Why ccp is important?
Hazard Analysis Critical Control Points (HACCP) is a system which provides the framework for monitoring the total food system, from harvesting to consumption, to reduce the risk of foodborne illness. The system is designed to identify and control potential problems before they occur. In its Model Food Code, the Food and Drug Administration has recommended the HACCP system “because it is a system of preventive controls that is the most effective and efficient way to assure that food products are safe ” (1999 FDA Model Food Code) . The application of HACCP is based on technical and scientific principles that assure safe food.
Currently, the food industry, including foodservice, supports the use of HACCP and its principles as the best system currently available to reduce and prevent foodborne illness. HACCP was first developed and used by the Pillsbury Company in the late 1950’s to provide safe food for America’s space program. Federal and state regulatory agencies have adopted the HACCP approach. Beginning in January of 1998, all seafood processors who ship their product across state lines will be required to have HACCP plans in place. Also in 1998, USDA began to require that meat and poultry processing plants have HACCP plans in place. Many state and local food regulatory agencies base their inspections on HACCP principles and may, in certain instances, require HACCP plans for specific food items. Food safety educators now use the principles of HACCP as the basis for their educational programs.
HACCP consists of seven steps used to monitor food as it flows through the establishment, whether it be a food processing plant or foodservice operation. The seven steps of the HACCP system address the analysis and control of biological, chemical and physical hazards.
In August of 1997, the National Advisory Committee on Microbiological Criteria for Foods adopted new recommendations on “Hazard Analysis and Critical Control Point Principles and Application Guidelines.” These guidelines are designed to facilitate the development and implementation of effective HACCP plans. The new recommendations are reflected in this document. For more information on HACCP principles, in particular formal HACCP, contact your local extension educator. Also, the reference list includes several excellent resources on HACCP.
Critical Control Point (CCP) – A procedure/practice (control) in food handling/preparation that will reduce, eliminate or prevent hazards. It is a “kill” step that kills microorganisms or a control step that prevents or slows their growth.
Hazard – Unacceptable contamination, microbial growth, persistence of toxins or survival of microorganisms that are of a concern to food safety.
Monitoring – Checking to determine if the criteria established by the critical control point(s) (CCP) have been achieved.
Risk – Probability that a condition(s) will lead to a hazard.
Severity – Seriousness of the consequences of the results of a hazard.
Practical HACCP principles adapt the seven HACCP steps into a form that is easily applied in a non commercial setting. The seven steps deal with the issues of thorough cooking and cooling which are the major causes of foodborne illness.
In order for this simplified, focused application of HACCP principles to be effective in reducing the risk of foodborne illness, Standard Operating Procedures (SOP’s) of personal hygiene, basic sanitation and food storage must be developed and adhered to. The SOP’s should be developed, taking into consideration the types of foods that will be prepared during the foods labs, the number of students involved in the food preparation activity and the type of equipment to be used. The SOP’s can be listed in the form of a checklist, which can be checked off as each item is accomplished.
1. Conduct a hazardous analysis. The purpose of a hazardous analysis is to develop a list of hazards which are likely to cause injury or illness if they are not controlled. Points to be considered in this analysis can include: skill level of employees; transport of food; serving elderly, sick, very young children, immune-compromised; volume cooling; thawing of potentially hazardous foods; high degree of food handling and contact; adequacy of preparation and holding equipment available; storage, and method of preparation. The next step is to determine if the factors may influence the likely occurrence and severity of the hazard being controlled. Finally, the hazards associated with each step in the flow of food should be listed along with the measures necessary to control the hazard.
2. Determine Critical Control Points (CCP’s) A critical control point is any step in which hazards can be prevented, eliminated or reduced to acceptable levels. CCP’s are usually practices/procedures which, when not done correctly, are the leading causes of foodborne illness outbreaks. Examples of critical control points include: cooking, cooling, re-heating, holding. To determine CCP’s ask the following questions:
3. Establish Critical Limits A critical limit ensures that a biological, chemical or physical hazard is controlled by a CCP. Each CCP should have at least one critical limit. Critical limits must be something that can be monitored by measurement or observation. They must be scientifically and/or regulatory based. Examples include: temperature, time, pH, water activity or available chlorine.
4. Establish Monitoring Procedures Monitoring is a plan which includes observations or measurements to assess whether the CCP is being met. It provides a record of the “flow of food” through the establishment. If monitoring indicates that the critical limits are not being met, then an action must be taken to bring the process back into control. The monitoring system should be easy to use and meet the needs of the food establishment, as well as the regulatory authority. It is important that the job of monitoring be assigned to a specific individual and they be trained on the monitoring technique.
5. Establish Corrective Actions If the criteria for a CCP is not being met, some type of corrective action must be taken. They must meet the standards established in Step 3, must be based on facts for normal working conditions and be measurable. Corrective actions may range, for example, from “continue cooking until the established temperature is reached” to “throw out the product,” depending on the severity of the situation.
HACCP plans should include the following: who is responsible for implementing the corrective action and what corrective action was taken. They should be established in advance as part of the HACCP plan.
6. Establish verification procedures These procedures are activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. An important aspect of verification is to determine if the plan is scientifically and technically sound. Also, that all the hazards have been identified and that, if the HACCP plan is properly implemented, these hazards can be effectively controlled. Verification can be accomplished by expert advice and scientific studies and observations of the flow of food, measurements and evaluations. Another means of verification is an on site review of the established critical limits. Each CCP will have one independent authority. This verification step provides an opportunity to make modifications to the plan if necessary.
7. Establish record-keeping and documentation procedures Record-keeping and documentation procedures should be simple to complete and include information that illustrates that the established standards are being met. Employees need to be trained on the record-keeping procedures and why it is a critical part of their job. Examples of records include time/temperature logs, checklists, forms, flowcharts, employee training records, and SOP’s.
(“Hazard Analysis Critical Control Point Principles and Application Guidelines”, Adopted August 14, 1997, National Advisory Committee on Microbiological Criteria for Foods)
1. Review menu and highlight potentially hazardous foods
2. Review recipes that include potentially hazardous foods and highlight problem ingredients.
3. Include critical temperatures and times in the recipes/procedures. Use critical temperatures established by USDA for consumer use. (Note critical temperatures may be somewhat different for the food industry and are based on state/federal regulations.)
4. Check food temperatures during preparation, holding, cooking and cooling. Food temperatures should be checked using a bi-metallic food thermometer. Remember, when cooling food, time is critical. The food needs to be cooled to 40° F in no more than two hours.
5. Correct if required temperatures are not being met. Specific steps to be taken should be previously established and could be included in SOP’s. For example, when roasting a chicken, if at the end of the prescribed cooking time, if the temperature has not reached 180°F, the correction is to continue cooking until that temperature is reached. However, in some cases, the “correction” may involve throwing the food item away because throughout the preparation process, the food may have been mishandled.
6. Verify that the previous steps are being followed.
7. Record time and temperatures. A system for recording temperatures should be developed. This system can be in the form of a notebook or charts that includes the intervals at which the temperatures should be taken and recorded.
Revised 5/00 University of Rhode Island Cooperative Extension Food Safety Education
Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.
Table of Contents
EXECUTIVE SUMMARY
DEFINITIONS
HACCP PRINCIPLES
GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES
IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN
APPENDIX A - Examples of common prerequisite programs
APPENDIX B - Example of a flow diagram for the production of frozen cooked beef patties.
APPENDIX C - Examples of questions to be considered when conducting a hazard analysis
APPENDIX D - Examples of how the stages of hazard analysis are used to identify and evaluate hazards
APPENDIX E - Example I of a CCP decision tree
APPENDIX F - Example II of a CCP decision tree
APPENDIX G - Examples of verification activities
APPENDIX H - Examples of HACCP records
The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee's November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs).
The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer.
In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working.
The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions.
In keeping with the Committee's charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards.
For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems.
The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems.
CCP Decision Tree: A sequence of questions to assist in determining whether a control point is a CCP.
Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met.
Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.
Control Point: Any step at which biological, chemical, or physical factors can be controlled.
Corrective Action: Procedures followed when a deviation occurs.
Criterion: A requirement on which a judgement or decision can be based.
Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.
Deviation: Failure to meet a critical limit.
HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.
HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.
HACCP System: The result of the implementation of the HACCP Plan.
HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.
Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.
Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.
Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.
Severity: The seriousness of the effect(s) of a hazard.
Step: A point, procedure, operation or stage in the food system from primary production to final consumption.
Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.
HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:
Principle 1: Conduct a hazard analysis.
Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.
Introduction
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.
HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.
The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.
Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Examples of common prerequisite programs are listed in Appendix A. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in federal, state and local regulations and guidelines (e.g., cGMPs and Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the basic conditions and practices expected for foods intended for international trade. In addition to the requirements specified in regulations, industry often adopts policies and procedures that are specific to their operations. Many of these are proprietary. While prerequisite programs may impact upon the safety of a food, they also are concerned with ensuring that foods are wholesome and suitable for consumption (Appendix A). HACCP plans are narrower in scope, being limited to ensuring food is safe to consume.
The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production. During the development of a HACCP plan, the HACCP team may decide that the routine maintenance and calibration of an oven should be included in the plan as an activity of verification. This would further ensure that all the food in the oven is cooked to the minimum internal temperature that is necessary for food safety.
Education and Training
The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.
Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.
Developing a HACCP Plan
The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.
In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.
Figure 1. Preliminary Tasks in the Development of the HACCP Plan
Assemble the HACCP Team
The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.
Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.
Describe the food and its distribution
The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.
Describe the intended use and consumers of the food
Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).
Develop a flow diagram which describes the process
The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.
Verify the flow diagram
The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.
After these five preliminary tasks have been completed, the seven principles of HACCP are applied.
Conduct a hazard analysis (Principle 1)
After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.
A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.
The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.
The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.
After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.
Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.
Appendix D gives three examples of using a logic sequence in conducting a hazard analysis. While these examples relate to biological hazards, chemical and physical hazards are equally important to consider. Appendix D is for illustration purposes to further explain the stages of hazard analysis for identifying hazards. Hazard identification and evaluation as outlined in Appendix D may eventually be assisted by biological risk assessments as they become available. While the process and output of a risk assessment (NACMCF, 1997)(1) is significantly different from a hazard analysis, the identification of hazards of concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk assessments addressing specific hazards or control factors become available, the HACCP team should take these into consideration.
Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).
For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this product.
The hazard analysis summary could be presented in several different ways. One format is a table such as the one given above. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.
Determine critical control points (CCPs) (Principle 2)
A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.
Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree (Examples of decision trees are given in Appendices E and F). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.
Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.
Establish critical limits (Principle 3)
A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.
Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.
An example is the cooking of beef patties (Appendix B). The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.
Establish monitoring procedures (Principle 4)
Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.
An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.
Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.
All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.
When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.
Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.
Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.
With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.
Establish corrective actions (Principle 5)
The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.
Establish verification procedures (Principle 6)
Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) (2) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a verification schedule is given in Figure 2.
One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.
Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.
Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.
In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.
Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3).
Examples of verification activities are included as Appendix G.
Figure 2. Example of a Company Established HACCP Verification Schedule
Establish record-keeping and documentation procedures (Principle 7)
Generally, the records maintained for the HACCP System should include the following:
Examples of HACCP records are given in Appendix H.
The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.
Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.
(1) National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997.
(2) An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Academy of Sciences, National Academy Press, Washington, DC.
(3) National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regulatory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187-195.
Examples of Common Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to:
Facilities: The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials.
Supplier Control: Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.
Specifications: There should be written specifications for all ingredients, products, and packaging materials.
Production Equipment: All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented.
Cleaning and Sanitation: All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place.
Personal Hygiene: All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene.
Training: All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.
Chemical Control: Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant.
Receiving, Storage and Shipping: All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness
Traceability and Recall: All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary.
Pest Control: Effective pest control programs should be in place.
Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.
Example of a Flow Diagram for the Production of Frozen Cooked Beef Patties
Examples of Questions to be Considered When Conducting a Hazard Analysis
The hazard analysis consists of asking a series of questions which are appropriate to the process under consideration. The purpose of the questions is to assist in identifying potential hazards.
Example I of a CCP Decision Tree
Important considerations when using the decision tree:
* Proceed to next step in the process.
Example II of a CCP Decision Tree
*Proceed to next step in the described process
Examples of Verification Activities
The Chinese Communist Party (CCP) is the founding and ruling political party of modern China, officially known as the People’s Republic of China. The CCP has maintained a political monopoly since Mao Zedong founded the People’s Republic in 1949, and it has overseen the country’s rapid economic growth and rise as a global power.
Chinese leader Xi Jinping has consolidated control over the infamously opaque party since coming to power in 2012. Some experts have called him the most influential Chinese leader since Mao, and Xi is poised to win an unprecedented third term during China’s twentieth party congress in 2022. Championing a vision for China’s “rejuvenation,” Xi has pursued a more assertive foreign policy strategy, which has increased tensions with the United States and its allies. At home, some of his policies, such as those aimed at reining in corruption and reducing poverty, have been widely popular, while others have received some pushback. Challenges facing the party include slowed economic growth, the COVID-19 pandemic, and the climate crisis.
As general secretary of the CCP, Xi sits atop the party’s power structure. He is also China’s head of state as president and the head of the military. But most of his power stems from his role as general secretary because of how China’s political system works: Party institutions and state institutions are technically separate, but the ultimate power comes from the CCP. As CFR’s Ian Johnson writes, “Run the party and you run China.” Xi will likely be given a third five-year term as general secretary during the CCP’s twentieth party congress in October 2022, breaking a trend in recent decades in which leaders have stayed on for two terms.
The son of a CCP revolutionary, Xi has worked to restore the party’s central role in society and reclaim China’s power on the world stage. These goals are expressed in his “Xi Jinping Thought” doctrine, which is expected to be enshrined in the party’s constitution. To those ends, Xi has overseen the modernization of China’s military, the harsh repression of minority communities throughout the country, and the increase of state control over private companies, among other actions.
Xi has consolidated his control of the party by ousting rivals and promoting supporters. He launched a massive anticorruption campaign in 2012 that has targeted more than four million officials, including high-level officials, or “tigers,” senior military figures, and lower-level party cadres, or “flies.” In promoting his supporters, Xi has created a faction of loyalists in the party leadership. There is some debate about whether Xi has any formidable opposition. Victor Shih, an expert on elite Chinese politics at the University of California, San Diego, has observed that top officials Wang Yang, Li Xi, and Hu Chunhua all have sizable factions separate from Xi. He writes that what happens to them during the twentieth party congress will determine how much of a check there is on Xi’s authority. Meanwhile, Xiaohong Xu, an Chinese history expert at the University of Michigan, writes that previously powerful factions are “dead” and power lies with Xi loyalists.
Xi’s elevation marks the first time that the CCP has moved toward strongman rule since Deng Xiaoping steered the party to consensus rule (or collective leadership) in the 1980s. Experts on modern China caution that relying on a single leader to navigate reforms could threaten the party’s survival. Former CCP insider Cai Xia has said that Xi’s consolidation of power has crushed any form of policy debate among the party’s top officials. Similarly, former CFR Senior Fellow Elizabeth C. Economy argued in Foreign Affairs that China’s economy has suffered because of Xi’s control. “Too much party control—perhaps too consolidated in Xi’s hands—has contributed to economic stagnation,” she wrote.
Inspired by the Russian Revolution, the CCP was founded in 1921 on the principles of Marxism-Leninism. Tensions between the Communist party and the nationalist Kuomintang, its primary rival, erupted into a civil war won by the Communists in 1949. Despite market reforms in the late 1970s, the modern Chinese state remains a Leninist system, like those of Cuba, North Korea, and Laos.
The 1989 Tiananmen Square protests and the collapse of the Soviet Union in 1991 triggered a series of existential crises for the party that forced it to reconsider its mandate. The Soviet implosion in particular pushed the CCP to examine the causes of regime collapse and institute intraparty reform to avoid a similar fate. It determined that an ossified party-state with a dogmatic ideology, entrenched elites, dormant party organizations, and a stagnant economy would lead to failure, according to David Shambaugh’s 2008 book, China’s Communist Party.
Since the 1990s, the CCP has shown a technocratic capacity to respond to the developmental stresses brought on by China’s dizzying economic rise. Today, the party has harnessed the rewards of globalization and economic development, lifting tens of millions of people out of poverty. The CCP has reimagined itself as a driver of change, guiding the country’s path to wealth and fueling a sentiment of national pride.
As of 2021, the CCP has more than ninety-six million members. Over 70 percent of them are men, though the number of women in the party has grown in recent years. The number of members with college degrees has also increased, as have members younger than forty. Agricultural and blue-collar workers make up roughly 30 percent of CCP membership.
Every five years, the CCP convenes its National Party Congress to set major policies and select top leaders. (This is not to be confused with the National People’s Congress , which is China’s legislature.) During this time, members choose the Central Committee, which comprises around 370 members and alternates including ministers, senior regulatory officials, provincial leaders, and military officers. The Central Committee acts as a sort of board of directors for the CCP, and it is required to hold annual meetings, known as plenums. The Central Committee also selects the Politburo, which has twenty-five members.
In turn, the Politburo chooses the Politburo Standing Committee through secretive, backroom negotiations. The Standing Committee functions as the epicenter of the CCP’s power and leadership, and its membership has ranged from five to nine people. Xi is at the top, as the party’s general secretary. The premier, Li Keqiang, heads the State Council, China’s equivalent of a cabinet. Li is expected to step down in March 2023.
Since a precedent took hold in 2002, members of the Politburo have been expected to step down after reaching the age of sixty-eight. Despite being sixty-nine in 2022, Xi is likely to stay on for a third term. Ahead of the twentieth party congress, however, analysts said older members of the Politburo Standing Committee would likely stick to the retirement age and step down.
While the Central Committee, Politburo, and Standing Committee generally give broad policy direction, actual governance of China can be quite decentralized. Policies can originate “haphazardly” in bureaucracies and ministries, within the Central Committee, inside the National Party Congress, or from think tanks and advisors, says Claremont McKenna College’s Minxin Pei. Chinese provinces enjoy significant autonomy, and subprovincial officials and leaders, appointed by the central government, have much control over local governance.
China’s military, the People’s Liberation Army (PLA), is technically the armed wing of the CCP, and its main objectives include protecting the party’s rule and defending the party’s interests. The CCP’s Central Military Commission, currently headed by Xi, oversees both the PLA and the People’s Armed Police, which primarily focuses on internal security. According to a 2020 U.S. Defense Department report on China’s military, the CCP sees the PLA as “a practical instrument of its statecraft with an active role in advancing the PRC’s foreign policy, particularly with respect to the PRC’s increasingly global interests and its aims to revise aspects of the international order.” For example, the PLA oversees the deployment of warships and aircraft near disputed areas of the East and South China Seas, as well as near Taiwan.
Leaders share concerns that public outrage and activism over a host of issues—such as income inequality, environmental threats, land grabs, food safety, and lack of consumer protection—could threaten the party’s control and catalyze democratic social change.
Economic slowdown. China, the world’s second-largest economy, has seen economic growth slow since its breakneck, double-digit growth in the early 2000s. The massive accumulation of debt by companies, local governments, and households, as well as the teetering real-estate sector, has led to concerns among policymakers. Under Xi, the party has increased its oversight and control of the economy, cracking down on tech firms and increasing state involvement in private companies.
COVID-19 pandemic. Public anger erupted over the government’s initial actions: after the virus was first reported in Wuhan in December 2019 and then spread throughout the country, ordinary citizens condemned the government’s slow response and its efforts to silence doctors who warned of the virus. Local and provincial governments locked down cities and halted industrial production. Thousands of people died. By mid-2020, China’s reported cases plummeted even as cases rose elsewhere, including in the United States and European Union countries. Party officials and state media pointed to the low case count to push a narrative that the CCP’s authoritarian governing model is superior to democratic models. With that framing, the party’s legitimacy has become tied to having few COVID-19 cases. That’s why China has upheld its strict “zero-COVID policy” through 2022 even as other countries relaxed restrictions. Though many Chinese people support the policy, some have criticized it, pointing to the economic losses resulting from frequent lockdowns and the challenges in obtaining food and medical care. CFR’s Yanzhong Huang warns that if Beijing loses support for its COVID-19 policy, “a regime once known for its technocratic efficiency could soon face a growing legitimacy crisis.”
Income inequality. The CCP grapples with growing income disparity. According to the World Inequality Database, the richest 10 percent of China’s population earn on average fourteen times more than the poorest 50 percent. (This is worse than inequality in many European countries, but better than in the United States and India.)
Environmental degradation. In the past decade, China has emitted more greenhouse gases per year than any other country. Air pollution, water scarcity, and soil contamination threaten the health and livelihoods of China’s people. Climate change also threatens the country’s food and water security. In his book Toxic Politics: China’s Environmental Health Crisis and Its Challenge to the Chinese State, Huang argues that the CCP’s failure to address pollution could lead citizens to question the party’s legitimacy. Indeed, as public awareness of environmental degradation has increased, the number of petitions and protests have grown.
Aging population. China’s aging population will test the party’s ability to provide for its people. Estimates suggest that retirees could account for more than 40 percent of China’s population by 2050. In response, the party has worked to broaden insurance coverage. Moreover, life expectancy has increased while the birth rate has declined. The CCP allowed married couples to have three children, ending a two-child policy, in 2021. But the birth rate has continued to decline, and CFR’s Carl Minzner warns that promoting births could come at the expense of women’s rights.
To counter threats to its control, the CCP has sought to further embed itself across layers of Chinese society and the economy. With Xi’s encouragement, the CCP has done so by silencing dissent; restricting religious groups, media organizations, environmental nonprofits, human rights activists, and lawyers; reining in the private sector; and combating corruption. It has also increased censorship of the internet, where many of the public’s grievances have been brought to light. which has eroded some of the CCP’s control over political communication despite being heavily censored in recent years.
When you set out to start a food business, you might have heard the importance of a food safety plan and identifying any critical control point, but do you know the importance of these things?
As a food handling business, you are responsible for many things, including the emotional experience of a delicious meal, attracting customers with a versatile menu, and producing wholesome food for consumption. To run a safe and successful food business, all requirements around food safety must be met to prevent the occurrence of any foodborne illness or any adverse health effects as a result of serving hazardous food. The initial steps to ensuring food safety are to conduct a hazard analysis and determine any critical control point in your whole food chain.
Identifying the potential hazards within your food handling process (ordering food, receiving food, storing food, etc.) is important to determine at which steps are these food safety risks most likely to occur. To address these hazards and produce safe food, critical control points along the manufacturing process are set.
In this article, we will be diving into the importance of critical control points and their contribution to a HACCP food safety plan.
By definition of the FDA, a critical control point is any process step where control can be applied for the prevention or elimination of any potential food safety hazard. A systematic approach and significant focus are being placed on a critical control point along your food production process. A breach or loss of control of the established parameters for this critical control point can cause adverse public health issues due to unsafe food.
The main prerequisite for assigning a critical control point based on the 7 HACCP principles is to identify the potential food hazards in each step. Food handlers are required to address all potential hazards that are reasonably likely to cause illness or injury if left uncontrolled. These hazards may include microbiological contamination, chemical contamination, or the presence of filth.
Examples of CCPs may include:
You need to carefully develop and document all your critical control points. A key purpose of accurately established CCPs is to serve as foundations for controlling food safety hazards. An accurate record of established CCPs is also one of the 7 HACCP principles and is essential for establishing a food safety management system when compiling your HACCP food safety programs.
It may be a bit confusing if you are new to these terms. Think of it this way, a critical control point is a step that when you forget to do, skip, or do not satisfy, would eventually result in lawsuits because of food safety issues. It does not get any clearer than that. End-product testing does not require any critical control point since not much can be done if the food product has already been processed.
A critical control point is considered a control measure and varies depending on the nature of your food manufacturing business, the type of food products you supply, and even the raw materials you use. A great example of varying critical control points per product is the measurement of internal temperature when cooking chicken or beef and storing vegetables.
To make chicken safe for consumption and remove the risk of Salmonellosis, your raw chicken must be cooked at around 165°F (75°C), whereas a slab of beef for roasting would only need 145°F (around 60°C-65°C). On another note, maintenance of elevated temperatures may not be applicable for food services that deal with fresh produce such as vegetables. Critical control points for such businesses may be chemical testing for pesticide residue or the presence of microbial toxins, and others.
Learn more about what critical control points do not include.
A control measure is an action or an activity that can minimize or eliminate an identified potential hazard or reduce its likelihood of occurrence to an acceptable level. In other words, a control measure is any action, step, task, process, or procedure intended to address a food safety hazard. The term control measure is used because not all hazards can be prevented, but all of them can be effectively controlled.
Control measures are not necessarily considered critical control points. They can be simple steps such as proper hygiene, adequate testing, sanitation routines, pest control, or regular training.
The first step to understanding a critical control point in food preparation is knowing that control measures are categorized according to their nature, relationship to the process, and the level of risk to the consumer should the measure fail.
Examples of control measures include:
• Control Points (CP)
• Critical Control Point (CCP)
• Prerequisite Programs (PRP)
• Operational Prerequisite Programs (oPRP)
• Quality Control Points (QCP)
The responsibility for food safety is a key element in maintaining a good reputation in the food industry. This duty includes identification of hazards, the establishment, and monitoring of CCPs, and applying verification steps to ensure control of food safety. These little steps from purchasing ingredients to plating the food that helps reduce the risk of any health hazard and keep your customers returning to their favorite point of deliciousness.
In a HACCP food safety plan, other terminologies such as control point, prerequisite programs, and operational prerequisite programs may come up. To sort out any possible confusion surrounding these terms, let’s look into four main terms that you will come across when determining control measures and any critical control point for food safety.
Control Point (CP): Any step where any biological, chemical and physical hazards can be controlled. This term is generally used for processes that may or may not be critical in eliminating hazards, but contribute to their prevention and reduction. An example of a control point may be prewashing potatoes to eliminate any physical hazard before blanching which serves a different purpose. Control Point is a concert used in the HARPC food safety system.
Critical Control Point (CCP): One of the key HACCP principles, a CCP refers to the step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. If the potential hazard can be reduced or eliminated in another upcoming process, a control point is not critical. The clearest distinction between a CP and a CCP is that CCPs are the final step at which you can reduce hazardous contaminations to an acceptable level. The term CCP is based on the principles of HACCP.
Prerequisite program (PRP): Necessary basic conditions and activities that are needed to maintain a hygienic environment throughout the food chain. You can control low and moderate risk levels by putting robust PRPs in place. Prerequisite programs are simple regulations such as proper employee hygiene, handwashing directions, pest control, and basic sanitary design principles. These programs promote sanitary conditions to prevent food safety issues and maintain clean facilities. As the name suggests, prerequisite programs are needed to establish a HACCP food safety plan with a solid foundation and are considered their basic framework. Examples of prerequisite programs for HACCP can also include quality assurance procedures, labeling, standard operating procedures, and recipes.
Common prerequisite programs may include:
Operational prerequisite program (oPRP): Intermediate measures and activities used to control the likelihood of high levels of identified risks in the manufacturing process. Employing OPRPs depends on food regulatory standards and varies from country to country. Operational prerequisite programs are not general steps, but rather specific to control certain hazards. These programs are the result of in-depth hazard analysis.
To put a distinction between PRP and oPRP, prerequisite programs are usually general to the process and not focused on any particular step in the process flow. For example, cleaning and sanitizing are activities that can apply to all steps, rooms, and items.
