Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company.
The more obvious impacts include:
- Packaging operations, where serialisation will have to be applied to product packaging at one or more levels.
- In the more complex serialisation models, this operational impact will extend into the distribution operations in central and/or local markets, where information on individual sale and shipment transactions needs to be gathered and added to the serialisation information.
- Particularly in the more complex track and trace models, significant IT capabilities will be required to manage serial numbers and track information related to the product and it’s movement.
However, the impacts go beyond these. Below I list some of these additional impacts:
- New customer support processes
- New supply interruption risks
- Modified supply routes
- New data management processes
Quality Assurance and Control
- New quality assurance requirements internally and externally
- New processes and tools
- Additional third party packaging supplier requirements
- New equipment and service provider management
- New and extended liabilities
- Complex legal interpretation of legislation
- New regulator relationships
- Monitoring and influencing technically complex emerging legislation
- New business risk management
- New governance
Research & Development
- New product design implications
All these impacts need to be considered and the appropriate solutions put in place. Given that these impacts affect many different functions and third parties, there is a high risk that solutions will not work well together unless the design of the overall solution is carefully managed and governed.
This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifying some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.