The heavy reliance that companies place on manual processes and disparate labeling systems is more times than not at the route of product recalls. In 2018 alone, labeling issues made up 9% of all medical device recall events, which comprised of the return of over a million units. For a business, the consequences are costly, with the average label change sitting at $350,000. However, despite the availability of automated technologies created to tackle these very issues, numerous companies still persevere with out-dated processes which leave labels exposed to error.
As regulations tighten, the cost of non-compliance is high. Labeling recall is therefore a predicament that manufacturers can no longer ignore. Targeting these issues will both enable manufacturers to eliminate that element of risk from the business as well as liberate a number of cost-savings.
In 2012, 10% of product recalls were label related; nothing has changed. If anything, this statistic is only going to accelerate in response to the introduction of new regulations as well as the rising demand for increasingly detailed and complex label content. Companies need to rethink their labeling infrastructure, of which four common scenarios stand out:
1. The risk of the wrong label
It doesn't take much. The consequence of a stray label or an IFU could be the cause of a product recall. Companies need to take precautions to avoid this as manual or weak processes could put the process in jeopardy.
The answer? Putting the right labeling system in place. Companies have two options: a ‘just in time’ labeling and IFU which prints at the packaging phase, or an integrated solution, which through pulling label-specific content from other systems offers Master Data Management. By doing so, companies are given the ability to make sure that reconciliation is correct, bestowing them increased control over the labeling process.
2. Batch integrity
There is always risk of the unexpected. Although the labels may already be approved, unforeseen issues such as hardware or software failure can be the cause of printing errors which can lead to breached regulations, and consequently recall. To tackle this, organizations need to ensure their structure is sturdy. Companies can no longer rely on manual and random inspection, batch integrity can only be achieved through improved automation. Standalone vision inspection systems or semi-automated inspection processes are good options. Through 100% automated inspection of all labels, Vision systems enable you to inspect every field on every label at the time of printing; a process that not only cuts down batch time, but also minimizes the chance of mistakes.
3. Local and international regulation
The management of market specific content can prove to be a considerable challenge. There are many complexities involved. Not only do all of the processes need to respond to the nuances of local and international regulation but they also need to be powerful enough to label products for multiple countries within a single label. In light of language translations, UDI requirements and symbology, this is a process which cannot be successfully managed manually though the deployment of humans, as it’s not just time consuming, but also both costly and risky. Instead, an automated labeling solution offers a safer alternative which can take control of master data sets. Through a ‘regulatory rule engine’ some label systems can even ensure all labels are compliant with the local regulations.
4. Undetected changes
By putting a process in place which is able to identify the source of master data errors, companies are able to decrease the risk of human error occurring. However, companies must also ensure that their system has been through the right checks, and has all of the tools in place, as without this it still runs the risk of producing costly master data errors. As a case in point, modifications to an ERP system run the risk of imposing undetected changes to the label if the system is without mechanisms which can approve workflows. A way of knowing if your system is effective is by whether it has a Notification Centre, as this will alert any users to outstanding errors or tasks relating to supplementary data.
Big or small, recalls are costly for any manufacturer, never mind the serious impact that they could have on humans. However, automation offers a traceable and robust system which can mitigate any potential risk.
In order to reach this point, a comprehensive view of labeling operations and touchpoints in relation to the rest of the organisation means that you aren’t attempting to resolve any issues in isolation. First, organisations should assess the market risk, and then as a result, invest in a labeling platform which is able to comply with the specific regulations; the benefits will follow- many companies are already saving millions annually just from this move alone.
With the ever changing landscape of technology, there are now solutions on offer fit for every type of organization, from Cloud/Saas and Hosted to On Premise. Yet, for many, the implementation of these services is still accompanied with apprehension, a barrier which many vendors have responded to with a ‘lifetime partnership’ approach’, which helps to ease any anxieties and smooth out the transition. These automated solutions can end the recurring insanity of labeling recalls and offer control, efficiency, and profitability. And it couldn’t be easier- automation is the first step to future proofing operations within the labeling supply chain.