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VERiFiCATionCOURSE INTRODUCTION. TheHACCP system is recognized
today asthe best method to ensure ood saety. Ithas evolved rom a
commercial advantageto a necessity or conducting business.Numerous
market recalls due to oodsaety ailures demonstrate that a lack
ocontrol in the production and handlingo ood products cannot be
orgiven.The consequences o causing harm to
consumer health can have a disastrouseconomic impact, and in the
worstcase scenario can result in bankruptcy,negative media
coverage, and possiblyprosecution o those legally responsibleat the
company.
An impressive percentage o marketailures occur when procedures
exist butare not well understood by employees.When such events
happen, a lack o e-ective verication o employee educationand
training is oten revealed, leading toa discrepancy between what a
managerbelieves happens on the plant foor andwhat actually takes
place on the produc-tion lines. Other ailures occur whenpeople
neglect to validate procedures,
demonstrate their eectiveness or under-stand scientic
aspects.
Verication and validation have there-ore become two undamental
tools ormanaging any quality system, and arerendered even more
important when itcomes to programs related to the controlor
elimination o consumer health haz-ards. They ensure that the
programs arewell designed, implemented, understoodand
supported.
MANAGEMENT COMMITMENT.
Achieving an unwavering commitmentto ood saety does not merely
involvestating a mission, vision and policy, but
rather assuring that upper and middlemanagement truly believe in
them andshare the belie with their personnel.It must be clear that
not just words areinvolved, but that supporting HACCPand the
Prerequisite Programs is theprimary responsibility o each and
ev-ery position at the company, rom themanagerial to the
operational level. Inthis manner, HACCP ceases to be justanother
assignment or the Quality Con-
trol Department; instead, departmentssuch as Production,
Maintenance andPurchasing become wholly responsibleor its
implementation.
In order to achieve this level o com-mitment, the HACCP Team
shouldexplain the real costs and the tangibleand intangible benets
that upper man-agement should be aware o prior tosigning the HACCP
Plan. For example,
does management understand thatPrinciple 5 o HACCP implies that
allproduction that passes through a CriticalControl Point (CCP)
that has deviatedrom one o its Critical Limits shouldbe
reprocessed, destroyed or set aside ornon-ood use? Perhaps the risk
posed bythe release o such batches has not been il-lustrated in
purely economic terms. Thereis a reason why HACCP uses the
terms:hazard, risk, Critical Control Point andCritical Limit. The
high risk that a oodsaety hazard presents to the consumeralso
represents a high risk or the brand.Much more important than any
qualitycomplaint or problem is the dierencebetween quality and ood
saety: quality
is negotiable, whereas ood saety is not.Although it is true that
internal indicatorsexist to measure the benets o a HACCPsystem, in
addition to the explicit andimplicit demands o external clients,
itis also true that there are ways o calcu-lating the implications
o a ood saetycomplaint, media coverage o consumerdeath, a
prosecution or market recallcosts. In all o the aorementioned
cases,it is dicult to reverse the impact on thecompanys
reputation.
EFFECTIVE TRAINING & EDUCATION.
Training is not all that is involved in anemployee program; but
rather educating
and developing skills. Educating involvesexplaining the mission
o every employee,which is to detect whatever problemscould put the
health o the consumer andthe brand in danger.
How many times has routine becomeengrained at the expense o the
mission,resulting in the accumulation o monthso perect records that
dont refect reality?The employee stops ollowing proceduresand
simply writes down what the result
should be based on a mental predisposi-tion that produces this
expected result:alsied records which have been lledout hours prior
to or ollowing the moni-toring, or records that have simply
beenneglected. Not only did this employeeail to understand the
mission, but thecompany also ailed by not detectingthe lack o
education and the lack overication.
The same thing happens with Pre-requisite Programs when an
employeecorrectly washes his hands, closes thedoor, applies the
correct cleaning pro-cedure, takes care o his uniorm and
hisbehavior but only in the presence o asupervisor or a visitor. He
knows what hehas to do and how to do it , but he does notknow why
he always has to do it well.