If you want to figure out which control measures are appropriate to identify hazards in your food business, you should evaluate the risk levels using a control point decision tree diagram or a risk matrix or use digital solutions to food safety. Alternatively, you can use our free CCP tool to determine the type of operation needed to control a particular hazard. All you have to do is identify the hazard of concern, the likelihood of its occurrence, and the potential effect that it may have on your operations. Our free tool will then show the correct operation that you will need.
Want a faster solution? Our built-in HACCP plan builder can help you fulfill all components of a HACCP plan in just an average of 1 hour. Our built-in software automatically generates all of the most important documents of your HACCP plan, including the identification of CCPs. What's more is that you can customize the identified CCPs, add more operations, or modify them as an OPRP. Our system offers the fastest and most convenient way toward food safety compliance.
Read more about OPRP and the differences between CCP and PRP here.
As you know by now, there are no generic CCP templates that fit all food businesses. Only you can decide what potential food quality hazard is applicable to your restaurant, burger truck, or café. Critical control points vary depending on the nature of the food establishment you have.Different restaurants that prepare similar foods can still identify different hazards and have different CCPs and preventive measures. This can depend on the layout of the food processing facility, equipment, ingredients used, type of food produced, processes employed, etc. If you are unsure whether a certain step should count as a CCP, put it on the list for evaluation.
Accurate identification of CCPs is a job of your HACCP food safety team consisting of experts in the various fields of your process. A critical control point is always related to hazards and can vary in nature depending on the identified food safety risk. Food hazards can be biological which includes bacteria, fungi, viruses, and other pathogenic microorganisms; chemical, such as chemical toxins, preservatives, and pesticides; or physical which can be in the form of pieces of hair, glass, or metal shards.
Critical control points for biological hazards are usually dependent on the physicochemical properties of your food product. The growth of bacteria and other pathogens is affected by nutritional properties, acidity level, moisture level, water activity, salt concentration, smoke point, and others. In terms of chemical contaminations, CCPs can be based on the degree of processing, raw materials used, and added preservatives.
Lastly, CCPs for physical contaminants are mostly based on the origin of the raw materials and sanitation of the processing area and that of the supplier.
Here are some common critical control points and their basic principles that may apply to most establishments in the food industry:
#1 Cold storage. Cold storage can be a CCP for different reasons. For example, if you offer raw meat to your customers, cold storage immediately becomes a CCP. The principle behind using cold storage for storing and transporting fresh or raw products is that at low food temperatures, all biological processes are slowed down or even stopped. Such biological processes include enzymatic (e.g. browning in fruits and vegetables, and proteolysis in fishes and meats) and microbiological reactions. Cold storage prevents the breakdown of the quality of your foods because it stops microorganisms from multiplying, sometimes even eliminating them, and prevents natural enzymatic breakdown occurs. Likewise, refrigerating precooked foods to prevent hazardous microorganisms from multiplying is another reason for using cold storage.
Fluctuations in temperature control keeping may help enteric pathogens to thrive by giving them time to recover and bringing the microbiological quality to unsafe levels and producing hazardous foods. In addition, drastic changes in surrounding temperature may sometimes cause softening of food tissues especially when they are frozen. During transport, if your food products are intended to be delivered within cold storage, this means that they tend to spoil if ambient temperatures are used.
#2 Thermal processing. Any specific heat process that is designed to destroy a specific microbiological pathogen at a specific time and temperature can often become a CCP. Thermal processing procedures are usually used for cooking safe food products such as canning, baking, and pasteurizing milk. Despite this, the principle of their use in a process can determine if they can be considered a critical control point.
Take canning and pasteurization as examples. In these processing methods, thermal processing is used not to cook the product, but to render them safe from microbial contamination. The factors affecting canning such as the time-temperature combination used for the process are determined by the target microorganism in low-acid foods which is Clostridium botulinum. On the other hand, although a similar concept is at play, pasteurization time-temperature combinations are meant for killing the microbial pathogens Coxiella burnetti and Mycobacterium tuberculosis. All of these pathogens are known to cause severe human health hazards such as hospitalization and death. In some cases, their presence and other enteric pathogens have been the cause for a business to become closed. This is why microbiological testing for their presence is a standard in these food operations.
Skipping these processes or not adhering to the correct standards may cause food safety issues for your business, and therefore they are considered critical control points. In the case of baking, thermal processing is only needed to transform dough into bread. If the established parameters are not met, no significant food safety issue may arise. At most, the only problem may be underbaking or overbaking your food products.
In terms of chemical hazards, thermal processing limits can also be applied. For products that have the appropriate combination of proteins and carbohydrates, overprocessing can lead to the formation of acrylamide. This substance is a known carcinogenic agent and is formed when your product is excessively heated. As such, avoiding unacceptable levels must be followed.
#3 Hot storage / displaying hot food ready for sale. When your finished product is pre-cooked and sold as hot food, it needs to be kept at 140°F (60°C)or above to prevent bacteria from multiplying while the food is on display or stored. The required temperature needs to be uniform around and within the food. This is a very common CCP for hotels, school cafeterias, and hot dog stands, among others. The principle behind this is keeping your food away from the temperature danger zone which is 40°F to 140°F (5°C to 60°C) or the range of temperature where most enteric pathogens thrive. As a rule of thumb ready, it is not safe to eat products from food services that are not supposed to be outside this zone for more than 2 hours.
#4 Cooling/preparing cooked foods for storage. Food that has been cooked can be left out at room temperature until it cools down enough to be put into the fridge. The cooling must happen as fast as possible and different countries have different standards when it comes to the temperatures the food must reach within the first 2-4 hours. The reason behind this CCP is that the longer your food takes to cold down, the more chance of surviving microorganisms to multiply increases. An abrupt temperature change will further hurt microorganisms and lessen their survival rate. The same principle applies to the thawing of foods. As you thaw your frozen foods, microorganisms that have survived will have the time to recover.
