While implementing the Food Safety Modernization Act (FSMA), FDA introduced training requirements into most final rules. These training requirements vary based on the role of the individual, but now, food companies are required to ensure employees are adequately trained. This discussion first summarizes the training requirements imposed by the FSMA final rules. Then, the discussion turns to ensuring training is effective and sufficient to ensure compliance with the requirements.
Though the language used by each regulation slightly differs, FDA has typically used the terms “Qualified Individual” and “Preventive Controls Qualified Individual” to refer to individuals with levels of responsibility for the safety of food. Throughout this discussion, the term “employee” will be used to refer to any employee who is engaged in food manufacturing, processing, packing, or holding, while “Qualified Individual” will be used to describe those individuals with oversight of the development and implementation of food safety programs.
Regulatory Requirements
cGMP and Preventive Controls for Human Food and Animal Food
The Preventive Controls for Human Food and for Animal Food rules requires that all employees are trained to ensure the safety of food as appropriate to the employee’s duties and must be trained in food hygiene and food safety. This training must include details on the importance of employee health and personal hygiene. 21 CFR 117.4(b) and 21 CFR 507.4(b).
In addition, supervisors are responsible for ensuring compliance by employees, and must additionally be trained to supervise the production of clean and safe food.
Qualified Individuals are responsible for the oversight of food safety plans, preventive controls, validation of preventive controls, and records review. Qualified Individuals must have completed training at least equivalent to the curriculum recognized by FDA or be otherwise qualified through job experience. Auditors must also be qualified through education, training, or experience to conduct audits. 21 CFR 117.180 and 21 CFR 507.53.
Trainings must be documented, and records retained demonstrating training as required.
Foreign Supplier Verification Program
A Qualified Individual must develop the Foreign Supplier Verification Program (FSVP), and perform each activity relating to the FSVP. Qualified Individuals must have the education, training, or experience necessary to perform these activities, and must be able to understand the language of any records that are reviewed as part of the FSVP. 21 CFR 1.503(a).
If audits are conducted as part of the FSVP, a Qualified Auditor must conduct the audit. Auditors can be qualified through education, training, or experience in auditing. 21 CFR 1.503(b).
Intentional Adulteration
Under the Intentional Adulteration rule, FDA has required that employees who are assigned to steps where a significant vulnerability exists and where a mitigation strategy is applied be appropriately trained to properly implement the mitigation strategy. Employees must also be trained in food defense awareness. 21 CFR 121.4(b).
Supervisors must be assigned to ensure compliance by employees, and must be qualified through education, training, or experience to act as a supervisor.
A Qualified Individual must be responsible for the preparation of the food defense plan, including conducting the vulnerability assessment and identification of the mitigation strategies. Qualified Individuals must be qualified either by completing training through a curriculum recognized by FDA or through job experience at least equivalent to the training. 21 CFR 121.4(c).
Records demonstrating training must be maintained, and must include the date of training, the type of training, and who was trained. 21 CFR 121.4(e).
Sanitary Transport
The Sanitary Transport rule requires that carriers of food who have responsibility for the sanitary conditions during transportation provide training to all employees engaged in transportation operations. This training must include coverage on the types of food safety problems that can arise during transportation, sanitary practices to address those potential problems, and the responsibilities of the carrier and employee. 21 CFR 1.910(a). Records must be maintained demonstrating that the training occurred, including the date of the training, type of training, and which employees were trained. 21 CFR 1.910(b).
Produce Safety
The Produce Safety rule dictates that all employees who handle produce must be trained on basics of food hygiene and food safety and the importance of health and personal hygiene, including symptoms that mean contamination of food is likely. Employees involved in harvest activities must additionally be trained on recognizing contaminated produce, not harvesting contaminated produce, inspecting containers and equipment before use to ensure they are clean and maintained, and correcting or reporting identified issues. 21 CFR 112.22.
All employees must be trained as appropriate to their responsibilities. Employees must be trained upon hiring and then periodically after. The rule requires that this periodic training occur at least annually and when observations or information suggest that employees are not meeting the standards required by FDA. All training must be done in a way that is easily understood by the employees being trained. 21 CFR 112.21.
Supervisors must be assigned to monitor compliance with these requirements, and at least one supervisor must complete training at least equivalent to the standardized curriculum recognized by FDA. 21 CFR 112.22 and 21 CFR 112.23.
Records of all trainings must be established and maintained; these records must include the date of training, the topics covered, and which employees were trained. 21 CFR 112.30.
How to Ensure Efficacy of Training
Although the FSMA rules do not typically expressly require an evaluation of effectiveness of required training, companies should ensure that all trainings are effective. By ensuring training is effective, a company can more easily demonstrate compliance with the requirements of the rules and the likelihood of compliance with food safety programs by employees increases. Even beyond those food safety trainings required by FDA, companies can utilize trainings to implement their food safety plans; effective training can be used to ensure that food safety programs are effective as implemented. Efficacy of training can be evaluated at multiple times, through multiple different methods.
First, as part of the training or immediately following the training, efficacy checks can be used. Typically, when checked immediately following training, efficacy checks will take the form of a quiz or other assessment. These assessments ask questions as to the content trained on, to determine if the trainee retained the information covered. Generally, these assessments are fairly short and cover the general topics discussed.
Additionally, efficacy of training can be evaluated by careful monitoring of the implementation of food safety plans. Here, by carefully reviewing food safety records and the effectiveness of the food safety plan, it can be determined if employees are sufficiently trained or if additional, targeted training would be beneficial. For example, if GMP audits regularly identify employee hygiene concerns, additional training on employee hygiene could be used to target this finding. Similarly, if sanitation monitoring regularly demonstrates that sanitation is being effective, it is likely that sanitation training was sufficient and effective.
Lastly, routine monitoring of employee actions can be used to ensure that training remains effective and can be used to identify necessary retraining. Here, an efficacy check could completed by observing employees as they complete food safety-related tasks. For example, observation of an employee monitoring the internal temperature of a product could be used to, first, ensure that the employee is correctly performing this requirement, and, second, determine if training on temperature checks remains effective. If observation identifies that employees are not correctly performing food safety tasks, it is likely that training on these topics was ineffective initially or needs to be refreshed to ensure continued efficacy.
FDA requires training in certain circumstances, but does not typically require that a company conduct effectiveness checks regarding those trainings. However, careful assessment of the efficacy of training can help a company ensure that food safety plans are implemented and effective. By ensuring employees are trained, a company can better ensure that employees with food safety responsibilities are adequately trained to fulfill those responsibilities.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.