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SixSigma
rocess mprovement
PresentedbyContentExpert:BethLanham,RN,BSN,MBA
,
FroedtertHospital,Milwaukee,WI
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SixSigma
is
a
projectfocused
resultsdriven
a roachto ualit
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Originatedby
Motorola
(1986)
electronicmanufacturingprocesses
Heavilyinspired
by
Previousqualityimprovementmethodologies QualityControlManagement,CQI,TQM
Basedontheworkofqualitypioneers
Deming,Juran,
Ishikawa,
Taquchi
and
others
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B late1990s
2/3Fortune
500
companies
Aimedatreducingcostsandimprovingquality
o ay Utilizedallovertheworld
Local overnments risons hos itals thearmedforces banksmanufacturing,etc.
Inrecentyears
x
w
u uyieldamethodologycalled LeanSixSigma.
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atwewere o ngwasn twor ngwe enoug
Incrementalimprovementsnotgoodenough
:
Focusoncustomerrequirements
Basedecision
on
data,
not
anecdotal
information
BeProactivevs.Reactive
Establishacultureofownershipvs.culpability
Itstheprocesses,notthepeople
Effectrapid
and
effective
change
Improvementeffortswerefragmented
Largesystemwi eprocesses ro en
Notholding
the
gains
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Or anizational
Datadrivendecisionmaking Benefits:Competitiveedge
Focusesoncustomerrequirements
Afocused/organized
approach
Service
Excellence
Redefinesprocessesforlongtermresults
Becomesingrainedinworkandthought
Leadership
Development
processes
Reliesonevidencebasedsolutions
Quality/Safety
HealthcareCosts
Rapid/effectivechange
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Methodologyaimed
at
Errorreduction
Goal Design/improve
processes
so
it
is
impossible
to
make
an
error
Relianceonperformancemeasurementsand
y
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..
servicesin
terms
of
averages:
Averagecost
Averagetimetodelivery
Averagenumber
infections
verageusage
Averagewaittime
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Are
These
Processes
the
Same?Process1 Process2
20 9
5 11 Goal=lessthan10
Aretheyperformingwell?
17 8
5 10 Process1 Process
2
15 10
5 9 Mean9.4 Mean9.4
5 11
5 10Areallthecustomersha ?
5 8
12 8
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Variation=
O ortunities
for
Errors
Process1 Process2
Average
9.4
9.4Minimum 5 8
Maximum 20 11
Standarddeviation 6.0 1.17
Customersfeelthevariation,
nottheaverage!!!!!!
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Process1 Process2
100
80
Mean 9.540
StDev 6.149
N 1000
Histogram of Process 1Normal
80
70
60
Mean 9.412
StDev 1.193
N 1000
Histogram of Process 2Normal
60
40Frequency 50
40
30
20
Frequency
24181260-6-12
20
0
Process 1
24181260-6-12
10
0
Process 2
Many
Defects
Fewer
Defects
expectations!
Exact
capability
can
be
measured!
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Howthe
customer
judges
our
products/services
Y=Theoutcomemeasureoftheprocess
Xs=InputsorvariablesthataffecttheY
Defect
Failure
to
deliver
what
the
customer
expects
Variation Theenemyofpredictableoutputandcustomersatisfaction
Sigma
Anexpressionofprocessyield,basedonthenumberof
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SixSi ma
APhilosophy of
Operational
Excellence
AsetofProblem
Tools/Tactics
AMeasure ofProcess
Capability
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Greekletter
Ameasureofprocesscapability Howcapableisourprocessofmeetingourcustomer s
expectations?
Arigorous,
structured
approach
to
problem
solving
Includesadefinedmethodologywithspecifictoolsandtactics
Amanagementphilosophy
Definitionscomplimentary,notcontradictory!
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Astatisticalconcept
Representsthevariationthatexistsinaprocess
Relativetothecustomerrequirements
A
process
operating
at
a
6
Sigma
level o tt evar at on,t att eprocessoutcomesare
99.9997%defectfree
= , , .
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Amoresensitiveindicatorthan%yieldor%good
Sigma Defects Yield DPMO
1 69.1% 30.9% 691,4622 30.8% 69.1% 308,538
3 6.7% 93.3% 66,807
4 0.62% 99.38% 6,210
5 0.02% 99.977% 233
6 0.0003% 99.9997% 3.4
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WhenComparedtoBestinClass
Antibiotic
at ona
ata
1000000
InpatientMedication
Accuracy
Overuse
Post
MI
10000
100000
llion
44,00098,000
PreventableHospital
Deaths(IOM
Report)
100
1000
efects/M
Anesthesia
1
10D DuringSurgery
Sigma DomesticAirline
FatalityRate
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1Si ma
5 &6
4Sigma
4
to5
Sigma
27
fold
Performance
Improvement
5 to 6 Si maAnother 69fold Performance Im rovement
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customerCriticalto ualit CT s
ThisisgenerallyreferredtoastheYoroutcomevariable
Examples:
waittime,
response
time,
turn
around
time,
%
newvisits,%mederrors,%falls,etc.
