Recalls: When the Unthinkable Occurs
May 1, 2010
by Richard F. Stier
Recalls and traceability go hand in hand with another prerequisite program — product identification. If the finished products and the ingredients, raw materials and packaging materials used to produce baked foods and snacks are not properly identified, it will not be possible to adequately trace anything. In addition, traceability is now mandated by Homeland Security through the Bioterrorism Act and the Reportable Food Registry (see “Traceability from FDA’s Guidance” ). In other words, processors must know where their products go and where ingredients, raw materials and packaging originates.
It is absolutely imperative that processors develop, document, implement and maintain programs that allow them to track and recover finished products and raw materials. Also, traceability and recall programs are more than mock recalls that processors conduct when they are subjected to a third-party audit. When such an exercise is conducted, processors know it is coming, and they make sure that all of their key people are available to do the work.
In reality, recalls occur neither at convenient times nor when all key people are available. It is for this reason that processors must not only have well-documented procedures, but they must ensure that persons responsible for doing the work have been trained on the procedures. It also is essential that operations ensure it has trained backups for each of the key positions.
Recall and traceability programs must consist of the following components:
- Identification of ingredients, raw materials including raw agricultural commodities, and packaging materials used to manufacture foods and ingredients
The ability to track these materials to the source
Proper identification of finished goods
A system to trace all products that are shipped
A recall plan
Mock recall programs
A recall action team
Dedication to educate and train the recall action team
Commitment to continuous improvement
One element that must be integrated into the program is proper communication, which includes internal and external contact and clearly defines how such exchanges shall occur.
Industry-wide, there are more gaps in programs that identify the raw materials, ingredients and packaging materials than those for finished goods. In fact, processors often forget or neglect to develop programs to track the packaging they use. Processors must track lot numbers of the packaging materials they use, especially food-contact materials. Other operations may decide to remove pallet tags, box labels or other documentation and save them as a means for tracking what is used. When performing this option, processors should mandate that the technician or operator write the date and time that the product was used on the tag and number them consecutively.
In addition, more operations are adopting bar coding as a means for tracking materials used in production. There are different strategies when using bar codes. Some processors mandate that all materials purchased be bar-coded by the vendor and used for tracing. Others print their own bar codes and affix the codes to the ingredient or packaging material. Operators can then either scan lots as they are used or remove the tag and attach it to a form. In this case, processors may elect to print multiple codes using a smaller format that can then be removed.
One of the major challenges when it comes to traceability is bulk ingredients. Many bakers and snack manufacturers purchase ingredients such as flour, whole grains, edible oils, sweeteners and other items in railcars or tanker trucks. The traceability issue comes from the fact that processors often comingle lots in storage tanks. They also do not clean bulk storage tanks often; once or twice a year is the norm. With comingled lots and infrequent cleaning, there will never be clear segregation of lots.
In a worst case scenario, a bakery that cleans its liquid sugar tanks once a year may learn in February that a lot purchased in November was adulterated with a nonfood-grade material. The assumption would be that every lot since that time and all product manufactured with ingredients from that tank could be adulterated. The reality of the situation, however, is that most bulk ingredients are generally safe, although processors should take a close look at their bulk storage handling and cleaning procedures and prepare a documented risk assessment on these programs. The end result should help confirm that the risk is minimal. This assessment also can be shared with auditors and potential clients. What it demonstrates are “due diligence” and a commitment to ensuring the safety and quality of operations and products.
DEVELOPING A RECALL PROGRAM.
The first step toward developing a good recall program is to ensure that management is committed to backing the program. This entails supporting education and training; developing the necessary documentation; and practicing, reviewing and updating the program as required. In addition, management should sign off on the program clearly indicating its support. A recall program will not happen overnight. It will take time and commitment.
Next, someone must be in charge of the program. This person may be called the recall action leader or team leader. This should be defined in the individual’s job description, and he or she should acknowledge in writing that they have accepted this responsibility. This person will be charged with:
Selecting the recall action or retrieval team — The team should consist of a cross-section of people such as technical/quality, production, shipping, receiving, purchasing, customer service, sales and marketing and legal. It is a good idea to ensure that each operating group has a backup.
Developing job descriptions for each member of the team — Clearly define the responsibilities of each member of the recall action or retrieval team. The basic description for the quality assessment (QA) coordinator might read as follows: “The QA coordinator is responsible for evaluating quality monitoring records and other issues to determine the extent of the problem and the causes. The QA coordinator shall work with the plant or production coordinator and other persons to determine the cause(s) of the problem.”
Developing procedures and work instructions for each team member — Failure to properly document what should be done and how it will be accomplished is a gap in many recall programs. Processors often create a general guideline but fail to develop the detailed work instructions. As an example, a general statement that simply states that customer service shall be responsible for tracing all products that are shipped is accurate and defines the expectation, but it does not tell anyone how to do the task. Detailed instructions should provide a step-by-step road map for the person doing the work. These should use screen shots, sample documents and any other references to ensure that the protocols are followed.
