Understanding Global Challenges

Inadequate Food Safety Management Systems

The global food market's rising challenges rationalize the strict measures the food industry should take and the urgency to adopt stringent risk-based preventive food safety standards to minimize the health risks associated with consuming unsafe food products. Introduced in the 1960s by the U.S. National Aeronautics and Space Administration, the Hazard Analysis and Critical Control Points (HACCP) preventive approach was further developed by the food industry (i.e., Pillsbury). Later on, HACCP was advocated and promulgated by international organizations and mandated by regulatory agencies such as the U.S. Food and Drug Administration as an effective preventive tool to manage the hazards throughout the farm-to-fork continuum and reduce the risks associated with foodborne diseases.

At the same time, driven by legal obligations to exercise due diligence and safe food production, industry stakeholders, such as retailers and nonprofit organizations, developed voluntary private food safety standards that integrate the HACCP system advocated by Codex Alimentarius to protect the reputations of businesses. Although voluntary, they generally became de facto mandatory standards that set out requirements for a risk-based food safety management system that were stricter than regulatory standards. Progressively, they were established to ensure compliance with customers' demands and regulatory requirements while addressing fraud and intentional adulteration in a global market.

Food safety systems are vital to control food safety risks, but they are not a silver bullet. Despite improvements in prevention systems, food recalls and illness outbreaks continue to hit the headlines, sometimes caused by food companies that passed certification audits of their food safety systems. A case in point is the massive multistate Salmonella outbreak caused by Peanut Corporation of America, which reportedly scored high on a third-party certification audit report.³

Emerging Threats

At specific points, food safety systems may fail due to shortcomings in the system itself, shortfalls in hygiene and food handling practices, ineffective preventive controls, or inadequate sanitary conditions and processing environments. Add to this, the global food industry continues to face challenges of novel food safety hazards, such as emerging contaminants, Shiga toxin-producing E. coli in flour, melamine adulteration in milk, Salmonella Typhimurium in peanut butter, E. coli O104:H4 in fenugreek seeds, and heat- and acid-resistant food pathogens.^4,5

Foodborne illness outbreaks are primarily caused by foodborne pathogens that could cause significant health outcomes and death. Also, most food recalls have a reasonable probability of containing a hazard that may pose health risks to consumers. Besides their legal and health implications, foodborne illnesses and food recalls are extremely costly. According to a Consumer Brands Association (formerly the Grocery Manufacturers Association) report, the industry endured a high cost of recalls, ranging from $9 million to more than $100 million primarily attributed to product disposal costs, business interruption, and customer reimbursement.⁶ Yet, a vast majority of these food safety problems could be controlled with human effort, the steering force of any system.

“Food safety systems are vital to control food safety risks, but they are not a silver bullet.”

Meeting These Challenges

A system is a collection of elements or components that are integrated to accomplish a common purpose. Specifically, a food safety system rests on three major pillars that compose interrelated elements:

• A framework for risk management (risk assessment, control measures, risk management components, and foundational programs)

• Resources (utilities, supplies, equipment, infrastructure, training, and technical expertise)

• Human assets

A failure in any or a combination of the elements has a great chance to set off a domino effect all the way down the food chain. Let’s take a closer look at the human component as an asset to the food industry. After all, systems are created by humans and are prone to human errors.

Step 1: Assess the Hazards and Risks

Risk-based food safety systems integrate science and a thorough risk assessment at all levels of the production flow by examining both hazards and risks. Similarly, the Current Good Manufacturing Practices, Hazards Analysis and Risk-Based Preventive Controls for Human Food regulation (21 C.F.R. Part 117) mandates the utilization of a risk assessment to establish the known and foreseeable hazards that need to be controlled through traditional CCP or other non-CCP preventive controls (e.g., allergen preventive controls, sanitation preventive controls, supplier preventive controls). Further, the rule delineates several considerations in evaluating the severity of the illness or injury caused, if the identified hazards were to occur, and the probability that the hazards will occur without preventive controls. The hazard evaluation must consider the effect of the following on the safety of the finished food for the intended consumer [21 C.F.R. §117.130(c)]:

1. The formulation of the food

2. The condition, function, and design of the facility and equipment

3. Raw materials and other ingredients

4. Transportation practices

5. Manufacturing/processing procedures

6. Packaging activities and labeling activities

7. Storage and distribution

8. Intended or reasonably foreseeable use

9. Sanitation, including employee hygiene

10. Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins)

Step 2: Educate and Train Workers

Given the above, there is no doubt that when transitioning to a risk-based approach in food safety, food processing companies should expand the expertise needed in this area and impart technical and scientific knowledge to responsible staff.

