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Turning Science into Caring
Supply Chain: Adding Customer Value
Anthony Orzechowski Director, R&D Quality Engineering
09-22511 v1.0
Presentation Supply Chain CapabilityDate: June 25, 2009
2 Company Confidential© 2009 Abbott
ConclusionWe can improve our customers’ ability to be competitive by providing means to translate quality measures into business impact
As suppliers, we should always want to help build our customers’ competitive advantage.
We can help them do this by …
– Relating the capability of key process outputs to safety and the financial impact on their business.
– Helping drive expanded business for the customer will in turn lead to expanded business for ourselves.
• This presentation illustrate one example of this translation by looking at a creative and helpful view of process capability.
Presentation Supply Chain CapabilityDate: June 25, 2009
3 Company Confidential© 2009 Abbott
50o 3’N
8o 21’E
Putting the Focus on the Customer
Family of integrated systems
High first-pass acceptance
Expanding assay menu
Pre- and post-analytics
Reliability
Scientific Leadership
Standardization
Consolidation
Workflow optimization
Results
Safety
Labor efficiencies
Cost pressures
Error reduction
Complexity
Presentation Supply Chain CapabilityDate: June 25, 2009
4 Company Confidential© 2009 Abbott
ARCHITECT “Family Commonality…”
Universal ARCHITECT
Sample CarrierRSH
Identical Software
Common Immunoassay
Reagents
i1000SR
Immunoassay
Immunoassay
i2000SR Immunoassay
c8000Clinical Chemistry
Common Clinical Chemistry Reagents
c16000Clinical Chemistry
Chemistry
Integration
ci8200Integrated
ci16200Integrated
Presentation Supply Chain CapabilityDate: June 25, 2009
5 Company Confidential© 2009 Abbott
Assessing Performance in a Clinical LaboratoryThe Essential Question …
“What amount of medical harm due to analytical error is it OK to let go undetected?”
Dr. Frederick A. Smith Children’s Hospital - Chicago
Dr. Frederick A. Smith - Children’s Hospital - Chicago
Presentation Supply Chain CapabilityDate: June 25, 2009
6 Company Confidential© 2009 Abbott
Measuring CapabilityMeasuring a Suppliers ability to Meet Customer Needs is a well accepted practice
• As suppliers we want to deliver solutions that will consistently be capable meeting the need posed by this essential question.
• This requires us to understand several key parameters …
– The Quality Specification (Total Error Allowable (TEa)
– Our expected Deviation from Target
– Our expected Variability about the process mean
• One traditional means to assess these together is a Capability index such as Cpk or Ppk.
Presentation Supply Chain CapabilityDate: June 25, 2009
7 Company Confidential© 2009 Abbott
Process Centered Capability Index — CpkCpk accounts for both inherent variation and a shift in mean.
kLSLUSLkCC ppk
16
1
LSL USL
Cp > 1.5
Cp = 1.0
Cp < 0.75
Target
USLLSL y
Cp is about 1.0, butCpk is about 0.5.
Presentation Supply Chain CapabilityDate: June 25, 2009
8 Company Confidential© 2009 Abbott
Typical Translation of Capability
Sigma Level = Cpk * 3
– But what does this mean to the customer relative to business impact?
– Is 12 Sigma twice as valuable as 6 Sigma to the customer?
– How do we help optimize value for the customer ?
Sigma Level Cpk DPMO Performance1 Sigma 0.33 690,000 Poor2 Sigma 0.67 308,000 Poor3 Sigma 1.00 66,800 Marginal4 Sigma 1.33 6,210 Good5 Sigma 1.67 230 Excellent6 Sigma 2.00 3.4 World Class
Presentation Supply Chain CapabilityDate: June 25, 2009
9 Company Confidential© 2009 Abbott
Visualizing the Impact of Capability Customer Quality Control
Process with Capability = 1.5
USL = Upper Specification Limit (In-House)LSL = Lower Specification Limit
Test MethodUncertainty
True Variabilityof the Product
Beta RiskBeta Risk
LSLLSL USLUSL
Process with Capability = 0.8
USL = Upper Specification Limit (In-House)LSL = Lower Specification Limit
Test MethodUncertainty
True Variabilityof the Product
Beta RiskBeta Risk
LSLLSL USLUSL
Visualizing the Impact of Capability on False Rejection and Acceptance
Presentation Supply Chain CapabilityDate: June 25, 2009
10 Company Confidential© 2009 Abbott
Translating Capability to Business ImpactMeasurement or improvement of capability should be related to tangible business results
• Simply supplying a measure of capability however does not directly translate into a quantified financial or business outcome for the customer.
