Root Cause Analysis

RobertKnake

PTPProgramManager

AmericanAssociationforLaboratory
Accreditation(A2LA)
Discussion Objectives

DefineRootCauseAnalysis

ProvideTips/Toolsforperformingarootcauseanalysis

Provideclarityinregardstocorrectiveactions,corrections,
preventativeactions,andcontinualimprovements
Lets Look at 17025

Section4.1.5a Authorities&Resources
Section4.7.2 CustomerFeedback
Section4.8 Complaints
Section4.9 NonconformingWork
Section4.10 Improvement
Section4.11 CorrectiveAction
Section4.12 PreventativeAction
Section4.14 InternalAudits
Section5.9.2 AssuringtheQualityofResults
Lets Look at 9001

Section7.3 DesignandDevelopment
Section7.6 ControlofMonitoringandMeasuring
Equipment
Section8.2 InternalAudits
Section8.3 ControlofNonconformingProduct
Section8.4 AnalysisofData
Section8.5 Improvement IncludesCA&PA

Asyoucanseetherequirementsareverysimilarto
17025justaslightlydifferentfocus
Terms to Consider

CorrectiveActions
Corrections
PreventativeActions
PreventingRecurrences
PreventingOccurrence
RootCause
Complaints
Nonconformities
Problems
Deviations
Departures
A2LA Specific Requirement

I102InstuctionsforRespondingtotheAssessorDeficiency
Report

PerISO/IEC17025:2005,clause4.11.2,yourcorrectiveaction
muststartwithaninvestigationtodeterminetherootcauseof
thedeficiency.Thereforethecorrectiveactionresponsemust
alsoincludethedocumentedresultsoftherootcauseanalysis
andtheobjectiveevidence(e.g.revised/updatedlab
procedures,paidinvoices,packagingslips,trainingrecords,
etc.)toindicatethatthecorrectiveactionshavebeen
implemented/completedtoaddresstherootcause.
Lets Define Some Terms

PreventiveAction FromISO90012005
actiontoeliminatethecauseofapotentialnonconformityor
otherundesirablepotentialsituation

NOTE1Therecanbemorethanonecauseforapotential
nonconformity.

NOTE2Preventiveactionistakentopreventoccurrence
whereascorrectiveactionistakentopreventrecurrence.
Lets Define Some Terms

CorrectiveAction FromISO90012005
actiontoeliminatethecauseofadetectednonconformityor
otherundesirablesituation

NOTE1Therecanbemorethanonecauseforanonconformity.

NOTE2Correctiveactionistakentopreventrecurrencewhereas
preventiveactionistakentopreventoccurrence.

NOTE3Thereisadistinctionbetweencorrectionandcorrective
action.
Lets Define Some Terms

Correction FromISO90012005
actiontoeliminateadetectednonconformity

NOTE1Acorrectioncanbemadeinconjunctionwithacorrective
action

Nonconformity FromISO90012005
nonfulfilment ofarequirement

Requirement FromISO90012005
needorexpectationthatisstated,generallyimpliedorobligatory
Lets Define Some Terms

RootCause ISO90012005doesnotdefineRC
Lets Define Some Terms

RootCause ASQGlossary
afactorthatcausedanonconformanceand
shouldbepermanentlyeliminatedthrough
processimprovement
What is a Root Cause Analysis (RCA)

Asystemofproblemsolving methodsaimedatidentifyingthe
rootcauses ofproblemsorincidents.

Predicatedonthebeliefthatproblemsarebestsolvedby
attemptingtocorrectoreliminaterootcauses,asopposedto
merelyaddressingtheimmediatelyobvioussymptoms.

Bydirectingcorrectivemeasuresatrootcauses,itishoped
thatthelikelihoodofproblemrecurrencewillbeminimized.
When Do I Need to do a Root Cause?

Section4.1.5a Authorities&Resources
Section4.7.2 CustomerFeedback
Section4.8 Complaints
Section4.9 NonconformingWork
Section4.10 Improvement
Section4.11 CorrectiveAction
Section4.12 PreventativeAction
Section4.14 InternalAudits
Section5.9.2 AssuringtheQualityofResults
Handling Problems

Identificationofproblems

Funneltheproblemsthroughthemanagementsystem

Initiate,implement,andmonitorcorrectiveactionstoresolve
problems
A CAR Requires What?