SYSTEM EVALUATION.By means o spe-cic inspections and audits at
each o theCCPs and Prerequisites, or o the entiresystem in general,
AIB denes Inspectionsand Audits in the ollowing way:
An inspection is a thorough physicalreview o a ood acility to
assess what
is actually happening in a acility at amoment in time. This
snapshot gives arealistic assessment o conditions thatcan be both
positive and negative orood processing. An inspection
ocusesonphysical review.
An auditis a systematic evaluation oood acility documentation to
determinei Programs and related activities achieveplanned
expectations. An auditor looks atdata over time to see i positive
or negativetrends are developing. An audit ocuses ondocumentation
review.
In strictly HACCP terms, one cansee a parallel between
inspecting asa means o verication, and au-
diting as a tool o validation.Said another way, with therst you
are assuring thatthe programs are beingcomplied with as theyare
written, whereas theother demonstrates to youthat the programs are
atleast eective and, i thereare improvement indicators,ecient.
VERIFICATION & VALIDATION. Botho these concepts belong to
Principle 6o HACCP.
Verifcationallows you to make surethat each employee is working
in accor-dance with the procedures, and that he orshe will continue
doing so. In HACCP,this means that the employee is inormedo the
hazards related to the job, as well asthe proper manner o
controlling them,
whether that is through Prerequisite Pro-grams or Critical
Control Points. Fromthis premise is born the need to veriythe
correct implementation o all Op-erational Prerequisites1 (those
which areessential or preventing the introductiono hazards) and the
CCPs (process stepsessential or controlling or eliminating
aninevitable hazard). There are three wayso conducting the
verication:
a. Supervision. This is the verica-tion that is normally carried
out by thearea supervisor. It consists o ensuringthat employees
ollow their procedures.Frequent verication should be includedin the
area supervisors job description.Being a routine task, this
activity is gen-
erally recorded only when a deviation isidentied.
b. In accordance with a pre-estab-lished requency. A verier, who
maybelong to any department, carries out thisverication. At least
one verier shouldbe identied or each Prerequisite Pro-gram and
every CCP, and an explanationshould be given regarding exactly
whatthe verication consists o, as well as therequency at which it
is carried out; orexample, once a week. The best time to
veriy a record is at the beginning orend o a shit, whereas the
best timveriy the level o education and traio the personnel in
charge o monitoa CCP or Prerequisite Program is atrandom moment,
without warning.idea is not to surprise the person and or aults,
but to be comorted in thetion that everyone knows their misand can
execute it.
c. At least during annual inteaudits. This, in some ways, is the
vecation o the entire system. It givesacility the opportunity to
revise athe Operational Prerequisite Progrand CCPs at least once a
year in oto ensure that the veriers are carrout their role
thoroughly. In essenceverier is veried. I the veriers werective
throughout the whole year, serndings should not be uncovered duan
internal audit.
With these three types o vericathe verier should always aim to
kthe level o training and education opersonnel that are principally
responor carrying out the correct contr
which might otherwise ail. Veriyinthis sense is much more than
just revrecords which, in the majority o care too perect to be
trusted withouaccompanying onsite verication refects the reality on
the foor.
In very practical terms, veriyingonly makes certain that the
recordscomplete and refective o what we must happen, but it also
indicates employees really did what they wrotthe records.
Validation consists o demonstra(i.e., having evidence) that each
progis capable o being eective i we comwith them. Validation
gathers all o
necessary scientic, experimental technical data together in
order to donstrate that no negligence took pThis data constitutes
evidence o diligence, in case the ollowing quesis asked: Did the
company do evthing possible to avoid consumer deFurthermore, these
two concepts, wappropriately applied, help to deteccause o systemic
ailures and to i mp
the operational indicators.
Achevg a uwaverg
cmmtmet t
saety es t merely
vlve statg a mss,
vs a plcy, but
rather assurg that upper
a mle maagemet
truly beleve them a
share the bele wth ther
persel.
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Validation must be conducted beorethe program eective dates
(PrerequisitePrograms and CCPs), at least once a year,and every
time that a change manage-ment mechanism causes a signiicantchange
to take place.
IN SUMMARY. To summarize:Validate: i we comply with the pro-
grams, they can be eective.
Veriy: we are complying with theprograms.Validate + Veriy = the
programs are
eective.
