Safety Science 55 (2013) 195206

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Safety Science
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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
b

Scientic and Technological Research Council of Turkey, MRC Food Institute, 41470 Gebze, Turkey
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:
FMEA
Dairy 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 a
major problem all around the world. Systematic risk control at each stage of the process is required to minimize or eliminate failures in the manufacturing process. The quantitative risk analysis method, Failure
Mode and Effect Analysis (FMEA), was applied for the risk analysis of six dairy products that are widely
consumed in Turkey. Comprehensive real data collected 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 processes were identied 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 total
risk priority number was calculated for the biological failures, which were followed by the chemical failures in all processes. Physical failures were found to pose the lowest risk. Failures were commonly
observed 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 that
implementing the FMEA methodology in dairy industry will decrease the possibility of failure noticeably
in all the manufacturing processes studied. Results of this study can be used by the manufacturers in different 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 the worlds 15th biggest producer of milk, and therefore
has a noticeable share in the 695 million tons of annual worldwide
milk production (Papademas and Bintsis, 2010; Republic of Turkey
Ministry of Economy). Cows milk accounts for 92.36% of the total
milk production in Turkey. Global cows milk production in 2010
was approximately 600 million tons while Turkey was the 10th largest cows milk producer in the world, accounting for 2.1% of world
production by producing over 12 million tons. In 2010, milk production increased four-fold compared to the previous year, and approximately 13 million tons of milk was produced in Turkey (Republic of
Turkey Ministry of Economy; DairyCo, 2012). In conjunction with
the increase in milk production, Turkeys exports of dairy products
increased by 89.26% in the last 5 years, while the exports of dairy
products reached $168.86 million in 2010 (Republic of Turkey Ministry of Economy). The high share of Turkish dairy products in the national and international food market increases the signicance of the
quality and safety of the products. Commercial dairy production is a
complex industry. Processing, sanitation, and storage methods, hu Corresponding author. Tel.: +90 216 5780861.
E-mail address: sozilgen@yeditepe.edu.tr (S. Ozilgen).
0925-7535/$ - see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ssci.2013.01.009

man involvement, as well as the types of equipment that are incorporated into the production process vary from producer to producer
depending on the production capacity, and the types of products
produced. For example, milking process can vary from simple hand
milking to highly complex automated milking, heating process can
vary from batch heat treatment to continuous heat treatment, or
cleaning process can vary from hand cleaning to highly automated
cleaning depending on the production capacity, and the types of
products produced. However, satisfying high safety standards is a
common requirement for all processes since milk and milk products
are perishable food products. According to World Health Organization (WHO), food-borne diseases are widespread and becoming
increasingly serious threats for both developed and undeveloped
countries all over the world. In 2005, 1.8 million people died from
diarrheal 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 biologically originated food-borne disease outbreaks in the world (Greig
and Ravel, 2009; Hassan et al., 2010). In 1985, an estimated of
200,000 total people, with 16,000 laboratory-conrmed cases,
contracted salmonellosis from contaminated pasteurized milk
distributed by one dairy plant in the Chicago area (Food safety,
2012). Similarly, 13,420 people got sick from food poisoning after

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

consuming contaminated skim milk and yogurt prepared with milk

powder in Japan (Asao et al., 2003). One of the recent studies showed
the urgent need to implement quality control programs, in dairy
processing, in Sudan since potential health hazards were concluded
in the research (Ibtisam et al., 2007). Ertas et al. (2010) isolated
Staphylococcus aureus, one of the most common agents in bacterial
food poisoning outbreaks, and staphylococcal enterotoxins from
the sheep cheese and dairy dessert samples collected in Kayseri in
Turkey. The safety and suitability of dairy foods for human consumption must be ensured through the implementation of proper
hygienic 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 signicantly in operation. In HACCP, the
primary purpose is controlling the process at critical control points
to 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 eliminate
potential failures associated to each stage of the process before
they enter to the next stage. It has been widely used by manufacturing companies for quality and safety assurance, addressing customer and governmental requirements, quality control and safety.
In recent studies, the method has been successfully employed for
risk analysis in numerous food processes such as, strudel manufacturing, production of potato chips, Turkish delight manufacturing,
powdered red pepper processing, and industrial processing of salmon (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 into
steps, and then detects the potential failures at each step. Quantitative evaluation of the risks is the main advantage of the FMEA
methodology, over the other risk analysis method. In the FMEA
methodology, potential risks of the processes are detected and assessed in every step by assigning values for frequency of each failure (O), seriousness of the failure (S) and possibility to detect the
failure (D) before consumption. A Risk Priority Number (RPN) is
calculated for each failure mode by multiplying the three determined values (O  S  D). Corrective actions are suggested for potential failures that have an RPN value larger than the selected
threshold value to reduce and eliminate the potential failures from
the system.
This study applies the FMEA methodology for quantication of
risk analysis in manufacturing processes of six widely consumed
dairy products in Turkey. The major signicance of this study is
that comprehensive real data collected from 75 audits carried out
in thirty dairy factories were used to implement the FMEA method
in dairy food manufacturing. Results from this study may help
manufacturers from different parts of the world in producing safer
dairy products, since almost all dairy products share common
manufacturing stages.

