The Hazard Analysis and Critical Control Points (HACCP) system is a globally recognized, systematic approach to food safety management. It identifies, evaluates, and controls hazards reasonably likely to cause illness or injury. This preventive system focuses on controlling the process from raw material procurement through manufacturing and consumption, rather than relying solely on end-product testing. Creating a compliant HACCP plan requires a structured methodology involving five preliminary steps before applying the seven formalized principles.
Establishing the Foundation and Prerequisites
Developing a HACCP plan begins with five preliminary tasks that define the scope and operational environment. The first step is to assemble the HACCP Team, which must be multidisciplinary, drawing expertise from engineering, production, quality assurance, and microbiology. This team is responsible for developing, implementing, and maintaining the entire plan.
The team must describe the product in detail, including its composition, processing methods, packaging, storage, and distribution method. Identifying the intended use and consumers is also necessary, as this determines the level of risk tolerance. For example, food for the general public has different considerations than food for vulnerable populations.
The team must construct a Flow Diagram outlining every step in the process, from receiving raw materials to final shipment. This diagram should include all process steps under the establishment’s control, such as ingredient addition, heating, and packaging. The final preparatory step requires the team to verify the flow diagram through an on-site walk-through to confirm it accurately reflects the actual operation.
Conducting the Hazard Analysis (Principle 1)
The first formalized principle involves conducting a comprehensive Hazard Analysis, the foundational step in the process. This analysis requires the HACCP team to systematically review every step in the verified flow diagram to identify all potential food safety hazards. Hazards are categorized as biological (e.g., bacteria, viruses), chemical (e.g., toxins, allergens), or physical (e.g., glass, metal fragments).
The analysis is performed in two stages: hazard identification and hazard evaluation. The team must evaluate the risk of each potential hazard by assessing its severity—the magnitude of the illness or injury it could cause—and the likelihood of its occurrence.
Only hazards deemed significant—those reasonably likely to occur and result in an unacceptable health risk—must be addressed in the formal HACCP plan. The team must document the justification for including or excluding each potential hazard, determining which ones require a control measure. This evaluation ensures the plan focuses resources on preventing the most relevant food safety risks specific to the facility’s operation.
Identifying Critical Control Points (Principle 2)
Once significant hazards are identified, the second principle focuses on determining the Critical Control Points (CCPs). A CCP is a step or point where control is necessary to prevent, eliminate, or reduce a significant food safety hazard to an acceptable level. If control is lost at this point, the safety of the final product is compromised.
The identification of CCPs is systematic, often guided by a CCP decision tree. This tree is a sequence of structured questions applied to each significant hazard at each process step. The questions determine if the hazard can be controlled at that step, if a subsequent step will eliminate the hazard, or if the current step is the last opportunity for control.
The decision tree is a useful tool for consistency but should not replace the expert knowledge of the HACCP team. The outcome is a concise list of specific steps, such as thermal processing or metal detection, necessary to control the identified hazards. A single CCP may control multiple hazards, or multiple CCPs may be necessary to control one hazard.
Establishing Critical Limits and Monitoring Procedures (Principles 3 & 4)
Principles 3 and 4 define the boundaries of safety and the mechanisms used to check those boundaries continuously. Principle 3 requires the establishment of Critical Limits, which are the maximum or minimum values a chemical, physical, or biological parameter must meet at a CCP to ensure product safety. These limits must be scientifically validated, measurable, and unambiguous, often based on regulatory standards or scientific literature.
Critical Limits include a specific cook temperature and hold time (e.g., 160°F for 15 seconds), a maximum pH level, or a minimum concentration of a preservative. If the process deviates from a Critical Limit, the product produced during that time is considered unsafe and requires corrective action. Setting a measurable limit ensures objective evidence of control.
Principle 4, Monitoring Procedures, defines how, when, and by whom the Critical Limits will be measured and observed. Monitoring is the scheduled measurement of a CCP relative to its limit, confirming the process is operating within the safe zone. The monitoring system must specify the method of measurement (e.g., thermometer), the frequency (e.g., every 30 minutes), and the responsible employee. Continuous monitoring, such as automated temperature recorders, is preferred, but sufficient intermittent monitoring is acceptable if it reliably indicates control.
Establishing Corrective Actions and Verification Procedures (Principles 5 & 6)
The next two principles address deviations from safe operating parameters and the overall effectiveness of the plan. Principle 5, Corrective Actions, outlines procedures followed immediately when monitoring indicates a deviation, meaning a Critical Limit has been breached. A corrective action must determine the proper disposition of the affected product, ensuring no unsafe product reaches the consumer, and correct the cause of the deviation to bring the process back under control.
The established procedure must detail who is responsible, how the affected product lot will be isolated and handled (e.g., reprocessing or destruction), and steps necessary to prevent recurrence. Records must be maintained for all deviations and corrective actions taken, providing a history of process control.
Principle 6, Verification Procedures, confirms the overall HACCP system is working effectively and is scientifically sound. Verification checks if the plan is working, distinct from monitoring which checks if the process is working. Verification activities include internal audits, calibration of monitoring instruments, observation of employees, and scientific validation that the Critical Limits are sufficient. The HACCP team must conduct a comprehensive verification of the entire plan at least annually or whenever significant changes occur in the process or product.
Documentation and Recordkeeping (Principle 7)
The final principle ensures the HACCP system is supported by comprehensive written documentation and accurate records. Documentation involves the written HACCP plan itself, including the hazard analysis summary, team list, product description, and decision-making documents used to establish CCPs and Critical Limits. This documentation provides the framework for the food safety management system.
Recordkeeping involves generating logs and reports during the plan’s operation, providing objective evidence that the system is being followed. Records maintained include monitoring logs from all CCPs, records of deviations and corrective actions, and documentation of verification activities like calibration checks and audit reports. Each record entry must be made at the time the event occurs, include the date and time, and be signed or initialed by the responsible employee.
Regulatory requirements dictate specific retention periods. For example, records for refrigerated products must be retained for at least one year, while records for frozen or shelf-stable products must be retained for at least two years. These records are subject to official review. Off-site storage is permitted after six months, provided they can be retrieved and provided on-site within 24 hours.
Implementation and Ongoing Plan Management
After the HACCP plan is fully written and documented, the process shifts to implementation and maintenance. A foundational element is ensuring that all employees whose tasks affect the plan are properly trained in their specific roles and responsibilities. Personnel must understand the significance of the CCPs, the exact monitoring procedure, and the steps required for corrective actions if a deviation occurs.
The HACCP plan is not a static document; it requires constant review. The team must perform a full reassessment of the plan at least annually to confirm its continued adequacy. Reassessment is also necessary whenever a change occurs that could affect the hazard analysis or the plan, such as a change in raw material suppliers, product formulation, equipment, or packaging.
Maintaining the plan involves the daily review of records, conducted by an individual who did not produce them, prior to shipping the product. This review confirms that all Critical Limits were met and that corrective actions were properly executed. This ongoing management loop ensures the system remains operational and delivers preventive control over food safety hazards.