Admittedly, the fear of recalls is a good selling point for a label management system. At best, this is a bit trite and hopefully not your biggest concern when it comes to labeling. Nevertheless, we think it is important to address this issue. In this article, we’ll show you what makes labelling errors more likely and how you can minimize this risk.
Product recalls due to wrong labeling
Risk management in labeling
Risk management is a prerequisite for all companies certified to ISO 9001. However, its effectiveness is very company-specific, and sensitivity to risk is usually a characteristic of the industry in which the company operates.
So which industries are risk-sensitive?
The life sciences market with its sectors: pharmaceuticals, medical technology, chemicals and food are already very risk-sensitive sectors by law. As these products are used in or on humans, they are subject to strict quality controls. Last but not least, labeling is of great importance here.
The products and their ingredients are identified and distinguished via the labeling. But also their use, handling and application is often indicated on the labels. Industries such as automotive or electronics also have a high risk sensitivity, as they have to manage mass production and human risks.
Every industry therefore has its own challenges when it comes to labeling. Find out which labeling challenges are important in your industry on our industry pages.
Which companies have the greatest risk?
We think that the risk is related to the company and not just the industry. Taking the food industry as an example, you can find several examples of product recalls on the internet due to the incorrect labeling of allergens (these must be specifically highlighted in the EU since December 13, 2014).
Whether this is an indicator of a particularly sensitive industry or not is for everyone to judge for themselves. However, these cases show how, for example, a new regulation can lead to product recalls. This is solely due to a supposedly minor adjustment in the labeling.
Need help with allergen labeling? Our experts will be happy to help you with the implementation.
Effectiveness of risk management
The effectiveness of risk management, in terms of labeling, is reflected in three important points:
Is labeling part of your risk analysis?
Without delving into the details of the risk analysis, the question arises as to how well the labeling process is mapped in your risk management. What is primarily important to us here is what conclusions and risk measures you have derived from this. Are you responsible for labeling in your company?
Then ask yourself the following questions:
Historical incidents in the labeling
Recurring or frequent incidents in labeling are a bad omen for risk management. They cast doubt on the effectiveness of risk management and therefore also increase the risk of a product recall. You should therefore record these incidents with a view to the history and assess them regularly.
Prevention of product recalls
Process design is where you have the most leverage to prevent product recalls. Three keywords are crucial here:
Single Source of Truth
Ideally, you have all the “original” data for labeling available in one system. A label management system accesses these original data sources directly and only formats them if necessary.
If you have the original data in different systems and can access it directly for labeling, this is also “single source of truth”.
If the original data from different systems is aggregated in one system, in the sense of a copy of data, you abandon the “single source of truth” approach. In such scenarios, the risk of errors in monitoring interfaces and data synchronization increases enormously. It should also be mentioned here that there is a much higher risk of errors with manual entries.
Fortunately, this is not often the case nowadays, but it was not uncommon in the past to save data directly in the label template. It is obvious that this creates a high potential for errors. With the label designers offered by OPAL, you can create generic templates to transfer the data to the label via variables. Read more about the generic approach here.
Data integrity
How trustworthy and secure are your data?
High data security is achieved through encryption, change traceability, multi-level approvals and authorization rules.
On the one hand, trustworthy data is created when it is ensured that the data can only be created or changed by people who are authorized, trained and experienced. On the other hand, it must be ensured that incorrect entries (data format, field length, etc.) are intercepted by the system and that changes require verification, for example using the dual control principle.
The OPAL Content & Alert Manager informs you (alerts) about changes to data and labels at any time. Changes are only applied once they have been checked by various people in the approval process. More details on the Content & Alert Manager.
Single Point of Management
Central management means that you can find out centrally and across all processes when, why , and where a label was printed with which data content. If you have different systems for different labeling processes, and as a result different interfaces and persons responsible, the complexity increases and with it the risk that a change has only been implemented in one system but not in the other, or even that it has been changed.
With OPAL LABELMANAGEMENT, you can manage all labeling decisions centrally in one application. Further advantages of centralized label management can be found here.
Our panic index for labeling
How panicked should you be about a product recall based on a labeling error?
You can use this checklist to measure the panic index:
| Question | No panic | Panic rises |
|---|---|---|
| Is the labeling process classified as business critical? | Yes | No |
| Is the label template selected automatically for a print process? | Yes | No |
| Is some of the data printed on the label entered manually? | No | Yes |
| Is there a documented and traceable process for changes to label templates? | Yes | No |
| Is there a documented and traceable process for changes to data printed on the label? | Yes | No |
| Are labels approved using the dual control principle? | Yes | No |
| Do you verify the printed labels by machine or visually? | Yes | No |
| Do you have an authorization concept for the creation and modification of labels? | Yes | No |
| Have you validated your labeling system? | Yes | No |
| Do you use different solutions for different locations, products or processes? | No | Yes |
How to make labeling a success factor
“Risks are always opportunities too” Everyone knows this saying, but we find it very appropriate here. Labeling is and remains a risk factor for product recalls. This is therefore an opportunity to counter this with a sophisticated and comprehensive label management system, and not “just” a printing program.
Eliminate today’s weaknesses in labeling and make it a success factor for your business.
Would you like to learn more about it?
Our experts will be glad to show you how to minimize your risks.
