British Food Journal

Standardized food safety management: the case of industrial yoghurt

Panagiotis Chountalas Dimitrios Tsarouchas Athanasios Lagodimos
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Panagiotis Chountalas Dimitrios Tsarouchas Athanasios Lagodimos, (2009),"Standardized food safety
management: the case of industrial yoghurt", British Food Journal, Vol. 111 Iss 9 pp. 897 - 914
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Standardized
Standardized food safety food safety
management: the case of management
industrial yoghurt
897
Panagiotis Chountalas
Department of Business Administration,University of Piraeus, Piraeus, Greece
Dimitrios Tsarouchas
Nosis Business Solutions, Athens, Greece, and
Athanasios Lagodimos
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Department of Business Administration,University of Piraeus, Piraeus, Greece

Abstract
Purpose – The recently introduced ISO 22000:2005 modified the classical HACCP approach by
embedding food safety into the wider context of a standardized management system and refining the
required safety control measures. There is little guidance regarding ISO 22000 implementation as well
as inconsistencies regarding definitions and control measures specifications. This paper aims to
provide a structured approach for the implementation of ISO 22000, applied to the case of industrial
yoghurt.
Design/methodology/approach – The approach consisted of two stages. The first primarily
comprises the interpretation of the ISO 22000 specifications. The second includes the application of
these requirements (as interpreted) to industrial yoghurt manufacture, considering all major varieties
(set, stirred and strained) and types (with or without flavourings).
Findings – The paper reveals a managerial perspective of ISO 22000, overcoming existing
inconsistencies for determining the necessary control measures, as applied to industrial yoghurt.
Research limitations/implications – This research is limited to the case of industrial yoghurt
considered. However, the methodology used is general and can apply to any other product.
Originality/value – This paper provides an interpretation of ISO 22000, based on other
standardized management system practices and widely accepted managerial principles. The
findings can help in the development of the necessary state-of-the-practice tools to facilitate future ISO
22000 implementations, in conjunction with the ISO 9001 quality standard.
Keywords Food safety, Quality standards, Dairy products
Paper type Conceptual paper

1. Introduction
Dairy products traditionally constitute a prime source of human nutrition. Today,
many dairy varieties are consistently consumed throughout the world either directly or
as ingredients of other foods (e.g. pastries, pies, etc.). In this context, yoghurt, which is
the focus of this paper, is a basic element of everyday nutrition in several South
European and other countries. Note that, in recent years, the consumption of yoghurt
and its derivatives follow a continuously increasing trend all over the EU (Tamime and
Robinson, 2004; Valli and Traill, 2005). British Food Journal
Vol. 111 No. 9, 2009
Because of their importance, the safety of dairy products has received particular pp. 897-914
attention by several official bodies. It is worth mentioning that the implementation of q Emerald Group Publishing Limited
0007-070X
HACCP has been enforced to all EU members by the 92/46 directive (for dairy hygiene). DOI 10.1108/00070700910992835
 BFJ Safety specifications were further enhanced by regulations 852/2004 and 853/2004
111,9 (Komorowski, 2006). It is partially due to such measures that most dairy products
present good safety records in the EU. Nevertheless, occasional outbreaks involving
Listeria monocytogenes, Salmonella spp., Escherichia coli and other pathogens have
occasionally been recorded in some countries (examples for yoghurt are given in
Varnam and Sutherland (1996) and Motarjemi (2002).
898 Focussed on HACCP implementation, several studies have addressed various dairy
products, such as: pasteurized or condensed milk (Dijkers et al., 1995; Ali and Fischer,
2002), a variety of cheeses (Mauropoulos and Arvanitoyannis, 1999; Arvanitoyannis
and Mavropoulos, 2000; Evrensel et al., 2003) as well as milk cream and butter (Ali and
Fischer, 2005). Possibly due to its robust nature, relatively few studies have addressed
yoghurt production. Shapton and Shapton (1994) presents CCPs and a HACCP system
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for yoghurt with fruit and nut puree, while Varnam and Sutherland (1996) gives safety
specifications for set and stirred yoghurt (see also Sandrou and Arvanitoyannis, 2000).
All the above studies are based on the HACCP approach, as described by its seven
principles in the Codex Alimentarius (Codex, 1993), which is referred hereafter as
classical HACCP. The recent introduction of the ISO 22000 international standard
(International Organization for Standardization – IOS, 2005a) has somewhat modified
this approach; namely, by strengthening managerial elements and refining safety
controls. Following established trends, ISO 22000 regards food safety as an integral
part of a wider standardized management system. This approach is identical to that
previously followed for addressing other specialized managerial (and technical) issues
such as quality (ISO 9001), environmental management (ISO 14001), occupational
health and safety (OHSAS 18001). In this context, an organization can voluntarily
decide to implement ISO 22000 and then seek certification by an authorized
certification agency, thus obtain an independent third party verification of its food
safety practices effectiveness (very efficient marketing tool in certain occasions).
The purpose of this paper may be described as follows. First, we present the main
principles of the ISO 22000 standardized safety management system and provide
practical guidance for the development of the associated safety plans. In doing so, we
also describe the major differences between ISO 22000 and classical HACCP. Moreover,
we provide specific interpretations of some of the ISO 22000 requirements that, as
given in the standard, appear inconsistent and not directly implementable. In the
absence of previous published research on this issue, this constitutes a first step
towards its resolution. Second, we provide an ISO 22000 implementation scheme for
industrial yoghurt, considering all major product varieties, namely set, stirred and
strained (stragiston in Greek), with or without flavourings.
The remainder of this paper is organized as follows. Section 2 briefly presents the
ISO 22000 standard and the specified safety plans. It also discusses issues that are
inconsistently described in the standard, providing interpretations necessary for
successful implementation. Section 3 describes the product, identifies the major
production processes and gives a process based typical production flow. Section 4
presents the hazard analysis considering all major production processes in turn.
Section 5 presents in detail the proposed safety plan developed for industrial yoghurt.
Finally, Section 6 discusses the main findings and draws conclusions with respect to
ISO 22000 application in the food industry.
 2. Standardized food safety management Standardized
In this section we present the key features of the ISO 22000 standard, focusing on the food safety
main elements that differentiate it from classical HACCP. We also provide an
interpretation of the standard specifications to determine the safety plans required for management
food safety implementation.