2. Materials and methods

Data were collected through 75 food safety providing system
(FSPS) audits that were carried out in thirty Turkish dairy companies between 2006 and 2011. Buttermilk, ker, yogurt, string
cheese, plaited cheese, and hard cheese processes were inspected
during the audits. Both eld controls and documentation controls
were carried out during the visits. The audits were carried out by
qualied food safety auditor in ve different areas: (1) adequacy
of the food safety programs, (2) pest control, (3) operational methods and personnel practices, (4) maintenance for food safety, and

(5) cleaning practices. A standard questionnaire and a check list

compiled from Turkish Food Codex, Hazard Analysis and Critical
Control Point system (HACCP), ISO 22000 food safety management
system (FSMS), British Retail Consortium (BRC) and International
Food Standard (IFS), was used to collect the data. Questions,
regarding the ve different areas, used in the questionnaire included the followings: Is ambient temperature controlled? Is the
staff trained on food safety at an appropriate level to pursue their
jobs? Is there adequate pest control? Are foods covered and date
marked? Is there a written cleaning and disinfection program in
operation? The data collected by the audits were used to develop
the FMEA methodology for each product.
The process food ow diagram for each dairy product was prepared based on the most common processes observed for the same
product during onsite visits (Figs. 1 and 2). Possible failure modes
in the process were identied and the potential hazards for each
failure mode were assessed based on the documentations collected
through the audits. The risk levels of the potential failures were
identied by calculating a Risk Priority Number (RPN) from three
variables: Frequency of occurrence for each failure (O), severity
of the failure (S), and possibility of detecting the failure (D); to
identify the risk level of each potential failure. The frequency of
occurrence for each failure mode was identied on a scale of 1
10, with higher ratings indicating a greater probability of failure.
The possibility of detecting the failure prior to consumption and
the severity of the failure to the consumer were also rated on a
scale 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 from
the documentations collected through the audits. The S values
were predicted from the similar studies in the literature. The risk
priority numbers were calculated by multiplying the values of
the variables O, S, and D. Possible corrective actions were suggested for each potential failure mode with risk priority numbers
higher 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
condence of 90%. At these points, the RPNs were recalculated to
understand the inuence of corrective actions on the improvement
of the process (Tables 13).
Sample Pareto graphs were constructed for yogurt manufacturing process by following the same procedure as Arvanitoyannis
and Savelides (2007) and Ozilgen et al. (2011) to visualize the percent contribution of the RPN of each stage to that of the total process before and after implementing the corrective action (Fig. 3).

3. Results and discussions

The most common failure modes detected during the audits, the
RPN values for each failure mode, and the improvements after
implementing the suggested corrective actions are given in Tables
13 for the manufacturing of each dairy product. The highest total
risk priority numbers were calculated generally for the biological
failures, 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, pretreatment was required to minimize or eliminate the risks associated
to raw milk before it was used in the process of other dairy products.
Some of the raw milk samples collected from companies did not
satisfy the requirements to produce safe dairy products. Some
companies preferred to own the farm and produce their own milk
whilst 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 quality of raw milk (Table 1). Unsanitary milking conditions and

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

197

Fig. 1. Process ow diagrams for, (a) milk pretreatment process, (b) pretreatment process for yogurt, ayran and ker productions, (c) pretreatment process for string cheese,
plaited cheese, and hard cheese.

unhealthy animals are the main sources of pathogenic microorganisms such as Staphylococcus ssp., Streptococcus ssp., Campylobacter
spp., Listeria monocytogenes, Escherichia coli, Mycoplasma spp.,

Mycobacterium tuberculosis, Cryptosporidium, Cyclospora, and Toxoplasma in raw milk. These pathogenic microorganisms may have
negative effects on human health if they exist in foods products

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

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

Table 1
A review of FMEA analysis and implementation of corrective actions for dairy products: physical hazards.

RPN

Corrective actions

RPN after
corrective
actions

Process, Processing stage that the potential risks were observed

Physical contaminants or small pieces

from the packaging materials and/or
lids
Rusty metal particles from the air
ventilation channels
Physical impurities from impure salt
and/or milk powder

180

36

140

30

120

10

Contamination due to improper

practices during the process

120

Supplier must be reliable. Staff training is required.

Quality control of packaging materials and lids must be
done periodically
Periodical maintenance and control of ventilation
system are required
Supplier must be reliable. Samples from each batch
must be dissolved in water during receiving to ensure
the purity
Staff training is required. Protective gears (bone, gloves,
arm covers, etc.) must be provided and used. Personnel
hygiene and practices must be strictly controlled

40

Foreign materials from the

environment

120

30

Teon coating particles from the

blanching equipment
Foreign materials from the transferring
equipments (boxes, cars, etc.)

120

Proper cleaning procedure must be applied.

