process consistently conforms to requirements. Validation is intended to
demonstratethat the process is stable.
Thereare a numberof goodstatisticaltools that can be usedas part of the
validation process. These include control charts, designed experiments,
capability studies, samplingplans,and failure modes andeffects analysis.
Control charts,samplingplans,and capability studiesare commonplacewithin
the foodindustry.These methodsare wellsuitedto validating a COPprocess.
The selectedmethodsmustinclude conformationof the critical-to-cleaning
criteria establishedat eachstepin the process.For example, preventing film
formation duringthe washing step is a critical-to-cleaningactivity. Therefore,
the validationprotocolmustconfirm that filmformation is not occurringand
willnot occur, provided that the process is properly executed. Likewise,
inactivationof the target microorganismto levels specifiedby the process is also
critical to the sanitization step of the process and must, therefore,be confirmed.
The validation methodsmust exposeand illuminate the causesof process
variation. It is imperativethat commoncausevariationis distinguishedfrom
special cause variation.When the validation process reveals special cause
variation, it is importantthat root causeanalysisis conducted and that aggressive
measuresare providedto eliminatethe source of variation.
Anotherimportant pointrelatedto the validation process is its impacton
related activities. Validating the COPprocess maywellimpactother aspects of
manufacturing.It is entirely reasonable to conceivevalidation affecting the
sanitation, quality control, GMP, and HACCP programs. For example,
validating the elements of the COPprocessmayhighlight weaknesses in the
master sanitationschedule or confirmthe validity of a criticallimitspecified in
the HACCP plan. Validation,in otherwords,shouldconfirmthat the COP
cleaningof equipment is not an exercisecompleted in isolation. The implication
and risk associated withimproperly cleanedequipmentwill not remain confined
to the COPtank, pipewasher or automated tote washer.
28.6 Recordsand process documentation
If thereis not a record,it did not happen.Goodrecord keepingis fundamentalto
foodsafety and it is also vitalto processverification.Records confirming that
the critical-to-cleaningactivitiesspecifiedfor eachstep in the COPprocess are
compulsory.The record-keeping program must include the data that will
confirm that the particularsof the processhavebeenachieved. For example,if
the processspecifiesa washtemperature of 180 ÎF (82 ÎC) for the duration of the
wash cycle, thentheremustbe a compellingand unambiguousdocumentto
demonstratethat the temperaturewas achievedand maintained for the entirety
of the washcycle.Likewise, whena MRL has beenestablishedfor a sanitizing
chemical or disinfectant, then yourrecords must provide proofthat the tolerance
was not exceeded.Moreover,and in addition to dailyprocess records, theremust
be a bodyof documentationthat providesa historical recordof howthe COP464 Handbookof hygiene controlin the foodindustry