What Are Critical Limits In Food Safety
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.

What are critical limits in a food safety plan?

A Critical Limit is a standard that you must meet to ensure that a health hazard does not occur at a Critical Control Point. For example, a Critical Limit at the cooking CCP would be cooking to a minimum specific internal temperature for a minimum amount of time.

What is included in critical limits?

Critical limits with a combination of criteria – In some cases, you may need to use more than one critical limit to control a hazard at a particular CCP. Such critical limits would be a set of criteria, such as temperature, time (minimum time exposure), physical product dimensions, water activity and moisture level.

minimum internal temperature of the patty oven temperature time in the oven determined by the belt speed rpm and patty thickness

How do you identify CCP?

I. Determining CCPs – In general, CCP determination involves identifying and characterizing the hazards, the control measures, and the processing steps where control is applied. Thus, it is imperative that the HACCP team revisit and re-evaluate the Hazard Analysis as well as the Flow Diagram.

If a significant hazard that is reasonably likely to occur is identified in the Hazard Analysis, it must be controlled somewhere in the food processing and handling system. Due to the rigorous HACCP requirements for setting appropriate CLs and monitoring, there are certain hazards in certain situations which are more appropriately controlled by prerequisite programs.

This has been the subject of some debate and has led to two approaches in dealing with such hazards. While they differ philosophically, the end result of these two approaches is similar.

Approach A: This approach is used by some HACCP auditors in the regulatory and private sector. It dictates that a hazard deemed significant in the Hazard Analysis must be controlled at a CCP. It then follows that a hazard which is, in fact, managed by a prerequisite program is considered not “reasonably likely to occur” because of the prerequisite program. Approach B: In this approach, prevention and control of identified significant hazards can either be at a CCP or through rigorously applied prerequisite programs.

No set number of CCPs is required in HACCP. Rather, CCPs must be determined for each specific food processing and handling system and be appropriate to that specific system. Having too many CCPs could unnecessarily encumber and burden the implementation of the HACCP plan.

Conversely, having too few CCPs could jeopardize food safety. CCPs that involve subjective control measures (e.g., visual parameters, observations) rather than objective control measures (e.g., temperature, time) are difficult to implement and require more creativity with regard to CLs and monitoring procedures.

For this reason, many HACCP plans now have fewer CCPs than they did historically, with the emphasis instead being placed on sound, well-conceived, and well-implemented Prerequisite Programs.

How do you validate critical limits?

So what do we mean by validation and verification? – Validation is a process of determining what critical limits are required, in order to control the hazard that has been defined. Verification is the process of checking that the critical limits that have been set, are being met on an ongoing basis.

  • So, to recap:
  • Validation is – proving that it will work.
  • Verification is proving that it is working every day.

The hazard would be ‘survival of salmonella in the dispatched finished product, due to ineffective heat treatment.’ To ensure the thermal kill of salmonella pasteurisation would be required, so 72°C for 15 seconds, or equivalent. We’ll use the time and temperature combination of 72°C for 15 seconds for this example.

Therefore, the critical limit would be a minimum of 72°C for a minimum of 15 seconds, To validate this, trials need to be conducted to show that the process can consistently produce a product that that meets the critical limits, To do this, a number of production runs would need to be assessed and the time and temperatures reached recorded,

The trials would need to be carried out at worst cas e, for example, with the egg at the coldest temperature that it would normally be processed. Data loggers would need to be used to show the temperature reached and how long it was held there for. Once this is complete, a report would need to be created, detailing all the evidence from the trials,

  1. This report would need to link the validation information with how the product would be verified for each batch produced on an ongoing basis.
  2. For example, the egg could be checked for temperature with a probe and when it reaches 72°C it would then need to be cooked for a further 2 minutes (this would need to be timed) to show that it has met the critical limits.

The validation is the trial work that shows that the process can achieve the critical limits. (Proving it will work.) The verification is the ongoing monitoring of the product every day to show that the critical limits are being met. (Proving that it is working every day.) Carrying out cleaning trials to show:

  1. That the cleaning procedure reduces the contamination to the required level.
  2. What monitoring limits need to be achieved using ATP and micro swabs to validate.