Environment must be free from waste and pests. The
sanitary conditions of the surroundings must be
controlled regularly
Approved maintenance procedure must be followed

Ayran and ker production, Filling, Closing; Yogurt production, Filling,

Closing; Hard cheese production, Packaging; Plaited and string cheese
production, Packaging
Yogurt production, Incubation; Hard cheese production, Resting, Cold
storage 1; Plaited and string cheese production, Cold storage 1
Yogurt, ker and ayran pretreatment,b Dry matter adjustment; Hard
cheese group pretreatment,c Blanching and kneading (both wet and dry);
Plaited and string cheese production, Resting
Ayran and ker production, Filling and closing; Yogurt production, Filling,
Closing, Transportation for sharp cooling; Hard cheese group pretreatment,
CaCl2 addition, Enzyme addition, Curding, Blanching and kneading, Portioning;
Hard cheese production, Molding, De-molding and shape cutting, Packaging;
Plaited and string cheese production, Plaiting, Resting, Packaging,
Transportation for packaging
Yogurt production, Incubation, Transportation for sharp cooling; Plaited
and string cheese production, Cold storage 1, Transportation for packaging

40

120

30

Metal, glass or plastic particles from the

ingredient containers (i.e. containers
of the cream, culture)

96

Proper cleaning procedure must be applied. The

sanitary conditions of the equipments must be
controlled regularly
Not required

Impurities due to inadequate

clarication
Inadequate ltration caused by torn or
damaged ltration equipment
Metal pieces from the worn mixing
pedals
Physical contaminants in raw milk due
to improper handling and
agricultural practices (glass, metal,
insect parts, etc.)
Plastic particles from the damaged
equipment (plastic measuring caps,
plastic drainer, etc.)
Physical contamination from torn or
damaged ltration equipment
Glass particles from the lamps of the
lling machine
Foreign particles, such as sponge parts
and bers from the cleaning
materials used for measuring cups

90

Not required

72

Not required

72

Not required

60

Not required

60

Not required

48

Not required

Milk pretreatment, Filtration

36

Not needed

Ayran and ker production, Filling and closing

36

Not required

Hard cheese group pretreatment, Blanching and kneading (both wet and
dry)
Hard cheese production, Transportation packaging; Plaited and string
cheese production, Cold storage 1, Transportation for packaging
Yogurt, ker and ayran pretreatment, Milk fat adjustment; Yogurt, ker
and ayran pretreatment, Dry matter adjustment; Yogurt, ker and ayran
pretreatment, Culture inoculation; Yogurt production, Culture inocculation;
Hard cheese group pretreatment, Culture inocculation
Milk pretreatment,a Clarication
Milk pretreatment, Filtration

Ayran and ker production, Mixing; Yogurt production, Mixing; Hard

cheese group pretreatment, Curd cutting
Milk pretreatment, Receiving of raw milk

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

a
b

Common failures and cause

Hard cheese group pretreatment, Blanching and kneading (both wet and
dry), CaCl2 addition, Enzyme addition

Hard cheese group pretreatment, CaCl2 addition, Enzyme addition

Milk pretreatment: common process for all dairy products.

Yogurt, ker, ayran pretreatment: common process for yogurt, ayran, and ker productions.
Hard cheese pretreatment: common process for hard cheese, plaited and string cheese productions.

199

Common failures and cause

Veterinary drug residues in milk due to

improper veterinary practices
High level of aatoxin in milk due to
improper agricultural practices and
from contaminated feed that are used
on the eld
Migration of chemicals from the
packaging materials

200

Table 2
A review of FMEA analysis and implementation of corrective actions for dairy products: chemical hazards.
RPN after
corrective
actions

Process, Processing stage that the potential risks were observed

32

Milk pretreatment,a Receiving of raw milk

32

Milk pretreatment, Receiving of raw milk

Supplier must be reliable. Food grade materials must only be

used. Quality control of packaging materials must be done
periodically
Supplier must be reliable. Food grade materials must only be
used. Quality control of packaging materials must be done
periodically
Supplier must be reliable. Food grade materials must only be
used. Quality control of sealing materials must be done
periodically
Staff training is required. Hand sanitizers must be placed
away from the packaging lines

80

80

80

Ayran and ker production, Filling and closing; Yogurt

production, Filling; Hard cheese production, Packaging; Plaited
cheese and string cheese, Packaging
Ayran and ker production, Filling and closing; Yogurt
production, Filling; Hard cheese production, Packaging; Plaited
cheese and string cheese, Packaging
Ayran and ker production, Filling and closing

70

Hard cheese production, Packaging; Plaited cheese and string

cheese production, Packaging

Periodic analysis must be carried out for verication. A

suitable ltration system i.e., reverse osmosis must be used
when necessary. Approved maintenance procedure must be
followed
Calibration of scales used for measuring the weight is
required. Staff must be trained on proper practices. Periodic
preservative analysis must be carried on for verication
Supplier must be reliable. Alkaline analysis must be carried
out for each batch

48

48

72

Yogurt, ker and ayran pretreatment,b Dry matter adjustment;

