Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Lean Six SigmaCase Study Examples
Prepared by Dr. Leonard R. HeppJanuary 5, 2010
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Product Specs Set &
Filed w/States for Approval
Product Concept is
Conceived & Validated
Product Launched in Distribution Channels
Noble Certainty: Regulatory Approval Time Is Uncontrollable
Production
Sales &Distribution
Service Solutions
Product Competitiveness
Speed toMarket/Vitality
Product Features
Product Concept
ProductLaunch
Regulatory Approval
0
50
100
150
200
250
300
State
Day
s
Single Product Regulatory Approval Times by State
Approval of 80% of all States and Key States Needed for Launching a Product
– Critical number of States needed for effective product launch
– Within the total of all approving States, at least 80% of Key States (high sales) must have approved
First Time Data Has
Been Seen!
Data Pages
Endorsement
Policy Form
Rider
-100 0 100 200 300 400
1
510
20304050607080
9095
99
Data
Per
cent
Average Baseline Performance: 126 Days with Standard Deviation of 90 Days Range of 0 to 642 Days
40% of Key States Approved in 100 days50% of Non-Key States in 100 Days
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Improved Performance:
Average Performance 90 Days with Standard Deviation 70 Days 80% of State Approvals now within 60 DaysA Major "Ah-Ha"...ability to deliver a significant % in ZERO days.
After
Before
-200 -100 0 100 200 300 400 500
1
5
10
20304050607080
90
95
99
Data
Per
cent
Normal Probability Plot for Total Span By Period
After
Before
-200 -100 0 100 200 300 400 500
1
510
20304050607080
9095
99
Data
Per
cent
Normal Probability Plot for Total Span By Period
Competitor
GE 2001/02
0 100 200
1
5
10
20
3040506070
80
90
95
99
Data
Per
cent
Normal Probability Plot for Avg State Span By CompanyCompetitor
GE 2001/02
0 100 200
1
5
10
20
3040506070
80
90
95
99
Data
Per
cent
Normal Probability Plot for Avg State Span By Company
50 day difference in state average
CompetitiveBenchmark
Key States
Non-Key States
After
Before
-200 -100 0 100 200 300 400 500
1
510
20304050607080
9095
99
DataP
erce
nt
Normal Probability Plot for Total Span By Period
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
-500 -250 0 250 500 750 1000
USLUSL
Process Capability Analysis for TimeSort
USL
Target
LSL
Mean
Sample N
StDev (Within)
StDev (Overall)
Cp
CPU
CPL
Cpk
Cpm
Pp
PPU
PPL
Ppk
PPM < LSL
PPM > USL
PPM Total
PPM < LSL
PPM > USL
PPM Total
PPM < LSL
PPM > USL
PPM Total
180.000
*
*
102.719
121
119.738
189.418
*
0.22
*
0.22
*
*
0.14
*
0.14
*
181818.18
181818.18
*
259327.85
259327.85
*
341640.04
341640.04
Process Data
Potential (Within) Capability
Overall Capability Observed Performance Exp. "Within" Performance Exp. "Overall" Performance
Within
Overall
“I don’t know where documents go after scanning”
“No clear process for what is being scanned and when.”
“Searching for documents is too time consuming.”
“Turnover and loss of institutional knowledge have caused process breakdowns.”
“Huge backlog that keeps building up.”
“Do not even know what a comprehensive deal file should contain for legal, customer reference ...”
“The late submission of [closing documentation due to backlog issues] … is raising our level of concern regarding operations”
>$30B market worthBaseline Performance Average Time To Locate a document...
