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PROCESSCONTROL|December2013/January2014

FoodPlantSOPs:TheBackboneofYourFood
SafetySystem
ByTimLombardo

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Coretoanyfoodmanufacturersfoodsafety/HazardAnalysisandCriticalControlPoints
(HACCP)planarethefacilitysprerequisiteprograms.Thefoundationofeach
prerequisiteprogramisitscorrespondingStandardOperatingProcedures(SOPs).

Bydefinition,anSOPisasetofwritteninstructionsthatdocumentafood
manufacturersroutineorrepetitiveactivity.Specifictofoodmanufacturingplants,the
termSOPiscommonlyappliedtoproduction,manufacturingandsupportarea
processes,jobsoractivities.Forallsanitationrelatedprocesses,jobsoractivities,the
termSSOP(SanitationSOP)isreserved.

ThedevelopmentanduseofSOPs/SSOPsareintegral
partsofasuccessfulfoodsafety,qualityandsanitation
system(seeFigure1),astheyprovideindividualswiththe
informationrequiredtoproperlyperformtheirjobs.
Furthermore,theuseofSOPsandSSOPspromotes
qualitythroughconsistentimplementationofaprocess,
taskorjob.Also,ifclearlywritten,SOPsandSSOPscan
minimizemiscommunicationandvariationbetweenindividualsororganizations.

ThetermSOPmayalsobeusedinterchangeablywithprotocol,jobinstructionor
workinstruction.

ImplicationsofaFoodRecall
TheimportanceofthedevelopmentanduseoffoodplantSOPs/SSOPscannotbe
overstated.Forexample,accordingtothemostrecentU.S.FoodandDrug
AdministrationsReportableFoodRegistryannualreport(fiscalyear,September2011
August2012),[1]37.9percentofallfoodrecallswereduetoundeclaredallergens.Inthe
courseoftheinvestigations,thetruecauseoftheserecallswastracedtoeitheran
SOP/SSOPthatdidnotexistorwasinadequate,ortoafailuretoadheretooneormore
oftheapplicableprocedures,including:

GoodManufacturingPractices
Labelreview
Residualchemicaltesting
Rawmaterialtesting
Sanitation
Housekeeping
Productprocessdesign
Rework
Holdandrelease

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Recallprocedures
Storage
Training
Productsequencing
Traceability
Supplierapproval

Inadditiontocreatingharmandgeneratingbadpublicity,recallsareexpensive:the
averagecostassociatedwiththeseallergenrelatedSOPfailureshasbeenestimatedat
$10millionperrecall.

BenefitsofSOPs
Inadditiontohelpingpromotefoodsafetyandpreventfoodrecalls,SOPscandothe
following:

Serveasthebasisforimplementinganeffectiveprogramtoincludeemployeetraining
aswellasatoolforonthefloorcoachinganddevelopment.

Identifycontrolpoints,aswellastheirlimits,tocontrolandvalidatetheprocess.
Correctiveactionsandpreventiveactionscanbeidentifiedinordertoaddresseach.

Establishtime,laborandmaterialrequirementsforajobortask.

Beusedaschecklistsbyinternalauditteammemberswhenauditingtheplants
programsandprocedures.

Ultimately,thebenefitsofavalidSOParereducedworkeffort,alongwithimproved
comparability,credibilityandlegaldefensibility.

DevelopingandMaintainingSOPs/SSOPs
SOPsandSSOPsshouldadheretothefollowingfoodindustrybestpractices.

KeySections
TheSOP/SSOPmustbeformattedinsuchawaythatitprovidesallpertinent
informationsothatanemployeewithsomeknowledgeofthearea,equipmentandtools
canreadandperformthefunctionsofthetaskbothsafelyandeffectively.

TitlePage
Clearlyidentifiestheprocedurename,anidentificationnumber,dateofissueand/or
revisionandthenameoftheapplicableplant,divisionanddepartmenttowhichtheSOP

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applies.Alsoincludedinthissectionarethesignaturesandsignaturedatesofthose
individualswhopreparedandapprovedtheSOP.Electronicsignaturesareacceptablefor
SOPsmaintainedonacomputerizeddatabase.

TableofContents
Atableofcontentsishelpfulforquickreferenceandlocationofspecificinformation,
changesorupdates.ItisespeciallyimportantforlengthyordetailedSOPs/SSOPs.

Introduction/Purpose
ThissectionwilldescribetheintentionfortheSOP/SSOPandallowsthereadertobetter
understandnotonlythehowbutthewhyaswell.Includedhereareanyapplicable
backgroundinformationandanoverview.

Responsibilities
Listofaccountabilitiesforallstakeholders,detailedbyposition.

