Traceability is the management tool that attains the whole stages of production, packaging, storage, shipment of a product, and all the processes it goes through until it reaches the point of sale can be recorded and the product can be tracked.
It is the process of making the product unique by assigning a special serial number to each manufactured product. But assigning the serial number is not enough for serialization. The assigned serial number should be applied to the product packaging by various methods and that number should also be defined for digital systems.
It is defined as the virtual interconnection of the transport unit and the serialized products contained in it. The process of establishing a hierarchy between the serialized drug X and the case Y in which it is contained is one of the most basic examples that can be given to aggregation. The most common method used to establish a virtual connection is to create data with a parent-child relationship. For more detailed information about the aggregation, you can read our blog.
Both of them are the most preferred barcode type for traceability operations. Datamatrix codes are physically smaller in size and can even hold the data density inside this area. Thanks to this, datamatrixes can be used even in very small parts. In addition, the datamatrix is the only 2D code approved by the GS1 for health products. QR codes are physically larger than datamatrix codes and have more data capacity.
Barcodes have 2 different types, one of them is 1D which is a one-dimensional code. An example of that is EAN, GS1 Databar, Code39, Code 93, and Code 128. Secondly, another barcode type is 2D which is a two-dimensional code. Examples are QR Code, Datamatrix, and Aztec Code. 2D Codes have much more capacity to contain information and also the imitation possibility is very low. Furthermore, the data can be read even if there is corrosion or damage in 2D Codes, easier than that in 1D Code.
An identifier assigned to a homogeneous quantity of a product that has identical manufacturing and packaging characteristics, including raw materials, manufacturing processes and timing. The batch or lot number associates an item with production information that the manufacturer considers relevant for the traceability of the trade item. The data may refer to the trade item itself or to items contained in it.
SSCC (Serial Shipping Container Code) is a code that allows you to identify transport units such as cases, pallets, sacks, and bags that facilitate the transportation and storage of products in the supply chain. SSCC labels are applied on the transport unit with the barcode GS1 – 128. SSCC is an 18-digit number used to identify logistics units, which can be any combination of trade items packaged together for storage and/ or transport purposes.
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard such as GS1. UDI permits the unambiguous identification of a specific medical device placed on the market. The UDI is composed of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world.
The production of a UDI comprises the following:
- A UDI device identifier (‘UDI-DI’) is specific to a device, providing access to the information laid down in Part B of Annex VI.
- A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI.
Here is our blog about UDI.
A new UDI-DI will be required every time there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements:
- name or trade name
- device version or model
- labeled as single-use
- packaged sterile
- need for sterilization before use
- quantity of devices provided in a package
- critical warnings or contra-indications and CMR/Endocrine disruptors
Manufacturers involved in the traceability system have to manage their production processes within a number of standards. Packaging safety, packaging compliance, and the processing of consumer-informative texts into the packaging are part of these standards. The control of these standards can only be carried out with high-tech cameras and appropriate software. Here is the top title of the technologies that perform these operations; they are called vision inspection. You can take a look at our page for detailed information.
In order to comply with legal regulations, ensure traceability and inform the end-user, some information is printed on the product packaging. OCR (Optical Character Recognition) technology is used to identify this information printed on the packaging, and OCV (Optical Character Verification) technology is used to verify the code.
OCR (Optical Character Recognition) technology compares the model of the printed alphanumeric character with the pattern of each character in the database. OCV (Optical Character Verification) on the other hand, receives preliminary information about what the specific alphanumeric model is and checks whether the current character is complete. For more information, you can reach our related article here.
The technology that allows a defective product detected at the production stage to leave the line is called the reject mechanism. For example, in food production, it is thanks to the reject mechanism that a product passing through the checkweigher is separated from the production line as a result of excluding it from the defined measure. The Reject mechanism becomes functional with the reliable software of the station through which the product passes.
It is called the process of collecting a product from the market as a result of detecting a problem after it reaches the consumer or after it is included in the supply chain.
Examples of situations that will cause a recall:
- An item that should not be in the product content should be included or an item that should be contained more than usual
- The presence of foreign matter in the packaging
- The emergence of health problems as a result of the use of the product.
