Combined HACCP and TOPSIS-based approach to prioritize risks in the salmon manufacturing process: a case study

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Combned HACCP and TOPSIS-based approach to prortze rsks n the salmon manufacturng process: a case study Carptella S.*, **, Certa A.*, Enea M.*, Galante G.M.*, Izquerdo J.**, La Fata C.M.*, Vella F.*** * Dpartmento dell' Innovazone Industrale e Dgtale (DIID) - Ingegnera Chmca, Gestonale, Informatca, Meccanca, Unverstà degl Stud d Palermo, Vale delle Scenze, bld.8, 90128 - Palermo - Italy (slva.carptella@unpa.t, antonella.certa@unpa.t, maro.enea@unpa.t, gacomomara.galante@unpa.t, concettamanuela.lafata@unpa.t) ** FluIng, Insttuto Unverstaro de Matemátca Multdscplnar, Unverstat Poltècnca de Valènca, Camno de Vera s/n, bld.8g, 46002- Valenca Span (zquer@upv.es) *** flava.vll93@gmal.com Abstract: The food safety rsk assessment s defned by the Codex Almentarus Commsson as the scentfc evaluaton of known or potental adverse health effects resultng from human exposure to food-borne hazards. Nowadays, the mplementaton of a systematc and dscplned rsk assessment approach n the food safety feld s recognzed to be a powerful tool for carryng out scence-based analyses and for reachng sound consstent solutons to food safety problems. Wth ths recognton, a combned Hazard Analyss and Crtcal Control Pont (HACCP) and Technque for Order of Preference by Smlarty to Ideal Soluton (TOPSIS)-based approach s proposed n the present paper to prortze rsks of the salmon manufacturng process of a real Sclan ndustry. Specfcally, the hazard analyss s frstly performed wthn the HACCP mplementaton to develop and evaluate a lst of potental bologcal, chemcal and physcal hazards whch may be ntroduced, ncreased or controlled at each step of the nvestgated manufacturng process. Then, the TOPSIS method s used to rank rsks arsng from contamnaton hazards prevously dentfed and evaluated aganst two dfferently weghted crtera, namely the frequency of Occurrence (O) and the Severty (S). The proposed structured and sem-quanttatve rsk assessment approach perfectly matches wth the current need hghlghted by the regulatory Authortes to rank food safety rsks so as to prortze regulatory controls. Keywords: Rsk prortzaton; HACCP; Fshng ndustry; TOPSIS. 1. Introducton and lterature revew Nowadays, rsk analyss s more and more consdered as a powerful tool on the bass of whch takng scence-based decsons n the food safety context wth the am of promotng ongong mprovements n the publc health. Wthn the food safety feld, rsk analyss s used to quantfy rsks caused by food-borne hazards to human health and to dentfy, assess and mplement approprate measures of nterventon to control such rsks (Butler, 2008). Accordng to the Regulaton EC No 178/2002 (Regulaton EC No 178, 2002), the food safety rsk analyss can be seen as a structured decson-makng system comprsed of three hghly nterrelated components, namely rsk management, rsk assessment and rsk communcaton. As concerns the rsk assessment whch the present paper s focused on, n 1991 the Food and Agrculture Organzaton of the Unted Natons (FAO) and the World Health Organzaton (WHO) have ontly recommended the ncorporaton of ts prncples nto the decson-makng process of the Codex Almentarus Commsson (CAC) (FAO/WHO, 2006). In ths regard, CAC defnes the food safety rsk assessment as the scentfc evaluaton of known or potental adverse health effects resultng from human exposure to bologcal, chemcal or physcal food-borne hazards (FAO/WHO, 1997). Generally speakng, the rsk assessment conssts of three man steps, namely the hazard dentfcaton, the exposure assessment, and the rsk characterzaton (FAO/WHO, 1995; FDA, 2013; Oscar, 2012). As concerns the hazard dentfcaton, t s often consdered as the most mportant step of the rsk assessment because an undentfed hazard n the early stages of the producton process can cause devastatng effects n later stages. The dentfcaton of bologcal, chemcal or physcal food-borne hazards s n common wth the Hazard Analyss and Crtcal Control Pont (HACCP) system tradtonally mplemented by food producers and processors as a comprehensve approach to the food control (Regulaton EC No 852, 2004; ISO 22000, 2005). Asserted by the Natonal Advsory Commttee for Mcrobologcal Crtera for Foods (NACMCF) as the frst prncple of the HACCP plan development, the hazard analyss actually comprses two stages, namely the hazard dentfcaton and the hazard evaluaton. The hazard dentfcaton ams at developng a 150