PREREQUISITE PROGRAMS. When aHACCP Team is asked i any o the
ol-lowing situations has ever occurred, themajority answer: yes,
sometimes more
than once. Leakyroofaboveaproductzone
Handwashingstationsthatlacksoap
in sensitive areas Birdnestabovenishedproductor
packaging materials Amissingallergencleaningrecord
Noevidencethatcleaningorsanitiz-
ing occurred ater a maintenance jobon a ood contact surace
Anunidentiablechemicalcom -pound container ound in a process-ing
area
All o these situations have various as-pects in common. They are
real situationsand in the majority o cases only
one immediate, incomplete correctiveaction is taken. For
example, coveringthe leak, supplying the dispensers withsoap,
removing the nest, or asking thesupervisor i the allergen cleaning
orthe sanitizing that should happen atercompleting the maintenance
job wasreally done (to which they reply: yes).However, these
circumstances should betaken more seriously, since all o themcould
signiy a dangerous contamination
o verication and validation should beadopted. But why wait until
unaccept-able and costly situations take place inorder to achieve
Prerequisite Programeectiveness? Now we turn to a reviewo these
Programs signicance in orderto better understand how to veriy
andvalidate them.
Prerequisite Programs are the basicconditions and procedures o a
com-
pany related to the production o oodthat ensure the compliance o
all legalrequirements, including the GMPs andany Standard
Sanitation Procedure that
should ensure sanitary conditions in aood handling environment.
In general,the Sanitation Prerequisite Programsprevent the
introduction o any adul-
terant: those that aect the quality othe product, those that
aect its legal-ity, and those that possibly aect oodsaety. In
HACCP, we are interested inthose adulterants that are hazards.
Theremaining adulterants can be controlledby the GMPs and other
general PerquisitePrograms.
The Prerequisites that are essential tocontrolling hazards are
called OperationalPrerequisite Programs in this text, an allu-sion
to the t erminology adopted by ISO22000. I an Operational
Prerequisite isessential to controlling hazards, then it isas
important as any CCP. The dierenceis that a CCP is a process step
character-
ized by one or various critical limits, whileOperational
Prerequisites are not processmanuacturing steps but rather
proces-sing environment control programs,characterized by various
conditions thatshould be monitored in such a way as tocontrol
multiple and, many times, vaguesources o contamination. In a way,
it ismore dicult to control multiple sanita-tion conditions than a
specic, measur-able critical limit or the elimination o a
strate that the control measurescorrect and based on science,
expence or regulations and veriyindemonstrate that the program
icompliance and that employees have been educated will contto
comply with it. Among the cmon Operational PrerequisitesWater
Quality, Maintenance or FSaety, Personnel Health and Hyg
Chemical Control, Supplier ConTransportation and Storage,
AlleControl, etc.Theconceptofvalidationa
applies to Customer Complaint grams, market recalls and
traceabsystems, and mock recalls. For exple, the eectiveness o the
traceabsystem can be measured in terms otime it takes to carry out
the exerand the percentage that can be trorward or backwards.As has
been mentioned in the ab
denitions, validation is complemeby practical activities and
vericasystematics. These activities are esseor Prerequisite
Programs. Even tho
it may appear repetitive, it is worth insist on the value o
visual vericao the activities, not just the recordsappear to
indicate their compliance. Hthe cleaning procedures been
compleDaily and nightly? Did anyone obshow the activities were
carried out match them to the procedures? The sapplies or post
maintenance cleanallergen cleaning; pesticide applicatchemicals
preparation; hand washprocesses; anti-backfow systems inpipes;
correctly illing out receivproduction and shipping records wexact
lot numbers; etc.
This article series will continu
the next issue o AIB Update. The ond article will address
vericationvalidation o the implementation o7 HACCP principles.
AIB
The author is an auditor and trainier fo
International.
(Endnotes)1 Operational Prerequisite Programs are uses by the
ISO 22000 Standard to dene programs that are essential or
preventinintroduction o hazards.
o some part o the production process. Itbecomes very dicult to
know how manyproducts could have been contaminated.Even i it were
easible to identiy theexact quantity o suspect products, whatwould
you do with them? There are veryew alternatives available; except
in rarecases, there are no sampling plans thatguarantee the
acceptability o a productwith respect to a contaminant. What
will
be analyzed? The presence o metallicparticles? Indicators?
