Critical Reviews in Food Science and Nutrition, 48:411429 (2008)

C Taylor and Francis Group, LLC

Copyright

ISSN: 1040-8398
DOI: 10.1080/10408390701424410

Application of ISO 22000 and Failure

Mode and Effect Analysis (FMEA)
for Industrial Processing of Salmon:
A Case Study
IOANNIS S. ARVANITOYANNIS1 and THEODOROS H. VARZAKAS2
1
University of Thessaly, School of Agricultural Sciences, Department of Agriculture, Animal Production and Aquatic
Environment, Fytoko Street, 38446 Nea Ionia Magnesias, Volos, Hellas (Greece)
2
Technological Educational Institute of Kalamata, School of Agricultural Sciences, Department of Technology of Agricultural
Products, Hellas (Greece) e-mail: tvarzakas@teikal.gr

The Failure Mode and Effect Analysis (FMEA) model was applied for risk assessment of salmon manufacturing. A tentative
approach of FMEA application to the salmon industry was attempted in conjunction with ISO 22000.
Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (salmon
processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which
the system depends. Critical Control points were identified and implemented in the cause and effect diagram (also known as
Ishikawa, tree diagram and fishbone diagram).
In this work, a comparison of ISO 22000 analysis with HACCP is carried out over salmon processing and packaging.
However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing
hazard. Fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing, and distribution were the
processes identified as the ones with the highest RPN (252, 240, 210, 210, 210, 210, 200 respectively) and corrective actions
were undertaken. After the application of corrective actions, a second calculation of RPN values was carried out resulting
in substantially lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa
(Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk
assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO 22000 system of a salmon processing
industry is anticipated to prove advantageous to industrialists, state food inspectors, and consumers.
Keywords

FMEA, ISO 22000, HACCP, Ishikawa diagrams, RPN, salmon manufacturing

INTRODUCTION
HACCP (Hazard Analysis and Critical Control Point) is an
administration system, in which the safety of foods is controlled
through an analysis and control of biological, chemical, and
physical risks, which may appear in every step of a product
production. Namely, HACCP receives isolated procedures of
quality control in various steps of production, elaborates them,
and unifies all of them in one unique system. Thus, an errors
prevention is assured through the production process, these errors being considered as new production risks when they occur.
Address correspondence to I. S. Arvanitoyannis (Dr, Ph.D.) Associate
Professor, University of Thessaly, School of Agricultural Sciences, Department of Agriculture, Ichthyology and Aquatic Environment, Fytoko Street,
38446 Nea Ionia Magnesias, Volos, Hellas (Greece); Fax: +302421093144;
Tel.: +302421093104. E-mail: parmenion@uth.gr.

Nowadays, a wide application of HACCP is proposed in the entire production system and foods traffic, which goes from the
field and the stable to the industry, the wholesale dealer, the
retailer, and finally the consumer.
The HACCP principle is applied in the sea-food industry since the decade of the 70s. In 1986 the National Marine
Sanctuary Foundation (NMSF) and the National Seafood Inspection Laboratory (NSIL) examined the probable risks in
seafood products by official request submitted by the American Congress (Garrett et al., 1995) In 1991 the research for the
HACCP application in the seafood industry was accomplished.
The basis for the introduction of inspection new systems such
as HACCP, ISO 9000 or QMP is included in the agreement for
the health and plant phytosanitary measures and requires that
all members apply the measures based on a risk evaluation supported by scientific elements (Karnichi, 1997). The agreements

411

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I. S. ARVANITOYANNIS AND T. H. VARZAKAS

for the national commerce of fish include also, among other

things, the Uruguay agreement (1994), while the revision is governed by the food code (Lupien et al., 1997).
At the end of 1986, the FAO fish industries department
(FAO/FII) adopted the HACCP approach in the qualitative evaluation of fish (Lupin, 1997). Nowadays, HACCP is applied or
shall be applied in the fish industry worldwide, given that the developed countries, such as the United States, help the developing
or even the underdeveloped countries to apply it (Trott, 1997).
The EU requirements for HACCP concern also the controls for
companies and refer to the main principles of internal audit. The
government of Canada also included HACCP in the qualitative
management program (QMP) (Barker and McKenzie, 1997).
In particular, the EU Council directive no 91/493/93 introduced the application of HACCP in the EU, which describes
the health regulations in the fishery production and distribution,
while specific attention is given on the determination of critical points control, the sampling, and the filing. Other processes
introduced by the same directive examine the cooked shrimps,
the mollusks, and the appliances used for the fishery packing
(Bijster, 1997).
The attempts for the establishment of an accomplished qualitative administration is supported by educating the fishermen,
using experienced inspectors, developing right practices of laboratories, culture, manipulation, construction, and using a reliable
standard system (Wiryanti, 1997). HACCP must be orientated
towards the product quality, the aid of personnel, and of course
the clients satisfaction (Love, 1997). The computational techniques serve the flow diagrams supporting the fish enterprises,
help the file-keeping, improve the risk analysis, and the critical
point control application (Norback, 1997). The internal inspections of enterprises based on HACCP refer to the installations
organization, the official regulations, the products and the production process for the products recall, and the purchase process
from the client (Valset, 1997).
Current Situation of Salmon (Salmo salar)
The salmon in the Atlantic ocean (Salmo salar) began to be
cultivated in the internal waters of England in the 19th century in
order to enforce its ferocious population. The aquaculture breeding in oceanic cages was used initially in Norway in the decade
of the 60S with a view to achieving a growth corresponding to
the commercial size. The aquaculture success in Norway urged
the development of salmons aquaculture in Scotland, Ireland,
Canada, the Northeast Coast of USA, and recently in Chile and
Australia (Tasmania). Apart from these countries, New Zealand,
France, and Spain have also a salmon production but a smaller
one.
In general, the countries producing salmon are situated between the geographical latitudes 40 70 in the northern hemisphere and 40 50 in the southern hemisphere. The premature
Norwegian success depicted its well-protected areas due to perfect hydrographic conditions (invariable temperature and salinity), so that the Norwegian government provided the salmon