A healthy recall process can occur with the application of traceability technologies.
It is the stage of presenting the product produced by the solution provider according to the specified requirements to the customer after quality control. If there is a problem in the FAT phase, correction requests may come or the product passes the test smoothly and the field phase begins.
These are the tests carried out at the place where the developed solution, the system, in other words, the machine, is put into operation. Field Acceptance Test results are included in the test protocols. Also, the results are signed by the client and the commission.
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in-vitro diagnostics medical devices. According to the latest information, Eudamed will be fully functional by May 2022.
GS1 is a global, neutral, non-profit standards organization that introduced the barcode in 1974, providing a common language to the industry. Supply chain family of standards, including identification, data capture and sharing. So, GS1 is to manage barcode standards used by retailers, manufacturers, and suppliers worldwide.
The hierarchy of product packaging. Each level includes a specific way of protecting and identifying the product during different types of handling. Recognized levels include “primary”, “secondary” and “tertiary”.
Primary Packaging Level: It is called the packaging that is in direct contact with the product. It is the packaging level where information about the product is written and ensures the protection of the product.
Secondary Packaging Level: The level of packaging where primary level packages are placed for transportation is called secondary packaging. However, this situation sometimes differs. For example, the box containing the drug blister or the box in which a perfume bottle is located in the retail sales stage is also the secondary packaging level, in this type of secondary level packaging, it is not intended for transportation, but for presentation to the consumer.
Tertiary Packaging Level: It is the level of packaging that is farthest from consumers. In general, the tertiary packaging level is used to protect the secondary level packaging, and most importantly, to transport and store them comfortably.
It is the most basic preferred method for the aggregation process. While a serialized product is a child, the pallet it is placed in has the status of a parent. The serial numbers of all the products in the box are entered into the system and the SSCC label is created and applied to the box. Here is a simple example of the parent-child relationship (hierarchy). In the next stage, the case becomes the child, and the pallet becomes the parent.
A protection label is a method that guarantees that a product purchased by a consumer has not been opened or modified. Thanks to the tamper-evident, the consumer can safely make their purchases. The most commonly used type of labels are transparent ones, but there are also varieties of labels with holograms.
The traceability system, which allows products to be tracked throughout their life cycle, is used in many industries, but the industries where it is widely used are as follows:
- Pharmaceutical and Medical Device Industry
- Food Industry
- Cosmetic Industry
- Agrochemical Industry
- Explosive Industry
Food Safety refers to handling, preparing, and storing food in a way to best reduce the risk of individuals becoming sick from foodborne illnesses or effects. On the other hand, food adulteration is the process of adding foreign or cheap substances to the content of a food product and deteriorating the properties of useful components in the content.
Checkweigher is an electromechanical system that can control the weight of products on the production line without stopping the line and automatically reject products with weights outside the specified ranges.
Brand image is a concept that is shaped by the positive or negative thoughts of consumers about the brand. The most important factor affecting the brand image is product quality. What is more, the correct declaration, content, quality of service, and advertisements may also affect brand image. So with a simple equation; customer satisfaction will have a positive effect on the image, while an unsatisfied customer base will have a negative effect on the brand image.
In production processes, more than one software is used from the simplest level to the most complex. The software that performs the control and communication of the hardware that performs serialization and aggregation operations in traceability operations is Line Manager (Level 2) software. Besides, The Plant Manager (Level 3) is a more complex software that can assign work orders to lines and store serialization and aggregation data with the information it receives from the EPCIS server or Level 4 software. Enterprise Manager (Level 4) software is used by companies with multiple production and storage facilities to provide a coordinated work system between these locations. The main function of the Level 4 software is to generate and manage unique serial numbers for traceability processes. More information about traceability software can be found here.
The concept of blockchain, which is growing in popularity with cryptocurrency, is a digital data system. A registration system in which data is shared and stored on a digital network without the need for a central authority is called a blockchain. Furthermore, it is impossible to change the data. For more detailed information about blockchain technology, you can read our corresponding blog.