OVERVIEW OF SIX SIGMA ( 6σ) FOR PROCESS IMPROVEMENT Presented by: Larry Bartkus of Biosense Webster...
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Transcript of OVERVIEW OF SIX SIGMA ( 6σ) FOR PROCESS IMPROVEMENT Presented by: Larry Bartkus of Biosense Webster...
OVERVIEW
OF SIX SIGMA (6σ) FOR
PROCESS IMPROVEMENT
Presented by:
Larry Bartkus of
Biosense Webster
and
Matthew Thompson of
FCI Management Solutions
Goals
Introduction to Six Sigma– Description– Philosophies– Benefits – Origin– Myths
Identify the five steps of DMAIC, the core of Six Sigma, and the logical flow from step to step.
List tools and concepts useful in each step. Brief introduction to DMADV
Six Sigma Description
– “… Six Sigma is a quality program that, when all is said and done , improves your customer’s experience, lowers your costs, and builds better leaders.” Jack Welch CEO GE
– Six Sigma is a proven set of tools and tactics used for process improvement, reduction of defects, and improved quality
– Six Sigma uses data and statistical analysis to zero in on root causes
– Six Sigma can be applied to any process
2
3
4
56
σσDefects per
Million opportunities
Defects per Million
opportunities
308,537
66,807
6,210
233
3.4 .
3σ to 6σ - 20,000 Times Improvement ... A True QFL
Six Sigma Measurement
Six Sigma: What Does it Mean
30%
6%
.6%
3.8 10,724 1%
2.5 158,686 16%
99.99966% Good (6 Sigma)
• 20,000 lost articles of mail per hour
• 5,000 incorrect surgical operations per week
• Two short or long landings at most major airports each day
• 200,000 wrong drug prescriptions each year
• Seven articles lost per hour
• 1.7 incorrect operations per week
• One short or long landing every five years
• 68 wrong prescriptions per year
99% Good (3.8 Sigma)
Six Sigma PerformanceSix Sigma Performance
Most Businesses Operate at about 3.5 Sigma
Six Sigma Philosophies
– When defects occur look to the process for the cause.– Excellent processes will allow average people to consistently
generate superior results.
Benefits– More loyal and satisfied customers (internal and external)– Financial savings through improved efficiency and effectiveness– Resolution of chronic problems
Origin– The late Bill Smith, a reliability engineer at Motorola, is widely
credited with originating Six Sigma and selling it to Motorola's legendary CEO, Robert Galvin.
Myths
THE DMAIC METHOD
Overview of the DMAIC Method
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1
Phase 1: Define
Goal Define the project’s purpose
and scope and get background on the process and customer
Output A clear statement of the
intended improvement and how it is to be measured
A high-level map of the process
A list of what is important to the customer
IMPROVE
CONTROL
MEASURE
ANALYZE
5 1
2
3
4
Bu
sin
ess
Cas
e
Pro
ject
Cha
rter
SIPOC
VOC
QFDDEFINE
Project Charter
Define
DefineDefine MeasureMeasure AnalyzeAnalyze Improve/Improve/ InnovateInnovate ControlControl
Product FlowSIPOC
Process OutputInput CustomerSupplier
Planning Level Build Plan Doctors
Quality
Engineering
JCIT
CapacityRequirements
Line Design
ComplianceIssues
Consulting
Improved CycleTimes /WIPReductions
Reduced QNC’s
Improved Efficiency/Improved Compliance
Shareholders
Quality
Regulatory
ReceiveFinished Goods
Trigger
Cut Work Orderto Line
Sequence WO'sThrough
Single Prod.Line
MarketingForecast
SterilizeRelease
Product toFinished Goods
EXISTING PROCESS FLOW
DefineDefine MeasureMeasure AnalyzeAnalyze Improve/Improve/ InnovateInnovate ControlControl
VOICE OF THE CUSTOMER
Input from floor associates
Why NotCampaign
Identify “hidden” non-compliance issues
Floor associate “buy-in” to improving the process
Ease of use
Documentation “mirrors” process
OperationsRapid
Improvement
Improved Product Build Documentati
onConsistency between documents
Compliance to procedures
Reduce QNC’s
Eliminate product mix-ups Simplified
Product FlowMitigate opportunity for “near miss” events
Create simplified process flow.
