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Failure mode and effect analysis for dairy product manufacturing: Practical

safety improvement action plan with cases from Turkey

Levent Kurt a, Sibel Ozilgen b,

a Scientific and Technological Research Council of Turkey, MRC Food Institute, 41470 Gebze, Turkeyb Food Engineering, Yeditepe University, Gastronomy and Culinary Arts Department, 34755 Istanbul, Turkey

a r t i c l e i n f o

Article history:

Received 15 August 2012

Received in revised form 18 December 2012

Accepted 11 January 2013

Available online 21 February 2013

Keywords:

FMEADairy products

Food safety

Preventive method

Case study

a b s t r a c t

The incidence of contamination of raw milk and dairy products by biological and chemical hazards is amajor problem all around the world. Systematic risk control at each stage of the process is required to min-

imize or eliminate failures in the manufacturing process. The quantitative risk analysis method, FailureMode and Effect Analysis (FMEA), was applied for the risk analysis of six dairy products that are widelyconsumed in Turkey. Comprehensive real datacollected from 75 food safety audits carried out in 30 dairy

factories between 2006 and 2011 were used to implement the method. Possible failure modes in the pro-cesses were identified and the potential risks for each failure mode were analyzed. Risk priority numbers

were calculated to identify the risk level of each potential failure. Generally speaking, the highest totalrisk priority number was calculated for the biological failures, which were followed by the chemical fail-

ures in all processes. Physical failures were found to pose the lowest risk. Failures were commonlyobserved in companies that were applying obsolete technologies, using intensive human handling, and

employing staff members with no previous food processing and hygiene training. It is concluded thatimplementing the FMEA methodology in dairy industry will decrease the possibility of failure noticeablyin all the manufacturing processes studied. Results of this study can be used by the manufacturers in dif-

ferent parts of the world to produce safer dairy products, since almost all dairy products share common

manufacturing stages. 2013 Elsevier Ltd. All rights reserved.

1. Introduction

Turkey is theworlds 15thbiggestproducer of milk, andtherefore

has a noticeable share in the 695 million tons of annual worldwidemilk production (Papademas and Bintsis, 2010;Republic of TurkeyMinistry of Economy). Cows milk accounts for 92.36% of the totalmilk production in Turkey. Global cows milk production in 2010

wasapproximately600 milliontonswhile Turkey wasthe 10thlarg-est cows milk producer in the world, accounting for 2.1% of worldproduction byproducing over 12 million tons. In 2010,milkproduc-

tion increasedfour-fold compared to the previous year, and approx-imately 13 million tons of milk was producedin Turkey (Republic ofTurkey Ministry of Economy;DairyCo, 2012). In conjunction withthe increase in milk production, Turkeys exports of dairy productsincreased by 89.26% in the last 5 years, while the exports of dairy

products reached $168.86 million in 2010 (Republic of Turkey Min-istryof Economy).The high share ofTurkishdairy productsin thena-tional andinternationalfood market increasesthe significanceof thequality and safety of theproducts. Commercial dairy production is a

complex industry. Processing, sanitation, and storage methods, hu-

man involvement, as well as the types of equipment that are incor-porated into the production process varyfromproducer to producerdepending on the production capacity, and the types of products

produced. For example, milking process can vary from simple handmilking to highly complex automated milking, heating process canvary from batch heat treatment to continuous heat treatment, orcleaning process can vary from hand cleaning to highly automated

cleaning depending on the production capacity, and the types ofproducts produced. However, satisfying high safety standards is acommon requirement for all processessincemilk and milkproducts

are perishable food products. According to World Health Organiza-tion (WHO), food-borne diseases are widespread and becomingincreasingly serious threats for both developed and undevelopedcountries all over the world. In 2005, 1.8 million people died fromdiarrheal diseases and most of these cases were caused by infected

foods; and milk and milk products are no exception (WHO, 2007).Dairy products are responsible for approximately 8.3% of biologi-cally originated food-borne disease outbreaks in the world (Greigand Ravel, 2009; Hassan et al., 2010). In 1985, an estimated of

200,000 total people, with 16,000 laboratory-confirmed cases,contracted salmonellosis from contaminated pasteurized milkdistributed by one dairy plant in the Chicago area (Food safety,2012). Similarly, 13,420 people got sick from food poisoning after

0925-7535/$ - see front matter 2013 Elsevier Ltd. All rights reserved.http://dx.doi.org/10.1016/j.ssci.2013.01.009

Corresponding author. Tel.: +90 216 5780861.

E-mail address:[email protected](S. Ozilgen).