Daily ATP testing to show that the clean has been carried out effectively. Metal detector trials to show:

  1. What test piece sizes can be achieved.
  2. Where the test piece should go.

Start, hourly and end of run testing of the metal detector using the test pieces. Carrying out cleaning trials to show:

  1. That the cleaning procedure reduces removes allergen residue.
  2. What monitoring limits need to be achieved using rapid swabs and allergen swabs to validate.

Daily allergen rapid swabs to show that the clean has been carried out effectively. The HACCP plan the team validates (agrees) that (this is not an exhaustive list):

  1. The scope covers all relevant information.
  2. The flow chart covers all the required process steps.
  3. The hazards at each process step have been covered.

Routine audit of the CCPs. Routine audit of the PRPs. HACCP review. The best way of remembering which are verification activities, is that they are checks or monitors that happen frequently, to prove that the system is working. VERI = VERY often! We’ve tagged this article as: We’ve got a range of products for organisations of every size. With 20 different courses, our food safety and GMP training is designed specifically for operatives working in the food industry, manufacturing or distributing ingredients, packaging, or finished product. Just fill in your details and we’ll keep you posted on the progress of the system audits plan within audIT.app : HACCP Validation & Verification Explained!

What is the critical limit for reheating food?

Temperature control: hot food – London Borough of Bromley This leaflet is for all food businesses including those involved in food preparation and production, retail premises, catering, restaurants, pubs, cafes, takeaway and fast-food shops or businesses working from home.

What is temperature control? Temperature control is the term used for making sure food is kept at a temperature that will keep it safe and limit the growth of food poisoning bacteria. The safety of food is preserved by good temperature control. For hot food the important temperatures are those achieved when processing, cooking and keeping food hot before and during service.

When food is cooked, food poisoning bacteria are reduced to a safe level. Storing hot food is referred to as ‘hot holding’. What happens if food temperature is not controlled? Certain micro-organisms (called pathogens) can contaminate food, grow in it and then, if eaten, make you ill.

  • These organisms multiply to high levels in a warm environment.
  • You cannot see them or know they are there – food will look, smell and taste completely normal.
  • Symptoms of food poisoning appear later if the food was contaminated and unsafe.
  • ‘High risk’ is the term used for food that is most likely to cause food poisoning, such as any food that is ready to eat (including cooked rice, cooked meats, shellfish and dairy products such as milk and cream).

These foods should always be kept either below 5°C or above 63°C. Between these two temperatures is the area known as the danger zone – the temperature range within which bacteria grow most quickly. Temperature above or below these limits gives the bacteria as little chance as possible to multiply.

  • The average room temperature is approximately 21°C – an ideal temperature for bacteria to grow.
  • We can eat pathogens and our body can deal with them – but only up to a certain level.
  • Taking in too many organisms is known as taking an ‘infective dose’, and this will make you ill.
  • Controlling the growth of bacteria to make sure levels always stay below the infective dose level is the method used to keep food safe.

What do I need to do? THINK ABOUT THE MENU AND THE FOOD YOU USE AND HOW YOU PROCESS IT Identify dishes and products that are high risk. It is important that all food handlers are trained to identify high-risk food and how to process it safely. One of the main causes of food poisoning is not cooking things properly.

MAKE SURE YOU HAVE THE RIGHT EQUIPMENT FOR THE JOBYou should have enough room in your oven and on top of the stove for the amount of food that you cook and process. You will also need suitable equipment to keep food hot if you are not going to use it immediately. Make sure that anyone preparing and cooking food knows how to use this equipment, and that they are familiar with recipe or product cooking times and temperatures.

USE A PROBE THERMOMETER It is good practice to use a probe thermometer to check that food is properly cooked. Probe thermometers are designed to take the ‘core’ temperature of the food. This means measuring the temperature at the thickest part of the food – normally the middle.

The thickest part will always be the last area to experience temperature change, so the correct reading here shows that the food will have reached the right temperature throughout. When you are cooking food, you must make sure it reaches a minimum core temperature of 70°C for two minutes (or an immediate reading of 75°C).

In Scotland the minimum core temperature is 82°C. The food can certainly be hotter than this, but the quality of some food may suffer if it is overcooked or heated. It is important to periodically check that the probe is working properly – it must be accurate.

  • You check this by putting the probe into a mixture of cold water and ice.
  • It must read between -1°C and +1°C.
  • Then put it into boiling water where it must read between +99°C and +101°C.
  • Any reading beyond these temperatures shows that the probe is not accurate and it must be correctly adjusted or replaced.