Reduce process related QNC’s by 50%
Reduce near miss eventsfrom 14 in 2004 to 4 (1 per quarter) in 2005
Reduce near miss eventsfrom 14 in 2004 to 4 (1 per quarter) in 2005
Phase 2: Measure
Goal Focus the improvement
effort by gathering information on the current situation
Output Data that pinpoints
problem location or occurrence
Baseline data on current process sigma
A more focused problem statement
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1
Baseline
Data
Sampling
Gage R&R
PatternsCapability
D M A I C
• The system to collect information is already established.
• 100% of Scrap forms from Work Orders for all products are captured into a Yield Database.
• Scrap form (FORM633) has information as Lot Number, Date, Shift, Product Number, Defect Code, Defect Description, Potential Cause, Work Station ID, Catheter Number, Scrap Quantity, and is signed by operator and supervisor / engineer.
• Yield Database has information as Product Number, Date, Lot Number, Description, Lot Quantity, Reworks, Scrap in Line, and Scrap in QA.
Documentation Time StudyAnalyze
Minutes per Work OrderMaximum = 26.5 min per W/O
8
32.5 2.5 2.5
2 2 2 2
0123456789
Form
Lent
h of
tim
e in
Min
utes
Burst Tester Gage R&R
AnalyzeMeasure Improve ControlDefine
Per
cent
Part-to-PartReprodRepeatGage R&R
100
50
0
% Contribution
% Study Var
Sam
ple St
Dev
6
4
2
_S=3.447
UCL=5.418
LCL=1.476
Operator 1 Operator 2
Sam
ple Mea
n 100
80
60
__X=86.10
Operator 1 Operator 2
UCL=88.81
LCL=83.38
OperatorsSettings
Operator 2Operator 1NominalMinimumNominalMinimum
100
75
50
OperatorsOperator 2Operator 1
100
75
50
Gage name: Gage R&R for Burst Values (Universal Tray)Date of study:
Reported by: J . ChanTolerance:Misc:
Components of Variation
S Chart by Operators
Xbar Chart by Operators
Burst By Settings ( Operators )
Burst by Operators
Gage R&R (Nested) for Burst Values
The total Gage Repeatability and Reproducibility is 12.38%, which is well below the acceptance criteria of less than or equal to 30% of the Total Variation. Measurement system is acceptable.
The Gage R & R study is able to show that the burst tester is capable of detecting different parts being measured as shown from the data reported by two different operators measuring the samples.
Process Capability-Current
Indiv
idual V
alu
e
4321
1.8
1.6
1.4
_X=1.5955
UCL=1.9437
LCL=1.2472
Movin
g R
ange
4321
0.4
0.2
0.0
__MR=0.1309
UCL=0.4278
LCL=0
Observation
Valu
es
4321
1.68
1.60
1.52
1.81.71.61.51.41.31.2
LSL
SpecificationsLSL 1.13
2.11.81.51.2
Within
Overall
Specs
WithinStDev 0.116076Cp *Cpk 1.34
OverallStDev 0.102049Pp *Ppk 1.52Cpm *
Process Capability Sixpack of C beforeI Chart
Moving Range Chart
Last 4 Observations
Capability Histogram
Normal Prob PlotAD: 0.350, P: 0.255
Capability Plot
Process Capability Ring 20 – Current Marking Method
0 1 2 3 4 5 6 7 8 9 10
169.70
169.95
170.20
170.45
Xbar and R Chart
Subgr
Mean
Mean=170.1
UCL=170.4
LCL=169.7
0.0
0.3
0.6
0.9
Rang
e
R=0.3515
UCL=0.9050
LCL=0
0 1 2 3 4 5 6 7 8 9 10
Last 10 Subgroups
169.8
170.0
170.2
170.4
Subgroup Number
Valu
es
169.5 170.5
Capability PlotProcess Tolerance
I I I
I I I
I ISpecifications
Within
Overall
169.5 170.0 170.5
Normal Prob Plot
169.6 170.0 170.4
Capability Histogram
WithinStDev:Cp:Cpk:
0.2076470.800.70
OverallStDev:Pp:Ppk:
0.1911310.870.76
Process Capability Sixpack for Prod. Ring20
DMDMAAII22CC
Phase 3: Analyze
Goal Identify deep root
causes and confirm them with data
Output A theory that has
