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The authors group key actions to consider when conducting a product recall and discuss how to execute them carefully and thoroughly.
Not too many words in the English language cause heads to turn and skin to crawl like the word recall. Product recalls are situations that all companies try their best to avoid, but if a recall is necessary, how does a company effectively develop and implement a plan without undue delay and confusion?
The actions to consider when conducting a product recall can be grouped into seven areas. Each of these areas should be executed carefully and thoroughly in order to effectively manage the recall activity. This article discusses the following seven recall areas: conducting a health-hazard assessment, planning a course of action, contacting the US Food and Drug Administration, getting the word out, the importance of keeping accurate records, staying focused, and when is the recall actually ended?
What is a recall and when is it necessary?
To effectively manage a product recall, it is important to first understand what constitutes a recall and when it is necessary. Simply put, a recall is necessary when a product is found to be defective in some way, and removing it from the market is the only way to ensure consumer safety. Recalls can be either voluntary (i.e., undertaken by the manufacturer or distributor at any time) or can be initiated at the request of FDA (usually reserved for urgent and serious situations).
A recall usually results from one or a combination of the following situations:
1. Company discovery: A company discovers, through its own routine testing program, that a product lot does not meet one or more of the specifications that are established for that product.
2. Customer complaint: Often a problem is discovered from customer complaints.
3. FDA observation: Recalls can also be necessitated as a result of an observation made by FDA during an inspection. Significant compliance deficiencies noted by FDA can result in a company having to recall some or all of its drug lots.
Conducting a health-hazard assessment
Not all product failures that are discovered by a company lead to a recall. To determine whether a recall may be necessary, the impact that the failure may have on the safety and efficacy of the product must be evaluated. This is done by conducting a health-hazard assessment. By performing and documenting the hazard-assessment, conclusions can be drawn as to the chance that a consumer can be harmed by using the product in question. Often, companies use product experts to consult in the assessment. The type of expert will depend on the nature of the product, (e.g., medical doctors, pharmacologists, and toxicologists). A summary of the basic elements that should be included in a health-hazard assessment are listed in Table I. If the overall conclusion is that there are or may be harmful effects from the failure, a recall will be necessary and removing the product from the marketplace becomes the top priority.
Table I: Health-hazard assessment elements.
An example of a situation when a recall was determined to be unnecessary was observed in a solid oral-dosage form plant. Table II shows an example of the health-hazard assessment that was conducted and how the ultimate conclusion was reached.
Table II: Example of a health-hazard assessment.
Planning a course of action
When the results of failing tests, product complaints, or compliance deficiencies noted during an inspection determine that a recall is necessary, time is of the essence and decisive action is critical. Communication lines among many different departments should be established. Vital information must be gathered, and a recall strategy needs to be generated. All these steps must be accomplished without delay. The completeness of this information will greatly reduce the effort that will be needed to execute the recall and ultimately remove the product from the marketplace. A list of the critical information that needs to be collected is presented in Table III. This information, along with the health-hazard assessment, will be among the first documents in the recall record and will drive the remaining recall activities.
Table III: Critical recall information list.
Once the company has gathered all the necessary information, a recall strategy is established. A recall strategy is essentially the blueprint of the actions that are to be taken to effectively and efficiently remove the product or products in question from the marketplace. This strategy must take into account all the factors that are involved with the recall and all the steps that are necessary to accomplish the desired goal (removing and accounting for all distributed product).
The recall strategy states the suggested depth of the recall. Recall depth is the level in the distribution chain to which the company will contact in order to retrieve the recalled product. There are three levels: wholesale level, retail level, and consumer level. The selected level is determined by the severity and probability of the health hazard associated with the product based upon the conclusions of the health-hazard assessment. Recalls on the wholesale level usually are necessary when the product poses little to no health risk.
The more serious the risk created by the product, the greater the depth of the recall. An example of a recall that may be conducted on the wholesale or retail level are a product with a label that had an inaccurate statement such as a warning for taking more than 8 tablets in 24 hours, when in fact the statement should be 12 tablets in 24 hours. Other examples include a product that, upon shelf life testing, failed to meet the potency specification prior to the stated expiration date or a product that failed a sterility test.
A recall on the consumer level is the most serious type of recall, as the product has a chance to cause serious health risks and even death. In this case, it is critical to remove as much product as possible from the market. An example of a recall that may be conducted to the consumer level is a product that contains an ingredient that may cause harm if taken in the quantities listed.
Besides the recall depth, a recall strategy includes the detailed plan for executing the recall, including how to communicate the recall and how the recalled product is to be handled and disposed.
Once the health-hazard assessment has been conducted, the critical-information list has been assembled and the recall strategy has been organized, the FDA regional office recall coordinator is consulted to discuss the product failure and the company's proposed course of action.
