Introduction
A crucial aspect of food microbiology is Hazard Analysis, which entails locating and evaluating potential risks during the food manufacturing process. By implementing control measures that reduce or eliminate the risks associated with these hazards, hazard analysis aims to avoid foodborne diseases. There are certain steps that must be followed during any Hazard Analysis. Hazard Identification, characterization, risk assessment, risk management, monitoring, and verification are the steps that get followed to ensure food safety and quality. 
A common condiment called tomato ketchup is made of ripe tomatoes, vinegar, sugar, and spices. A thorough risk analysis of each step in the product's manufacture, processing, and packaging is carried out as part of a high priority to ensure the product's quality and safety. Chemical and microbiological risks that can appear during these stages are carefully considered. 
Each danger is classified according to its seriousness so that the potential risks can be understood better and addressed. High-risk individuals are denoted by the color red, medium-risk individuals by the color yellow, and low-risk individuals by the color green.
Overall, risk analysis is important to main the quality and safety of the food and reduce foodborne illnesses.

Table 1: Hazard Analysis for Tomato Ketchup Production with Hazard Category Ratings and Control Measures

Process Steps	Hazard 	Hazard Explanation	Hazard Category	Control Measures
Receiving and inspecting raw tomatoes	Presence of pathogens (mold or microorganisms) such as Salmonella	When making ketchup, receiving and examining fresh tomatoes poses a risk of mold contamination or the presence of dangerous bacteria. This is because soil, where tomatoes are cultivated, has the potential to harbor dangerous bacteria and fungi. These viruses can represent a serious health danger to consumers if they are permitted to contaminate raw tomatoes and then used to make ketchup.	Yellow (Medium risk)	Tomatoes should be purchased from reputable vendors who follow good agricultural and handling procedures. Incoming tomato lots should also be routinely inspected and sampled using visual inspection and microbial testing. Finally, storage areas should be kept at a consistent temperature (4 to 10°C) and kept clean.
Raw material handling and storage	Contamination with heavy metals, pesticides and mycotoxins	The risk of pesticide, heavy metal, and/or mycotoxin contamination during the preparation of ketchup is connected to the use of sugar, vinegar, and spices. These chemicals can be made from raw sources that include potentially dangerous elements that could endanger human health. While mycotoxins can be created by fungi that grow on crops during storage or transportation, pesticides and heavy metals can enter the food chain via industrial or agricultural sources. These pollutants have the potential to impair the safety and quality of the ketchup if they are not found and eliminated before processing.	Yellow (Medium risk)	Get raw materials from reputable vendors and regularly test them for contamination.
Washing, sorting and grading	Contaminants or cross-contamination 	The risk of contamination or cross-contamination throughout the ketchup production process is connected to washing, sorting, and grading. Due to dirty equipment or improper handling procedures, contaminants including dirt, debris, or harmful microbes may be introduced throughout these processes. If the same tools and utensils are used for various batches of ketchup without being properly cleaned and sanitised, cross-contamination may result. This may lead to the transmission of undesirable chemicals, allergies, or dangerous bacteria to the ketchup, raising the possibility of consumer health hazards.	Green (low risk)	Maintain proper sanitation of the equipment and utensils using periodic cleaning and sanitising procedures; remove rotten or damaged tomatoes during sorting and grading to reduce microbial load; practise good personal hygiene by production staff, including handwashing, using gloves, and dressing appropriately.
Cutting and chopping	Cross-contamination (cutting equipment)	Cross-contamination from cutting instruments is the risk connected to cutting and chopping during the preparation of ketchup. If the cutting and chopping equipment is not thoroughly cleaned and sanitised or if there is cross-contamination between batches, bacteria or other dangerous germs may be introduced to the ketchup throughout the process. This may result in the ketchup becoming contaminated with germs, raising the danger of customers contracting a foodborne illness.	Yellow (medium risk)	Use proper handling and hygiene techniques during this process, such as avoiding the use of the same equipment for different allergens without cleaning, and regularly clean and sanitise cutting equipment using approved chemicals and adhering to the manufacturer's recommendations. Ensure the proper maintenance of equipment to prevent the buildup of foreign materials.
Heating (80 to 90 degrees) and cooking	Insufficient heating or cooking results in under processed ketchup with a chance of pathogenic bacteria surviving.	The risk of inadequate heating or cooking during the preparation of ketchup is that it will result in under-processed ketchup with a chance of harmful bacteria surviving. To get rid of any potentially hazardous germs in the ketchup, heat treatment is crucial. These microorganisms may survive and remain in the final product if the required heating and cooking temperatures are not reached or are not maintained consistently, potentially resulting in consumer sickness.	Red (high risk)	To ensure a constant cooking temperature, use automated cookers equipped with temperature sensors; periodically check and record the temperature to keep a cooking log; and create and adhere to standard operating procedures (SOPs) for cooking time and temperature.
Mixing (sugar, vinegar, and spices)	Cross-contamination with allergens (gluten or mustard)	To make the finished ketchup product, the cooked tomato mixture is mixed with sugar, vinegar, and spices. The possibility of cross-contamination with allergies, such as mustard or gluten, or other chemical dangers is one risk connected to this procedure.