Promoting knowledge of hazard sources and risk management is essential to enhance safe food handling practices and compliance. Still, knowledge alone is insufficient to ensure safe practices and staff compliance. There is enough research evidence that knowledge is not the sole determinant of human behavior, and that training alone does not change behavior. Moreover, we and others have shown that knowledge may not necessarily translate into practices under the influence of risk misperceptions. Misperceptions may stem from social and cultural influences (beliefs, motivation, previous experiences, and optimistic bias where people tend to overestimate certain risks and underestimate others).^7,8

Anecdotally, there were occasions when unhygienic practices and food mishandling were captured during my audits. More concerning, the observed wrong performances were overlooked due to complacency and risk underestimation by the responsible senior staff. In this case, the preventive food safety system would be flawed with human mistakes that could introduce contamination risk to the facility and products and were not explicitly addressed in formal training. On the flip side, when the supervisor doesn't recognize the type and source of allergens running on the production line, the system is also worryingly weak. These cases are examples of limited knowledge-based training in identifying practices that need improvement for a robust food safety system.

Within this context, the Preventive Controls rule (21 C.F.R. §117.4) specifically requires that each individual engaged in manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision must be a qualified individual, that is, have the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties; supervisory personnel have the additional responsibility of ensuring compliance by individuals.

The fundamental principle of any food safety system is that all process activities and controls are established in procedures and must be applied by staff according to clear instructions and assigned tasks. These are the people who will be needed to operate and manage the system, implement procedures, take necessary and swift actions in the event of a loss of control, and steer daily operational improvements.

In the food industry, senior management and staff commonly share the responsibility of ensuring the safety of food products. However, multiple organizational and human factors influence staff compliance with food safety system requirements and safe food handling. These include limited knowledge, inadequate training (quality and frequency), lack of accountability, and insufficient resources. Furthermore, workloads and customer requests can get overwhelmingly demanding. Amid peak production hours or the pressure of successive annual audits against multiple standards to maintain certifications, unintentionally overlooking or bypassing procedural instructions, or reversion to old practices and beliefs, is likely to occur even after a training session.

To predict determinants of a food handler's behavior and complement the findings on what impedes proper food handling in food production environments, researchers applied the theory of planned behavior (TPB). The TPB shows that the performance of behavior or individuals' behavioral intention is determined by different motivational factors;⁹ these include attitude (the degree to which performance of the behavior is positively or negatively valued), subjective norm (the perceived social pressure of whether to perform the behavior as established by social group identity), and perceived behavioral control (perceived availability of opportunities and resources required to perform the behavior contributing to the perceived ease or difficulty in its performance). Hence, a motivating working environment and employee’s satisfaction, availability of management's support, and resources are essential elements for enacting what has been learned on food safety and system requirements to ensure compliance and safer practices.

Step 3: Evaluate the Company’s Food Safety Culture

Recently, there has been increased focus in research on the role of organizational factors on improving employees' food safety behaviors and the culture of food safety system implementation, referring to this as the food safety culture. The food safety culture is defined as the aggregation of the prevailing, relatively constant, learned, shared attitudes, values, and beliefs contributing to the hygiene behaviors used within a particular food handling environment.¹⁰ This concept has evolved by adapting organizational cultural elements that are context specific, such as the safety culture within the occupational safety and health sectors. Researchers identified six indicators of a food safety culture: (1) employees' perceptions of the management system and style, (2) leadership, (3) communication, (4) sharing of knowledge and information, (5) accountability, and (6) risk perception and work environment.¹⁰

Similarly, the Global Food Safety Initiative defined a food safety culture as the shared values, beliefs, and norms that affect mindset and behavior toward food safety in, across, and throughout an organization. The group outlined five dimensions and critical components of a food safety culture within an organization: (1) vision and mission—the reason for the existence of food companies and how those principles are translated into execution messaging; (2) people—the behaviors of humans as a determining factor that impacts the safety of food; (3) consistency—addressing the provision of resources for the feasibility of implementation of food safety programs; (4) adaptability—the ability of an organization to respond to ever-changing conditions and demands; and (5) hazard and risk awareness—promoting understanding of actual and potential food safety hazards and risks at all levels throughout the company.

