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British Food Journal: Article Information
British Food Journal: Article Information
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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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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.
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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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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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.
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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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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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.
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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