aquaculture with high expenditures (FAO Fishery Statistics,

2002).
The Irish production is more restricted with regard to the
Norwegian one. The profits, however, derived from the salmon
aquaculture exceed far and away those derived from fishery.
Apart from these countries, the salmon aquaculture is presented
in North America as well as in Chile, which competes with the
countries of the northern hemisphere because of low production
costs and easy access to fish flour for the production of salmon
foods. The fast production increases have led to reduced prices,
which, thereafter, have exercised constant pressure toward the
producers to reduce the production costs. The important future
industry expansion may be based on the development of coastal
areas, given that most of the available suitable coastal areas are
already in use and due to the increased competition and further
expansion in protected areas.
Nowadays, the great majority of salmon production in the
Atlantic Ocean (Salmo salar) is a hybrid stock which comes
initially from the ferocious salmon crossed with the Norwegian
one. Some programs of family procreation are currently in force,
in order to determine the family frame with increasing production possibilities or resistance in illnesses. The use of gender or
the genetic treatment of Salmon salar is not widely used in the
cultivated fishes. (http://www.fao.org/figis/servlet/static?dom=
culturespecies&xml=Salmosalar.xml).
The ferocious salmon of the Atlantic Ocean appears in the
North Atlantic Ocean, in the European countries (from Portugal
to Russia), and the north American coasts. They also appear
around the North Atlantic Ocean islands (i.e. England, Iceland,
Greenland). They pass up to four years of their life in deep waters
and eat red herrings, squids. In the maturation beginning, fish
stop eating and return to their original rivers to birth (October
January). Most of the fish die after the oviparous period; although
some of them may return to the sea as kelts.
The eggs are released and greased. The hatched eggs get
an eye after 250 hot days and are hatched after 250 more hot
days during the spring. The hatched larvae eat their lecithin
bag stocks for 300 hot days until they receive external feed as
fry. The young fish remain in rivers, eating insects loopers and
small fish for a 25 year period until they began to be adapted
in the sea water, where they are transformed in smolts and
emigrate to the sea (normally from MarchJune), to build up and
mature. The smolts are normally about 2030 gr. The sea fish can
reach big sizes and when they begin their emigration in order to
birth, usually reach 813 Kg. (http://www.fao.org/figis/servlet/
static?dom=culturespecies&xml=Salmo salar.xml
METHODOLOGY-FMEA ANALYSIS
For detailed event analysis and risk assessment what is commonly conducted and proposed is the Failure Mode and Effects
Analysis-FMEA (Kumamoto and Henley, 1996). FMEA is proposed as long as its use will help the classification of risk ruled
by the factors of Severity (S), probability of Occurrence (O),
and probability of Detection (D) of raw materials at risk. The

ISO 22000, FMEA ANALYSIS FOR SALMON PROCESSING

Figure 1

Flow diagram of salmon processing

413

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I. S. ARVANITOYANNIS AND T. H. VARZAKAS

FMEA technique considers each item that comprises the total

system. Analysis is made, based both on the best expert opinion
and historical information for similar items, of all the ways that
each component or subsystem might fail to fulfill its intended
function (James, 1998).
Therefore, the study group agrees that, the complete understanding of all possible effects of GMOs in the product system
is critical and all possible reactions or repercussions must be
evaluated by means of risk analysis. Failure Mode and Effect
Analysis (FMEA) appears to be an appropriate matrix for this
activity (McDermott et al., 1996).