515 minutes with Standard Deviation 780 MinutesRange of 0 to >4500 minutes (basically lost document issues)
Prepared by Dr. Leonard R. Hepp
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1 3 4 5 6 7
0
100
200
300
400
500
600
700
800
Subgroupsort
Tim
eS
ort
Boxplots of TimeSort by Subgroup(means are indicated by solid circles)
CMS
PF
SF
-2000 -1000 0 1000 2000 3000 4000
1
510
20304050607080
9095
99
Data
Per
cent
Normal Probability Plot for Time_Min By Bus
Segmentation AnalysisBest-in-Class Identified
After Project Results:1.5 minutes Average with 1 minute standard deviationElimination of Lost Documents
Prepared by Dr. Leonard R. Hepp
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R e s o l u t i o n o f E v e n t
S u p p l i e r
SSS u p p l i e r
SSS u p p l i e r
SSSSSSIII n p u t
( U s e n o u n s )
III n p u t
( U s e n o u n s )
IIIII n p u t
( U s e n o u n s )
PPP r o c e s s
( U s e v e r b s )
PPPPP r o c e s s
( U s e v e r b s )
OOO u t p u t
( U s e n o u n s )
OOOOO u t p u t
( U s e n o u n s )
CCC u s t o m e r
CCCCC u s t o m e r
K e y Q u e s t i o n s
W h a t a r e t h e p r o c e s s b o u n d a r i e s ?S t a r t :
S t o p :
R e - E n g i n e e r E x i s t i n g P r o c e s s
1
2
3
4
P M , L P , R e c r u i t m e n t , R e t e n t i o n
B e n e f i t s , P a y P r a c t i c e s
E v e n t o c c u r s
R e s o l u t i o n o f e v e n tL e a d e r s h i p
H u m a n R e s o u r c e s
E m p l o y e e s
E m p l o y e e C o m p l a i n t
E m p l o y e e
E v e n t t a k e s p l a c e
I n t e r a c t i o n b e t w e e n e m p l o y e e & G E F A
G E F A i n v e s t i g a t e s
G E F A p r o v i d e s p o s i t i o n t o e m p l o y e e
E m p l o y e e a c c e p t s E m p l o y e e r e j e c t s
C o m p l a i n t f i l e d
W h a t i s i n c l u d e d / e x c l u d e d i n t h e s c o p e o f t h i s p r o j e c t ?I n c l u d e s :
E x c l u d e s :
W h a t i s t h e U n i t , O p p o r t u n i t y , D e f e c t ?
H a s t h i s p r o c e s s m a p b e e n v a l i d a t e d b y k e y p e o p l e ?
U n i t = e a c h c o m p l a i n t ; O p p o r t u n i t y = o n e p e r a c t i o n ; D e f e c t = E a c h c o m p l a i n t , b a d a c t i o n
Y e s
S u b p r o c e s s e s i n c l u d e :
- P e r f o r m a n c e M a n a g e m e n t- L a b o r P r a c t i c e s- R e c r u i t m e n t- R e t e n t i o n
E N D
G O T O S T E P 2
25
30
35
40
45
50
55
60
65
70
Below 50:
Needs Improvement
51-69: Caution
70 +: Great Score
Lowest Scoring Mgmt. Practices QuestionsLowest Scoring Mgmt. Practices Questions
Drill Down On 6 Lowest Themes
Overall Management Practices Score = 47
Management of Associate Complaints50% lead to next level resolution requirementsSignificant legal cost issues in some casesMorale & Employee Engagement is Suffering (Average Survey Satisfied Ranking-@47%)
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Policy & Procedure 2001 InventoryPolicy & Procedure 2001 Inventory Too Many PoliciesToo Many Policies
2001 Bad Complaints2001 Bad Complaints Inconsistent Adherence:Inconsistent Adherence:Focus On Labor Practice & Performance ManagementFocus On Labor Practice & Performance Management
• Policy & Practices:
• Unstable Environment: Massive Restructuring & Turmoil in Environment (Acquisition, Integration, Downsizing)
Quantity of Policies
Adherence to Policies/Practices
Communication
Huge Variation in Practices
After Project:Less than 5% next resolution issuesNear elimination of legal case issuesQuality-Growth Survey…Average @65%
Mgmt Practice Changes
Policy Changes
Communication
Bad Complaint Complaints that occurred when the proper Policy & Process were not followed
Good Complaint Complaints that occurred when the proper Policy & Process were followed
Tracking Mechanism Put in PlaceTracking Mechanism Put in Place
IMPROVEMENT FOCUS
0
2
4
6
8
10
12
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Sales Leaders' Compensation Plans Stakeholder Assessment
NameStronglyAgainst
ModeratelyAgainst Neutral
Moderately Supportive
Strongly Supportive Issues & Concerns Identify "Win" Drivers Influence Strategy
Who can help?