Ensuring all team members and backups are trained — Each and every team member must be trained on the recall program as a whole and ontheir specific task(s). These sessions must be documented and the company needs to be sure people understand what they are supposed to do. Ideally, training should be based on the documented procedures, and there needs to be some means to verify that the staff fully understands what is expected of them. Part of the training must also be working as a team. And make sure that legal counsel participates in the sessions, even if it is going to cost money. Your legal counsel or the firm needs to know what is being done and the people with whom they will work if there is a recall.
Training the workforce — Another failure in many programs is that management ignores the workforce when developing a recall program. Plant workers also must be trained on how 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 because recalls attract the news media, people may be looking for their 15 minutes of fame. Workers must receive training on their roles in a recall, which is fairly simple. Keep quiet, and we will keep you informed.
Defining the spokesperson — The spokesperson will be responsible for communicating with the media and regulatory agencies. The important point is to ensure that there is one story and that the company presents a united front. Of course, public statements should be developed in conjunction with the legal department.
Developing mock recall procedures — Most companies mandate that at least one mock recall be done per year.
In reality, with third-party audits and customer demands, companies usually exceed that number. A general policy for a company might read something like the following:
“This facility shall conduct mock recalls at least two times a year. The results of the mock recall including percentage of product recovered, time to conduct the recall and records documenting the location of the product that was the subject of the recall shall be maintained in a recall log book. It is the company’s policy that at least 99% of the product must be traced within four (4) hours of initiating the mock recall. After each mock recall, the recall action team shall meet to discuss the exercise. Minutes shall be kept from each meeting. If there are issues that need to be addressed, a corrective action plan with timelines shall be established.”
It is imperative that standards for conducting mock recalls be established. Some processors mandate that the exercise be completed within two hours, whereas others allow more time. The percent recovery is an area that each processor should think about. For example, a large operation that produces thousands of cases might want to set a more stringent standard. If a company sets a recovery of 98%, an acceptable recovery in a 20,000 case lot would be 19,600 cases. Does having 400 cases unaccounted for give you a warm and fuzzy feeling?
REVIEW AND UPDATE.
After each recall, whether it is a mock recall or a real event, the recall action team must evaluate how things went, even if all went well. If a company has to conduct an actual recall, this review should include:
- Development of corrective action and control procedures to prevent recurrence of the problem
- A review of what was done well and where improvements are needed
- Assessment of the extent of the loss and who should be held responsible for the loss (supplier, other third party, etc.)
- Retrieval related costs and the bearer of nay loses (company, insurance, etc.)
- Action plans for improvement
- When all of the above steps have been completed, the recall coordinator should inform everyone involved that the retrieval has been concluded.
Recalls are a fact of life. FDA and the US Department of Agriculture both understand that being able to execute a recall is essential to ensuring a safe food supply. In fact, the two agencies met jointly in November to address the issue and discuss how improvements to the system could be made. Every processor must develop, document and implement a recall program. And each person involved in the program must be trained. To ensure that the program works in the event of a recall, the company must practice as a team. An actual recall is not the time to learn that your program does not work.
Traceability from FDA’s Guidance — Reportable Food Registry
What records must be established and maintained by non-transporters of food? For non-transporters, i.e., companies that own food or who hold, manufacture, process, pack, import, receive or distribute food for purposes other than transportation, the records must:
- Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date received; quantity and type of package and packaging; and identify the immediate transporter previous sources, including the name, address, telephone number and, if available, fax number and e-mail address. Persons who manufacture, process or pack food also must include lot or code numbers or other identifier if the information exists.
- Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date released; quantity and type of packaging; and identify the immediate transporter subsequent recipients, including the name, address, telephone number and, if available, fax number and e-mail address. Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists. The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.
Classes of Recalls
Class I Recall
This is an emergency situation involving the removal from marketing and distribution channels those products that, because of a deficiency, pose a serious threat to health or life. An example would be a lot of food or an ingredient found to contain salmonella or a product thought to contain glass. In a Class I Recall, top priority must be given to the complete and immediate removal of recalled products from all levels of the distribution chain all the way down to the consumer level.
Class II Recall
This is a priority situation in which a product deficiency may cause temporary or medically reversible adverse health consequences and where the possibility of serious health consequences is remote. In a Class II Recall, products must be removed from all levels of the distribution chain.
Class III Recall
This is a routine situation in which adverse health consequences of a product deficiency are highly improbable or non-existent. Products are recalled because of adulteration or misbranding not involving a health hazard. Examples of Class III recalls are situations involving improperly labeled products or products contaminated with filth. In a Class III recall, products must be removed from wholesale levels of the distribution chain. FDA generally requires that products be recalled to the wholesale level.
This is a situation where no violation is involved, or the violation is minor and product is not subject to seizure under current FDA or USDA policies or guidelines. An example from the baking industry might be a product with poor color.
Stock recoveries involve the recovery of products that remain under the complete control of the processor and its clients, regardless of the severity of the problems.