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SMG 1121.50
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF COMMUNICATIONS AND QUALITY PROGRAM MANAGEMENT
Effective Date: 08/07/2012
1. OFFICE OF COMMUNICATIONS AND QUALITY PROGRAM MANAGEMENT (DLLRF)
A. Provides leadership, coordination and management of the Associate Commissioner for Regulatory Affairs (ACRA) priority policies and issues impacting ORA and Agency operations. Identifies, triages, supervises, and tracks related actions from start to finish in conjunction with senior leadership across ORA.
B. Provides leadership and direction for all ORA internal communications. Prepares, coordinates, and develops relevant material in collaboration with other FDA technical, regulatory, and policy units as necessary.
C. Oversees project management activities of major ORA-wide or other ACRA-level initiatives following project management best practices. Develops policies and procedures on all aspects of project planning.
D. Manages and maintains the Office of Regulatory Affairs' Quality Management System (QMS).
2. INTERNAL COMMUNICATIONS STAFF (DLLRF1)
A. Creates and coordinates an internal communications program that effectively keeps all constituencies informed and builds support for ORA's mission.
B. Develops and implements internal communications strategies for key ORA initiatives to ensure employees are educated and engaged.
C. Evaluates effectiveness of internal communications and adjusts future efforts accordingly.
D. Manages ORA’s Intranet site.
3. QUALITY MANAGEMENT SYSTEMS STAFF (DLLRF2)
A. Develops programs to ensure that quality provisions are planned, developed and implemented to identify, prevent and correct unsatisfactory conditions and elements which influence the regulatory correctness and responsiveness of transactions and services.
B. Provides policy guidance and advisory assistance to ORA managers in the development of strategies for applying quality management to core program areas.
C. Communicates and trains managers and staff on QMS principles, requirements, and status of implementation within the applicable organization.
D. Conducts a Quality Management System Assessment (QMSA) which is a comprehensive review and evaluation of materials, tools, processes, and strategy of ORA’s quality system to determine adequacy and compliance with established Quality Management System guidelines.
E. Conducts Reviews ORA QMS programs according to documented procedures to ensure continuing suitability, adequacy and effectiveness of the QMS.
4. PROJECT COORDINATION STAFF (DLLRF2)
A. Provides for ORA's project management support on ORA-wide assignments involving complex problems and issues related to Agency programs, strategies, and implementation of new legislation.
B. Manages, conducts, and analyzes studies designed to improve ORA’s business processes and procedures. Coordinates with leadership and staff throughout ORA to gather input, develop recommendations for efficiencies in current work processes, and implement changes..
5. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Office were approved by the Commissioner of Foods and Drugs on August 7, 2012.