If mixing tools, containers, or utensils have previously come into touch with allergen-containing substances without being thoroughly cleaned, cross-contamination may result. For people with allergies or sensitivities, this poses a danger and, when consumed, may result in mild or serious adverse responses.	Yellow (medium risk)	Implement an allergen management programme, which should include proper allergen handling, labelling, and storage. You should also clean and sanitise equipment between batches using the right cleaning supplies and techniques. Finally, you should use the right internal training and communication to ensure that allergen controls are understood and followed.
Homogenization, pasteurization, and consistency	Insufficient pasteurization temperature or uniformity, which allows thermophilic microbes to survive and produce foodborne illnesses like Bacillus or Clostridium.	Inadequate pasteurization temperature or consistency, which can allow thermophilic bacteria like Bacillus or Clostridium to survive and cause foodborne diseases, is a risk linked with homogenization, pasteurisation (95 to 100° C), and consistency during the preparation of ketchup. The removal of potentially hazardous germs from ketchup through pasteurisation is necessary, although thermophilic bacteria have been known to withstand this process if the temperature or consistency aren't right. These germs could live and stay in the finished product if the ketchup is not cooked to the proper temperatures or at regular intervals, potentially making consumers sick.	Red (high risk)	Establish validated critical control points (CCPs) for consistency, pasteurisation temperatures, and homogenization (e.g., minimum 12° Brix for ketchup); routinely track and record process parameters (e.g., with the aid of digital logging devices); validate and periodically confirm the effectiveness of the pasteurisation process.



