1. Steaming/Heating of the tomatoes: (80 to 90 degrees Celsius)
- Parameter: Heating temperature
- Justification: Heating the tomatoes at the right temperature (80 to 90°C) is crucial to ensure proper inactivation of pathogens, such as Salmonella or E.coli, which are commonly associated with raw produce. Insufficient cooking can lead to the survival of these pathogens, posing a risk to consumers’ health.
- Monitoring Plan: To ensure that the ketchup is heated at the required temperature, a continuous monitoring system should be in place. This can be achieved using automated temperature control systems that allow regular checks and adjustments as needed. The data from these devices should be recorded and reviewed to ensure compliance with the established cooking parameters.

2. Heating/Cooking: (95 degrees Celsius)
- Parameter: Cooking temperature
- Justification: this heat treatment applied to the ketchup to eliminate thermophilic bacteria, such as Bacillus or Clostridium species, which can cause foodborne illnesses. Ensuring the right temperature (95°C) is essential to achieve a sufficient level of microbial inactivation while preserving product quality.
- Monitoring Plan: Regular monitoring of the temperature should be conducted, combining automated systems and manual checks. The records should be logged, and any deviations from established parameters must trigger an investigation and corrective action.

3. Cooling: (below 5 degrees Celsius)
- Parameter: Cooling temperature
- Justification: Rapid cooling of the ketchup after pasteurization (below 5°C) is necessary to prevent the growth of harmful microbes, such as Listeria monocytogenes and Clostridium perfringens. These bacteria can proliferate in the temperature “danger zone” (between 4°C and 60°C) if cooling is not conducted efficiently.
- Monitoring Plan: A continuous monitoring system should be implemented to ensure that cooling occurs at the required temperature. This can be achieved using automated temperature control and monitoring equipment. The data recorded should be reviewed regularly to ensure compliance with the established cooling parameters.

4. Filling and Packaging
- Parameter: Cleanliness of the packaging equipment and adherence to regulatory requirements for material safety
- Justification: Maintaining cleanliness of the packaging equipment is crucial to prevent environmental or packaging contamination from pests, foreign objects, or cleaning product residue. In addition, providing safe packaging material that meets regulatory requirements is critical to ensure food safety.
- Monitoring Plan: Frequent visual inspections of equipment before and during the filling process should be conducted. Additionally, sampling from batches at regular intervals can help check for contaminants in the final product. Any deviations from established cleanliness and material safety standards should trigger corrective actions.

5. Storage
- Parameter: Temperature and humidity of the storage environment
- Justification: Effective storage conditions are necessary to prevent the growth of mold and spoilage organisms due to poor temperature or humidity management. Proper storage ensures the product’s safety and quality during its shelf life.
- Monitoring Plan: Regular monitoring and recording of temperature and humidity levels in storage rooms should be conducted using appropriate sensors and loggers. This data should be reviewed regularly to ensure compliance with the established storage parameters.

Detailed Information on Out of Specification (OOS) Rules and Corrective Actions:

1. Steaming/Heating of the tomatoes: (80 to 90 degrees Celsius)
- OOS Rule: Cooking temperature falls below the established limits
- Corrective Action: If a deviation occurs in the cooking process, the temperature should immediately be increased to achieve the required specification. The batch should be assessed for any signs of compromised safety or quality. If the deviation is too significant and cannot be corrected, the affected product should be discarded to ensure consumer safety.

2. Heating/Cooking: (95 to 100 degrees Celsius)
- OOS Rule: Cooking temperature falls below the established limits
- Corrective Action: If the process deviates from its set parameters, corrective actions should be taken by adjusting the temperature to meet the required limits. The affected product should undergo quality and safety assessments. If the deviation is significant and the product cannot be salvaged, it must be discarded to prevent any potential risks to consumers.

3. Cooling: (below 5 degrees Celsius)
- OOS Rule: Cooling temperature falls above the established limits
- Corrective Action: In case the cooling temperature rises above the set limit, the cooling equipment must be promptly checked, and adjustments should be made to ensure proper cooling. The affected product must be analyzed for potential spoilage or contamination. If the product does not meet safety or quality standards within a reasonable time frame, it should be discarded.

4. Filling and Packaging
- OOS Rule: Contamination is observed in the product or packaging materials, or equipment is not up to regulatory requirements
- Corrective Action: If contamination or non-compliance with regulatory requirements is identified, the affected equipment must be cleaned and sanitized immediately. The product should be repackaged to ensure food safety. In case the contamination is severe or unmanageable, the affected products should be discarded as a precautionary measure.

5. Storage
- OOS Rule: Temperature or humidity falls outside the established limits
- Corrective Action: If temperature or humidity values deviate from the established limits, adjustments should be made to the storage environment controls (e.g., air conditioning or dehumidifiers) to meet the required parameters. The products should be inspected for any signs of spoilage or mold growth. If deviations have resulted in significant product compromise, the affected products should be discarded.


please give me a few references that contains the above information and also tell me which information is related to which referece