2.1 Process-based system 899

One weakness of classical HACCP concerns its integrity as a management system.
Although basic requirements for the HACCP system management do exist, these are
rather general (with focus on whats), giving few implementation details (very little on
hows). As a result, classical HACCP has often been implemented as an isolated system,
poorly integrated with other management systems. Under such inefficient
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implementations, systematic adaptation to changes and continuous improvement

become hard to accomplish.
In line with all other standardized management systems, the systemic approach
adopted by the ISO 22000 standard is based on the application of process management
principles. A number of management philosophies, such as TQM and Six Sigma, are
also based on these principles (see Hammer, 2002; Lloréns-Montes and Molina, 2006).
Core element of process management is the concept of processes. In this context, the
management system of an organization can be viewed as a single large process, which
may be broken down to several sub-processes (Bhuiyan and Alam, 2005). Effective
management of these processes ensures effective management of the whole
organization (see Armistead et al., 1999). It should be noted that in the case of ISO
22000, as mentioned in ISO/TS 22004 (giving guidelines for applying the standard),
processes are considered in terms of food safety (IOS, 2005b).
A key tool for effective process management is the well known Deming cycle
Plan-Do-Check-Act (PDCA). Plan concerns the design of processes, in a way that fully
specifies which activities are to be done (when, by whom and how) so as to ensure
repeatability and consistency. Do covers the implementation of these activities, in
accordance with the plan. Measurements of end-to-end process performance and
assessment of these measurements in order to facilitate targets setting are actually part
of Check. Finally, Act refers to process improvement and ensures that the critical
activities are executed in the most efficient and effective manner. Processes
standardization is also an important issue (see Davenport, 2005).
In order to apply the PDCA cycle, ISO 22000 has adapted a requirements
presentation scheme directly analogous to the ISO 9001:2000 quality systems standard.
Specifically, after three initial clauses (giving scope, references and definitions) the ISO
22000 requirements are grouped into five clauses:
(1) food safety management system;
(2) management responsibility;
(3) resource management;
(4) planning and realization of safe products; and
(5) validation, verification and improvement.

Under the first clause, the organization establishes and documents a food safety
management system and defines its scope (i.e. products, processes and sites). The
 BFJ management responsibility clause specifies requirements covering safety policy
111,9 definition, safety planning (through objectives and targets), communication issues and
management review. Provision of all resources necessary for the implementation of the
system is the scope of the resource management clause. In the planning and realization
of safe products clause, all production processes affecting products safety need be
designed and the respective safety plans developed. In fact, this clause includes most
900 technical requirements of classical HACCP (and is the only clause drastically different
from its ISO 9001 counterpart). Finally, the last clause specifies requirements which
ensure system verification (i.e. the system ability to reliably deliver expected safety
outcomes) and continuous improvement.
For implementing any standardized management system, a company needs to
identify and redesign its processes so as to incorporate the specifications of the
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respective standard. Processes interactions also need to be determined. In most cases,