been tested and confirmed
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1
Process
Analysis
Mu
lti-Vari
Org
anize
Cau
ses
Hyp
oth
esisT
esting
Reg
ression
DoE
D M A I C
D-1237-02-SD-1237-01-S
1.34
1.32
1.30
1.28
1.26
1.24
1.22
1.20
1.18
1.16
PART NUMBER
Av
erag
e pe
r W
O
1
2
Multi-Vari Chart for Short in Ring
Shif t
D-1237-01-S D-1237-02-S
1.00
1.05
1.10
1.15
1.20
1.25
1.30
1.35
PART NUMBERA
ver
age
per
WO
1
2
Multi-Vari Chart for No Reading
Shif t
D-1237-01-S D-1237-02-S
0.98
1.08
1.18
1.28
1.38
1.48
1.58
1.68
1.78
PART NUMBER
Av
erag
e pe
r W
O
1
2
Multi-Vari Chart for Lasso out of RoundnessShif t
D-1237-02-SD-1237-01-S
1.35
1.30
1.25
1.20
1.15
1.10
1.05
1.00
PART NUMBER
Av
erag
e pe
r W
O
1
2
Multi-Vari Chart for Damaged Ring
Shif t
D-1237-01-S D-1237-02-S
1.00
1.05
1.10
1.15
1.20
1.25
1.30
1.35
PART NUMBER
Av
erag
e pe
r W
O
1
2
Multi-Vari Chart for Damaged Spine Cover
Shif t
D-1237-01-S D-1237-02-S
1.0
1.1
1.2
1.3
PART NUMBER
Av
erag
e pe
r W
O
1
2
Multi-Vari Chart for Tip going BackwardsShif t
Benchmarking - InternalS
trat
egic
Ad
van
tage
•Advanced Applications•High Interactivity
e.g. online forms•Knowledge Mgt hub
•Primary CommunicationsVehicle
•Content Rich
Tier 4
Transforming
Features
Tier 1
Basic Presence
Basic Company
Information
Tier 3
Integrating
•Communities•Advanced Search•Value-add tools
•Moderate Interactivity
•Personalisation•Extensive information
•Basic Search
Tier 2
Searching
Analyze
Regression Analysis
Analyze
Forecasted Demand08/15/05- 07/15/05
Month
Gra
nd T
ota
l
121086420
40000
39000
38000
37000
36000
35000
34000
33000
32000
31000
S 2661.11R-Sq 7.0%R-Sq(adj) 0.0%
Fitted Line PlotGrand Total = 34329 + 193.1 Month
7% Increase in demand/year
Design of Experiment
AnalyzeMeasure Improve ControlDefine
23 Factorial Design
Factors Low HighTemperature 245 F 260 F
Pressure 55 PSI 90 PSITime 2 SEC 3 SEC
Design of Experiment
AnalyzeMeasure Improve ControlDefine
Hi
Lo0.00000D
New
Cur
d = 0.00000
MaximumBurst Va
y = 94.6429
2.0
3.0
55.0
90.0
245.0
260.0Pressure TimeTemp
[245.0] [75.0] [3.0]
Phase 4: Improve
Goal Develop, pilot, and
implement solutions that address root causes.
Output Identification of
planned, tested actions that should eliminate or reduce the impact of the identified root causes
CONTROL
MEASURE
ANALYZE
5
2
3
DEFINE
1
Solutions
FMEA
Pilot
Implemen-
tation
IMPROVE4
D M A I C
•Improvement team created with members of Quality, Production, Engineering and R&D areas to propose and evaluate ideas.
•Brainstorming tool was used to gather ideas on how to solve the problems identified.
•Ideas were evaluated per following criteria: feasible, high impact, easy, low cost, and quick.
•Following tables summarizes solutions agreed by consensus of the improvement team.
D M A I C
PROBLEM BRIEF DESCRIPTION PROPOSED SOLUTION
Some acceptance criteria are not clear for associates.
Rejection of good product exposes it to damage during rework operations.
Train associates on visual acceptance criteria.
Lasso to tip method. Defective bonding of Compression Coil and Lasso Stem
PU is applied before the components are in place and is partially removed during installation of components.
Add a new hole to apply PU to bond components once they are in place.
Prep. lasso stem method. Poor burnishing of Nitinol wire.
Current burnishing method is not ergonomic causing associates make defects after some time.
Design a new fixture to hold Nitinol during burnishing.
