application of iso 22000 and failure mode and effect analysis

Critical Reviews in Food Science and Nutrition, 48:411–429 (2008)Copyright C©© Taylor and Francis Group, LLCISSN: 1040-8398DOI: 10.1080/10408390701424410

Application of ISO 22000 and FailureMode 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 AquaticEnvironment, Fytoko Street, 38446 Nea Ionia Magnesias, Volos, Hellas (Greece)2Technological Educational Institute of Kalamata, School of Agricultural Sciences, Department of Technology of AgriculturalProducts, Hellas (Greece) e-mail: [email protected]

The Failure Mode and Effect Analysis (FMEA) model was applied for risk assessment of salmon manufacturing. A tentativeapproach 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 (salmonprocessing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon whichthe system depends. Critical Control points were identified and implemented in the cause and effect diagram (also known asIshikawa, 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 processinghazard. Fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing, and distribution were theprocesses identified as the ones with the highest RPN (252, 240, 210, 210, 210, 210, 200 respectively) and corrective actionswere undertaken. After the application of corrective actions, a second calculation of RPN values was carried out resultingin 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 riskassessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO 22000 system of a salmon processingindustry 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 anadministration system, in which the safety of foods is controlledthrough an analysis and control of biological, chemical, andphysical risks, which may appear in every step of a productproduction. Namely, HACCP receives isolated procedures ofquality 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 er-rors being considered as new production risks when they occur.

∗Address correspondence to I. S. Arvanitoyannis (Dr, Ph.D.) AssociateProfessor, University of Thessaly, School of Agricultural Sciences, Depart-ment of Agriculture, Ichthyology and Aquatic Environment, Fytoko Street,38446 Nea Ionia Magnesias, Volos, Hellas (Greece); Fax: +302421093144;Tel.: +302421093104. E-mail: [email protected].

Nowadays, a wide application of HACCP is proposed in the en-tire production system and foods traffic, which goes from thefield and the stable to the industry, the wholesale dealer, theretailer, and finally the consumer.

The HACCP principle is applied in the sea-food indus-try since the decade of the 70s. In 1986 the National MarineSanctuary Foundation (NMSF) and the National Seafood In-spection Laboratory (NSIL) examined the probable risks inseafood products by official request submitted by the Ameri-can Congress (Garrett et al., 1995) In 1991 the research for theHACCP application in the seafood industry was accomplished.

The basis for the introduction of inspection new systems suchas HACCP, ISO 9000 or QMP is included in the agreement forthe health and plant phytosanitary measures and requires thatall members apply the measures based on a risk evaluation sup-ported by scientific elements (Karnichi, 1997). The agreements

411

412 I. S. ARVANITOYANNIS AND T. H. VARZAKAS

for the national commerce of fish include also, among otherthings, the Uruguay agreement (1994), while the revision is gov-erned 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 eval-uation of fish (Lupin, 1997). Nowadays, HACCP is applied orshall be applied in the fish industry worldwide, given that the de-veloped countries, such as the United States, help the developingor even the underdeveloped countries to apply it (Trott, 1997).The EU requirements for HACCP concern also the controls forcompanies and refer to the main principles of internal audit. Thegovernment of Canada also included HACCP in the qualitativemanagement program (QMP) (Barker and McKenzie, 1997).

In particular, the EU Council directive no 91/493/93 intro-duced the application of HACCP in the EU, which describesthe health regulations in the fishery production and distribution,while specific attention is given on the determination of criti-cal points control, the sampling, and the filing. Other processesintroduced 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 qual-itative administration is supported by educating the fishermen,using experienced inspectors, developing right practices of labo-ratories, culture, manipulation, construction, and using a reliablestandard system (Wiryanti, 1997). HACCP must be orientatedtowards the product quality, the aid of personnel, and of coursethe client’s satisfaction (Love, 1997). The computational tech-niques serve the flow diagrams supporting the fish enterprises,help the file-keeping, improve the risk analysis, and the criticalpoint control application (Norback, 1997). The internal inspec-tions of enterprises based on HACCP refer to the installationsorganization, the official regulations, the products and the pro-duction process for the products recall, and the purchase processfrom the client (Valset, 1997).