additional processes related with various internal operations (such as targets setting,
internal audits etc.), often not previously identified and standardized, will need to be
designed. As a final step, written standard operating procedures (SOPs) need to be
developed, effectively describing all activities for implementing the processes (as
designed) together with the respective managerial responsibilities. For the ISO 22000
standard, a safety plan according to given specifications is also required, as described
in the next section. When developed, the safety plan needs to be integrated within
respective SOPs for actual use.
It can be stated that ISO 22000 implementation provides a food safety system
designed, operated and continuously updated (improved) as an integral part of overall
organization management. Note that classical HACCP, practically designed to operate
as an effective stand-alone system, may lead to inefficient implementations, with food
safety not integrated within but operating in parallel with other management systems.
This is probably one of the reason why many related studies, in order to ensure
appropriate action, include all sort of measures that may directly (or indirectly) impact
food safety in the HACCP plan. For example, Shapton and Shapton (1994) define a CCP
at the inoculation stage of yoghurt production, apparently only due to the need for
personnel training. Based on ISO 22000 such measures are not part of the HACCP plan
(see next section).
Last, it is worth stressing the ISO 22000 requirement for quantitative objectives and
targets. By establishing a system driven by objectives, ISO 22000 provides a solid
basis for improvement and the determination of acceptable hazards levels (i.e.
remaining risk). It is worth noting that, through the food safety objectives (FSO)
concept, public health goals may be systematically translated into quantitative
operational targets for food safety management (for discussions of FSO see Stringer,
2005; Gorris, 2005).

2.2 Hierarchical safety controls

Classical HACCP effectively specifies two safety control levels (i.e. Prerequisite
Programs (PRPs) and the HACCP plan). The differentiation between these two levels,
however, is rather weak and not generally understood. As a result, most early
implementation studies included both levels in the HACCP plan (see Untermann, 1999),
practice which decreases system efficiency and increases safety costs (see economic
 analysis in Roberto et al. (2006)). The ISO 22000 standard imposed an additional Standardized
control level, thus created a three-level safety control hierarchy, namely: food safety
(1) PRPs; management
(2) Operational Prerequisite Programs (O-PRPs); and
(3) HACCP plan.

In the following, we briefly present each of these control levels, providing specific
901
interpretations when necessary (to cover issues where the standard specifications are
unclear or inconsistent).
The PRPs define all basic conditions and activities that are necessary to maintain a
hygienic environment throughout the food chain (Subclause 3.8), by enforcing the
implementation of the appropriate GMP and GHP specifications throughout the
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organization. Therefore, we can generally interpret PRPs as the control measures

covering the design and the basic operations of all infrastructures deployed (hardware
and operating practices) and which impose specifications for the development of the
system SOPs (see previous section). Typical PRPs examples include cleaning and
sanitation of production equipment, maintenance, personnel selection and training, etc.
Thus, PRPs cover management activities necessary for any food organization and have
a weak association with the specific food product produced. Note, however, that PRPs
may control serious hazards and fully complement safety control at operational level.
Operational safety control, which directly relates to the product and production
process used, is accomplished by the other two control levels, namely:
(1) O-PRPs; and
(2) the HACCP plan.

ISO 22000 does not give a direct definition of the HACCP plan and defines O-PRPs as
follows: O-PRPs are those PRPs identified by the hazard analysis as essential in order
to control the likelihood of introducing food safety hazards (Subclause 3.9). By this
definition, O-PRPs are directly related to PRPs. However, this is not consistent with the
way they are subsequently treated by the standard, since both the O-PRPs and the
HACCP plan are specified as the outcome of the hazard analysis that defines the
measures to control the hazards essential to food safety (Subclause 7.4.4) other than
those covered by the PRPs. Adopting this view (which is fully supported by ISO/TS
22004, Subclause 7.4.4) for the relation between the HACCP plan and O-PRPs, we still
need to separate the measures entering each plan.
The ISO 22000 standard specifies a set of six criteria for this separation. However,
little application guidance is offered either in this standard or in ISO/TS 22004. To deal
with this issue, we adopted an implementation approach where the principal criteria
for hazard control categorization are:
.
the hazard level (in terms of hazard severity and frequency of occurrence); and
.
the feasibility of monitoring this hazard in a timely manner and enable
immediate corrective actions.

Thus, hazards with more severe impact to consumer health, higher risk of occurrence
and higher ability to be timely monitored are confronted by the HACCP plan. The
remaining hazards are controlled by establishing appropriate O-PRPs.
 BFJ This categorization clearly depends on the actual design of the production system.
111,9 Assume, for example, a production flow design where some hazard cannot possibly be
timely controlled and should, thus, be controlled by an O-PRP. However, if this hazard
impact on public health is severe, it needs to be part of the HACCP plan. Therefore,
redesign of the production processes is required (e.g. a production delay may be
introduced that will act as a product quarantine) in order to enable direct control of the
902 hazard, through the HACCP plan.
A final issue concerns the specific control measures incorporated in the O-PRPs and
the HACCP plan. Given any process, a control measure is entirely defined by all the
elements that describe the respective control loop: scope, critical parameters monitored,
critical limits and corrective actions. ISO 22000 clearly stresses the need for the
establishment of such a typical control mechanism both for the O-PRPs (Subclause 7.5)
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and the HACCP plan (Subclause 7.6.1). Note that specifications for particular control
measures types are not given in the standard, since they are dependent on the
particularities of the processes under control.