• To help in this translation from a QC standpoint,
– Relate it to the Essential Question … What level of error is OK to let go undetected?
– Understanding how this question is assured at our customer will help to understand the value they place on higher levels of capability.
Presentation Supply Chain CapabilityDate: June 25, 2009
11 Company Confidential© 2009 Abbott
Relationship of Sigma to Cpk
Sigma is simply a different view of Capability
The Sigma Level is directly analogous to measuring capability through Cpk.
Sigma = (TEa – Bias)/(SD)
The difference between Cpk and Sigma Level is:
– Sigma Level measures the deviation from target (truth) rather than the Spec Limit and,
– The value is normalized by dividing by the variability, not 3x the variability.
– Sigma Level = Cpk * 3
USL (TEa)LSL (TEa)
Sigma is about 1.5Cp is about 1.0 but,
Cpk is about 0.5
Bias
%CVDefectsT
rue
Val
ue
See:• Six Sigma Quality Design and Control, Second Edition and • Westgard.com
Presentation Supply Chain CapabilityDate: June 25, 2009
12 Company Confidential© 2009 Abbott
Application of Sigma Concepts and Metrics for QC Selection Application of Sigma Concepts and Metrics for QC Selection Higher Sigma Levels allow Larger Shifts to go undetected and still produce a safe result
-7s -6s -5s -4s -3s -2s -1s 0s 1s 2s 3s 4s 5s 6s 7s
Critical Shift Limit risk of a “bad”test result
to 5% (this can be tuned
to the situation)
1.65s
Risk of 5% means quality requirement cuts the error distribution at 1.65s Risk of 5% means quality requirement cuts the error distribution at 1.65s from mean. from mean.
Shifts greater than this must be detected. Shifts greater than this must be detected.
See: Six Sigma Quality Design and Control, Second Edition
The higher the Sigma Level The higher the Sigma Level Delivers higher Allowable Critical Shifts Delivers higher Allowable Critical Shifts
Presentation Supply Chain CapabilityDate: June 25, 2009
13 Company Confidential© 2009 Abbott
Relationship of Sigma to SEcritHigher Sigma Levels allow Greater Shifts to go undetected and still produce a safe result
Critical Systematic Error (SEcrit)
– Index used to describe size of error that needs to be detected by QC procedure
SEcrit = [(TEa – Bias)/SD] – 1.65
– Sigma = SEcrit + 1.65
– Can relate SE to rejection characteristics of QC rules and numbers of QC measurements using known power curves
SigmaLevel
USLLSL
Sigma is about 1.5Cp is about 1.0 but,
Cpk is about 0.5
Bias
%CVDefectsT
rue
Val
ue
See:• Six Sigma Quality Design and Control, Second Edition
Presentation Supply Chain CapabilityDate: June 25, 2009
14 Company Confidential© 2009 Abbott
Method Decision Chart - Evaluating the System Capability
Method Decision Chart
0.0%
4.0%
8.0%
12.0%
16.0%
20.0%
24.0%
0.0% 2.0% 4. 0% 6.0% 8.0% 10.0% 12.0%
All
ow
ab
le I
na
cc
ura
cy
In a method decision chart, allowable error is plotted with the systematic error component on the Y-Axis and the random error component on the X-Axis.
