Edition 94
Smart QR Labels and Product Recalls in the Medical/Pharma Industries
by RLA Standards Committee , , Reverse Logistics Association

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Product Recalls are especially disastrous in medical applications. Not only do they incur potential liabilities, but they have a lasting impact on branding and corporate reputation. None the less, they are inevitable. Whether through supply chain snafus or human error, such calamities may occur. All corporations must be prepared for such events.

Your company will be judged on the effectiveness and timeliness of your response. Using Smart QR Labels (12N codes) can improve your processes measurably by providing more information in less space in your product labels. Furthermore, the information will be accessible in the field through any smart-phone. This means that end-users-- whether medical professionals or even consumers will be able to accurately identify items under recall simply by scanning a QR code with their phone.

How would this work? There are more than one way to implement such a system using Smart QR Label (SQRL) codes. In all examples, the manufacturer (or distributor) would put a specially created QR code label both on the actual device and the packaging before shipping to customers. That label would be encoded with sufficient information such as serial numbers, batch numbers, date of manufacturer, place of manufacture, etc. The granularity of the data would be defined by the manufacturer. Obviously the more information provided, the more precise the recall. The capacity of the label is 4000 characters which can include multiple web addresses (URLs). Putting the label on the packaging allows for products to be identified that are still “on-the-shelf” while labels on the actual product will identify products in-use. The labels can be paper, plastic or even etched onto products and can be as small as 1/2 inch (though label capacity is tied to label size).

Once labeled, product recall protocols can be implemented that properly and accurately identify defective items. The items to be recalled can be identified as broadly or as narrowly as the manufacturer deems necessary. Another Smart QR Label (SQRL) code is created for the recall campaign. This can be mailed with the recall notice as a paper image. The image can be emailed and/or posted on websites. Customers can scan it with a smart phone or an industrial scanner. It will down-load a small applet onto their phone. Using that phone with the applet, the user would simply scan the product in question: the applet would reply with either a message that the product scanned was safe or with directions of how to return it if it is identified as defective. The user experience in the process would be smooth and simple. The information would be accurate, secure and build confidence in the manufacturer’s professional response to an unfortunate situation.

An alternative, but equally re-assuring protocol would involve the customer registering a product. In this case, the QR code on the product (with all the relevant information as above) would indicate that the user should “register” their product by scanning the code. In this scenario, the user’s scan would instigate a registration process that would collect the user’s data from their phone (name, address, etc.) along with the product details encoded in the label. With a single click, the product would be registered with the pertinent data. That data could be searched for the recalled items and a targeted communication could alert the user to the situation. This solution for medical devices provides even more granularity for precision recalls.

The first method is ideal for pharmaceuticals and food products. Because of the capacity of the QR code technology, using the Smart QR Label protocols developed by the Reverse Logistics Association allows the recall information to be inconspicuously merged with additional fields of information that would be useful to consumers. Side effects, drug interactions and ingredients can all be included in the same label.

This smart label protocol, recently approved by ANSI (MH10.8.1.12N) enables multiple fields to be included in a single, compound label. When the reader application scans the code, it displays a menu of the fields on the smart phone screen. One of those labels would read “Recall Information.” That field would contain a web address created for each product. When not on recall, that page would simply read, “This product is safe to use. Thank you for being our customer….” Because this field is mingled with other fields, it does not bring undue attention to the reality of product recalls. However, it would give peace of mind to consumers who heard rumors of product problems—even if related to another manufacturer’s product.

Regulatory practice necessitates the inclusion of disclosure information for pharmaceutical products. While not replacing these documents, allowing access to them from a smart phone will please consumers since the fine print and complex content of such documents are overwhelming. Accessing the same information on the web allows for more readability and hyper-linking of data to provide a richer and more understandable product description. One label does it all.

The second method described above is ideal for medical device product registration. With a single click, consumers can register their products with 100% accuracy. Customer ID from the smart phone reduces the risk of typos. The product recall notices would be targeted directly to those registered.

For more about how this new labeling system can help you with developing protocols for product recalls, contact the Reverse Logistics Association at info@rla.org, or visit our website at rla.org/sqrl. The RLA is a trade association focused on best practices related to reverse logistics. The 12N protocols were developed by its Standards Committee.
RLM
RLA Standards Committee

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