Current Situation of Salmon (Salmo salar)

The salmon in the Atlantic ocean (Salmo salar) began to becultivated in the internal waters of England in the 19th century inorder to enforce its ferocious population. The aquaculture breed-ing in oceanic cages was used initially in Norway in the decadeof the 60’S with a view to achieving a growth corresponding tothe commercial size. The aquaculture success in Norway urgedthe development of salmons aquaculture in Scotland, Ireland,Canada, the Northeast Coast of USA, and recently in Chile andAustralia (Tasmania). Apart from these countries, New Zealand,France, and Spain have also a salmon production but a smallerone.

In general, the countries producing salmon are situated be-tween the geographical latitudes 40◦–70◦ in the northern hemi-sphere and 40◦–50◦ in the southern hemisphere. The prematureNorwegian success depicted its well-protected areas due to per-fect hydrographic conditions (invariable temperature and salin-ity), 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 theNorwegian one. The profits, however, derived from the salmonaquaculture exceed far and away those derived from fishery.Apart from these countries, the salmon aquaculture is presentedin North America as well as in Chile, which competes with thecountries of the northern hemisphere because of low productioncosts and easy access to fish flour for the production of salmonfoods. The fast production increases have led to reduced prices,which, thereafter, have exercised constant pressure toward theproducers to reduce the production costs. The important futureindustry expansion may be based on the development of coastalareas, given that most of the available suitable coastal areas arealready in use and due to the increased competition and furtherexpansion in protected areas.

Nowadays, the great majority of salmon production in theAtlantic Ocean (Salmo salar) is a hybrid stock which comesinitially from the ferocious salmon crossed with the Norwegianone. Some programs of family procreation are currently in force,in order to determine the family frame with increasing produc-tion possibilities or resistance in illnesses. The use of gender orthe genetic treatment of Salmon salar is not widely used in thecultivated fishes. (http://www.fao.org/figis/servlet/static?dom=culturespecies&xml=Salmosalar.xml).

The ferocious salmon of the Atlantic Ocean appears in theNorth Atlantic Ocean, in the European countries (from Portugalto Russia), and the north American coasts. They also appeararound the North Atlantic Ocean islands (i.e. England, Iceland,Greenland). They pass up to four years of their life in deep watersand eat red herrings, squids. In the maturation beginning, fishstop eating and return to their original rivers to birth (October–January). Most of the fish die after the oviparous period; althoughsome of them may return to the sea as “kelts.”

The eggs are released and greased. The hatched eggs getan eye after 250 hot days and are hatched after 250 more hotdays during the spring. The hatched larvae eat their lecithinbag stocks for 300 hot days until they receive external feed as“fry.” The young fish remain in rivers, eating insects loopers andsmall fish for a 2–5 year period until they began to be adaptedin the sea water, where they are transformed in “smolts” andemigrate to the sea (normally from March–June), to build up andmature. The smolts are normally about 20–30 gr. The sea fish canreach big sizes and when they begin their emigration in order tobirth, usually reach 8–13 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 com-monly conducted and proposed is the Failure Mode and EffectsAnalysis-FMEA (Kumamoto and Henley, 1996). FMEA is pro-posed as long as its use will help the classification of risk ruledby 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 413

Figure 1 Flow diagram of salmon processing


FMEA technique considers each item that comprises the totalsystem. Analysis is made, based both on the best expert opinionand historical information for similar items, of all the ways thateach component or subsystem might fail to fulfill its intendedfunction (James, 1998).

Therefore, the study group agrees that, the complete under-standing of all possible effects of GMOs in the product systemis critical and all possible reactions or repercussions must beevaluated by means of risk analysis. Failure Mode and EffectAnalysis (FMEA) appears to be an appropriate matrix for thisactivity (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 ofsalmon alteration (Fig. 1). The fish are harvested alive from theaquaculture 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-insulatingmaterial, which are covered with ice. During their transfer, thetemperature must be kept at low levels (0◦–4◦C ). In partic-ular, the main events which occurred after the fish death arethe muscular inflexibility, the autooxidation, and the bacterialdenaturation. Consequently, the fish freeze must start just af-ter their capture, so that its temperature could be reduced to3◦C or even more in about one hour (ICMSF, 1998). Great at-tention should be paid in case the aquaculture farms are faraway from the alteration farms. In this case, the transportationis made with vans with freeze temperature (−18◦C). The stageof fish collection is a critical control point, since they mightbe polluted by biological and chemical factors, which dependson the area where the fattening farm is installed as well as onthe prevalent conditions (Pedrosa-Menabrito,1990). This is themain reason why the sampling control is absolutely necessary(Table 1).