Definitions
Thissectionincludesalistofterms,phrases,wordsoracronymsandtheirapplicable
meanings.Sincethereaderwillalreadyhavesomeknowledgeofthetaskorequipment,
onlyuncommonandunfamiliartermsshouldbedefined.Forexample,inatesting
procedure,Listeriamaynotneedtobedefined,whereasinanenvironmentalmonitoring
procedure,Listeriamayrequiredefinition.

Materials
Wherenecessary,listthematerials,equipment,checklistsandsupportingdocuments
requiredtocompletetheactivityortask.

Safety
Includesalistofanypersonalinjuryorlossoflifewarnings,suchasconfinedspace.
Thissectionshouldexplainwhatwillhappeniftheprocedureisnotfollowedoris
followedincorrectly.

Procedure(s)
Eachprocess,taskorsteptobetakeninsequencewillbelistedinthissection.One
SOP/SSOPdocumentmaycontainseveralproceduresformultipleprocessesor
subprocesses.

Training
ListthetrainingrequirementsfortheSOP/SSOPaswellasthefrequencyoftraining(i.e.,
onetimeorannually).

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Documentation
Identifytheformstobeusedandreportstobewritten,aswellasthedataandrecord
storagelocationandduration.

ComplianceVerificationandValidation
Describeanycontrolstepsandprovisionsforreviewand/oroversight.Verificationwill
includeaperiodicreviewoftheSOP/SSOPandthecorrespondingactivities.(Arewe
doingwhatwesaywearedoing?)Alternatively,validationwillincludeaperiodicreview
oftherecords,reportsandotherdocumentation.(ArethegoalsoftheSOPbeing
accomplished?)Alldeviationsshouldbereportedandtrended,andacorrective
action/preventiveactionplandevelopedtoaddresseachopportunity.

References
Listofallcitedregulatory,companyorfacilityreferences.

DocumentRevisionHistory
Listofallreviews,updatesandrevisionsmadetotheSOP/SSOP.

Content
SOPsandSSOPsshouldbeclearlywordedsoastobereadilyunderstandablebyaperson
knowledgeableaboutthegeneralconceptoftheprocedure.Usediagrams,flowcharts,
picturesandcomputerscreenshotstohelpbreakuplongsectionsoftextandto
summarizeaseriesofstepsforthereader.Thesevisualaidsespeciallyhelpinthe
trainingoftheSOP/SSOP.

Caremustbetakentoincludeallnecessaryinformationwithoutbecomingtoodetailed.
Belowisanexamplewithanadequatelevelofdetailandanotherwithtoomuchdetail,
makingtheSOP/SSOPoverwhelmingtotheuser.

Goodexample:Step4.Rinsethoroughlywithwarmwater.

Poorexample:Step4.Rinsethoroughlyusingthesanitationstationlocatedonthe
backwall,nearthedoor,withboostedpressure,warmwater.Usethebluehosefitted
witha24gpm,15degreefanspraynozzle.Turnonmainvalveatsanitationstation.

DevelopmentProcess
WhendevelopinganSOP/SSOP,asubjectmatterexpert(SME)shouldprepareawritten
draftoftheprocedure.Thisdraftisthenreviewedbyotherplantorareaexperts.The
purposeofthisreviewistosolicitcomments,suggestionsandideasforimprovementand

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clarification.

OncetheSOP/SSOPhasbeendrafted,thecontentmustthenbeverified.Thisisbest
accomplishedbyhavingtheSMEwalkthroughtheprocedure,onthefloor,takinginto
considerationallkeyparameters(e.g.,time,equipmentspeed,samplelocation,etc.).
UpdatetheSOP/SSOPwithallnecessarychanges.Pictures,diagrams,flowchartsand
computerscreenshotsshouldbeinsertedatthistime.

OncetheSOP/SSOPisinfinaldraftform,anequipmentorprocessexpert,suchasa
trainingsupervisor,shouldperformtheprocedureaswritten.Ifpossible,tobestidentify
anyandallgaps,conductmorethanoneexpertreview.Theseexpertswillthenprovide
thefinalupdatesandrefinementsrequiredtocompletetheSOP/SSOP.

Whenfinalized,theSOP/SSOPshouldthenfollowtheappropriateapprovalprocess,as
identifiedinthecompanyspolicy,andbepublished.

RevisionsandReviews
AnSOP/SSOPisaneverchanging,livingdocument.Assuch,inaneffortto
continuouslyimproveaprocessortask,updatesarerequired.Indeed,improvements
shouldbeactivelysoughtandchangesoftenmade.Thesemustalwaysbetrackedand
communicatedeffectively.

Thiscontinuousimprovementcyclecanbestbe
describedbyavariantoftheDemingcircle,alsoknownas
plan,do,check,act(PDCA).[2]TheDemingcircleisan
iterative,fourstepmethodusedforthecontroland
continuousimprovementofprocesses(Figure2).

