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HACCP: Understanding Hazard Analysis and the Critical Control Point System

Introduction

A new safety system known as Hazard Analysis and Critical Control Point (HACCP) is sweeping the U.S. food industry. Although the name may be unfamiliar to most people, the concepts of the system date back nearly 30 years. Simply put, HACCP (pronounced “hassip”) is a science-based process control system whereby potential hazards in a food production process are identified and subsequent action taken to prevent their occurrence. The Pillsbury ® Company first implemented this approach in the development of food for the U.S. space program. Since then, numerous U.S. food companies have incorporated the system into their manufacturing processes. HACCP is in place in many other countries, including Canada. By adopting HACCP, the occurrence of foodborne hazards is reduced; resulting in improved public health protection, increased consumer confidence and overall business success.

Why now?

In the past, food inspection relied on the senses (sight, smell and touch) to detect potential hazards. This sys-tem was developed in the 1930s when the threat of physical contaminants and diseased animals were of great concern. However, this process failed to prevent hazards from occurring. Today, the challenges facing the food industry are predominantly microbiological and chemical in nature. Of the two, microbiological contaminants such as Salmonella enteritidis, Clostridium botulinum, Listeria monocytogenes and Escherichia coli O157:H7pose the most significant threat. A system to prevent the growth and spread of these organisms was required since microbes cannot be detected by sight. Additionally, with the growth of the food industry; the increasing variety of products; and the number of processes used; federal, state and local agencies are continuously challenged to ensure food safety. HACCP places the responsibility for food safety on the processing plants, allowing them to develop a program that addresses their specific applications.

Legislation

Many of the principles governing HACCP are already in place in the FDA-regulated, low-acid canned food industry. Similarly, a 1995 final rule that went into effect December 1997 established HACCP for the seafood industry. The FDA has also incorporated HACCP into its Food Code—a document that provides guidance to and serves as model legislation for state and territorial agencies that license and inspect food service establishments, retail food stores and food vending operations in the United States. Moreover, the U.S. Department of Agriculture established HACCP for meat and poultry processing plants. Establishments with 500 or more employees were required to implement HACCP-specific plans by January 1998 with the rest of the industry following suit by January 2000. The FDA is now considering regulations that would make HACCP the food safety standard throughout other areas of the food industry, including both domestic and international food products. The National Advisory Committee on Microbiological Criteria for Foods, the National Academy of Sciences and the Codex Alimentarius have endorsed HACCP as the most effective method of preventing microbiological, chemical and physical food hazards.

Fundamentals of the System

For HACCP to be most effective, its principles must be applied to all aspects of the food industry including growing, harvesting, processing, manufacturing, distributing, merchandising and preparing food for consumption. A successful HACCP program requires a strong management commitment to implement its principles. This management commitment provides employees with a clear understanding of the importance in producing safe food.

Prerequisites

HACCP must build upon a solid foundation of pre-existing programs for it to be successful. These programs provide the basic framework necessary for the production of safe food products. The National Advisory Committee on Microbiological Criteria for Foods states that programs such as current Good Manufacturing Practices (cGMP), personal hygiene, supplier control and cleaning/sanitation are critical in the development and implementation of an effective HACCP plan. Many of these programs and practices are outlined in federal, state and local regulations and guidelines.

Details of HACCP

The concept of HACCP is relatively simple; however, application of the program can be challenging. HACCP is based upon seven basic principles.

1. Analysis of workplace hazards 
2. Identification of Critical Control Points 
3. Establishment of Critical Limits 
4. Monitoring of Critical Control Points 
5. Application of Corrective Actions 
6. Verification Procedures 
7. Documentation of the System

(Specifics regarding these seven principles are mentioned later in this document.)

Prior to applying a HACCP plan to a specific product and process, five tasks must be accomplished:

• Establish a team of individuals with detailed knowledge and experience of the process to be analyzed. 
• Describe the food involved and any process-related methods.
• Categorize the intended use and consumers of the food.
• Establish a flow diagram for the process outlining the steps involved (a simple block diagram is sufficient).
• Verify the flow diagram through on-site inspection of the operation.

Once these preliminary tasks have been completed, implementation of the HACCP principles can take place. The following is an overview of the seven HACCP principles. Please consult the references at the end of this document for additional information.

1) Analyze and Identify Potential Hazards

Identify potential food-related hazards and suggest appropriate control measures. A hazard is any biological (e.g., bacterium), chemical (e.g., toxin) or physical contaminant (e.g., broken glass) that could cause illness or injury if not properly controlled. During this step it is important to review the entire flow process of an item from receipt, storage and preparation to its final distribution. After a thorough review is conducted and the potential hazards are identified, a list of control measures should be generated. Control measures are actions or activities that will prevent, eliminate or reduce the hazard. A detailed study of process hazards is critical for successful implementation of an effective HACCP plan.

