As when implementing any new procedure to your organization, it’s important to have a plan going into the implementation stages of serialization. Luckily, there are resources and best practices that will help you organize, prioritize and execute your implementation plan with minimal errors or business disruptions.
Establish a clear strategy. The emphasis here is on clear. Outlining roles and responsibilities in black and white will eliminate repeat work or tasks that are unaccounted for. Johnson & Johnson’s presentation recommends identifying key stakeholders responsible for IT, engineering, quality, change management, customer experience and regulatory affairs. Using risk management and standards like ISO can help guide the responsibilities for each of those groups.
Look for helpful resources. The FDA has released many guides and resources to help make your transition smoother. On July 20, 2017, the FDA announced that they created the Supply Chain Security Toolkit for Medical Products. This comprehensive resource covers the entire supply chain lifecycle of medical products and focuses on implementing processes and procedures to improve quality and increase supply chain security. Regulators from 21 nations, along with stakeholders and representatives will be collaborating to further develop strategies for securing medical product supply chains on a global scale. This shows a worldwide effort in preventing, detecting and responding to falsified medicines and products before they reach consumers.
Manage change, documents and training. When implementing serialization, many things are going to change. With that comes many documents and procedures that employees need to be trained on. Having a centralized system ensures that everyone receives the same standardized training. It also gives you a secure place to store documents and templates for easy access during implementation and future audits or inspections.
Integrate corrective action with your supply chain. Having a corrective action process that is automated from beginning to end gives you the confidence that issues will be handled quickly, efficiently and uniformly. This is often a bigger challenge when supply chains are extended and intricate; having a corrective action system that lets you integrate your supply chain and include them in the process is invaluable. Supplier corrective actions ensure quick response time for efficiency and make sure suppliers are performing up to your quality standards.
Manage risk and recalls. Many recent standards are stressing the importance of risk management and risk-based thinking. Having proven risk tools like a risk matrix or decision tree within your quality management system helps you translate risk into a measurable number, allowing you to prioritize and act on higher risks. Applying that theory to your supply chain, you can reduce the likelihood of serialization errors and recalls. The key here is to take a systematic and quantifiable approach to risk and recall management.
Capture and analyze the data. Every decision you make during the implementation phase will have an impact on the overall outcome. When your data updates in real time, you can see the impact of every decision as soon as it happens. You can then look back on the data, viewing overall trends or drilling down to specifics, to make improvement decisions backed by data.
Implementing a serialization process may seem like a lot of work, and that’s because it is. But the work put in now will prove to be worth it for the lifespan of the organization. Some organizations are looking at this change solely from a compliance standpoint, and are making the changes because they need to.
But to get the most out of a serialization program, decision makers should understand the larger benefits serialization can provide. This system gives you a way to quickly trace products up and down the supply chain. It helps you prevent recalls in the first place, and in worst case scenarios limit the damage and cost of recalls that do happen. Most importantly, it improves the detection of counterfeit drugs, which keeps the industry honest and secures patient safety.
Don’t get overwhelmed by the changes to come. If you take things one small step at a time and utilize the resources around you, you can realize these benefits through product and supply chain security.