lst of potental chemcal, bologcal and physcal hazards whch may be ntroduced, ncreased, or controlled at each step of the producton process under nvestgaton. The hazard evaluaton ams at characterzng each dentfed potental hazard by the related Occurrence (O) and Severty (S). Specfcally, O stands for the probablty/frequency of occurrence of the hazard whereas S represents the level of damage as a consequence of the hazard occurrence. Therefore, the hazard analyss to be conducted as the frst prncple of HACCP refers to the process of collectng and evaluatng nformaton on each hazard assocated wth the food under consderaton to look at the condtons that may cause the hazard to be present or to ncrease and to decde whch hazards must be addressed n the HACCP plan (Oscar, 2012; Natonal Advsory Commttee for Mcrobologcal Crtera for Foods, 1998). However, none specfcaton s suppled by the techncal lterature as concerns the way how such a collecton and evaluaton of hazards nformaton need to be performed (Oyarzabal, 2015). Wth ths recognton, the present paper proposes a structured and sem-quanttatve rsk assessment approach based on HACCP and Technque for Order of Preference by Smlarty to Ideal Soluton (TOPSIS) (Hwang and Yoon, 1981) to address the prortzaton of rsks arsng from food-borne hazards. Referrng to a real smoked salmon manufacturng process, the hazard analyss s frstly performed to dentfy hazards whch are of such sgnfcance to cause nury or llness f not effectvely controlled. Then, the TOPSIS method s used to rank rsks arsng from the occurrence of food-borne hazards prevously lsted. In ths regard, two dfferently weghted evaluaton crtera are taken nto account to characterze hazards, namely the related frequency of Occurrence (O) and Severty (S). To the best of the authors knowledge, ths s the frst attempt n the lterature of usng the TOPSIS method for the food safety rsk assessment. Actually, the man part of the exstng lterature proposes the Falure Mode and Effects Analyss (FMEA) (IEC 60812, 2006) to deal wth such an ssue. In (Ozlgen, 2012) the rsk assessment of a confectonary manufacturng process s performed by FMEA, and potental falure modes, ther effects and causes are dentfed n the process flow. Then, the Rsk Prorty Number (RPN) related to each processng stage s computed and stages fnally ranked on the bass of ther contrbuton to the rsk. Referrng to two medum-sze bakeres located n Poland, Trafalek and Kolanowsk (2014) propose a combned HACCP and FMEA approach for the dentfcaton of hgh and crtcal rsks n HACCP areas of verfcaton and recordkeepng. One more tme, Xaochuan and Qang (2015) ntegrate FMEA nto HACCP to analyze potental falure modes and RPNs of meat products. Obtaned results are then used to formulate the HACCP plan of meat products. Varzakas (2011) and Arvantoyanns and Varzakas (2008; 2009) use FMEA for the rsk assessment of pastry processng, snals ndustry and salmon processng respectvely, and carry out a comparson between ISO 22000 (2005) and HACCP. Varzakas and Arvantoyanns (2007) combne FMEA and prelmnary hazard analyss together wth Fault Tree Analyss (FTA) (Curcurù et al. 2013) for the rsk assessment of a corn curl processng plant. Kurt and Özlgen (2013) approach the crtcalty assessment of manufacturng processes of sx wdely consumed dary products n Turkey by means of the tradtonal RPN method. Sxty-seven process hazards are dentfed and the related RPNs computed to dentfy the rsk level of each hazard. The remander of the paper s organzed as follows. The TOPSIS method s descrbed n Secton 2 whereas the applcaton case s presented n Secton 3. Secton 4 reports a bref dscusson about the man strengths of the proposed approach n respect to the extant body of lterature and fnal conclusons are drawn n Secton 5. 