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From: Food Quality & Safety magazine, February/March 2010

How to Manage a Recall Effectively

Using a quality management system can improve the recall process

by Brenda Percy

In the food and beverage industry, brand equity is imperative to an organization’s success. A recall is one of the most devastating things that can happen to any organization within this industry. Added to the cost to consumers and the U.S. Food and Drug Administration (FDA), there are regulatory issues and negative customer reactions to address, as well as the possible effect on market share to consider.

Recently, publicity has increased surrounding recalls of products like peanut butter, spinach, and pet food. Companies must establish measures to effectively mitigate recall risk, or, if a recall is necessary, to manage the process as quickly and efficiently as possible.

Fortunately, companies can employ several methods to lower their recall risk, including proactive measures such as implementing food safety initiatives to enhance quality and safety in the production process and adopting technology solutions such as a quality management system (QMS).

Proactively Mitigating Recall Risk

Clearly, preventing a recall is better than conducting one. Incorporating safety and quality into food manufacturing lowers the overall recall risk. Food safety processes such as hazard analysis and critical control points (HACCP) and initiatives such as Safe Quality Food (SQF), International Food Standard (IFS), and the British Retail Consortium (BRC) have been established to ensure that safety practices are followed and the safest possible food is produced.

In the unfortunate event of a recall, an organization must react immediately by following the best practices of recall management; it must have an established plan so that there is no question about the course of action and who must be involved in each step. Conducting a mock recall is one way to ensure that all processes are still effective.

In addition to the existing food safety measures, there are several proposed bills in Congress that would give the FDA even more power over the areas it oversees, enabling the agency to reduce the risk of defective food being released to the market and ultimately reducing the recall rate. These include:

  • The Food Safety Enhancement Act: This act serves as a proactive measure for food safety by preventing food safety problems. It creates an up-to-date registry of all food facilities that serve consumers in the United States and requires all U.S. food manufacturers and food importers to register annually. It requires each food facility to conduct a hazard analysis and establish a food traceability system. The act ultimately enhances the FDA’s ability to block unsafe food from entering the food supply.1
  • The Safe Food Enforcement, Assessment, Standards and Targeting Act of 2009: This act requires food companies to implement food safety plans and register with the Secretary of Health and Human Services annually. It allows the FDA to order recalls, detain unsafe food, and set traceability requirements.2
  • The Food Safety Modernization Act of 2009: This initiative strengthens enforcement by granting the FDA capabilities that include ordering recalls, requiring that all products be traceable, detaining and destroying unsafe food, and applying civil fines to those organizations that break laws.3
  • Food and Drug Administration Globalization Act of 2009: This act would enable the FDA to order recalls, require that all products be traceable through the use of electronic records, fine noncompliant organizations, and protect whistle-blowers from retaliation.4

 

While these initiatives are intended to incorporate safety into each step of the production process, it would be impossible to mitigate the need for a recall completely. Therefore, an organization must prepare for a recall event and must ensure that the recall process is as efficient and painless as possible.

Let’s review an ideal recall management scenario and describe how automated tools enhance the process.

Recall Information to the FDA

Once it is determined that a recall is necessary, the process must be put into action immediately. The FDA must receive all product-related information—the recalling manufacturer’s name and information, the reason for recall (including a detailed description of the defect), how this has affected the safety of the product, and the date the issue occurred.5 The company must also include the volume of food product that was produced. Additional information that must be submitted includes the quantity and distribution dates and the amount of product that is on hold due to the recall, along with the distribution pattern. The company must inform the FDA of the number of direct accounts in order to retrieve all products from facilities and consumers.

If the organization does not already have one established, a recall plan must also be developed at this point. A recall plan is an important part of an efficient recall management system. Every organization should have a recall plan and should conduct drills to ensure the plan’s effectiveness. This helps to guarantee that, in the event of a recall, all of the necessary steps are executed thoroughly and correctly the first time.

