Imagine the scenario: The Food and Drug Administration (FDA) announces an ingredient is contaminated. The bad news: You use this ingredient in one of your products. People have been infected, some hospitalized. You have days — no, hours — to retrieve the product from the market and replace the contaminated ingredient in your supply chain. AND you haven’t had any recall training to prepare you for a involuntary product recall. Below are the product recall and response communication steps and what you should know when facing an involuntary recall.
Internal communication during a crisis like this is imperative. Delay action and you could face fines from the FDA — and, even worse, hospitalize thousands of customers. You need to act quickly. You need to remain calm. But most of all you need to communicate.
This is where a good business continuity plan comes in. It helps you handle communications when you receive recall requests from the FDA, Centers for Disease Control and Prevention (CDC), Consumer Product Safety Commission (CPSC), supply chain partners, or whomever. Without a plan, you could put your entire business (and thousands of people) at risk.
Use your business continuity plan to improve product recall response times.
Step 1: Determine the Nature of the Threat
The FDA and other government agencies issue product recalls pretty frequently. (There were 4,217 recalls from federal agencies in one year alone.) Some are more serious than others. But you need to monitor each one. This way, you can determine the nature of the threat and communicate the right information to other product and quality control managers, manufacturers, distributors, retailers, and other partners in your supply chain.
Product recalls, market withdrawals, and safety alerts from the government — the FDA, in particular — tend to be long and wordy, with lots of surplus information. The FDA lists all the reasons behind the recall, required actions, and perhaps some photos. Determining the severity of the threat can be difficult.
Think up the best way to communicate information from the FDA and other government agencies to people in your business and supply chain. People can feel overwhelmed with too much information — where the threat originated, the steps the FDA has taken, the number of people affected, etc. — so just communicate the facts:
- The ingredient/material being recalled
- The reason for the recall
- The steps your business will take
- The consequences of not taking/delaying action
Step 2: Pick One Communication Channel
Supply chains are complicated beasts, with many different tentacles — manufacturers, suppliers, retailers, distributors, etc. All of these different companies use different communication methods, which makes it difficult to share information quickly. For example, you might email a supplier, video call a manufacturer, and phone a retailer.
Imagine you had one communication platform where you share recall information promptly. This would speed up recall response times significantly. A good product recall management system comes in handy here. It streamlines communication between you and your supply chain partners so you can handle product recalls more effectively. The result? You can avoid penalties. Save your business. Save lives.
Mock Recalls’ platform Trievr Recall Management is a product management software solution for suppliers, manufacturers, and product and quality control managers in the pharma, medical device, food, cosmetics, and other industries. It eliminates the need to manually coordinate recalls, saving you time and money. You can also:
- Improve compliance
- Avoid penalties
- Improve customer trust
- Boost your reputation as a responsible, compliant company
By incorporating a software solution into your business continuity plan, you can mitigate the risks associated with not responding to product recalls quickly enough. It’s as simple as that. Manual methods and outdated software will no longer cut it. Today, companies in all sectors need to respond to recall requests quickly — or jeopardize their entire business.
Step 3: Report Recalls/Recall Request Responses to the Relevant Bodies
This is one of the most important parts of your business continuity plan. It’s all very well and good removing a product (or ingredient/material) from your supply chain, but you could still risk fines for non-compliance by not reporting the right information to the authorities.
It’s a legal requirement to report recalls to the relevant bodies — FDA, CDC, CPSC, etc. — even if you didn’t receive a recall request in the first instance. The reasons for this are obvious. Other businesses might use the same (or similar) ingredient or component and there could be a risk to the general public.
Some people tend to underestimate the power of federal agencies when it comes to product recalls. The FDA, for example, has a series of enforcement actions for businesses that don’t report recalls, including:
- Warning letters
- Seizure (When the FDA removes your products from warehouses/stores)
- An injunction (When a court order prevents you from manufacturing/selling products)
- Criminal prosecution
The penalties for criminal prosecution are severe:
“Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment for up to one year,” says the FDA. “Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment for up to three years.”
If you want to remain compliant, you need to set up a series of mock recall events for reporting product recalls and recall request responses. This means delegating tasks to different people in your business and including this information in your business continuity plan.
Learn more about each department’s role during a product recall
More About Mock Recalls
MockRecalls is a mock recall planning, training and consulting company focused to test your recall readiness.
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.
Mock Recalls, was created by our sister company Trievr Recall Management. Trievr has been helping organizations in pharma, medical device and several other industries successfully conduct product recalls and withdrawals seamlessly through its SaaS based on-demand system for over 10 years.
While working with many of its clients, TRIEVR discovered that most had a recall plan in place, but many had not tested the recall plan with a mock recall inventory-based traceability exercise or a recall simulation to test the organizations entire process.
To meet this vital need, Mock Recalls has partnered with RQA, Inc., a global leader in providing quality assurance, crisis management, and risk mitigation consultancy and training, to offer a recall simulation and mock recall training program, utilizing TRIEVR’s Recall platform, that challenges your organization’s capabilities and training and readiness, from initial incident identification to recovery of the affected product.
Final Word
The product recall process can be complicated because there are so many moving parts. Ultimately, you need to communicate the right information to the right people at the right time. Creating a business continuity plan with mock recall planning lets you manage product recalls in your business and sets expectations for all employees and supply chain partners.
Looking to test your product recall readiness? MockRecalls will help create and/or test your recall program. Click here to learn more or call us!