FDA Digital Recalls Pilot Program

RESEARCH, EXPERIENCE DESIGN • 2020 • TraceLink

 

TraceLink’s view of a Digital Recall

Summary

Product recalls in the US market is a manual, time-consuming and multi-layered process. It is costly and understanding the efficacy of the process is a mandated but often-difficult aspect of assuring recall success.

As the US government makes a move towards a digital process through a pilot program exploration, TraceLink's approach leverages existing serialization information on their network to facilitate faster, more accurate recalls. Our goal was to reduce the average recall completion time down from 9+ months with intangible success and design a solution that provided a clear and trackable pipeline for a recall, regardless of product and recall severity.

Design

Objective

Manufacturers and producers across supply chains need an efficient, cost-effective, and traceable solution to recalling products from the market with insight into specific product locations and responses from supply chain partners.

  • Provide a producer (Manufacturer, Brand Owner, Repackager) and consumer (Warehouse, Distribution Center, Hospital, Pharmacy) view of the recalls process with clear calls to action for responding to a recall

  • Ensure all current recall specification and data is included in the digital design

  • Identify opportunity areas for TraceLink to expose critical information for Healthcare and Phara companies already using the Network for serialization

Research

  • FDA recalls research, including paper documentation review, and summary of existing materials

  • Customer calls with key Network partners to discuss their current recalls practices and workflow and identify efficiency goals

  • Larger Customer Forum discussions across business segments, to understand consumer needs when responding to recalls

  • Design iteration and user testing sessions

Approach

In order to truly make a digital recalls process efficient, we needed to directly engage the people who dealt with recalls in their work. Armed with the research of business analysts and product management, product and design identified the ideal workflows for a recalls process that included validation and submission of this information to regulatory and governance entities. Engineering added the system security perspective and added context on where and when data could be fetched or rendered to the design.

Using the TL42 Design System and the capabilities scheduled to be released on the Life Sciences Cloud roadmap, the prototype offered a robust experience complete with roles, experiences built based on what mattered to a user’s place in the process.

Solution

TraceLink’s solution to the recalls problem provided robust insights into the location of recalled product, the response activity of partners in the supply chain, leverages existing data to populate recalls, and ensures accurate record-keeping for compliance and regulatory oversight. In short, the solution provided a streamlined recalls creation through closure experience, and didn’t require tedious book-keeping overhead.

Outcomes

The pilot was tested across user groups and ultimately submitted to the FDA program. The solution itself was optimized with the pharmaceutical industry in mind, as serialization has some strict regulatory oversight internationally, however the design offered configuration to enable a simpler experience and reused across varying supply chains.

TraceLink provides their own case study and report on the pilot program: