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Traceability
Think about a system that provides you the opportunity to learn a product’s story in its life cycle. Imagine that you could reach the information such as product’s authenticity, expiry date, provenance by the technology the system provides you. You know what, there already exists the system that we have just thought about, and its name is traceability.
What is traceability?
Traceability is the management tool that enables reaching all data of a product’s journey in the supply chain. Through track and trace, it becomes possible to learn the product’s origin, the raw materials in it, where and how it is supposed to be used. As a summary, it includes data of manufacturing date and time, equipment used for manufacturing and packaging, personnel involved in manufacturing and packaging, raw materials and components, physical locations of inventory throughout its life.
How is traceability implemented?
In a way to have traceability marks in the supply chain, serialization and aggregation are undeniable steps that a manufacturer should take.
Serialization
Serialization is the first step of traceability. It is the process and results of defining, assigning and affixing unique serial numbers to product packaging at any level.
To learn more about pharmaceutical serialization please click here and read our blog.
To learn more about food serialization please click here and read our blog.
Aggregation
Aggregation is the next step after serialization. One of the aggregation definitions is: for the aim of enhancing the efficiency of serialization business operations including data exchange and/or regulatory requirements, the documented parent/child relationships between uniquely identified goods and the uniquely identified outer container that they are stored within.
To learn more about aggregation please click here and read our blog about aggregation.
Is It Mandatory To Use Traceability Systems?
There is no single answer to this question because it may differ from country to country. For example, pharmaceutical traceability first became mandatory in the Republic of Turkey, under the control of the Turkish Medicines and Medical Devices Agency (TİTCK). Currently, it has started to be implemented in many countries around the world or is in the form of a pilot application. Likewise, medical device traceability is becoming more common. The Russian Federation can be given as an example for food traceability. In Russia, track and trace is mandatory for goods such as milk and dairy products which have short shelf life, and for some beverages. More importantly, if automation, optimization and brand reliability are desired in production, track and trace is a must for all manufacturers.
Why traceability is a need?
Food and non-food products, as well as pharmaceuticals, can be traced and removed from stores as soon as they become defective or unsafe. Both the producer and the consumer want to trust the product. If it is a manufacturer reading this, it will be understood very well what we mean, but from the consumer’s point of view, it can be questioned how the manufacturer cannot trust his own product in the first step. The answer is hidden in the product’s journey of the supply chain. The manufacturer will not be aware of the mishaps after the production process if there is no traceability system.
How does traceability benefit?
The data provided by traceability bring people in reliability. The importance of traceability cannot be limited by categorizing according to manufacturers, end-users, governments. That is why it can be said that the advantages of traceability have a wide variety. Some of them are:
Combat Counterfeiting
Counterfeiting affects both the manufacturer and end-user. All industries would be damaged from counterfeiting but especially impacts on the pharmaceutical industry can be fatal. Having its products counterfeit or stolen is one of the worst things that can happen to a company. Because the revenue will decrease as consumers would buy the counterfeit ones. Through traceability, the origin of the ingredients can be known and proven if needed, products every move will be traced and cannot be stolen in any spot of the supply chain, the spot where a product might have been damaged or compromised can be pinpointed.
Recall Process
Viewing from a manufacturer’s eye, traceability would benefit as easing the recall process. If there occurs any problem with the product that has already been distributed to the markets, through traceability the manufacturer will be able to find the product and recall it or its series.
Regulatory Compliance
Authorities want manufacturers to benefit from traceability technology and be compliant with regulations. For instance, the FDA notifies people with the regulations to be aware of where the product has been, where is it now, where it is going to be stored, who is handling the product.
Identification of Supply Chain Spots Needs to be Developed
Undoubtedly, manufacturers would want to increase operational efficiency. Traceability is a tool not only to trace the product in its journey but also to identify the weak spots and develop these parts.
Transparent Supply Chain
Many companies try to prepare reports so as to make their supply chain more transparent, however, they face traceability problems because of the lack of product journey records.
