Professional Documents
Culture Documents
OF SIX SIGMA
(6) FOR
PROCESS IMPROVEMENT
Presented by: Larry Bartkus of Biosense Webster and Matthew Thompson of FCI Management Solutions
Goals
g
Introduction to Six
Sigma
g g g
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
gDescription
Six Sigma is a quality program that, when all is said and done , improves your customers 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
Six Sigma Measurement
2.5 3.8
3 4 5 6
Six Sigma
g Philosophies
When defects occur look to the process for the cause. Excellent processes will allow average people to consistently generate superior results.
g Benefits
More loyal and satisfied customers (internal and external) Financial savings through improved efficiency and effectiveness Resolution of chronic problems
g 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.
g Myths
5 CONTROL 4 IMPROVE
1 DEFINE 2 MEASURE
3 ANALYZE
Phase 1: Define
Goal g Define the projects purpose and scope and get background on the process C PO and customer SI C Output VO 1 5 g A clear statement of the QFD DEFINE CONTROL intended improvement and how it is to be measured 4 2 g A high-level map of the IMPROVE MEASURE process g A list of what is important to 3 the customer
Busin es Case s
ANALYZE
Pr Ch ojec art t er
Project Charter
Define
Supplier
Input
Process
Output
Custom er
Level Build Plan Im proved Cycle Tim es /WIP Reductions Reduced QNCs Im proved Efficiency/ Im proved Com pliance
Sterilize
Identify hidden non-compliance issues Floor associate buy-in to improving the process
Ease of use Documentation mirrors process Operations Rapid Improvement Improved Product Build Documentation Consistency between documents Compliance to procedures Reduce QNCs
Reduce process related QNCs by 50%
Eliminate product mix-ups Simplified Product Flow Mitigate opportunity for near miss events Create simplified process flow.
Reduce near miss events from 14 in 2004 to 4 (1 per quarter) in 2005
Define
Measure
Analyze
Improve/ Innovate
Control
Phase 2: Measure
Goal g Focus the improvement effort by gathering information on the current situation
5 CONTROL
1 DEFINE
Output Baseline Data 4 g Data that pinpoints 2 Sampling IMPROVE problem location or MEASURE occurrence Gage R&R g Baseline data on current 3 Patt process sigma erns ANALYZE Ca g A more focused problem pa bil ity statement
D M A I
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.
Analyze
2.5
2.5
2.5
33 5
61 8
61 5
63 3
62 1
61 7
61 6 rm Fo
rm
rm
rm
Fo
rm
rm
rm
Fo
Fo
Fo
Fo
Form
Fo
Fo
Fo
rm
05 1
C o m p o n e n ts o f Va ria tio n
100 Percent
% C o n t r ib u t io n % Study Va r
Bu rs t By S e ttin g s ( O p e ra to rs )
100 75 50 S e tti n g s O p e r a to r s
50
G a g e R& R
Re p e a t
Re p r o d
P a r t- to - P a r t
Minim um N o m ina l O p e r a to r 1
Minim um N o m ina l O p e r a to r 2
S C h a rt b y O p e ra to rs
6 Sample StDev O p e r a to r 1 O p e r a to r 2 U C L= 5 .4 1 8 _ S = 3 .4 4 7 LC L= 1 .4 7 6 100 75 50
Bu rs t b y O p e ra to rs
4 2
O p e r a to r 1 O pe ra t or s
O p e r a to r 2
Xb a r C h a rt b y O p e ra to rs
O p e r a to r 1 Sample Mean 100 U C L= 8 8 .8 1 _ _ X = 8 6 .1 0 LC L= 8 3 .3 8 O p e r a to r 2
80
60
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.
