Six Sigma Orientation

Presented By: Joseph Duhig

University Medical Center Alliance / Methodist Healthcare

November 21, 2003

The Century of Quality We are headed into the next century which will focus on quality we are leaving one that has been focused on productivity Dr. Joseph M. Juran

SIX SIGMA

Sigma, , is a letter in the Greek alphabet. It is used as a symbol to denote the standard deviation of a process (standard deviation is a measure of variation). A process with six sigma capability means having six standard deviations between the process mean and either specification limit. Essentially, process variation is reduced so that no more than 3.4 parts per million fall outside the specification limits. Hence, as a metric, the higher the number of sigmas, the better. The Six Sigma term is also used to refer to a:
--philosophy

--goal --methodology

to drive out waste, and improve the quality, cost and time performance of any business.

What is Six Sigma?

Sigma
Defects per Million Opportunities

2 3 4 5 6

308,537 66,807 6,210 233 3.4

(69.1% good)

(93.3% good)

(99.4% good) (99.98% good)

.

(99.99966% good)

3 to 6 - 20,000 Times Improvement... A True Quantum Leap

Six Sigma Benchmarks

IRS Tax Advice (phone in)

1,000,000

100,000

Defects per Million

Doctor Prescription Writing Restaurant Bills

10,000
Airline Baggage Handling

1,000

Average Company

100 10

Best-in-Class
1 1

Sigma (Short Term) Scale of Measure

Domestic Airline Fatality Rate (0.43 PPM)

Getting To Six Sigma - Some Examples

3.8 Sigma 99% Good
20,000 lost articles of mail per hour Unsafe drinking water for almost 15 minutes each day 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

Six Sigma 99.99966% Good

Seven articles lost per hour

One unsafe minute every seven months

1.7 incorrect operations per week One short or long landing every five years 68 wrong prescriptions per year

THE CENTURY OF QUALITY

We are headed into the next century which will focus on quality we are leaving one that has been focused on productivity Dr. Joseph M. Juran

WHAT IS SIX SIGMA QUALITY?

Quality

Product Features

Freedom from Deficiencies

That Customers Want

At Six Sigma Levels

Design for Six Sigma

Improve to Six Sigma

METHODOLOGY
DEFINE Identify, prioritize, and select the right project(s) Identify key product characteristics & process parameters, understand processes, and measure performance Identify the key (causative) process determinants Establish prediction model and optimize performance Hold the gains

MEASURE

ANALYZE

IMPROVE

CONTROL

INPUT Project Mission Statement

Module Deliverables Possible Tools

Define

Measure

Analyze

Improve

Control

Define customers & CTQs Prioritized list of customers/segments Prioritized list of CTQs VOC Continuum, Surveys, Interviews

Establish Project Ys List of Project Ys Performance Measurement Matrix

Develop and test hypotheses on the sources variation and cause-effect relationships Stated theory (s) Hypothesis testing results ANOVA, tests for equal variance, regression, ttests, tests for proportions, contingency tables, nonparametric tests, Detailed Process Map, C&E Diagram, FMEA, Pareto

Generate Solution Alternatives List of possible solutions to test or operating parameters for experimentation

Design and implement sustainable feedback mechanisms and methods to achieve self control for dominant variables. SPC charts in place Feedback mechanisms and Mistake Proofing devices implemented

Assess Risk List of possible risks evaluated for level of seriousness and corresponding abatement actions as needed.

Identify possible Xs
List of Possible Xs

Define process to be improved High level Process Map

Detailed Process Map, C&E Diagram, FMEA Plan Data Collection

Control Plans and Documentation. Updated Standard Operating Procedures (SOP), Process Maps, FMEA Preventative Maintenance Plans Personnel trained

Define Project Charter

Project Charter

Data Collection Plan Validate Measurement System Reliable Measurement System Gage R&R, Discrete Data Measure Analysis Determine Process Capability Baseline Six Sigma values

Develop the list of vital few causes of process performance List of vital few variations that account for the majority of variation in performance Quantified $ Opportunity

Test Solution Alternatives. Select Solution(s) to optimize performance Results of DOE and/or pilot and/or simulation Designed Experiments, Pilots, Simulations

Document Project work. Close Project Final project report Audit plan

SIX SIGMA TOOLBOX

Analysis of Variance (ANOVA) Box Plots Brainstorming Cause-effect Diagrams Correlation & Regression Design Of Experiments Evolutionary Operation (EVOP) FMECA Graphs and Charts Histograms Hypothesis Testing Lean Manufacturing (Lean Enterprise) Measurement System Analysis Mistake Proofing Pareto Analysis Process Capability Studies Process Control Plans Process Flow Diagrams Quality Function Deployment Response Surface Methods Scatter Diagrams Standard Operating Procedures (SOPs) Statistical Process Control Stratification

Why We Need Six Sigma in Healthcare

Presented By: Joseph Duhig University Medical Center Alliance / Methodist Healthcare
November 21, 2003

The Century of Quality We are headed into the next century which will focus on quality we are leaving one that has been focused on productivity Dr. Joseph M. Juran

GOOD NEWS

Incredible Advances in Medicine 2 Million Articles/20,000 Journals/Year Applying this knowledge is like: Trying to drink water from a fire hose

BAD NEWS
The average time from discovery of knowledge until that knowledge is in wide-spread use is over 17 years

The IOM Roundtable

The call to action...
Serious and widespread quality problems exist throughout American medicine. These problems occur in small and large communities alike, in all parts of the country, and with approximately equal frequency in managed care and fee-for-service systems of care. Very large numbers of Americans are harmed as a result.

