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 check list 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. A. Initiate ORA Quality Audit Program On Hold On Hold 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. Complete Scheduled ORA Quality Audits for FY 2012 9/31/2012 On Hold word text word definition http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm FDA-TRACK ORA Dashboard