2. Overvew on the TOPSIS method The tradtonal TOPSIS method was frstly proposed by Hwang and Yoon (1981) and further developed by Hwang et al. (1993) as a Mult-Crtera Decson Makng (MCDM) technque by means of whch rankng alternatves on the bass of ther ratngs aganst dverse qualtatve and/or qualtatve crtera opportunely weghted. TOPSIS has been wdely appled n the lterature because of ts ablty to deal wth dfferent decson problems addressed to the rankng of alternatves even n uncertan envronments and/or n the presence of multple decson makers (Aello et. al, 2009; Awasth et al., 2010; Zeydan et al., 2011; Carptella et al., 2016a; 2016b). The method s grounded upon the concept of dstances between each alternatve and the postve (Azmuth) and the negatve deal (Nadr) solutons. Therefore, the best alternatve among those under nvestgaton s that characterzed by the shortest dstance from the Azmuth and the greatest dstance from the Nadr. The mplementaton of TOPSIS conssts of the followng steps. 1. Collecton of scores g of each alternatve (wth =1,,n) aganst each crteron (wth =1,,k). Elements g consttute the so called decson matrx. 2. Defnton of the mportance weght of each crteron,.e. w. 3. Computaton of the weghted and normalzed decson matrx where the generc element u s (Eq. 1): u w z,, (1) where z s the ratng of the alternatve under the crteron normalzed by the equaton (2): z g 2 g, 4. Identfcaton of the postve and negatve deal solutons A (Eq. 3) and A (Eq. 4) respectvely: (2) 151

A u,..., 1 u k = max u I ', mn u I '' (3) A u,..., 1 u k = mn u I ', max u I '' (4) where I ' refers to beneft crtera and crtera. 5. Computaton of dstances S and alternatve from A (Eq. 5) and respectvely. S S ( u u ) ( u u ) 2 2,, I '' to the cost S of each A (Eq. 6) 6. Computaton of the closeness coeffcent C (Eq. 7), wth 0 C 1. S C S S, 7. Rankng of alternatves on the bass of the obtaned closeness coeffcents, namely f C >C m then the alternatve has to preferred to the alternatve m. 3. Case study The combned HACCP and TOPSIS-based approach to prortze rsks s here appled to the smoked salmon manufacturng process of Scly Food, a Sclan ndustry whch has been operatng n the fshng sector for many years as a dvson of the Mancuso Group. Scly Food commercalzes ts products n Italy and n foregn markets both wth ther own brands and prvate labels as well. Wth the am of assurng qualty and safe fnshed products, the company pays partcular attenton to the selecton of raw materals and to the control of the manufacturng process. In ths regard, supplers are from Alaska, Norway and Scotland, and a dedcated productve structure of 4800 m 2 over an area of 16000 m 2 was opened n Scly n 2013 accordng to the hghest standards of safety. Envronmental and productve process parameters, products specfcatons and rules regardng the staff are certfed by the Brtsh Retal Consortum (BRC) and the Internatonal Food Standard (IFS). The smoked salmon manufacturng process begns wth the recevng of frozen salmons and ends wth the dstrbuton of fnshed products to customers (Fgure 1). (5) (6) (7) Fsh recevng Dstrbuton Defrostng Packagng and labellng Acceptance check Slcng Fgure 1: Process flow dagram Washng and saltng Smoke flavourng Stages of the salmon manufacturng process are detaled n the followng. Fsh recevng and defrostng: receved fllets of frozen salmons are frstly defrosted nto approprate rooms where the temperature s opportunely montored. Acceptance check: once defrosted, the temperature, the weght and the ntegrty of salmons fllets packages are checked. Then, a sample of