RESULTS & DISCUSSION

Flow Diagram Analysis
It is important for the flow diagram to be designed correctly,
since the productive procedure is based on it for its function.
The fish harvesting is the first stage in the flow diagram of
salmon alteration (Fig. 1). The fish are harvested alive from the
aquaculture farms, which are installed in properly chosen areas
(Pedrosa-Menabrito, 1990) and are killed by means of freeze
(ice overlay), which must be produced mechanically (Lupin,
1995). The fish are carried in boxes made by heat-insulating
material, which are covered with ice. During their transfer, the
temperature must be kept at low levels (0 4 C ). In particular, the main events which occurred after the fish death are
the muscular inflexibility, the autooxidation, and the bacterial
denaturation. Consequently, the fish freeze must start just after their capture, so that its temperature could be reduced to
3 C or even more in about one hour (ICMSF, 1998). Great attention should be paid in case the aquaculture farms are far
away from the alteration farms. In this case, the transportation
is made with vans with freeze temperature (18 C). The stage
of fish collection is a critical control point, since they might
be polluted by biological and chemical factors, which depends
on the area where the fattening farm is installed as well as on
the prevalent conditions (Pedrosa-Menabrito,1990). This is the
main reason why the sampling control is absolutely necessary
(Table 1).
The next stage is that of weighing. This stage allows us to
know the amounts of fish to be altered and help us to classify
the fish correctly, in order for a sort of classification of the produced product to exist with regard to the weight (CFIA, 1997a).
Classification comes next to the weighing stage, followed by
evisceration. The processing industry should comply with hygiene principles as well as GMP practices in order to avoid
undesirable effects on the quality of the altered product. Therefore, the workers must wear gloves and a skull-cup as well as a
white pinny up to the knees and white boots. Aside from these,
hygiene seminars must be organized regularly for the workers
in order to understand the terms of hygiene. The evisceration is
applied to big fish in fishing vessels or in terrestrial processing

Figure 2

Tree diagram for CCP detection in salmon processing.

units. As it has already been mentioned above, great attention is

paid to the observance of strict hygiene rules, since, during this
procedure, microorganisms may infect the exposed fish flesh
(ICMSF, 1998). One can employ both manual workers and/or
automatic machines with a speed of 55 fish/ minute for round
fish and 30 fish/minute for flat ones. The complete disinfection
of machines is very important because the residues of the process (flesh, blood etc) are an excellent substrate for pathogenic
microorganisms (Olsen, 1995).
During the evisceration stage the production line is divided
in three sub-parts:
i) the part of fresh salmon,
ii) the part of frozen salmon and
iii) the part of filet processing.
In fresh salmon production line the next stage is that of blood
removal. This stage is a critical control point (CCP) because
the used water must be potable and well-filtered so as to remove harmful substances and microorganisms and be compatible with the requirements of the 80/778/EC instruction. Afterwards calibration is carried out where these fish get classified

415

Biological.
Pathogenic
microorganisms, parasites
Chemical
Heavy metals, pesticide residues
Physical
Extrinsic deformations, bruises
Biological.
No identified hazard
Chemical.
No identified hazard
Physical.
No identified hazard
Biological.
No identified hazard
Chemical.
No identified hazard
Physical.
No identified hazard
Biological.
Microbial infection, parasites
Chemical.
Chemical contamination
Physical.
Foreign matter
Biological.
Water infected with
pathogenic
microorganisms.
Chemical.
Infectious agents in water.
Physical.
No identified hazards
Biological.
Microbial contamination.
Chemical.
Heavy metals.
Physical.
Non potable water.

Receipt of fishes

Washing

Blood removal

Evisceration

Grading

Weighing

(2) Determination of hazards

YES
YES

YES
YES

YES

YES

YES

YES

YES

YES

YES

NO

YES
YES

NO

YES

NO

NO
NO

NO

NO

YES

NO

NO

NO
NO

NO

NO

NO

YES
NO

NO

YES

NO

NO

(4) Is the step

specifically
designed to
eliminate or
reduce the likely
occurrence of
hazard to an
acceptable level?
(Yes/No)

YES

(3) Do
preventative
control measures
exist? (Yes/No)

Questions used to determine a CCP according to HACCP analysis

(1) Processing step

Table 1

NO

NO

NO

YES

YES

YES

YES

YES

YES

NO

NO

NO

NO

NO

NO

YES

YES

YES

(5) Could
contamination
with identified
hazards(s) or
could this increase
to unacceptable
levels? (Yes/No)

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

NO

NO

NO

(6) Will a
subsequent step
eliminate
identified
hazard(s) or
reduce likely
occurrence to
acceptable levels?
(Yes/No)

(Continued on next page)

CCP3

CCP2

CCP1

(7) Is this step a

critical control
point? (Yes/No)

416

Biological.
No identified
Chemical
No identified hazard
Physical
Foreign matter
Biological.
Microbial contamination, parasites
Chemical.
Chemical contamination
Physical.
No identified hazard
Biological.
Microbial contamination, parasites
Chemical.
Chemical contamination
Physical.
No identified hazard
Biological.
Microbial contamination, parasites
Chemical.
Chemical contamination
Physical.
Foreign matter
Biological.
Growth of pathogenic microorganisms.
Industrial chemical compounds.
Chemical.
Physical.
None.
Biological.
No identified hazards
No identified hazard
Chemical.
Physical.
No identified hazard
Biological.
Microbial infection.