AspecificRequirementand
Evidencethattherequirementhasnotbeenmet
Ifyoudonthaveeitherofthem,thenyoudont
haveaNonconformity!
AndyoudonthavetoinitiateaCorrectiveAction!!
Corrective Actions vs. Corrections

CorrectiveAction actiontoeliminatethecauseofa
detectednonconformityorotherundesirablesituation
Correction actiontoeliminateadetectednonconformity
candoacorrectionalongwithacorrectiveaction
acorrectioncanbe,forexample,aretest
ThereisacleardifferencebetweenaCorrectionanda
CorrectiveAction
Root Cause Analysis (RCA)

ISO/IEC17025,Section4.11.2
NOTE:Causeanalysisisthekeyandsometimesthemost
difficultpartinthecorrectiveactionprocedure.
Oftentherootcauseisnotobviousandthusacarefulanalysis
ofallpotentialcausesoftheproblemisrequired.
Potentialcausescouldincludecustomerrequirements,the
samples,methodsandprocedures,staffskillsandtraining,
consumables,orequipmentanditscalibration.
ARETHESEGOODEXAMPLESOFROOTCAUSES?
Reactive vs. Proactive

RCA,initiallyisareactivemethodofproblem
detectionandsolving.
BygainingexpertiseinRCAitbecomesapro
activemethod.
RCAisabletoforecast thepossibilityofan
incidentevenbefore itcouldoccur.
How do I Start a RCA
Start with a New Mindset

Peoplearegenerallynottheultimatecausesofproblems.
Peopleimplementprocesses.
Mostpeopledontcometoworkeachdayplanningto
sabotagetheirownwork.
Dontwasteallyourenergyfightingthesurfaceissues.
Passivevoiceispreferredtoavoidcastingblame.
BobdidntcompleteformA21correctly.
FormA21lackednecessaryreviewandapproval.
Avoid These Show Stoppers

Itwillneverworkhere
Weretoobusyforthat
Wealreadytriedthatonce
Thatsnotourpolicyhere
Itisntinthebudget
Goodthoughtbutimpractical
Topmanagementwillnevergoforit
Nooneelseisdoingitthatway
Wealwaysdoneitthatway
GoodIdea,Illgetbackwithyou(neverdoes)
Howdowedealwithsuchcomments?
Principles of RCA

Mustbeperformedsystematicallyasan
investigation.
Notablamegame
Notlookingfortheimmediatefix
Digdeeper
Establishasequenceofeventsortimeline
Understandtherelationshipsbetweencontributory
factors
Identify the Types of Causes

Cause(CausalFactor):Eventorconditionthatresultsinaneffect.Anything
thatshapesorinfluencestheoutcome.
ProximateCause:Theevent(s)thatoccurred,includinganycondition(s)that
existedimmediatelybefore,whichdirectlyresultedinitsoccurrenceand,
ifeliminatedormodified,wouldhavepreventedtheundesiredoutcome.
Alsoknownasthedirectcause(s). Canbebothequipmentandhuman
based.
RootCause:Oneofmultiplefactors(events,conditionsororganizational)
thatcontributedtoorcreatedtheproximatecauseandsubsequent
undesiredoutcomeand,ifeliminated,ormodifiedwouldhaveprevented
theundesiredoutcome.Typicallymultiplerootcausescontributetoan
undesiredoutcome.
General Process for Performing a RCA

1. Definetheproblem.
2. Gatherdata/evidence.
3. Askwhyandidentifythetruerootcauseassociatedwiththe
definedproblem.
4. Identifycorrectiveaction(s)thatwillpreventrecurrenceof
theproblem.
5. Implementthecorrectiveaction(s).
6. Observethecorrectiveactionstoensureeffectiveness.
7. Ifnecessary,reexaminetheRCA.
Tools and Techniques for RCA

FlowCharts
Records
Documents
Interviews
FiveWhys
CauseandEffect
Diagramming
Checklists
Flow Charts

Processflowpresentedingraphicalformatstarting
frombeginningoftask.
Easytofollowpicture.
Identifieslinkagesbetweensubjects.
Boxesconnectedbylinesshowworkflow.
Diamondssignalyes/nodecisionpoints.
Lackthedetailofproceduresanddocuments.
Maybeoflimitedusetocomplexsystemfailures.
 Problem