Safety Science 55 (2013) 195206

Contents lists available atSciVerse ScienceDirect

Safety Science

j o u r n a l h o m e p a g e : w w w . e l s e v i e r . c o m / l o c a t e / s s c i
http://dx.doi.org/10.1016/j.ssci.2013.01.009mailto:[email protected]://dx.doi.org/10.1016/j.ssci.2013.01.009http://www.sciencedirect.com/science/journal/09257535http://www.elsevier.com/locate/sscihttp://www.elsevier.com/locate/sscihttp://www.sciencedirect.com/science/journal/09257535http://dx.doi.org/10.1016/j.ssci.2013.01.009mailto:[email protected]://dx.doi.org/10.1016/j.ssci.2013.01.009

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consuming contaminated skim milk and yogurt prepared with milkpowderinJapan(Asao et al., 2003). One of therecent studies showed

the urgent need to implement quality control programs, in dairyprocessing, in Sudan since potential health hazards were concludedin the research (Ibtisam et al., 2007).Ertas et al. (2010) isolatedStaphylococcus aureus, one of the most common agents in bacterialfood poisoning outbreaks, and staphylococcal enterotoxins from

the sheep cheese and dairy dessert samples collected in Kayseri inTurkey. The safety and suitability of dairy foods for human con-sumption must be ensured through the implementation of properhygienic control of milk and milk products throughout the process,

from farm to table.Hazard Analysis and Critical Control Point (HACCP) method has

been widely applied for producing safe foods (WHO, 2008).Although HACCP and Failure Mode and Effect Analysis (FMEA) have

similarities, they differ significantly in operation. In HACCP, theprimary purpose is controlling the process at critical control pointsto eliminate or decrease the risk of hazards (McDonough, 2002).Failure Mode and Effect Analysis (FMEA) is a powerful systematic

preventive method for risk management, which aims to eliminatepotential failures associated to each stage of the process beforethey enter to the next stage. It has been widely used by manufac-

turing companies for quality and safety assurance, addressing cus-tomer and governmental requirements, quality control and safety.In recent studies, the method has been successfully employed forrisk analysis in numerous food processes such as, strudel manufac-turing, production of potato chips, Turkish delight manufacturing,

powdered red pepper processing, and industrial processing of sal-mon (Scipioni et al., 2002; Arvanitoyannis and Varzakas, 2007a,2007b; Arvanitoyannis and Varzakas, 2008;Ozilgen et al., 2011;Ozilgen, 2012). Failure mode and effect analysis is a bottoms-up

approach that essentially divides the manufacturing process intosteps, and then detects the potential failures at each step. Quanti-tative evaluation of the risks is the main advantage of the FMEAmethodology, over the other risk analysis method. In the FMEA

methodology, potential risks of the processes are detected and as-

sessed in every step by assigning values for frequency of each fail-ure (O), seriousness of the failure (S) and possibility to detect thefailure (D) before consumption. A Risk Priority Number (RPN) is

calculated for each failure mode by multiplying the three deter-mined values (O SD). Corrective actions are suggested for po-tential failures that have an RPN value larger than the selectedthreshold value to reduce and eliminate the potential failures from

the system.This study applies the FMEA methodology for quantification of

risk analysis in manufacturing processes of six widely consumeddairy products in Turkey. The major significance of this study is

that comprehensivereal data collected from 75 audits carried outin thirty dairy factories were used to implement the FMEA methodin dairy food manufacturing. Results from this study may help

manufacturers from different parts of the world in producing saferdairy products, since almost all dairy products share commonmanufacturing stages.

2. Materials and methods

Data were collected through 75 food safety providing system

(FSPS) audits that were carried out in thirty Turkish dairy compa-nies between 2006 and 2011. Buttermilk, kefir, yogurt, stringcheese, plaited cheese, and hard cheese processes were inspectedduring the audits. Both field controls and documentation controls

were carried out during the visits. The audits were carried out byqualified food safety auditor in five different areas: (1) adequacy

of the food safety programs, (2) pest control, (3) operational meth-ods and personnel practices, (4) maintenance for food safety, and

(5) cleaning practices. A standard questionnaire and a check listcompiled from Turkish Food Codex, Hazard Analysis and CriticalControl Point system (HACCP), ISO 22000 food safety managementsystem (FSMS), British Retail Consortium (BRC) and International

Food Standard (IFS), was used to collect the data. Questions,regarding the five different areas, used in the questionnaire in-cluded the followings: Is ambient temperature controlled? Is thestaff trained on food safety at an appropriate level to pursue their

jobs? Is there adequate pest control? Are foods covered and datemarked? Is there a written cleaning and disinfection program inoperation? The data collected by the audits were used to developthe FMEA methodology for each product.