3. Product and production specifications

In this section we present the description of industrial yoghurt, including its intended
use. This is followed by an analysis of yoghurt production flow, providing all the major
specifications of the processes involved.

3.1 Product and intended use

Yoghurt is a dairy product obtained by fermentation of milk in combination with the
action of a suitable starter culture and coagulation. Milk used comes from various
animals such as cows, goats, sheep and buffaloes. The product fat and total solid
composition is usually 10 percent higher than original milk, while pH varies between
4-4.4. The product is packaged in plastic polystyrene pots and during preservation it is
maintained at a temperature of 0-68C until its expiration date, circa 40 days from the
production date (Codex, 2003).
The major varieties of yoghurt (analyzed in this paper) are as follows: set, stirred
and strained yoghurt. The principal difference between set and stirred yoghurt is that
the incubation process is carried out in pots for the first and in tanks for the latter.
Strained yoghurt is derived from fermented milk after the removal of surplus whey.
The protein content of this product is increased and the fat content is at least 8 percent,
with the exception of strained yoghurt from cows’ milk that should be at 5 percent
(Varnam and Sutherland, 1996).
It should be noted that each of the above varieties may be flavoured to form
different distinct finished products. Fruit flavoured yoghurt, for example, contains a
maximum of 50 percent (m/m) of non dairy ingredients and additives such as
stabilizers, colouring agents and flavourings such as fruits, juices, sweeteners, flavour
enhancers. The non-dairy ingredients can be mixed in prior or after fermentation
(Codex, 2003).
Yoghurt can be consumed by people of all ages, from young children to elderly
people. Yoghurt products are delivered to final consumers through food retailers, who
each may be categorized as large supermarket chains and smaller stores (e.g. kiosks,
canteens). The difference between two is on the degree that storage and preservation
processes are implemented, in order to ensure adequate hygienic conditions.
 3.2 Production flow Standardized
Figure 1 shows a typical yoghurt production flow, using standard symbols to food safety
represent the production processes for all three varieties studied, with possible fruit
flavouring. In contrast with other flow diagrams (e.g. Mauropoulos and management
Arvanitoyannis, 1999; Ali and Fischer, 2002), this diagram clearly distinguishes
the types of processes involved (batch or flow processes), and is generic and covers
all possible yoghurt varieties. 903
Observe that two types of production processes are mainly involved in yoghurt
production:
(1) flow processes (performed in a continuous mode from start to end); and
(2) batch processes (performed for a specific time period into tanks).
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Processes are separated with storage units. Based on Figure 1, production is performed
in the following four stages:
(1) raw materials receipt and storage;
(2) initial processing to inoculation;
(3) final processing and packaging; and
(4) finishing and logistics.

In the following we present in detail all the above stages. Note that the emphasis is not
given to the technology used (which may vary among organizations), but to the
physical content and specifications of the processes involved.
3.2.1 Raw materials receipt and storage. All raw materials (including packaging) are
periodically received in batches from suppliers. Individual receipts are tested (if
required) and stored under particular conditions specified for each material. In this
context, it is worth stating the following specifications:
.
Raw milk. Need for filtering to remove foreign bodies; stored in silos at a
temperature circa 0-48C (Arvanitoyannis and Mavropoulos, 2000).
.
Cream. Stored in silos at a temperature circa 0-48C (Council of European
Communities - CEC, 1992).
.
Starter culture. Consists of Streptococcus thermophilus and Lactobacillus
bulgaricus in proportion 1:1 (Sandrou and Arvanitoyannis, 2000); should be of
high vitality with high resistance to bacteriophages; stored at a temperature circa
408C (deep freeze).
.
Flavourings. Received as heat treated purees in bulk containers or tanks.

For all other raw materials (i.e. milk powder, stabilizers and sweeteners) and the
packaging materials used no particular specifications need to be given.
3.2.2 Initial processing to inoculation. This stage of production is common for all
yoghurt varieties. Raw milk is first centrifuged and its fat and solid content
standardized. This is necessary for the production of yoghurt with differentiated fat
and total solid content. Centrifugation allows the reduction of the initial cream content
to required levels. After further processing (primarily heat treatment to destroy
pathogens – see also below), surplus cream may be stored as a finished product.
 BFJ
111,9

