Establishing a critical limit is based on the identified potential hazard and CCPs of your HACCP plan.
In controlling food safety, critical limits must be established as a reference for acceptable levels of food safety standards. These critical 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.
Key takeaways
Establishing critical limits in a HACCP plan is important because it allows food businesses to distinguish safe from unsafe conditions at each Critical Control Point, ensuring that any process stays within bounds that prevent food safety hazards.
TL;DR: Critical limits act as a safety threshold: if a measurement falls outside this limit, the product may be unsafe and require corrective action.
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.
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.
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:
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.
As a food safety or quality manager or food handler, you may be wondering: How do I know what the critical limit should be for my CCP? Where do these numbers come from?
Critical limits should be derived from regulatory requirements (e.g., USDA/FDA guidelines or local food codes) or scientific evidence, including published research, industry studies, or validated experiments.
For example, if a pathogen needs a 5-log reduction, scientific studies might show that cooking to 167°F (75°C) for 15 seconds achieves this and, as a result, that temperature and time become your critical limits.
Once a critical limit is chosen, the food safety team should validate it to confirm that the business operating at that limit indeed controls the hazard.
For some businesses, critical limits are mandated by law and non-negotiable, such as pasteurization temperatures and minimum cooking temperatures.
Each critical limit must be a measurable or observable criterion. Be sure to be specific, not vague, in your critical limit definitions. For example, instead of “cook thoroughly,” use "cook to an internal temperature of 165°F (74°C) for at least 15 seconds” as the measurable critical limit.
Critical limits in a food safety plan 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:
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 examples for other hazards or processes could look like this:
Whether you're in a central kitchen, production facility or retail, as you can see, critical limits aren’t only about cooking temperature. They apply to any parameter (e.g., time, temperature, pH, etc.) that keeps a hazard in check.
Once we have a critical limit, how do we ensure it’s met, and what if it’s not? These are great questions, and there are a few things to note once you've established the critical limits in your operations.
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.
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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:
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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