CEO X Is variable comp an appropriate % of total
comp?
Overall Business Peformance
Strong execution focus. Keep informed of change in direction.
Periodic updates.
Laming Project Team
Business GMs X Sales/Business Goals, Mix, Market Competitive,
Retention, Culture
Develop repeatable process that incents
the desired behaviors which results in
meeting key goals.
Keep GMs involved along the
way as project develops.
Laming, Mays
Sales Leaders X X Will the plans use measures that I feel are important to my business? Will the
plan metrics in the plan be given the right
weight? Will I be paid the correct level of
compensation
Fair, Equitable, Competitive,
Significant upside opportunity, Strong link
to "my" strategy
Communication Plan - emphasis benefits of new
plan
Business GMs
CompensationTeam
X Will the comp plan be easy to administer?
Will the plans be consistent across all
businesses?
Repeatable process, maximize automation,
Fair, equitable, competitive
Involvment in the solution
Mays
Reviewed Sales Leader & Business Leader VOC Collected at beginning of project
Reviewed benchmarked information
Project team brainstormed potential variation sources
Validated finding with HR & Business Leaders
Reviewed Sales Leader & Business Leader VOC Collected at beginning of project
Reviewed benchmarked information
Project team brainstormed potential variation sources
Validated finding with HR & Business Leaders
DataData--Driven ApproachDriven Approach
Lack of Leadership Mandate
Lack of Centralized Accountability
Lack of a Process
Key Findings
Created CAP Plan to Communicate Shared Need & Mobilize Commitment
Designed a Centralized Process
Key Improve Actions
Mobilizing Commitment&
Creating Shared Need
Need to Focus On
Multiple, competing Compensation approachesNo standards for key elementsNo cross-business comparisons or market differentiations.
Prepared by Dr. Leonard R. Hepp
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Business HRMBus Leader &Sr. Sales Leader
Enter Results Into Sales Leader Comp
ModelYes
NoAre there
any exceptions?Are there
any exceptions?
Send Bonus Target to Sr. Sales Leader for Review/Approval
Input Sr. Sales Leader Changes into Sales
Leader Comp Model & Document Reason for
Exception
Send Approved Sales Leader Comp Model to Comp COE – One
Week Prior to Planned Communication Date
Discuss Exceptions with HRM
Collect Results forRequired ElementsCollect Results forRequired Elements
Sr. Sales LeaderCommunicate Sales
Bonus to Sales Leader(as appropriate) & Notify
Payroll
Sr. Sales LeaderCommunicate Sales
Bonus to Sales Leader(as appropriate) & Notify
Payroll
Comp COE VP Comp
Review Plans
Discuss Plan with Business Leader, SHRM & SVP-HR (if needed) & Approve
Document Final Approval
Cycle Time = 5 business days
Actions Taken Ne
w S
EV
Ne
w P
RO
B
Ne
w D
ET
Ne
w R
PN
Rev iew Process
Plan not receiv ed by due date
Delay in rev iew /approval. 9
Delay in submittal 9
Publish timeline and schedule rev iew s 3 243
Build trotter matrix to track completion Stev e Ow ens
M atrix built & communicated 9 3 1 27
Rev iew Process
Plan not receiv ed by due date
Sales Ldr w on't know w hat they 're acountable for 9
Delay in submittal 9
Publish timeline and schedule rev iew s 3 243
C ommunicate
model & requirements. C oord w / AIM team to identify S tev e Ow ens
M odel communicated. 9 3 1 27
Pay ments outs ide of plan
N ot paid according to plan
Potential of ov erpaying/underpaying 9
Dev iation from process 3 N one 9 243
Develop a process to audit
C omp C O E/1Q
Process identified 9 3 3 81
Plan is rev iew d by H R C omp C OE
Submitted plan doesn't meet requirements
Plan is out of spec
9 Business dev iates from process
9 C omp C OE rev iew s all plans