904
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Figure 1.
Generic production flow
diagram for industrial
yoghurt production
 After standardization, stabilizers are added (only for flavoured yoghurt) and the Standardized
mixture is stabilized. In order to destroy pathogens (but not already existing toxins) the food safety
mixture is subsequently heat treated (pasteurized). Heat treatment takes place in a flow
mode (through an appropriate heat exchanger) at 858C for 30 min or at 958C for up to management
5 min (Law, 1997). The alkaline phosphatase test may be used to verify successful heat
treatment (Harding, 1991). The mixture is then cooled to the inoculation temperature.
Inoculation takes place in a batch mode in tanks where a specific volume of milk is 905
inoculated with 2 percent (per volume) starter culture at the temperature of 40-458C
(Varnam and Sutherland, 1996). The starter culture mix is usually produced from its
ingredients in the lab and then added to the inoculation tank.
3.2.3 Final processing and packaging. As shown in Figure 1, this stage depends on
the yoghurt variety been produced. At this stage yoghurt is fermented and incubated
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in tanks at a temperature of 40-458C. The incubation process usually takes three to four
hours, in any case until lactic acid content reaches 0.85-0.95 percent (Tamime and
Robinson, 2004). The above specifications during incubation are crucial in order to
ensure final product quality and avoid syneresis and shelf-life reduction.
The set yoghurt variety is fermented in plastic pots after aseptic packaging, where
flavourings are added (if required). After incubation, set yoghurt is gradually cooled to
storage temperature. In contrast, both the stirred and strained yoghurt varieties are
fermented inside the incubation tanks and then aseptically packaged (see Figure 1).
There are differences, however, in the respective processes. For the stirred yoghurt,
after incubation the coagulum is first stirred inside the tank to liquefy and then cooled
to a temperature circa 20-308C. Flavourings are added with static-in-line mixers
connected directly to the yoghurt flow. For the strained yoghurt, incubation is followed
by mechanical separation. Specifically, after preheating at circa 608C, surplus whey is
removed from the coagulum (by centrifugation) and the mixture is gradually cooled at
circa 20-308C. This is followed by standardization of the fats and solids content using
the necessary additional.
For all yoghurt varieties, aseptic packaging is used. This packaging process
involves sanitization of all packaging materials on the packaging lines just before
filling. Sanitization may be implemented in a number of ways such as H2O2, steam and
UV light (see for a discussion Mittendorfer et al., 2002).
3.2.4 Finishing and logistics. For all yoghurt varieties, finishing consists of a
maturing period for circa two to three days where the product is stored at a
temperature of 0-68C. This period effectively acts as a quarantine, where any quality or
safety problems and hazards may show in the final product. All measurements
necessary may be performed during and at the end of this maturing period.
The last production stage also includes logistics and retailing. Finished products are
loaded in trucks, transported and distributed to the retail shops. Yoghurt need to be
maintained in retail stores at the temperature of 0-68C until the expiration date (Codex,
2003).

4. Hazard analysis
We now present the results of the hazard analysis. Hazards are identified throughout
the production chain presented in the previous section. Hazards (with references giving
the associated critical limits) are presented in the order of the production flow.
 BFJ 4.1 Raw materials receipt and storage
111,9 The hazards at this stage relate to critical materials receipt and storage. Raw milk
constitutes a suitable substrate for dangerous pathogens and other microorganisms,
which may contaminate milk after collection. At above circa 68C (for some time),
Bacillus cereus grows and forms spores that produce a dangerous toxin unaffected by
heat treatment (Christiansson, 1992). At circa 108C, Staphylococcus aureus grows,
906 producing a toxin capable of severe forms of food poisoning. At circa 158C, Salmonella
grows and reproduces at somewhat higher temperatures. To control these hazards it is
imperative for the milk to be chilled at 0-48C immediately after collection and
maintained at this temperature during transportation and storage (see Arvanitoyannis
and Mavropoulos, 2000). Also note that total microorganisms count is a good indicator
of the general quality, hygiene and safety of milk, since increased microbial growth
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influences the efficiency of heat treatment (CEC, 1992).