The product details are submitted to FDA in the form of a recall submission document, which contains all the details that are necessary for FDA to evaluate the product failure, how that product failure will affect consumer safety, and the adequacy of the planned course of action. This includes product details, a description of the problem, distribution information, the health-hazard assessment, and the proposed recall strategy.
Getting the word out
Once a recall has been deemed necessary, taking the next steps can be critical to the successful implementation of the product recall. It is now time to get the word out. According to the established and documented recall strategy, a recall communication is drafted.
The recall communication is the means by which the details of the recall and the instructions to the recipients are relayed. The depth of the recall determines the level to which this communication involves (i.e., wholesale, retail or consumer). The communication could be by mail, fax, telephone call, or a combination of media to wholesalers and retailers. When the largest population needs to be notified, a public alert may be warranted. This would be disseminated by appearing in newspapers, on websites, over the radio, for example, with the goal of alerting the largest number of people in the quickest amount of time.
The communication should be concise and instructions detailed and easily understood. The clarity of the communication will dictate the ease and level of compliance that will take place once that communication is received. Table IV lists the main elements of a written recall communication.
Table IV: Basic elements of a written recall communication.
The Importance of Keeping Accurate Records
At this point, it is vital that adequate systems be put into place to address each of the different company departments that will be affected by the recall (e.g. receiving, accounting, or customer service). Proper planning at this stage will avoid chaos later when telephone calls and recalled product start pouring in.
When conducting a product recall, as with most parts of the FDA-regulated industry, keeping detailed and accurate records is absolutely critical and the most important facet of the recall. Records such as the consignee list, who was contacted via the recall communication, proof of receipt, status of recalled product, and additional attempts to contact consignees who didn't respond to the initial communication are some examples of the records that must be kept. Keeping accurate inventory-accountability records is equally critical. This includes the product sent back from consignees and being stored in the warehouse for ultimate destruction.
Each department needs to have accurate records, so that years later, exact details can be retrieved, if needed. One of the best ways to keep track of the recall details is to set up a spreadsheet, so that reference to the information can be easily and quickly accessed. An example of such a spreadsheet is shown in Table V.
Table V: Recall spreadsheet example.
As the recall proceeds and the recall communication has been sent, it is virtually a full-time job to manage the recall progress. Keeping the recall on target is very important not only from a compliance standard point (i.e., getting the defective product off the market) but from a company perspective because completing the recall as quickly as possible is also financially prudent and desired.
Two ways that help the recalling company stay focused are by conducting effectiveness checks and status reports. Most times, depending on the type and depth of the recall, FDA will require that effectiveness checks be performed as part of the recall strategy. Effectiveness checks are additional verification that each of the consignees has received the recall communication and is taking the appropriate action as directed by the recalling company. These are performed by mail, phone, email, etc. If these checks show that the means by which the company communicated the recall were not effective (e.g., not reaching the correct people, or not presenting clear instructions on what to do with affected product) the company will need to take additional steps until the recall is shown to be effective.
As part of the recall strategy, status reports to FDA are required at intervals agreed upon by the company and the agency. Status reports summarize the current state of the recall (e.g., how many consignees have responded, how much product has been accounted for, and how much has not been accounted for). This information is not only required by FDA, but is a great way to keep upper management informed and to ensure that the recall process does not get stalled.
While some companies manage product recalls in-house, performing all the detailed steps and preparing all records that are involved, many outsource this task to project-management-focused regulatory compliance consulting firms.
When is the product recall officially ended?
Recall communications have gone out, consignees have responded, product has been returned, status reports have been submitted, effectiveness checks have been completed. One might think the recall is now over, however, that is not something a company can decide. The official recall termination notice must come from FDA. A company can request that the recall be terminated by submitting a recall summary report stating that all efforts have been exhausted for the product retrieval and justifying that the recall strategy has been successfully and completely implemented. If FDA agrees, the recall termination letter will be sent by FDA to the recalling company.
Product recalls are very time consuming, requiring cooperation, organization, and levelheadedness for a company to survive relatively unscathed. Resources are often stretched to accommodate the increased requirements and the company usually becomes under increased scrutiny by FDA from a compliance perspective.
No company wants to be involved in a product recall. However, if the situation is unavoidable, proper training, planning, and execution of the recall can result in only minor operational and financial disruption.
Nancy Cafmeyer is a project manager, and Jonathan M. Lewis is a principal, both at Advanced Biomedical Consulting (ABC), St. Petersburg, FL, tel. 888.671.4292, fax 888.316.7537, firstname.lastname@example.org.
1. Code of Federal Regulations, Title 21, Food and Drugs, Chapter 1 – Subchapter A – General (Government Printing Office, Washington, DC), Part 7
2. FDA, Guidance for Industry: Product Recalls, Including Removals and Corrections, (Rockville, MD, Nov. 3, 2003).