Yes Isolated No
Incident

Record RCA

Yes Critical No
Issue

Lab
CAR
Decides
RCA May Lead to Determination of
an Isolated Incident

Notprocessproblemortraining.
Examples:samplenotinjectedintoinstrument,
liquidmediaorslanttubenotinoculatedwithloop,
glassrodtoohotfromBunsenburnerwhenmaking
spreadplates,etc.
Laboratorydiscretiononhowtoproceedbasedupon
theirknowledgeandprocedures.
Keepinmind4.9.2.
Records

Verifycompliancewithrequirements.
EntireRCAprocessdependsonavailableandreliable
records.
Patternsinremedialactionrecords.
Systemmustcontrolrecordsproperly.
Objectiveevidenceofsystembreakdowns.
Maynotbecompleteorreadilyavailable(couldbea
nonconformanceinitsownregard).
Documents

Canoutlinerequirementsofaprocess.
Explainswhatshouldhappen.
Dontneedtorelyonmemory;addsconsistency.
Describesthecharacteristicsofapositiveoutcome.
Maynotbeunderstandableormaynotexist.
Interviews

Havestaff(andothers)explaintheirdocumentsand
actions.
Havetheproblemexplained.
Maybetheonlysourceofinformation.
Helpstounderstandworkflow.
Canbesubjectiveorassociatedwithblame.
Five Whys

Helpfulintracingthechainofevents(starting
withthenonconformanceandworking
backwards)
Cause and Effect

Presentsanaccessible
picture/diagram.
Useheadingstoorganize
theRCA.
Categorizequestionsbelow
appropriateheading.
Makesthepotentialcauses
moreapparentbyframing
situationintomacroview.
Cause and Effect Principles

Causeandeffectarethesamething

Causesandeffectsarepartofthesamecontinuumofcauses

Eacheffecthasatleasttwocausesintheformofactionsand
conditions

Aneffectexistsonlyifitscausesexistinthesamepointin
timeandspace
Causes Are Effects

Effects Causes

Injury CausedBy Fall

Fall CausedBy WetFloor

WetFloor CausedBy LeakyValve

LeakyValve CausedBy Seal Failure

SealFailure Caused By NotMaintained

Each Effect Has At Least Two Causes

PrimaryEffect

Caused By

Actions Conditions

APrimaryEffectisanyeffectthatwewantto
preventfromrecurring
Actions and Conditions

Actions Momentarycausesthatbringconditionstogetherto
causeaneffect,sometimescalledactioncauses

Conditions causesthatexistovertimepriortoanaction

Actionsarethecausesmosteasilyidentifiedbutconditions
arecausesthatweeitherignoreorarebeyondourknowledge
Where Theres Smoke Theres Fire

OpenFlameCausedbyWhat?

Actions MatchStrike

Conditions IgnitionSource,CombustibleMaterial,
Oxygen

*AnEffectexistsonlyifcausesexistatthe
sametime
Fishbone Diagram
Definitions

Material:incorrect,degradation,certificatesofanalysis
People:training,verbalmiscommunication,lackof
communication,staffchangedmidproject
Machinery:defective,notmaintained,notcalibrated,
overloaded
Method:procedures,workinstructions,amendments
Measurement:calibrations,appropriate
Environment:temperature,humidity,workarea,distractions
Checklists

Canbeusefultokeeptrackofquestionsand
potentialcauses.
Helpfultoorganizeoverallprocess.
Needstobeusedwithothertoolsto
determinespecificrootcause.
What to be Cautious About When
Selecting Corrective Action

Changingtoomanyvariablesatoncemaybeaproblem.
SelecttheoneactionthatisMOSTlikelytocorrectthe
problem.
Recordthefindingsandobservationsafterthisadjustmentis
madetoseeifitfixestheproblem.
Iftheproblemhappensagain,selectanothervariablefrom
thelist.
Conclusions

CABsoftenoverlooktheimportantproblemsolving
techniquesofRCA.
RCA,ifusedeffectively,canbeapowerfultoolto
preventproblemsfromhappeningagain.
Canhelpyourlaboratoryrunmoreefficientlyby
savingtime,staffresources,andmoney.
Questions?
Contact Information

Foradditionalinformation:
RobKnake
A2LA
5301BuckeystownPike,Ste.350
Frederick,MD21704
Direct:3016443218
Email:rknake@A2LA.org