7-4 - RECALL ENTERPRISE SYSTEM

The Recall Enterprise System (RES) is to be used by district and center recall personnel to submit, update, classify, publicize, and terminate recalls. Basic recall guidance and procedures remain essentially unchanged from those used prior to the initiation of RES. RES User Guides on CD have been provided to field and center recall coordinators. The RES application currently has some help information available for each screen. Additional detailed guidance will be developed and added to the application.

The RES increases efficiency in processing recall information by:

1. allowing field coordinators to input recall information via an on-line, Intranet system;
2. combining five separate documents for a recall event into a single system, allowing users to build a record of the entire recall by entering information as it becomes available thus reducing preparation time and providing consistency throughout the agency;
3. reducing duplication of efforts between the Field Offices, OE, the centers, and Office of Public Affairs;
4. increasing communication of recall information between the field and headquarters offices;
5. providing a central, searchable database to more efficiently track information and generate and disseminate reports of recall activities;,
6. using a uniform Health Hazard Evaluation (HHE) form to promote consistency in evaluating potential health hazards and/or risks agency-wide while supporting wider use of electronic precedent health hazard assessment files to expedite recall classifications; and,
7. Providing the public with “real-time” information about the FDA recall process