A serial number in any manufacturing business is exceptionally critical. Without it, it can be difficult or even impossible to trace a manufactured item’s origin, batch, quality, and other production-relevant attributes.
Therefore, serialisation is a necessary part of the manufacturing process and must continue to evolve as the operation’s needs change. That’s because it paves the way for manufacturers to seamlessly manage their production cycles and supply chain operations and further improve the consistency and efficiency of processes.
Yet serialisation is often one of the most overlooked manufacturing processes. Often, manufacturers spend too much time and effort manually analysing data to identify any problems in the serialisation process. This causes billions of dollars each year to be lost due to counterfeiting.
One of the biggest challenges with serialisation is keeping up with how fast the line is moving. It’s a problem that all serialisers face. For example, manufacturers might want to record the state of a complex object at every step in its lifetime so that if something goes wrong, they can figure out what happened.
But how do they keep track of all those changes? They’re constantly adding new information and removing old details as an item progresses through production. So, to make sense of what’s happening and why, they need a way to record these state changes that also produces a continuous stream of information that doesn’t require slowing down the line.
The integrity of the data is critical to ensure that it can be used for future analysis and decision-making. Data management requirements include identifying, collecting, storing, and validating the data set.
In addition, organisations should consider the consequences of incorrect or missing data when determining whether to use a serialisation approach or not.
For example, if gaps in the serialisation process result in missing data, there may not be enough information to reconstruct the entire product history. This could impact decisions around recall strategies and inhibit other risk mitigation plans.
Some companies have been using serialisation for decades, while others are just starting with its implementation. Regardless of where your organisation falls on this spectrum, integrating new technology into an existing system can be challenging. It forces you to consider how the current processes might require transformation to work accurately with this new technology.
Consider employing ERP integrations that offer integrated inventory management and serialisation capabilities as one way to make integration more manageable and efficient. Such integrated solutions allow you to quickly and easily incorporate new processes into the existing infrastructure without disrupting other operations or compromising data integrity.
The possibility of human error increases as more steps are added to a process. And these errors can be costly and lower the quality of the final product.
Suppose an employee does not follow through with a step or checks off a box they are supposed to be administering. In that case, this could result in incorrect information being entered into the database or, worse, no information being entered at all.
This means that manufacturers will be working with inaccurate data, which could cause problems down the line when trying to track down an issue or initiate a recall.
This can be avoided by automating the serialisation process as much as possible. Automation will also help save time on repetitive tasks as machines would undertake them.
The manufacturing industry is one of the most regulated industries in the world, and it’s getting more regulated all the time. The current regulatory climate will likely increase in complexity and cost over the next few years, so companies will need to invest even more heavily in ensuring compliance with these regulations.
In essence, manufacturers must comply with multi-fold requirements when implementing serialisation processes within their facilities. Not only do they have to follow the standards of their industry, but also those of their state.
In the United States, for example, Food and Drug Administration (FDA) requires all medical devices to be marked with an identifying number before being released onto the market.
When dealing with multiple standards across multiple states and industries, keeping track of each of these updated parameters can become problematic, which qualifies as a serious serialisation challenge.
Indeed, several challenges come to the fore in the serialisation arena, hinting even more pressingly at the importance of implementing accurate, efficient, and reliable serialisation processes.
But to run a serialised material manufacturing facility, you must realise best-in-class compliance and technology and avoid common pitfalls that can hamper the efforts.
That’s precisely what experts at QodeNext can help you with. Reach out to us today.
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