Hard cheese group pretreatment,c Blanching and kneading
(both wet and dry); Plaited cheese and string cheese
production, Resting
Hard cheese group pretreatment, Dry blanching and kneading;
Hard cheese cheese production, Packaging; Plaited cheese and
string cheese production, Packaging
Milk pretreatment, Receiving of raw milk

48

80

Proper cleaning procedure must be applied. Periodic pH and/

or electrical conductivity tests must be carried out regularly in
nal rinsing water

42

168

Proper cleaning procedure must be applied. Periodic pH and/

or electrical conductivity tests must be carried out in nal
rinsing water of the process. Detergents and sanitizers must
be stored in a separate area to foods

14

168

Periodic analysis must be carried out for verication. A

suitable ltration system i.e., reverse osmosis must be used
when necessary. Approved maintenance procedure must be
followed

42

RPN

Corrective actions

392

360

Supplier must be reliable. Antibiotics analysis must be carried

out for each batch with antibiotic kits
Supplier must be reliable. Total aatoxin analysis must be
carried out for each batch with aatoxin kits

320

Heavy metal residues from the packaging

material

320

Heavy metal residues from the seal

320

Contamination from the hand sanitizers

that is placed close to the packaging
lines
Heavy metal residues from water
(arsenic, antimony, boron, cadmium,
chrome, copper, lead, mercury, etc.)

294

288

Excessive use of preservatives (both

direct addition and spraying after
production)
Chemicals residues in raw milk due to
adulteration of raw milk (alkaline
addition)
Contamination from chemical substances
in water (bromate, cyanide,
acrylamide, benzene, etc.)

288

280

224

Pesticide residues in milk from

contaminated feed and/or water
(dioxins, organophosphates, etc.)

192

Detergent and/or disinfectant residue due

to inadequate rinsing of measuring
equipment and utensils after cleaning
(manual cleaning)

175

Detergent and/or disinfectant residue

from the equipment and utensils due
to inadequate rinsing and improper
storage of chemicals (CIP cleaning)

Nitrite, Nitrate contamination from water

Periodic analysis must be carried out for verication. A

suitable ltration system i.e., reverse osmosis must be used
when necessary. Approved maintenance procedure must be
followed
Supplier must be reliable. Periodic pesticide analysis must be
carried out

Yogurt, ker and ayran pretreatment, Dry matter adjustment;

Hard cheese group pretreatment, Blanching and kneading (both
wet and dry); Plaited cheese and string cheese production,
Resting
Milk pretreatment; Receiving, Yogurt, ker and ayran
pretreatment, Dry matter adjustment; Hard cheese group
pretreatment, Blanching and kneading (both wet and dry);
Plaited cheese and string cheese production, Resting
Hard cheese cheese group pretreatment, CaCl2 addition,
Enzyme addition, Blanching and kneading (both wet and dry),
Portioning; Hard cheese production, Molding, De-molding and
shape cutting; Plaited cheese and string cheese production,
Resting
Milk pretreatment, Filtration, Thermisation and cooling,
Clarication, Cold storage; Yogurt, ker and ayran
pretreatment; Fat separation, Dry matter adjustment, Milk fat
adjustment, Homogenization, Pasteurization; Ayran and ker
production, Transportation to the tank, Filling and closing;
Yogurt production, Transportation to the yogurt tank, Filling;
Hard cheese group pretreatment, Pasteurization and Fat
separation, Cold storage, Transportation to production tanks
Yogurt, ker and ayran pretreatment, Dry matter adjustment;
Hard cheese group pretreatment, Blanching and kneading (both
wet and dry); Plaited cheese and string cheese production,
Resting

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

Yogurt, ker and ayran pretreatment, Dry matter adjustment;

Hard cheese group pretreatment, CaCl2 addition, Enzyme
addition, Blanching and kneading (both wet and dry); Plaited
cheese and string cheese production, Resting
40

Milk pretreatment: common process for all dairy products.

Yogurt, ker, ayran pretreatment: common process for yogurt, ayran, and ker productions.
Hard cheese cheese pretreatment: common process for hard cheese cheese, plaited and string cheese productions.
a

10
10
3

150

Staff must be trained on handling and labeling of chemicals.

Label control must be done daily. Foods and chemicals must
be stored separately. Inventory forms must be lled properly

32
2
8
2
160
8
5

Lubricant residues in foods from the

pedals
Mycotoxins from the contaminated
cheeses that are added during the
process
Chemical contaminants due to the use of
empty food containers to store
chemicals and mislabeling of
containers

168

Standard maintenance program must be applied. The food

grade lubricating oils must be used
Periodic analyses of old cheeses must be carried out

40

Ayran and ker production, Mixing; Yogurt production,

Mixing; Hard cheese cheese group pretreatment, Curd cutting
Hard cheese group pretreatment, Dry blanching

