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FOODBORNE PATHOGENS AND DISEASE
Volume 10, Number 1, 2013
ª Mary Ann Liebert, Inc.
DOI: 10.1089/fpd.2012.1286

Food Safety Systems in a Small Dairy Factory:

Implementation, Major Challenges,
and Assessment of Systems’ Performances

Sueli Cusato,1 Augusto H. Gameiro,2 Carlos H. Corassin,1 Anderson S. Sant’Ana,3

Adriano G. Cruz,4 José de Assis F. Faria,4 and Carlos Augusto F. de Oliveira1

Abstract
The present study describes the implementation of a food safety system in a dairy processing plant located in the
State of São Paulo, Brazil, and the challenges found during the process. In addition, microbiological indicators
have been used to assess system’s implementation performance. The steps involved in the implementation of a
food safety system included a diagnosis of the prerequisites, implementation of the good manufacturing
practices (GMPs), sanitation standard operating procedures (SSOPs), training of the food handlers, and hazard
analysis and critical control point (HACCP). In the initial diagnosis, conformity with 70.7% (n = 106) of the items
analyzed was observed. A total of 12 critical control points (CCPs) were identified: (1) reception of the raw milk,
(2) storage of the raw milk, (3 and 4) reception of the ingredients and packaging, (5) milk pasteurization, (6 and 7)
fermentation and cooling, (8) addition of ingredients, (9) filling, (10) storage of the finished product, (11)
dispatching of the product, and (12) sanitization of the equipment. After implementation of the food safety
system, a significant reduction in the yeast and mold count was observed ( p < 0.05). The main difficulties
encountered for the implementation of food safety system were related to the implementation of actions es-
tablished in the flow chart and to the need for constant training/adherence of the workers to the system. Despite
this, the implementation of the food safety system was shown to be challenging, but feasible to be reached by
small-scale food industries.

Introduction understanding concerning the benefits provided by the sys-

tem, normally thought of as being limited or of an intangible

T he basis of a food safety system consists of a combi-

nation of good manufacturing practices (GMPs), of the
sanitation standard operating procedures (SSOPs), and of the
hazard analysis and critical control point (HACCP) system
(Bata et al., 2006). Whereas GMP includes a series of basic
procedures and conditions to be adopted to guarantee food
safety and conformity with specific legislation (Anon, 1997),
the HACCP system is a preventive approach that identifies
the critical control points (CCPs) of a production process in
order to control product safety (ICMSF, 1998).
Implementation of the GMPs and SSOPs is a fundamental
prerequisite to make implementation of the HACCP system
feasible (Codex, 2003). A reduced implementation of HACCP
by small to medium sized companies (Taylor, 2003; Ehiri et al.,
1995; Sampers et al., 2012) is due mainly to the lack of a clear
nature (Henson et al., 1999). In addition, since motivation for
implementing HACCP by an industry is directly connected to
the expectations of the costs/benefits related to it (Henson
et al., 1999), adoption of the HACCP system by these indus-
tries is more complicated.
In Brazil, implementation of the HACCP system in small
to medium sized dairy processing unities is of fundamental
importance to public health, since this segment is mainly
composed of a variety of small to medium sized industries
that supply a large proportion of the population. Thus, the
objective of the present study was to report the im-
plementation of a food safety system in a small dairy pro-
cessing plant, to examine the challenges encountered, and to
assess the role of food handlers’ training in the im-
plementation of the system.

1
Department of Food Engineering, Faculty of Zootechny and Food Engineering, University of São Paulo, Pirassununga, Brazil.
2
Department of Nutrition and Animal Production, Faculty of Veterinary Medicine and Zootechny, and 3Department of Food and Experi-
mental Nutrition, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.
4
Department of Food Technology, Faculty of Food Engineering, University of Campinas, Campinas, Brazil.