1 81 If can't meet plan requirements in 2003, must hav e plan for meeting
Business H RM
Issue identified and communicated that must hav e a plan for '04 9 9 1 81
Acceptance of change
Sales leaders resisting change
Sales leaders leav e/demotivated 9
Lack of communication & understanding 9
Rely on H RMs to prov ide data 3 243
Implement C AP plan to create shared need & mobilize commitment
Project team & SH RM s
Implement C AP plan 9 3 3 81
0
Item/Function
Potential Failure Modes
Potential E ffects of
Failure
S
E
V
Potential C auses of
Failure
P
R
O
B
C urrent Design
C ontrols
D
E
T RPN
Recommended Actions
Target Date and
Responsibility
Action Results
Strong Risk Mitigation PlanStrong Risk Mitigation Plan
Weekly status update to project teamResults posted to QuickPlace
Weekly status update to project teamResults posted to QuickPlace
Rigorous Method to Track Progress Against Feb. 28 DeadlineRigorous Method to Track Progress Against Feb. 28 Deadline
Trotter Matrix
FMEA
After ProjectSingle standards policy with 6 key criteria assessments55-95% reduction in Compensation Programs across businesses.
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
89% of INVAs are Defects89% of INVAs are Defects
Count 1615 891 273 31Percent 57.5 31.7 9.7 1.1Cum % 57.5 89.2 98.9 100.0
Co
unt
Perc
ent
Department OtherManufacturingQAFinance
3000
2500
2000
1500
1000
500
0
100
80
60
40
20
0
Pareto Chart of I NVAs by Department (1/ 1/ 06 - 6/ 30/ 06)
Baseline Capability Info
Baseline Capability Info
35% of Picks are Defects35% of Picks are Defects
Count 2947 1391 251Percent 64.2 30.3 5.5Cum % 64.2 94.5 100.0
Count
Perc
ent
Department QAFinanceManufacturing
5000
4000
3000
2000
1000
0
100
80
60
40
20
0
Pareto Chart of PI CKs Department (1/ 1/ 06 - 6/ 30/ 06)
Current Performance (1H06)Non-Manufacturing Transactions are “Defects”
56.5% of Transactions are Defects56.5% of Transactions are Defects
Count 3220 3006 1142 31Percent 43.5 40.6 15.4 0.4Cum % 43.5 84.1 99.6 100.0
Count
Perc
ent
Department OtherQAFinanceManufacturing
8000
7000
6000
5000
4000
3000
2000
1000
0
100
80
60
40
20
0
Pareto Chart of All Transactions (PICKs and INVAs) by Department
0.565 DPU/DPO
565,000 DPMO
1.3 Sigmast
Process Yield = 43.5%
Project Focus
QFD: Big Y’s to Little y’s
1
1
5
3
3
Sam
ple andR
elease
3
3
9
9
9
Co
nsu
mp
tion
(PIC
K, IN
VA
)
9
9
1
1
3
Cycle C
ounts
114Timely Data
9
9
1
9
Bin C
ard R
econciliation
9
9
1
9
Batch R
ecord R
econciliation
5Accuracy
5Time
5Resources
3Ease of Use
Importance
Customer Needs
1
1
5
3
3
Sam
ple andR
elease
3
3
9
9
9
Co
nsu
mp
tion
(PIC
K, IN
VA
)
9
9
1
1
3
Cycle C
ounts
114Timely Data
9
9
1
9
Bin C
ard R
econciliation
9
9
1
9
Batch R
ecord R
econciliation
5Accuracy
5Time
5Resources
3Ease of Use
Importance
Customer Needs
What’s
How’s
Y >>>> y
Project Focus (y’s)
Relationships
9
1
3
High
Low
Medium
52 138 142 142112
Measure
Step 1
Measure
Step 1
Missed Picks, Cycle Count Adj., MTs, Cleaning, WasteMissed Picks, Cycle Count Adj., MTs, Cleaning, Waste
Analyze
Step 6
Analyze
Step 6
Establish Process Capability
Count 322359 1107 290 180 96 41 39 29Percent 0.856.5 26.5 6.9 4.3 2.3 1.0 0.9 0.7Cum % 100.056.5 83.1 90.0 94.3 96.6 97.6 98.5 99.2
Co
un
t
Pe
rce
nt
Reason Code
4000
3000
2000
1000
0
100
80
60
40
20
0
Pareto Chart of Transactions by Reason (Non-Manufacturing)Department2 = Other
Missed Picks, Cycle Count Adjustments, Empty Containers, Cleaning and Waste represent 70% of the defects
Significant X’s
BEFORE Project:Multiple missed PICs and Count Adjustments (35% Defects)Empty, Lost, damaged Containers (18% Defects)Bar Code errors; lost signals from portable readers > “bad” data (56% Defects)
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
KEY Recognized Improvements w/ New Process!