ThePDCAstepsforeachsuccessiveDemingcircleincludethefollowingfourphases:

Plan(DevelopProcedures)
DeveloptheSOPsandSSOPs,establishingtheobjectivesandprocessesnecessaryto
deliverthedesiredresults.Thiswill,inturn,establishgoals,prioritiesandbaselinesto
achieve.Establishingtheseexpectationsmakescompletenessandaccuracyofthe
SOP/SSOPapartofthetargetedimprovement.

Do(PerformProcedures)
PerformtheSOPs/SSOPs.Inotherwords,executetheplan,conducttheprocessand
maketheproduct.Collectdataforcharting,trendingandanalysis.

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Check(VerifyandValidateProcedures)[3]
VerifyandvalidatetheSOPs/SSOPsbystudyingtheactualresults,asmeasuredinthe
Dosection.ComparetheseresultswiththetargetsorgoalsfromthePlansection.
LookfordeviationsbetweenthedevelopmentandtheexecutionoftheSOP/SSOP.
ChartingdatacanmakeitmucheasiertoseetrendsoverseveralDemingcycles.

Act(ReviseandImproveProcedures)
Foreachsignificantdifferencebetweenactualandplannedresults,oncetherootcause
hasbeendetermined,developacorrectiveaction/preventiveaction(CAPA)plan.
Determinewheretoapplychangesthatwillincludeimprovementoftheprocessor
product.If,afteroneortwopassesthroughtheDemingcircle,theprocessdoesnot
improve,furtherrefinetheCAPAplantoincludemoredetailinthenextiterationofthe
cycle(s).Alternatively,greaterattentionmayberequiredinadifferentstageofthe
process.

SOP/SSOPrevisionsandupdatesshouldbecategorized
sothatallthestakeholdersunderstandtheamountof
changethathasoccurredaswellastheextentof
employeetrainingrequiredwiththechanges(Table1).

DocumentControl
Documentcontrolistheprocessofinitiating,updating,changingandexpiring
companydocuments.Alldocumentsandrecordsshouldbemaintainedineitheran
electronicormanualsystem.

Ataprescribedtime(i.e.,immediatelyafterproduction,weekly,etc.),alldocumentsand
recordswillbecollected.Oncecompiled,allofthedocumentsandrecordswillthenbe
storedinashorttermarchive,inanareathatwillalloweasyaccessforreferenceas
needed.

Asarchivedrecordsbegintoexceedthemaximumlengthoftimeforshorttermstorage,
theywillbemovedtoalongtermstoragelocationforaminimumof2yearsorshelflife
plus1year,whicheverislonger.Local,stateandfederalregulationsaswellascustomer
requirementsmayprescribealongerduration.

Disposalofexpireddocumentsandrecordsshouldoccuronascheduledbasisandin
accordancewithanestablishedpolicy.

Access
EasyemployeeaccesstoeachSOPandSSOPisamust.Therefore,themostcurrent

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versionoftheSOPandSSOPmustbereadilyavailable.Accesscanbeintheformof
eitheraprintedmanualorelectronicaccess.Ifaprintedmanualisused,proceduresand
practicesmustbeinplacethatensurethemanualiscontrolledandthattheupdatesare
current.

Fornewemployeesorforemployeesworkinginanunfamiliarornewarea,havinga
physicalcopyinhandmaybeespeciallyuseful.Thiscopycanbeusedasquickreference
foranewworkassignmentorforcoachingactivities.

Whetherconsideredaprotocol,workinstructionorjobinstruction,SOPsandSSOPs
mustbeintegralandfoundationalpartsofallfoodmanufacturingfacilitiesfoodsafety
program.

TimLombardoistheleadstaffscientist(foodsafetyandmicrobiology)forCovance
Laboratories,nutritionalchemistryandfoodsafetydivision.AgraduateofSam
HoustonStateUniversityinHuntsville,TX,hehasheldmanykeypositionsinthefood
manufacturingindustry,includingproduction,qualityandsanitationpositionsat
factoryandcorporatelevels.WithCovance,Timprovidesfoodsafetyconsulting
supporttofoodmanufacturersinallaspectsoffoodsafety.Hecanbereachedat
tim.lombardo@covance.com.

References
1.FDAFoodsandVeterinaryMedicineProgram.2012.TheReportableFoodRegistry:
TargetingInspectionResourcesandIdentifyingPatternsofAdulteration.Second
annualreport:September8,2011September7,2012.
2.Moen,R.andC.Norman.2010.Circlingback:ClearingupmythsabouttheDeming
circleandseeinghowitkeepsevolving.QualityProgressMagazineNovember.
3.Baldus,K.andV.Deibel.2007.HowtovalidateyourGMPandprerequisiteprograms.
FoodSafetyMagazine13(2):1217.

Categories:Facilities:Sanitation,FoodPlantSOPsSanitation:EnvironmentalMonitoring,SSOPs
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