Allowable Imprecision (%CV)
Presentation Supply Chain CapabilityDate: June 25, 2009
15 Company Confidential© 2009 Abbott
Method Decision Chart - Evaluating the System Capability
Method Decision Chart
0.0%
4.0%
8.0%
12.0%
16.0%
20.0%
24.0%
0.0% 2.0% 4. 0% 6.0% 8.0% 10.0% 12.0%
Allowable Imprecision (%CV)
All
ow
ab
le I
na
cc
ura
cy
Example: Total Allowable Analytical Error (TEa) = 20%
If a particular analyte could allow up to 20% (at 95% Confidence the allowable random and systematic error could be plotted as shown below
Total Allowable Error bound at 95% Confidence (i.e.. 2
Sigma)
Presentation Supply Chain CapabilityDate: June 25, 2009
16 Company Confidential© 2009 Abbott
Method Decision Chart - Evaluating the System Capability
Sigma Value = (TEa – BIAS) / (SD)
Sigma Value = (TEa – BIAS) / (SD)
Method Decision Chart
0.0%
4.0%
8.0%
12.0%
16.0%
20.0%
24.0%
0.0% 2.0% 4. 0% 6.0% 8.0% 10.0% 12.0%
Allowable Imprecision (%CV)
All
ow
ab
le I
na
cc
ura
cy
Zone A Less than 2 Sigma
Zone B
Example: Total Allowable Analytical Error (TEa) = 20%Zone A < 2 SigmaB > 2 Sigma
Zone A < 2 SigmaB > 2 Sigma
Presentation Supply Chain CapabilityDate: June 25, 2009
17 Company Confidential© 2009 Abbott
Method Decision Chart - Evaluating the System Capability
Method Decision Chart
0.0%
4.0%
8.0%
12.0%
16.0%
20.0%
24.0%
0.0% 2.0% 4. 0% 6.0% 8.0% 10.0% 12.0%
Allowable Imprecision (%CV)
All
ow
ab
le I
na
cc
ura
cy
Zone I Less than 2 Sigma
II
V
Example: Total Allowable Analytical Error (TEa) = 20%
IIIIV
Zone I < 2 SigmaII 2 to 3 SigmaIII 3 to 4 SigmaIV 4 to 5 SigmaV > 5 Sigma
Zone I < 2 SigmaII 2 to 3 SigmaIII 3 to 4 SigmaIV 4 to 5 SigmaV > 5 Sigma
Error Budget WindowWill the design meet requirements? With what confidence?
Sigma Value = (TEa – BIAS) / (SD)Sigma Value = (TEa – BIAS) / (SD)
Presentation Supply Chain CapabilityDate: June 25, 2009
18 Company Confidential© 2009 Abbott
Relationship of Sigma Level to QCAs the Sigma Level Rises, the amount of Customer QC drops and the financial impact to the customer is improved making the Customer more Competitive
Reference: Westgard Workshops - Quality Assessment from Test Outcome Data: Use of PT Data to Estimate Quality of Lab Tests, 2006 – Madison, WI
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
0.0 1.0 2.0 3.0 4.0
1.65 2.65 3.65 4.65 5.65
13s/2of32s/R4s/31s/6x 0.07 613s/22s/R4s/41s 0.03 412.5s 0.04 412.5s 0.03 213s/22s/R4s 0.01 213s 0.00 213.5s 0.00 213s 0.00 1
Pfr N
Pro
bab
ility
fo
r R
ejec
tio
n (
P)
3 4 5
DesirableError
Detection
DesirableFalse
Rejection
Systematic Error (SE, multiples of s)
Sigma Scale
Presentation Supply Chain CapabilityDate: June 25, 2009
19 Company Confidential© 2009 Abbott
Why High Analytical Capability Is Important to a Laboratory Director
• Lower performance leads to increased costs
• 6 sigma performance is our ideal benchmark for practical reasons
Sigma Metric
QC Impact Example QC(at 90% AQA based upon OpSpec Charts)
FalseRejects
6 Sigma Any rule will do 3.5 SD Rule with 2 controls
~0%
5 Sigma Relatively simple QC Rules 13s/22s/R4s
with 2 controls~1%
4 Sigma Complex QC 13s/22s/R4s/41s
with 4 controls(e.g. 2 reps at 2 ctrl levels)
~3%
<3 Sigma Extensive QC. QC alone will not assure quality
13s/22s/R4s/31s/6x with 6 controls (e.g. 2 reps at 3 ctrl levels)
~7%
Hig
her C
osts an
d C
om
plain
ts
Presentation Supply Chain CapabilityDate: June 25, 2009
20 Company Confidential© 2009 Abbott
Value Stream MappingA Flow Chart with Data to Help Visualize Problems
1Suppliers Customers2 3 4
Sub-Optimal Process:
1Suppliers Customers2 4
Future State Process:> 99% FPA
65% FPA
Redo
QC QC QC QC
99%98%90%
Rework
Scrap
Delay
Presentation Supply Chain CapabilityDate: June 25, 2009
21 Company Confidential© 2009 Abbott
Independent Analysis Confirms Six SigmaSten Westgard independently reviewed data from Abbott’s 2007 AACC ARCHITECT c16000 technical poster
• "7 out of 9 methods are world class” - “It is rare to find so much good news in a method evaluation study
< 3 Sigma = Poor Performance
3 – 6 Sigma = Good Performance
6 Sigma = World Class Performance
http://westgard.com/qcapp45.htm - QC APPLICATIONA Site Evaluation of Abbott Architect c16000
Presentation Supply Chain CapabilityDate: June 25, 2009
22 Company Confidential© 2009 Abbott
How do our competitors perform with Six Sigma?
