If the organization does not already have one established, a recall plan must also be developed at this point. A recall plan is an important part of an efficient recall management system. Every organization should have a recall plan and should conduct drills to ensure the plan’s effectiveness. This helps to guarantee that, in the event of a recall, all of the necessary steps are executed thoroughly and correctly the first time.
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Explore This IssueFebruary/March 2010
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Process automation using technology solutions like quality management systems can help mitigate recall risk by drastically decreasing the chance of human error and providing visibility and traceability down the food chain.
The recall plan covers everything from submitting information to the FDA to notify the public to evaluating the recall. It is essentially the company’s map of the recall process, directing the manufacturers through each step of the process. For example, the organization will need to describe the notification method and how it will be sent (overnight or facsimile, for example).5 The company must submit a report stating exactly what information has been communicated to customers who already have the product. If the product must be returned, the organization must also state exactly how it will conduct this process. There are several QMS tools that can help with issues that come up during a recall.
Corresponding QMS Solution—Complaints: A QMS complaints application can help by logging and keeping track of all complaints. A complaints application manages the investigation and resolution of customer complaints in compliance with FDA guidelines.
Corresponding QMS Solution—Product Returns: Traceability is key when conducting a recall, because the company must retrieve all defective products within 30 days. This QMS function enables the organization to identify and track various returns and identify the return reason, as well as the material and quantities that must be returned. This function must also record and track the disposition of the returned product.
Corresponding QMS Solution—Notify the Public: Once the recall information has been submitted to the FDA and the recall plan has been established, the organization must then notify all parties involved or affected. This can be done through various media channels, whether through press releases, recall notification letters to consumers and facilities, or similar channels. All recall notification letters must identify and describe the problem as well as explain the depth to which the recall has been implemented, whether it is retail, wholesale, or user level.5 This step must also include detailed return instructions for customers and a return response form.
Corresponding QMS Solution—Document Control: Having the required documentation such as notification letter templates, Web site templates, press release templates, work instructions, and similar records is key to providing a quick response in a recall. Using a revision-controlled document control system, an organization can ensure that the necessary documentation is available within the system and is accurate and controlled. This type of system also ensures management of the creation, approval, distribution, and archiving of these controlled documents.
Corresponding QMS Solution—Evaluate the Recall: Once the public has been notified and the recall has been initiated, the organization must then conduct a recall evaluation. This will enable the organization to benchmark its effectiveness and assess the progress of the ongoing recall. During this stage, the company must create recall status reports, which should consist of the date each customer was notified, the number of customers notified, the number of customers who responded, the quantity of product that was accounted for or returned, and the details of the effectiveness check.
Once the root cause of the recall is discovered, this information should be sent to the local FDA district recall manager, along with any corrective actions that have been established. A recall termination call is the final step and can be started once all parties involved have been notified and all traces of the product have been recovered. Before the FDA will consider termination, a final status report should also be sent to the local FDA district recall manager.5