## 4 Other Management Tools in Conjunction with ISO 22000 (Fmea Analysis-Pareto and Ishikawa Diagrams)  
### Fmea  
In FMEA analysis, risk of contamination and its presence at Hazardous Fraction in the final product, is expressed with the Risk Priority Number (RPN) which is defined as follows:  
Where S: Severity of contamination risk, O: Occurrence of contaminated ingredient, D: Detection probability of contaminated ingredient. \[\text{RPN}=\text{S}\times\text{O}\times\text{D} \tag{1}\]  
where S: severity, O: occurrence, D: detection. Corrective action is carried out when RPN is greater than 130. RPN assessment is carried out and corrective actions are proposed per identified hazard. Following calculation of RPN' (after undertaking corrective actions), a new classification of Hazardous Elements is shown (Table 6, [57]). Best expert opinion and product history (epidemiological studies) aid the analysis based on the different ways each component or subsystem might fail to comply with its intended function [58; 59]. Failure mode and effect analysis (FMEA) model has been applied for the risk assessment of ready to eat vegetables manufacturing. FMEA was attempted in conjunction with cause and effect diagrams. Critical control points have been identified and implemented in Ishikawa diagrams. Quantification of risk assessment was carried out by determining RPN per identified processing hazard. The highest RPNs (225, 225, 180 and 144, respectively) were correlated with receiving, storage and distribution, packaging and cooling and corrective actions were undertaken. Following the application of corrective actions, RPN values were below the upper acceptable limit of 130 [57]. Other case studies included FMEA analysis of salmon manufacturing. The highest RPNs (252, 240, 210, 210, 210, 200, respectively) were correlated with fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing and distribution and corrective actions were undertaken. After application of corrective actions, new RPNs were substantially lower [60]. Another case study involved FMEA model applied in conjunction with cause-and-effect analysis for the risk assessment of octopus processing (_Octopus vulgaris_). The highest RPNs (378, 294, 280, 252, 245 and 144, respectively) were correlated with chemically contaminated product, decomposed raw materials, scombrotoxin presence in the final product, incorrectly labelled product, storage in cans (foreign matter) and defective products, and corrective actions were undertaken. Following the application of corrective \begin{table}
\begin{tabular}{p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt} p{113.8 pt}} \hline \hline  & & \multicolumn{1}{c}{**Defective Products**} & & & & & & & & **Estimated Corrective Actions Result** \\ \hline
**Production Step** & **Hazards** & **Causes** & **S** & **O** & **D** & **RPN** &
\begin{tabular}{c} **Corrective Actions** \\ \end{tabular} & **S’** & **O’** & **D’** & **RPN’** \\ \hline Receiving of raw materials & & & & & & & & & & \\ T\({}_{r}\leq 5\)\({}^{\circ}\)C & & & & & & & & & & \\ Refrigeration & Physical, Chemical or & Wrong handling & 8 & 5 & 4 & 160 & Not required & 7 & 2 & 2 & 28 \\ Trez & 18-22 \({}^{\circ}\)C & & & & & & & & & & \\ Environment & & & & & & & & & & & \\ \hline \hline \end{tabular}
\end{table} 
Table 6: FMEA Table of hazardous processing methods for food products for the receiving stage. actions, new RPN values led to considerably lower values (below the upper acceptable limit of 130) [61; 62]. Failure Mode and Effect Analysis (FMEA) has been applied for the risk assessment of snails manufacturing. Quantification of risk assessment was carried out by determination of the RPN per identified processing hazard. The highest RPNs (280, 240, 147, 144, respectively) corresponded to sterilization of tins, bioaccumulation of heavy metals, packaging of shells and poisonous mushrooms, and corrective actions were undertaken.