• An evaluation of several common, high volume assays on a competitive chemistry system is published on www.westgard.com
• 4 out of 8 assays are < 6 Sigma (50%)
• 2 out of the 4 assays are < 3 Sigma = Poor performance!
0
1
2
3
4
5
6
7
8
9
10
Sodium Potassium Chloride BUN Glucose CK Total Protein HbA1c (%)
Abbott Competitor
6 Sigma
Presentation Supply Chain CapabilityDate: June 25, 2009
23 Company Confidential© 2009 Abbott
Error Budgeting Designing a Safe Product that will make our Customers more Competitive
ConventionalRequirements
Approach
Analytical QualityPlanning Budget
StableImprecision
StableInaccuracy
StableImprecision
StableInaccuracy
QC Safety Margin
Traditional Error Budget Approach
TotalError
Allowablein a
Patient Result
Presentation Supply Chain CapabilityDate: June 25, 2009
24 Company Confidential© 2009 Abbott
Reference: Westgard Workshops - Quality Assessment from Test Outcome Data: Use of PT Data to Estimate Quality of Lab Tests, 2006 – Madison, WI
Assessing Capability Impact to the Business Lower Sigma Levels will result in Significant QC and Costs
Presentation Supply Chain CapabilityDate: June 25, 2009
25 Company Confidential© 2009 Abbott
Assessing Capability Impact to the Business Higher Sigma Levels will result in Reduced QC and Costs
Reference: Westgard Workshops - Quality Assessment from Test Outcome Data: Use of PT Data to Estimate Quality of Lab Tests, 2006 – Madison, WI
Presentation Supply Chain CapabilityDate: June 25, 2009
26 Company Confidential© 2009 Abbott
Assessing Capability Impact to the Business Difference in Sigma Levels can be Used as a Competitive Advantage due to Differences in the Impact to the Business - Safety, Process Flow and Cost
Reference: Westgard Workshops - Quality Assessment from Test Outcome Data: Use of PT Data to Estimate Quality of Lab Tests, 2006 – Madison, WI
Presentation Supply Chain CapabilityDate: June 25, 2009
27 Company Confidential© 2009 Abbott
Assessing Capability Impact to the Business Difference in Sigma Levels can be Used as a Competitive Advantage due to Differences in the Impact to the Business - Safety, Process Flow and Cost
Reference: Westgard Workshops - Quality Assessment from Test Outcome Data: Use of PT Data to Estimate Quality of Lab Tests, 2006 – Madison, WI
Presentation Supply Chain CapabilityDate: June 25, 2009
28 Company Confidential© 2009 Abbott
Conclusions Benefits of Using Quality Specifications
• Clinical Laboratories
– Directly links assay performance requirements to medical utility and to Laboratory workflow impact due to Quality Control.
– Provides a clear unambiguous means for clinical laboratories to communicate their performance needs to diagnostic manufacturers.
• Diagnostic Manufacturers
– Provides a means for effective development and control of performance specifications
– Provides a means for diagnostic manufacturers to clearly discuss on-going Quality performance with their clinical laboratory customers.
Thank You !!!
A Promise for Life