Obviously, there is no consensus on the best approach or common theoretical background to measure a food safety culture or assess the relationship between organizational culture and performance. However, what shows in common is that the food safety culture is a behavior-based system that focuses on processes, people, and the organizational culture. It is a concept that is primarily founded on TPB reasoning. Also, what commonly stands out as a crucial element for infusing a food safety culture is “risk awareness/risk perception.” Without a proper understanding of the sources and transmission routes of hazards, and the approaches to proactively mitigate the risks, food safety is vulnerable no matter how well-designed the systems and properly engineered the facilities.

“Risk-based food safety systems integrate science and a thorough risk assessment at all levels of the production flow by examining both hazards and risks.”

Maintaining a Strong Food Safety Culture

A strong food safety culture means everyone understands how and why their tasks are essential to product safety. They correctly perceive the nature and level of risks potentially related to their organization's environment and perform their functions responsibly. However, to achieve sustainable improvement in practices, top management of food companies needs to decrease overconfidence in systems and heighten their attention on the human assets through continued motivation and promotion of behavioral changes, while considering the following:

• The staff assigned to develop a risk-based food safety system and oversee its implementation ought to carry beliefs and attitudes that assimilate with a risk-based approach, that is, being proactive; embracing their responsibilities and the ultimate purpose of the food safety system (i.e., consumer health); being vigilant to details in the food processing environment, a sharp observer to capture errors in process and practices, and adept at managing risks; and keeping abreast of local and global scientific news on food hazards and risk prevention.

• Management should establish clear communication with the staff at all levels to increase risk perception, foster compliance, and establish trust.

• Management should initiate a transition toward adopting:

1. Context-specific training structured to be commensurate with the staff activities and relatable to the facility conditions, the specificity of each stage of the process flow, and foreseeable behaviors. All food handlers/food workers should be qualified for their tasks by understanding the source of hazards, the underlying principles of given instructions, and the impact of their assigned functions on food safety. In establishing a food safety culture, supervisory staff should be, at the core, competent, equipped with the know-how and skills to acknowledge the risks, reinforce adherence to procedures and safe food handling practices, and ascertain the staff's positive performances.

2. A behavior-based training approach designed to target behavioral change by establishing appropriate strategies to increase staff perceptions of food safety risks, identify and address optimism bias, and address complacent attitudes and practices. It is suggested that this approach could potentially reduce the incidence of foodborne illnesses. For instance, a behavior-based training showed substantial improvement in employees' handwashing performance and frequency compared with knowledge-based training, that is, the standard form of training structured to increase knowledge.

Behavior-based training is a recognized bottom-up approach that has been widely adopted to address occupational and health risks. It has a proven effect on promoting people-focused interventions that influence employee actions to prevent an accident or injury before it occurs.

In the context of food safety, a behavior-based training strategy can be established by employing behavioral analysis anchored to the TPB to identify keys areas for performance improvement. More specifically, the behavior-based training may take different approaches with different groups and individuals and can be developed based on a prior determination of:

1. Staff attitudes toward food safety risks, guidelines, system requirements, the impact of foodborne diseases and recalls, importance of food safety, etc.

2. Subjective norms, such as their perception of supervisors, leadership, coworker relationships, and the requirement to comply with company policies and regulatory requirements; the management value of food safety; and the importance of adherence to food safety practices.

3. Perceived-behavior control to identify perceived personal and organizational barriers to improving performance and fulfilling assigned tasks.

In summary, behavior-based training is a useful approach to enhance knowledge and instill a food safety culture by permitting feedback and staff engagement with necessary continuous improvement. Through behavioral analysis and by taking different approaches with different groups and individuals, the training will account for work environment factors that influence staff performance, that is, work pressure, peer influence, and management support. At the same time, training programs can be created to address the cultural and social effects on staff perceptions of risk—fear of negative consequences and past experiences. While this kind of training targets behavioral changes by identifying barriers that hamper compliance, it may also determine the need for a system change or tweak to reinforce desirable behaviors in the organization.

Dima Faour-Klingbeil, Ph.D., is a researcher and international consultant in food safety and regulatory systems. She has made several research contributions, particularly in behavioral sciences research on food safety, focusing on understanding the determinants of food safety attitudes and practices. Dima is the director and principal consultant of DFK for Safe Food Environment (www.dfkfoodsafety.com). She helps national and international food businesses strengthen their food safety culture and adopt a risk-based preventive approach to mitigate food safety risks through training, auditing, technical, and scientific advice. She has served as a consultant and as a member of expert working groups in international organizations.