The next stage is that of weighing. This stage allows us toknow the amounts of fish to be altered and help us to classifythe fish correctly, in order for a sort of classification of the pro-duced product to exist with regard to the weight (CFIA, 1997a).Classification comes next to the weighing stage, followed byevisceration. The processing industry should comply with hy-giene principles as well as GMP practices in order to avoidundesirable effects on the quality of the altered product. There-fore, the workers must wear gloves and a skull-cup as well as awhite pinny up to the knees and white boots. Aside from these,hygiene seminars must be organized regularly for the workersin order to understand the terms of hygiene. The evisceration isapplied 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 ispaid to the observance of strict hygiene rules, since, during thisprocedure, microorganisms may infect the exposed fish flesh(ICMSF, 1998). One can employ both manual workers and/orautomatic machines with a speed of 55 fish/ minute for roundfish and 30 fish/minute for flat ones. The complete disinfectionof machines is very important because the residues of the pro-cess (flesh, blood etc) are an excellent substrate for pathogenicmicroorganisms (Olsen, 1995).

During the evisceration stage the production line is dividedin 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 bloodremoval. This stage is a critical control point (CCP) becausethe used water must be potable and well-filtered so as to re-move harmful substances and microorganisms and be compat-ible with the requirements of the 80/778/EC instruction. After-wards calibration is carried out where these fish get classified

Tabl

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Que

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(Con

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415

Tabl

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417

Tabl

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Cri

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.Pr

oces

ssh

ould

notl

astm

ore

than

1ho

ur.

Poss

ible

susp

icio

nfo

rco

ntam

inat

ion

shou

ldpl

ace

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prod

ucto

nho

ld

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erm

inat

ion

ofth

epo

ssib

leco

nseq

uenc

esin

fishe

sfr

omw

rong

appl

icat

ion

ofth

ete

chni

que

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rosc

opic

cont

rol.

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pera

ture

reco

rdin

gm

eter

s.Sa

mpl

ing

for

mic

robi

olog

ical

cont

rol.

For

ever

ylo

tpr

oduc

edin

1ho

ur

Prod

uctio

nst

aff,

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uctio

nsu

perv

isor

Goo

dhy

gien

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actic

e,to

ols

disi

nfec

tion

follo

win

gev

isce

ratio

n.

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essi

ngR

evie

wof

the

evis

cera

tion

tech

niqu

ean

dm

acro

scop

icco

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lof

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sto

dete

ctan

yco

ntam

inat

ion

Blo

odre

mov

alB

iolo

gica

ldan

ger:

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ogen

icm

i-cr

oorg

anis

ms.

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pres

ence

.Pr

oces

ssh

ould

notl

astm

ore

than

1ho

ur.

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ible

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icio

nfo

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ion

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ldpl

ace

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ld

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erm

inat

ion

ofth

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nseq

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rong

appl

icat

ion

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ete

chni

que

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rosc

opic

cont

rol.

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pera

ture

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rdin

gm

eter

s.Sa

mpl

ing

for

mic

robi

olog

ical

cont

rol.

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ever

ylo

tpr

oduc

edin

1ho

ur

Prod

uctio

nst

aff

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uctio

nsu

perv

isor

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dhy

gien

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e,go

odfil

trat

ion

ofw

ashi

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ater

Proc

essi

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the

tech

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ctan

yco

ntam

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ion

File

tmak

ing

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ogen

icm

i-cr

oorg

anis

ms.

No

pres

ence

.Pr

oces

ssh

ould

not

last

mor

eth

an1

hour

.Po

ssib

lesu

spic

ion

for

cont

amin

atio

nsh

ould

plac

eth

epr

oduc

ton

hold

Det

erm

inat

ion

ofth

epo

ssib

leco

nseq

uenc

esin

fishe

sfr

omw

rong

appl

icat

ion

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ete

chni

que

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rosc

opic

cont

rol.

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pera

ture

reco

rdin

gm

eter

s.Sa

mpl

ing

for

mic

robi

olog

ical

cont

rol.

For

ever

ylo

tpr

oduc

edin

1ho

ur

Prod

uctio

nst

aff.

Prod

uctio

nsu

perv

isor

Goo

dhy

gien

e..

Tem

pera

ture

cont

rol.

Proc

essi

ngre

cord

sC

ontr

olle

dhy

gien

ean

dsa

nita

tion.

Tem

pera

ture

mea

sure

men

ts

418

Chi

ling/

Free

zing

Para

site

s.Fr

rezi

ngat

−18◦

C.