The process food flow diagram for each dairy product was pre-pared based on the most common processes observed for the sameproduct during onsite visits (Figs. 1and2). Possible failure modes

in the process were identified and the potential hazards for eachfailure mode were assessed based on the documentations collectedthrough the audits. The risk levels of the potential failures wereidentified by calculating a Risk Priority Number (RPN) from three

variables: Frequency of occurrence for each failure (O), severityof the failure (S), and possibility of detecting the failure (D); toidentify the risk level of each potential failure. The frequency of

occurrence for each failure mode was identified on a scale of 110, with higher ratings indicating a greater probability of failure.The possibility of detecting the failure prior to consumption andthe severity of the failure to the consumer were also rated on ascale of 110, where 10 was the least likely chance of detecting

the failure and high severity effect of the failure, respectively.Numerical rankings for variables O and D were established fromthe documentations collected through the audits. The S valueswere predicted from the similar studies in the literature. The risk

priority numbers were calculated by multiplying the values ofthe variables O, S, and D. Possible corrective actions were sug-gested for each potential failure mode with risk priority numbershigher than 100. The maximum value of a possible RPN is 1000

(10 10 10) and 100 is equal to the 10% of it with a statistical

confidence of 90%. At these points, the RPNs were recalculated tounderstand the influence of corrective actions on the improvementof the process (Tables 13).

Sample Pareto graphs were constructed for yogurt manufactur-ing process by following the same procedure as Arvanitoyannisand Savelides (2007)andOzilgen et al. (2011)to visualize the per-cent contribution of the RPN of each stage to that of the total pro-

cess before and after implementing the corrective action (Fig. 3).

3. Results and discussions

The most common failure modes detected during the audits, theRPN values for each failure mode, and the improvements after

implementing the suggested corrective actions are given inTables13for the manufacturing of each dairy product. The highest totalrisk priority numbers were calculated generally for the biologicalfailures, followed by the chemical failures, in all of the processes.

Physical failures were found to pose the lowest risk.Milk is the main ingredient for all dairy products. Therefore, pre-

treatment was required to minimize or eliminate the risks associatedto raw milk before it was used in the process of other dairy products.

Some of the raw milk samples collected from companies did notsatisfy the requirements to produce safe dairy products. Somecompanies preferred to own the farm and produce their own milkwhilst the others supplied milk from third party companies. In

both cases the hygienic conditions of the milking environment,and the health condition of the animals from which the milk was

obtained were observed to play a critical role in the sanitary qual-ity of raw milk (Table 1). Unsanitary milking conditions and

196 L. Kurt, S. Ozilgen/ Safety Science 55 (2013) 195206

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unhealthy animals are the main sources of pathogenic microorgan-isms such as Staphylococcusssp., Streptococcusssp., Campylobacter

spp., Listeria monocytogenes, Escherichia coli, Mycoplasma spp.,

Mycobacterium tuberculosis, Cryptosporidium, Cyclospora, andToxo-plasma in raw milk. These pathogenic microorganisms may have

negative effects on human health if they exist in foods products

Fig. 1. Process flow diagrams for, (a) milk pretreatment process, (b) pretreatment process for yogurt, ayran and kefir productions, (c) pretreatment process for string cheese,

plaited cheese, and hard cheese.

L. Kurt, S. Ozilgen/ Safety Science 55 (2013) 195206 197

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Fig. 2. Process flow diagrams for, (a) ayran and kefir production, (b) yogurt production, (c) string cheese and plaited cheese productions, (d) hard cheese production.


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above the legal limits given in the food codex (Arvanitoyannis andMavropoulos, 2000; Metin and ztrk, 2002; Chye et al., 2004;

Doumith et al., 2004; Dawson, 2005; Compton et al., 2008; Skand-amis et al., 2008; Turkish Food Codex, 2008; Guven et al., 2010).The health effects of consuming these microorganisms may rangefrom mild symptoms to death. With such serious health risks, sim-ple controls might not be enough to prevent the failures in raw

milk unless a series of control measures and corrective actionsare applied. In company pathogen analysis during receiving ofraw milk is not a practical task for companies. It requires timedemanding microbiological tests, as raw milk has to be processed

immediately after its receipt. In addition, in-company analysiscan be risky for the company if the sterile conditions are not pro-vided in their own laboratories. Therefore, implementation of pre-ventive control measures from farm to receiving of raw milk by the

company was suggested as a better solution to decrease the risk ofpathogen contamination in raw milk. Educating the farmers onfood safety, proper handling, hygiene, and sanitation practices,improvement in the sanitary conditions of the milking environ-

ment and equipment, immediate cold storage of milk in doublewalled steel tanks after milking, and heat treatment processes,maintaining cold chain during on-field storage, transportation of

milk to the plant, and upon receipt by the plant, and regular veter-inary controls on field were the most common preventive actionssuggested to ensure the sanitary quality of raw milk (Table 1).

