There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing Recall Management. Let's face it—no one likes talking about recalls; there is no positive side to recalls, and certainly no one "wins" when a product is recalled. This is a double whammy when you are a medical device manufacturer—not only are you recalling a defective product, but you are also facing regulatory scrutiny and potential customer endangerment. So when I speak about medical device recalls, many are apt to have a system in place to manage processes in the unfortunate event of a recall. The critical factor in this case is what system is best suited to effectively and efficiently manage the recall process?
The FDA website states, "A well-built Quality Management System should reduce the number of (or prevent) recalls, returned or salvaged products, and defective products entering the marketplace." Recall Management is a necessity in businesses today; the best and most effective means to automate recall processes is through an automated Quality Management System (QMS), which enables seamless compliance with the best practices of Recall Management.
Best Practices of Recall Management
Implementing a Recall Management system using an automated QMS guides an organization seamlessly through the recall process and enables integration with other functions across the enterprise. So what areas of recall management can a QMS provide solutions?
1. Submit Recall Information to the FDA: Once it is determined that a product or device warrants a recall, the process must be swiftly put into action. The FDA must receive all information related to the product such as the name and information of the recalling firm, name of manufacturer, as well as the reason for the recall, including a description of exactly how the product is defective, how this has affected the safety of the product, and the date the issue occurred. An FDA Health Hazard Evaluation (HHE) form, which shows the organization’s assessment of the health risk, must be completed and sent to the FDA. The company must also include the volume of product that was produced. They will need to submit the quantity and dates of distribution and the amount of product that is on hold due to the recall. They will then need to submit the distribution pattern and inform the FDA of the number of direct accounts that they deal with in order to retrieve all products back from facilities and consumers.
A recall plan must also be established at this point if the organization does not already have one in place. A recall plan is an important part of an efficient Recall Management system. Every organization should have a plan in place in the event of a recall and should conduct drills or “mock recalls” on their plan to gaurantee its effectiveness. This helps to ensure that in the event of a recall, all of the necessary steps are executed thoroughly and correctly, the first time. The recall plan covers everything from the submission of information to the FDA and how the public will be notified to the evaluation of the recall. It is essentially the company’s “map” of the recall process, telling them exactly which direction they need to go for each step in the process.
QMS Solution—Complaint Handling linked to MedWatch (eMDR): QMS functions such as Complaint Handling can help in this process by logging and keeping track of all complaints in the QMS. A Complaint Handling application manages the investigation and resolution of customer complaints in compliance with FDA guidelines. For Life Science organizations, a benefit of many QMS solutions is the ability to integrate directly with the FDA's Electronic Submissions Gateway using the electronic MedWatch Form (eMDR). This allows the user to create reports of adverse events affecting a medical device organization from the QMS and send them directly to the FDA, bypassing the need to fax or mail in reports—resulting in faster response time.
2. Notify the Public: Once the recall information has been submitted to the FDA and the recall plan has been put into place, the organization must then notify all parties involved. This can be done through various media channels, including press releases or recall notification letters to consumers and facilities. All recall notification letters must include the identification and description of the problem, and the depth to which the recall has been implemented, whether retail, wholesale, or user level. This step must also include detailed return instructions for customers as well as a return response form.
QMS Solution—Document Control: Having the required documentation such as notification letter templates, website templates, press release templates, work instructions and similar records is key to providing a quick response to a recall. Using a revision controlled Document Control system, organizations can ensure that the necessary documentation is available within the system and is accurate and controlled, and ensures management of the creation, approval, distribution and archiving of these controlled documents.
3. Evaluate the Recall: Once the public has been notified and the recall has been initiated, the organization must then conduct a recall evaluation to check its effectiveness. This will enable the organization to benchmark its effectiveness and assess the progress of the ongoing recall. During this stage, recall status reports must be created. These status reports should consist of the date each customer was notified, the number of customers who were notified, the number of customers who responded, the quantity of product that was accounted for or returned, as well as 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 at this point. Termination of the recall is the final step and can be started once it is determined that 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.
QMS Solution—Corrective and Preventive Action (CAPA): In addition to determining root cause and investigation, the CAPA provides a method for recording and tracking any corrective actions taken, as well as verification of effectiveness of the corrective action. Using Quantitative Risk Assessment, organizations can conduct a Risk Assessment at the root cause phase, as well as at the effectiveness phase, to ensure that corrective actions reduce the risk or recurrence to acceptable risk levels. An automated CAPA should have the ability to generate multiple report types throughout the process, including a CAPA history report which details the CAPA process from start to finish, as well as any other related records that are critical to the CAPA. This type of reporting is critical to the recall process, and provides complete transparency when submitting information to the FDA.
QMS Solution—Change Management: Forty-four percent of medical device recalls are caused by inadequate design control. Change Management links quality into the product lifecycle and maps quality at each step in the process starting from product design. Change Management applications provide the workflow and business rules necessary to execute and manage a change within the organization across multiple operational areas. Design, supply chain, production, and post-market data are all linked to a holistic Change Management process, with quality and compliance as the backbone. Furthermore, the recall information is integrated into every phase of the Change Management process, enabling the data retrieved during the recall to be factored into the design, production, and execution of the change. This ensures that once the recall is closed, the Change Management process “learns” from the data collected, and mitigates the risk of recurrence in the next product lifecycle.
In many ways, a recall can be seen as an emergency process for crisis management. Much like a crisis management plan, you need to have the process outlined in detail, and you need to practice what needs to be done in the event of such an event. So too is the Recall Management Plan. Companies run "mock recalls" to make sure the process is seamless and effective, and need a system that will have the workflow and business rules to ensure efficiency. Quality Management Systems provide the framework and processes to help companies plan for the worst and hope for the best.