6
ISSUES FOR IMPLEMENTATION OF A FOOD SAFETY SYSTEM
Materials and Methods
Characteristics of the dairy processing plant
and product chosen for implementation
The study was carried out in a dairy located in the central
region of the State of São Paulo that processed approximately
15,000 L of milk per day. The HACCP system was only im-
plemented for the yogurt production line, taking into account
the specific product-process nature of this system. The list of
ingredients and packaging used in the manufacture of the
skim (0–0.5% fat) and semi-skim (1.5–1.7% fat) yogurt can be
found in Supplementary Table S1 (Supplementary Data are
available online at at www.liebertpub.com/fpd).
Implementation of the food safety systems
Preliminary steps: Diagnosis of the prerequisite programs
and implementation of the GMPs and SSOPs. The first step
of the preliminary procedures involved a meeting with those
in charge of the dairy, in order to present the objectives,
steps to be followed, responsibilities concerning the costs
involved, potential benefits, and difficulties with respect to
implementing the system.
Then, a team was formed that was responsible for coordi-
nating and implementing the corrective measures of GMPs
and HACCP. The HACCP team was formed of food handlers
and was coordinated by the dairy processing plant manager.
The next step was an evaluation of the status of the dairy in
relation to the implementation of the prerequisite programs
(diagnosis). The diagnosis was carried out by way of visits to
the internal and external areas of the dairy, using a check-list
developed by the Brazilian Sanitary Surveillance Agency
(Anon, 2002). The check-list used consisted of 150 questions
contemplating buildings and installations, equipment, furniture
and utensils, food handlers, food production and transport, and
documentation (Anon, 2002). During the initial diagnosis, each
item on the check-list was classified as ‘‘conforming’’ (when the
requisite was fully adhered to), ‘‘not conforming’’ (when the
requisite was partially or not adhered to), or ‘‘not applicable.’’
The percentage of conformities and nonconformities per section
was calculated, and the processing plant was classified based on
the percent of conformity (Anon, 2002).
The HACCP team was responsible for coordinating and
implementing the corrective measures to improve the adap-
tation to the prerequisite programs (GMPs and SSOPs). A
follow-up on the implementation of the prerequisite pro-
grams was carried out, following the preparation of a report
on the initial diagnosis and a flow chart (Dias et al., 2012). The
nonconformities were corrected and re-evaluated in parallel
with the other activities involved in implementation of the
food safety system, as described in Dias et al. (2012).
Preliminary steps: Training of the food handlers. An in-
dividual questionnaire was used concerning the hygiene
habits of the food handlers and their knowledge concerning
GMPs (see Supplementary Table S2). Based on the results
obtained from this questionnaire, a training course was set up
for the current dairy workers for them to acquire the necessary
knowledge by way of descriptive classes, using illustrative
figures and photos of the current conditions of the dairy.
These workers were encouraged to debate the subject and
make critical evaluations with respect to conforming to the
requisites indicated by legislation (Anon, 2002). The training
7
course developed was then presented to current and new
workers so as to make them conscious of the importance of
these tools in the safety of processed products. A total of three
training courses were given, each covering one of the fol-
lowing: GMP, SSOP, and HACCP (Table 1). The changes in
behavior and the difficulties encountered before and during
implementation of the food safety system were observed by
the team responsible, so as to facilitate future actions.
Implementation of the HACCP system in the yogurt pro-
cessing line. In parallel to implementation of the GMPs and
SSOPs, the HACCP system was also implemented for the
yogurt processing line. Thus, the HACCP team worked on the
preparation of the HACCP plan per se, following all the pre-
liminary activities and the application of the seven HACCP
principles as described by Codex Alimentarius (Codex, 1997).
For the hazard analysis (principle 1), in addition to the
hazards and innocuousness of the foods (biological, chemical,
and physical) as described by Codex Alimentarius (Codex,
1997), hazards that caused a loss of quality and/or integrity of
the product according to the Brazilian legislation were also
considered (Anon, 1998). Hazards of physical, chemical, and
microbiological origins that could occur in the yogurt, raw
materials, and processing environment were determined ac-
cording to Forsythe (2002), Walstra et al. (2001), Tamine and
Robinson (1991), and Oliveira et al. (1999). The CCPs of the
process were identified using the decision tree established by
Codex Alimentarius (principle 2) (Codex, 1997), and for each
CCP, critical limits were established based on the literature,
legislation, or expertise of the HACCP team (principle 3). In
some cases, safety limits were established so that the critical
limits were not passed, and CPP monitoring procedures were
established, considering the ease of measurement and speed in
obtaining the results and in correcting deviations. Monitoring
procedures included visual observations, measurements, and
laboratory analyses, and also the frequency of carrying them
out and designation of an employee responsible for them
(principle 4). Corrective actions were established when the
monitoring procedure indicated that the CCPs were out of
control (principle 5). All records generated during the moni-
toring of each CCP and notations of the corrective actions
taken were recorded (principle 6). For this purpose, control
and analysis spreadsheets, already available in the dairy, were
updated and altered, allowing space to note the corrective
actions applied and the name of the person responsible, as
recommended by Mortimore and Wallace (1998).
In addition, HACCP plans were prepared for the yogurt
processed in the factory, known as ‘‘HACCP for yogurt pro-
cessing,’’ containing the following information: presentation of
the company, product description and expected use, product
identification, ingredients and type of package, study of haz-
ards, production flow chart with identification of the CCPs,
description of the processing steps, control plan for the CCPs,
and a summary of the plan. The HACCP manual allowed for
an overview of the HACCP plan and was used as supporting
material during auditing. The principle of verification (prin-
ciple 7) considered the following: revisions of the processing
flow chart, the critical limits, the records and the monitoring
measurements, assessment of deviation from the critical limits,
and microbiological analyses of the final products. The inter-
val for verification was generally 30 days, which could be in-
creased with consolidation of implementing the HACCP plan.
8 CUSATO ET AL.

