What is Traceability in Production? How is it Done?

In today's world, products and thus production have become highly advanced and diversified. Along with this, production methods, logistics approaches, and even additives have been affected by this development. This situation has led to the establishment of certain legal regulations. With the regulations made, the concept of traceability has emerged.

Traceability in production is a process that enables the tracking and recording of a product from the moment of production through packaging, storage, shipment, and reaching the point of sale. This system is very important for efficient and sustainable production.

With traceability, throughout the production chain, every phase can be monitored and shared by producers, suppliers, distributors, and retailers, alongside improved efficiency, accuracy, visibility, and security. Additionally, it allows an examination of records ranging from the shipment date of the product, warehouse exit, final inspection, to the machine that produced it, the operator using the machine, interim controls, the entry of raw materials and auxiliary materials into the warehouse, and the entry controls to the suppliers providing these products. In this way, potential errors can be easily detected and resolved with prompt action, or precautions can be taken for the future. In short, when looking at traceability from the perspective of management systems, it refers to the ability of a product or service to be traced backward, which is crucial for employees and ultimately for the consumer from the production to the sale process.

There are many reasons for the importance of traceability, but the most important reason is consumer health. The other main reasons for transitioning to traceability applications are listed below:
● Combating counterfeiting,
● Protecting brand image,
● Meeting legal requirements.

Especially in the pharmaceutical industry, where counterfeiting directly impacts human life, the concept of traceability is used and developed much more. The information about where, when, and for what purpose the product is located in pharmaceuticals and other industries is significant for both preserving the manufacturer’s image and for the consumer.

Traceability offers many advantages. First and foremost, its greatest advantage is its positive contribution to human health. Every consumer wants to know under what conditions, with what materials, and how the product they use was produced and reached them. Traceability provides significant advantages in this regard for the consumer. Besides health protection, reaching a quality product, obtaining a safe product, learning the sources related to the products, and being able to provide evidence in legal pathways in case of any issue are a few of the advantages that traceability offers to individuals. Furthermore, the correct use of resources through traceability will benefit future generations and the world, making it the greatest societal advantage. Additionally, supply chain management, ensuring product safety and quality control, and the positive impact of product safety provided by traceability on marketing are some of the companies' advantages. Meanwhile, other significant benefits are listed below:
● The most efficient use of raw materials,
● Making shelf life more efficient and reducing costs,
● Digital data tracking and automated data control,
● Detection of non-standard/defective products,
● Establishing an effective recall system,
● Preventing counterfeiting and preserving brand image.

Traceability can be conducted in two ways as provided below:
● By Lot: Lot number, which may also be referred to as batch number in some sources, refers to products produced in a single batch. Additionally, the model number should not be confused with the lot number. The model number is a number that remains constant even if production machines and times change.
● By Serial Number: The serial number is a number given to individually produced products. Even if the products are produced on the same machine, by the same operator, or on the same day, the serial numbers will differ from each other.

When lot and serial number come together, the traceability of all products sold by the company is ensured.

What is a Traceability Label in Production?

To enable easy and low-cost tracking and traceability of products, traceability labels, commonly known as barcode systems, have been developed. A barcode is a system that represents numbers and codes that can be read by machines. Barcodes are widely used in the supply chain to identify products and monitor all areas within the process.

With a barcode, stock codes, serial numbers, personnel codes, and other information can be easily viewed. Manually entering this information into computers can be time-consuming, tedious, and most importantly, prone to errors, which is why barcode readers are utilized.

Currently, there are 255 different types of barcodes worldwide, so appropriate barcode selection should be made for efficient and effective application. In making this selection, factors such as data size/shape, data density, and security should be considered.

Commonly used barcode types include:
● Code39 - displays numbers, letters, and special characters,
● Code 128 - displays numbers, letters, and special characters,
● EAN13 - contains only numbers,
● EAN8 - contains only numbers,
● ITF - contains only numbers.

In Turkey, the numbering systems generally used are EAN (International Article Numbering Association)-UCC (American Numbering Association) and FRID (Radio Frequency Identification).

Is Traceability Testing Mandatory?

Traceability appears in every standard facing manufacturers and consumers. Particularly concerning product safety, traceability is seen as a separate item in commonly used GFSI approved BRCGS, IFS, FSSC standards, as well as in ISO standards on which the FSSC standard is based, specifically ISO 22000.

In sectors such as food, cosmetics, and pharmaceuticals, where the fundamental aim is to produce safe products, traceability is not only a standard measure but also a legal obligation in many countries. For example, in Turkey, pharmaceutical traceability has become mandatory under the supervision of the Turkish Medicines and Medical Devices Agency (TİTCK). With traceability, it can be determined that a product is not safe by the operator or legal authorities, and in this case, the product is recalled. A traceability system must cover all production, process, and distribution stages that could determine which customers the products went to, including the raw materials and packaging materials entering into the product.

How Long Should Traceability Tests Be Monitored?

According to GFSI approved standards, the traceability system should be checked at least once a year. However, it may be tested more frequently in cases of changes in the traceability system or customer requests. With the traceability test, the sustainability of the traceability system is checked and thus the rectification of any disruptions in the system is ensured. Furthermore, at least once a year, a traceability test should be conducted from raw material to finished product and from finished product to raw material.

What Are the Procedures and Phases of Traceability Testing?

The purpose of conducting traceability tests is to identify points in the traceability system that are malfunctioning and need improvement, and to correct them. In the traceability test, there should be a summary on the cover page or presented as a summary report. The following items should be included in the summary:

● Date of the traceability test,
● Start time of the traceability test,
● End time of the traceability test,
● Name and surname of the person conducting the traceability test,
● For the traceability test from the finished product to raw material: the finished product lot/batch number, production date, expiration date, production quantity,
● For the traceability test from raw material to finished product: the raw material lot/batch number, delivery date, delivery quantity, expiration date,
● List of forms collected for the traceability test,
● Evidence of mass balance.

Businesses may add other items to the summary section in addition to the items listed above.

While conducting the traceability test, the following steps should be followed:
● Should be done from raw material to the finished product,
● Should be done from the finished product to raw material,
● The test should be completed within 4 hours
● The test must also include the calculation of mass balance,
● Tests should be conducted for each different product group.

When these steps are followed, the test is completed. The process of performing the tests from raw material to finished product and from finished product to raw material is defined in the continuation of the article.

How is the Test from Raw Material to Finished Product Conducted?

The following steps should be followed for the traceability test from raw material to finished product:
● Selection of any raw material and primary packaging material according to the product recipe or the contents of the label,
● Determination of the lot/batch of the selected raw material,
● Identification of which supplier the raw material of the determined batch number came from, when, and in what quantity,
● Determination of where and in what quantity the raw material of the specified batch number was used in what product batches,
● Identification of any waste related to the raw material of the specified batch number in relevant productions if available,
● Determination of the remaining quantity of raw material in stock in the warehouse,
● The total quantity of raw material entering and the quantity of raw material used and waste in productions must be equal.

How is the Test from Finished Product to Raw Material Conducted?

The following steps should be followed for the traceability test from finished product to raw material:
● Selection of a lot/batch for any finished product,
● Identification of when and in what quantity the finished product from the relevant batch was sent to which customers,
● Balancing the quantity sent to customers with the quantity produced,
● Determination of the lot numbers of the raw materials used within the finished product batch,
● Identification of which supplier the raw materials came from, when, and in what quantity,
● Determination of the batch number and usage amount of reprocessed products used in the finished product,
● Traceability and quantity of the reprocessed product.