Sorting

Icing

Hunging

Dressing

Skin removal

Filet making

Head removal

(2) Determination of hazards

NO

NO
NO

NO
NO
NO

NO

NO
NO

NO
NO
NO

NO

NO

YES
NO

NO

YES

NO

YES
NO

NO

YES

YES

NO

NO

YES
YES

NO

YES

YES

YES
NO

YES

YES

YES

YES

(4) Is the step

specifically
designed to
eliminate or
reduce the likely
occurrence of
hazard to an
acceptable level?
(Yes/No)

YES

(3) Do
preventative
control measures
exist? (Yes/No)

Questions used to determine a CCP according to HACCP analysis (Continued)

(1) Processing step

Table 1

NO

NO
NO

NO

YES
NO

YES

NO

NO

NO

NO

NO

NO

NO

NO

NO

YES

YES

YES

(5) Could
contamination
with identified
hazards(s) or
could this increase
to unacceptable
levels? (Yes/No)

YES

YES
YES

YES

YES
YES

YES

YES

YES

YES

NO

NO

NO

YES

YES

YES

NO

NO

NO

(6) Will a
subsequent step
eliminate
identified
hazard(s) or
reduce likely
occurrence to
acceptable levels?
(Yes/No)

CCP4

(7) Is this step a

critical control
point? (Yes/No)

417

Distribution

Freezing

Labelling

Casing

Cooling with air

or ice

Sorting

Chemical.
Industrial chemical compounds
Physical.
Foreign matter.
Biological.
No identified hazard
Chemical.
No identified hazard
Physical.
Foreign matter
Biological.
Growth of
microorganisms, parasites.
Chemical. Rare.
Physical.
Foreign matter.
Biological.
Growth of pathogenic microorganisms.
Chemical.
Chemical contamination.
Physical.
Foreign matter.
Biological.
No identified hazard
Chemical
No identified hazard
Physical.
Foreign matter
Biological.
Microbial growth, parasites
Chemical.
Rare.
Physical.
Deterioration, quality loss due to slow freezing.
Boo o.
Microbial growth and contamination
Chemical contamination
Chemical.
Physical.
Product destruction
NO
NO

YES
YES

NO

YES

NO

NO

YES

YES

NO

NO

NO
YES

NO

NO

NO

YES
NO

NO

YES

NO

NO

YES

NO

YES

YES

YES
YES

YES

YES

YES

YES

NO

NO
YES

NO

NO

YES
YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

YES

NO

YES

NO

NO

NO

NO

NO

NO
NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

NO

YES

YES

CCP7

CCP6

CCP5

418

Filet making

Blood removal

Evisceration

Whole salmon
receiving

Determined by
national
regulations
<100 ppm
histamine
>2mg per 100 gr
body weight

(3) Critical limits

measure
Determination of
the cultivation
area

(4)
WHAT

No presence.
Determination of
Process should
the possible
not last more
consequences
than 1 hour.
in fishes from
Possible suspicion
wrong
for contamination
application of
should place the
the technique
product on hold
Biological danger: No presence.
Determination of
Pathogenic miProcess should
the possible
croorganisms.
not last more
consequences
than 1 hour.
in fishes from
Possible suspicion
wrong
for contamination
application of
should place the
the technique
product on hold
Pathogenic miNo presence.
Determination of
croorganisms.
Process should not
the possible
last more than 1
consequences
hour.
in fishes from
Possible suspicion
wrong
for contamination
application of
should place the
the technique
product on hold

Pathogenic
microorganisms
from breeding
unit.
Biotoxins.
Histamine
formation.
Environmental
infectious
agents and
pesticides
Heavy metals
Biological danger:
Pathogenic microorganisms.

(2) Significant
hazards

(6)
FREQUENCY

(7)
WHO

Macroscopic
For every lot
control.
produced in 1
Temperature
hour
recording
meters.
Sampling for
microbiological
control.
Macroscopic
For every lot
control.
produced in 1
Temperature
hour
recording
meters.
Sampling for
microbiological
control.
Macroscopic
For every lot
control.
produced in 1
Temperature
hour
recording
meters.
Sampling for
microbiological
control.
Production staff.
Production
supervisor

Production staff
Production
supervisor

Production staff,
Production
supervisor

Chemical and
For every supplier Production
microbiological
supervisor.
analysis
Quality Control
Macroscopic
Staff.
control
Questionnaire for
the location of
the breeding
unit

(5)
HOW

Control.

Critical control points, hazards, critical limits, corrective actions and records for salmon processing

(1) Critical control

point (CCP)

Table 2

(9) Records

Good hygiene.
.
Temperature
control.

Good hygiene
practice, good
filtration of
washing water

Good hygiene
practice, tools
disinfection
following
evisceration.

Review of the
technique and
macroscopi
control of fishes
to detect any
contamination

Review of the
evisceration
technique and
macroscopic
control of fishes
to detect any
contamination

Review, control,
and record
correction one
week following
incident
occurrence.

