Developing a Recall Plan
May 01, 2009
by Kimberlie Clyma
A recall program is much more than the capability to conduct a mock recall, although this element is included in nearly all third-party audits. Recall programs are not simply the ability to "identify the initial distribution of the finished product," but they also must be able to monitor what goes into the products.
A good recall program must include identification of ingredients and raw materials including raw agricultural commodities and packaging materials used to manufacture foods and the ability to track these materials to the source. It should also feature proper identification of finished products and a system to trace all goods that are shipped. A good recall program will appoint a recall action team, and the company will commit to educating and training all members of this team. It will include mock recall programs. Most importantly, it will focus on communication.
MAKING A COMMITMENT. Whether it’s training people to ensure that programs are followed or speaking with the media, the regulators and the public in event of a recall, communication is an essential element to recall programs.
Of course, management must make the commitment to build and maintain a recall program. A crisis such as an illness or act of bioterrorism is not the time to learn that your plan doesn’t work. Delays in responding to such an emergency can result in increased costs, bad publicity and the potential of heightened regulatory intervention.
Product recall programs are much more than having systems to properly code and track products. Unlike mock recalls that take place during the course of third-party audits, most actual recalls occur when least expected. Companies know a mock recall exercise will be included in a third-party audit, so they are prepared. The right people are in place, and anyone who might be needed has been forewarned.
In real life, recalls occur at inconvenient times. This is just one of the reasons for developing, documenting and implementing a solid recall plan. Part of implementation must include training of the recall action team and all employees on what is expected of them in the event of a crisis.
WRITING A PROGRAM. A recall plan needs to be a written program that plant management can use as guidance in case of an actual recall as well as to establish protocols for training. The following is a blueprint a company could use for putting together its own plan.
Potential causes of recalls. This section will highlight potential causes of recalls focusing on what could happen in the plant. The section may include summaries of food safety and quality programs designed to ensure the production of safe, high-quality foods. For example, a snack bar manufacturer might elaborate on the potential for foreign material contamination and the measures such as metal detectors, magnets and attention to Good Manufacturing Practices designed to prevent such problems.
Recall classification. The class of a recall is defined by the Food and Drug Administration (FDA). The processor should make an effort to define what would be expected with the different types of recalls and how the company would interact with regulatory agencies.
Manufacturing controls. This section describes what is done in the facility to ensure that finished products and ingredients may be tracked. The processor might describe how products are coded, what the code means, how raw materials, ingredients and packaging materials are tracked and what is done by warehouse workers and the shipping department to ensure traceability. Procedures may be referenced by name and/or number.
Recall action or retrieval team. Each company should establish a recall action or retrieval team. This section should describe the recall action team and summarize the role or roles that they are to play in the event of a recall. The recall action team is headed by a recall coordinator. It is his or her duty to ensure that the team is properly trained and fully understands what it must do in the event of a recall. The recall action team should include the following persons or groups: production manager, quality manager, distribution manager, warehouse manager, plant manager and legal counsel.
One member of the group will be designated as a communications representative, and this person will deal with the media, regulatory agencies and the general public. There should be documented job descriptions for all team members as well as written procedures for all activities related to a potential recall. These events should clearly define communications in a crisis. Who deals with the media? The regulators? Customers? The section should also mandate that the company conduct mock or practice recalls. Define the company standard for a mock recall, that is, what percentage of product should be recovered within a set period. Some company standards may be a minimum of 99.9% within two hours, whereas others will accept nothing less than 100% recovery.
Follow-up. After every recall, whether it is a practice exercise or a real event, the recall action team shall meet to discuss the exercise. With mock recalls, the purpose of these meetings will be to discuss the recall exercise, evaluate performance and examine how things might have gone better.
If the company has conducted an actual recall, the follow-up meeting would address development of corrective action and control procedures to prevent recurrence of the problem. It also would assess the extent of the loss and determine who should be held responsible for the loss. During follow-up, the recall action team would evaluate what retrieval-related costs and losses are covered by insurance.
When all above steps have been completed, the retrieval coordinator would inform everyone involved that the reclamation has been concluded.
Appendix. The recall program should include an appendix. This should contain up-to-date contact information including phone numbers, cell numbers, pagers and e-mails for all members of the recall action team; contact information for all distributors, buyers and warehouses; regulatory contacts; and sample letters or forms that would be required in the event of a recall. FDA district offices are listed on the Web at www.cfsan.fda.gov/~dms/district.html, so there is no excuse to not keep this information up-to-date. It is a good idea to review this list at regular intervals and date all pages so the company knows it is using updated lists.
AVOIDING MISSTEPS. Although the outline of what should make up a recall program appears rather straightforward, many companies do not follow the blueprint. Remember recalls rarely occur at the most opportune times, and that plus a failure to prepare properly are a recipe for disaster. The biggest failures with recall programs include lack of documented procedures, training and practice, as well as failures to train backup and involve the workforce.
Lack of documented procedures. There should be documented job descriptions for all team members, plus written procedures for all activities related to a potential recall. Many companies have not taken the time to create these procedures. It is impossible to ensure that people are properly trained without documented procedures or work instructions. The recall coordinator must make sure procedures are not only developed and written down but accurately reflect what must be done in a crisis. These steps should be reviewed at minimum once a year to ensure they have not become obsolete.
Lack of training. All members of the recall action team plus any plant worker who may be involved in a recall must receive training on their role in case of such an event. Obviously, members of the recall action team will have much greater responsibilities, but warehouse workers and quality and/or technical people will also play a role. The quality personnel may be charged with reviewing records and/or testing product in an effort to determine what happened." A recall will involve the whole team, so they must know their jobs.
Lack of practice. It is essential that the recall action team and others practice what must be done in the event of a recall. Mock recalls are only a part of the picture. They should be more than just tracking all the cookies made during first shift on a particular day. Cliff Coles of California Microbiological Consulting said he asks more of the companies he audits. He will ask that the company not only track the product in question but to also provide him with all production, quality, sanitation and HACCP records from the period in which the recall is being done. This is what would happen if there was a real recall. The work to figure out what happened must start as soon as the actual tracking begins. Ideally, a full-scale practice exercise should be conducted at least once a year and preferably more often. An actual crisis is not the time to "test drive" the system.
Failure to train backups. All too often processors fail to train backups. Key personnel take vacations, attend off-site meetings and can get sick. As noted above, "What if Joe is out?"
Failure to involve the workforce. Plant workers must also be trained as to how they are to act in the event of a recall. If there is a recall, management should call workers together and explain the situation. They may be nervous about their jobs, and given that recalls attract the news media, people may be looking for their 15 minutes of fame. Workers must receive training on their role in a recall, which is fairly simple — "Keep quiet, and we will keep you informed."
Lack of communication. Don’t let poor communication disrupt your plans in the event of a recall. Members of the recall action team must communicate well with one another, and designated members of the team need to be responsible for talking with regulators and the media, if necessary.
For additional information on building your programs, check out FDA guidance found at www.fda.gov/ora/compliance_ref/recalls/recallpg.html.
Recalls are a fact of life in today’s food industry. Even manufacturers of products that appear safe such as breakfast cereals and potato chips have had recalls as a result of food-borne illness. Snack food manufacturers and bakers must take the time and make the effort to develop recall programs that include complete documentation of all activities that may be involved in such a crisis and train all persons who may be involved, especially the recall action team. Finally, they need to make sure that these people understand their roles through training and practice, and proper communication within the company and with other stakeholders such as your customers and the regulators.
This article can also be found in the digital edition of Baking & Snack, May 1, 2009, starting on Page 57. Click here to search that archive.