what does recall readiness mean for a product recall when developing a mock recall plan and exercise

Imagine the scene: You wake up, turn on your laptop, and read your emails. There’s a message from someone at your legal department:

“We’ve received a product recall notice from the FDA. One of our products contains a dangerous ingredient. We need to act now.”

The FDA (and other federal agencies) issue warnings like this all the time. They typically post information about recalls, corrections, and removals on their website when a product violates the law. At this point, it could be too late. You might not know what to do because you lack a proper product recall prevention strategy.

That’s why it’s so important to plan. Preparing product recall responses now will improve product safety and liability and protect your business reputation.

How a Product Recall Notice Affects Your Organization

The cost of a product recall is, on average, $10 million, but it can reach over $100 million in some cases. That’s because many organizations are completely unprepared for a product recall situation and don’t know what to do.

Responding to a recall notice is much more than removing affected products from supply chains. You need to:

Respond to the FDA (or other government agency that issued the notice) on time or face expensive penalties for non-compliance.
Remove affected products from retail stores and other physical locations, which requires a lot of logistics.
Issue press releases and statements that reassure the public about your safety protocols. Otherwise, the product recall could damage your business reputation.
Change your supply chain workflows because of the recall.
You might even need to compensate affected customers.

You won’t have long to execute these tasks. Plus, the longer you take to respond to a recall notice, the more damage you might do.

Why You Need a Mock Recall Product Prevention Strategy

The FDA recently published its final guidance outlining steps companies should take to develop recall policies and procedures that include training, planning, and record-keeping to help significantly reduce the time a recalled product remains on the market. The purpose of this guidance was to clarify FDA’s recommendations for industry and Agency staff regarding timely initiation of voluntary recalls under 21 CFR part 7, subpart C – Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities.

The FDA guidance describes an array of best practices for creating, testing, and executing a recall plan. Because of the FDA’s heightened expectations, along with the greater risk and complexity involved in today’s recalls, training – including regular mock recall exercises – has become an essential part of the recall preparation process.

It is imperative that your organization plan, train and test for a product recall. This includes developing and executing mock recalls at least twice a year.

You might think a product recall notice won’t affect your organization, but what if it does? Creating a prevention plan now enables your team to act quickly and more effectively in a recall situation so you can avoid product safety and liability penalties. Here are some benefits of creating a prevention plan:

Identify recovery goals for your business in the event of a recall.
Identify recovery tools and technologies that improve recall responses.
Speed up recall response times.
Define department roles during a recall.

Consumer Product Recalls and Compliance Issues in 2021

What to Include in Your Prevention Plan

Your prevention plan should describe the steps to take after receiving a product recall notice. Include instructions for your entire organization or create specific prevention plans for different departments (legal, compliance, manufacturing, production, PR, etc.). Here are some steps to include:

How to reach suppliers, partners, retailers, logistics providers, and other people in your supply chain.
How to communicate information about affected products to the media.
How to communicate information about affected products to consumers.
How to respond to government notices quickly and avoid penalties for non-compliance.
How to improve product safety and liability in the future.
How to improve product recall response department roles.

3 Medical Device Regulatory Compliance Issues in 2021

Plan, Develop, and Test and Repeat a Mock Recall Plan

MockRecalls is a mock recall training and consulting program to test your recall readiness. We have partnered with RQA to insure that our program meets and exceeds all FDA recall requirements. We are purely focused on protecting your product investment by working with you to create a new recall plan or analyze your current recall plan and then put it through a mock recall or recall simulation test to insure you are prepared for a possible product recall.

Our program can analyze your company’s readiness in many of the typical elements of the recall process including:

Initiation, investigation, and communication process
Recall working team and decision team composition and dynamics
Team roles and responsibilities
Process flow and lot traceability
And retrieval capability and effectiveness checks

Our recall simulation program is conducted as an escalating model using real product facts and potential issues, with multiple inputs such as consumer complaints, social media, FDA/USDA/local health department and law enforcement. Conducting a recall simulation will also allow the recall team and all involved personnel to become familiar with their responsibilities throughout the recall procedure. This gives them time to effectively communicate any concerns about the plan while the company isn’t dealing with the pressure of an actual recall.

Incorporate Recall Management Software Into Your Product Recall Prevention Strategy

One of the most critical components of your recall prevention plan is detailing the technologies that will monitor and manage recalls. If you still rely on manual methods or use several programs to track product recall information, consider recall management software. This tool lets you control recalls from one system and automate many of the tasks associated with recall management.

Trievr is a product recall management system that comes with the following features:

Manage product recalls on-demand with none of the manual tasks. There’s no more paperwork.
Enhance product safety and liability.
Centralize product recall management with one system. There’s no need for several programs or bloated software.
Lifetime document storage. Keep recall-related documents in the cloud for compliance and legal reasons.
Product recall templates.
Auto-alerts that notify team members about recall-related tasks.
Real-time dashboards that track recalls.
Enhanced security: Trievr never shares data and takes part in the EU-U.S. and Swiss-U.S. Privacy Shield frameworks.

Schedule a live free demo of Trievr here!

Final Word

Nobody wants to receive a product recall notice, but you should prepare for the worst-case scenario. Detailing the steps you will take during a product recall emergency minimizes the impact of the recall, reduces the likelihood of penalties, and protects your business reputation. Recall readiness performed with Mock Recalls elite training along with recall management software like Trievr into your prevention plan makes it easier to track and manage recalls from one system, making this program a valuable addition to your organization.

Looking to test your product recall readiness with across your organization? MockRecalls will help create and/or test your recall program. Click here to learn more or call us!