(10) Verification

Processing records Controlled

hygiene and
sanitation.
Temperature
measurements

Processing

Processing

Stop fishing
Receiving records
authorized by
control agencies
Remove fishes.
Stop working with
these suppliers.

(8) Corrective
action

419

Distribution

Growth of
Products should not TTI label per
pathogenic mibe exposed to
packaged unit
croorganisms.
temperatures over
Chemical
4 C for more
contamination.
than 3 hours.
Inadequate
marking,
weight,
dehydration.
Possible presence Time and
Colour changes
of Clostridium
temperature
showing
botulinum toxin
should not
thermal
in the
exceed the limit
decomposition.
packaging with
for thermal
reduced
decomposition of
oxygen, if the
the product.
product is not
transported in
the right
packaging

Temperature of
cooling air.
Time period of
ice.

Casing/ Marking

Frrezing at 18 C.
Cooling at 4 C
for 24 hours.

Parasites.

Chiling/Freezing

Macroscopic
control during
storage and
distribution

Macroscopic
control during
packaging and
marking before
freezing.

Macroscopic fish
control.
Temperature
recording
meter.

Packaging
operator

Fridges and
freezers
operator.

Before storage,
Packaging
distribution and
operator
acceptance of
packaged
product

Every packaged
unit

Continuous,
freezing cycle.

Reject/destruct
any packaged
product
exceeding the
critical TTI
limit

Placement of
labels one hour
after casing
ready to be
stored

Maintenace of
fridges and
freezers.
Repeat of the
process.

Verification TTI
records

Verification TTI
records

Packaging records
before
distribution
showing any
product being
rejected due to
TTI changes

Internal activation
trials for new
TTIs, and
recording of
validation
sheets for each
order given by
the suppliers.

Temperature
Review, control
control chart for
and correction
each freezing
of the records in
cycle.
a week from
preparation.
Recording of the
daily
temperature
inside the
fridges.

420

I. S. ARVANITOYANNIS AND T. H. VARZAKAS

with regard to the size and quality. Thereafter the fish are placed
in heat-insulating packages, which are covered with transparent
membrane suitable for foods. The packings freeze/conservation,
which is effected in 4 C, follows. This stage is a CCP, because
the fish will be spoiled if the temperature is higher (Garthwaite,
1992). For this reason the control of cooling installations is necessary at regular periods. The fish are then placed in boxes which
are marked in their external side (CFIA, 1997). In this stage
the personnel must abide by the hygiene rules, so as to avoid
contamination of the packaged fish. Moreover, labelling must
be definite and correct. The boxes are placed in the freezer
18 C till their transport to the market for sale. It is important
for the temperature to remain frozen during the transport, which
should be carried out with transportation vehicles operating at
(18 C).
In the freezer salmon department, the stage of evisceration
is followed by the stage of ice placement, which must be mechanically produced (Lupin, 1995). Thus, one should keep the
temperature of the fish body low in order to avoid contamination and denaturation. Afterwards, they are washed with water,
which is potable and well-filtered so as to remove harmful substances and is compatible with the requirements of the instruction 80/778/EC in order to remove the extra ice and calibrate
the fish more easily with regard to the size and quality. Then,
the fish get hung to drain their liquids at a temperature of (4 C).
Following that, they get iced on their surface, i.e. a small layer of
ice is added to protect them from possible contamination. They
are then placed in cases and labeled (CFIA, 1997). During the
encasement the above-mentioned hygiene measures are applied.
Finally, the cases are placed in freeze conditions at 20 C or
even lower temperature (Hsing-Chen and Chen 1995) in view
of their transport to the market for sale.
In the process of fillet-making following evisceration washing with water follows with blood removal. The same measures
are applied in order to avoid contamination and product denaturation. Sorting out follows as well as placement of fish on ice
in order to be maintained at low temperature. The next step is
the head removal, which is considered as a critical point (CCP),
Table 3

since the risk of entrance of foreign matter (hair) into the fish
exists, which is undesirable and figures among the natural risks.
Following head removal washing is carried out to remove any remaining offals. Fillet making then follows during which a transverse section is carried out along the vertebral column on both
sides of each fish. A good fillet-making removes almost all the
intial microbial count of the fish, hence it is easy to produce fillets with no microbes and with a satisfactory shelf life from a fish
with high microbial loads (Papanastasiou, 1990). Despite that,
this stage is a CCP because the fillets might be contaminated by
pathogenic microorganisms and physical hazards. The possibility of appearance of skin, bones, and membranes in fillets also
exists. Regular preventative maintenance in conjunction with
continuous monitoring of the production line and direct corrective actions in case of deviations could prevent such phenomena.
Product lots with defects get exemptions and get processed for
a second time (Huss, 1995b). To reduce these hazards the processing units use good hygiene and control practices. Following
removal of the skin of the fillets they get imbibed in a dressing
sauce. This is considered a CCP because the sauce could carry
microbial load or pathogenic microorganisms such as E. coli.
Cleaning from the remaining sauce then follows as well as
macroscopic control for the presence of defective fillets. The
whole process should not last for more than an hour due to
the possible danger of spoilage of filets. The next stage is that of
cooling and the process of addition of ice. Fillets are then placed
in packages derived from heat-insulating material covered by a
transparent membrane suitable for food. Packaging should be
carried out under cooling conditions or lower to avoid possible
growth of microorganisms (Garthwaite, 1992). Fresh, frozen,
and salmon fillets should be packaged in cases which should
be labeled. Labeling should be carried out thoroughly not to
destroy packaging, whereas labels should be in accordance with
all regulations mentioning all the substances added in foods.
In the case of a deviation in labeling the machines should be
stopped, the right labels should be placed, and the defective
load should be isolated and relabeled (CFIA, 1997b). Finally,
cases are frozen until sold.