Define
Measure
Analyze
Improve
Control
Process Capability-Current
Process Capability Sixpack of C before
I C har t
Individual Value UCL=1.9437 1.8 1.6 1.4 LCL=1.2472 1 2 3 4 1.2 1.3 1.4 1.5 1.6 1.7 1.8 _ X=1.5955
LSL
0.2
0.0
C apability P lot Within S tD ev 0.116076 Cp * C pk 1.34 Within O v erall S pecs O v erall S tD ev 0.102049 Pp * P pk 1.52 C pm *
DMAI2C
Capability Histogram
UCL=170.4
Mean
Range
Last 10 Subgroups
170.4
Values
Within StDev: 0.207647 Cp: 0.80 Cpk: 0.70 Overall StDev: 0.191131 Pp: 0.87 Ppk: 0.76
Capability Plot
I I I
I I
Overall Specifications
I
169.5
170.5
Subgroup Number
Phase 3: Analyze
Goal
g Identify
5 CONTROL 4 IMPROVE
1 DEFINE 2 MEASURE
3 ANALYZE
Do E
s es oc is Pr alys An
Hypothe s Testing is
Mult
Organize Causes
i i-Var
D M A I
1.25
Av erage per WO
Av erage per WO
1.28
Av erage per WO
1.48
1.20
1.38
1.15
1.28
1.10
1.18
1.05
1.08
PART NUMBER
PART NUMBER
PART NUMBER
Av erage per WO
1.20
Av erage per WO
1.20
Av erage per WO
1.2
1.15
1.15
1.10
1.10
1.1
PART NUMBER
D-1237-01-S
D-1237-02-S
PART NUMBER
PART NUMBER
Benchmarking - Internal
Strategic Advantage
Tier 4
Transforming
Tier 3
Integrating
Tier 2 Tier 1
Basic Presence
Personalisation Extensive information Basic Search Communities Advanced Search Value-add tools Moderate Interactivity
Searching
Advanced Applications High Interactivity e.g. online forms Knowledge Mgt hub Primary Communications Vehicle Content Rich
Analyze
Features
Regression Analysis
Forecasted Demand 08/15/05- 07/15/05
F it t e d L in e P lo t
G ran d T o tal = 3 4 3 2 9 + 1 9 3 .1 M o n th 40000 39000 38000 Grand Total 37000 36000 35000 34000 33000 32000 31000 0 2 4 6 M onth 8 10 12
S R-S q R - S q (a d j) 2 6 6 1 .1 1 7 .0 % 0 .0 %
7% Increase in demand/year
Analyze
Design of Experiment
Analyze
Improve
Control
Phase 4: Improve
Goal g Develop, pilot, and implement solutions that address root causes. Output Solutions g Identification of planned, tested FMEA actions that should eliminate or reduce Pilot the impact of the identified root causes
5 CONTROL 4 IMPROVE
1 DEFINE 2 MEASURE
en m ple tion Im ta
3 ANALYZE
D M A I
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
PROBLEM
BRIEF DESCRIPTION
PROPOSED SOLUTION
Train associates on visual acceptance criteria. Add a new hole to apply PU to bond components once they are in place. Design a new fixture to hold Nitinol during burnishing.
Some acceptance criteria are not clear for associates. Lasso to tip method. Defective bonding of Compression Coil and Lasso Stem
Rejection of good product exposes it to damage during rework operations. PU is applied before the components are in place and is partially removed during installation of components.
Prep. lasso stem method. Current burnishing method is Poor burnishing of not ergonomic causing Nitinol wire. associates make defects after some time.
ASSESSING RISK
An Example:
RISK 12. Support Plan not in Place Description
FMEA FMEA
t Pilo t Pil o
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 golive. 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 customers resources to ask IntegWare to implement higher valueadded initiatives in PDM (such as developing PART/BOM configuration management features, JDE integration, etc.) 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.