Coo

ling

at4◦

Cfo

r24

hour

s.

Tem

pera

ture

ofco

olin

gai

r.T

ime

peri

odof

ice.

Mac

rosc

opic

fish

cont

rol.

Tem

pera

ture

reco

rdin

gm

eter

.

Con

tinuo

us,

free

zing

cycl

e.Fr

idge

san

dfr

eeze

rsop

erat

or.

Mai

nten

ace

offr

idge

san

dfr

eeze

rs.

Rep

eato

fth

epr

oces

s.

Tem

pera

ture

cont

rolc

hart

for

each

free

zing

cycl

e.

Rev

iew

,con

trol

and

corr

ectio

nof

the

reco

rds

ina

wee

kfr

ompr

epar

atio

n.R

ecor

ding

ofth

eda

ilyte

mpe

ratu

rein

side

the

frid

ges.

Cas

ing/

Mar

king

Gro

wth

ofpa

thog

enic

mi-

croo

rgan

ism

s.C

hem

ical

cont

amin

atio

n.In

adeq

uate

mar

king

,w

eigh

t,de

hydr

atio

n.

Prod

ucts

shou

ldno

tbe

expo

sed

tote

mpe

ratu

res

over

4◦C

for

mor

eth

an3

hour

s.

TT

Ila

belp

erpa

ckag

edun

itM

acro

scop

icco

ntro

ldur

ing

pack

agin

gan

dm

arki

ngbe

fore

free

zing

.

Eve

rypa

ckag

edun

itPa

ckag

ing

oper

ator

Plac

emen

tof

labe

lson

eho

uraf

ter

casi

ngre

ady

tobe

stor

ed

Ver

ifica

tion

TT

Ire

cord

sIn

tern

alac

tivat

ion

tria

lsfo

rne

wT

TIs

,and

reco

rdin

gof

valid

atio

nsh

eets

for

each

orde

rgi

ven

byth

esu

pplie

rs.

Dis

trib

utio

nPo

ssib

lepr

esen

ceof

Clo

stri

dium

botu

linu

mto

xin

inth

epa

ckag

ing

with

redu

ced

oxyg

en,i

fth

epr

oduc

tis

not

tran

spor

ted

inth

eri

ght

pack

agin

g

Tim

ean

dte

mpe

ratu

resh

ould

not

exce

edth

elim

itfo

rth

erm

alde

com

posi

tion

ofth

epr

oduc

t.

Col

our

chan

ges

show

ing

ther

mal

deco

mpo

sitio

n.

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rosc

opic

cont

rold

urin

gst

orag

ean

ddi

stri

butio

n

Bef

ore

stor

age,

dist

ribu

tion

and

acce

ptan

ceof

pack

aged

prod

uct

Pack

agin

gop

erat

orR

ejec

t/des

truc

tan

ypa

ckag

edpr

oduc

tex

ceed

ing

the

criti

calT

TI

limit

Ver

ifica

tion

TT

Ire

cord

sPa

ckag

ing

reco

rds

befo

redi

stri

butio

nsh

owin

gan

ypr

oduc

tbei

ngre

ject

eddu

eto

TT

Ich

ange

s

419


with regard to the size and quality. Thereafter the fish are placedin heat-insulating packages, which are covered with transparentmembrane suitable for foods. The packings freeze/conservation,which is effected in 4◦C, follows. This stage is a CCP, becausethe fish will be spoiled if the temperature is higher (Garthwaite,1992). For this reason the control of cooling installations is nec-essary at regular periods. The fish are then placed in boxes whichare marked in their external side (CFIA, 1997β). In this stagethe personnel must abide by the hygiene rules, so as to avoidcontamination of the packaged fish. Moreover, labelling mustbe definite and correct. The boxes are placed in the freezer−18◦C till their transport to the market for sale. It is importantfor the temperature to remain frozen during the transport, whichshould be carried out with transportation vehicles operating at(−18◦C).

In the freezer salmon department, the stage of eviscerationis followed by the stage of ice placement, which must be me-chanically produced (Lupin, 1995). Thus, one should keep thetemperature of the fish body low in order to avoid contamina-tion and denaturation. Afterwards, they are washed with water,which is potable and well-filtered so as to remove harmful sub-stances and is compatible with the requirements of the instruc-tion 80/778/EC in order to remove the extra ice and calibratethe 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 ofice is added to protect them from possible contamination. Theyare then placed in cases and labeled (CFIA, 1997β). During theencasement the above-mentioned hygiene measures are applied.Finally, the cases are placed in freeze conditions at −20◦C oreven lower temperature (Hsing-Chen and Chen 1995) in viewof their transport to the market for sale.

