Getting Started--On Multiple Fronts
Industry Market Manager, Strategic Initiatives
Getting a serialization program started can be challenging. Companies that are most successful establish cross-functional teams for planning, implementation, sponsorship, and milestone reviews. Begin planning now with representation from all company functions, including packaging, manufacturing, information technology, marketing, sales, distribution, procurement, third-party logistics service providers (3PLS), contract manufacturing organizations (CMOs), trade management, brand protection, and legal and compliance. Everyone must have a seat at the table right from the beginning.
Figure 1 outlines the many interdependencies that must occur to ensure that all requirements are understood and included in what can only be described as an infrastructure overlaid on top of, and integrated with, your current corporate systems. Figure 2 shows the roles of those corporate systems and their functional impacts. Your manufacturing department, for instance, may be responsible for asking CMOs to make the manufacturing and packaging line upgrades necessary for serialization. Legal and compliance officers may need to conduct ongoing compliance audits of the packaging and labeling you produce.
Timing is equally important. Communication among all company departments must occur early enough for effective decision making. Last-minute discussions can only delay company progress.
It does seem that 2011 is well into the future, given the deep breadth of the California delay, but it really is not. In addition to wholesalers needing serialized product in mid-2010, there are limited industry capacities in both equipment and expertise. These include IT integration and packaging execution system implementation, to name just two. Trading partners must ensure that they understand your strategy and have time to prepare. Looking at it from a timeline perspective, companies will find that there really are only 24 months to prepare. If drug makers wait until next year to begin, two major problems will occur:
- There will be a severe strain on expertise and equipment capacities.
- Wholesalers will be overwhelmed and may not be able to handle all new serialized SKUs at the same time.
Additionally, there are other considerations that should be made. These may include:
- Changing Regulations: State, Federal, and Global. Who do you listen to and how do you react to change?
- New Requirements. Trading partners and large retailers will push beyond regulatory requirements in search of efficiency.
- New Services from CMOs, Packagers, 3PLS, etc. As more companies invest, more services will become available.
- Evolving Technology. Enterprise architecture, enterprise resource planning (ERP) software changes, plant upgrades, new software, etc., are all evolving.
- Availability of Hardware, Software, and Services. How long are lead times? Do you have the right skills available to you?
- And . . . as always, it’s business as usual. Acquisitions, divestitures, new product launches, partnerships, process overhauls, outsourcing opportunities, workforce changes, etc., are still taking place.
To begin considering all these aspects, approach planning as a strategic activity at the corporate level. Prepare a cohesive timeline with all of your internal and external stakeholders, and gain buy-in from each of them on what the deliverables are and when they will be completed. Timelines should include enough time for testing, problem solving, and ultimate deployment.
Once responsibilities are well organized internally, you can then begin strategizing with contract manufacturers, printed packaging suppliers, and equipment providers for package engineering and data carrier development, and data exchange requirements. Engage only with proven technology, software, and printed packaging vendors that have serialization and e-pedigree experience. It is crucial that such experience is within pharmaceutical, because at this stage in time, you do not want to be another company’s learning curve.
Because serialization requires several technologies and processes to work together in order to be successful, companies truly need a team approach.
Imagine this worst-case scenario—and then try to avoid it: your IT and quality team members avoid all your serialization planning meetings. IT begins working independently with an RFID technology provider, forges some sort of agreement, and then presents you, the packaging team member, with tags to use. You aren’t happy, but there already may be some sort of contract in place, so you get started anyway. Quality then gets involved six weeks later and finds compatibility issues. Regulatory steps in, too, and has other concerns. And now marketing is upset because the product may not be serialized in time for the scheduled launch.
If all departments were to meet from the beginning and throughout the evaluation and implementation periods, all team members would be apprised of all requirements, challenges, assessments, and procedures. Likely technologies could be evaluated and chosen together. And your deadlines met!
Nosco would like to acknowledge contribution to this article by the California Express Team.