MeasuretheYagainstthetarget
Target=
customer
expectations
or
specifications
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Process
Ca abilit
Lower
SpecificationUpper
Specification
10
y
Limit m t
5Frequenc
AverageAverageDefectDefect DefectDefect
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Focusedon
identifying
the
root
causes
Rootcauseanalysis
Processvariables
are
called
Xs
Y = x1 + x2 + x3 + x4, etc.
r mary me r c = com na onof a variety of variables (xs)
Whatarethevariablesthatinfluence
themain
metric?
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Understandingthe
customers
needs
Anal zin business rocesses
Institutingappropriatemeasurementmethods
Em hasison
mana ement
of
rocesses
Wedonthavefaultypeople,wehavefaultyprocesses!
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Define Measure Analyze Improve Control
Establish
current
capability
SelectKey
CTQs**
Developdata
Charter
project
Optimization
Cycletime
Variability
Determine
capability
ofnew
rocessIdentifykey
sourcesof
variability
co ectionp an
Define
performance
ProcessMap
CollectVOC
ost
Validationof
Improvements
Implement
process
controls
Define
performance
objectives
s an ar s
Validate
measurement
ent y
CustomerCTQs
Review
Implementation EnsureGainsare
Sustainedsys emss or ca a a
*VOCVoiceofCustomer
**CTQCritical
to
Quality
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Tools
of
Six
Si ma= ,
ProcessMap Regression
FMEA(FailureModeand HypothesisTest
EffectsAnalysis) 95%ConfidenceInterval
Cause EffectDiagram ANOVA
are o agram es gno xper men s
GageR&R ControlPlan
ProcessCa abilit StatisticalProcessControl
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Six
Si ma Ke
Pla ers Oversee or
StrategicProjects
SkilledinSixSigma
chooseprojects
ResolveIssuesChampionsBlack
BeltsToo s
TeachGreenBelts
Leadership
Executive
FullTime
Strategic PartTime
ponsors
Master
BlackBeltsProjects
Program
Administration
o
Projects
Helptochange
GreenBelts
TeachBlack
BeltsandGreen
Belts
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Pr
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Launchin
a
Pro ect
Identifya Sponsor Champion Energy/passiontosolvetheproblem
Defineboundaries/scope
Establishstretchgoals
Providedirectionandsupporttotheteam
Removebarriers
Accountablefor
completion,
implementation
and
sustaining
resultsfromtheproject
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Define Measure Analyze Improve Control
CharterprojectProblemstatementHowdoweknowwehaveaproblem?
improvement?
ProjectScopeandTeam
g
eve
rocess
ap IdentifyCustomerCTQs
Reviewhistoricaldata
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ExampleProjectCharterQMS Project Team Charter
Business Process Team/Svc Line: Project Team Members Review Timing
Project Name: Target Completion Date: Project Type:
CAP WO PDSA Lean DMAIC
Process Owner: Milestones TBD based on methodology
Black Belt:
Finance Representative:
Project Overview
Problem Statement (*MOMS criteria):
In Sco e:
Out of Scope:
Customers and Stakeholders:
Goal (s): (**SMART criteria)
Target Performance Indicators and levels:
Expected Benefits/Business Case (target savings, target metric reduction):
Assumptions:
Signatures
Project Chair(s) Signature: Champion Signature: Master Black Belt signature:
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ProblemStatement Howdoweknowwehaveaproblem?
Measureable,Observable,Manageable,Significant
GoalStatement
Howwillweknowifwehavemadeanimprovement?
SMARTcriteria pec c, easurea e, a na e, ea s c, me y
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urpose: ograp ca y sp ay eprocessma oreven s
Suppliers Whoprovidestheinputstoyourprocess?
Inputs Whatmaterials,resourcesanddataareneededtoexecuteprocess?
ProcessSte s
57stepsthatuseinputstochangeintooutputs. Useveryspecificstartandstoppoints!
Out uts What
is
the
output
of
the
process?
What
did
the
customer
receive?
Customers Who receives the out uts of the rocess?