Table 1. Themes and Sub-Themes from the Training of GMP, SSOP, and HACCP Given
to Employees from the Dairy Industry

Themes Sub-themes

GMP 1. Definition of the production chain—from the farm to final consumer

2. Definition of food safety and contamination
3. Types of contamination
4. Importance of microbiological contamination
5. Definition and symptoms of foodborne diseases
6. Optimal conditions for the growth of microorganisms
7. Contamination by microorganisms—elimination, inhibition, prevention
8. Definition of GMP
9. Where to apply the principles of GMP—personal hygiene, environment, equipment
10. Habits for the correct handling of foods
11. Benefits of GMP—food safety, longer shelf-life, reduced losses, better working environment,
consumer satisfaction
12. Need to change the behavior and commitment of all employees
SSOP 1. Definition of SSOP/work instructions
2. Importance of hygiene—how to avoid contamination
3. Types of surfaces to be cleaned and cleaning agents
4. Conditions for an effective cleaning—water temperature, solution concentration, exposure time,
mechanical action
5. Phases of the hygiene process—pre-rinsing, detergent solution, rinsing, sanitizing
6. Presentation of work instructions
HACCP 1. Review of some concepts—supply chain, food safety, types of contamination
2. Contamination—how to avoid it
3. HACCP—definition, brief history
4. Principles of HACCP
5. Study of the hazards in a dairy industry
6. Flowchart of the yogurt production
7. Identification of the CCPs and their critical limits
8. Methods of monitoring
9. Records—importance of the correct completion
10. Benefits of HACCP

GMP, good manufacturing practice; SSOP, sanitation standard operating procedure; HACCP, hazard analysis and critical control point;
CCPs, critical control points.

Indicators used in the implementation
of food safety systems
A total of 319 samples of yogurt were analyzed for yeasts
and molds, and total and fecal coliforms. These microbial
groups were used to indicate the hygienic quality and shelf
life of the yogurt. The yeast and mold, and total and fecal
coliforms counts (colony-forming units [CFU]/g) were car-
ried out using the methodologies recommended by the Na-
tional Animal Reference Laboratory of the Brazilian Ministry
of Agriculture (LANARA, 1981).
Statistical analysis
The results obtained in the microbiological analyses were
checked for statistical differences between the period before and
after implementing the HACCP system. Analysis of variance
and the t-test were used for comparison of means, adopting a
level of rejection of a = 0.05 (Gacula and Singh, 1984).
Results
Assessment and implementation
of the GMPs and SSOPs
In the initial diagnosis for implementation of the GMPs,
conformity of 70.7% with legislation was observed for the
items analyzed (Table 2) (Anon, 2002). The item ‘‘food han-
dlers’’ presented the highest percentage of conformity
(85.7%; n = 12), whereas the item ‘‘record keeping’’ presented
the lowest value (15.4%; n = 2). Table 3 shows the main
nonconformities found after carrying out the initial diag-
nosis in the dairy processing plant. A flow chart was pre-
pared by the HACCP team in order to correct the

Table 2. Conformity (%) of the Dairy Industry in Terms of Implementation of Good Manufacturing Practices

Analyzed parameters Total of analyzed items Number of conforming items Conformity (%)

Buildings and facilities 70 56 80.0

Equipments and utensils 21 16 76.2
Food handlers 14 12 85.7
Production and transportation of foods 32 20 62.5
Documentation 13 2 15.4
Total 150 106 70.7
ISSUES FOR IMPLEMENTATION OF A FOOD SAFETY SYSTEM 9

Table 3. Nonconformities Related to Good Manufacturing Practices (GMPs)