the receved lot s sent to the laboratory for the mcrobologcal testng and to verfy the presence of foregn bodes. The mcrobologcal testng ncludes the post-mortem ph montorng. For ph values greater than 7, the whole lot s reected and sent back to the suppler. Washng and saltng: such a stage s performed nto a specfc room whch s santzed every three hours to avod the fsh contamnaton by the lstera monocytogenes bacterum. The temperature s kept beneath the 7 C and salmons are manually placed on steel shelves where they are checked to ensure the absence of resdual scales and mpurtes due to the flletng process. Then, fshes are washed wth water and fnally salted. Smoke flavourng: washed and salted salmons fllets are placed on approprate trolleys and ntroduced nto partcular ovens where the humdty and the temperature are opportunely montored. Generally speakng, there are two types of smoke flavourng processes, namely the so-called hot smoked salmon that takes place at temperatures of about the 70 C, and the cold one whch uses a temperature between 25 C and 30 C. The company makes a cold smoke flavourng process whch makes use of beechwood and lasts for 15-18 hours. As the hot smoked salmon process, the cold one appled on farmed fshes and together wth approprate hygenc condtons assures safety and qualty products. Slcng: such a stage starts wth the automated skn removal and carres on wth a manual removal of resdual skn and bones. Then, fllets are sent to a slcer machne whch produces slces havng a thckness of 1.5 mm, and trays of dfferent sze and weght are manually prepared. Packagng and labellng: salmons trays are weghed by a specfc machne and vacuum packed to avod ar bubbles and thus the development of bactera. 152

Packages are labelled to nclude nformaton such as expraton date, lot number, etc. A further laboratory check s performed on samples of fnshed products before the dstrbuton. As aforementoned, assurng the qualty and the safety of products s the man goal of Scly Food. To such an am, all lots are montored durng all stages of the manufacturng process by the extracton of samples whch are sent to the laboratory for the mcrobologcal testng. As requred by the HACCP, the organzaton also performs the hazard analyss of the smoked salmon manufacturng process wth the am of dentfyng known and potental hazards that may have an adverse effect on the human health. Table 1 syntheszes the dentfed hazards and the process stage they are connected to apart from the analyss of supplers whch s drectly performed by salmon supplers before sendng the fsh to Scly Food. Process phase Fsh recevng Smoke flavourng Fsh recevng and Packagng All phases Analyss of supplers Table 1: Identfed hazards Hazards Aeromonas Hydrophla Heavy metal (Hg, Cd, Pb) Salmonella SPP Benzopyrene and other polycyclc aromatc hydrocarbons Parastes Allergens Foregn bodes, metals, glass, stones Plastc foregn bodes Lstera Monocytogenes Staphylococcal enterotoxns Formaldehyde Resdues of medcnal products PBC and PCDD The man part of hazards reported n Table 1 s specfcally regulated n order to contrbute to the protecton of publc health and establsh harmonzed safety crtera on the acceptablty of food, n partcular as regards the presence of certan pathogenc mcroorgansms. For nstance, the Commsson Regulatons EC No 2073/2005 (Commsson Regulaton EC No 2073, 2005) and No 1881/2006 (Commsson Regulaton EC No 1881, 2006) need to be compled for the lstera monocytogenes whereas the benzopyrene s regulated by the Commsson Regulaton EC 835/2011 (Commsson Regulaton EC 835, 2011). Startng from the necessty recognzed by the Scly Food to mplement a systematc rsk assessment approach, the next prortzaton of hazards reported n Table 1 s performed by usng the proposed TOPSIS method. Actually, the hazard analyss as the frst prncple of HACCP does not represent the man focus of the present paper whch s nstead addressed to the proposal of a sem-quanttatve and structured