipates a significant number of these standard operating procedures will be implemented in the next fiscal year, as well as the formalization of several internal metrics to monitor mission critical activities. The establishment of this program emphasizes our commitment to meeting the same quality standards to which our stakeholders are held. The establishment of the Quality Assurance Program marks the completion of Phase I for this project. Phase II of this project will build upon the foundation of Phase I and will begin in FY 2011.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Establish Quality Assurance Manual

5/1/2010

Completed 4/19/2010

B. Establish Quality Assurance Plan

5/1/2010

Completed 4/19/2010

C. Develop a list of priority OBRR office specific Standard Operating Procedures (SOPs) as part of the quality initiative

7/1/2010

Completed 6/29/2010

D. Complete Staff training on the Quality Assurance Manual

8/1/2010

Completed 7/30/2010

E. Complete Staff training on the Quality Assurance Plan

8/1/2010

Completed 7/30/2010

F. Draft first OBRR office specific SOP under the OBRR Quality Assurance Program

9/1/2010

Completed 5/17/2010

G. Finish first OBRR office specific SOP under the OBRR Quality Assurance Program

11/1/2010

Completed 10/19/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.