Process automation using technology solutions like quality management systems can help mitigate recall risk by drastically decreasing the chance of human error and providing visibility and traceability down the food chain.

The recall plan covers everything from submitting information to the FDA to notify the public to evaluating the recall. It is essentially the company’s map of the recall process, directing the manufacturers through each step of the process. For example, the organization will need to describe the notification method and how it will be sent (overnight or facsimile, for example).5 The company must submit a report stating exactly what information has been communicated to customers who already have the product. If the product must be returned, the organization must also state exactly how it will conduct this process. There are several QMS tools that can help with issues that come up during a recall.

Corresponding QMS Solution—Complaints: A QMS complaints application can help by logging and keeping track of all complaints. A complaints application manages the investigation and resolution of customer complaints in compliance with FDA guidelines.

Corresponding QMS Solution—Product Returns: Traceability is key when conducting a recall, because the company must retrieve all defective products within 30 days. This QMS function enables the organization to identify and track various returns and identify the return reason, as well as the material and quantities that must be returned. This function must also record and track the disposition of the returned product.

Corresponding QMS Solution—Notify the Public: Once the recall information has been submitted to the FDA and the recall plan has been established, the organization must then notify all parties involved or affected. This can be done through various media channels, whether through press releases, recall notification letters to consumers and facilities, or similar channels. All recall notification letters must identify and describe the problem as well as explain the depth to which the recall has been implemented, whether it is retail, wholesale, or user level.5 This step must also include detailed return instructions for customers and a return response form.

Corresponding QMS Solution—Document Control: Having the required documentation such as notification letter templates, Web site templates, press release templates, work instructions, and similar records is key to providing a quick response in a recall. Using a revision-controlled document control system, an organization can ensure that the necessary documentation is available within the system and is accurate and controlled. This type of system also ensures management of the creation, approval, distribution, and archiving of these controlled documents.

Corresponding QMS Solution—Evaluate the Recall: Once the public has been notified and the recall has been initiated, the organization must then conduct a recall evaluation. This will enable the organization to benchmark its effectiveness and assess the progress of the ongoing recall. During this stage, the company must create recall status reports, which should consist of the date each customer was notified, the number of customers notified, the number of customers who responded, the quantity of product that was accounted for or returned, and the details of the effectiveness check.

Once the root cause of the recall is discovered, this information should be sent to the local FDA district recall manager, along with any corrective actions that have been established. A recall termination call is the final step and can be started once all parties involved have been notified and all traces of the product have been recovered. Before the FDA will consider termination, a final status report should also be sent to the local FDA district recall manager.5

Corresponding QMS Solution—Corrective and Preventive Action (CAPA): In addition to determining root cause and investigation, the CAPA provides a method for recording and tracking any corrective actions taken, as well as verifying the effectiveness of the corrective action. Using quantitative risk assessment, an organization can conduct a risk assessment at the root cause phase, as well as at the effectiveness phase, to ensure that the corrective actions taken reduce recurrence risk to acceptable risk levels. An automated CAPA should have the ability to generate multiple report types throughout the process, including a CAPA history report that details the CAPA process from start to finish, as well as any other related records that are critical to the CAPA. This type of reporting is critical to the recall process and provides complete transparency when submitting information to the FDA.

Corresponding QMS Solution—Centralized Reporting: Once the recall is executed, it is important to provide a comprehensive report. Through use of real-time, enterprise reporting tools, organizations can create status reports for each recall phase. This type of reporting provides visibility into the overall causes of the recall, offers a clear report for the FDA to review at each phase, and helps foster continuous improvement in identifying trends to prevent similar occurrences—or to execute a product or process change.

Reaping the Benefits

The QMS’s recall management system ensures that an organization is seamlessly guided through each step of the recall process. While familiar QMS functions such as document control, corrective action, complaints handling, and centralized reporting can be leveraged for recall management, there are other benefits.