Increased acidity can be the indication of microbial growth inmilk, but, acidity measurement in raw milk during its receipt is

not a guarantee for pathogen-free milk, since not all pathogens in-crease the acidity of the medium. Alkaline substances such as bak-ing soda, bleach, and hydrogen peroxide, were detected in some ofthe raw milk samples collected from the companies. These chem-

icals were used by milk collectors and/or farmers either to decreasethe acidity of the milk or as microbiological preservatives. Electri-cal conductivity testing together with somatic cell counting andacidity measurement during receipt was recommended for each

batch of raw milk to avoid raw milk adulteration (Table 1).

Although the processes were automated, intensive humaninvolvement was observed at several production stages of somedairy products. For example, in ayran and kefir production, the

cups and the lids were fed to the filling lines by the staff. Similarly,the culture inoculation, ingredient addition, molding and de-mold-ing, plaiting, kneading, and portioning stages of some dairy pro-cesses were carried out by staff. Poor personal hygiene, and

improper handling and practices by the staff were observed to bethe most common causes for potential biological failures for themanufacturing stages that require intensive human involvement(Table 1). Education of the staff on personal hygiene and safety

rules were suggested as a main corrective action to minimize thepotential risks arising from the workers. Adequate changing roomsand bathrooms, hand washing areas with soap, paper towels, high

quality disinfectant, and hot and cold water were recommended toensure a proper degree of personal hygiene for safe food produc-tion (WHO, 2008). Transportation between the processing stages,such as from the processing area to the storage area, or transporta-

tion to the storage area after receiving of the product were notautomated and required intensive human involvement in somecompanies. Increased time gaps between the stages due to impro-per manufacturing practice were observed in some production

units. The standardization of the process flow, and staff educationon the procedure were highly recommended for the companieshaving this problem at any stage of the process.

Cross contamination was another common potential cause for

biological failures observed during the visits. Improper cleaningpractices and an unsanitary environment were the basic sources

of cross contamination. Clean in Place (CIP) techniques weremostly applied in the cleaning of closed systems such as pipelines,L

ubricantresiduesinfoodsfrom

the

pedals

4

7

6

168

Standardmaintenanceprogramm

ustbeapplied.

Thefood

gradelubricatingoilsmustbeuse

d

2

4

5

40

Ayranandkefirproduction,

Mixing;Yo

gurtproduction,

Mixing;Hardcheesecheesegrouppret

reatment,Curdcutting

M

ycotoxinsfrom

thecontaminated

cheesesthatareaddedduringthe

process

5

8

4

160

Periodicanalysesofoldcheesesm

ustbecarriedout

2

8

2

32

Hardcheesegrouppretreatment,Dryblanching

C

hemicalcontaminantsduetotheuseof

emptyfoodcontainerstostore

chemicalsandmislabelingof

containers

3

10

5

150

Staffmustbetrainedonhandling

andlabelingofchemicals.

Labelcontrolmustbedonedaily.

Foodsandchemicalsmust

bestoredseparately.

Inventoryfo

rmsmustbefilledproperly

2

10

2

40

Yogurt,

kefirandayranpretreatment,

Drymatteradjustment;

Hardcheesegrouppretreatment,CaCl2addition,

Enzyme

addition,

Blanchingandkneading(bothwetanddry);Plaited

cheeseandstringcheeseproduction,R

esting

a

Milkpretreatment:commonprocessforalldairy

products.

b

Yogurt,

kefir,ayranpretreatment:commonprocessforyogurt,

ayran,

andkefirproductions.

c

Hardcheesecheesepretreatment:commonprocessforhardcheesecheese,

plaitedandstringcheeseproductions.


