At a recent conference on e-commerce in an impromptu side discussion, a handful of audience members predicted that serialization will soon be coming to the food industry. As the former publisher of Healthcare Packaging, I had a ringside seat to the pharma sector’s struggle to implement serialization. It is important to look at where serialization came from, and even more critical to understand how disruptive and expensive it can be to an operation.
No pharma companies voluntarily took on serialization. It stemmed from California legislation to protect consumers and evolved into the FDA’s Drug Supply Chain Security Act (DSCSA). It is a legal compliance issue that has cost millions of dollars to implement. And while there has been talk of greater visibility into the supply chain, most case studies have not realized a lot tangential benefits, at least not yet. For the pharma industry, serialization is seen as a necessary evil, and an expensive one.
The disruption caused by implementing serialization on a line is not only the high cost. Equipment must be updated or changed to allow proper access to cameras and orientation of codes. This requires new cross-functional teams and additional training. If a carton falls off the conveyor, you just can’t put it back. Pulling product for testing is also problematic. Disruption from serialization has included whole new line configurations, shut downs of six months or more, and an immediate loss of OEE upon startup.
In most pilot tests, OEE does return after a significant drop of three or more months. Pharma has the added burden of FDA validation which also slows restarting the serialized line. On a positive note, sometimes serialization was used as leverage with finance teams to replace legacy equipment not equipped to deal with the challenge.
There is a huge issue of aggregation. Do I need to know parent/child relationship of cartons in a case or cases in a pallet? What happens to these relationships when cases are broken up at a contract packaging facility? These are the processing and packaging line considerations.
The real headache is with data. Millions of unique serial numbers are generated and stored, called up for use, and then passed through the enterprise. There are software packages to manage this data, but it has to integrated into other manufacturing systems in use. An industry group has been trying to develop standards for the data, but the going has been slow.
As one conference attendee from a global confectionary brand mentioned, “I really can’t see any value to serializing a dollar candy bar. And I can’t sell a $4.00 candy bar.”
Authentication, track and trace, supply chain logistics and food safety is critical. Saying “serialization” is coming to food is fraught with pitfalls, but looking to pharma for lessons learned is critical.