Top 3 Ways the QAD Traceability Module Reduces Product Recall Risk

Posted on: May 4, 2021 | By: Ethan Naegele | QAD Manufacturing, QAD Business Process, QAD Distribution

The word “recall” is enough to keep medical device manufacturers rolling in their beds at night. With the scope and size of the industry, even small failures in tiny parts can mean incredibly costly fixes. Having a way of limiting the impact of a recall is something that’s always worth exploring. This article discusses the disastrous effects that recalls can have on medical device manufacturers, as well as three features of the QAD ERP that medical device manufacturers can leverage to reduce the chances and impact of product recall.

The Effects of Recalls on Medical Device Manufacturers

34 medical devices were recalled by the FDA in the United States from January 2017 to September 2019. We know that such recalls are worst nightmare scenarios for medical device manufacturers, but just how damaging are they? A McKinsey report has found that the costs of a product recall can be up to $600 million and about a 10% loss in shares. Not to mention, the need for a medical device recall means that the patient has been put in potentially life-threatening danger. With all these costs in mind, manufacturers will look to find the most effective ways to reduce recall risk.

To help mitigate these risks, many manufacturers are making an effort to more accurately identify supply chain shortcomings. Otherwise, the necessary recalls may be delayed. One question that arises for manufacturers is how to better identify these shortcomings in the supply chain. Fortunately, the QAD ERP application offers a traceability module that can help to limit a manufacturer’s chance of recall exposure by doing just that and more. Here are the top 3 ways that the traceability module can help manufacturers reduce this recall risk.

1. Serialization

Whenever goods are received, either through purchase orders, work orders or production schedules, a lot or serial number can be attached. This attachment process can also facilitate the building of intelligent lot or serial numbers. This, in turn, can allow the user to track information on an item or set of items such as the expiry or manufactured date, along with the site where it was produced. All reports, browses, picklists, production orders, pre-shippers, shippers, and any other documents will reference that lot or serial number. Additionally, when transferring, consuming, or shipping those goods, the lot or serial number is referenced. By doing this, users gain insight into where their products are coming from, where they are going, and when they may expire.

2. Lot Trace Workbench

Using the Lot Trace Workbench, users can trace lot creation and usage throughout the entire process. If a customer has an issue with a product, users can trace it to when the manufactured parts were produced, to when the raw materials were received, to which supplier sent the materials and when the materials were consumed in the production process. Similarly, if a supplier discovers an issue with a raw material, users can trace it to when those raw materials were used, to which finished goods may be affected, to which customers may be affected.

3. Test Specifications

Additionally, users can configure test specifications to record quality information. If users need to certify that raw materials or finished goods meet certain criteria, they can set up test specifications to test against and produce Certificates of Conformity, if required. Any lots or serials that fail to meet the criteria can be sent to a rework area, or rejected completely, to ensure that only high-quality product is delivered. In this way, users can limit the potential for failure.

Next Steps

If you are interested in learning more about traceability and how you can maximize benefits from QAD ERP software, please contact us here.



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