Automation: Automating the recall management process helps mitigate the chance of human error while ensuring efficient task completion. Additionally, the QMS enables automation of various other business processes and workflows, such as employee training and internal audits. This is necessary because in a complex system, there are often many employees and many training materials. Timely completion of training cannot be achieved without the use of automated tools.

Flexibility: The ability of a system to adapt to business processes is of paramount importance. Too often, organizations must build their process around or adapt to a quality system. The use of an automated QMS will provide companies in the food and beverage industry with the ability to seamlessly change and improve along with their processes and enable them to adapt the system to their organization.

Visibility: The QMS provides visibility into data from multiple sources through robust integration layers as well as with intelligent business rules to enable collaboration across all areas of the enterprise. It also heightens visibility into business processes. For example, it provides visibility into supplier qualifications with a supplier rating and inspection tool. This is extremely beneficial for organizations in the food and beverage industry, because it allows them to rate their suppliers and, ultimately, ensure that they are using the best suppliers.

Integration: The QMS’s tools are able to “talk” to each other and are linked to other tools across the enterprise. This ability to interact with outside systems and to collaborate and coordinate across the business is critical to uncovering any gaps in processes. It also creates visibility from one operational area to the next.

Make the Recall Process Work

The recall process is time consuming and extremely complex. It must be thoroughly executed at every level to achieve the desired result—the effective retrieval of the defective product and a quick termination of the recall. Items left unaccounted for or parties not contacted will increase the recall length, raise costs, and decrease consumer confidence and brand equity. Adopting food safety standards and using automated recall management procedures will result in a total system for mitigating recall risk or enhancing the recall process if a recall is required.

A recall can happen within any organization and can have a dramatic effect on brand equity. If a recall occurs, an organization with the necessary tools will have the upper hand in informing all parties involved, pulling all defective products, and processing the recall as quickly as possible, reducing the amount of time and money spent. Process automation using technology solutions like QMS can help mitigate recall risk by drastically decreasing the chance of human error and providing visibility and traceability down the food chain.

In the unfortunate event of a recall, an organization must react immediately by following the best practices of recall management; it must have an established plan so that there is no question about the course of action and who must be involved in each step. Conducting a mock recall is one way to ensure that all processes are still effective. Once an organization has executed its recall management plan, it must still be aware that the recall cannot be terminated until every defective item has been returned, all parties involved or affected have been notified, and processes have been put in place to mitigate the risk of reoccurrence. Once the recall has been closed, the organization can then seek out ways to improve quality, foster continuous improvement, and rebuild brand equity. â– 

 

Percy is a product marketing analyst at EtQ Inc. Reach her at bpercy@etq.com or (516) 293-0949, ext. 26.

References

  1. U.S. House of Representatives. H.R. 2749: Food Safety Enhancement Act of 2009. Congressional Research Service Summary. Govtrack Web site. Available at: www.govtrack.us/congress/bill.xpd?bill=h111-2749&tab=summary. Accessed January 26, 2010.
  2. U.S. House of Representatives. H.R. 1332: Safe FEAST Act of 2009. Congressional Research Service Summary. Govtrack Web site. Available at: www.govtrack.us/congress/bill.xpd?bill=h111-1332&tab=summary. Accessed January 26, 1010.
  3. U.S. House of Representatives. H.R. 875: Food Safety Modernization Act of 2009. Congressional Research Service Summary. Govtrack Web site. Available at: www.govtrack.us/congress/bill.xpd?bill=h111-875&tab=summary. Accessed January 26, 2010.
  4. U.S. House of Representatives. H.R.759: Food and Drug Administration Globalization Act of 2009. Congressional Research Service Summary. Govtrack Web site. Available at: www.govtrack.us/congress/bill.xpd?bill=h111-759&tab=summary. Accessed January 26, 2010.
  5. U.S. Food and Drug Administration. Guidance for Industry: Product Recalls, Including Removals and Corrections. FDA Web site. Available at: www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm. Accessed January 26, 2010.

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