1. Risk Assessment: A Practical Guide to Assessing Operational Risk
Chapter 15:
Food Processing Risk Assessments
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2. Food Processing Risk Assessments
Objectives
Introduce the Potential Risk in Food Processing
Review Risk Assessment Techniques and Tools used in the Food Industry
ISO 31000/ANSI Z690.2 and Food Safety Management Systems Integration
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3. Food Processing Risk Assessments Overview
The food industry is unique from other industries, in that it must consider risk to both employee health and safety and public safety and health.
The high degree of exposure, the potential severity level of food-borne illnesses, and the legal ramification that can result require an organization to properly assess and manage food safety.
A clear understanding of the food processing steps, and characteristics of products being handled, is needed to efficiently prevent potential hazards in the food chain.
This presentation will summarize how fundamental risk assessment principles such as the Hazard Analysis of Critical Control Points (HACCP) are applied in food hazard identification and how to successfully implement Prevention through Design (PtD) principles in the food industry.
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4. Food Processing Risk Assessments Introduction
Thousands of years ago, ancient people learned that spoiled or contaminated food made people sick.
Throughout history, various methods were implemented to preserve food and to reduce the threat of foodborne illnesses caused from biological, chemical and physical contamination.
The use of refrigeration, filtration and pasteurization technologies have led to the development of food preservation practices.
Almost every person relies on the national and international food supply system
These developments have increased the risk of foodborne illnesses.
Due to the specialty and severity of food risk, food processing risk assessment is a necessary and fundamental component to food safety and risk management.
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5. Risk Assessment Techniques in the Food Industry
A significant number of national and international standards for food safety are available.
Such standards mandate risk assessment in order to control certain parameters and help guarantee the safety of the food supply.
Numerous methods are available for assessing risk, it is important to have some understanding of the different methodologies, their applications, advantages and disadvantages, to make the best selection.
This chapter offers a simplified risk assessment method that could be applied in the food industry.
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6. Risk Assessment Techniques in the Food Industry
Hazard Analysis and Critical Control Points (HACCP) is a management system extensively used in advanced food companies to identify, analyze and control biological, chemical and physical hazards through the whole food production process to achieve food safety (U.S.FDA, 2011).
HACCP provides a structure for hazard identification and placement of controls at critical points in a process to effectively prevent hazards from occurring.
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7. Risk Assessment Techniques in the Food Industry
The HACCP concept originally started from production process monitoring used during World War II because traditional "end of the pipe" testing on artillery shell's firing mechanisms could not be performed, and a large percentage of the artillery shells made at the time were either duds or misfiring (MIL-STD-105).
The HACCP approach was further developed by Pillsbury Corporation with the U.S. National Aeronautics and Space Administration (NASA) in the 1960’s.
During the 1970s, HACCP was widely applied in the industry.
In 1994, the organization of the international HACCP Alliance was established for the U.S. meat and poultry industries.
The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) provided information for international standards on the development and implementation of HACCP principles. The General Accounting Office (GAO) endorsed HACCP as a scientific, risk-based system to protect public health.
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8. Risk Assessment Techniques in the Food Industry
The HACCP system is a science based methodology that identifies specific hazards and measures the control effectiveness to ensure food safety.
HACCP, similarly to a safety risk assessment, is a tool to assess food safety hazards and identify control measures that will focus on prevention rather than end-product testing.
HACCP principles rely on prevention to achieve the main food safety objective – the maximum frequency or concentration of a hazard in food at the time of consumption that provides or contributes to the ‘appropriate level of protection’ (ALOP).
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9. Risk Assessment Techniques in the Food Industry
Other critical risk assessment tools include: Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
FMEA, discussed in Chapter 8, is a methodology to analyze the potential failure modes that may occur in a product or process; assess the severity, likelihood and detectability level of each failure mode; prioritize all failure modes based on risk level; and provide control measures to eliminate or reduce the harm.
FTA is a systematic methodology that is widely used in system reliability, maintainability and safety analysis.
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10. Risk Assessment Techniques in the Food Industry
This presentation demonstrates a theoretic application of a simplified risk assessment methodology, including controls and preventive measures applicable in the food industry.
The utilization of Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA) methodologies and the implementation of HACCP principles may reduce the probability of physical, chemical and biological hazard contamination.
Other identified data demonstrates that risk assessment tools will contribute to the implementation of the food safety system in food industry to minimize risk, improve productivity and quality of products, and reduce unnecessary waste.
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11. Food Safety related Hazards
The food industry is different from other industries in that it requires an excellent understanding of the characteristics of products being handled as well as the process itself to efficiently prevent the development of potential hazards and to control the ones that exist.