Reduced Support Resource Requirements
Centralized Manufacturing Ops Responsibilities, Centralized
< 0.05 FTE (< $5K)0.5 FTE ($60K)Finance
00.25 FTE ($15K)QA
New ProcessOld ProcessDepartment
< 0.05 FTE (< $5K)0.5 FTE ($60K)Finance
00.25 FTE ($15K)QA
New ProcessOld ProcessDepartment
0.5 Contractor ($10K)
No ResponsibilityBin Card Reconciliation
0.25 FTE ($15K) No ResponsibilityBatch Record Reconciliation
0.25 FTE ($15K) All Operators Involved
> 0.5 FTE (>$30K)
WIP Transactions
New ProcessOld ProcessDepartment
0.5 Contractor ($10K)
No ResponsibilityBin Card Reconciliation
0.25 FTE ($15K) No ResponsibilityBatch Record Reconciliation
0.25 FTE ($15K) All Operators Involved
> 0.5 FTE (>$30K)
WIP Transactions
New ProcessOld ProcessDepartment
BR Reconciliation
reduced to 20% Audit
Completed Real-Time,
During Mfg. Review
Conducted During Mfg. BR Review
Same Resource Requirements (~1 FTE), but at Savings > $50K
43.5%
1.3
565,000
OLD
119,000DPMO
88.1%Process Yield
2.7Sigmast
NEW
43.5%
1.3
565,000
OLD
119,000DPMO
88.1%Process Yield
2.7Sigmast
NEW
Observation
Ind
ivid
ua
l V
alu
e
987654321
1000000
750000
500000
250000
0
UCL=98640
LCL=-4089
Baseline New Process
_X=47276
Observation
Mo
vin
g R
an
ge
987654321
600000
450000
300000
150000
0__MR=19313
UCL=63101
Baseline New Process
LCL=0
I-MR Chart of Inventory Carrying Cost by Status
X = 424865
MR = 206943
Key, Performance Indicating Metrics!
Reduced Inventory Carryover
10X reduction On Average & Range!
After Project:Less than 0.1% PIC Defects (99.8% Reduction)95 % Reduction in empty/lost/damaged containers“Bad” Data issues reduced by 85%
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
“Production Up 35% in 2008 yet Inert Gas Usage has increased by 150% … something has to change!”
Brainstorming of Gas Usage Issues
$35K77Maintenance
$36K025Process & Technical Development
$304K2785TOTAL
$91K315Quality Control – AR&D
$142K1738Manufacturing
Est. Annual Cost# with Regulators
Total # Ports w/ Opportunities
Department
$35K77Maintenance
$36K025Process & Technical Development
$304K2785TOTAL
$91K315Quality Control – AR&D
$142K1738Manufacturing
Est. Annual Cost# with Regulators
Total # Ports w/ Opportunities
Department
Root Cause: Close-up of Isolation Points
Time
SCFM
14
13
12
11
10
9
8
7
6
Building 1SCFM every 5 min
Up the Ramp.
Valve location:
Boiler Room
MA-04,-05,-06.
