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U.S. Department of Health and Human Services

About FDA

Quality Assurance Program (Phase II)

Description: Continue to strengthen the Quality Assurance Program by developing standard operating procedures for critical processes and establishing a strategic plan.

Public Health Outcome: Continued improvement in the Quality Assurance Program will increase the efficiency and consistency of application reviews.

Accomplishment: The second year of a formal OBRR Quality Assurance (QA) Program has proven to be a tremendous asset to the Office. The QA Staff continued to develop standard operating procedures (SOPs) to streamline, consolidate, and standardize business processes/operations within OBRR which has culminated in the drafting and implementation of twenty-five SOPs this year. Focusing on our customers, several internal metrics were implemented this fiscal year to monitor mission critical areas which directly relate to improving customer satisfaction. An ambitious QA Program Strategic Plan for FY 2012-2016 was formulated which continues to focus on improving the efficiency of the Office’s operations and customer satisfaction.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Finalize priority OBRR Quality Assurance Program procedures

2/28/2011

Completed 1/20/2011

B. Attain senior management approval to implement the priority OBRR Quality Assurance Program procedures

4/30/2011

Completed 4/8/2011

C. Complete staff training on the OBRR On-boarding of New Employees Standard Operating Procedures (SOPs)

6/30/2011

(7/31/2011)

Completed 7/29/2011

D. Complete staff training on the OBRR Regulatory meetings with Sponsors and Applicants SOP

7/31/2011

Completed 7/29/2011

E. Complete staff training on the priority OBRR Quality Assurance Program procedures

10/31/2011

Completed 10/31/2011

F. Develop a Strategic Plan for the OBRR Quality Assurance Program

11/30/2011

Completed 11/29/2011

G. Communicate the OBRR Quality Assurance Program Strategic Plan to the Staff

12/31/2011

Completed 12/30/2011

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.