Three categories of hazards are related to food safety:
biological hazards,
chemical hazards and
physical hazards.
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12. Techniques for Assessing Food Risk
As previously described in this text, the ISO series (ISO Guide 73:2009; ISO 31000:2009; and IEC/ISO 31010:2009) is a family of standards relating to risk management codified by the International Organization for Standardization.
The main goal of this series is to provide principles and generic guidelines on risk management. The ISO standards were nationally adopted by the American National Standards Institute in 2011.
ISO 31000/ANSI/ASSE Z , Risk Management Principles and Guidelines standard provides a universally recognized paradigm for practitioners and companies employing risk management processes.
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13. Techniques for Assessing Food Risk
The following process for managing risk (Clause 5), illustrated in Figure was selected for detailed evaluation of the applicable risk assessment tools.
Figure 15.1 Risk Management Process reprinted with permission from ISO 31000/ANSI/ASSE Z (Courtesy of the American Society of Safety Engineers)
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14. Techniques for Assessing Food Risk
In 2011, ANSI released its Prevention through Design standard, ANSI/ASSE Z
The authors believe that multiple risk assessment techniques listed in both ISO 31010/ANSI Z690.3, Risk Assessment Techniques, and ANSI Z590.3 are applicable to the food industry.
Table A.1 in ISO 31010/ANSI Z lists 31 tools used to assess risk and includes HACCP. According to Table A.1, HACCP is “Strongly Applicable” for Risk Identification, Consequence, and Risk Evaluation; however, HACCP is “Not Applicable” for determining Probability and Level of Risk. (ISO 31010/ANSI Z )
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15. Techniques for Assessing Food Risk
HACCP
For some time, the application of HACCP in food processing has been recommended by the U.S. Food and Drug Administration (FDA).
The reason for its use in food safety is that the HACCP methodology enables organizations to implement an effective management system used to identify, prevent and control food hazards within a process.
HACCP provides a scientific safety assurance theory that prevents hazards from entering the process rather than inspecting and evaluating the products by end-testing.
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16. Integration of Risk Assessment Methods
The following scenario of a frozen salmon processing operation without sufficient control measures is presented to demonstrate integration of various risk assessment methods including HACCP, ANSI Z590.3 Prevention through Design, and ISO 31000/ANSI Z690.2 principles.
Fish Bone Diagram – To aid in understanding of the process, a simple process map using a fish bone diagram of the salmon processing is pictured below in Figure 15.2.
Figure 15.2 Salmon Processing Simplified Process Map
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17. Integration of Risk Assessment Methods
The use of a process map or diagram helps the communication of the process steps, potential hazards and necessary control points: in essence a ‘road map’ for the process being assessed. In addition to the process map, a sequence of risk assessment techniques is presented as shown in Figure 15.3.
Figure 15.3 ANSI Z690.2 Risk Management Process and Assessment Tools Alignment
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18. Integration of Risk Assessment Methods
Hazard/Risk Identification - ISO 31000/ANSI/ Z states that the goal of risk identification is to generate a comprehensive list of risks. There are a variety of risk assessment tools and techniques that can be used at this stage.
Preliminary Hazard Analysis - After completing the preliminary tasks discussed above, the HACCP team begins with identifying hazards/risks and performs a preliminary hazard analysis (PHA). Hazards that are not likely to occur would not require further consideration within a HACCP plan. 
Simple Hazard Assessment - The FDA suggests a simple hazard assessment form presented in Table 15.3 (next slide). The simple form allows each step to be briefly described, potential hazards associated with each step, justification for including the hazard exposure, and a determination of whether the hazard will be included in the HACCP plan.
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19. Integration of Risk Assessment Methods
Step
Potential Hazard(s)
Justification
Hazard to be addressed in plan? Y/N
Control Measure(s)
Fish Receiving
Enteric pathogens: e.g., Salmonella, verotoxigenic-E. coli
Enteric pathogens have been associated with outbreaks of foodborne illness from improperly processed fish Y
TBD
Table Sample Hazard Analysis Form
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20. Integration of Risk Assessment Methods
iFMEA – To assist in the identification of hazards and potential failures, an initial Failure Mode and Effects Analysis (iFMEA) can be used. Using an iFMEA has some advantages such as assigning/calculating probability and level of risk during the risk analysis step which HACCP is not able to provide.
The iFMEA form, presented in Table 15.4, can be described as a preliminary step of a Failure Mode and Effects Analysis.