In the process of fillet-making following evisceration wash-ing with water follows with blood removal. The same measuresare applied in order to avoid contamination and product denat-uration. Sorting out follows as well as placement of fish on icein order to be maintained at low temperature. The next step isthe head removal, which is considered as a critical point (CCP),

Table 3 ISO 22000 Analysis Worksheet for determination of some prerequisite programs

Are the technical Do they contribute in Does the effectivenessinfrastructure and the Is it the control of of the remaining Is it a

preventative maintenance feasible to recognisable food control measures prerequisitePROCESSING STEP program adequate evaluate them? safety hazards? depend on them? program?

Weighing YES YES NO YES YESGrading YES YES NO YES YESWashing YES YES NO YES YESSorting YES YES NO YES YESHead removal YES YES NO YES YESSkin removal YES YES NO YES YESDressing YES YES NO YES YESHunging YES YES NO YES YESIcing YES YES NO YES YESSorting YES YES NO YES YESLabeling YES YES NO YES YESFreezing YES YES NO YES YES

since the risk of entrance of foreign matter (hair) into the fishexists, which is undesirable and figures among the natural risks.Following head removal washing is carried out to remove any re-maining offals. Fillet making then follows during which a trans-verse section is carried out along the vertebral column on bothsides of each fish. A good fillet-making removes almost all theintial microbial count of the fish, hence it is easy to produce fil-lets with no microbes and with a satisfactory shelf life from a fishwith high microbial loads (Papanastasiou, 1990). Despite that,this stage is a CCP because the fillets might be contaminated bypathogenic microorganisms and physical hazards. The possibil-ity of appearance of skin, bones, and membranes in fillets alsoexists. Regular preventative maintenance in conjunction withcontinuous monitoring of the production line and direct correc-tive actions in case of deviations could prevent such phenomena.Product lots with defects get exemptions and get processed fora second time (Huss, 1995b). To reduce these hazards the pro-cessing units use good hygiene and control practices. Followingremoval of the skin of the fillets they get imbibed in a dressingsauce. This is considered a CCP because the sauce could carrymicrobial load or pathogenic microorganisms such as E. coli.

Cleaning from the remaining sauce then follows as well asmacroscopic control for the presence of defective fillets. Thewhole process should not last for more than an hour due tothe possible danger of spoilage of filets. The next stage is that ofcooling and the process of addition of ice. Fillets are then placedin packages derived from heat-insulating material covered by atransparent membrane suitable for food. Packaging should becarried out under cooling conditions or lower to avoid possiblegrowth of microorganisms (Garthwaite, 1992). Fresh, frozen,and salmon fillets should be packaged in cases which shouldbe labeled. Labeling should be carried out thoroughly not todestroy packaging, whereas labels should be in accordance withall regulations mentioning all the substances added in foods.In the case of a deviation in labeling the machines should bestopped, the right labels should be placed, and the defectiveload should be isolated and relabeled (CFIA, 1997b). Finally,cases are frozen until sold.

Tabl

e4

Oth

erex

ampl

esof

prer

equi

site

prog

ram

s,co

ntro

lmea

sure

s,m

onito

ring

proc

edur

es,c

orre

ctiv

eac

tions

(Ada

pted

from

Can

adia

nFo

odIn

spec

tion

Age

ncy,

1998

)

Mon

itori

ngPr

oced

ure

Stan

dard

Con

trol

Mea

sure

Wha

tH

owFr

eque

ncy

Who

Cor

rect

ive

Act

ion

Plan

tCon

stru

ctio

nan

dE

quip

men

t1.

Insp

ectio

nof

cons

truc

tion

and

equi

pmen

t.1.

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stru

ctio

nan

deq

uipm

ento

fth

epl

ant

1.In

spec

t1.

Pre-

seas

on1.

QA

supe

rvis

or1.

Rec

ord

alld

efici

enci

eson

corr

ectiv

eac

tion

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tSan

itatio

n&

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iene

2.C

ontin

uous

mon

itori

ngof

plan

ten

viro

nmen

tby

trai

ned

pers

onne

l.2.

Ove

rall

plan

tco

nditi

ons

2.M

onito

ring

2.O

ngoi

ng2.

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uctio

nM

anag

erre

port

whe

nth

ede

ficie

ncy

is3.