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pasteurization equipment, and storage and process tanks. Manualcleaning techniques were mainly used for small utensils and

equipment. The biological failure risk was higher in manual clean-ing compared to the CIP technique, since it required more humaninvolvement. Educating staff on using proper cleaning agents andapplying proper cleaning procedures was the main corrective ac-tion suggested that addresses the potential failures from improper

cleaning practices. The quality of environmental air was commonlyneglected, but it was a very important factor concerning the safetyof food products. Precautions were suggested to control the qualityof air at different stages of the process (Table 1). Some processes

such as filtration of raw milk, the filling and closing stages of yo-gurt manufacturing, and the resting and packaging stages ofcheeses were susceptible to contamination from the environment;since they were carried out in open air. Flying pests were one of the

major contamination sources of biological failures, especially inopen processes (Table 1). Sanitary conditions of packaging materi-als and lids were suggested to be controlled regularly to avoidcross contamination since failures were observed in several pro-

duction units.Temperature control was detected as another critical reason for

potential biological failures at a number of stages. Inefficient heat

processing and improper or fluctuating storage and transportationtemperatures were the most common reasons for this failure. Heatprocessing parameters and storage and transportation conditionsmay show variations depending on the type of the product andthe purpose of the process. Corrective actions were suggested con-

sidering the nature of the products produced and the purpose ofthe heating process (Table 1).

Insufficient heat application during sealing, sealing machinemalfunction, use of unsuitable covers, and operator mistakes were

observedto cause improper package sealing of somedairy products;which mayresult in post-process contamination(Table 1). Post pro-cess contamination is difficult to be controlled by the producerswhen theproductis distributedfor sale. Food spoilage causedby im-

proper sealing is usually detected by the consumers. Failures must

be eliminated from the process by applying proper preventive ac-tions before the product reaches the consumer (Table 1).

The total risk priority number was found to be the second high-

est for the chemical failures. Veterinary drugs that were used totreat the animals and improve their health were the major poten-tial chemical hazards found in raw milk. Aflatoxin and pesticideresidues were the other most common failures in raw milk ob-

tained from the animals fed with contaminated feed. Contact sur-faces of the foods, such as packaging materials and seals, weredetected as a potential source of chemical contamination throughmigration into foods for the companies that were using nonfood-

grade materials in their productions (Table 2).Antibiotics are the most common veterinary drugs used in ani-

mal care. The presence of antibiotic residuals in foods obtained

from animals is an important health threat since it leads to in-creased microbial resistance in human in latest years. Allergic reac-tions and a decrease in the total numbers of useful bacteria in thehuman intestine are other possible adverse effects of prolonged

exposure to veterinary drug residues (Doyle, 2006; Toldr and Reig,2006). Growth promoter residues in food products may have car-cinogenic effects on humans. Trembling, headaches, and depres-sion are the other symptoms reported after consuming meat

contaminated with growth promoters (Doyle, 2006). The use ofsubstances having hormonal action is banned in many countries.Prolonged exposure to pesticides can result in cancer of the soft tis-sue, brain, lung, liver, digestive system and urinary tract; as well as

birth defects, and damage to the nervous systems (Younes and Ga-lal-Gorchev, 2000). Heavy metals are mostly not biodegradable and

therefore can accumulate in the vital organs of humans. They maycause neurological disorders, Alzheimers, Parkinsons disease,Table

3

(continued)

C

ommonfailuresandcause

O

S

D

RPN

Correctiveactions

O

S

D

RPNafter

cor

rective

act

ions

Process,

Processingstagethatthepoten

tialriskswereobserved

M

icrobialgrowthduetoincreasedtimelap

betweenprocesses

6

6

3

108

Stafftrainingisrequired.

Standa

rdfoodflow

directivesmust

beobeyed

2

6

2

24


Fillingto

closing;Yogurt

production,

Closingtocoldstorage;Ha

rdcheeseproduction,

Packagingtocoldstorage;Plaitedchee

seandstringcheese

production,

Packagingtocoldstorage

M

icrobialgrowthduetoenvironmental

temperaturefluctuationduringthe

process

6

6

3

108

Stafftrainingisrequired.

Standa

rdfoodflow

directivesmust

beobeyed

2

6

2

24

Hardcheeseproduction,

De-moulding

andshapecutting

M

icrobiologicalcontaminationcausedby

inadequatecleaning

3

8

4

96

Notrequired

Milkpretreatment,Clarification

G

rowthofpathogensduetoinappropriate

incubationtemperature

5

9

2

90

Notrequired


Incubatio

nintanks,

Yogurt

production,

Incubation

M

icrobiologicalcontaminationfrom

inappropriatecleaningmaterials(i.e.,

sponge)

6

7

2

84

Notrequired

Milkpretreatment,Filtration

a

Milkpretreatment:commonprocessforalldairy

products.

b

Yogurt,

kefir,ayranpretreatment:commonprocessforyogurt,

ayran,

andkefirproductions.

c

Hardcheesepretreatment:commonprocessforhardcheese,

plaitedandstringcheeseproductions.


