ORA Workplanning, Inspection, and Tracking System

FDA has notified NTEU that it plans to implement a Workplanning, Inspection, and Tracking System (WITS).

Change brings opportunityPursuant to Article 3 of the CBA, the FDA has notified NTEU that the Office of Regulatory Affairs (ORA) plans to implement a SharePoint site branded as the “Workplanning, Inspection, and Tracking System” (WITS) to identify and improve FDA Foreign Inspection inefficiencies. Per the notice, ‎WITS will replace the use of numerous, uncontrolled Excel spreadsheets to manage the planning and scheduling required for foreign inspections. The agency contends that WITS will allow for full transparency of the foreign inspection scheduling and planning process by incorporating all the separate Excel spreadsheets into a single list that can be accessed by multiple users simultaneously. Per the notice, the WITS SharePoint site includes the following improvements:

  • Provide for multiple staff to be able to schedule and plan foreign food inspection trips using the same establishment list simultaneously. This would allegedly allow for minimizing duplicate efforts, improved documentation and evaluation of communication with foreign establishments, verifying which facilities are viable for inspection, scheduling and planning foreign food inspection trips, compiling the logistics related to the foreign food trips, and the ability to quickly identifying staff during emergencies.
  • Provide a list of available foreign food trips that are announced through the ORA News for which investigators may volunteer.
  • Provide seamless transition of firms and the sharing of information between the Center for Food Safety and Applied Nutrition (CFSAN), Office of International Programs (OIP), and ORA.
  • Improve the efficiency of the foreign food trip planning and scheduling by automatically populating template documents.
  • Display foreign facilities on a map for ease of selection into a trip during work-planning which would allegedly reduce the travel distance between firms.

The agency has confirmed that WITS will not replace eNSpect or the Field Accomplishment and Compliance Tracking System. The agency also shared with NTEU a presentation (available upon request) of the results of an analysis of the foreign food traveler feedback forms in QMiS.

NTEU has requested a briefing to learn more about WITS.  If you have any comments or questions, please contact your chapter president.