Insp

ectio

nof

cons

truc

tion

and

equi

pmen

t.3.

Con

stru

ctio

nan

deq

uipm

ento

fth

epl

ant

3.In

spec

t3.

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thly

3.Q

ASu

perv

isor

iden

tified

.2.

QM

PSu

perv

isor

will

4.Pe

rfor

mpr

even

tativ

em

aint

enan

ceon

cons

truc

tion

and

equi

pmen

t.4.

n/a

4.O

nlin

ech

ecks

4.Q

uart

erly

4.E

ngin

eers

sign

and

date

the

corr

ectiv

eac

tion

5.In

spec

tion

ofPl

ants

anita

tion

5.E

ffec

tiven

ess

ofcl

eani

ngpr

oced

ures

5.V

isua

lobs

erva

tion

5.Pr

ior

toda

ilyst

art-

up5.

QA

Staf

fre

port

.3.

The

plan

tman

ager

6.V

erifi

catio

nof

proc

essi

ngw

ater

trea

tmen

tsys

tem

.6.

Eff

ectiv

enes

sof

chlo

rina

tor

6.Te

stin

gfo

rre

sidu

alch

lori

neat

end

oflin

e6.

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hsh

ift

6.Q

ASt

aff

will

veri

fyth

atth

eap

prop

riat

eco

rrec

tive

7.SO

Psfo

rth

efo

llow

ing

and

appl

ied

bytr

aine

dem

ploy

ees:

•SO

Pfo

rcl

ean-

upan

dsa

nita

tion.

•SO

Pfo

rem

ploy

eehy

gien

e.•S

OP

for

Pest

Con

trol

.

7.A

pplic

atio

nof

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7.m

onito

ring

7.da

ily7.

QA

supe

rvis

orac

tion

was

take

n.

8.O

nly

clea

ners

,san

itize

rs,a

ndlu

bric

ants

appr

oved

for

use

info

odpr

oces

sing

faci

litie

sw

illbe

used

.

8.A

ppro

ved

clea

ners

,sa

nitiz

ers,

and

lubr

ican

ts

8.m

onito

ring

8.on

cepe

rw

eek

8.Q

Asu

perv

isor

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Pfo

rth

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spec

tion

and

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age

ofcl

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ngag

ents

,san

itize

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ndlu

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ants

.

9.A

pplic

atio

nof

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9.In

spec

t9.

Upo

nre

ceip

t9.

QA

staf

f

10.V

erif

yte

mpe

ratu

reon

reco

rder

char

ton

refr

iger

ated

stor

age.

10.T

empe

ratu

reof

refr

iger

ated

stor

age

10.V

isua

llych

eck

char

t10

.Dai

ly10

.QA

Staf

f

421


Table 5 FMEA analysis and implementation of corrective actions

Processing stage Dangers Surveillance activity S O D RPN Corrective action S′ O′ D′ RPN′

Fish receiving BiologicalMicroorganisms

ChemicalToxins, pesticides,Heavy metals

Physicalbruises, deformations

Determination of breedingarea

Questionnaire for the locationof the new cultivation unit

7

7

2

6

6

3

6

5

2

252

210

12

Fish removal.Stop cooperation with bad

suppliers.Stricter sampling control

during receivingRegular audit of new

cultivation area as well asconditions in the area.

7

7

—

3

4

—

4

4

—

84

112

—

Evisceration BiologicalMicroorganisms growth

ChemicalChemical contamination

PhysicalForeign matter

Macroscopic fish control.Temperature control meter.Sampling for microbiological

examination

7

7

6

5

5

3

6

5

4

210

175

72

Good hygiene practice,wash the tools wellfollowing evisceration.

Reject or repeat the process.

7

7

—

3

4

—

4

3

—

84

84

—

Blood removal BiologicalMicroorganisms growth

ChemicalRarely found

PhysicalRarely found


examination

7

—

—

5

—

—

6

—

—

210

—

—

Good hygiene practice,good filtration of thewashing water

Repetition

7

—

—

4

—

—

2

—

—

56

—

—

Filet making BiologicalContamination withpathogenicmicroorganisms


PhysicalForeign matter


control

7

7

6

5

5

2

6

6

4

210

48

Good hygiene practice..

Temperature control

7

7

—

4

4

—

3

2

—

84

56

—

Cooling/Freezing BiologicalParasites

ChemicalRarely found

PhysicalRarely found

Macroscopic fish control.Temperature control meter

7

—

—

5

—

—

6

—

—

210

—

—

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

fish quality.

