Serialisation is not new. It’s the process of putting a unique number on a product. While the idea has been around for a while, its use has come back into the spotlight because of the benefits it offers in an increasingly complex global supply chain.
At the consumer level particularly, a serialised unique identification process enables traceability and authentication via systems such as chain of custody, chain of ownership, product identifier authentication or recall – and readily available technology can be used with all of these.
The pharmaceutical industry has quite well developed serialisation, but changing regulations in various countries around the world will most likely see mass serialisation become a reality across a host of industries.
So why is it necessary?
There is a lack of real-time transparency with products changing ownership a number of times. Serialisation gives complete traceability and enables authentication at every level in the supply chain — especially at the consumer level.
Along with the complexities of an increasingly world-spanning supply chain, counterfeiting is another major reason why serialisation is becoming necessary. Counterfeiting affects not only company bottom lines, but in the case of foods and pharmaceuticals, poses a public health risk.
While there’s consumer-level and supply chain justifications for serialisation, there are also several business benefits:
- Brand protection: it gives the ability to detect and manage counterfeit product threats
- Reverse logistics and recalls: it gives greater granularity of data to aid recalls, returns, withdrawals and rebates, and shrinks loss recovery.
- Inventory control and supply chain visibility: it improves visibility of the exact item and quantities delivered at each point in the supply chain, so provides a better insight into raw materials ordering as well as process scheduling.
- Consumer connection: it gives the ability to build consumer trust through product verification or authentication, and, therefore, the opportunity for the brand to connect directly with the consumer.
- Returns: it gives the ability to detect returns that were not originally sold to the customer.
To effectively implement serialisation and traceability, a business needs to understand the requirements from a compliance perspective, as well as their brand objectives. Typically, a traceability/serialisation system has these building blocks:
- unique identification codes
- data-capture mechanisms
- managing links across the chain
- data communication across the supply chain
Flexibility is key. A system that meets current regulations is great, but it should also be able to accommodate change if regulations alter in the future. (With the way regulations have changed so far, that’s really “when” regulations change.)
Serialisation can be implemented in three stages:
- At the consumer level, with a unique number on the unit using a data carrier (e.g. data bar, 2D code, numeric code).
- Using the existing Global Trade Item Number (GTIN); a serialised GTIN can be used for a more integrated approach.
- Across the supply chain, including cartons and pallets, for complete supply chain visibility and end-to-end track and trace.
Here are a few things to think about before implementing serialisation:
- review data management from an enterprise level (ERP/MES), a plant level (MES), line level (SCADA) and machine level (PLCs and equipment)
- consider the impact on your existing processes and line speeds
- determine the code’s location and permanency
- choose the right data carrier (i.e. QR, Datamatix, GS1 Datamatrix barcodes)
- use GS1 standards
- think of aggregation strategies when serialising beyond the consumer-unit level
- choose a technology partner who understands serialisation and can provide serialisation-ready devices and solutions
From our experience with serialisation, here are a few more things to think about:
- move 2D barcodes away from other barcodes on the packaging so your scanning is efficient
- use a data reader for online verification
- make sure any rework or removing samples for QA doesn’t cause serial number linking to go out of sync
- test print on several substrates
- use barcode grading
- control pallet aggregation and avoid cartons being moved around before a pallet is completely wrapped up and labelled
- control products being picked up from the line
- make sure your existing network can handle the data flow
- ensure your existing systems can inter-operate with serialisation-control software
- have clear processes on how will any rework (if needed) will be handled
- use validation processes in line (vision inspection, data readers)
Serialisation has many business and supply chain benefits. As with every new process, make sure it really is right for your business. If you’re unsure, start with a pilot program and evaluate from there.
Mark Dingley is chairman of the Australian Packaging and Processing Machinery Association and heads operations at Matthews Australasia. Contact him at email@example.com
Image: www.outsourcing-pharma.com and www.businessnewsdaily.com