Valve location:
Outside MA-02
MA-07,-08.
Valve location:
Outside MA-02
MA-01,-02,-03.
Valve location:
Outside MA-01
PP1,2,
Chromatography.
Valve location:
Outside PP1
Project Opportunity:>$100K in Savings if usage is in balanceStreamlined processes and proceduresPosition for growth in 2009
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Two Quick Fixes and One Major FixTwo Quick Fixes and One Major Fix
Root Cause Analysis
The median baseline level in Building 1 is 11.190 scfmcompared to 3.370 scfm
in Building 2
People Equipment
Methods Piping
Vacuum PumpsUse ArgonPurge
Ports left open
NMR Uses Constant ArgonPurge
Reactors DryingUnder Argon
Leaks
1 3
3
1
1
Focus is on MAFocus is on MA--04 through MA04 through MA--0808
Time
SCFM
14
13
12
11
10
9
8
7
6
Building 1SCFM every 5 min
Up the Ramp.
Valve location:
Boiler Room
MA-04,-05,-06.
Valve location:
Outside MA-02
MA-07,-08.
Valve location:
Outside MA-02
MA-01,-02,-03.
Valve location:
Outside MA-01
PP1,2,
Chromatography.
Valve location:
Outside PP1
Index
Arg
onR
eadin
g
740666592518444370296222148741
11
10
9
8
7
6
5
4
3
BaselinePage29Bldg1_1BaselinePage36Bldg1NEWMfgLowNEWMfgMedian
ProcessStatus
Time Series Plot of ArgonReadingBaseline BEFORE Leak Corrections
Plant in “Shut-Down”
Baseline AFTER Leak Corrections
Plant in “Shut-Down”
5/4/07 CONTROL Data – Baseline 1
Plant in Running Mode
5/5-7/07 CONTROL Data – Baseline 1
Plant in Running ModeNOTE Overlap!
Plant Usage during operationCan Meet BEST-IN-CLASS
Benchmark Usage when Shut-Down!
Project Results:$90K in Saving; additional $50K with investmentNew Technology to monitor systems in placeGame Changer Opportunity in Alternate Material
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
Project SpotlightExubera® Make-Release Cycle Time
Key actions by the team:Stable work practicesStep visibility Cross training in Mfg. & QAIn-process BPR clearance in JulyReduced redundanciesIdentifying & addressing issues earlyReduced material transfer work (i.e. Hold)Team empowerment action itemsQC data packet reduced to 1 level reviewBatch Disposition Group improvements
A Cross-Function, multi-project team approach to this critical business metric:Exubera® BPR Sub-process:BPR Team Leads: XXX & YYY
Disposition ReleaseQC
BPR
EM
ER
Mfg
BPR Cycle Time
MFG Start
BPR
OK
- M
F G E
nd
9/1/20068/1/20067/1/20066/1/20065/1/20064/1/20063/1/20062/1/2006
80
70
60
50
40
30
20
10
0
Scatterplot of BPR OK - MFG End vs MFG Start
*Undefined Endpoint
14Apr06 – Identification of Process Improvements02May06 –1st Process Improvement Meeting
21Jun06 – Team Empowerment Session
14Jul06 –In-Process BPR Clearance
*
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
15.915.815.715.615.515.415.3
LSL USLProcess Data
Sample N 125StDev(Overall) 0.0318339
LSL 15.22Target *USL 15.98Sample Mean 15.8109
Overall Capability
Cpm *
Pp 3.98PPL 6.19PPU 1.77Ppk 1.77
Observed PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL 0.00PPM > USL 0.05PPM Total 0.05