REHEATING FOOD THAT HAS BEEN COOKEDThe same rule applies to food that is reheated. If you use a microwave to reheat food, make sure there are no cold spots. Cold spots are areas that receive the lowest thermal energy. You should thoroughly reheat food to a minimum core temperature of 75°C.

  • In Scotland it must be reheated to a minimum of 82°C) You can only reheat food once and if you do not use it after reheating, you must throw it away.
  • At 63°C bacteria stop growing and above this temperature start to die.
  • At 75°C enough of them have been destroyed to reduce levels to below the threshold that would make you ill, making the food safe to eat.

Not all bacteria may be destroyed by reheating. Some may survive, especially those that are able to form a ‘spore’ (create a tough outer layer to protect themselves). Spores can survive cooking, which means they may be present in cooked food. If the food temperature falls back into the danger zone, organisms which have survived will start to grow again.

traditional equipment such as an oven or the top of the stove a bain-mariea heated trolley or hot cupboard

Using the oven or the top of the stove will keep food hot but there is a risk the food will dry out and its quality spoil. A bain-marie provides a layer of heat around the food, while not leaving heat in direct contact with food. A very simple form of bain-marie is to put a pan into a tray of very hot (simmering) water on the stove.

You can buy a bain-marie as a piece of equipment – this could be a unit designed for kitchen use or a display counter. They can be heated by either electricity or gas (please note: electric models, unlike gas versions, use dry heat and must not be filled with water). Whichever method you choose, you must not use hot-holding equipment to heat food.

You must heat the food quickly and thoroughly to a minimum core temperature of 75°C using cooking equipment, and then transfer it to the hot-holding unit. How do I cool food safely? If you are going to cool cooked food, either to use as a cold dish or to reheat, you must do this as quickly as possible.

leaving it in a cool placetaking it out of the original cooking containerusing a fan to circulate cool aircooling foods like rice and pasta by running them under the cold tapputting the container in cold waterbreaking down the food into smaller quantities, which will cool much quicker than large amounts

You should never leave high-risk food to cool for longer than 90 minutes before storing it in the fridge. Read our ‘Temperature control: cold food’ leaflet for more information. You can leave low-risk food to cool and then store it appropriately. It is not as important to cool low-risk food so quickly.

Some food can be cooked and rather than kept hot, served as it is cooling. You should only keep hot food out of temperature control for two hours at the most. You can only reuse this food if, after two hours, you return it immediately to at least 75°C (for example, by reheating it quickly). You must keep the food above 63 ° C from that point as hot food can only be kept out of temperature control once.

Depending on the type and quality of the food and what you are going to use it for, it may be better to throw it away. A quick reminder Remember, it is a criminal offence to use food that is not fit for people to eat. By using spoiled, out-of-date or unsafe food, you are risking your customers’ health and your reputation.

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Alternatively, contact your local environmental health service for advice. Please note This leaflet is not an authoritative interpretation of the law and is intended only for guidance.© 2023 itsa Ltd.

: Temperature control: hot food – London Borough of Bromley

What is the difference between target limit and critical limit?

What is the difference between critical and operational limits? There are distinct differences between operational limits and critical limits. Both have a vital role to play in producing safe food. Establishing a critical limit at a critical control point is also a legal requirement.

Every critical control point will have a critical limit set for each control measure. A critical limit is the third principle of HACCP and an absolute value that separates the acceptable (safe) from the unacceptable (unsafe) at an operational condition. It must be achievable, measurable, detectable in real time and related to the control measure.

Criteria used to set critical limits include physical, chemical and sensory parameters. These include measurements of temperature, time, size, moisture level, pH, Aw, visual appearance and texture. Setting a microbiological critical limit for a critical control point is not practical because it relates to the hazard and not the control, and levels cannot be monitored on a timely basis.

  • A failure to achieve a critical limit is called a deviation.
  • Critical limits must be validated.
  • This requires the HACCP team to provide evidence to support a justification for a critical limit.
  • Evidence to justify a critical limit can be a process where tests are conducted internally because data is not readily available or can be a review of information.

