Unlike twenty years ago, manufacturers today no longer relinquish responsibility for a product once it is delivered. Now, consumer recalls are weekly occurrences: problems like bacterial contaminations, sterility assurance risks, undeclared ingredients, metal / glass / plastic particles, and oversized tablets have highlighted the need for Life Sciences manufacturers to know exactly where ingredients came from, where they went, and even what machinery they were processed on.
Perhaps this was best summed up by Susan J. Wilkinson, a Smarter Food Supply Networks Subject Matter Expert, with IBM Global Business Services, who wrote “Consumers and governments now hold brand owners fully responsible for everything related to their products,” (FoodLogistics.com, May 2012.)
Here's the bottom line: traceability is an essential aspect of the modern manufacturing environment. Also known as “track and trace,” if it isn't already, traceability should be an integral part of a Life Sciences organization's quality management system.
What does traceability mean?
In its simplest terms, traceability means knowing where a product came from and where it went. It's achieved by giving each unit of production a unique identification code – often a batch or lot number – and logging that through the manufacturing process. Extending the use of these codes to suppliers and customers results in what's often referred to as “one up, one down,” traceability across the supply chain.
Since manufacturers by definition “assemble,” the material or source information has to be linked to the recipe or bill of material. Thus traceability requires an ERP system with the ability to link suppliers, deliveries, and product identification codes to the manufacturing batches and eventual process output.
Regulation and Granularity
In the early days of traceability, lot or batch-level record-keeping was sufficient. However, in many industries, and especially the Life Sciences, a combination of consumer demand and government regulation are driving an increasing level of granularity, down to the individual item.
For an example, look at the Guidance Note on Medical Device Tracking issued by the FDA in January 2010. Addressing the requirements of the Safe Medical Devices and other Acts, this states that “Device tracking is intended to ensure that the Food and Drug Administration (FDA) can require a manufacturer to promptly identify product distribution information and remove a device from the market.”
Traceability and Recalls
When a processing fault or error is discovered, the responsible manufacturer halts production and quarantines goods that might be affected. In many cases though, this is not sufficient to protect the end customer as short lead times and minimal supply chain inventory mean every product is made and shipped as quickly as possible. As a result, if a processing or production problem is discovered the affected goods could be many miles from their origin.
At this point the manufacturer is into a recall situation. All those customers who may have received defective goods have to be contacted and the items recovered. The expense of performing a recall can be huge but easily outweighed by the cost, in terms of reputation damage and lost business, of doing nothing. As a result, many recalls are carried out voluntarily, although agencies such as the FDA have the power to force a recalcitrant manufacturer's hand if necessary.
Importance of Traceability
Traceability lets a manufacturer minimize the size and scope of a recall by providing detailed information about the source, processing and distribution of raw materials and finished goods. The more granular the record-keeping - even down to the discrete item level - the smaller a recall can be. Traceability out to the end-user or customer also helps the manufacturer verify that every affected item has been retrieved, providing a measure of recall effectiveness.
When track and trace thinking is integrated within a single ERP and Quality Management System, an organization can respond quickly, minimizing possible adverse consequences. In turn, this protects the brand, showing that traceability is good for business.
No one chooses to get into a recall situation, but occasionally errors are made. An effective traceability system minimizes negative business impacts while protecting end-users and satisfying regulatory authorities.
Learn about the Top 6 Benefits of Supply Chain Traceability in a Recall Situation.