Solutions
FMEA
Pilot
Implem
en-
tatio
n
Solutions
FMEA
Pilot
Implem
en-
tatio
n
RISK 12. Support Plan not in Place
Description IntegWare does not want to put Biosense Webster in a position of being overly reliant for day-to-day level 1 support of the system after go-live. IntegWare typically suggests that we assume the role of a second level support for a limited number of hours per month. IntegWare suggests it is typical for Day-to-Day (level 1) support will be a highly resource consuming task for three-six months after go-live. To use IntegWare for this might be an ineffective usage of the customer's resources. The project ownership should be transferred to the customer if at all possible. It would be a better usage of the customer’s resources to ask IntegWare to implement higher value-added initiatives in PDM (such as developing PART/BOM configuration management features, JDE integration, etc.) MITIGATION To mitigate this risk, we have discussed a support concept at BWI. This will be a combo function between Doc services (they will handle basic application admin functions) and IM who will handle IT functions. Still need to setup support contract for IntegWare to support system. Celeste has added to the schedule a support contract for level 2 support from IntegWare.RISK LEVEL HIGH
UPDATED 5/2/03
ASSESSING RISKAn Example:
AnalyzeMeasure Improve/ ControlDefine
Estimated Cost Benefit
100101
CMM vs. Estimated Cost Avoidance
$0
$1
$2
$3
$4
$5
1 2 3 4 5
Mill
ion
s
Capability Maturity Model (CMM) Level
Cu
mu
lati
ve
Co
mp
lian
ce
R
isk
($
)
Cumulative Risk ($) Compliance Cost
Risk reduction = $1.7 Million
1.6 2.5
Pilot/Pilot Plan
AnalyzeMeasureDefine Control
Used Japan Custom line as a pilot- Medium size production line- Minimize the production Impact
– Kanbans Cards
– Signals, Lights
– Performance Measures
Improve/
Phase 5: Control
Goal Use data to evaluate both the
solutions and the plans Validate that all changes adhere to
all operating company change control, GMP, and compliance requirements
Maintain the gains by standardizing processes
Outline next steps for on-going improvement
Output Before-and-After analysis Monitoring system Completed documentation of results,
learnings, and recommendations
IMPROVE
CONTROL
MEASURE
ANALYZE
5
2
3
4
DEFINE
1C
on
trol
Standardize
Document
Monitor
Evaluate
Closure
D M A I C
•All new tooling, processes, clarifications, and visual aids documented in PIs.
•Creation of MOPXXX with all the quality criteria for Variable Lasso Deflection and Contraction performance.
•MOP003 updated with reference to new created MOPXXX.
•PU quality criteria documented in WSS001 and available in QA workbenches.
D M A I C
•Yields Chart is published every week.
Work Orders Built
Yield Goal
Scrap Produced
Yield Actual
I-MR Charts of Burst Tester
AnalyzeMeasure Improve ControlDefine
Burst Values
Indiv
idual V
alu
e
302928272625242322212019181716151413121110987654321
115
110
105
100
_X=105.88
UCL=113.76
LCL=97.99
Observation
Movin
g R
ange
302928272625242322212019181716151413121110987654321
10
5
0
__MR=2.97
UCL=9.69
LCL=0
Universal Tray Packaging (CA Sealer)I n-H20
Burst ValuesIn
div
idual V
alu
e
302928272625242322212019181716151413121110987654321
110
105
100
95
_X=100.72
UCL=109.68
LCL=91.76
Observation
Movin
g R
ange
302928272625242322212019181716151413121110987654321
12
8
4
0
__MR=3.37
UCL=11.01
LCL=0
Universal Tray Packaging (Juarez Sealer)I n-H20
Lessons Learned
• Culture shock• Resources• Scope creep / Identifying the critical few• Management buy-in of change of policies• Time management & deliverables challenges• J&J Goals too high for small operating company (CMM
goal of Level 3 per J&J Corp Strategy)• Difficult to measure compliance
Project Closure
Improvement must be continuous, but individual initiatives and project teams come to an end.
Learn when it’s time to say goodbye. Effective project closure weaves together the themes
of:– Project purpose.– Improvement methods.– Team skills and structures.
Develop managerial systems to capture learnings and enable the organization to address system issues.
Documentation and recognition are two critical aspects of project team closure.
Celebrate!