Credible sources of information include scientific studies, regulatory or industry guidelines and expert knowledge. The findings on how critical limits were established and validated must be documented and available for review. This is important for three reasons: the HACCP team may need to benchmark current information against new data, justifications may be checked during audit or the validation study may be required to support a due diligence defence in court.

Operational limits are more stringent than critical limits and include target and action levels. A target level creates an area of tolerance before a critical limit is breached. This provides an opportunity to intervene before a deviation occurs at a critical limit. An action level is a measurable point between a target level and critical limit where appropriate action taken to bring the process under control.

For example: a target level for cooking a product could be 78OC with a critical limit of 75OC and action level at 76OC to bring the process back under control. Critical limits and operational limits must be communicated clearly to CCP monitors. This can happen during HACCP training and when limits are included in standard operating procedures and CCP monitoring records.

A review of critical and operational limits should happen when there is a significant change or new information becomes available (e.g. process, legislation, new scientific information, threat to safety, feedback from an audit). Read more articles on food safety on our blog page. Critical limits are covered on all our food safety and HACCP courses.

Join an open course running in Milton Keynes, Corby or London (East Acton). Call or send us an email to find out more on how we can support your business. : What is the difference between critical and operational limits?

What are the parameters for critical limits?

Step 8 _ establishing and validating critical limits Critical limits establish whether a CCP is in control, and can, therefore, be used to separate acceptable products from unacceptable ones. Critical limits should be measurable or observable and typically use minimum and/or maximum values or critical parameters, such as temperature, time, moisture level, pH, a w, conveyor belt speed, etc.

establish critical limits that are measurable or observable;use critical limits to differentiate acceptable from unacceptable products; andvalidate critical limits.

: Step 8 _ establishing and validating critical limits

What is an example of a critical limit in HACCP?

What is an example of a critical limit? – In food restaurants, the most common example of a critical limit and boundaries for food safety is the range of internal cooking temperature used for ensuring the level of doneness of food. A good example would be cooking chicken to an internal temperature of 74°C (165°F).

Is freezing a CCP?

It is important that the thermal centre of the product is chilled as quickly as possible to prevent the outgrowth of pathogenic microorganisms or the production of microbial toxins. Freezing may be a CCP. See HACCP Annex to the General Principles of Food Hygiene (CAC/RCP 1-1969).

What are the 4 keys to food safety?

Do you know how to keep food safe at home? The easy lessons of “Clean, Separate, Cook and Chill” will help protect you and your family from foodborne illness. Foodborne illness is a serious public health threat and all of us are susceptible. Consider the numbers: Each year, approximately 48 million cases of foodborne illness occur in the United States alone, according to the Centers for Disease Control and Prevention.

  1. Of those cases of foodborne illness, more than 128,000 people are hospitalized and approximately 3,000 people die.
  2. That is why it is critical that people understand the dangers of foodborne bacteria.
  3. While everyone is at risk for foodborne illness, there are those that face a higher risk if they consume unsafe food.

At-risk persons include the very young, older adults, pregnant women, and those with weakened immune systems. These food safety steps are especially important for them, and the messages of the Be Food Safe campaign can be a life saver. But the last line of defense against foodborne illness is in our own kitchens.

Clean! Wash hands and utensils to avoid spreading bacteria when preparing food. Find out how to prepare food in a sanitary way, Separate! Use different cutting boards for meat, poultry, seafood, and veggies. Learn more about the importance of separating foods during preparation, Cook! You can’t tell it’s done by how it looks! Use a food thermometer. Find out how to ensure your food is cooked thoroughly, Chill! Keep the fridge at 40 °F or below to keep bacteria from growing. Learn more about proper chilling,

What steps needs to be taken when critical limits are not met?

The Seven HACCP Principles – HSI The first principle in HACCP is to conduct a hazard analysis. This involves studying the production process of a food and developing a list of hazards that are likely to cause injury or illness if they are not controlled.

  1. Food hazards can be biological, such as bacteria or viruses; chemical, such as toxins or antibiotics; or physical, such as broken glass or metal filings.
  2. During the analysis process, you will need to determine if any of these situations are likely to occur.
  3. The hazard analysis provides the basis for determining the critical control points The second principle in HACCP is to determine the critical control points.

A critical control point is a step in the food production process where performing a particular procedure will prevent, eliminate, or reduce the hazard to an acceptable level. If this particular step or procedure is not done correctly, it is likely to cause an unacceptable food risk.