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cancer, and low birth weight in humans if the consumption ex-

ceeds the legal levels given in the food codex (Salama and Radwan,

2005; Muhammad et al., 2009). Some biological toxins are realthreats to human health due to their extremely toxic, carcinogenic,and mutagenic characteristics (Bircan et al., 2008). Working with

an approved supplier was the major corrective action recom-mended addressing the potential chemical contamination risk indairy products. Approved suppliers have an appropriate food safetyprogram in place and they are primarily responsible for providing

safe and consistent quality of raw ingredients to the companies.Antibiotics and aflatoxin analysis in each batch of raw milk usingspecial kits was the other preventive action recommended sinceit is a rapid and cost effective method for companies of all sizes.

Implementation of proper water treatment procedures were ob-served to be essential for the companies that were using wells tosupply water (Table 2).

Chemical contamination risks due to malpractices, such as the

presence of cleaning agent residues in products due to inadequate

rinsing and inappropriate use of hand sanitizers, contamination

due to mislabeling containers, and uncontrolled use of food addi-

tives were observed as potential failure risks at different stagesof production of dairy products. Corrective solutions, particularlystaff education were recommended for each specific case to com-

pletely remove the risk from the processes (Table 2).Physical failures were found to pose the lowest risk for all

manufacturing processes. Improper operating and maintenanceprocedures were the common causes for potential physical con-

tamination risks at the stages that posed those risks (Table 3).Generally speaking, failures were commonly observed in com-

panies that were applying obsolete technologies, such as the onespracticing hand milking as opposed to ones using milking ma-

chines, using intensive human handling, and employing staff mem-bers that have no food processing and hygiene training.Implementing all of the recommended corrective actions andchanging the whole process at once is a difficult and costly transi-

tion for the producers. Therefore, each company agreed to initially

Fig. 3. Pareto diagrams for total risk classification, including chemical, physical, and biological risks, of yogurt processing (a) prior to corrective actions, (b) after corrective

actions.


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apply the corrective actions that would help them satisfy the min-imal legal requirements in producing safe foods. Since most com-

panies applied a different combination of corrective actions, itwas possible to observe the remedial effects of different correctiveactions on the different stages of the processes. Therefore, for thepurpose of this study, risk priority numbers were calculated for anew risk situation assuming all suggested corrective actions were

theoretically applied to the same dairy manufacturing process (Ta-bles 13). The RPN values appeared to have reduced noticeably forall processes after undertaking the suggested corrective actions.Hence, implementing FMEA methodology in dairy industry de-

creased the possibility of failure in the manufacturing processes,reduced the cost of production, and eliminated large changes inthe process during manufacturing. The results of this study signif-icantly highlight the importance of systematic control at each stage

of the process to minimize or eliminate risks in dairy foodproduction.

4. Conclusion

The main purpose of the FMEA application was to quantify therisk analysis by determining the RPN values for each potential pro-

cessing hazard in processing of dairy products. The results indi-cated that biological failures were the major risks with thehighest RPN followed by the chemical failures in all dairy manufac-turing processes. Failures were commonly observed in companies

using the obsolete technologies, using intensive human handling,and employing staff members that have no previous food process-ing and hygiene training. Based on the results of FMEA analysis,food safety improvement actions for different stages of dairy food

manufacturing processes were suggested. Implementation of thoseactions appeared to have reduced the RPN values below theacceptable limit of 100. Our results clearly show the importance

of incorporating a good systematic preventive method for riskmanagement in the dairy manufacturing industry. The results fromthis study might help large number of dairy product manufacturers

in producing safe products since the study provides comprehensivereal datacollected from 75 audits carried out in thirty dairy facto-ries, and almost all dairy products share common manufacturingstages.

Acknowledgment

We acknowledge the support from the Scientific and Techno-logical Research Council of Turkey, MRC Food Institute throughout

the study.

References

Arvanitoyannis, I.S., Mavropoulos, A.A., 2000. Implementation of the Hazard

Analysis Critical Control Point (HACCP) system to Kasseri/Kefalotiri andAnevato cheese production lines. Food Control 11 (1), 3140.Arvanitoyannis, I.S., Savelides, S.C., 2007. Application of failure mode and effect

analysis and cause and effect analysis and Pareto diagram in conjunction withHACCP to a chocolate-producing industry: a case study of tentative GMOdetection at pilot plant scale. Int. J. Food Sci. Technol. 42 (11), 12651289.

Arvanitoyannis, I.S., Varzakas, T.H., 2007a. A conjoint study of quantitative andsemi-quantitative assessment of failure in a strudel manufacturing plant bymeansof FMEAand HACCP, cause andeffect and Pareto diagram. Int. J. Food Sci.Technol. 42, 11561176.

