Ten Real-Life Serialization Speed Bumps and How to Avoid Them
If you’re a manufacturer or CMO just approaching serialization, you might assume you should start at the packaging level. But that's overlooking the bigger picture, and tunnel vision on that one aspect could lead to big problems, even impacting the continuous supply of product to the market.
We’ll take a look at 10 stories from the field that demonstrate how projects went awry when serialization wasn’t approached more holistically, along with strategic recommendations to help you avoid the pitfalls of a packaging-first approach. Then, we’ll outline the five areas of serialization that must be addressed in a coordinated way in order to achieve compliance readiness on time and at the lowest possible cost.
1. Speed Bump: Costly Downtime
One company had to take down their packaging lines for six weeks to perform serialization upgrades. Since they didn’t yet have plans in place, they didn’t properly deploy line-level software that would support data exchange for higher-level systems. The lines had to be taken completely out of production again, then revalidated when they went back up, this time with the proper configurations and interfaces in place.
Strategy: Stage and test your stack
Have your entire application stack pre-staged and tested prior to bringing any of your packaging lines down. Test out processes from end to end by using sandbox testing environments.
2. Speed Bump: Message Failure
During early pilot projects for EPCIS standardization, a company had mistakenly hard coded a GS1 CPG standard rather than a GS1 U.S. healthcare standard. This meant that the wholesale distributor was unable to accept the manufacturer’s EPCIS messages and serial numbers.
Strategy: Research downstream standards in advance
Before you implement any changes on the packaging line, be sure to research and understand all the downstream standards and requirements to avoid costly and time-consuming implementation errors at the packaging level.
3. Speed Bump: Missing the Global Picture
A company used the U.S. healthcare guidelines for EPCIS implementation, which did not take into account any of the global regulations for EPCIS data exchange. They implemented to this standard without considering that the product being packaged on this line was for global distribution. This can lead to further costly customizations and prevent interoperability.
Strategy: Think globally and use a standardized approach
Make sure that all market destinations are considered and implement a flexible, template-driven approach. If contract-packaging for others, understand the market destination of each product and the corresponding requirements.
4. Speed Bump: No Interoperability
A company chose to hard code a version of EPCIS with their own customized extension data. This worked fine for their internal purposes, but they discovered that their EPCIS data was not interoperable with any external parties.
Strategy: Understand downstream partner requirements to ensure interoperability
Be certain that you understand what your downstream partners and government authorities requirements are, and make sure you are following interoperability standards.
5. Speed Bump: No Data Standard
One manufacturer was incorrectly informed that they could manage all communications with CMOs through a single standard EPCIS interface. In fact, there is no EPCIS standard for requesting serial numbers from the manufacturers and providing them to a CMO, and many global brand owners have unique data, file format, and sequencing requirements. In addition, your software must be able to ensure that all serialization results from the CMO are complete and accurate.
Strategy: Talk to CMOs about data exchange ASAP
Right away, talk to CMO partners about managing data exchange capabilities and expectations to ensure accuracy. Early communication will help you avoid cost overruns and time delays, and minimizes the risk of missing compliance deadlines.
6. Speed Bump: Failed CMO Integration
With an initial focus on their internal lines, a manufacturer began developing company-specific data requirements and transactions between the line systems and their custom back-end data management systems. Later, when the company tried implementing their CMOs, those company-specific integrations could not be supported by the CMOs. To achieve compliance, they had to spend considerable time and resources developing more company-specific maps, which drove up their cost.
Strategy: Find out how external integrations differ from internal specifications
Don’t assume that specifications that are developed for internal lines will always be leveraged externally. Conduct research early to pinpoint what specifications are needed to collaborate with your CMOs.
7. Speed Bump: Brand-As-CMO Forces Delays
Brands that also act as a CMO must think about how they will service their customers. In one case, a brand was so focused on their own serialization needs that they neglected to tell their line system vendor about their customer’s data requirements. This put their customer’s entire serialization project at risk, forcing a delay of several months.
Strategy: Understand your customer’s data requirements
If your company acts as a CMO for other brands, you must fully understand their data requirements before you begin implementing your lines. Chances are that their requirements are going to be different from yours, which means that there are considerations to be made when communicating with your line vendor.
8. Speed Bump: Global Variabilities
Companies that do not think about global regulations when doing their line installations have run into issues where they were missing important data elements required by various countries.
Strategy: Find out how global data requirements impact line systems
Master data is not just used in reporting and compliance. Your master data management practice cascades all the way through the process—starting with serial number generation. Each country is going to have different requirements that need to be anticipated.
9. Speed Bump: Data Values Don't Match
A company reported an issue where their line system was using lot numbers with no hyphen, while their ERP system was using a hyphen. This meant that when they went to ship, the two values did not match.
Strategy: Synch data between disparate systems
Don’t get caught with data values that don’t match up between different systems. Be certain that your ERP data and other serialization data are in synch and that all data formats for all destination markets and trade partners are understood from the beginning. Downstream trade partners and authorities are certain to reject and quarantine product containing associated non-conforming data.
10. Speed Bump: Validated Lines Go Down
Only after implementing and validating their lines, a company discovered that certain events required transactional reporting by various countries at the time of commissioning, or even prior to commissioning, on the packaging line. They faced downtime issues because they did not build these capabilities into their line deployments from the beginning.
Strategy: Know the data requirements of commissioning in advance
When developing your initial design, you should understand what events and what data are required. Some countries will require the reporting of an event before or upon commissioning. These elements need to be designed in the serialization process from the beginning.