7

—

—

4

—

—

3

—

—

84

Casing /marking BiologicalGrowth ofmicroorganisms


PhysicalImproper marking,weight, dehydration

Macroscopic control duringpackaging and markingbefore freezing

8

8

4

5

6

5

6

5

5

240

240

100

Good personnel hygienePlacement of labels in less

than an hour afterplacement in cases.

Sampling control

7

7

—

4

4

—

3

3

—

84

84

—

Distribution BiologicalPathogenicmicroorganisms,Clostridium botulinumτoξ ινης

ChemicalPhysical

Wrong placement,foreign matter

Macroscopic control duringfreezing, storage anddistribution

8

84

5

54

4

52

160

20032

Good personnel hygieneReject/destroy any

packaged product hasexceeded the critical TTI(temperature, time) limit

Adjustment of thedistribution vehicles

7

7—

3

4—

4

4—

84

112—

Risk Determination

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

ronment, and the personnel who deal with food. Consequently,the risk analysis is a procedure which enables us to find if thepossible risks are important and if they must be controlled. Dur-ing this procedure the risk importance will be defined in ac-cordance with the present levels, the sizes, or the doses of thecauses generating it. Moreover, the effect of the cause variesdepending on the foods and the sensibility of the person who


Figure 3 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 thanothers and there is a great variety in the intensity of the ef-fect. However, there is always a level below which the pres-ence of such a cause is considered acceptable. The hazards areclassified in three large categories: biological, chemical, andphysical.

The possibly harmful substances appear in many feedstocksand usually at very low levels. They become hazardous whentheir level or the level of toxins they produce, increase so as tocause illness. For viruses and parasites in foodstuffs the samephenomenon occurs as in naturally occurring toxins and chem-ical substances.

HACCP is a dynamic system and during the analysis ofHACCP all changes already done or due to be carried out shouldbe 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 newhazard. Hence, the possible new hazards should be analysedduring and after the end of the manufacturing process (CodexAlimentarius Commission, 1997).

Determination of CCP’s and Implementationof Corrective Actions

A (CCP) is the point where control is carried out to pre-vent or remove a possible danger for product food safety orreduce it at an acceptable level. Hence, hazard analysis withdetermination of CCPs in the manufacturing line helps us de-termine the critical limits for each CCP, or identify the criteriawhich determine when a product is suitable or not. To deter-mine the critical control points a tree diagram is being employed(Fig. 2) (Lee and Hathaway, 1998). This is derived from what


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 forMicrobiological Criteria for foods (NACMCF).

In the case of a deviation from a CCP and its critical limit,and corrective action should be employed. Corrective actionshould ensure that the CCP is under control. Deviation pro-cedures should be documented in HACCP records.

In Table 2, critical points, critical limits, and corrective ac-tions are determined during the manufacturing processing ofsalmon. Verification is also shown as well as the necessaryrecords. Table 3 also describes an ISO22000 analysis worksheetfor determination of the prerequisite programs.

Table 4 shows other examples of prerequisite programs, con-trol measures, monitoring procedures, and corrective actions.

Results of Failure Mode and Effects Analysis

In FMEA analysis, a risk of contamination and its pres-ence at Hazardous Fraction in the final product, is expressed

with the risk Priority Number (RPN) which is defined asfollows:

RPN = S × O × D (1)

Where S is the Severity of contamination risk, O is thesupply probability occurrence of the contaminated ingredi-ent, and D is the Detection probability of the contaminatedingredient.

FMEA tables were constructed where Hazardous Elements(ingredients) are assessed and the RPN was calculated as can beseen in Table 5.

The classification of hazardous elements occurs according tothe RPN assessment as can be seen in Table 5 and correctiveactions are proposed per identified hazard. The new RPN iscalculated following undertaking of corrective actions.

Table 5 helps us to understand for which CCP’s correctiveaction needs to be applied. The limit for RPN is 130 and if this


Figure 5 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 hazardsto be eliminated are bioaccumulation of heavy metals and toxinformation. RPN for these specific dangers exceeds the criticalsafety limit. Following application of corrective actions such aschange of supplier, regular control, and audit of the new culti-vation area and stricter control during receiving of the salmon,the RPN number is reduced to normal levels. This is the wayone should work with the other CCP’s, taking the necessarymeasures where necessary. The possibility of occurrence as wellas the detection probability of a specific danger are factors whichchange dramatically following application of corrective actions,with RPN numbers below the safety limit. However, the severityof contamination risk rarely gets reduced with implementationof corrective actions.