Arvanitoyannis, I.S., Varzakas, T.H., 2007b. Application of failure mode and effectanalysis (FMEA), cause, and effect analysis and Pareto diagram in conjunctionwith HACCP to a potato chips manufacturing plant. Int. J. Food Sci. Technol.,14241442.

Arvanitoyannis, I.S., Varzakas, T.H., 2008. Application of ISO 22000, Failure Mode,and Effect Analysis (FMEA) for industrial processing of salmon: case study. Crit.Rev. Food Sci. Nutr. 48, 411429.

Asao, T., Kumeda, Y., Kawai, T., Shibata, T., Oda, H., Haruki, K., Nakazawa, H., Kozyki,S., 2003. An extensive outbreak of staphylococcal food poisoning due to low-fatmilk in Japan: estimation of enterotoxin A in the incriminated milk andpowdered skim milk. Epidemiol. Infect. 130, 3340.

Bircan, C., Barringer, S.A., Ulken, U., Pehlivan, R., 2008. Aflatoxin levels in dried figs,nuts, and paprika for export from Turkey. Int. J. Food Sci. Technol. 43, 14921498.

Chye, F.Y., Abdullah, A., Ayob, M.K., 2004. Bacteriological quality and safety of rawmilk in Malaysia. Food Microbiol. 21 (5), 535541.

Compton, C.W.R., Rhodes, F.M., McDougall, S., 2008. Consideration of on Farm

Provisions for Raw Milk Production. A Report Prepared for the New ZealandFood Safety Authority. (27.07.12).

DairyCo., 2012. World Milk Production. (19.07.12).

Dawson, D., 2005. Foodborne protozoan parasites. Int. J. Food Microbiol. 103 (2),207227.

Doumith, M., Buchrieser, C., Glaser, P., Jaquet, C., Martin, P., 2004. Differentiation ofthe major Listeria monocytogenes serovars by multiplex PCR. J. Clin. Microbiol.42 (8), 38193822.

Doyle, M.E., 2006. Veterinary Drug Residues in Processed Meats Potential HealthRisk. FRI Briefings Food Research Institute, University of Wisconsin-Madison. (7.06.11).

Ertas, N., Gonulalan, Z., Yildirim, Y., Kum, E., 2010. Detection ofStaphylococcusaureus enterotoxins in sheep cheese and dairy desserts by multiplex PCRtechnique. Int. J. Food Microbiol. 142 (12), 7477.

Food Safety: Information on Foodborne Illnesses (Letter Report, 05/08/96, GAO/RCED-96-96). (7.12.12).

Greig, J.D., Ravel, A., 2009. Analysis of foodborne outbreak data reportedinternationally for source attribution. Int. J. Food Microbiol. 130 (2), 7787.

Guven, K., Mutlu, M.B., Gulbandilar, A., Cakir, B., 2010. Occurrence andcharacterization of Staphylococcus aureus isolated from meat and dairyproducts consumed in Turkey. J. Food Saf. 30 (1), 196212.

Hassan, G.M., Al-Ashmawy, M.A.M., Meshref, A.M.S., Afify, S.I., 2010. Studies onenterotoxigenicBacilluscereus in rawmilkand somedairyproducts. J. Food Saf.39 (3), 569583.

Ibtisam, E.M., Zubeir, El., Mahboba, I.A., 2007. The hygienic quality of raw milkproduced by some dairy farms in Khartoum State, Sudan. Res. J. Microbiol. 2(12), 988991.

McDonough, J.E. 2002. Proactive Hazard Analysis and Health Care Policy. (31.01.11).

Metin M., ztrk, G.F., 2002. Dairy Products Analyse Methods. Ege MeslekYksekokulu Basmevi, Bornova _Izmir.

Muhammad, F., Akhtar, M., Javed, I., Zu-Rahman, J.I., Anwar, M.I., Hayat, S., 2009.Quantitative structure activity relationship, and risk analysis of some heavymetal residues in the milk of cattle and goat. Toxicol. Ind. Health 25 (3), 177

181.Ozilgen, S., Bucak, S., Ozilgen, M., 2011. Improvementof thesafety of thered pepper

spice with FMEA and post processing EWMA quality control charts. J. Food Sci.Technol.. http://dx.doi.org/10.1007/s13197-011-0371-7.

Ozilgen, S., 2012. Failure Mode and Effect Analysis (FMEA) for confectionerymanufacturing in developing countries: Turkish delight production as a casestudy. Cinc. Tecnol. Aliment 32 (3), 110.

Papademas, P., Bintsis, T., 2010. Food safety management systems (FSMS) in thedairy industry: a review. Int. J. Dairy Technol. 63 (4), 489503.