Raw milk may be contaminated by antibiotics, the residues of various livestock
therapeutic treatments. Besides their cumulative effects on consumers, antibiotics can
also inhibit yoghurt fermentation (e.g. Mauropoulos and Arvanitoyannis, 1999). While
the specific antibiotic types found in raw milk depend on several factors (e.g. livestock
type and region) and even differ between seasons, the most common antibiotics in raw
milk include: penicillin, cephapirin and cloxacillin. The allowable concentration limits
for each antibiotic type are given in regulation 2377/90 (CEC, 1990a). In addition, high
somatic cells count is a good indicator of mastitis (often infecting livestock) that
degrades milk hygiene (Haenlein, 2002) and should not exceed certain limits (Sandrou
and Arvanitoyannis, 2000).
Finally, raw milk may also contain heavy metals (such as Pb), mycotoxins (such as
aflatoxin M1) and dioxins that may pass to breeding livestock through the respective
food chain (Mauropoulos and Arvanitoyannis, 1999). Pb is implicated for mental
disorder and cardiovascular diseases, while aflatoxin M1 and dioxins are considered
carcinogenic (European Commission – CEC, 2001). As with the antibiotics, these
chemical substances do not immediately impact human health but show a cumulative
effect.
Cream and milk powder are two industrial dairy products used as raw materials.
Cream may be contaminated by air-born pathogens after its production (during storage
and transportation from suppliers). Since these pathogens are virtually identical to
those found in raw milk, cream need always be maintained chilled at 0-48C. However,
care is required for the presence of Listeria monocytogenes bacteria, which may grow
even at low temperatures (Ali and Fischer, 2005). While those hazards may also
generally appear in milk powder, since this raw material undergoes heat treatment
during yoghurt production (see Figure 1), respective risks are effectively eliminated.
Note that both cream and milk powder may contain antibiotics, heavy metals,
mycotoxins and dioxins which can be dealt as in raw milk.
The quality of the starter culture is crucial. Starter culture should be free from
foreign bacteria and of high vitality, in order to ensure proper and safe conditions in
yoghurt fermentation and coagulation. Specifically, microbial growth in the starter
culture ingredients (particularly coliforms, yeasts and moulds) can pose a hazard
because apart from the contamination of the inoculated milk it can hinder the
fermentation process (they obstruct starter culture bacteria growth). The presence of a
 non-vital culture can inhibit milk coagulation. Culture vitality is measured by the Standardized
coagulation time and the amount of produced lactic acid (Tamime and Robinson, 2004). food safety
The condition of flavourings such as fruits, juices, additives (sweeteners, flavour
enhancers, colouring matters), added after heat treatment, can affect yoghurt safety. management
The main hazards in flavourings are microbiological (specifically coliforms, yeasts and
moulds). The presence of coliforms is an indicator of low hygiene. Yeasts and moulds
can grow in the acidic yoghurt environment and cause spoilage. In addition, fruits 907
must be free from heavy metals (EC, 2001) and pesticides that can be extremely
harmful above critical limits. The major pesticides associated with each type of fruit
flavouring together with the associated critical limits are found in directive 90/642/EEC
(CEC, 1990b). Also note that additives should be added in conformance with national
and international legislation (Codex, 1995) due to their chemical texture, which can be
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hazardous above certain limits.

4.2 Initial processing to inoculation

The only hazard at this stage relate to inefficient heat treatment, since already existing
pathogens are not destroyed. This can happen if heat treatment temperature drops
bellow 75oC for at least 20 sec (Dijkers et al., 1995). Provided that all raw materials are
safe before use, no other hazards are present.

4.3 Final processing and packaging

The hazards at this stage are related to the incubation and packaging processes.
During incubation and packaging airborne pathogens (such as coliforms, moulds and
yeasts) constitute possible hazards, which cannot be timely controlled at this stage (see
Section 4.4). Packaging materials could be a source of microbial contamination, which
is effectively eliminated under aseptic packaging conditions.
Finally, the presence of foreign bodies such as packaging material fragments
(metals etc.) and adhesives is a critical subject that can impose a physical hazard. Metal
detectors and optical control are necessary for the detection of these hazards and their
elimination.

4.4 Finishing and logistics

The product maturing period provides the time necessary for detecting hazards
introduced at previous production stages. Owing to the acidic nature of yoghurt (see
Section 3.1), the only spoilage microbes that may appear are coli forms, yeasts and
moulds, for which critical limits have been defined (Mayoral et al., 2005). Finally, in the
logistics and retailing stage, long exposure to high temperature (above circa 68C)
favours the growth of yeasts and moulds (Viljoena et al., 2003).

5. Proposed safety plan

We now present the safety management plan for industrial yoghurt production,
developed on the basis of the identified hazards in the respective analysis using the ISO
22000 logic. The plan consists of both O-PRPs and the HACCP plan given in Tables I
and II respectively, while the corresponding CCPs are shown in Figure 1.
Before discussing the plan, the content of the tables need to be explained. Both
tables are similarly structured. Each row corresponds to a particular control measure
imposed to reduce or eliminate one (or more) identified hazard. Each control measure
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BFJ

908
111,9

Table I.

production
for industrial yoghurt
Proposed HACCP plan
Controlled
CCP Scope Control measures hazard Critical parameters Action limits Corrective actions