Found at the Audited Dairy Industry

Item Nonconformities

Buildings and Residues from the effluent treatment exposed to the environment and with flies
facilities External door without automatic closing
Lack of screen against the entry of insects—window of the warehouse
Taps without automatic shutoff device
Absence of records from the hygiene of facilities
Absence of proper identification of chemical cleaning products and absence of proper use of such
products
Absence of a person that is responsible for cleaning the water tank and its documentation
Absence of an adequate area for storage of wastes (garbage)
Absence of a door in the room for hygiene chemical materials
Improper storage of ingredients—incidence of sun light on the packagings
Equipment and No records of preventive maintenance for equipments
utensils Absence of a skilled employee responsible for the hygienization of equipments and records of the
hygienization process
Food handlers Failure in personal cleanliness—GMP
Failure in hygiene habits during food processing
Absence of continuous training program (GMP) and records of such program
Production and Lack of inspection of raw materials, ingredients, and packaging at reception
transportation of Failure in hygienic and organized storage of packagings and ingredients
foods Failure in the controling and access of the staff in the production area
Lack of control and records of temperature in the cold load
Failure in the identification and storage of expired and/or demaged products
Absence of a sampling procedure for laboratory analysis of the final product
Transportation of the final product in inadequate temperature, jeopardizing the integrity of the product
Documentation Absence of a handbook of GMP
Lack of procedures for cleaning the equipments/facilities and records of such procedures
Lack of procedures for hygiene/health of food handlers and records of such procedures
Lack of procedures for preventive maintenance/calibration of equipments and records of such
procedures

nonconformities and was put into practice between August
and December of 2006.
Role of training in the implementation
of food safety systems
During the training sessions, it was evident that, although
most of the workers knew what food contamination meant,
they had never received training before. In addition, greater
resistance to changes in habits and conduct with respect to
hygiene could be observed with time by the longer-term
workers, as compared to those recently admitted. Another
difficulty encountered was the high turnover of workers,
impeding the consolidation of a team with the desired work
standard and resulting in improvements taking longer than
expected. It was found that some workers had problems
filling in the CCP monitoring records, either due to forget-
fulness or because they failed to recognize the importance of
doing it.
Implementation of the HACCP system
The hazard analysis, taking into account hazards that could
affect the safety and quality of the food and determination of the
CCPs, indicated a total of 12 CCPs: (1) reception of the raw milk,
(2) storage of the raw milk, (3 and 4) reception of the ingredients
and packaging, (5) milk pasteurization, (6 and 7) fermentation
and cooling, (8) addition of ingredients, (9) filling, (10) storage of
the finished product, (11) dispatching of the product, and (12)
sanitization of the equipment (Fig. 1). A summary of the
HACCP plan, only including the CCPs, is available in Supple-
mentary Table S3.
During implementation of the HACCP system for the yo-
gurt production line, it was observed that six of the 12 CCPs
had not been maintained completely under control, whereas
for the others the deviations were promptly corrected.
Indicators of the implementation efficiency of the food
safety system in the dairy processing plant
Table 4 shows the results of the microbiological analyses of
319 yogurt samples taken before and after implementation of
the food safety system. A statistical difference was found
between the means for the yeast and mold counts before and
after implantation of the HACCP ( p < 0.05), with a tendency
to fall while the system was being implanted. No differences
were found between the means for the total coliform counts
before and after implanting the HACCP ( p = 0.215), with a
tendency to remain below the limit of 2.0 log CFU/g stipu-
lated by legislation. The distribution of the values for fecal
coliforms was similar, no statistical difference being found
between the two periods ( p = 0.928). It was shown that these
microorganisms were absent in the majority of samples ana-
lyzed, with a few sporadic contaminations giving counts
above the permitted level (1.0 log CFU/g).
Discussion
Although no data exist on the minimum percentage of
conformities with the GMPs to guarantee success of the
10 CUSATO ET AL.

FIG. 1. Flow chart of the manufacture of skim and semi-skim yogurt.