MITIGATION
HIGH 5/2/03
$5 $4 $3 $2 $1
1.6 2 .5
$0 1 2 3 4
Compliance Cost
1 10 100
Define
Measure
Analyze
Improve/
Control
Pilot/Pilot Plan
Used Japan Custom line as a pilot Medium size production line Minimize the production Impact
Signals, Lights
Kanbans Cards
Performance Measures
Define
Measure
Analyze
Improve/
Control
Phase 5: Control
Goal
g Use
ize rd da an t St en m cu Do
trol Con
g Validate
that all changes adhere to E va all operating company change lu at e Mo control, GMP, and compliance nit or requirements the gains by standardizing processes next steps for on-going improvement analysis
Clos ure
g Maintain g Outline
5 CONTROL
1 DEFINE 2 MEASURE
Output
g Before-and-After g Monitoring g Completed
4 IMPROVE
system
3 ANALYZE
D M A I
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
Scrap Produced
Yield Goal
Yield Actual
105
10
UCL=9.69
Moving Range
5 __ MR=2.97
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Observation 19 20 21 22 23 24 25 26 27 28 29 30
LCL=0
Individual Value
105 _ X=100.72
100
__ MR=3.37
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Observation 19 20 21 22 23 24 25 26 27 28 29 30
LCL=0
Define
Measure
Analyze
Improve
Control
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
gImprovement
must be continuous, but individual initiatives and project teams come to an end. gLearn when its time to say goodbye. gEffective project closure weaves together the themes of: Project purpose. Improvement methods. Team skills and structures. gDevelop managerial systems to capture learnings and enable the organization to address system issues. gDocumentation and recognition are two critical aspects of project team closure. gCelebrate!
DMAIC Pathway
Define
Measure
Analyze
Design
Verify/ Validate
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
DEx Methodology
Team Charter
Opportunity Define
Business Case Opportunity Statement Goal Statement Project Scope Team Selection Project Plan
Generation 1Generation 2Generation 3 Vision Product/ Service Generation Technologies/ Platforms
3 ID CCRs 4 Review 5 Develop Concepts 6 High-Level Design 7 Capability 8 Design Review 9 Develop Details 10 Simulation 11 Cost Analysis 12 Design Review 13 Procurement 14 Implementation
Qtr 4, 1999 1, 2000 2, 2000 3, 2000 Qtr Qtr Qtr IDTask Name Sep N ov ec Feb Apr ayunJulAug ep Oct D Jan Mar M J S 1 ID Customers 2 ID Needs
7 Correlatio n (I) Target goals 3 Characteristic/Measur es (how)(I) 1 4 Need 2 Theme 3 Measures (Hows) Customer needs (Whats) Customer Requirem ents (V) Critical process characteristics (Hows) Measures (Whats) House Of Quality #2 6 5 Relationships (What vs. How) (I) How important Targets/Specs (B)(I) Technical Evaluation (B) Importance (V) Cust omer Rati 2 ng (B) (V)
Theme 1 Need 1
Measure
Need 7 Need 8
House Of Quality #1
Need 5
o Pr
to
g pin ty
Creative Techniques
White
Red
Black
Blue
Green
Yellow
Ben
IZ TR
Analyze
Hazard Rate h(t) Early Failures
Design ng Princi arki E ples xper chm imen tatio n Customer Trials
Non-Linear Thinking
Build on Ideas
Combine Ideas
Compare
Worke rs
Worke r 1 Ins pe c tor 1
SYSTEM
Ins p e ctors
P1
M V1 M V2 Valves
Bilge Failure
FAULT TREE
System Failure
Proce s s 1
Card
P2 Bilge
Ins p e cto r 3
P roce s s 2
Re cord e r 1
Ins p e ct 2 Worke r 3
Pumps
Pump Failure
Valve Failure
Re corde rs
Re cord e r 2
P ro ce s s 3
Ins p e ct 3
Pump P1 Fails
Pump P2 Fails
Pump V1 Fails
Pump V2 Fails
Time (t)
Re corde r 3
(1 - (1-Rv)2)
DesignProductionDelivery Processes
DesignProductionDelivery Processes
Supporting Processes
Products
Services
Design Elements
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
Verify/Validate
Start
Supporting Processes
Products
Services
Design
Type of Design
Type of Design
Discrete
Type of data ?
Continuous
Yes
No
No
Yes
No
Equal opportunity ?
Yes
Individual measurements Individual measurements or subgroups ? Rational Subgroups Individuals charts EWMA chart
Transfer
Act Check
Plan Do
Stable
(In control)
Either/Or
Lower Spec
LCL
p chart
no chart
u chart
c chart
X, R or s chart
Yes
Yes
Lower Spec