ISO 22000 Analysis Worksheet for determination of some prerequisite programs

PROCESSING STEP
Weighing
Grading
Washing
Sorting
Head removal
Skin removal
Dressing
Hunging
Icing
Sorting
Labeling
Freezing

Are the technical

infrastructure and the
preventative maintenance
program adequate

Is it
feasible to
evaluate them?

Do they contribute in
the control of
recognisable food
safety hazards?

Does the effectiveness

of the remaining
control measures
depend on them?

Is it a
prerequisite
program?

YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES

YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES

NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO
NO

YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES

YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES

421

6. Verification of processing water

treatment system.
7. SOPs for the following and applied
by trained employees:
SOP for clean-up and sanitation.
SOP for employee hygiene.
SOP for Pest Control.
8. Only cleaners, sanitizers, and
lubricants approved for use in food
processing facilities will be used.
9. SOP for the inspection and storage
of cleaning agents, sanitizers, and
lubricants.
10. Verify temperature on recorder
chart on refrigerated storage.

1. Inspection of construction and

equipment.
2. Continuous monitoring of plant
environment by trained personnel.
3. Inspection of construction and
equipment.
4. Perform preventative maintenance
on construction and equipment.
5. Inspection of Plant sanitation

Control Measure

10. Temperature of
refrigerated storage

8. Approved cleaners,
sanitizers, and
lubricants
9. Application of SOPs

5. Effectiveness of
cleaning procedures
6. Effectiveness of
chlorinator
7. Application of SOPs

1. Construction and
equipment of the plant
2. Overall plant
conditions
3. Construction and
equipment of the plant
4. n/a

What

3. Monthly
4. Quarterly

3. Inspect
4. Online checks

10. Visually check chart

10. Daily

9. Upon receipt

9. Inspect

10. QA Staff

9. QA staff

8. QA supervisor

7. QA supervisor

7. daily

8. once per week

6. QA Staff

5. QA Staff

4. Engineers

3. QA Supervisor

2. Production Manager

1. QA supervisor

Who

6. Each shift

8. monitoring

6. Testing for residual

chlorine at end of line
7. monitoring

5. Prior to daily start-up

2. Ongoing

2. Monitoring

5. Visual observation

1. Pre-season

Frequency

1. Inspect

How

Monitoring Procedure

Other examples of prerequisite programs, control measures, monitoring procedures, corrective actions (Adapted from Canadian Food Inspection Agency, 1998)

Plant Construction and

Equipment
Plant Sanitation &
Hygiene

Standard

Table 4

1. Record all deficiencies

on corrective action
report when the
deficiency is
identified.
2. QMP Supervisor will
sign and date the
corrective action
report.
3. The plant manager
will verify that the
appropriate corrective
action was taken.

Corrective Action

422
Table 5

I. S. ARVANITOYANNIS AND T. H. VARZAKAS

FMEA analysis and implementation of corrective actions

Processing stage

Dangers

Surveillance activity

RPN

Corrective action

S

O

D

RPN

Fish receiving

Biological
Microorganisms
Chemical
Toxins, pesticides,
Heavy metals
Physical
bruises, deformations

Determination of breeding
7
area
Questionnaire for the location 7
of the new cultivation unit

252

84

210

112

12

210

84

175

Fish removal.
Stop cooperation with bad
suppliers.
Stricter sampling control
during receiving
Regular audit of new
cultivation area as well as
conditions in the area.
Good hygiene practice,
wash the tools well
following evisceration.
Reject or repeat the process.

84

72

210

56

210

84

56

48

210

84

240

84

240

84

100

160

84

8
4

5
4

5
2

200
32

112

Evisceration

Biological
Microorganisms growth
Chemical
Chemical contamination
Physical
Foreign matter
Blood removal
Biological
Microorganisms growth
Chemical
Rarely found
Physical
Rarely found
Filet making
Biological
Contamination with
pathogenic
microorganisms
Chemical
Chemical contamination
Physical
Foreign matter
Cooling/Freezing Biological
Parasites
Chemical
Rarely found
Physical
Rarely found
Casing /marking Biological
Growth of
microorganisms
Chemical
Chemical contamination
Physical
Improper marking,
weight, dehydration
Distribution
Biological
Pathogenic
microorganisms,
Clostridium botulinum
o
Chemical
Physical
Wrong placement,
foreign matter

Macroscopic fish control.

