Behind the Brazil Guideline: Intent, Use Cases, and What Comes Next

With the December 2015 Phase 1 deadline looming, companies that do business in Brazil are making final preparations. Key to their readiness is “Brazilian Medicine Traceability using GS1 EPCIS,” the implementation guideline. We spoke with Elizabeth Waldorf - one of the two technical editors - to understand how companies can use it, remaining challenges, and what comes next in Brazil.

What purpose does the guideline serve?

There are a lot of unknowns with the Brazil regulations. If you focus on all that uncertainty, it’s easy to become paralyzed. But the law isn’t going away.

The guideline is an enabler, channeling companies’ efforts in a productive way and helping them do something other than saying “this can’t be done.” It serves as a blueprint to advance preparation and readiness activities while also anticipating future revisions to accommodate implementation learnings.

How, specifically, can it help companies prepare for RDC 54 requirements?

The standard includes many choreography examples for how business-to-business exchanges of compliance data will work. A choreography is an end-to-end process that illustrates, for example, the electronic information exchange between manufacturer, distributor, and dispenser that parallels the physical delivery of the serialized products. Companies can select the example messages corresponding to the business scenario choreographies that best fit their operations, and modify them for their own needs.

The guideline and choreography examples will help them think through the parties they’re interacting with, what type of data they should collect and send or should expect to receive and – for different types of business transactions – what role do they play?

In addition to this initial guideline, what other resources will be available to help companies manage RDC 54?

The workgroup and authors will be working on next versions of the guideline. While the current one outlines the framework for capturing corrections and retracting events, the initial release primarily focuses on illustrating a “happy path” – it doesn’t cover any anomalies or exceptions. The next version will elaborate on how to proceed when there are unintended errors or when things generally don’t go as planned. And versions beyond that will make adjustments based on industry learnings, which no one is in a position to provide yet.

Even with the blueprint, what challenges will supply chain companies face?

The end-to-end nature of the RDC 54 requirements adds a lot of complexity. The guideline provides a blueprint for compliance, but companies will still need to work out many new processes.

The first step is understanding exactly what data needs to be exchanged with whom. Beyond that, companies need to assess and modify business processes to establish the necessary communication hooks to orchestrate the capturing, sending, and receiving of RDC 54 compliance data. They also need to be prepared to resolve any issues that may arise in the process. Once you’ve shipped product, how do you now let your supply chain partner know that you’ve done their part and the next move is theirs?

And if you haven’t selected a solution provider, you still have the entire evaluation and procurement process to complete.

How has your role with the development of the guideline informed TraceLink’s Brazil solution?

I got invaluable insight into local requirements and what supply chain members felt was important. I also gained better understanding and context for why something is required.

The “Nota Fiscal,” an official document in Brazil which basically proves the existence of a commercial act, is a great example. Local businesses were adamant that this be captured, even though it’s not required from a compliance perspective. Through work group discussions, I came to understand that nothing in Brazil can take place without this. With that understanding, I made sure that TraceLink built the necessary capabilities into an upcoming release.

My participation shaped our current Brazil solution, but it will also continue to help guide our solution roadmap and inform how we architecturally plan out our product to encompass everything that companies will need to be successful in Brazil.

Waldorf is co-chair for the GS1 Brazil working group and is also active in standards development within GS1 Global and GS1 US. In her role at TraceLink, she analyzes global regulatory serialization and traceability regulations and translates them into business and product requirements for TraceLink’s portfolio of track and trace solutions. Prior to TraceLink, she spent 20 years at AMGEN where she held a range of traceability, supply chain, government compliance reporting, enterprise architecture and commercial operations roles.