method to prortze the dentfed food-borne hazards on the bass of ratngs expressed by the organzaton HACCP team. Therefore, the TOPSIS method s appled to rank rsks related to ther occurrence and severty. On the TOPSIS pont of vew, dentfed hazards reported n Table 1 hence represent the alternatves to be ranked on the bass of ther evaluatons aganst crtera, namely the occurrence O and the severty S. In partcular, a four-pont scale s used for the frst crteron whereas the severty s assessed on a fve-pont scale. Both scales are characterzed by a decreasng preference versus, namely the smaller the ratng, the smaller the probablty of occurrence and the severty. Ratngs of alternatves aganst crtera (.e. g ) are reported n Table 2 and then normalzed by the equaton (2). As concerns crtera, they are assumed equally weghted,.e. w O = w S = 0.5. The elements u of the weghted and normalzed decson matrx (Table 3) are then computed by the equaton (1) whereas equatons (3) and (4) are used to compute the postve and negatve deal solutons (.e. n Table 4. A and A respectvely) syntheszed Table 2: Hazards ratngs aganst crtera O and S Hazards O S Aeromonas Hydrophla 1 2 Heavy metal (Hg, Cd, Pb) 1 4 Salmonella SPP 1 3 Benzopyrene and other polycyclc aromatc hydrocarbons 2 5 Parastes 1 1 Allergens 1 3 Foregn bodes, metals, glass, stones 1 3 Plastc foregn bodes 2 1 Lstera Monocytogenes 4 4 Staphylococcal enterotoxns 1 3 Formaldehyde 1 2 Resdues of medcnal products 1 3 PCB and PCDD 1 4 153

Table 3: Weghted and normalzed matrx Hazards O S Aeromonas Hydrophla 0.0857 0.0884 Heavy metal (Hg, Cd, Pb) 0.0857 0.1768 Salmonella SPP 0.0857 0.1326 Benzopyrene and other polycyclc aromatc hydrocarbons 0.1715 0.2210 Parastes 0.0857 0.0442 Allergens 0.0857 0.1326 Foregn bodes, metals, glass, stones 0.0857 0.1326 Plastc foregn bodes 0.1715 0.0442 Lstera Monocytogenes 0.3430 0.1768 Staphylococcal enterotoxns 0.0857 0.1326 Formaldehyde 0.0857 0.0884 Resdues of medcnal products 0.0857 0.1326 PCB and PCDD 0.0857 0.1768 Table 4: Ideal solutons Hazards O S A + 0.0857 0.0442 A - 0.3430 0.2210 On the bass of computed closeness coeffcents (Eq. 7), the followng Table 5 syntheszes the fnal rankng results. On the bass of the performed analyss, the most dangerous hazard s the lstera monocytogenes. Actually, such a bacterum causes the lsteross, a dsease partcularly dangerous for pregnant women, mmunecompromsed patents, chldren and elderly. The bacterum can be present both n raw and smoked fshes, t survves to refrgerator temperatures and t partcularly prolferates between 30 C and 38 C. As a consequence, the temperature s montored durng all stages of the process and t s mantaned between 10 C and 12 C, and opportune hygenc measures for personnel are taken as well. Then, the second poston s taken by the benzopyrene and the other polycyclc aromatc hydrocarbons released durng the smoke flavourng stage of salmons. Therefore, the lstera monocytogenes, the benzopyrene and the other polycyclc aromatc hydrocarbons result to be the most crtcal hazards whch must be addressed nto the HACCP plan. Table 5: Rankng of rsks Hazards C Lstera Monocytogenes 0.1325 Benzopyrene and other polycyclc aromatc hydrocarbons 0.4661 Heavy metal (Hg, Cd, Pb) 0.6632 PCB and PCDD 0.6632 Plastc foregn bodes 0.7418 Allergens 0.7547 Foregn bodes, metals, glass, stones 0.7547 Staphylococcal enterotoxns 0.7547 Resdues of medcnal products 0.7547 Salmonella SPP 0.7547 Aeromonas Hydrophla 0.8675 Formaldehyde 0.8675 Parastes 1 In the lght of the obtaned results, the organzaton decdes to undertake the followng preventve measures. Further agreements wth supplers about the mcrobologcal testng to be performed to ensure the ntegrty of raw materals. Specfc hygenc measures desgned to reduce external contamnatons. Durng the manufacturng process, such measures concern tools, machneres as well as the personnel whch are oblged to wear approprate coveralls accordng to the adopted standards. Mcrobologcal testng based on systematc samplng to more accurately montorng all those hazards that cannot be vsually detected such as the heavy metal contamnaton whch may occur durng the salmons aquaculture nto oceanc cages. 