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

201

above the legal limits given in the food codex (Arvanitoyannis and
Mavropoulos, 2000; Metin and ztrk, 2002; Chye et al., 2004;
Doumith et al., 2004; Dawson, 2005; Compton et al., 2008; Skandamis et al., 2008; Turkish Food Codex, 2008; Guven et al., 2010).
The health effects of consuming these microorganisms may range
from mild symptoms to death. With such serious health risks, simple controls might not be enough to prevent the failures in raw
milk unless a series of control measures and corrective actions
are applied. In company pathogen analysis during receiving of
raw milk is not a practical task for companies. It requires time
demanding microbiological tests, as raw milk has to be processed
immediately after its receipt. In addition, in-company analysis
can be risky for the company if the sterile conditions are not provided in their own laboratories. Therefore, implementation of preventive control measures from farm to receiving of raw milk by the
company was suggested as a better solution to decrease the risk of
pathogen contamination in raw milk. Educating the farmers on
food safety, proper handling, hygiene, and sanitation practices,
improvement in the sanitary conditions of the milking environment and equipment, immediate cold storage of milk in double
walled steel tanks after milking, and heat treatment processes,
maintaining cold chain during on-eld storage, transportation of
milk to the plant, and upon receipt by the plant, and regular veterinary controls on eld were the most common preventive actions
suggested to ensure the sanitary quality of raw milk (Table 1).
Increased acidity can be the indication of microbial growth in
milk, but, acidity measurement in raw milk during its receipt is
not a guarantee for pathogen-free milk, since not all pathogens increase the acidity of the medium. Alkaline substances such as baking soda, bleach, and hydrogen peroxide, were detected in some of
the raw milk samples collected from the companies. These chemicals were used by milk collectors and/or farmers either to decrease
the acidity of the milk or as microbiological preservatives. Electrical conductivity testing together with somatic cell counting and
acidity measurement during receipt was recommended for each
batch of raw milk to avoid raw milk adulteration (Table 1).
Although the processes were automated, intensive human
involvement was observed at several production stages of some
dairy products. For example, in ayran and ker production, the
cups and the lids were fed to the lling lines by the staff. Similarly,
the culture inoculation, ingredient addition, molding and de-molding, plaiting, kneading, and portioning stages of some dairy processes were carried out by staff. Poor personal hygiene, and
improper handling and practices by the staff were observed to be
the most common causes for potential biological failures for the
manufacturing 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 the
potential risks arising from the workers. Adequate changing rooms
and bathrooms, hand washing areas with soap, paper towels, high
quality disinfectant, and hot and cold water were recommended to
ensure a proper degree of personal hygiene for safe food production (WHO, 2008). Transportation between the processing stages,
such as from the processing area to the storage area, or transportation to the storage area after receiving of the product were not
automated and required intensive human involvement in some
companies. Increased time gaps between the stages due to improper manufacturing practice were observed in some production
units. The standardization of the process ow, and staff education
on the procedure were highly recommended for the companies
having this problem at any stage of the process.
Cross contamination was another common potential cause for
biological failures observed during the visits. Improper cleaning
practices and an unsanitary environment were the basic sources
of cross contamination. Clean in Place (CIP) techniques were
mostly applied in the cleaning of closed systems such as pipelines,

202

Table 3
A review of FMEA analysis and implementation of corrective actions for dairy products: biological hazards.
O

RPN

Corrective actions

RPN after
corrective
actions

Process, Processing stage that the potential risks were observed

High number of pathogen (E. coli O157:H7,

Salmonella spp., Mycobacterium
tuberculosis, Shigella dysenteria, etc.) in
milk caused by improper handling

10

720

10

90

Milk pretreatment,a Receiving of raw milk

Pathogenic microorganisms from water

432

36

Yogurt, ker and ayran pretreatment,b Dry matter

adjustment; Hard cheese group pretreatment, Blanching and
kneading (both wet and dry); Plaited cheese and string cheese
production, Resting

Microbiological contamination due to

inappropriate practices

392

Supplier must be reliable. Immediate cooling below 5 C is

required after receiving. Cold chain must be kept from farm to
receiving. The pH and/or acidity controls must be done for
each batch. Periodic pathogen analysis must be done for
verication
Periodic microbiological analysis must be carried out for
verication. Microbiological treatment must be applied to
water by using chemical agents like chlorine, ozone or UV
based systems. Approved maintenance procedure must be
followed
Staff training on personnel hygiene and hand washing is
required. Disinfectants must be supplied from the approved
sources. Personal hygiene must be strictly controlled. Periodic
microbiological analysis must be carried out (swab controls)
for verication

48

Microbial growth due to temperature

abuse during transportation

336

The standard control program must be applied. The

temperature must be controlled properly

84

Contamination due to air coming from the

ventilation channels

336

72

Contamination due to improper sealing of

the covers

320

64

Pathogen contamination from the

contaminated culture and other
ingredients
High number of spoilage microorganisms
in milk due to improper handling before
and during receiving

315

Proper cleaning procedure must be applied. Periodical

maintenance and a ventilation system control are required.
The quality of air must be controlled periodically
Maintenance program on sealing equipments must be applied.
Periodic controls must be done after sealing. Sealing operators
must be trained
Supplier must be reliable. Staff training on proper handling of
cultures and other ingredients is required