Specic pathogens?I there is a possibility that
biologicalcontamination occurred, no one will
know what to analyze. Finally, i there isa situation involving
possible contamina-tion, the retained lot(s) should probablybe
destroyed or reprocessed or used or
a non-ood purpose, as is the case whenthere is a deviation rom a
critical limit!
In situations such as these, who hashonestly opted to take such
a radical deci-sion as destroying products or conductinga market
recall? Very ew have, especiallysince a lot o money is put on the
linewhen basic errors are committed. Thatbeing said, risky products
leave the plantevery day because people dont avoid basicerrors.
HACCP is an illusion i an incor-ruptible commitment to
Prerequisites isnot made.
But the story does not st op here. Letsimagine that a company
has retainedand destroyed the suspect products. The
news would no doubt make its way tothe directors, who would not
permit thesame problem to happen twice, given theimmense cost that
the events represent. Aroot cause analysis would be carried out,and
it would be discovered that a simplegap in the implementation o
Prerequi-site Programs was the problem. Finally,it would be agreed
that these Programsshould be reinorced, that preventivemeasures
should be taken, and that tools
Verfcat a valat have becme tw uametal tls r maagg ay qualty
system, a are reere
eve mre mprtat whe t cmes t prgrams relate t the ctrl r elmat
csumer health hazars.
They esure that the prgrams are well esge, mplemete, uerst a
supprte.
risk associated with a well dened hazard.In act, the majority o
market recalls arecaused by the lack o control o a Prereq-uisite
Program. For this reason, many othe health requirements should be
con-sidered non-negotiable, as is the case withcritical limits.
What is more, no CCP canbe eective i the Preventive Programs arenot
eective. The majority o AIB audi-tors would say without a doubt
that 80
to 100% o hazards are controlled by aPrerequisite Program. The
rationale driv-ing this conclusion is rarely recognized:that the
eectiveness o
HACCP dependsin large measure i not complete-ly on
Prerequisite
Programs. In act, certaincompanies have been able tovalidate a
HACCP system withoutCCPs. Since the heart o HACCP is theanalysis o
hazards, companies shoulddemonstrate that their Prerequisite
Pro-grams are capable o controlling hazards(validation data) and
that the Programsare correctly implemented (eectiveverication).
Consequently, all ood acilities shouldtest to see i their
Prerequisite Programsare valid; or example:
Itshouldbedemonstratedthatthe
requency and methods o cleaning andor sanitizing are adequate to
achieve
the level o physical, microbiologicaland chemical cleaning that
would su-ciently avoid hazardous contaminationby allergens, pests,
pathogens or chemicalresidues. There are experimental, ocialand
quick methods and techniques thatexist to obtain said results. In
general,these tests are done at a minimum o onceper year, or in
accordance with environ-mental changes, in the worst
processingconditions (or simulating them) in order
to demonstrate that the program ensuresood saety in situations o
the highestlevel o potential contamination. Verica-tion is later
responsible or demonstratingthat there is permanent compliance
withthe program.
Itshouldbevalidatedthatthepre-ventive control measures or the
watersupply are eective, that the pipes andplumbing control system
protect potable
water rom recontamination prior to use,and that interconnections
between theclean and contaminated water systems
are not generated. Oten, valida-tion consists o a
microbiologi-
cal analysis o indicators atvarious water usage points,
including at least the ar-thest point in the pipe.
Thereshouldbeevidence that the IPMprogram allows or:u
Controlling pest
populations that aresusceptible to transmit-
ting ood-borne diseases.This is typically conrmed
with customer complaintsand trend analysis or the
monitoring o live or dead pestsand indications o the presence o
pestsor damaged product.u Eventual pesticide applications
that wont present chemical contami-nation hazards. Validation
here consistso having the technical inormation oall the products
used: labels with theactive ingredient, dose, quantity andmanner o
application. In certaincountries, this inormation is evencontrolled
by the local government.
Another example:Inadditiontotheabsenceoffood
saety customer complaints, oreignmaterial control programs can
be vali-dated by the number o rejects in theoreign material
elimination devices,such as: objects caught in the lters;rejected
in siter tailings; retained bymagnets; rejected by the metal
detec-tors, X-rays, optical detectors,
etc.TheotherfundamentalPrereq-
uisite Programs are managed in thesame ashion. Validating to
demon-