HACCP, the fact that the company was classified in group II
(51–75% of conformities) by the Brazilian Sanitary Surveillance
Agency (ANVISA) (Anon, 2002), indicated that the industry
was at an intermediate level with respect to its hygiene prac-
tices (Table 2). A more judicious classification with respect to
the impact of implementing the GMPs could not be made, since
this classification criterion is based solely on the absolute
number of conformities. However, it is known that the GMP
items can impact differently on food safety, since the chances of
contamination depend on the nonconformity in question. The
nonconformities encountered in the initial diagnosis of the
GMPs indicated that the basic conditions for implanting
HACCP had still not been established, and thus adjustments
were made in order to conform to the prerequisite programs.
The introduction of a food safety culture in the factory
was implemented by the training programs based on the
individual questionnaires that each food handler filled out
(Table 1). The trainings showed that, in general, the be-
havioral changes were more apparent soon after the ses-
sions. However, these changes became less perceptible as
time went by, especially during periods of increased pro-
duction. Thus, constant training was found to be extremely
important to guarantee that hygiene practices are main-
tained. This is because it is known that the repetitive na-
ture of these tasks is one of the factors responsible for a
reduction in the quality of hygiene during the handling of
foods (Almeida et al., 2002). Therefore, it appears that
frequent training in small groups of three or four people,

Table 4. Counts of Molds and Yeasts, Total Coliforms, and Fecal Coliforms
Quantified Before and After the HACCP Implementation

Molds and yeasts (log CFU/g) Total coliforms (log CFU/g) Fecal coliforms (log CFU/g)

Before HACCP implemenattion 2.22 – 1.12a 1.55 – 1.17a 0.13 – 0.43a

After HACCP implemenattion 1.89 – 1.18b 1.43 – 1.26a 0.13 – 0.45a

Results express the mean – standard deviation from 319 analyses (final products) performed before and after the HACCP implemenation.
In the same column, means followed by different letters differ significantly ( p < 0.05) in accordance with the t-test.
HACCP, hazard analysis and critical control point.
ISSUES FOR IMPLEMENTATION OF A FOOD SAFETY SYSTEM
organized so as to avoid interference with the production
rhythm and allowing for a discussion of the specific fail-
ures of each one, is more efficient than sessions with larger
numbers of workers.
Issues related to food handlers were still observed during
the implementation of the HACCP system for the yogurt
production line. Although some records were known to all the
workers, since they were already part of the routine of the
dairy, it could be seen that they were incorrectly filled in and
with data not always corresponding to the facts. This issue
was solved by individual meetings with those responsible for
this task. In addition, the workers responsible for filling in the
forms were invited to take part in their preparation, so as to
increase their obligation and motivation, as recommended by
Taylor (2003).
Deviations in the CCPs were due to a variety of causes, such
as from a lack of adequate equipment, failures in monitoring,
and problems with suppliers. With respect to pasteurization, it
was found that for several days the graph of the pasteurization
time was not recorded, due to failure on the part of the workers
in utilizing the graphs. In this case, various meetings were held
with those responsible for pasteurization, when they were
oriented as to how to correct the problems encountered, and
from that moment, this CCP remained under control. Failures
in monitoring and the absence of corrective actions allowed for
the temperature of the cold store to reach 24C on one day in
the month of July, leading to the deterioration of various
products stored there. From this month, the group of workers
responsible for the dispatching sector was further trained, and
thereafter monitoring was carried out correctly, as were cor-
rective actions when necessary.
The number of CCPs determined at the start of the im-
plementation of the HACCP system in the dairy was high
(n = 12). However, as the food safety culture was still being
created in the company, it was decided to maintain the 12
CCPs in the HACCP plan (see Supplementary Table S3). It is
known that some of these CCPs—such as storage of raw milk,
addition of ingredients, fermentation, cooling and cutting of
the coagulum, filling, storage of the finished product, dis-
patching of the product, and sanitization of the equipment—
can be controlled by the prerequisite programs. Thus, only the
reception of the raw milk, reception of the ingredients and
packaging, and the pasteurization of the milk and of the
mixture should remain as CCPs in the HACCP plan for the
manufacture of yogurt in this company.
Success in the implementation of the food safety system
was assessed through the use of microbiological indicators.
As shown in Table 4, the mean values of yeast and mold
populations tended to remain below the maximum limit es-
tablished by legislation of 2.3 log CFU/g (Anon, 2000). This
result is consistent with hygiene failures identified in the
monitoring of the CCPs, which was justified by the turnover
of employees during the initial period.
Conclusion
This study highlights the main challenges faced in the
implementation of food safety systems by a small dairy
industry. The main difficulties encountered for the im-
plementation of food safety system were related to the
actions established in a flow chart for constant training/
adherence of the workers to the system. Despite this, the
11
implementation of the food safety system led to significant
reductions in the populations of indicator microorganisms,
showing that although challenging it is feasible to be car-
ried out by small-scale food industries.
Disclosure Statement
No competing financial interests exist.
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