DMAIC Pathway
New product Development - DEx Roadmap - DMADV
• DEFINE – Develop the Business Case, Scope & Charter the Project• MEASURE – Gather & Quantify Design Inputs (Customer, Technical, Business,
Regulatory)• ANALYZE – Develop and Investigate Conceptual Designs• DESIGN – Develop Detailed Product/Service/Process Designs• VERIFY/VALIDATE – Confirm design outputs meet design input requirements and
ensure specifications conform with intended uses and users; Scale-up manufacture and release the product or scale-up and implement the new process; Finally, transfer to process owners
Verify/ ValidateVerify/ ValidateDesignDesignAnalyzeAnalyzeMeasureMeasureDefineDefine
Opportunity
Define
Measure
Analyze
Design
Verify/Validate
Transfer
DEx MethodologyIDTask Name1 ID Customers2 ID Needs3 ID CCRs4 Review5 Develop Concepts6 High-Level Design7 Capability8 Design Review9 Develop Details
10Simulation11Cost Analysis12Design Review13Procurement14Implementation
SepOctNovDecJanFebMarAprMayJunJulAugSepQtr 4, 1999Qtr 1, 2000Qtr 2, 2000Qtr 3, 2000
Business CaseGoal Statement
Project Plan
Opportunity StatementProject ScopeTeam Selection
Team Charter
Generation 1Generation 2Generation 3
Vision
Product/ServiceGeneration
Technologies/Platforms
Theme 1
Need 1 Need 2
Theme 2
Need 3 Need 4
Need 5
Theme 3
Need 7
Need 8
1
Customer
Requirements
(V)
3Characteristic/
Measures (how)(I)
Target goals
7
Correlation (I)
2
Custome
rRating(B) (V)
4
Relationships(What vs.
How)(I)
6
5
Impo
rtan
ce
(V)
How importantTargets/
Specs(B)(I)
Technical Evaluation (B)
Measures(Hows)
Cus
tom
er n
eeds
(Wha
ts) House
Of Quality
#1
Criticalprocess characteristics
(Hows)
Mea
sure
s(W
hats
) House Of
Quality #2
Creative Techniques
Experimentation
Proto
typing
Customer Trials
Design PrinciplesBenchmarking
TRIZ
White Red Black Blue Green Yellow
Start With What You
Know
Get Other Perspec-
tives
Non-Linear Thinking
Build on Ideas
Combine Ideas Compare
FAULT TREESYSTEM
RELIABILITY PREDICTION
SystemFailure
PumpP1
Fails
PumpP2
Fails
PumpV1
Fails
PumpV2
FailsR = RBil X (1 - (1-Rp)2) x
(1 - (1-Rv)2)
PumpsBilge Valves
P1
P2
V1M
V2M
BilgeFailure
PumpFailure
ValveFailure
Time (t)
Haz
ard
Rat
e -
h(t)
Random FailuresEarly
FailuresWearou
t Failure
s
Proces s 2
Proces s 1
Proces s 3
Worke r 1
Ins pe ctor 1
Worke r 2
Ins pe ctor 2
Worke r 3
Ins pe ctor 3
Re corde r 3
Re corde r 2
Re cord e r 1
Card
Ins pe ct 1
Ins pe ct 2
Ins pe ct 3
Card Drop Shop - Proce s s Mod e l
Re cord e rs
Worke rs
Ins p e ctors
DevelopProcess
Control Plan
ErrorProofing andContingency
Planning
DetailedDesignReview
Prepare PilotTest Plans
Act Plan
Check Do
Start
Type of data
?
Counting items with an
attribute or countingoccurrences?
Equalsamplesizes
?
Equal opportunity
?
Continuous
Yes
No
Yes
Rational Subgroups
Discrete
Yes
No
No
Do limits look right?
Try individuals charts
Need to detect small shifts
quickly?
Individual measurements
or subgroups?
Do limits look right?
YesNo
Either/Or
No
Yes
Individualmeasurements
OccurrencesItems withattribute
p chart
Try transformation to make data normal
no chart u chart c chart X, R or s chart
Individualscharts
EWMAchart
Unstable (Not in control)
Stable (In control)
Within spec limits
Upper Spec
Lower Spec
Upper Spec
Lower Spec
UCL
LCL
UCL
LCL
Outside spec limits
Upper Spec
Lower Spec
Upper Spec
Lower Spec
UCL
LCL
UCL
LCL
Type of Design
Pro
du
cts
Ser
vice
s
Des
ign
-P
rod
uct
ion
-D
eliv
ery
Pro
cess
es
Su
pp
ort
ing
Pro
cess
es
Type of Design
Design Elements
Pro
duct
s
Serv
ices
Des
ign-
Pro
duct
ion-
Del
iver
yP
roce
sses
Supp
orti
ngP
roce
sses
1. H\W Products
2. S\W Products
3. Services
4. Analyses
5. Information Systems
6. Processes and Methods
7. Human Resources
8. Site \ Facilities
9. Equipment \ Tools
10. Materials \ Supplies
11. Sales \ Marketing
12. Other Non-Technical
Question & Answer