72

315

56

Microbial growth caused by inadequate

processing time and/or temperature

10

300

10

40

Yogurt, ker and ayran pretreatment, Pasteurization; Hard

cheese group pretreatment Pasteurization and Fat separation

Contamination from the packaging

materials and/or lids

294

Supplier must be reliable. Immediate cooling below 5 C is

required after receiving. Cold chain must be kept from farm to
receiving. The pH and/or acidity controls must be done for
each batch
The pasteurization process control must be computerized.
Thermometers/probes must be calibrated regularly.
Maintenance procedure must be ensured. Staff must be
trained about food safety and the controlling the system
Supplier must be reliable. Periodic microbiological analysis
must be carried out (swab controls) for verication

Ayran and ker production, Culture inoculation, Filling and

closing; Yogurt production, Culture inoculation, Filling, Closing;
Hard cheese group pretreatment,c Culture inoculation, CaCl2
addition, Enzyme addition, Curding, Blanching and kneading
(both wet and dry), Portioning; Hard cheese production,
Molding, De-molding and shape cutting, Packaging; Plaited
cheese and string cheese production, Plaiting, Resting,
Packaging
Ayran and ker production, Transportation; Yogurt
production, Transportation; Plaited cheese and string cheese
production, Transportation; Hard cheese group
pretreatment, Transportation
Yogurt production, Incubation; Hard cheese production,
Resting, Cold storage 1; Plaited cheese and string cheese
production, Cold storage 1
Ayran and ker production, Filling and closing; Hard cheese
production, Packaging; Plaited cheese and string cheese
production, Packaging
Ayran and ker production, Culture inoculation; Hard cheese
group pretreatment, Culture inoculation,CaCl2 addition,
Enzyme addition; Yogurt production, Culture inoculation
Milk pretreatment, Receiving of raw milk

84

Contamination from the environment

294

Positive pressured air ventilation with hepa-lters must be

installed. Ventilation system and lters must be maintained.
The microbiological quality of air must be controlled regularly

42

Microbiological contamination caused by

inadequate cleaning or improper
storage of equipment and utensils, i.e.,
measuring cups, blades (manual
cleaning)
Microbiological contamination from

288

Proper cleaning procedure must be applied. Periodic

microbiological analysis must be carried out (swab controls)
for verication

64

280

Supplier must be reliable. Periodic microbiological analysis

80

Ayran and ker production, Filling, Closing; Yogurt

production, Filling, Closing; Plaited cheese and string cheese
production, Packaging; Hard cheese production, Packaging
Ayran and ker production, Filling, Closing; Yogurt
production, Filling, Transportation for cooling; Plaited cheese
and string cheese production, Resting, Packaging,
Transportation for packaging; Hard cheese production,
Packaging
Hard cheese group pretreatment, CaCl2 addition, Enzyme
addition, Blanching and kneading (both wet and dry), Curd
cutting, Portioning; Hard cheese production, Molding, Demolding and shape cutting, Packaging; Plaited cheese and
string cheese production, Resting, Cold storage 1, Packaging
Yogurt, ker and ayran pretreatment, Dry matter adjustment

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

Common failures and cause

contaminated chemicals that are used

during processing, i.e., salt and milk
powder
Microbial growth due to temperature
abuse during storage

must be carried out for verication

280

The standard control program must be applied. The storage

room temperature must be controlled properly

84

Ayran and ker production, Cold storage; Yogurt production,

Cold storage; Hard cheese production, Resting, Cold storage 1,
Cold storage 2; Plaited cheese and string cheese production,
Cold storage 1, Cold storage 2
Milk pretreatment, Cold storage

Microbial growth due to improper storage

temperature

252

28

Microbiological contamination caused by

inadequate cleaning of equipment,
utensils or connectors (CIP)

240

The cooler equipped or heat isolated tanks must be employed.

The inner temperature of the tank must be measured
regularly. Thermometers/probes, which are used for
temperature measurements, must be calibrated regularly
Proper cleaning procedure must be applied. Periodic
microbiological analysis must be carried out (swab controls)
for verication

64

Microbial growth caused by improper

process time and/or temperature

240

Microbiological contamination due to

improper storage conditions

240

64

Parasite in water

224

28

Yogurt, ker and ayran pretreatment, Dry matter

adjustment; Hard cheese group pretreatment, Blanching and
kneading (both wet and dry); Plaited cheese and string cheese
production, Resting

Microbial contamination due to mishandling

224

The process control must be computerized. Thermometers/

probesmust be calibrated regularly. Approved maintenance
procedure must be followed. Staff must be trained about food
safety and the controlling the system
Adequate facilities for hygienic storage must be provided.
Proper cleaning procedure must be applied. Periodic controls
(swabs) must be carried out for verication
Periodic microbiological analysis must be carried out for
verication. Microbiological treatment must be applied to
water by using chemical agents like chlorine, ozone or UV
based systems. Approved maintenance procedure must be
followed
Staff training on personnel hygiene and hand washing is
required. Personnel hygiene control must be done regularly

