“By failing to prepare, you are preparing to fail.” – Benjamin Franklin
“It wasn’t raining when Noah built the ark.” – Howard Ruff
The COVID-19 pandemic has forced us to confront an uncomfortable, ubiquitous reality about the human experience: Sometimes, despite our best efforts, catastrophe shows up at our doorstep, uninvited and unexpected, unleashing havoc on our lives and businesses. However, what it has also shown is that those who were prepared — even minimally — endured a lot less stress and were able to spend valuable time concentrating on larger, more important issues, rather than worrying about having enough toilet paper or setting up a home office.
Likewise, if you are a manufacturer or importer of consumer products, and a potential “catastrophe” shows up on your doorstep in the form of an unexpected product safety complaint, preparing now could prevent an existential threat to the company later. A poorly executed product recall could cause your company to suffer a severe financial impact,[1] not to mention the potential risk to consumer health — while taking simple steps beforehand would have prepared your company to react quickly and efficiently to a problem in the supply chain, including a determination on whether to recall a product.
As detailed below, such planning should include an up-to-date written Recall Plan to maximize efficiency and help minimize future liability in the event of a product recall. Likewise, a necessary part of any Recall Plan should be a regularly scheduled “Mock Recall,” which your legal counsel can help develop to make as realistic as possible. Given today’s technology, Mock Recalls could not be easier to plan through Zoom videoconferencing, webinars, and the like.
Conducting a Mock Recall
With guidance from your legal counsel, your company should practice your Recall Plan by conducting a Mock Recall (and ideally continue to do so on a biannual basis). The objectives of your Mock Recall will be to test your company’s ability to:
- Evaluate and classify product complaints;
- Stop production;
- Contact appropriate regulatory authorities within mandatory timeframes;
- Draft and submit documentation for regulatory authorities;
- Locate and isolate all defective products as quickly as possible (e.g., within two to three hours or a reasonable amount of time);
- Notify the distribution chain to stop sales;
- Contact recipients of any in-transit shipments of products;
- Remove defective products from the distribution chain and from the possession of consumers;
- Communicate accurate and understandable information in a timely manner to the public about the product defect, the hazard, and the correction action; and
- Collect, maintain, and locate necessary records.[2]
By performing such regular simulations, your company can avoid many common issues related to employee turnover, contact information changes, and unforeseen updates to regulations or reporting requirements. A learning session after each Mock Recall is critical to initiate immediate corrective actions, if any deficiencies are found in your company’s Recall Plan. If deficiencies are identified, at the very least, you should modify your Recall Plan and run another Mock Recall.
Other Necessary Steps for Your Recall Plan
While you should work with legal counsel to develop a Recall Plan specifically tailored to your business’s needs, here are necessary steps to include in any Recall Plan.
Designate a Recall Team
Every product manufacturer should have a designated “Recall Team” to avoid confusion and maximize efficiency in the event of a recall. The composition on the Recall Team can be adapted to fit the needs, size, and regulatory framework applicable to your company. Legal counsel can assist you to determine which positions should be appointed on your Recall Team. Some to consider:
- Chief Recall Coordinator
- Legal counsel
- Regulatory Affairs Coordinator
- Distribution Coordinator
- Media Communicator
- Operations Coordinator
- Records Coordinator
- IT Coordinator
Every member of your team should understand their individual roles and responsibilities, which should be clearly delineated in your written plan. The Chief Recall Coordinator should oversee maintaining and updating the Recall Plan, as well as all supporting documents. In the event of a recall, he or she should have the authority to act on behalf of the company, while keeping management informed as events unfold. The Chief Recall Coordinator should have up-to-date contact information for all team members and alternates and should also have access to all information regarding the safety of your company’s products, including quality control records, engineering analyses, test results, consumer complaints, warranty returns or claims, lawsuits, and insurance claims.
Educate Appropriate Staff on Regulatory Reporting Obligations
Of course, every complaint related to the safety of a consumer product should be taken seriously and evaluated by the appropriate company representatives. However, complaints can come in many forms and degrees of severity. Careful review by knowledgeable staff may indicate that a full recall is unwarranted under applicable legal regulations. Understanding your company’s legal obligations and planning your responses in advance can help to avoid panicked reactions and unnecessary headaches down the road.
Delineate Clear Strategies Based upon the Severity of the Complaint and Circumstances Surrounding the Recall
Recalls come in many shapes and forms. Your company should develop a plan based upon the level of threat and other unique circumstances. For example, your Recall Plan will likely depend on whether the safety threat has been identified before or after the product has entered commerce. A flowchart can be a helpful addition to a written Recall Plan to ensure the correct course of action is understood and followed.
Identify Applicable Regulatory Agencies and Prepare a “Recall To-Do” List for Each One
Depending on your industry, there will likely be several different regulatory agencies involved in the recall process (e.g., CPSC, FDA, etc.). Having a detailed understanding of what steps must be taken with respect to each one will ensure your Recall Team does not overlook critical, mandatory communications during such a stressful time. Your Recall Plan should identify the regulatory authorities you will need to contact and include key contact and reporting information to ensure a timely and appropriate response. It is also critical that your Recall Team has a thorough understanding of the documentation each agency will require. Putting together recall “to-do lists” with this information now will save precious time down the road.
Put Together Contact Information for All Parties
Necessary contacts you will need at your fingertips may include your shipping company, wholesalers, retailers, consumer, and media. Make sure your distribution lists have up-to-date contact information and are in an easily accessible form that can be quickly sent to the appropriate regulatory authorities, if necessary.
Prepare Templates of Draft Recall Documents
Consider working with an attorney to prepare templates for recall documents such as recall notices, news releases, and communications with distributors. Prepare notices that can be posted in various electronic forms, including email, social media, and blogs. It is critical that you allow your legal counsel to review and evaluate these documents in advance.
By implementing a Recall Plan now, including a plan for regularly scheduled Mock Recalls, you can ensure your business is not caught off guard in the event of an unexpected product safety complaint.
[1] The costs of a recall and subsequent litigation can be staggering. For example, in 2007, Menu Foods, once the largest producer of pet foods in North America, was bought out after a disastrous recall and related litigation cost the company over $66 million. In 2012, Westland/Hallmark Meat Packing Co. was forced into bankruptcy after it spent $116 million recalling 143 million pounds of beef and an additional $500 million to settle with the federal government and numerous plaintiffs in a class action. https://www.foodqualityandsafety.com/article/the-business-of-recalls-from-booming-to-bankrupt/.
[2] Recall Handbook: A Guide for Manufacturers, Importers, Distributors and Retailers on Reporting Under Sections 15 and 37 of the Consumer Product Safety Act and Section 102 of the Child Safety Protection Act and Preparing for, Initiating, and Implementing Product Safety Recalls Including CPSC Fast Track Product Recall Program and use of Social Media, U.S. Consumer Product Safety Commission, p. 18 (2012), available at https://www.cpsc.gov/s3fs-public/8002.pdf
