How to Use Digital Threads to Handle Product Recalls
July 14, 2022
The Current Scenario of Product Recalls
The U.S Food and Drug Administration (FDA) recently published industry guidance for recalls. Named”Recalls Guidance for Medical Device Manufacturers.” This guide provides recommendations on preparing voluntary product recalls and offering FDA rapid response. Both of which are vital in an age where technology is a driving force across every facet of our lives. To ensure your company is prepared for a recall and can quickly respond, the FDA recommends having a digital thread (PLM) before or simultaneously initiating the recall process.
The FDA provides information and recommendations for companies doing recalls. And those who may need a recall if their products are on the market. To ensure the safety of consumers who use medical devices, it recommends proactive work to create a PLM solution to improve recalls.
Becoming recall ready with a digital thread is a crucial step in helping ensure patient safety. With such an impactful subject, it’s easy for even the most substantial companies to lose sight of what’s at hand. By being prepared with the right PLM solutions, you can respond faster when a recall situation arises. Furthermore, you can more effectively manage your product recall process.
Becoming Recall Ready
A digital thread can make it easy to prepare for product recalls. This is done by tying together many different resources into one place. It’s a proactive way of protecting your company and getting ahead of what could be a detrimental situation. By following the steps laid out by both the FDA and CPSC, you are not only mitigating the risks for your company but also for consumers. It is essential to identify what types of products will be recalled. So that you know how many items need to be reviewed before announcing a recall and who needs to receive the information first.
Below, we discuss some general considerations that manufacturers can take in advance of potential product recalls:
- Establish a recall communications plan.
- Identify appropriate personnel and train them on their responsibilities.
- How a digital thread can help prepare for product recalls.
- Identify relevant products and use good product coding.
What to Include in Your Recall Communications Plan
Products to be recalled
An easy way to ensure that the products are recalled is to use a unique code for each product instead of one code for all products. Ideally, it should be a principle that all manufacturers would have. This way, if one part of the company has received a recall notice and another hasn’t, two identical notices were sent with two different codes. It will be much easier for the company’s customers who receive the information to know if it applies to them.
The Reason for the Product Recall
What will the recall be for? Who is responsible for communicating about the recall? Will it be a high-level corporate executive or a lower-level employee who can understand and relay the information to affected customers?
The Affected Product(s).
What products are affected by this recall? If multiple products are being recalled, will different parts of the company have other notices sent to them to notify everyone about it? This could lead to confusion.
What Customers Should Do.
It’s always crucial that customers know when a product has been recalled. What they should do in light of that fact, and contact customer care where they can get more information.
Establish a Recall Communications Plan
Organizations need to have a clear and defined communications plan in the event of a product recall. This will include who is responsible for releasing messages. Also, what information should be included, when such communications should be removed, where the letters can be accessed, and how consumers should react when they’re affected.
Product recalls are not just an exercise in communicating with customers. It’s an opportunity to conduct root-cause analyses. This helps to identify any issues with your product or process that led to the problem. But more importantly, it’s another opportunity to inspect your overall quality and manufacturing processes to see if any issues can be addressed before they become serious safety hazards.
Additionally, if a product recall is needed, keep the product off the market until a fix is found. If it would be too difficult for you to keep an entire line or entire product off the need for an extended period, then at least make sure that people who can’t avoid using the product (e.g., children) are not exposed. It’s better for consumers for businesses to take this step instead of scrambling when their products start making customers sick.
Benefits of Recall Plans
The ability of companies to take advantage of the media’s need for news and information about a recall should not be overlooked. Take advantage of this opportunity to drive more traffic to your company website, social media profiles, or whatever you have in place that allows you to share your story. Taking steps to ensure you’re going to be a part of the ongoing conversation means crafting your message, identifying who will say what, and working with journalists and bloggers who are already writing on your behalf.
Recall or not, if consumers want to learn more about the products they buy, they go to the manufacturer’s website. If your recall involves several products with complex (or even simple) histories, make sure you have a system that allows easy access to that information. If a recall requires a mass mailing of product literature, consider how much of this can be put online so people can read it at their convenience. A well-maintained and updated website is essential at times like these.
What to do During a Recall
During a recall, distributors and retailers should be able to quickly and easily see which products have been recalled for examination. The digital thread enables fast traceability of all results and metadata from any suspect product back through all stages of production to initial test results. This allows operators to see which batches could be affected and take appropriate action to contain the issue.
The digital thread consists of a set of data structures. Each frame contains details on a manufactured product, such as its serial number or batch number, the initial test results (including parts per billion), or who placed an order for it in what channel. All the data structures are linked together through powerful database queries that help operators review each alert against current production data. The digital thread also includes an audit trail of all performed activities for each product. Which can be used to track every step taken in the production and testing process.
Therefore, any operator or manager with access to the digital thread can easily see which products are associated with a recall and quickly review all activities related to a specific lot. This way, operators can take appropriate action without disrupting their daily business activity.
Consequences of Failure
Experienced professionals’ Digital traceability programs do not work without the support of quality and manufacturing professionals. These professionals understand their role in managing communication, investigation, and audit activities. Such professionals must have complete access to information systems and understand how to find, analyze, report, and act upon relevant information. Failure to put such procedures in place will undermine the very purpose of digital traceability.
Furthermore, failure to implement a meaningful recall procedure is one of the most common reasons for product recalls. This is due to flaws in the manufacturing process or failure to adhere to necessary regulations. Recalls are often announced years after problems begin surfacing because companies don’t acknowledge their existence. As they don’t know how or where they originate on the supply chain.
Product recalls are detrimental to a company’s growth. They are time-consuming and cost the company both monetarily and in terms of brand image. One can mitigate or even remove the damages caused by implementing a strong PLM platform such as KloudPLM.
Our cloud-based secure platform helps to design, process, and formulate product manufacturing processes. Streamlining the manufacturing process, and reducing product errors. Schedule a demo today to know more,