2) Identify Critical Control Points

A critical control point (CCP) is defined as a point, procedure or step at which a food safety hazard could either be eliminated, prevented or reduced. Examples of CCPs include testing for metal fragments, conducting thermal processing, preventing cross-contamination of microbes between different foods, chilling and testing for chemical residues. CCPs should be carefully developed and documented. Initially, there is a tendency to identify an excessive number of steps or procedures as CCPs thereby making the process unwieldy and less effective.

Some questions to ask when developing CCPs are:

• Can the CCP be monitored; and 
• How will the CCP be documented or recorded?

Thorough analysis and identification of CCPs by knowledgeable professionals is fundamental in controlling food safety hazards.

3) Establish Preventative Measures with Critical Limits

Preventative measures with critical limits are established for each control point. Critical limits are maximum and/or minimum values that will prevent, eliminate or reduce a biological, chemical or physical hazard. A CCP will have at least one and possibly several control measures to achieve this goal. Critical limits or standards must be scientifically based and readily monitored. Examples of critical limits include time, temperature, pH, water activity, moisture and titratable (means of measuring) acidity. Potential sources for establishing critical limits are regulatory standards and guidelines, demonstrated results and expert consultants. An example of a critical limit is the control of time and temperature in the cooking of hamburger patties to destroy enteric pathogens such as E. coli O157:H7.

4) Monitor the Critical Control Points

Established monitoring is a planned sequence of observations or measurements used to determine whether or not a CCP is under control. Ideally, monitoring should be continuous to assure accurate readings. In addition, most monitoring procedures require near-immediate results so that loss of control or deviations can be observed instantly. Tests related to microbiological observations are usually not practical due to their lag-time in producing results; chemical and physical measurements are frequently preferred because their results are achieved quickly and are generally more effective for assuring control of microbiological hazards. However, in some applications there may be no substitute for microbiological testing. Potential methods for monitoring CCPs include time and temperature recordings, pH measurements and observation of the procedure by sight or smell. Another important component of this step is to record and log the measurements, establishing a written record for later use in verification. The individual(s) chosen for monitoring should under-stand the purpose and significance of monitoring; be adequately trained in the monitoring procedure; be unbiased in their duties and reporting; and accurately report the monitoring data.

5) Define Corrective Action(s)

Prior to enforcing a HACCP plan, corrective actions should be established for each CCP. Unfortunately, deviations will likely occur and an individual must be empowered to prevent possible hazardous foods from reaching consumers. When a deviation is noted from established critical limits, immediate and documented corrective actions are crucial. Corrective actions should determine and correct the cause of deviation and establish whether a food product should be discarded. In addition, the actions taken to restore the procedure to compliance should be documented. Examples of corrective actions include adjusting thermostats for proper temperature control, reheating or recooking a product and discarding a product that is deemed to potentially pose a health hazard.

6) Establish Verification Procedures

Verification activities determine the effectiveness of the HACCP plan and ensure the system is operating correctly. One of the most important aspects of this principle is the initial validation that the HACCP plan is scientifically and technically reliable. Using the verification procedures, an establishment should conduct frequent review of the HACCP plan and its components. In addition to in-house reviews, periodic verification by an independent expert or team should be performed. If deficiencies are noted during the verification step (in-house or independent), the HACCP plan must be modified to correct the problem(s).

7) Establish Record-Keeping and Documentation Procedures

Maintaining records of the HACCP plan is necessary to ensure that critical limits are working and being monitored. Documentation should be kept for the entire food process. These records should include a summary of the hazard analysis, a detailed listing of the HACCP plan, verification records and any documentation generated during the HACCP plan operation. The records associated with this process should be kept on file at the establishment and easily accessible.

Conclusion

HACCP is a proactive plan based on preventing hazards. By monitoring and detecting potential problems throughout an entire process, identification of hazards and application of corrective measures can be implemented immediately. HACCP enables companies to be apply prevention and detection methods to their specific application(s), giving them the freedom to adopt new techniques and technologies more rapidly than previously possible. A successful HACCP plan is built upon a firm commitment from upper management with well-trained and motivated employees actively involved in the process. Under HACCP, responsibility for ensuring food safety is now appropriately placed on the food manufacturer or distributor. Adoption of this plan will result in the reduced likelihood of hazards and assure consumers that the products they consume are as safe as science and technology allow.

Commonly Asked Questions

Sources for More Information

U.S. Department of Agriculture Food Safety and Inspection Service (FSIS)
Office of Policy, Program Development, and Evaluation (OPPDE) 
Inspection Systems Development Division 
Room 202, Cotton Annex Building 
300 12th Street SW 
Washington, D.C. 20250-3700

Food Safety and Inspection Service 
Web site: http://www.usda.gov/fsis

U.S. Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
200 C Street SW Washington, D.C. 20204

9 CFR Part 417, Department of Agriculture, Food Safety and Inspection Service 
Contents of HACCP Plans

International HACCP Alliance 
Texas A&M University 
120 Rosenthal Center 
College Station, TX 77843-2259 
Web site: http://haccpalliance.org/

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