For several years, I managed a beverage plant where we continually had issues with placing sugar products into non-sugar product containers. They were produced, packaged, and shipped to customers because of poor manufacturing practices. These product crossovers and manufacturing mistakes came from different sources; constant production schedule changes, production schedule variances between quality and production, material handling errors, incorrect labeling, just to name a few. These production mistakes cost money by causing downtime and requiring rework…when they were identified.
But what about the risk to consumers that might be diabetic or allergic to certain ingredients? We depended on file cabinets full of paper and files on computers to track the information and make it traceable in the event of an issue escaping our facility. With new serialization requirements, the data collection and tracking requirement is magnified dramatically as the individual container must be traceable.
Now think about pharmaceuticals! What would or could happen if you placed the wrong medicine into the wrong capsules? This could lead to serious health issues or even death. Pharmaceutical companies are now required to mark packages with a product identifier, serial number lot number, and expiration date.
In spite of the new regulations, imagine not having file cabinets full of spreadsheets or lab results, or hundreds of files stored on your computer to maintain data for what will soon be a least six (6) years. Now it will be easy to trace returned product from customers because the product cans, bottles, or bags inside the box was opened. And, manufacturers will have all that information stored in an electronic system at their fingertips.
Think of the benefit Taketa would have realized in its airbag recall. It initially effected 46 million inflators in 29 million cars that has now been expanded to affect 64 million to 69 million inflators, and 42 million cars. How much more quickly could they have responded and addressed the issue for their customers?
As you look further into serialization, a good article to read is Serialization – A Worldwide Challenge – ISPE. Some of the terms to pay attention to are:
- Product Tracing – When sterilization comes into play, product tracing will be required but the nature of the requirement changes. In 2023 Track and Trace and Serialization will converge.
- Verification – In the event of a suspect product inquiry supply chain companies will have a short window to produce relevant transaction documents. The challenge is getting all those documents in a short period. Businesses need a storage and retrieval mechanism that supports these queries.
- Serialization – When serialization with its end to end tracing takes effect, companies will manage many transactions with many items and several partners. This will bring about two different challenges; Supply Chain communications and Data Volume challenges.
With automated serialization, you can create and maintain detailed data in electronic systems, insuring compatibility throughout all stages of production and distribution. Our partner, AVEVA is getting out in front of this issue with a full series of regulatory compliance applications…check it out here.