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U.S. Department of Health and Human Services

About FDA

ORA Quality Audit Program

Description: As ORA continues to meet the demand for an increased number of inspections, its adherence to quality will be paramount in ensuring that work is done in a consistent and cost effective manner. The objective for this project is to implement an audit program, and begin internal audits using an audit checklist that will provide ORA with information as to functionalities and uniformity of its Quality Management System (QMS). This audit cycle will cover all ORA units that are not already audited by 3rd party accreditation services. The audit cycle is three years long, and will cover all of ORA.

Information is current as of February 18, 2015.

Accomplishment: The Office of Regulatory Affairs' (ORA) Office of Communications and Quality Program Management's (OCQPM) Quality Management System (QSM) introduced the Standard Audit Program (SAP) in Fiscal Year 2014 (FY2014).The goals of the SAP for FY2014 were to (1) standardize ORA's programmatic approach to internal and external quality system audits (per standard operating procedure ORA QMS.004, Audits) and (2) to provide critical continual improvement data for the overall management review and the planning process conducted as part of the Core Process Project and QMS in general. The audits were performed by qualified internal auditors. Information from the SAP contributed to management awareness of the overall health and needs of the ORA QMS. The first year of the SAP Program was launched in March 2014 and concluded on 9/30/2014. There are two more additional years in the program plan, with the intent to objectively audit all ORA QMS Quality Units by end of FY2016.

The FY2014 SAP audits were conducted in geographic and organizational units across ORA. The QMS consists of 51 Quality Units represented in the SAP FY2014. There are 25 field District and Regional Offices and 13 Headquarters Quality Units (or Offices). Thirteen of the Quality Units in ORA QMS are part of Laboratory Operations (Lab Quality Units). Five (5) International Mail Facilities participated in the SAP for FY2014. For the SAP audit scope in FY2014, all Quality Units (except Laboratories due to their accreditation cycle) were required to perform standard quality system audits, using related process specific checklists, to include but not limited to, the Core Processes of OEI Management, Partnership Management, Monitoring Import Operations, and Facilitation and Training of staff by reviewing the Regional Training Officer Approval Process. A final, annual interim audit program report was produced.

Briefing Status: Completed

Prior Briefing Status: On Track

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Complete Audit Program Training with ORA QSMs

11/15/2011

Completed 11/15/2011

2. Complete Gap Analysis of Quality Management System in every ORA Quality Unit

12/1/2011

Completed 12/1/2011

3. Have 10 ORA QSMs Certified by American Society for Quality (ASQ) as Auditors

12/15/2011

Completed 12/15/2011

4. Complete Evaluation of Gap Analysis

12/31/2011

Completed 2/7/2012

5. Complete Schedule of ORA Quality Audits

3/31/2012

Completed 5/1/2012

6. Update Audit Program Training with ORA QSMs

12/31/2013

Completed 12/31/2013

7. Update Schedule of ORA Quality Audits

12/31/2014

Completed 3/1/2014

8. Initiate Scheduled ORA Quality Audits

3/25/2014

Completed 3/31/2014

9. Complete Scheduled ORA Quality Audits, External HQ Team and Unit led Audit Types reviewing the QMS and Core Processes

8/1/2014

Completed 8/1/2014

10. Complete HQ Unit led Audits for QMS and Core Processes

9/30/2014

Completed 9/30/2014

11. Account for all FY2014 SAP audits, Internal and External

9/30/2014

Completed 9/30/2014

Footnotes

  • The dates in italics under the milestone due dates are modified milestone due dates which had to be updated due to real-time delays. The milestone status reflects the current reporting quarter's status. If a milestone is missed, the milestone will remain delayed until the milestone is complete.

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.