Temperature control meter.
Sampling for microbiological
examination

Macroscopic fish control.

Temperature control meter.
Sampling for microbiological
examination

Macroscopic fish control.

Temperature control meter.
Sampling for microbiological
control

Macroscopic fish control.

Temperature control meter

Macroscopic control during

packaging and marking
before freezing

Macroscopic control during

freezing, storage and
distribution

Risk Determination
Risk analysis is a procedure which provides with the information and conditions for the appeared risks, in order to decide
which are important for the food safety and which should be
examined in the HACCP applied by each firm. The risks in
the foods safety may be derived from the feedstocks, the envi-

Good hygiene practice,

good filtration of the
washing water
Repetition

Good hygiene practice.

.
Temperature control

Adjustment of fridges.
Repeat process.
Hold the lot and assess the
fish quality.

Good personnel hygiene

Placement of labels in less
than an hour after
placement in cases.
Sampling control

Good personnel hygiene

Reject/destroy any
packaged product has
exceeded the critical TTI
(temperature, time) limit
Adjustment of the
distribution vehicles

ronment, and the personnel who deal with food. Consequently,

the risk analysis is a procedure which enables us to find if the
possible risks are important and if they must be controlled. During this procedure the risk importance will be defined in accordance with the present levels, the sizes, or the doses of the
causes generating it. Moreover, the effect of the cause varies
depending on the foods and the sensibility of the person who

ISO 22000, FMEA ANALYSIS FOR SALMON PROCESSING

Figure 3

423

Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP receiving of fresh salmon).

receives it. Some causes for example are more dangerous than
others and there is a great variety in the intensity of the effect. However, there is always a level below which the presence of such a cause is considered acceptable. The hazards are
classified in three large categories: biological, chemical, and
physical.
The possibly harmful substances appear in many feedstocks
and usually at very low levels. They become hazardous when
their level or the level of toxins they produce, increase so as to
cause illness. For viruses and parasites in foodstuffs the same
phenomenon occurs as in naturally occurring toxins and chemical substances.
HACCP is a dynamic system and during the analysis of
HACCP all changes already done or due to be carried out should
be taken into account. Every change could introduce a hazard,
hence each change could cause the process of hazard analysis.
Once a HACCP plan is implemented it is essential to be main-

tained continuously. Each new raw material could bring a new

hazard. Hence, the possible new hazards should be analysed
during and after the end of the manufacturing process (Codex
Alimentarius Commission, 1997).

Determination of CCPs and Implementation

of Corrective Actions
A (CCP) is the point where control is carried out to prevent or remove a possible danger for product food safety or
reduce it at an acceptable level. Hence, hazard analysis with
determination of CCPs in the manufacturing line helps us determine the critical limits for each CCP, or identify the criteria
which determine when a product is suitable or not. To determine the critical control points a tree diagram is being employed
(Fig. 2) (Lee and Hathaway, 1998). This is derived from what

424

I. S. ARVANITOYANNIS AND T. H. VARZAKAS

Figure 4

Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP evisceration of fishes).

is being developed from the National Advisory Committee for

Microbiological Criteria for foods (NACMCF).
In the case of a deviation from a CCP and its critical limit,
and corrective action should be employed. Corrective action
should ensure that the CCP is under control. Deviation procedures should be documented in HACCP records.
In Table 2, critical points, critical limits, and corrective actions are determined during the manufacturing processing of
salmon. Verification is also shown as well as the necessary
records. Table 3 also describes an ISO22000 analysis worksheet
for determination of the prerequisite programs.
Table 4 shows other examples of prerequisite programs, control measures, monitoring procedures, and corrective actions.
Results of Failure Mode and Effects Analysis
In FMEA analysis, a risk of contamination and its presence at Hazardous Fraction in the final product, is expressed

with the risk Priority Number (RPN) which is defined as

follows:
RPN = S O D

(1)

Where S is the Severity of contamination risk, O is the

supply probability occurrence of the contaminated ingredient, and D is the Detection probability of the contaminated
ingredient.
FMEA tables were constructed where Hazardous Elements
(ingredients) are assessed and the RPN was calculated as can be
seen in Table 5.
The classification of hazardous elements occurs according to
the RPN assessment as can be seen in Table 5 and corrective
actions are proposed per identified hazard. The new RPN is
calculated following undertaking of corrective actions.
Table 5 helps us to understand for which CCPs corrective
action needs to be applied. The limit for RPN is 130 and if this

ISO 22000, FMEA ANALYSIS FOR SALMON PROCESSING

Figure 5

425

Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP cooling and freezing).

number exceeds 130 corrective action should be implemented.

