HACCP plan

What is the purpose of establishing a critical limit in a HACCP plan?

A critical limit is a range of maximum and minimum values used as a reference in controlling a critical control point ...

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  • A critical limit is a range of maximum and minimum values used as a reference in controlling a critical control point (CCP) to reduce or eliminate any potential hazard.
  • Critical limits must be measurable, observable, and can be monitored during the actual operations for the control of food safety.
  • Establishing a critical limit is based on the identified potential hazard and CCPs of your HACCP plan.

In controlling food safety, limits must be established as a reference for acceptable levels of food safety standards. These limits will dictate whether a process was effective in controlling a food safety hazard or not. As there are many different types of food establishments and food processing plants, there will be different standard operating procedures for establishing critical limits. This operation is an important part of a Hazard Analysis and Critical Control Point (HACCP) system in the food industry and is a major principle. If you are not familiar with the term, read our thorough article about what is HACCP.  

In choosing a critical limit for a critical control point (CCP), only the most significant conditions must be considered to become very specific and avoid confusion to ensure consumer safety. Wrong limits can lead to a significant occurrence of foodborne illnesses from unsafe food which is something you want to avoid as a food business owner or manager. Perhaps one of the most well-known critical control points with a significant critical limit is cooking chicken to the correct internal temperature which is 165°F (74°C).

In the United States, the Centers for Disease Control and Prevention estimates that at least 1 million people get sick because of improperly cooked chicken. The critical limit for cooking chicken has been widely campaigned throughout the years and has been established ever since. Critical limits are set to prevent such issues from occurring. 

In this article, we will be discussing the importance of HACCP critical limits and how to establish one for every critical control point in your operations for the protection of intended consumers. 


critical limit for chicken


Critical limit definition

A critical limit is a specific range of values for any biological, physical, or chemical parameter that is controlled by a critical control point. Critical limits are measurable criteria of minimum and maximum standards that dictate whether a CCP is successful in controlling a food safety hazard and that you are only producing safe food for consumption. It tells you if the preparation is enough or has not satisfied acceptable levels.

Deviation from the basic conditions of critical control limits can lead to foodborne illnesses or related injuries. Any unmonitored non-compliance with acceptable limits can warrant an observation from a food safety agency and can lead to significant complaints from intended consumers. Critical limit values must be based on proven and established scientific studies, in-house experimental results with proper documentation, expert information, or as mandated by a food agency.

In establishing HACCP critical limits, it is always important to consult with food regulatory authorities such as the USDA (Food Safety and Inspection Service) and your local health agency for applicable government regulations. Different locations, especially in the United States, may have varying critical limits for some critical control points of their food safety management systems.


Characteristics of a critical limit

In establishing a critical limit, you cannot just choose any value. You must have a strong basis as well as solidly established critical control points. This step can only be achieved once significant food safety hazards and appropriate CCPs have been established. As such, prerequisite steps to establishing a critical limit must be accurately performed to ensure the effectiveness of each limit.

In addition, critical limits must have the following characteristics to serve their purpose:

  • Observable. Visual observation of any deviation must be perceivable by a food handler to address them. Especially in a fast-paced production run, some critical limits may prove to be harder to see. As such, the criteria for establishing a critical limit is it must be easily detected.
  • Can be monitored in real-time. As mentioned, the detection of compliance with critical limits will be performed while the production line is running. As such, it must be physically possible to detect any deviation in real-time for food handlers to be able to immediately apply any corrective action. 
  • Measurable. Any critical limit must be measurable by appropriate methods such as titration for acidity level, microbiological testing, chemical tests, visual inspection, and other analytical testing procedures. The results of these tests will be compared with the established standards to determine the safety of products for consumption. 

These characteristics are crucial and part of the systematic approach to food safety in establishing critical limits. It is also important to note that multiple HACCP critical limits can be employed in each CCP. In doing so, you have to make sure that each limit can be accurately measured.


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What is the purpose of establishing a critical limit in a HACCP plan?

Setting critical limits gives you control over food safety and ensures that the food you serve or sell is safe for consumers. Establishing a critical limit is a food establishment's significant assurance that any food safety hazard is properly controlled. The absence of critical limits defeats the purpose of having critical control points. 