48

Pathogens from contaminated chemical

additives
Isolation of Staphylococcus spp. and
Streptococcus spp. in milk which might
be the indication of animals with
mastitis disease
Parasites (Protozoa Cryptosporidium spp.,
etc.) in milk from unhealthy animal
sources
Microbiological contamination from inplant delivery carts

210

Supplier must be reliable. Brine must be pasteurized regularly

72

Yogurt production, Transportation for sharp cooling; Plaited

cheese and string cheese production, Transportation for
packaging
Plaited cheese and string cheese production, Resting

200

Periodic veterinary controls on elds are required. Somatic cell

count must be done regularly

32

Receiving of raw milk, milk pretreatment

192

80

Receiving of raw milk, milk pretreatment

192

64

Yogurt production, Filling

Microbiological contamination (E. coli

O157:H7, Shigella spp., Salmonella spp.)
form pests, such as ies
Microbiological contamination from the
cream containers

189

Supplier must be reliable. Parasite analysis must be carried

out regularly. Periodic veterinary controls on elds are
required
Proper cleaning procedure must be applied. Periodic
microbiological analysis must be carried out (swab controls)
for verication
The milk receiving facility must be isolated. Effective pest
control management is required

54

Milk pretreatment, Filtration

168

64

Yogurt, ker and ayran pretreatment, Milk fat adjustment

Mold growth due to inadequate moisture

removal

168

48

Hard cheese production, Resting

Microbiological contamination due to

inadequate cleaning of equipment
(manual cleaning)
Microbiological contamination from
improperly sealed mixing pedals

160

Cleanliness of containers must be controlled. Periodic

microbiological analysis must be carried out (swab controls)
for verication
Special equipment must be used for hard cheese blocks to
improve moisture removal. Hard cheese blocks must be
turned upside-down periodically
Proper cleaning procedure must be applied. Periodic
microbiological analysis must be carried out (swab controls)

32

Milk pretreatment, Filtration

112

Standard maintenance program must be applied

42

Ayran and ker production, Mixing; Yogurt production,

Mixing

Milk pretreatment, Thermisation, Cooling, Filtration; Yogurt,

ker and ayran pretreatment, Fat separation, Dry matter
adjustment, Milk fat adjustment, Homogenization,
Pasteurization; Yogurt production, Transportation to the tank,
Filling; Hard cheese group pretreatment, Pasteurization and
Fat separation, Transportation to production tanks; Ayran and
ker production, Transportation to the tank, Filling and closing
Milk pretreatment, Thermisation and Cooling; Yogurt, ker
and ayran pretreatment, Cooling; Hard cheese group
pretreatment, Cold storage, Blanching and kneading (both wet
and dry)
Milk pretreatment, Cold storage

203

(continued on next page)

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

Milk pretreatment: common process for all dairy products.

Yogurt, ker, ayran pretreatment: common process for yogurt, ayran, and ker productions.
Hard cheese pretreatment: common process for hard cheese, plaited and string cheese productions.

Not required
84
7
6

Not required
90
9
5

8
3

96

Not required

Ayran and ker production, Incubation in tanks, Yogurt

production, Incubation
Milk pretreatment, Filtration

Milk pretreatment, Clarication

24
6
6
6

Microbial growth due to environmental

temperature uctuation during the
process
Microbiological contamination caused by
inadequate cleaning
Growth of pathogens due to inappropriate
incubation temperature
Microbiological contamination from
inappropriate cleaning materials (i.e.,
sponge)

108

Staff training is required. Standard food ow directives must

be obeyed

24
2
6
2
Staff training is required. Standard food ow directives must
be obeyed
108
6
6
Microbial growth due to increased time lap
between processes

RPN after
corrective
actions
D
S
O
Corrective actions
RPN
Table 3 (continued)

S
O
Common failures and cause

Ayran and ker production, Filling to closing; Yogurt

production, Closing to cold storage; Hard cheese production,
Packaging to cold storage; Plaited cheese and string cheese
production, Packaging to cold storage
Hard cheese production, De-moulding and shape cutting