Table 15.4 Sample iFMEA Form
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21. Integration of Risk Assessment Methods
Risk Analysis - The risk analysis step involves ‘developing an understanding’ of the risks.
As the second step with risk assessment, risk analysis provides the necessary input to the risk evaluation step, and assists in making proper decisions regarding risk treatment. Critical Control Points (CCP), Fault Tree Analysis (FTA) and FMEA, among others, can be used during the risk analysis step.
Critical Control Points
Critical Control Point Decision Tree - (next slide)
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22. Integration of Risk Assessment Methods
Risk Analysis
2. Critical Control Point Decision Tree - To help identify critical control points within a process, the authors developed a CCP decision tree as an Excel form with step directions. A flow chart describing the steps is presented in Figure 15.4.
Figure 15.4 CCP Decision Tree Flowchart
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23. Integration of Risk Assessment Methods
Risk Analysis
2. Critical Control Point
Figure 15.5 CCP Decision Tree identification tool
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24. Integration of Risk Assessment Methods
Risk Analysis
3. FMEA and RPN - After the determination of the most hazardous processes and possible consequences, a detailed analysis of the process or operation can be performed.
The risk analysis step will involve analyzing severity of consequences and probability of occurrence. As stated in ISO 31010/ANSI/ Z HACCP (CCP) is “Not Applicable” for Probability assessments.
Other tools of a more specialized nature may have application in areas of food safety management.
Severity/probability/likelihood of food contamination can be assessed using a FMEA or FTA methodology.
An example of FMEA & RPN worksheet is presented in Figure (next slide)
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25. Integration of Risk Assessment Methods
Risk Analysis
3. FMEA and RPN example
Figure 15.6 Example of FMEA & RPN worksheet
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26. Integration of Risk Assessment Methods
Risk Analysis
4. FTA – As described by ANSI Z590.3, Fault Tree Analysis (FTA) is a top-down, deductive logic model that traces the failure pathways for a predetermined, undesirable condition or event, called the TOP Event.
FTA generates a fault tree (a symbolic logic model) entering failure probabilities for the combinations of equipment failures and human errors that can result in the incident or exposure.
Each immediate causal factor is examined to determine its subordinate causal factors until the root causal factors are identified (ANSI Z ).
An example of FTA is presented in the next slide.
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27. Integration of Risk Assessment Methods
Risk Analysis
4. FTA Example
FTA Example: The bacterial species, Vibrio parahaemolyticus related illnesses have been associated with consumption of raw, undercooked fish or oysters. What is the likelihood of Vibrio infection if an employee did not wash hands properly (probability of contamination 25%); used contaminated cutting board (probability of contamination 12%); and used contaminated knife (probability of contamination 17%)? These events are mutually exclusive. Therefore, “OR” gate FTA is applicable for the Vibrio parahaemolyticus contamination example in Figure This example is for educational purposes and does not represent actual conditions. In fact, CDC Foodborne Diseases Active Surveillance Network (CDC, 2014a) reports suggest that the probability of Vibrio parahaemolyticus related illnesses is much lower than represented. [There were only 242 confirmed Vibrio parahaemolyticus infections in the United States during 2013*. Data for 2013 are preliminary. (CDC, 2014b).]
Figure 15.7 FTA “OR” gate probability example
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28. Integration of Risk Assessment Methods
Risk Evaluation - The purpose of risk evaluation is to support the decision making process. It is generally based on the outcomes of risk analysis, and the priority for environmental, health, and safety interventions. Risk evaluation involves determining the level of risk found during the risk assessment process with risk criteria established when the CCPs were considered. Example:
FMEA performed for a process may require a more detailed FMEA for each step of the process.
Performing detailed FMEA for specific steps of the process may be time consuming, however, such decisions will be influenced by the organization's risk acceptance and the risk criteria or ‘as low as reasonably practicable’ ALARP that have been established.
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29. Integration of Risk Assessment Methods
Risk Evaluation
1. Bow Tie Analysis - The conventional Bow Tie methodology (covered in Chapter 9) can be used for risk evaluation. ISO 31010/ANSI Z690.3 defines bow tie analysis as a simple diagrammatic way of describing and analyzing the pathways of a risk from causes to consequences. The focus of the bow tie is on:
the prevention barriers between the causes and the risk, and
protection barriers between the risk and consequences.
However, the “conventional” bow tie analysis is not a quantitative tool. A conventional bow tie analysis is presented in Figure 15.8 (next slide).
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30. Integration of Risk Assessment Methods
Risk Evaluation
1. Bow Tie Analysis example
Figure 15.8 Example of Conventional” Bow Tie Analysis
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31. Integration of Risk Assessment Methods
Risk Evaluation
2. Modified Bow Tie Analysis –
A modified bow tie analysis was developed where, the hazards and consequences are quantitatively defined based on the risks and probabilities of occurrence.
