process was originally developed. These records should identify all key
personnelinvolvedwiththe development process. The record mustalso include
evidenceof the risk assessmentprocessas wellas informationsupporting or
justifying the critical-to-cleaning criterion established at each step of the
process.Perhaps the mostimportantaspect of record keepingthat is frequently
overlooked is the needto document changeto the process. Whenthe process is
changed, or the nature of the objectto be cleanedis changed, these eventsmust
be included in the COPprocess records. Moreoverthe actions taken in response
to thesechanges must also becomepart of the record.Records are an integral
and necessarypart of the COPprocess.
28.7 Summary..
COPcleaning of foodprocessingequipment is considerablymore involved than
scrubbing the componentwitha brushand thenplacingit into a tankcontaining
hot water.Whilethesewerethe accepted methodswhen UptonSinclair'sThe
Junglewas firstpublished, it is now,however, a generally acceptedfact that
COPcleaningis a scienceand risk-basedactivity. The formalCOPprocessis
composedof five discretesteps: pre-wash rinse;cleaning wash;post-washrinse;
sanitization; and a post-sanitizationrinse.Moreover,eachstepof the process
contains discreteactivities that are critical to the success of the entireCOP
process.The delineation of the critical-to-cleaningcriteria,on a stepwisebasis,
is essentialfor developinga stableCOPprocess.Critical-to-cleaning criteria
includeselecting a detergent basedon the physical and chemicalcharacteristic
of a specificsoil type.Theyalso involvetemperature and the amountof force
appliedduringthe post-wash rinse.Critical-to-cleaning criteria (temperature,
concentration,and exposure time)for the sanitizingstep of the process,must be
basedon resistance data of the target organism.Usinga sanitizerthat is capable
of a 5Dreduction in the targetorganismwhen 6 Dis required will produce a
processfailure.Understandingthe capabilityof the process is vitalto predicting
the outcomes of applyingthat process.As statedpreviously, COPcleaning is
widelyusedwithinthe foodprocessing industry. Pipewasher, tote and tub
washers, batchand continuousdishwasher, COPtank-type washerand sinks are
usedfor this application.It is noteworthy,withregardto the discussion of stable
processes, that manualCOPcleaningapplicationsare inherentlyunstable.This
type of COPprocess reliesexclusively on human interventionsfor its execution.
Thefactsare thateachwilling worker'sapproach to the task,thoughwell
intended, will be different.This differenceis a sourceof specialcausevariation
and will thereforemake it impossible to predictthe outcomesof theiractionsin
applyinga COPprocess. Thisis an importantconsiderationin termsof risk
management.
The capabilityof the processmustalso be validated.Thatis, measuresmust
be providedthat will enableconfirmation of the assumptions that underpin the
process.Validation is a critical but often overlooked aspect of COPprocess
Improvingcleaning-out-of-place(COP) 465