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

Process, Processing stage that the potential risks were observed

204

pasteurization equipment, and storage and process tanks. Manual

cleaning techniques were mainly used for small utensils and
equipment. The biological failure risk was higher in manual cleaning compared to the CIP technique, since it required more human
involvement. Educating staff on using proper cleaning agents and
applying proper cleaning procedures was the main corrective action suggested that addresses the potential failures from improper
cleaning practices. The quality of environmental air was commonly
neglected, but it was a very important factor concerning the safety
of food products. Precautions were suggested to control the quality
of air at different stages of the process (Table 1). Some processes
such as ltration of raw milk, the lling and closing stages of yogurt manufacturing, and the resting and packaging stages of
cheeses 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 in
open processes (Table 1). Sanitary conditions of packaging materials and lids were suggested to be controlled regularly to avoid
cross contamination since failures were observed in several production units.
Temperature control was detected as another critical reason for
potential biological failures at a number of stages. Inefcient heat
processing and improper or uctuating storage and transportation
temperatures were the most common reasons for this failure. Heat
processing parameters and storage and transportation conditions
may show variations depending on the type of the product and
the purpose of the process. Corrective actions were suggested considering the nature of the products produced and the purpose of
the heating process (Table 1).
Insufcient heat application during sealing, sealing machine
malfunction, use of unsuitable covers, and operator mistakes were
observed to cause improper package sealing of some dairy products;
which may result in post-process contamination (Table 1). Post process contamination is difcult to be controlled by the producers
when the product is distributed for sale. Food spoilage caused by improper sealing is usually detected by the consumers. Failures must
be eliminated from the process by applying proper preventive actions before the product reaches the consumer (Table 1).
The total risk priority number was found to be the second highest for the chemical failures. Veterinary drugs that were used to
treat the animals and improve their health were the major potential chemical hazards found in raw milk. Aatoxin and pesticide
residues were the other most common failures in raw milk obtained from the animals fed with contaminated feed. Contact surfaces of the foods, such as packaging materials and seals, were
detected as a potential source of chemical contamination through
migration into foods for the companies that were using nonfoodgrade materials in their productions (Table 2).
Antibiotics are the most common veterinary drugs used in animal care. The presence of antibiotic residuals in foods obtained
from animals is an important health threat since it leads to increased microbial resistance in human in latest years. Allergic reactions and a decrease in the total numbers of useful bacteria in the
human 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 carcinogenic effects on humans. Trembling, headaches, and depression are the other symptoms reported after consuming meat
contaminated with growth promoters (Doyle, 2006). The use of
substances having hormonal action is banned in many countries.
Prolonged exposure to pesticides can result in cancer of the soft tissue, brain, lung, liver, digestive system and urinary tract; as well as
birth defects, and damage to the nervous systems (Younes and Galal-Gorchev, 2000). Heavy metals are mostly not biodegradable and
therefore can accumulate in the vital organs of humans. They may
cause neurological disorders, Alzheimers, Parkinsons disease,

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

205

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

cancer, and low birth weight in humans if the consumption exceeds the legal levels given in the food codex (Salama and Radwan,
2005; Muhammad et al., 2009). Some biological toxins are real
threats 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 recommended addressing the potential chemical contamination risk in
dairy products. Approved suppliers have an appropriate food safety
program in place and they are primarily responsible for providing
safe and consistent quality of raw ingredients to the companies.
Antibiotics and aatoxin analysis in each batch of raw milk using
special kits was the other preventive action recommended since
it is a rapid and cost effective method for companies of all sizes.
Implementation of proper water treatment procedures were observed to be essential for the companies that were using wells to
supply 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 additives were observed as potential failure risks at different stages
of production of dairy products. Corrective solutions, particularly
staff education were recommended for each specic case to completely remove the risk from the processes (Table 2).
Physical failures were found to pose the lowest risk for all
manufacturing processes. Improper operating and maintenance
procedures were the common causes for potential physical contamination risks at the stages that posed those risks (Table 3).
Generally speaking, failures were commonly observed in companies that were applying obsolete technologies, such as the ones
practicing hand milking as opposed to ones using milking machines, using intensive human handling, and employing staff members that have no food processing and hygiene training.
Implementing all of the recommended corrective actions and
changing the whole process at once is a difcult and costly transition for the producers. Therefore, each company agreed to initially

206

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

apply the corrective actions that would help them satisfy the minimal legal requirements in producing safe foods. Since most companies applied a different combination of corrective actions, it
was possible to observe the remedial effects of different corrective
actions on the different stages of the processes. Therefore, for the
purpose of this study, risk priority numbers were calculated for a
new risk situation assuming all suggested corrective actions were
theoretically applied to the same dairy manufacturing process (Tables 13). The RPN values appeared to have reduced noticeably for
all processes after undertaking the suggested corrective actions.
Hence, implementing FMEA methodology in dairy industry decreased the possibility of failure in the manufacturing processes,
reduced the cost of production, and eliminated large changes in
the process during manufacturing. The results of this study significantly highlight the importance of systematic control at each stage
of the process to minimize or eliminate risks in dairy food
production.
4. Conclusion
The main purpose of the FMEA application was to quantify the
risk analysis by determining the RPN values for each potential processing hazard in processing of dairy products. The results indicated that biological failures were the major risks with the
highest RPN followed by the chemical failures in all dairy manufacturing processes. Failures were commonly observed in companies
using the obsolete technologies, using intensive human handling,
and employing staff members that have no previous food processing 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 those
actions appeared to have reduced the RPN values below the
acceptable limit of 100. Our results clearly show the importance
of incorporating a good systematic preventive method for risk
management in the dairy manufacturing industry. The results from
this study might help large number of dairy product manufacturers
in producing safe products since the study provides comprehensive
real data collected from 75 audits carried out in thirty dairy factories, and almost all dairy products share common manufacturing
stages.
Acknowledgment
We acknowledge the support from the Scientic and Technological Research Council of Turkey, MRC Food Institute throughout
the study.
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