A conventional risk assessment matrix from the ANSI Z590.3 Prevention through Design standard can be used to produce a risk factor (which is Severity x Occurrence) or a Risk Priority Number (RPN) from the FMEA. A combination of both is presented in Figure 15.9 (next slide).
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32. Integration of Risk Assessment Methods
Risk Evaluation
2. Modified Bow Tie Analysis Example
Figure 15.9 Example of modified Bow Tie Analysis
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33. Integration of Risk Assessment Methods
Risk Evaluation
3. Process Map - A scenario of salmon processing without sufficient control measures is used to demonstrate a food risk assessment process. The process incorporates a combination of methods to minimize and control food- related hazards. The simplified process map of the salmon processing presented below in Figure displays the key steps.
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Figure Salmon Processing Simplified Process Map

34. Integration of Risk Assessment Methods
Risk Evaluation
4. CCP Decision Tree (CCP DT) - The frozen salmon processing is evaluated according to the HACCP management system resulting in six Critical Control Points identified. These identified CCPs represent the key points that may cause defects in product quality or food safety. An example of partially completed CCP Decision Tree (CCP DT) Form is presented below in Figure
Figure CCP Decision Tree Form
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35. Integration of Risk Assessment Methods
Risk Evaluation
5. Detailed FMEA & RPN - Hazards identified in the CCP DT are transferred to FMEA tool for further risk analysis and evaluation. The FMEA form provides a detailed analysis of each operation based on the occurrence, the severity and the detection of hazards, which is a similar theory to the hazard analysis of CCP. An example is presented below.
Figure FMEA detailed analysis based on identified CCPs
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36. Integration of Risk Assessment Methods
Risk Evaluation
5. Detailed FMEA & Bow-Tie integration
Following the analysis, the top three ranked hazards are transferred to the Bow Tie analysis form as shown in the Current State (before appropriate controls) Bow Tie analysis Figure below.
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Figure Bow Tie Diagram based on FMEA Detailed Analysis

37. Integration of Risk Assessment Methods
Risk Evaluation
6. Current State Bow Tie/FMEA - Preventive controls and protective measures are then identified for each critical control point. Using the FMEA, the resulting estimated RPNs for the identified process operations were improved significantly after implementing the recommended CCP controls (see recommended actions column in Figure 15.14).
Figure FMEA Assessments of CCPs
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38. Integration of Risk Assessment Methods
Risk Evaluation
After the controls were identified, HACCP team can add the control measures to the process map. A simple process map with the suggested improvements is presented below in Figure
Figure Process map with added control measures
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39. Integration of Risk Assessment Methods
Risk Evaluation
7. Future State Bow Tie/FMEA - The same top three ranked hazards and recommended actions are transferred to the Future State (after controls were implemented) Bow Tie analysis form shown in Figure
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Figure Bow Tie diagram based on FMEA recommended actions

40. PtD and HACCP Integration
Worker safety and consumer safety should both be considered during analysis.
It is essential to include Safety, Health and Environmental professionals in a HACCP as well as the development of workplace design solutions that will benefit both workers and the public.
Integrating HACCP and PtD principles will help to modify the production process to eliminate and control biological, chemical or physical hazards in food products, as well as protect workers from injuries and illnesses.
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41. PtD and HACCP Integration
The integration of HACCP and PtD principles helps ensure end-products are safe for consumption and that risks to workers remain acceptable as presented in Figure
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Figure HACCP and PtD principles integration

42. PtD and HACCP Integration
PtD principles should be used in the food industry to anticipate and identify potential food safety hazards and eliminate or reduce the risks to an acceptable level. A HACCP and PtD integration approach is presented below in Figure
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Figure HACCP and PtD integration

43. Conclusion
In conclusion, the combination of risk assessment methodologies suggested in ANSI Z590.3 PtD and ISO 31010/ANSI/ Z690.3, and implementation of CCPs controls, designed to minimize food related illnesses, will improve food quality, worker safety and reduce financial losses.
Risk and its corresponding risk factor scores or Risk Priority Numbers can be significantly reduced by implementing appropriate controls, as demonstrated in the examples presented.
The risk assessment process should be used for continuous improvement within an Operational Risk Management System.
Such a process should include an appropriate combination of methodologies and an effective HACCP plan.
PtD and HACCP integration can lead to greater food safety, worker safety and health, as well as financial and non-financial benefits to an organization.
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