Process Capability of CTF 3 (15.60 +/ - 0.38mm) (R)
15.915.815.715.615.515.415.3
LSL USLProcess Data
Sample N 125StDev(Overall) 0.0298743
LSL 15.22Target *USL 15.98Sample Mean 15.8442
Overall Capability
Cpm *
Pp 4.24PPL 6.97PPU 1.51Ppk 1.51
Observed PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL 0.00PPM > USL 2.76PPM Total 2.76
Process Capability of CTF 3 (15.60 +/ - 0.38mm) (R)
FLEX Lot 102210
Q+ Lot 102210
15.915.815.715.615.515.415.3
LSL USLProcess Data
Sample N 125StDev(Overall) 0.0323148
LSL 15.22Target *USL 15.98Sample Mean 15.776
Overall Capability
Cpm *
Pp 3.92PPL 5.73PPU 2.10Ppk 2.10
Observed PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Process Capability of CTF 3 (15.60 +/ - 0.38mm) (L)
15.915.815.715.615.515.415.3
LSL USL
Process Data
Sample N 125StDev(Overall) 0.0249849
LSL 15.22Target *USL 15.98Sample Mean 15.805
Overall Capability
Cpm *
Pp 5.07PPL 7.81PPU 2.33Ppk 2.33
Observed PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Process Capability of CTF 3 (15.60 +/ - 0.38mm) (L)
FLEX Lot 102210
Q+ Lot 102210
0.2240.1920.1600.1280.0960.0640.032
USLProcess Data
Sample N 125StDev(Overall) 0.0032733
LSL *Target *USL 0.25Sample Mean 0.013496
Overall Capability
Cpm *
Pp *PPL *PPU 24.08Ppk 24.08
Observed PerformancePPM < LSL *PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL *PPM > USL 0.00PPM Total 0.00
Process Capability of CTF 2 (Rad. 0.025mm Max) (Max)
0.2380.2040.1700.1360.1020.0680.0340.000
USLProcess Data
Sample N 125
StDev(Overall) 0.00568468
LSL *
Target *USL 0.25
Sample Mean 0.011544
Overall Capability
Cpm *
Pp *
PPL *PPU 13.98
Ppk 13.98
Observed Performance
PPM < LSL *
PPM > USL 0.00PPM Total 0.00
Exp. Overall Performance
PPM < LSL *
PPM > USL 0.00PPM Total 0.00
Process Capability of CTF 2 (Rad. 0.025mm Max) (Max)
FLEX Lot 102210
Q+ Lot 102210
2.462.402.342.282.222.162.10
LSL USLProcess Data
Sample N 125
StDev(Overall) 0.0323002
LSL 2.1
Target *USL 2.5
Sample Mean 2.20651
Overall Capability
Cpm *
Pp 2.06
PPL 1.10PPU 3.03
Ppk 1.10
Observed Performance
PPM < LSL 0.00
PPM > USL 0.00PPM Total 0.00
Exp. Overall Performance
PPM < LSL 487.64
PPM > USL 0.00PPM Total 487.64
Process Capability of CTF 1 (2.30 +/ - 0.20mm)
FLEX Lot 102210
2.462.402.342.282.222.162.10
LSL USLProcess Data
Sample N 125StDev(Overall) 0.0311652
LSL 2.1Target *USL 2.5Sample Mean 2.16555
Overall Capability
Cpm *
Pp 2.14PPL 0.70PPU 3.58Ppk 0.70
Observed PerformancePPM < LSL 0.00PPM > USL 0.00PPM Total 0.00
Exp. Overall PerformancePPM < LSL 17716.69PPM > USL 0.00PPM Total 17716.69
Process Capability of CTF 1 (2.30 +/ - 0.20mm)
Q+ Lot 102210
NO IMPACT ON ACCEPT/REJECT DECISION BY NEKTAR!There is no statistical (to 99.9% confidence) difference between vendors.
Removal of 2Removal of 2ndnd QC Test Verification will QC Test Verification will have no material impact!have no material impact!
Establish Performance Criteria Baseline & Run Statistics
After Results:Supplier CoA Verified…no in-coming QC Reassessment
Cost Savings $60K; Cost Avoidance >$125K!