Ishikawa Fish Bone Diagram

The Ishikawa diagram or fishbone diagram, invented byIshikawa, a Japanese quality control statistician, is an analy-sis tool that provides a systematic way of looking at effects andthe causes that create or contribute to those effects. It may be re-ferred to as a cause-and-effect diagram. Due to its resemblanceto a fish skeleton it is often referred to as the fishbone dia-gram (http://quality.enr.state.nc.us/tools/fishbone.htm). An im-plementation of the Ishikawa diagram for each CCP in salmonprocessing is given in the following figures.

In Fig. 3 the possible causes for problems in the receivingstep are identified. It is essential that the fresh salmon used forprocessing is of high quality. Suppliers should be carefully se-lected. The supplier must provide the company with the appro-priate documents that certify the origin of salmon and if it is


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 thatthe salmon arrives in very good condition. If it contains a highconcentration of heavy metals or pesticide and insecticideresidues or germs, no further production step or specific treat-ment will be able to reduce the hazards.

The excess quantity of pesticides due to soil removal is ledto the sea where it could cause huge problems. The bioaccu-mulation of these substances could be reduced with the righttraining and education. Trained human personnel and the rightlab equipment could easily diagnose these kinds of problems.

In Fig. 4 the possible causes for occurring problems in evis-ceration of fishes are identified. The main hazard resides in thepresence of foreign matter, a physical hazard that could causeproblems in the equipment and in the next processing stage.Moreover, problems could occur due to lack of personnel train-ing 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 stageare due to equipment and human personnel. Lack of person-nel training could lead to wrong handling of temperature orhumidity which are key parameters in this process and shouldbe monitored online.

Control of equipment could be inadequate or unable to pro-vide the suitable temperature or humidity due to bad mainte-nance.

In Fig 6 the causes for problems in packaging/labeling areidentified. The problems are due to material and equipment aswell as personnel. Packaging materials could be inappropriate tocome into contact with food, however, trained personnel couldhelp to avoid this problem and replace them if a situation isproblematic. Packaging equipment could be problematic due to


Figure 7 Application of the Cause-and-Effect diagram (Ishikawa diagram) to salmon (CCP distribution).

bad or ineffective maintenance or lack of trained engineers to beable to carry out the job.

In Fig. 7 the causes for the problems in distribution are iden-tified. Wrong temperature at the distribution vehicles is eitherdue to wrong adjustment or inadequate equipment which hasbeen badly maintained. Personnel could not be well trained dueto lack of funds or no investment in training for firms.

Finally, special attention at all previous stages should bemade to avoid cross-contamination from the residing microfloraof 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 ofcritical control points, the determination and the failure mode,cause and effect analysis, aim at assuring the safety and qualityof the product. It does not seem possible to speculate whether

one is more effective than the other. One of the main advantagesof the Ishikawa diagram is that it presents in a comprehensiveway the stages that can cause problems in production and fo-cuses on the roots of these problems so as to identify the mostsuitable solution.

Figure 8 displays a tree diagram (four questions) for deter-mining which hazards can be controlled by the application ofprerequisite programs, thereby reducing the number of CCPs.

CONCLUSIONS

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


Figure 8 Tree diagram for determination of prerequisite programs accordingto ISO 22000.

Mode and Effect Analysis (FMEA) model was applied for therisk assessment of salmon manufacturing. The main emphasiswas put on the quantification of risk assessment by determiningthe RPN per identified processing hazard. Fish receiving, cas-ing/marking, blood removal, evisceration, fillet making, cool-ing/freezing, and distribution were the processes identified asthe ones with the highest RPN (252, 240, 210, 210, 210, 210,200 respectively) and corrective actions were undertaken. Afterthe application of corrective actions, a second calculation of RPNvalues was carried out resulting in substantially lower values (be-

low the upper acceptable limit of 130). It is noteworthy that theapplication of Ishikawa (Cause and Effect or Tree diagram) ledto converging results thus corroborating the validity of conclu-sions derived from risk assessment and FMEA. Therefore, theincorporation of FMEA analysis within the ISO 22000 systemof a salmon processing industry is anticipated to prove advanta-geous to industrialists, state food inspectors, and consumers.

Figure 8 displays a tree diagram (four questions) for deter-mining which hazards can be controlled by the application ofprerequisite programs, thereby reducing the number of CCPs.

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