Project Management

Serialization project: reduce impact on OEE and productivity – expert tips


When thinking about implementing a serialization and track & trace solution, companies face all sorts of challenges and complexities.

Regulatory challenges in the pharmaceutical industry

For the pharma industry, certainly the biggest challenge (after the regulatory deadlines) is the coordination of a large number of constituents; stakeholders as well as regulatory bodies and requirements. Furthermore, regulatory requirements tend to evolve and differ from country to country (there currently are about 40 different legislations in place, a number that will increase over time as a lot of countries are already debating regulatory requirements to tackle counterfeiting of drugs and medicines).

Challenges, pitfalls and complexities of serialization projects

The complexities to take into account before even choosing a serialization solution are so complex that oftentimes companies forget to think about operational, financial and productivity-related considerations. Indeed, a serialization solution should not only be flexible and scalable to cater for future legislation, new markets etc. Companies should also think about the overall roll-out period of the solution and how to effectively plan this stage to reduce impact on OEE and productivity.

OEE and the 3 phases of a serialization project

Typically, serialization projects are thought about in three broad steps: project planning and preparation, implementation on a pilot line and roll-out on site-level as well as follow-up and evaluation. The question is, how do you achieve efficient preparation and quick roll-out phases and, in addition, manage Overall Equipment Effectiveness (OEE) on your lines?

Planning stage

According to Evren Ozkaya, founder and CEO of Supply Chain Wizard, it is crucial to put in place a competent project management team and to clearly define and understand the criteria to be included in your Request For Proposal (RFP) during the planning stage. Each proposal needs to be thoroughly analyzed and cross-examined against prior defined benchmarks to be sure to select the right vendor for your project and budget.

Avoid productivity drops during implementation and roll-out

Invest time to do an up-front strategic planning for the roll-out phase. Whether you work with a qualified system integrator taking care of the overall project management or go for a multi-vendor approach combining a software developer and machine builders or device suppliers, you need to ensure that a complete and clear Statement of Work is defined between you and your vendors. Use a pilot project to standardize almost everything before rolling out your serialization solution across your packaging plant. Indeed, repeated testing and refining on a single line will save you time and money as your trial-and-errors will be limited to one line only and won’t be repeated across all your lines. You can then roll-out the optimized standard solution on all subsequent lines directly without delay.

OEE after implementation: Follow-up and evaluation

If you have chosen a centrally configurable process management software, impact on OEE should be minimal after implementation. Central, site-level configuration minimizes the risk for human error and ensures fast and seamless changeovers for all your packaging lines without compromising Overall Equipment Effectiveness (OEE). A standardized software solution will in addition minimize incompatibilities with existing equipment.

To go beyond compliance, you can use your track & trace and business intelligence solution to leverage the opportunities that lie in the wealth of data generated through serialization. More on this in an upcoming post.

To learn more about how to evaluate OEE and how to minimize impact on productivity when implementing a serialization solution, watch our free on-demand webinar on OEE and line productivity.


Chuck Sailer is an architect, developer, and project leader with notable success in designing, developing, and implementing all facets of world-class, commercial software within a broad range of industries and technologies. Chuck recently joined the Adents team and will be a regular contributor to thought leadership pieces and blogs.


Serialization of medicines in Russia: Deadline is officially extended!
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