Each critical control point within your food operation must at least have one critical limit that will prevent the production of hazardous foods. One of the well-known examples of establishing critical limits is the standard range for cooking foods to the correct internal food temperatures. Different foods are known to have varying thermal processing requirements. The CCP for this type of situation is the food temperature and the processing time needed to reach the target value.

An example of this situation would be the pasteurization of milk. Pasteurization was established to control enteric pathogens such as Mycobacterium tuberculosis in producing wholesome food such as milk. The initial safe limit set for pasteurizing milk was 63°C (145°F) for 30 minutes. This cooking time-temperature combination was specifically set to target the mentioned enteric pathogen. Soon after the establishment of this limit, it was increased to 71°C for at least six seconds to target the biological hazard Coxiella burnetii.

Noncompliance with these established critical limits has been proven to cause foodborne illnesses from these major pathogens. In turn, this results in lower productivity for the consumers and complications for your food business. Not only will this negatively affect your profits, but your reputation and consumer confidence as well.

Other critical limits that can be applied in any food industry business include the assurance of sanitary conditions in a food facility. The procedures for monitoring critical limits in sanitation must be based on sanitary design principles that aim to prevent the multiplication of pathogens. Critical limits in this area may be established as the minimum and maximum contact time and frequency of the chemical sanitizing solution.

In a mandate from the Oregon Food Code, food contact surfaces must be cleaned every 4 hours to become effective. Allowing the surfaces to go uncleaned longer than 4 hours can attract the growth of pathogens. In addition, a study on the effectiveness of chemical sanitizer showed that when they are used less than the prescribed time, their efficacy will not be enough to kill pathogens on surfaces and ensure sanitary conditions.  Adequate time must be established to ensure the effectiveness of this CCP.


What is the difference between a critical limit from an operating limit?

Both critical limits and operational limits are sets of values for parameters in controlling food safety. Where a safe limit is mainly established to maintain food safety, operational limits, although more stringent, are established not only for food safety purposes. Operating limits are applied to provide food handlers with a safety margin. These limits normally have a shorter range than a critical limit which allows operators to apply corrective actions before the parameters even reach critical values.

An operating limit is a reasonable parameter used to reduce the likelihood of a deviation. These limits can be used to address any expected variation in the processing equipment and processing methods to maintain acceptable critical limits. Operational limits are the values in between the target and the critical values. As an example, if the target internal temperature is 71°C (160°F) and the critical limits are set as 66°C and 76°C (150°F and 168°F), the operational limit would be 69°C and 73°C (156°F and 163°F).


What are critical limits in a food safety plan?

Critical limits can be set on many different factors based on your preparation process or the characteristics of your food items. They can be any biological, chemical, or physical parameter. Limits devised from any potential hazard must be measurable as discussed above to prevent loss of control of food safety. Each product and food operation may have one or a combination of critical limits. 

A critical limit may be a value or combination of any of the following factors:

  • Temperature
  • pH
  • Humidity
  • Moisture level Acidity
  • Processing time
  • Flow rate
  • Water activity
  • Salt concentration
  • Chlorine level or any other chemical sanitizer
  • Presence of filth (e.g. metal fragments)
  • Allowable toxin level or other chemical hazards
  • Preservative and chemical residue concentration

In combination with establishing critical limits in a food processing plant, appropriate monitoring procedures and forms must be made to ensure the adequacy of preparation. Monitoring records will serve as proof of compliance and as a reference should there be any complaints in the future. Without proper monitoring procedures and established monitoring frequency, critical limits can easily become non-compliant without the food handlers even noticing them. 


critical limit in a hamburger patty


Which is an example of a critical limit in a hamburger patty HACCP plan?

To concretely show how the concept of critical limits works, here is an example for a hamburger patty manufacturer. In cooking hamburger patties, the most common critical limit is the minimum internal temperature which is at 71°C (160°F) for at least 15 seconds. Hamburger patties are a rich source of nutrients for biological hazards under the right conditions. One of the most famous foodborne illness outbreaks named Jack-in-the-box is related to contaminated patties. Undercooking hamburger patties or not hitting the target critical limits increases the risk of allowing these pathogens of living. 