The third principle in HACCP is to establish critical limits for each critical control point. A critical limit is a maximum or minimum value that must be met at a critical control point to prevent, eliminate, or reduce a hazard to an acceptable level. A critical limit ensures the hazard is controlled.

It must be based on scientific findings or regulatory requirements. To assign critical limits, the HACCP team uses principles that are based on scientific findings and technically correct procedures that can be measured and validated. The fourth principle in HACCP is to establish procedures to monitor the critical control points.

  • Monitoring involves making measurements and observations that will help determine whether the critical limits are being met.
  • Monitoring also provides a record of the safety of foods as they flow through your establishment and the preventive controls you have in place.
  • The fifth principle in HACCP is to establish corrective actions.

Corrective actions are procedures that must be followed when a required critical limit for a critical control point is not met. If monitoring shows that a critical limit has not been met, some type of corrective action must be taken. The corrective action must ensure that the critical control point is brought back into control and that unsafe product does not get shipped.

It also must be based on normal working conditions and be documented. The sixth principle in HACCP is to establish verification procedures. These procedures are activities, other than monitoring, that determine the HACCP system is working properly. They confirm that the plan is being practiced as written.

The seventh principle in HACCP is to establish recordkeeping procedures to verify that the plan is being implemented as written and, if necessary, provide proof of regulatory compliance. Examples might include time and temperature logs, checklists, documentation of corrective actions, food flow diagrams, employee training records, control measures, and standard operating procedures.

What are 2 examples of CCP?

GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES – 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.

  1. Prerequisite programs are established and managed separately from the HACCP plan.
  2. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan.
  3. 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.

  1. 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.
  2. This should also include information the control of foodborne hazards related to all stages of the food chain.
  3. 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.

  1. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology.
  2. 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.
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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.

  1. The first, hazard identification, can be regarded as a brain storming session.
  2. 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.

  1. Such considerations do not include common dietary choices which lie outside of HACCP.
  2. 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.

Step Potential Hazard(s) Justification Hazard to be addressed in plan? Y/N Control Measure(s)
5. Cooking Enteric pathogens: e.g., Salmonella, verotoxigenic- E. coli enteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beef Y Cooking

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.

  1. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP.
  2. 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.

  1. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP.
  2. Critical limits should not be confused with operational limits which are established for reasons other than food safety.
  3. 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 (a w ), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance.

  1. Critical limits must be scientifically based.
  2. For each CCP, there is at least one criterion for food safety that is to be met.
  3. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella,
  4. 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.

Process Step CCP Critical Limits
5. Cooking YES Oven temperature:_° F Time; rate of heating and cooling (belt speed in ft/min): _ft/min Patty thickness: _in. Patty composition: e.g. all beef Oven humidity: _% RH

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.

  1. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.
  2. All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.
  3. 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.

  1. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations.
  2. 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.

  1. In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority.
  2. Such authorities can be internal or external to the food operation.
  3. 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.

  1. Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies.
  2. It is important that individuals doing verification have appropriate technical expertise to perform this function.
  3. 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

Activity Frequency Responsibility Reviewer
Verification Activities Scheduling Yearly or Upon HACCP System Change HACCP Coordinator Plant Manager
Initial Validation of HACCP Plan Prior to and During Initial Implementation of Plan Independent Expert(s) (a) HACCP Team
Subsequent validation of HACCP Plan When Critical Limits Changed, Significant Changes in Process, Equipment Changed, After System Failure, etc. Independent Expert(s) (a) HACCP Team
Verification of CCP Monitoring as Described in the Plan (e.g., monitoring of patty cooking temperature) According to HACCP Plan (e.g., once per shift) According to HACCP Plan (e.g., Line Supervisor) According to HACCP Plan (e.g., Quality Control)
Review of Monitoring, Corrective Action Records to Show Compliance with the Plan Monthly Quality Assurance HACCP Team
Comprehensive HACCP System Verification Yearly Independent Expert(s) (a) Plant Manager
(a) Done by others than the team writing and implementing the plan. May require additional technical expertise as well as laboratory and plant test studies.