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SIPOCExample
Suppliers-Who providesthe inputs?
Inputs-Materials,
resources,
data
Process Steps Outputs-What did thecustomer
receive?
Customers- Who benefits?
Infection Control
H.C P roviders
(Physicians, nurses,
nursing assistants,therapists,
Policies &
Procedures
CDC guidelines
So ap
High quality
care
Avoidance /
reduction ofhospital
Pat ients
CMS
Third Party
PayorsWash hands
n er pa en
room
technicians,
emergency medicalstaff, dental staff,
pharmacists,laboratory staff,
autopsy staff,students and
trainees, contractual
Alcohol hand rub
Dispensers
Sinks
Paper towels
acquired
infections
Clean hands
Decrease in
skin irritation
Other patients
S ta ff
Famil ies
upon en er ng
Patient
Encounterstaff not employed
by the healthcarefacilit y, and persons
not directly involvedin patient care but
potentially exposedto inf ect ious agents.)
Clinical Routine
Degree of urgent
care required
Extent of contact
Increased
patientconfidence
Wash hands
upon exiting
Operations
Patient con dition
or ers
Call lights
Operational
routines
Leave patient
room
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What outhink Whatitactuall is What ouwouldlikeit
itis tobe.
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Identifyand
prioritize
all
customers
Whoisimpactedthe mostbytheprocess?
Whoisthemostdissatisfiedwiththecurrentprocess?
Solicitfeedback
How does the customer view the rocess?
Whatdoesthecustomervaluefromtheprocess?
Whatdoesthecustomerexpectfromtheprocess?
Whatdoes
the
customer
want
most
of
the
time?
Whatisthelimitthecustomeriswillingtotolerate?
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a e o er na ys s
StronglyModeratelyNeutralModeratelyStrongly
Whowill
be
affectedbyany
chan es from this
project?
Beginaddressing
issuesearl !
Noteveryone
needstobestrongly
supportive!
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Define Measure Analyze Improve Control
DefinePerformanceStandards
DataCollection
MeasurementSystemAnalysis
ProcessXs(Variables) OutputsorYs
X2
X3
Y2
Y3TheProcess
X4 Y4
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usesto
judge
your
performance
SixSi malin o:Thebi Y
HowwillIknowifIhavemadeanimprovement?
Howwill
the
Y
be
defined
and/or
measured?
VOC CTQ Y
Expecttobeseen WaitTime Pt.checkinatfrontdesktofirst
within
15
min
of
appt. contact
with
staff
physician.
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TranslatetheCustomerexpectationsintoMetricsTarget:
SpecificationLimits:
What
are
the
limits
the
patient
is
willing
to
tolerate?
VOC CTQ Y Target UpperLimit
Expecttobeseen Wait Pt.checkinatfront 15min 30min
within
15
min
of
appt.Unhappyif>30min
Time desk
to
first
contact
withstaffphysician.
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Process Env ironment Management
Managers not accountableClutter o bstructing sink
i i i li
- -
Don't have adequate resources
No communication r e: pt impact if non-compliant
Lack motivation to set an example
No incentives/rewards to comply
No corrective a ction for non-compliance
Spot checks not currently done
Divisions not accountable
Lack of institutional safety climate
Understaffing/Overcrowding
Carrying items into patient room
Need to take care of patient and can't
No ongoing education on process for
No reminders posted
No sin k i n t he r oo m
Difficulty monitoring process
regularlyEquipment is not wiped down
before/after contactPeople are not aware to wash hands
i i i li
during pt
compliance
hygiene
Lack hand
Inadequate org. structure for accountability
No role model for hand hygiene
Lack of institutional priority for hand hygiene
Delays in getting needed equipment
No alcohol wipes
No t e no u h h an d dis e nse rs
Low risk of acquiring infe ctions fro m
No lotion accessible
Lack immediate feedback/outcomes
processNot part of the yearly evaluation
Skeptical abo ut e ffectivenessInterf eres w/HCW relationship with pts
Disagree w/recommendationsFamily/visitors una ware re:han dwashing
i
Soap/alcohol dispenser empty
Broken dispenser
Overflowing garbage
No towels
Staff work areas are dirty
Too many people in room, in way of sink
E ui ment in wa of sink
hgyiene on the rate of HAINo data to show the impact of hand
Skin irritation by hand hygiene agents
Inconvenient location of hand sanitizer
Lack of e ducation mate rials
Family/visitors don't see being part of PCOther personnel not aware
Pts/visitors insulted when asked t o w ashPts not at ease asking someone to wash
People forgetPeople set in their ways
Not part of the Froedtert cultureNot seen as a priority
Concerned w/skin irritationDon't understand nee d fo r handwa shing
Feel that no need to wash w/gloves
Sponsoredby
the
Wisconsin
Office
of
Rural
Health
and
the
Wisconsin
Hospital
Association.