1 Raw milk receipt Acceptance control of Microbial Total colony count . 105 cfu/g Rejection of raw milk
incoming raw milk if T , 48Cgrowth (B)
(results within 4 hours from
Antibiotics Antibiotic presence Per antibiotic
receipt) (C) type
Somatic Somatic cells count . 4 *105 cfu/g
cells (P)
2 Raw milk and cream Acceptance control of raw milk Microbial Total colony count . 105 cfu/g (raw Rejection of raw milk or
storage and cream, when indicated by growth (B) milk) cream respectively
O-PRP 3
. 2 *104 cfu/g
(cream)
3 Heat treatment Process control Pathogens Temperature/Time period , 758C for .20 Procedure stop – restart
(B) sec heat treatment
4 Starter culture Acceptance control of starter Microbial Coliform count . 1 cfu/g Rejection of starter
ingredients storage culture ingredients before use growth (B) culture ingredients
Yeasts count . 10 cfu/g
Moulds count . 1 cfu/g
Non-vital Lactic acid quantity (after 4 , 0.85% or
culture (B) hours milk coagulation) . 0.95%
5 Flavourings storage Acceptance control of Microbial As per CCP 4 As per CCP 4 Rejection of flavourings
incoming flavourings growth (B)
6 Cream receipt Acceptance control of Microbial Total colony count . 2 *104 cfu/g Rejection of cream
incoming cream if T , 48C growth (B)
(results within four hours from
receipt)
7 Packaging Process control Foreign Adhesives Any Rejection of finished
bodies (P) product
Packaging material fragments Any
8 Finished product Acceptance control of outgoing Microbial As per CCP 4 As per CCP 4 Rejection of finished
quarantine finished product after two days growth (B) product
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O- Controlled
PRP Scope Control measures hazard Critical parameters Action limits Corrective actions
1 Raw milk suppliers Periodic verification of suppliers Aflatoxin (C) Toxin presence . 0,05 mg/kg Discussion with
conformance suppliers
Heavy metals Pb presence . 0,02 mg/kg Supplier rejection
(C)
Dioxins (C) Dioxins presence . 3 pg/g of
milk fat
Microbial Staphylococcus . 10 cfu/g
growth (B) count
Bacillus cereus Any
count
Listeria count Any
Salmonella count Any
2 Cream and milk powder Periodic verification of suppliers Aflatoxin (C) As per O-PRP 1 As per O-PRP Discussion with
suppliers conformance 1 suppliers
Heavy metals Supplier rejection
(C)
Dioxins (C)
Microbial
growth (B)
Antibiotics (C) Antibiotic presence Per antibiotic
type
3 Raw milk and cream Process control Microbial Temperature/time . 48C for .4 Control measure as per
storage growth (B) period hours CCP 2
4 Flavourings suppliers Periodic verification of suppliers Heavy metals Pb presence > 0,05 mg/kg Discussion with
conformance (C) suppliers
Pesticides (C) Pesticide presence Per pesticide Supplier rejection
type
5 Logistics Process control Microbial Temperature/Time . 68C for .8 Finished product
growth (B) period hours withdrawal
6 Retailers Periodic verification of finished Microbial As per CCP 4 As per CCP 4 Finished product recall
products status growth (B) Expiration date Passed Discussion with
retailers
Standardized

yoghurt production
(O-PRPs) for industrial
management

prerequisite programs
Proposed operational
food safety

909

Table II.
 BFJ has a given scope referring to a production process, only related with a particular CCP
111,9 for the HACCP plan (according to ISO 22000). Turning to hazards, all are classified
according to type: biological (B), chemical (C) or physical (P). Each hazard is related
with one (or more) specific critical parameter for which the exact action limits are
specified. These are developed on the basis of the hazards critical limits (given in
Section 4) or the production process specifications (given in Section 3.2). Finally, each
910 control measure is related with specific corrective actions, taken if any of the respective
parameters is found out of control during implementation (see below).
Another point for clarification concerns the control measures used in the plan and
for which no specifications are given in ISO 22000. We have applied three general
control measure types as outlined below:
(1) Process control. This is the continuous monitoring of a process during
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realization. It is applied in two different modes; direct and indirect process

control. The first is the closed-loop version of process control that uses direct
hazard measurements as control parameters. The second is the semi-closed loop
version of process control and is applied when direct hazard measurements
cannot be timely achieved. It implicitly assumes that, when process parameters
(e.g. temperature) are at the required level, process hazards are under control.
(2) Acceptance control. Applies to batch-processes in order to control hazards
associated with individual output batches. It takes place at the end of a process
and leads to decisions for batch acceptance or rejection. Note that storage and
raw materials receipts can be directly regarded as batch-processes for the
purpose of safety control.
(3) Periodic verification. The regular conformance testing of products and processes
which are under the control of suppliers or retailers. Respective specifications
should be commonly agreed and fully outlined in the respective contracts. It
primarily concerns hazards whose timely control by the production
organization is not possible or with relatively low occurrence risk.