Republic of Turkey Ministry of Economy, Turkey Becomes Worlds 15th BiggestMilk Producing Country. Republic of Turkey Ministry of Economy (22.07.12).

Salama, A.K., Radwan, M.A., 2005. Heavy metals (Cd, Pb) and trace elements (Cu, Zn)contents in some foodstuffs from the Egyptian market. Emirates J. Agric. Sci. 17(1), 3442.

Scipioni, A., Saccarola, G., Centazzo, A., Arena, F., 2002. FMEA methodology design,implementation and integration with HACCP system in food company. FoodControl, 495501.

Skandamis, P.N., Yoon, Y., Stopforth, J.D., Kendall, P.A., Sofos, J.N., 2008. Heat and

acid tolerance of Listeria monocytogenes after exposure to single and multiplesublethal stresses. Food Microbiol. 25 (2), 294303.

Toldr, F., Reig, M., 2006. Methods for rapid detection of chemical and veterinarydrug residues in animal foods. Trends Food Sci. Technol. 17, 482489.

Turkish Food Codex, 2008. Gida Maddelerindeki Bulasanlarin Maksimum LimitleriHakkinda Teblig, Resmi Gazete: 17.05.2008-26879.

World Health Organization, WHO, 2007. Food Safety and Foodborne Illness. http://www.who.int/mediacentre/factsheets/fs237/en/index.html (18.07.12).

World Health Organization, WHO, 2008. Hazard Analysis and Critical Control PointGeneric Models for Some Traditional Foods A Manual for the EasternMediterranean Region. (18.04.12).

Younes, M., Galal-Gorchev, H., 2000. Pesticides in drinking watera case study.Food Chem. Toxicol. 38, 8790.

http://www.foodsafety.govt.nz/elibrary/industry/Consideration_Farm-Identifies_Known.pdfhttp://www.foodsafety.govt.nz/elibrary/industry/Consideration_Farm-Identifies_Known.pdfhttp://www.dairyco.org.uk/datum/milk-supply/milk-production/world-milk-production.aspxhttp://www.dairyco.org.uk/datum/milk-supply/milk-production/world-milk-production.aspxhttp://fri.wisc.edu/briefs/FRIBrief_VetDrgRes.pdfhttp://www.gpo.gov/fdsys/pkg/GAOREPORTS-RCED-96-96/html/GAOREPORTS-RCED-96-96.htmhttp://www.gpo.gov/fdsys/pkg/GAOREPORTS-RCED-96-96/html/GAOREPORTS-RCED-96-96.htmhttp://www.fmeainfocentre.com/handbooks/HazardAnalysis.pdfhttp://www.fmeainfocentre.com/handbooks/HazardAnalysis.pdfhttp://dx.doi.org/10.1007/s13197-011-0371-7http://www.tcp.gov.tr/english/habere.cfm?haberkodu=1101013http://www.tcp.gov.tr/english/habere.cfm?haberkodu=1101013http://www.who.int/mediacentre/factsheets/fs237/en/index.htmlhttp://www.who.int/mediacentre/factsheets/fs237/en/index.htmlhttp://www.emro.who.int/ceha/pdf/E-HACCP.pdfhttp://www.emro.who.int/ceha/pdf/E-HACCP.pdfhttp://www.who.int/mediacentre/factsheets/fs237/en/index.htmlhttp://www.who.int/mediacentre/factsheets/fs237/en/index.htmlhttp://www.tcp.gov.tr/english/habere.cfm?haberkodu=1101013http://www.tcp.gov.tr/english/habere.cfm?haberkodu=1101013http://dx.doi.org/10.1007/s13197-011-0371-7http://www.fmeainfocentre.com/handbooks/HazardAnalysis.pdfhttp://www.fmeainfocentre.com/handbooks/HazardAnalysis.pdfhttp://www.gpo.gov/fdsys/pkg/GAOREPORTS-RCED-96-96/html/GAOREPORTS-RCED-96-96.htmhttp://www.gpo.gov/fdsys/pkg/GAOREPORTS-RCED-96-96/html/GAOREPORTS-RCED-96-96.htmhttp://fri.wisc.edu/briefs/FRIBrief_VetDrgRes.pdfhttp://www.dairyco.org.uk/datum/milk-supply/milk-production/world-milk-production.aspxhttp://www.dairyco.org.uk/datum/milk-supply/milk-production/world-milk-production.aspxhttp://www.foodsafety.govt.nz/elibrary/industry/Consideration_Farm-Identifies_Known.pdfhttp://www.foodsafety.govt.nz/elibrary/industry/Consideration_Farm-Identifies_Known.pdf

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