Seguimiento de lotes: la importancia del seguimiento de lotes para los fabricantes

The ability for manufacturers to track products from raw materials to the end consumer is not only a matter of operational efficiency, but can impact quality, consumer satisfaction, and adherence to industry compliance standards. Lot tracking is an important component of traceability that should be made a priority for all manufacturers.

In this blog post, we will review the basics of lot tracking and how digital lot tracking software can simplify this process for manufacturers.

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Lot tracking, also known as batch tracking, refers to the ability to monitor a batch of manufactured products throughout the entire supply chain. A batch refers to a group of products from the same production run made under the same manufacturing conditions from the same materials.

A lot tracking system allows manufacturers to assign a unique lot number to a batch and retrieve information about the products such as the source of the raw materials, expiration date, and where the products were stored or distributed. Multiple finished goods can have the same lot number, whereas a serial number refers to the identification of a single product.

The ability to track product batches can be helpful for manufacturers across a wide variety of industries. However, it is most critical for highly regulated industries that produce high volume, perishable goods such as pharmaceuticals or food and beverage products that are most vulnerable to recalls.

Streamlining Compliance

For both food and beverage and life sciences manufacturers, lot tracking is required in accordance with Good Manufacturing Practices (GMP) set forth by the United States Food and Drug Administration. In the current Code of Federal Regulations, the FDA states:

“Records shall be maintained of examinations of raw materials, packaging materials, and finished products, and of suppliers' guarantees or certifications that verify compliance with Food and Drug Administration regulations and guidance documents or action levels.”

Keeping paper documentation of batch records as a lot tracking system is not only time consuming, but prone to human error. A digital lot tracking system ensures audit procedures are followed and all the data is properly captured and stored in a reliable source along the entire supply chain.

Efficient Traceability

Product recalls are one of the greatest challenges modern manufacturers face. From 2017-2020, the United States Food and Drug Administration (FDA) has reported a total of 1,010 recall press releases.

In the New Era of Smarter Food Safety Blueprint, the FDA emphasizes the importance of tech-enabled traceability for comprehensive outbreak and recall response. Having accessible, reliable digital batch records ensures defective or contaminated products are removed from the marketplace as quickly as possible.

Furthermore, having a digital lot tracking system reduces waste associated with product recalls for manufacturers. Traditional methods of production tracking create data silos and leave large gaps in process visibility. In the event of a defective or contaminated product, data captured through lot tracking allows a manufacturer to isolate the root cause of the issue to exact batches and at what point in production the issue occurred. This results in the recall of the minimum amount of products affected rather than losing all products associated with broad attributes like the time range a product was produced. This level of process visibility can even prevent defective or contaminated products from moving to the next stage of production or being distributed.

Gestión de existencias

Lot tracking can help improve inventory management and order fulfillment processes. By assigning lot numbers based on expiration dates, manufacturers can indicate when a product must be sold by and ensure the oldest products are being distributed first.

Batch records can include where the batch is being stored, so groups of products can be easily located, therefore increasing the efficiency of fulfillment operations.

Leading manufacturers in regulated industries are turning to Tulip’s Frontline Operations Platform to digitize their lot tracking processes. With the help of barcodes, scanners, and manual data entry, raw ingredients and products can easily be tracked at every station using Tulip.

Dynamic work instruction apps can be configured to collect key batch information through a guided workflow. Batch, operator, and machine data are stored tables in real-time, and are accessible through a digital history record app.

Using Tulip’s guided workflows to collect information and digital batch records capabilities to view the records, you can accomplish any of the following:

• Crea una tabla en la que se almacenen todos los registros de lote

• Tener la posibilidad de buscar y filtrar esa tabla por persona, lote y otros criterios

• Permitir que un operario registre un nuevo lote antes de comenzar a trabajar

• Ofrecer recomendaciones sobre las cantidades concretas en función del tamaño del lote y de la receta de cada producto fabricado, tal y como se especifica en la BOM en la tabla de instrucciones.

• Comprueba que el operario haya introducido las cantidades correctas de cada ingrediente antes de que pueda continuar.