Since this food item is commonly cooked frozen, the use of a food thermometer in measuring their temperature during cooking is highly recommended. In such case, you must follow state regulations such as the federal mandate of cooking them to 71°C (160°F) for beef patties, and 74°C (165°F) for turkey patties as administered by the USDA. Never consider undercooking or partially cooking meat as even a small portion of undercooked patty can carry the risk of foodborne illnesses.


To help you further understand more topics about critical limits, here are some answers to the most frequently asked questions about this topic:


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). Below this, undercooked chicken is known as a potential source of food poisoning from pathogens such as Salmonella.

The established critical limits for this food preparation process are made to ensure that microbiological hazards such as enteric pathogens are controlled, if not eliminated, for the assurance of food safety and the production of wholesome food and safe food products. 


How would you determine a critical limit in the HACCP process?

Critical limits are determined based on the accurate identification of CCPs of your food business. Each CCP must have at least one critical limit to determine compliance. These limits must be based on established scientific reports or food safety regulations.


What would validate a critical limit?

The initial validation of critical limits can be done using references such as an accurate record of peer-reviewed scientific reports, in-house experiments that include a sequence of observations, or food regulatory agency legislations. An aspect of verification procedures is that verification records must be kept as references all the time.


What is the difference between critical control points and critical limits?

Critical limits are measurable values set for a CCP. They are applicable standards based on federal regulations set to determine the compliance of CCP and if foods are produced following food safety regulatory standards. On the other hand, critical control point examples are any procedure within the food chain where control measures can be applied to manage or eliminate any health hazard. On the other hand,


What should happen if a critical limit has been exceeded?

Corrective actions are set for each critical limit in case they are breached. These corrective actions aim to manage critical limits to acceptable levels. They can also be used to make decisions on whether to dispose of or reprocess the product.


Digital solution to establishing critical limits

A huge percentage of the success of your HACCP plan implementation relies on the correct identification of hazards, establishment of your critical limits, and their corresponding monitoring procedures. As such, your critical limits and CCPs must be based on a solid foundation of assessment and accurate reports. This step is just one of the many basic principles of making a comprehensive HACCP food safety management plan. Countless revisions for comprehensive verification procedures will also follow once initial critical limits have been established.

This is where using our built-in HACCP plan builder software comes in. Our system allows fast, accurate, and most especially, the automatic establishment of critical limits in a HACCP plan. In some cases, food business owners hire a food safety consultant for independent expert advice and to guide them with each method of preparation of the HACCP plan making. Despite this, hiring a food safety consultant is not a cheap assignment. To ensure that the HACCP food safety programs plan-making is easier, use our built-in HACCP plan builder software at FoodDocs.

Our system guarantees an automatically generated HACCP plan in just 1 hour! Our team of food safety experts have joined forces and created a food safety software that is intuitively capable of making a comprehensive HACCP plan based on your operations. This means that the HACCP plan that our system produces is tailored specifically to your food business.

How do we do that? Through our machine-learning program and preset questions about your food business, our system cross-references your answers with the most advanced HACCP plans in the same market as yours. Once you finish signing up and fulfilling all the prepared questions, you will be given a complete HACCP plan with the following components:

  • A basic block type flow diagram of your everyday operations
  • Accurate hazard identification and hazard analysis
  • Established critical control points for each significant hazard
  • Accurate and scientific-based critical limits for each CCP
  • Appropriate procedures for any monitoring technique and digital CCP monitoring forms 
  • Corrective actions in case of limit breach
  • Complete verification step
  • Established recordkeeping and documentation procedures

Our built-in digital HACCP plan builder was built to help you become HACCP-compliant most efficiently and effectively. In addition, to accommodate any particular operation that is unique to your business, you can customize the generated HACCP plan for you. 

While a digital HACCP plan is also a movement towards a more sustainable food chain, our system does not completely exclude the traditional process. You can invite your food safety auditor to view your HACCP plan, send your plant through an email, or download and print it for manual submission.

HACCP plan making is already a tough project, then going digital does not have to be a cumbersome task! Our system at FoodDocs would only require an average of 1 hour to make your plan and you can save at least 15x less than hiring a food safety consultant while helping you satisfy the requirements of any regulatory authority. Dedicate more of your processing time in implementing and maintaining food safety once you finish making your HACCP plan with our built-in software.

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