Establish record-keeping and documentation procedures (Principle 7) Generally, the records maintained for the HACCP System should include the following:

  1. A summary of the hazard analysis, including the rationale for determining hazards and control measures.
  2. The HACCP Plan Listing of the HACCP team and assigned responsibilities. Description of the food, its distribution, intended use, and consumer. Verified flow diagram. HACCP Plan Summary Table that includes information for: Steps in the process that are CCPs The hazard(s) of concern. Critical limits Monitoring* Corrective actions* Verification procedures and schedule* Record-keeping procedures* * A brief summary of position responsible for performing the activity and the procedures and frequency should be provided The following is an example of a HACCP plan summary table:
    CCP Hazards Critical limit(s) Monitoring Corrective Actions Verification Records


  3. Support documentation such as validation records.
  4. Records that are generated during the operation of the plan.

Examples of HACCP records are given in Appendix H,

What is the most common CCP?

What Is a Critical Control Point (CCP)? A critical control point (CCP) is a moment during a production process where an equipment failure or human error could cause food contamination, resulting in customer illness or damage to the business itself. CCPs are times when can be implemented that can prevent a food safety hazard from occurring.

This may include eliminating the possibility of contamination through cooking temperatures, reducing the chance of microbial growth through storage procedures, or minimizing cross-exposure through sanitation processes. The most common CCPs within food safety are in the cooling and heating of ingredients, where products must pass through a temperature zone that can encourage pathogen growth.

It’s critical that food and ingredients during the cooking stages do not remain in those danger zones for longer than a pre-established period of time. : What Is a Critical Control Point (CCP)?

What is the difference between CCP and CP in HACCP?

A CCP indicates a high food safety risk (likely to occur) and a CP indicates a low food safety risk (not likely to occur). Food safety relies on identification and control of CCP’s, while, CP’s may be used for quality specifications.

What is a critical limit for storing food in a refrigerator suggest?

Storing food in the fridge – Your fridge temperature should be at 5 °C or below. The freezer temperature should be below -15 °C. Use a thermometer to check the temperature in your fridge.

What are critical limits of cross contamination?

Skip to content Global Leaders in Food Safety Testing Worldwide, a llergens are the primary culprit behind food product recalls, and there has been a dramatic increase in these events over the last several years. (1), (2) Beyond the considerable public health risk, a product recall can be financially devasting with an average food compan y price tag of $10 million (USD) or more in direct costs alone.

  • 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.

HACCP Principles 2 and 3 for Allergen Hazard Control Assuming the proper hazard analysis has been conducted and quality document control procedures are in place, this two-part blog will briefly review the practical aspects of a robust allergen control program following HACCP guidance (Principles 2-6).

  1. Part I will discuss Principles 2 and 3.
  2. Principle 2: Determine Critical Control Points (CCPs) Cross-contamination, whether the result of naturally occurring allergens, undisclosed allergens or ineffective hygiene procedures, creates a significant hazard for food processors.
  3. Therefore, it is imperative to identify critical control points defined as points in the process where controls can be applied to prevent, eliminate, or dramatically reduce a safety hazard risk.

Specific CCPs vary by facility but may include: Sourcing and Supplier Management Principle 3: Establish Critical Limits A critical limit is the maximum (or minimum) value to which a biological, chemical, or physical parameter must be controlled at a CCP.

  • Each CCP should have one or more control measures to assure identified hazards are prevented, eliminated, or reduced to acceptable levels.
  • Ensuring allergen proteins are detected at the appropriate levels is particularly challenging because definitive regulatory guidance on detection limits is lacking worldwide (with the exception of gluten).

Therefore, it is incumbent upon food processors to understand how allergen test manufacturers establish their limits of detection (LOD) to fulfill the critical limits principal of HACCP and thereby protect product integrity and public welfare. Read the complete whitepaper for additional details: Validating Label Claims via Allergen Limits Testing The US FDA describes four methods that may be used to establish allergen test sensitivity (limit of detection threshold).

  1. Analytical Method This dedication to establishing the proper critical limits is only one of the benefits that position Hygiena as your premium HACCP partner, from environmental monitoring to allergen detection. LEARN MORE about Hygiena’s Allergen Detection Solutions In Part II of this blog series, we will explore HACCP Principles 4-6 and dive deeper into the user-friendly solutions Hygiena offers for effective and consistently reliable allergen testing. Rob Knox 2022-06-21T01:52:36-07:00