Drug recalls by the U.S. Food and Drug Administration (FDA) have skyrocketed in recent years, reaching more than 9,000 recalls in 2015.
And while nobody likes to think about the possibility of a recall, having a plan ahead of time can mean the difference between a streamlined recall and widespread public scandal.
The steps discussed in this post can help set you up for a smooth recall process, even if you outsource recall management to an outside consulting firm.
Get Your Records in Order
The first and most important step in preparing for effective recall management is to make sure you have an efficient, organized and easily accessible recordkeeping system.
Once you or the FDA initiates a recall, you will need to provide a vast amount of information in your recall submission, including:
- Product information such as lot numbers, labels, product description, expiration dates, licensing and registration numbers.
- Recall information on the product defect, copies of test results and sample analysis, how the problem occurred and complaint details.
- Health hazard assessment that details the health risk associated with the defect.
- Distribution information detailing all the entities to which you sold the product.
- Recall strategy information on how you plan to contact the companies and patients who received the product.
Open the Lines of Communication
It’s important to establish effective systems of communication before a recall occurs, something that will improve the efficiency of your everyday operations. Again, you should leverage the QMS here rather than relying on email for communication.
Email is inefficient for several reasons:
- Information is easily buried or lost altogether.
- Separate email chains can lead to conflicting information or decisions.
- It’s difficult for your team members to access important information.
The QMS efficiently centralizes key communications around recall information. This will save many hours (and likely mistakes) as you:
- Collect information from various departments related to the recall.
- Record results of effectiveness checks on communicating recall information to the public.
- Provide status reports to the FDA, which can also be useful for keeping management informed.
Manage Feedback Proactively
Another key strategy to streamline potential recalls is to manage consumer complaints proactively. Effective complaint handling helps you detect problems earlier, which can help limit the scope of the recall.
Within the QMS, you want to leverage Complaint Handling tools that allow you to:
- Collect all pertinent details related to the complaint.
- Launch any necessary investigations or corrective actions.
- Report on complaint trends to get a high-level view of where you might have a problem.
Establish a Risk-Based Compliance Assurance Process
Often, a product recall comes with increased regulatory scrutiny from FDA. To ensure that you can survive the heat—and potentially prevent other problems in the first place—you need to have an effective compliance assurance process established.
Many companies use some form of the following process to ensure regulatory compliance:
- Track all applicable legislative and regulatory requirements in the QMS.
- Link each requirement to existing controls.
- Identify gaps where requirements do not have controls, or where controls are likely insufficient to prevent a problem.
- Assess the risk of each gap to prioritize the high-risk areas where you should implement new controls.
Of course, the best way to manage a recall is to prevent it in the first place. Having these systems in place is a solid first step, allowing you to take a risk management approach to monitoring production, managing suppliers and verifying that products meet specifications. While problems can be difficult to predict or control, preparing ahead of time is what ultimately will help stem your losses and protect your company’s reputation.