We can now briefly discuss the proposed safety plan. As hazard analysis indicated,
yoghurt is not really favouring the growth of most pathogens. In this context, most
hazards to be controlled mainly relate with incoming raw materials not undergoing
heat treatment or with substances (such as heavy metals and somatic cells) not affected
by this process. Provided that heat treatment is effectively accomplished and
appropriate storage conditions are maintained, few hazards (such as air-born
pathogens and foreign bodies) may affect product safety (see also van Schothorst and
Kleiss (1994), for a similar discussion).
Referring to the proposed HACCP plan in Table I, all but three CCPs relate to raw
material receipts and storage conditions. It is worth noting the two-level acceptance
control scheme applied to incoming raw milk (CCP 1) and cream (CCP6). Thus,
incoming supplies are first tested for temperature and only if found acceptable are
other tests of these acceptance control measures conducted. Otherwise these supplies
are directly rejected. A similar two-level scheme applies to the use of raw milk and
cream after storage (CCP 2) where microbial growth is tested only in case where actual
storage temperature has deviated from standard specifications. Also note that starter
culture undergoes acceptance control before actual use (CCP 4), since pathogens may
grow if storage conditions are violated. While most other controls of the HACCP plan
 are self-evident, it is worth clarifying the final product storage (CCP 8). Here an Standardized
acceptance control is imposed after the product maturing period (that also acts as food safety
quarantine) just before shipment. This control is mainly associated with air-born
pathogens not covered by previous control measures throughout production. The management
maturing period allows these pathogens, if present, to grow at detectable levels and so
be eliminated.
Turning to the O-PRPs in Table II, many relate to suppliers and the periodic 911
verification of their conformance to agreed specifications. Of these, note those related to
hazards that cannot be timely detected (O-PRP 1, O-PRP 2 and O-PRP 4) and whose
control can best be achieved though the conditions that affect their occurrence,
effectively at the first stages of the respective supply chain (i.e. in this case at the farm).
It is finally worth addressing the programs related with logistics and retailing (O-PRP
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5 and O-PRP 6). The first ensures the required conditions during transportation
(particularly for long distances). The second imposes a control on retailers to ensure
product safety at the retailers disposal.
A final issue concerns the corrective actions in the proposed safety plan. Notice that
all respective actions directly relate to ensuring product safety by effectively
disallowing hazards propagation throughout the production flow. In fact, no other
actions could have been prescribed at this level since this presupposes foreknowledge
of all cause-effect relationships, not really available beforehand (see also Untermann
(1999), for a criticism of the practice of including various prescriptive maintenance
details in applications of classical HACCP). In the context of ISO 22000, if a hazard is
identified, the exact causes need first be established and the appropriate actions
decided according to causes though the established SOPs.

6. Discussion and conclusions

The introduction of the ISO 22000 standard will eventually seriously impact food
safety practices. According to the most recent official data (IOS, 2007), more than one
million ISO 9001 and ISO 14001 certificates were awarded by the end of year 2006
worldwide, while yearly certification growth rates still remain high. Even allowing for
the specialized scope of the food safety standard, if only part of these standardized
management systems certification trends find application for ISO 22000, numerous
food companies will sooner or later seek certification worldwide.
It can be expected that the first candidates for implementing ISO 22000 will be
companies already certified by the ISO 9001 quality standard. There are two main
reasons for this. As it was previously found for environmental management,
enterprises already certified for their quality system were the prime adopters of ISO
14001, effectively building on their experience with standardized management systems
and the certification culture they have developed (see discussion in Lagodimos et al.,
2007). Perhaps more important, however, is the chosen design for the ISO 22000
standard, which has adopted a structure (as well as systemic characteristics) virtually
identical to those of ISO 9001. As a result, users of the later can easily integrate food
safety within their quality system. A quick and effective method for achieving this is
by treating food safety specifications as an additional element of product and process
quality. Under this approach, operation according to ISO 9001 will implicitly satisfy
the requirements of ISO 22000 implementation as well.
 BFJ One feature that differentiates somewhat ISO 22000 from other standardized
111,9 management systems are the requirements for specific food safety controls. The
standard has adopted and refined the regulatory specifications of classical HACCP,
effectively introducing one additional level of operational control (i.e. O-PRPs) which,
together with the HACCP plan, constitutes the respective safety plan. In the absence of
an established state-of-the-practice for the implementation of these control
912 specifications, this research effectively constitutes a contribution in this direction.
Using a particular interpretation of the standard specifications, we provided a practical
approach for deciding whether a hazard is controlled by the O-PRPs or the HACCP
plan. This was subsequently applied for the development of the standardized safety
plan for industrial yoghurt production.
In doing so, we have considered all main varieties of the product (i.e. set, stirred and
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strained yoghurt) with or without fruit flavouring. Hazard analysis was based on a
typical production flow which was presented in a generic form covering all product
varieties and types. Following the ISO 22000 logic, assuming that the necessary PRPs
to implement GMP and GHP safety requirements already exist, the hazards associated
with all processes in the production chain are identified and its severity determined.
After specifying the particular control measures required, the respective HACCP plan
and O-PRPs are proposed.
A final issue concerns the operationalization of the proposed safety plan in real
manufacturing. By separating PRPs from operational control according to ISO 22000,
the proposed plan is generic and can be applied to any yoghurt producer without or
with only minor modifications, provided that the production flow used corresponds to
that analyzed hereF. In this context, operationalization will primarily consist of
defining the control measures details (such as analytic methods, sample sizes and
sampling frequencies) and the development of the infrastructure necessary for
implementation. If the food producer is already ISO 9001 certified, there is only need for
determining PRPs (on the basis of technology and practices employed) and modify
existing SOPs accordingly. Otherwise, there is also need for developing the SOPs to
cover all ISO 22000 systemic requirements (highly unlikely to be done for the purpose
of food safety alone).

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Corresponding author
Panagiotis Chountalas can be contacted at: pchountalas@yahoo.gr

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