Sampling and analysis	False-negative results for pathogen detection or inaccurate allergen quantification are examples of improper sampling or analysis that leads in wrong assessment of product safety and quality.	Inaccurate sampling or analysis that results in an incorrect assessment of the product's safety and quality is the risk connected with sampling and analysis during the production of ketchup. This may lead to erroneous allergen quantification or false-negative results for pathogen detection. To ensure that a ketchup product satisfies safety and quality criteria, sampling and analysis are essential. However if the sampling or analysis is not done correctly, it could produce false results that lead to incorrect assessments of the product's quality or safety. For instance, significant foodborne infections might result if a contaminated batch of ketchup is wrongly deemed safe.	Yellow (medium risk)	Establish a routine sampling schedule using a representative and random methodology; use approved equipment and techniques for analysis (such as ISO, AOAC, or FDA methods); instruct staff on sampling and testing procedures; and take part in proficiency testing schemes or other external quality assurance initiatives.
Cooling (below 5 degrees Celsius) 	Lack of cooling causes spoiling or the growth of harmful microbes like Listeria monocytogenes or Clostridium perfringens.	Inadequate cooling during the ketchup-making process poses a risk of spoiling or the growth of harmful microbes like Clostridium perfringens or Listeria monocytogenes. In order to keep germs from growing and potentially compromising the safety and quality of the ketchup, cooling is a crucial step. When ketchup is not properly and quickly chilled, it can provide the perfect environment for hazardous organisms to flourish. Foodborne infections may result from product spoilage or the proliferation of harmful bacteria as a result of this.	Yellow (medium risk)	Make sure that cooling equipment (such as fast chillers or ice jackets) is properly maintained and working; if necessary, alter the chilling process based on the product type or batch size. Monitor and control cooling temperatures using digital thermometers or temperature data recorders.
Filling and packaging	environmental or packaging contamination brought on by pests, extraneous objects, or leftover cleaning product residue.	Contamination from the environment or packing materials, such as insects, foreign objects, or leftovers from cleaning agents, poses a risk during filling and packaging during the preparation of ketchup. Ketchup can become contaminated by the environment or packaging materials during the filling and packaging process, posing major dangers to consumer health and safety. Insects or foreign objects in the plant area, as well as cleaning chemical residues on packaging materials like containers, lids, and seals, can all be sources of contamination.	Green (low risk)	Use automatic CIP (clean-in-place) systems to ensure that filling and packaging equipment is cleaned and sanitized correctly; use visual product inspection to find flaws or contaminants; use packaging materials that are suitable for use with food, such as BPA-free plastics; and adhere to regulatory requirements for material safety.
Storage	due to poor storage circumstances, such as high humidity, temperature swings, or extended storage times, mould or spoiling organisms might grow.	The risk involved with storage during the preparation of ketchup is the development of mould or spoiling organisms as a result of poor storage practises. Once the ketchup has been packaged, safe storage practises are essential to preserving the product's quality and safety. When ketchup is kept at high humidity levels, temperature swings or extended storage times may cause mould or spoilage organisms to thrive, which may compromise the product's safety and quality. It is possible for ketchup to become contaminated with these dangerous germs, which could result in a foodborne illness.	Yellow (medium risk)	In order to prevent product ageing, implement temperature and humidity controls in storage areas (e.g., keeping the temperature below 25° C and the relative humidity below 65%); regularly check and maintain storage conditions using digital sensors or data loggers; and adhere to FIFO (first-in, first-out) or FEFO (first-expired, first-out) inventory management practises.
Distribution	Damage or contamination that occurs during shipment, such as leaks, packing being crushed, or being pierced by insects or sharp items.	Distribution risks during ketchup manufacture include transportation damage or contamination, such as leaks, packaging damage from crushing, or penetration by insects or sharp things. May be exposed to dangers like vibrations or impacts, harsh weather, or other elements during transit that could affect the product's quality and safety. The materials used for packing could be harmed, allowing contamination from things like insects, dust, or dirt. Moreover, sharp items may cut through the packing, causing ketchup to flow out and perhaps contaminate other foods.	Green (low risk)	Implement traceability protocols for product tracking using barcodes, QR codes, or RFID tags to facilitate recalls or investigations if necessary. Use appropriate packaging materials and designs to ensure product integrity, such as robust secondary and tertiary packaging, tamper-evident seals, or shrink wraps.


use the above information and use additional information if required and complete the following:

It is now time to select the critical control points. Any of the process steps you previously categorized as having a high likelihood and/or high severity of outcome can be labelled as critical control points.
To ensure that food is safe, these are the steps that have to be carefully controlled. In order to control these steps, we need to identify the critical parameter that must be maintained. The parameter must be measurable, such as temperature, heating time, moisture content, microbial count, etc.
For each of your CCPs, define parameter values that make sense for your product (for instance, a control point for a potato product might be a bioburden value for the raw potatoes. After washing, the potatoes might have an acceptable cfu/g limit of 50,000 because they are going to be cooked and further treated downstream). Justify your choice in these limits. Hint, many of these limits are already established and published by industry members. If your process has more than 5 CCPs, choose only 5.What methods will you use to monitor these control points?
Describe the monitoring plan for your CCPs. Will the parameter be continuously monitored, or done in batches/samples?
Finally, create rules for when each of your identified CCPs is “OOS” (Out of specification). Occasionally, a production error will happen, (human errors, loss of utilities, broken equipment, etc.) and a CCP will fall outside of the acceptable range. Should the food immediately be thrown out? Or can the food be re-processed in some way that does not diminish the quality of the product? Remember that the company’s management will not want to throw the food product out, but sometimes this is the only acceptable option when consumer safety is the first priority. If the deviation can be corrected with minimal consequence, this would be the best option. Some examples of corrective actions: Cooking the food for a longer time, a repeat washing step for equipment, an extended curing/drying period until the parameter is met.

Describe what action would be taken in each case if your CCP deviates from your established limits
Complete the Report: In one document, assemble all the components of your HACCP plan:
Title page
Introduction describing the food choice and a brief outline of how the food is made
Summary of recommended HACCP points
Process Map (revised based on feedback from your first submission)
Hazard Analysis (revised based on feedback from your first submission)
Summary of CCP parameters, justifications
Congratulations, you have just designed a HACCP plan, and completed FMB573! This is your final assessment of the course.