Read more about different critical control point examples.
Toxin testing - this method can be considered as a critical control point for products that are considered high-risk. An example of high-risk products would be peanuts, corns, and other grains. If you are in the industry of peanuts and cereals, you are most certainly familiar with how important the levels of Aflatoxin are. This compound is a toxin produced by microorganisms under the genus Aspergillus. Aflatoxin is a highly regulated biological toxin because of its adverse effects on humans and animals and is most usually found in the mentioned products. As such, its detection during receiving is very important.
Food recalls in past related to this compound are recorded. Failure to detect breaches of acceptable levels may cause loss of control of safety, consumer complaints, human health hazards, and lawsuits. Raw materials are inspected and held in the storage warehouse before acceptance. Once proven clear of contaminants, they are accepted for use.
Filth detection process - this step is commonly considered as a general critical control point to monitor, detect, and control physical hazards. Filth detection in a food processing facility can be done in many different ways. Aside from visual observations, another example would be sieving a sample batch of flour from your storage area. Using a specific size of sieve that will only allow the flour to pass through will prompt your quality assurance specialists and food safety supervisor if there are physical contaminants. These contaminants are usually broken glass, pieces of metals, pieces of jewelry, and other sharp objects. Other methods can be done using a magnet or a metal detector to collect metal contaminants. These physical hazards can cause injury if ingested by consumers. The size of these filths is usually used as a physical parameter to determine the risk they have. Once they go undetected in inspection, they can easily work their way to the finished product.
Product formulation control - during production, the specified amount of ingredients and raw materials are provided to your in-line employees. Preweighed ingredients are usually brought to the production and are ready for use. The product formulation control point is done by verifying the amount of these materials before use. Exceeding or lacking the allowable or required weights and amounts, respectively, of certain products such as preservatives or other ingredients can lead to health hazards. If too little acidulant is added to your food product which is expected to have a low pH level, microbiological hazards may multiply in this condition and create a food quality hazard.
Conducting a hazard analysis and identifying critical control points can be a time-consuming task. Not to mention that if you are quite inexperienced and your HACCP food safety team lacks specialization, there are chances that you might miss some critical control points. This fact may then lead you to hire a food safety consultant and can cost you quite a lot.
Luckily, those days are over. FoodDocs, your digital solution for food safety management system can determine the CCPs in your operations and processes smoothly and quickly. Our built-in software can automatically identify the CCPs in your food operation based on the nature of your business with just a few clicks. You can even generate monitoring forms for different tasks such as thermal monitoring procedures, pest control, and other documents which can be used as a comprehensive verification procedure and control CCPs. We aim to make your lives easy and for food safety to be accessible to everyone.
When handling food, you need to analyze and describe which control measures can be applied for each hazard. Many preventive control measures are put in place to avoid food contamination from the production environment (e.g., staff, pests, water supply, etc.), but other measures aim to reduce or eliminate hazards directly linked to specific production processes. (These can lead to the establishment of CCPs or operational PRPs – more about these later.)
A critical control point is established after the hazard identification and analysis in your production process. Analysis of hazards is usually done by using established scientific studies, opinions from experts, and food laws and regulations. A lot of time goes into the identification and validation of which operations can be considered as CCPs.
After identifying which hazards are present, a critical control point can be evaluated for assignment. A method is considered a CCP if there is no other subsequent step that will minimize or eliminate the potential hazard present in the product. This means that the process must be successfully executed. A series of factors are considered before a process step is considered as a critical control point. This is why it is helpful to use a risk matrix or a decision tree diagram to identify the risk level of each step of the whole process and provide a detailed explanation and justification.
When conducting a hazard evaluation, consider the likelihood of exposure and the severity of the potential consequences if the hazard is not properly controlled. Severity is the seriousness of the consequences of exposure to the hazard (for example, the magnitude and duration of illness or injury and the consequences). You can use the following to evaluate the likely occurrence of a hazard:
If you choose to use a decision tree to determine the risks of each step in the process of food handling, remember that more than one step in a process can be involved to control a hazard, and more than one hazard may be controlled by a specific control measure.
As a rule, you need to determine which steps apply to your business and where the potential hazard could come from. Once you have identified all the hazards and their risk levels, you must ensure that you put controls and appropriate corrective actions in place for each one of them.
All of these tasks can easily be performed using our food safety software. You can keep records in our software system, set up your procedures for monitoring, and keep an eye on the records in the activity log. Using the features of our digital food safety system, you can leave the analysis to us and let us suggest which are the most important critical control points of your food processing plant.
Along with this suggestion, you can even generate your monitoring forms for each CCP, download them, and print them for the whole HACCP team. The best part is you do not have to wait long. The whole process of shifting to a digital food safety management system will only take 15 minutes.
The whole process of making a HACCP food safety plan can be very time-consuming, costly, and tiring to do. It requires efforts from all team members and has grave consequences if left unchecked. A good HACCP food safety is continuously used and updated regularly. Whether you are a long-time player in the food industry or a newcomer, making a HACCP food safety plan will always be a difficult task. Dealing with a business offering different products with different processes is a whole other story. Each product and step may require its own HACCP food safety program.
All of these tasks can be prone to frequent review and revisions and can even result in seeking help from a food safety consultant. What if there is a way for you to do all these tasks with a method that is 500x faster and 15x cheaper? Our built-in food safety software at FoodDocs was developed to help you get through all the HACCP documents without breaking a sweat. Our HACCP program builder was designed to generate the most relevant hazards, critical control points, control measures, and validation activities fit for your business.
