Handbook of Hygiene Control in the Food Industry

of applyingthemmayyieldhighlyvariableresults. Variabilityin the outcomes
of applyinga COPprocess,in mostinstances,can be attributed to the following
factors: typeof soil that is targetedfor removal; cleaningwaterchemistry;
detergent type; processing temperatures; exposure times; type of sanitizing
agent;and timeof exposureto the sanitizing compound.It is broadlyaccepted
that processvariability arisesfromeithercommoncause' orspecial cause'
circumstances (Deming, 1993). Common cause' variation is the normal oscillationsof a stableprocess within the boundaries of its control limits. By contrast,special cause'variation is indicative of an unstableprocess.Processes
that exhibit special cause' variation are unreliable. The most profound distinction between acommon causeprocess' and a special causeprocess' is predictability. In the caseof a COPwet-cleaningprocess, aspecialcause'
variationmightinvolvehighmicrobial counts(100colony-formingunits,cfu)/
unit areawhenthe uppercontrol limitspecifiesless than10 cfu/perunit area
examined. Properlydefining the capabilities and therefore expectations of a
COPprocessis critical to ensuring its effectiveness.

28.3 Definingthe process

The first step in developinga COPprocessis the determinationof an appropriate
cleaning objective. Thecleaning objective, or more precisely the process
objective,is the aim or intent of the appliedprocess.In otherwordsit is the
specificationdelineatingwhat the process is expected to deliver.Cleaning
objectivescan be constructed around two fundamentalconcepts; soil removal
and reduction in microbiologicalburden. Cleaning objectivesare customarily
definedby fourmajorcriteria:

1. Cleaning± refersto the completeremovalof foodsoil,other residues and
   theirassociatedodorsusing appropriatecleaning chemicals in accordance
   withrecommended protocol.


2. Disinfection± refersto inanimateobjectsand the action of inactivating all
   vegetativemicroorganisms(not spores).


3. Sanitize± is a US term and denotesa processwherebymicroorganismsare
   reduced to safe levelsas definedby publichealth authorities. The official
   US definition (Association of Official Analytical Chemists) of sanitizingfor
   product contact surfaces is a procedurethat reduces the contaminationlevel
   by 99.999%(5 logs) in 30 seconds.Theprocedureas definedfor non-
   contact surfaces requires a 99.9%(3 log)reduction in contaminants.The
   standardtest organismsareStaphylococcus aureusandEscherichiacoli.


4. Sterilization± refers to the statistical destructionand eliminationof all
   livingorganisms.

Establishing cleaningobjectivesis a risk-basedexercise whichcannotor should
not be conducted in isolation. Riskassessment is a logical, systemicactivity that
provides identification, measurement, quantification,and evaluation of the

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