Gary Day explains the key principles of track and trace, how an effective system should work, and the industries in which the concept has become essential aid to compliance

Over time, the complexity of manufacturers’ supply chains has increased, bringing with it a growth in the requirement for traceability. While a manufacturer may need to know the origins of its raw material inputs from upstream, its downstream customers are just as likely to require the option to revisit when and where the product was made and by whom.

In an age of heightened quality standards and regulatory demands, traceability is vital. The consequential benefit of this is a greater level of accountability at each stage of the supply chain. One way in which companies can achieve this through automation is via a track and trace system.

What is track and trace and why is it needed?
The term ‘track and trace’ may not be new, but the manner in which it is implemented by today’s manufacturers is often much more technologically complex than its earlier iterations.

In simple terms, a track and trace system applies unique serialization coding onto products during production and packaging, which stays with the product throughout the logistics phase and connects machine automation with factory business systems.

One significant development which has increased the need for track and trace systems is the introduction of new legislation and regulations from the governing bodies of industries. There has been a clamp down on the accountability applied to products within certain sectors, and the serialization of packaging through track and trace can help companies meet those now mandatory requirements.

How does track and trace work?
To ensure products are fully traceable through the supply chain, track and trace systems use unique codes at every stage of the packaging process. This coding is given to each individual product, so it can be traced at any point.

The process begins at the primary packaging point and unique codes are assigned at each stage, until the product is placed on a pallet to be shipped out. These codes are usually generated by a system with an external interface and can be applied in various different ways, including laser, inkjet or ‘print and apply’ technology.

A key aspect of track and trace is the validation and authentication of the unique codes at each stage of the process. Once the code has been applied at each packaging point, it is verified, validated and authenticated before the product can move onto the next stage of the production or packaging process.

If there is an issue with the code, a non-authentication alert is triggered, and the product packaging will not go any further along the supply chain. In short, if the code cannot be traced, the product will be removed.

Crucially, the same code stays with the product throughout the logistics phase, with serialization connecting machine automation with the business systems of the factory in question.

Which industries requires track and trace?
One sector in particular where the need for serialization has become imperative is tobacco, due to the introduction of new legislation. In May 2016, the EU Tobacco Products Directive (EUTPD II) came into force, bringing with it stricter regulations.

To understand exactly how the tobacco industry is innovating, it is important to understand Article 15 and 16 of the EU TPD legislation, which has implications for traceability and security. Tobacco legislation states that manufacturers must implement a traceability system (Article 15), under which all unit packets of tobacco products are required to be marked with a unique identifier. In this context, track and trace prevents spurious products from entering the market.

The pharmaceutical industry is another with an extensive requirement for strict track and trace systems. Due to the number of stakeholders involved in the supply chain – manufacturers, distributors, dispensers and patients, for example – pharmaceutical products are passed through many pairs of hands which could lead to misuse and counterfeit products entering the market.

Track and trace in the pharmaceuticals industry is integral to mitigating the risks posed by counterfeit drugs and allows the pharmaceutical supply chain to manage is products more efficiently. Pharmaceutical track and trace legislation is already in place around the world – the EU enforced serialization in 2017; the US has the Drug Quality and Security Act; and China implemented mandatory serialization on more than 500 products deemed to be an essential list.

The demand for traceability is developing at such a rapid rate that we are now seeing legislation begin to drive requirements for coding and tracking of other product categories such as soft drinks and alcoholic beverages as well as the aggregation of pharmaceutical products. In some markets, such as Russia, the expectation is that all consumer products will require unique traceable codes which are tracked at every stage of the supply chain, just as tobacco is now. The ultimate aim is for a greater number of global markets to eliminate the illegal trade of contraband and counterfeit products.

Rather than being a ‘nice to have’, the use of a bespoke track and trace system designed for the specific needs of a production line should be considered essential for helping the business to meet regulation and improve its processes.

Gary Day
Gary Day is technical director at Sewtec Automation. Sewtec Automation designs, manufactures, installs and commissions complex industrial automation systems for global blue-chip clients in the pharmaceutical, medical, food and beverage, personal care, pet care and tobacco industries.

In excess of 85 per cent of the company’s sales are exports. Last year, Sewtec Automation’s turnover more than doubled to a record £28m with EBITDA of £9m and the company aims to achieve a turnover of £50m by 2023.
https://sewtec.co.uk