Some of the things we can do for you include:
Never worry again about how to identify CCPs for your HACCP food safety program with FoodDocs. Our system automatically ranks the hazards in your food operations based on our established risk assessment matrix. We automatically suggest the appropriate level of activity for each hazard. Action levels vary as PRP, oPRP, CP, or CCP. Our suggestions are based on the knowledge of our food safety experts, related literature, and information from our customers in similar food businesses as yours. Through this combined information, you can be assured that all documents and data we provide are accurate.
In addition, we understand that some countries and food companies have specific critical control operations that are very unique. This is why we allow our customers to input new hazards and control measures in their HACCP plan. All you have to do is identify the hazard, input its level of likelihood and severity of potential damage, and we will automatically suggest which action level is most appropriate for this hazard.
We base the HACCP plan we build for you on the mandatory requirements and regulations of your location. Through our built-in HACCP builder, you do not have to worry about how to identify the critical control points of your business and create a flow diagram and monitoring records for each of them. In addition to all of these great features, we have built a complete template hub containing various monitoring forms and checklists for your food business that you can freely use and edit depending on your needs.
Our services even come with a free 14-day trial enough for you to build your whole HACCP plan. Complete your HACCP plan within just 1 hour and download and print it for all of your employees. You can even use invite food safety auditors to view your digital HACCP plan to save on printing it! Build your HACCP plan sustainably and efficiently.
A CCP is a step in which a control can be applied to slow or stop the growth of microorganisms.
In the Life Sciences space, CCPs are an important part of a system known as Hazard Analysis Critical Control Points (HACCP). HACCP delivers the framework for controlling the pharmaceutical production process, with the goal of lowering the risk of illness and injury in manufacturing.
Every step in the chain that may require pathogen reduction becomes a CCP: pre-processing, storage, shipping, and more. More complex CCPs may include allergen inclusion or even toxic metal detection in pharmaceuticals.
The U.S. Department of Agriculture Food Safety and Inspection Service requires processors to maintain at least one CCP. Generally, this means the CCP will be the point at which the pharmaceutical is most susceptible to microbial growth or other key health and safety issues.
The process is also imperative in regulations such as ISO 22000, which requires manufacturers to meet the minimum human health and safety standards. The benefits of CCP regulations expand throughout the pharmaceutical manufacturing supply chain.
It’s essential to note that CCPs are not a substitute for good hygiene practices. Rather, they should include these practices. In addition, a CCP should consistently focus on control safety over quality issues. Quality controls are crucial as well, but they are a separate entity that must be considered individually.
The HACCP process involves a number of concepts in addition to Critical Control Points. These include:
A risk is the likelihood that conditions will result in a hazard.
Hazards involve contamination or microbial growth that could compromise food safety.
Monitoring, in this context, means determining whether the responsible parties have met the CCP criteria.
Severity assesses how serious the outcomes of a hazard may be.
Critical limits are the maximum and/or minimum value at which a parameter should be controlled to prevent the food hazard from taking place.
CCPs are based on factors such humidity, acidity, and more. Even sensory information like appearance, smell, and texture play a role.
A series of unique steps comprise the HACCP system. Each one helps to address the control of pharmaceutical manufacturing biological, physical, and chemical hazards.
These steps include:
Here it’s essential to compile a list of hazards that may result in illness or injury without the proper controls. Whether or not the pharmaceutical will be given to vulnerable groups (like the elderly or the immunocompromised), employees’ training and skill levels, the transportation process, level of contact with the pharmaceutical, and storage and transportation are all key considerations.
This is the time to identify and define the Critical Control Points over the course of the supply chain. It’s essential to keep in mind that CCPs—when defined incorrectly or inadequately—may lead to illness or harm. Examples of CCPs include storage, transportation, and distribution. Be sure each CCP outlines the best ways to monitor, measure, and document the pharmaceutical throughout the supply chain.
A critical limit makes sure the hazard—biological, physical, or chemical—is controlled by the CCP. All critical limits should be rooted in science. These limits may come from regulatory guidelines, surveys, or expert findings. Examples of critical limits include time, temperature, chlorination, and other factors. It’s imperative that they can be monitored by observation or measurement (and revisited as needed).
Monitoring procedures feature observations or measurements recorded by a trained professional that determine whether the Critical Control Point is met. They provide written documentation of the flow of pharmaceutical through the facility and across the supply chain. If these procedures reveal the critical limits aren’t met, workers must take measures to comply with the relevant regulatory bodies.
If at any point in the food system professionals struggle to meet the CCP criteria, the responsible party must take corrective action as appropriate. All corrective actions should be based on fact and measurable (as well as documented) so that any gaps or shortcomings can be quickly rectified. An example of a corrective action is to discard the product and store future iterations at a lower temperature.
Verification procedures go beyond monitoring and assess the validity of the HACCP plan—ensuring the system is functioning so workers can make changes as needed. This is where experts will confirm the plan is science-backed and technically-valid. From there, one can determine all hazards are identified and controlled. Expert advice or even an onsite review of the critical limits may play a role here as well.
All aspects of the HACCP plan should be recorded and documented, with data and visuals included to reflect the relevant standards. Team members should be trained on documentation procedures and understand why recordkeeping is so paramount. Time and temperature logs, flowcharts, staff training records, and standard operating procedures (SOPs) are all documents you’ll want to have on hand.
HACCP is a research-backed tool for mitigating human health hazards in pharmaceutical manufacturing. CCPs are an integral part of this overall strategy. While manufacturers should include at least one Critical Control Point in each of their products, it’s typically most effective to begin with a single product that includes limited hazards. That way Life Sciences organizations can understand clearly what the concept of a CCP entails and elaborate on their strategy moving forward.
Curious about other concepts linked to Risk Mitigation?
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