4. Dscusson As emphaszed n the manual (FAO/WHO, 2005), tradtonal food safety systems are recognzed as nadequate to cope wth the complex, persstent pervasve and evolvng array of food safety ssues exstng today. To the contrary, modern food safety systems need to be scence-based to effectvely cope wth, and respond to, the wde range of food safety challenges. As a concept, a scence-based approach to food safety s not completely new. What s new s the use of scence-based approaches wthn the rsk analyss framework farly recently ntroduced n the food safety feld to effectvely manage, evaluate and communcate rsks. Actually, scence-based results may support Decson Makers (DMs) to mnmze the occurrence of food-borne hazards, to reduce and manage rsks, and to mprove the outcomes of decson-makng. However, food safety hazards potentally occurrng n whatever manufacturng envronment are generally numerous so that settng prortes among them s fundamental to enable nformed decson-makng and 154

resource allocaton. Wth ths recognton, the proposed TOPSIS-based approach represents a structured way to set prortes among food-borne hazards. As mentoned n Secton 1, the extant body of lterature on such an ssue s manly focused on the proposal of the tradtonal FMECA by means of whch food-borne hazards are ranked on the bass of related RPNs. Nevertheless, the general use of the RPN method has been wdely crtczed to have several shortcomngs (Certa et al., 2017a; Certa et al., 2017b; Lu et al., 2013) some of whch are lsted below. RPNs parameters (.e. O, S and Detecton D) are equally weghted. Dfferent combnatons of O, S, and D may produce exactly the same value of RPN, but ther hdden rsk mplcatons may be totally dfferent. The mathematcal formula for calculatng RPN has been debated, because there s no ratonale n obtanng the RPN as a product of the rsk factors O, S and D. The TOPSIS method allows at dfferently weghtng crtera on the bass of the DM perceptons. The latter makes able a better management of the nformaton avalable on the decson-makng problem to be dealt. 5. Conclusons The hazard analyss s the frst prncple of the Hazard Analyss and Crtcal Control Pont (HACCP) system commonly mplemented by food producers and processors as a comprehensve approach to the food safety control. It s defned as the process of collectng and evaluatng nformaton on each known or potental hazard assocated wth the food under consderaton. However, none specfcaton s suppled by the techncal lterature about the way how such a collecton and evaluaton of hazards nformaton need to be performed. Wth ths recognton, a structured and sem-quanttatve rsk assessment approach based on HACCP and TOPSIS was proposed n the present paper to prortze rsks arsng from food-borne hazards of a real smoked salmon manufacturng process. Specfcally, the hazard analyss was frstly performed to dentfy hazards whch could be of such sgnfcance to cause nury or llness f not effectvely controlled. Then, the TOPSIS method was used to rank rsks arsng from the occurrence of foodborne hazards prevously lsted. To the prortzaton am, hazards were evaluated aganst two dfferently weghted evaluaton crtera, namely the frequency of Occurrence (O) and the Severty (S). The proposed approach classfed the lstera monocytogenes, the benzopyrene and the other polycyclc aromatc hydrocarbons released durng the smoke flavourng stage as the most crtcal hazards on whch payng attenton to assure safety and qualty fnshed products. On the bass of the obtaned results, the subect s company decded the more approprate measures to be undertaken to mnmze the mpact of the aforementoned hazards on the nvestgated manufacturng process. 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