Hazard analysis and critical control point (HACCP) guidelines are the primary preventive approach applied in the United States to keep food safe from biological, chemical, and physical hazards at every stage of the production process or food chain. HACCP guidelines were revised extensively in 1997 and promulgated. Much more recently, HACCP has added radioactivity to its list of hazards.
If your company is required to comply with HACCP guidelines—and they are applicable in food manufacturing to preparation processes such as packaging and distribution, as well as to retail sales and food serving—your steps are laid out in the seven principles of HACCP. The overriding goal of these principles is to prevent harm to customers (and also to mitigate damage to the reputation of your brand and customer loyalty). The plan’s methodology emphasizes a systematic approach to the entire process, and the result is a HACCP plan and food safety system for your business. The fundamentals of HACCP have been applied successfully to growing, harvesting, processing, manufacturing, distributing, merchandising, and preparing food for consumption. The details for each stage, industry, and business will be different, of course. (Prerequisite quality assurance, such as good manufacturing practices, is viewed as a foundation for HACCP success.)
Systematic Planning, Implementation, and Monitoring
Because the essence of HACCP is systematic planning and vigilance, its implementation at a company requires an across-the-board effort. This means that the plan must have complete buy-in by top management and the company must adopt a commitment to making food safety and quality an enduring priority. It means the kind of leadership that catalyzes the interest and commitment of employees at all levels. One tool of management is regular training in key concepts, control points, standards, and best practices in monitoring different kinds of processes and stages in production (see “Employee Roles in a HACCP Program,” below).
The HACCP Team
All of these and other roles are defined by the HACCP team you form to create and launch the plan. Special knowledge and expertise, representation from various departments, and other considerations go into choosing your team. Depending on your industry, size, and any special issues, your plan might include production, sanitation, quality assurance, food safety, manufacturing, and operations. In addition, you probably will need to involve consultants with specific technical expertise. When creating your team, you’ll want to think about the following elements.
Products and processes to cover: Get clear about your final food product—ingredients, recipes, and final product standards, for example—and how it is prepared, including materials, equipment, and processes.
Food product use and users: This element could be considered the public at large, but also, more specifically, babies and children, hospital patients, or members of the armed services.
Distribution and storage methods: A key variable, for instance, will be at what temperature the food is distributed (room temperature, chilled, frozen).
The procedure: How does the food move through the parts of the system that your firm controls? What are the stages where the HACCP process is vital, and what are the checkpoints?
Check your flow diagram on site: Whether your core team or an outside inspector handles this component, you must check the accuracy of the flow diagram “on the ground” and modify it as needed to both perfect and, if possible, streamline it. Usually, the more attention you bring to these “setup” steps, the better you will be prepared to apply the seven principles of HACCP.
Implementing HACCP Principles
FDA guidelines offer comprehensive guidance for the entire HACCP process, including instructions for each guideline, a glossary of key terms, diagrams, tables, and appendices. It is not the goal of this article to repeat that information, but to offer an overview of the seven principles—the essentials—and how they progress.
1. Conduct a Hazard Analysis
The HACCP system is built on the identification of hazards. In this context, a “hazard” is a “biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” The standard is “reasonably likely,” and the preventive measures (control responses) are required to reasonably control the hazards. In other words, no complex, continuous process is perfect. The focus is on hazards that are reasonably likely to occur. Although your company is focused on quality, and safety is an aspect of quality, the HACCP process should focus resolutely on hazards and not quality.
An effective, comprehensive hazard analysis that follows the guidelines but zeroes in on your facility or retail location is of the essence, because each facility is different. If potential hazards are overlooked, no amount of adherence to a food safety system will protect you. In the same vein, the severity of the hazard, not in general but in your particular case, should correlate with the amount of effort devoted to it.
2. Determine Critical Control Points (CCPs)
A CCP is a step in your process—whether it is manufacturing or food preparation—where the right procedure makes the difference between controlling a potential health hazard or failing to do so. Attention to CCPs in conducting your business reduces the risk of harm to the public. FDA guidelines illustrate a CCP decision tree useful in diagramming each CCP.
3. Establish Critical Limits
No operating conditions at every point are immutable. When your planning team has identified CCPs, the next step is to establish the range within which your process can vary at a given CCP without tipping over from a safe to an unsafe operation. These limits must be referrable to scientific factors, guidelines, regulatory standards, experts, or experimental results. When challenged, the range you have set must refer to one of these justifications. A few examples might help you to concretize the kinds of factors to consider as you establish the range of allowable variation: humidity, pH, physical dimensions, salt concentration, sensory information (visual appearance, smell), temperature, time, viscosity, or water activity.
4. Establish CCP Monitoring Procedures
Once you’ve identified the CCPs that are relevant to your business and established safe ranges within which the process may vary, the challenge become monitoring them. Continuous monitoring that is accomplished electronically is ideal. The alternative is periodic or intermittent monitoring, which is often performed manually. When you automate, you increase the accuracy, control, and visibility of the process. By monitoring a specific point in the process, you will know if the trend is toward loss of control, and you can act to remedy the problem. You also record when a deviation occurs. Employees trained to conduct monitoring have to have accountability and, for this reason, must schedule their work and documentation outcomes.
5. Establish Corrective Actions
Deviations can occur in any process, so your corrective actions must be available to implement immediately. Determine the cause of noncompliance and correct the situation so that the CCP is back under your control. At the same time, you must decide on the appropriate way to dispose of the non-compliant product, and document what you discovered and how you have managed the process. Your HACCP planning will identify the people responsible for these steps and where you will store the documentation of the steps taken.
6. Establish Verification Procedures
The HACCP process must not only perform its protective function; its performance at any given moment must be verifiable. You may verify your monitoring, but, more broadly, you will need to verify the successful operation of the HACCP system as a whole at your specific location and facility This is not only product testing, as important as that may be. It is a direct, regular review of the HACCP plan itself. Initially, the goals will be to validate the plan’s technical and scientific aspects, which can be done through scientific studies, observations on location, measurements on location, or evaluations on location.
7. Establish Record-Keeping and Documentation Procedures
The systematic approach of HACCP requires objectivity, which makes it crucial to maintain records for all aspects of the HACCP and be prepared to be audited. The FDA guidelines give this enumeration of aspects of the system to be documented: core team, assigned roles and responsibilities, description of the product, intended use and consumer, flow diagram, CCPs, hazards likely to occur, critical limits, monitoring, corrective actions, verification procedure, verification schedule, and documentation procedures.
Applying an effective HACCP plan will ensure the safety and loyalty of your customers, your brand’s reputation, and the long-term success of your business.
Hansen is the VP of Technical Solutions at SafetyChain Software.