To establish the proper recall plan and team, companies need to ask an array of questions to get the right answers. In many cases, it really comes down to reviewing recall terms and questionnaires.
1. Why is it important for a facility to have a recall plan in place? What's the purpose?
Under the Food Safety Modernization Act (FSMA), FDA now has the authority to order a mandatory recall if a responsible party refuses to voluntarily cease distribution or recall food subject to hazards that are reasonably likely to cause serious adverse health consequences or death to humans or animals. Facilities required to comply with FSMA Section 103 - Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (HARPC) must establish a food safety plan that includes a written recall plan as one of its preventive controls.
The purpose of a recall plan is to ensure a company has the ability to remove the suspect product (product in violation of the law) from the market in a timely and effective manner. Food companies maintain both legal and moral responsibilities to provide safe products to consumers. A well-established recall plan will minimize the impact of suspect product in the marketplace; it can save lives, money, and a company's reputation.
A recall plan will focus on preparing personnel to handle the situation, including notification of regulatory agencies, customers, and if warranted, the media. The plan will also identify the persons involved, each person's responsibility and specific guidance for each activity, and include routine tests of the program and people.
The success of a recall plan is largely dependent upon the knowledge and skills of those executing the plan. For this reason, the selection and training of the recall team members is a critical activity in the development of the plan. It may be best to first identify the activities that must be covered during a recall before identifying team members. The activity may dictate who would be best to hold the responsibility for it.
In addition to assigning a primary person to be responsible for each activity, an alternate or back-up person should be assigned in the event of absences of primary team members. It is important not to over-assign tasks to one individual. While a single person may be best qualified to do multiple tasks, it is important to keep in mind that many of these tasks will need to be handled simultaneously. It is important that responsibilities of each individual are clearly identified before a recall is occurring. Additionally, the recall team may be the same as a crisis management team.
Once team members have been selected, the contact information for each team member must be provided. This should include off-hours contact information such as home and cell phone numbers. A means of communicating between team members for the initial assembly at the facility should be developed, such as a phone tree. In some situations, team members may need to be contacted from an off-site location.
For example, if the initial notification is made during off-hours, calling the team for assembly may need to begin prior to arrival of the original contact person at the plant. For this reason, the contact information should be kept on a cell phone. It will be important that contact information is kept current.
The recall team must consist of anyone who will be needed to accomplish these tasks. Additional support personnel may be included in the recall activities, even though they are not part of the recall team.