Prepared by Dr. Leonard R. Hepp
All Rights Reserved
QC10 Oall
Perc
ent
150100500-50
99.9
99
95
90
80706050403020
10
5
1
0.1
43.13 22.95 71 4.400 <0.00526.15 6.125 46 0.553 0.146
Mean StDev N AD P
A-DE
Seg 1
Probability Plot of QC10 OallNormal - 95% CI
Step
Days
QA CoAQC CoAExternal CoASup ReviewInternal TestsQC Log/ShipMfg Deliver
250
200
150
100
50
0
Boxplot of Days vs StepRef Std
736 01098908 01097
InstrumentsEquipment
Mfg eWO Completed
Mfg PrepareSamples
andTRF
MfgDeliver
Samples & TRF to QC
QC TRF Check Sample Log In
Internal or External
Test
Sample Testing
11 Attributes 9 SOP’sAnalysts
sign up for each tests
Prepare samples for
shipping to PFE
Contract Lab Management820 03537
Test Results forAttributes908 05116
QC SupervisorData Review
908 03132908 07696
Results Meet
Specification
External
Complete Data Packet
with CoA
QC Approved CoA
100%QA
Review
Packet & CoA Correct
QA Approved CoA
Yes
No
MLT ParticulatesAttributes
Process Poorly defined
Internal
Not Correct
Correct
No Operator Errors
Lab Investigations
908 05456
OperatorError
Page2 Supervisor
Review Checklist
Assignable CauseInvalidate
Result
Retest
Yes
Hypothesis as to cause
No
Exception Reports
901 03438
QADetermines Disposition
No
QC Protocol
Yes
QA Protocol Approval
Sample Retest
Report:Invalidated Old
Result
Data Review
No
Yes
Training999 00524
Chemicals, Reagents, Solutions 735 00449908 01064
Ref Std736 01098908 01097
InstrumentsEquipment
Mfg eWO Completed
Mfg PrepareSamples
andTRF
MfgDeliver
Samples & TRF to QC
QC TRF Check Sample Log In
Internal or External
Test
Sample Testing
11 Attributes 9 SOP’sAnalysts
sign up for each tests
Prepare samples for
shipping to PFE
Contract Lab Management820 03537
Test Results forAttributes908 05116
QC SupervisorData Review
908 03132908 07696
Results Meet
Specification
External
Complete Data Packet
with CoA
QC Approved CoA
100%QA
Review
Packet & CoA Correct
QA Approved CoA
Yes
No
MLT ParticulatesAttributes
Process Poorly defined
Internal
Not Correct
Correct
No Operator Errors
Lab Investigations
908 05456
OperatorError
Page2 Supervisor
Review Checklist
Assignable Cause
Ref Std736 01098908 01097
InstrumentsEquipment
Mfg eWO Completed
Mfg PrepareSamples
andTRF
MfgDeliver
Samples & TRF to QC
QC TRF Check Sample Log In
Internal or External
Test
Sample Testing
11 Attributes 9 SOP’sAnalysts
sign up for each tests
Prepare samples for
shipping to PFE
Contract Lab Management820 03537
Test Results forAttributes908 05116
QC SupervisorData Review
908 03132908 07696
Results Meet
Specification
External
Complete Data Packet
with CoA
QC Approved CoA
100%QA
Review
Packet & CoA Correct
QA Approved CoA
Yes
No
MLT ParticulatesAttributes
Process Poorly defined
Internal
Not Correct
Correct
No Operator Errors
Lab Investigations
908 05456
OperatorError
Page2 Supervisor
Review Checklist
Assignable CauseInvalidate
Result
Retest
Yes
Hypothesis as to cause
No
Exception Reports
901 03438
QADetermines Disposition
No
QC Protocol
Yes
QA Protocol Approval
Sample Retest
Report:Invalidated Old
Result
Data Review
No
Yes
Training999 00524
Chemicals, Reagents, Solutions 735 00449908 01064
Complicated QC Internal/External Process >>> Simplified Lean Value Stream >>> 7 Key SubProcess with 4 driving Cycle Time!
40% Reduction in Mean and 90% Reduction in Variance!Business grew 2X but required NO additional resourcesMajor Ah-Ha … Opportunity to REDUCE Testing by sample changes
DramaticDramaticImprovementsImprovements