Hence, for salmon receiving, considered to be one of the CCPs,
corrective action should be applied. More specifically hazards
to be eliminated are bioaccumulation of heavy metals and toxin
formation. RPN for these specific dangers exceeds the critical
safety limit. Following application of corrective actions such as
change of supplier, regular control, and audit of the new cultivation area and stricter control during receiving of the salmon,
the RPN number is reduced to normal levels. This is the way
one should work with the other CCPs, taking the necessary
measures where necessary. The possibility of occurrence as well
as the detection probability of a specific danger are factors which
change dramatically following application of corrective actions,
with RPN numbers below the safety limit. However, the severity
of contamination risk rarely gets reduced with implementation
of corrective actions.

Ishikawa Fish Bone Diagram

The Ishikawa diagram or fishbone diagram, invented by
Ishikawa, a Japanese quality control statistician, is an analysis tool that provides a systematic way of looking at effects and
the causes that create or contribute to those effects. It may be referred to as a cause-and-effect diagram. Due to its resemblance
to a fish skeleton it is often referred to as the fishbone diagram (http://quality.enr.state.nc.us/tools/fishbone.htm). An implementation of the Ishikawa diagram for each CCP in salmon
processing is given in the following figures.
In Fig. 3 the possible causes for problems in the receiving
step are identified. It is essential that the fresh salmon used for
processing is of high quality. Suppliers should be carefully selected. The supplier must provide the company with the appropriate documents that certify the origin of salmon and if it is

426

I. S. ARVANITOYANNIS AND T. H. VARZAKAS

Figure 6

Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP casing-labeling).

genetically modified or not. It is of essential importance that

the salmon arrives in very good condition. If it contains a high
concentration of heavy metals or pesticide and insecticide
residues or germs, no further production step or specific treatment will be able to reduce the hazards.
The excess quantity of pesticides due to soil removal is led
to the sea where it could cause huge problems. The bioaccumulation of these substances could be reduced with the right
training and education. Trained human personnel and the right
lab equipment could easily diagnose these kinds of problems.
In Fig. 4 the possible causes for occurring problems in evisceration of fishes are identified. The main hazard resides in the
presence of foreign matter, a physical hazard that could cause
problems in the equipment and in the next processing stage.
Moreover, problems could occur due to lack of personnel training with the immediate effect of non-compliance with good

hygiene practices, wrong handling during disinfection of tools,

and bad functioning of equipment due to lack of maintenance.
In Fig. 5 the possible causes for the chilling/freezing stage
are due to equipment and human personnel. Lack of personnel training could lead to wrong handling of temperature or
humidity which are key parameters in this process and should
be monitored online.
Control of equipment could be inadequate or unable to provide the suitable temperature or humidity due to bad maintenance.
In Fig 6 the causes for problems in packaging/labeling are
identified. The problems are due to material and equipment as
well as personnel. Packaging materials could be inappropriate to
come into contact with food, however, trained personnel could
help to avoid this problem and replace them if a situation is
problematic. Packaging equipment could be problematic due to

ISO 22000, FMEA ANALYSIS FOR SALMON PROCESSING

Figure 7

427

Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP distribution).

bad or ineffective maintenance or lack of trained engineers to be

able to carry out the job.
In Fig. 7 the causes for the problems in distribution are identified. Wrong temperature at the distribution vehicles is either
due to wrong adjustment or inadequate equipment which has
been badly maintained. Personnel could not be well trained due
to lack of funds or no investment in training for firms.
Finally, special attention at all previous stages should be
made to avoid cross-contamination from the residing microflora
of the plant. Hence, good cleaning and sanitizing procedures
(prerequisite programs) will avoid the occurrence of pathogens.
In conclusion, one can easily understand that the combination of
critical control points, the determination and the failure mode,
cause and effect analysis, aim at assuring the safety and quality
of the product. It does not seem possible to speculate whether

one is more effective than the other. One of the main advantages
of the Ishikawa diagram is that it presents in a comprehensive
way the stages that can cause problems in production and focuses on the roots of these problems so as to identify the most
suitable solution.
Figure 8 displays a tree diagram (four questions) for determining which hazards can be controlled by the application of
prerequisite programs, thereby reducing the number of CCPs.

CONCLUSIONS
In this work a comparison of ISO22000 analysis with HACCP
is carried out over salmon processing and packaging. Failure

428

I. S. ARVANITOYANNIS AND T. H. VARZAKAS

low the upper acceptable limit of 130). It is noteworthy that the

application of Ishikawa (Cause and Effect or Tree diagram) led
to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the
incorporation of FMEA analysis within the ISO 22000 system
of a salmon processing industry is anticipated to prove advantageous to industrialists, state food inspectors, and consumers.
Figure 8 displays a tree diagram (four questions) for determining which hazards can be controlled by the application of
prerequisite programs, thereby reducing the number of CCPs.
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Figure 8 Tree diagram for determination of prerequisite programs according

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