CopyrightoftheWisconsinOfficeofRuralHealth.
People Materials Equipment
i i i
Not enough sinks available
Sinks don't wo rk
Patient room is out of gloves
Don't know proper handwashingOnly touch equip., no need to wash
Feel that wash hands enoughToo busy/Not enough time
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Data Collection Sam lin
Datamust
be
representative
of
the
process
Datamustbereliable
Mustcapturemeasurementsofimportance
ENTRY EXIT
OBS # Role(s) Hand Hygiene Notes Hand Hygiene Notes
1 Sink Y / N Gloves On Sink Y / N Gloves On
Hand Rub Y / N Urgent Hand Rub Y / N Removed gloves
None Y / N Full Hands? None Y / N Full Hands?
Group Did Not Observe Y / N Blocked Access Did Not Observe Y / N Blocked Access
Direct Exit to Enter?
2 Sink Y / N Gloves On Sink Y / N Gloves On
Hand Rub Y / N Urgent Hand Rub Y / N Removed gloves
None Y / N Full Hands? None Y / N Full Hands?
Group Did Not Observe Y / N Blocked Access Did Not Observe Y / N Blocked Access
Direct Exit to Enter?
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Measurement
S stem
Anal sis
MSA
owaccura e s emeasuremen process
Howmuch
variation
is
there
in
the
measurement
Attempttominimizecontrollablefactorsthatcould
exaggerate
the
amount
of
variation
in
the
dataExample:
Iwanttomeasureseconds. Theclockonly measuresminutes
Result:Thevariationofthemeasurementsystemistoolargetostudy
the current level of rocess variation
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Performedby
all
RNs
Patientsgivenscores,basedonassessmentcriteria
DoortoBalloonTime Clocks
1. ReproducibilityDoesRN#1getthesamescoreasRN#2?
2. RepeatabilityDoesRN#1alwaysgetthesamescorewhen
ace w esame n ngs
Totalmeasurementsystemvariabilityshouldbeassmallas
possible,butalwayslessthan30%.
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Define Measure Analyze Improve Control
Establishcurrentcapability
Identifykeysourcesofvariability
e neper ormanceo ect ves
Howistheprocessperformingtoday?
Dowe
need
to
shift
the
mean
or
reduce
variation?
WhatarethekeyXsthataredrivingtheY?
Howdoyouknow?
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Graphical
Tools Flowdiagrams,frequencyplots,Paretocharts,etc.
StatisticalTesting DescriptiveStatistics,ProcessCapabilityHypothesistesting,Regression
DesignedExperiments
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Dis la in theData
Variable: Pt Wait Time
Descriptive StatisticsBoxplots of Pt Wait Tim e by CL INIC
( means are indicated by solid cir cles)
10 35 60 85 110 135 160
A-Squared:P-Value:
Mean
StDevVarianceSkewnessKurtosisN
i i
32.0180.000
23.1551
15.3332235.1081.251964.39234
2559
Anderson-Darli ng Normal ity T es t
100
150
(inmin)
95% Confidence Interval for Mu
20 21 22 23 24
i i1st QuartileMedian
3rd QuartileMaximum
22.561
14.924
.11.00021.000
33.000153.000
23.750
15.765
95% Confidence Interval for Mu
95% Confidence Interval for Sigma
95% Confidence Interval for Median
50
PtWaitTim
OverallStatisticsByPatient:
95% Confidence Interval for Median20.000 22.000
i l i
HAC
ORO
ORT
0
40
Scatterplot of Hand Hygiene Events vs Time of Day
Metric Wait Time Exam Time Total TimeMean 23.16 18.94 42.10
Median 21 16 40
30
20
and
Hygiene
Events
. . .
Sample Size 2559 2559 2559
Min 0 0 3
Max 153 99 18316141210860
Time of Day
H
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Howisthe rocess erformin toda ?
Dowe needtoshiftthemeanorreducevariation?
T T
1.235 1.239 1.241 1.245 1.233 1.235 1.239 1.241 1.245
USL USLLSL LSL
Hypothesis Testing
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HypothesisTesting
e ng
o
e
oo
auses
Test Details P-ValueRole DTY, EVS, Lab, LCs, PCAs, RNs, RTs 0.002
PValues