Source: 2002 Institute for Healthcare Improvement

What is Wrong??

OVERUSE (of procedures, medications, visits that cannot help)

UNDERUSE (of procedures, medications, visits that can help) MISUSE (errors of execution)

Source: 2002 Institute for Healthcare Improvement

Examples of OVERUSE

30% of children receive excessive antibiotics for ear infections

20% to 50% of many surgical operations are unnecessary 50% of X-rays in back pain patients are unnecessary

Source: 2002 Institute for Healthcare Improvement

Examples of UNDERUSE

50% of elderly fail to receive pneumococcal vaccine

50% of heart attack victims fail to receive betablockers 27% of high blood pressure is adequately treated

Source: 2002 Institute for Healthcare Improvement

Examples of MISUSE

7% of hospital patients experience a serious medication error 44,000-98,000 Americans die in hospitals each year due to injuries in care

Source: 2002 Institute for Healthcare Improvement

What the IOM Said.

The patient safety problem is large.

It (usually) isnt the fault of health care workers. Most patient injuries are due to system failures.

Source: 2002 Institute for Healthcare Improvement

The Situation Health Care Costs

14 12 10 8 6 4 2 0 Large Firms All Firms

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

How Hazardous is Health Care? (Leape)

100000

DANGEROUS (>1/1000)
Healthcare

REGULATED

ULTRA-SAFE (<1/100K)

10000

Driving

1000

Scheduled Airlines
100

10

Mountain Climbing Bungee Jumping

Chemical Manufacturing Chartered Flights

European Railroads Nuclear Power

1,000,000 10,000,000

1 1 10 100 1000 10,000 100,000

Number of encounters for each fatality

Source: 2002 Institute of Healthcare Improvement

Core Conclusions

There are serious problems in quality and safety.

--Between the health care we have and the care we could have lies not just a gap but a chasm.

The problems come from poor systemsnot bad people

--In its current form, habits, and environment, American health care is incapable of providing the public with the quality health care it expects and deserves.

We can fix itbut it will require changes.

Source: 2002 Institute for Healthcare Improvement

The First Law of Improvement

Every system is perfectly designed to achieve exactly the results it gets

Quality is a system property

Source: 2002 Institute for Healthcare Improvement

Why Six Sigma?

Variation is the Key: Six Sigma is all about understanding variation in providing care that is:

Safe Timely Efficient Effective Equitable Patient-centered

How is Six Sigma different from traditional Performance Improvement Approaches Strategically Deployed Financially Focused Trained Professionals vs. Good Intentioned Amateurs Statistically Based Y = f(x) Project Management is Built-in Measurement System is Validated Focus on Mistake Proofing Failure Modes and Effects Analysis (FMEA)

The Business Case Doing Well by Doing Good

Six Sigma Impact on Net Income
Six Sigma Results Decreased cost/unit Decreased # units/case Decreased LOS Discounted FFS Per Case Per Diem Shared Risk

Decreased # of cases

PROJECT FOCUS
Define
Process Characterization The right project(s), the right team(s)

Measure

Y
Analyze Improve

Process Problems and Symptoms Process outputs Response variable, Y

Process Optimization

Control

Xs

Independent variables, Xi Process inputs The Vital Few determinants Causes Mathematical relationship

Goal: Y = f ( x )

PROCESS CONTEXT FOR MEASUREMENT

CTQs

S
Suppliers

I
Inputs

P
Process

O
Outputs

C
Customers

Measures

Measures

Measures

Process Map

Y = f(X1, X2,... , Xn)

AHRQ Medicare SMR vs. Standardised Charge, 1997 (Random Sample 250 Hospitals Plotted)
180 160 140 120 100 80 60 40 20 0 0 5000 10000 15000 20000 25000

Source: 2002 Institute for Healthcare Improvement

The cohorts had similar baseline health across quintiles But were treated differently.

Per-capita Medicare Spending 1996 2000 $ 3,922 $ 4,439 $ 4,940 $ 5,444 $ 6,304 $ 5,229 $ 5.692 $ 6,069 $ 6,614 $ 8,283

Ratio: High to Low:

1.61

1.58

Glucose Levels of Diabetic Cardiac Surgery Patients

OR First Case Start Time

SOURCES OF VARIATION
People Place Procedure

Process Process

Provisions

Measurement

Patrons

5 Ps + 1 M

COMMON vs. SPECIAL CAUSES

Measurements

Common Causes
MEASURE

Common or Special ?

Special Causes
MEASURE

Investigate all of the variation Measurements

ANALYZE

Investigate specific data points

ANALYZE

Develop solutions for the vital few process and input Xs

IMPROVE

Sustain The Improvements

CONTROL

Develop solutions for special causes and implement as appropriate

IMPROVE

COMMON vs. SPECIAL CAUSES

Two Types Of Mistakes
How you treat variation . . .

Common Causes
Focus on fundamental process change

Special Causes
Mistake 1 Tampering (increases variation)

Common
What the variation really is...

Causes

Special Causes

Mistake 2 Underreacting (missed prevention)

Focus on investigating special causes

CALCULATING SIGMA - YIELD

Rolled Throughput Yield
Suppose we say that there are 4 key characteristics which must be executed (without error) in order to par the hole. In this case, what is the probability of accomplishing the task error free?

3
Tee Shots Fairway Shots .9331 .9331

With Shifting

6
.9999966 .9999966

Chipping
Putting Rolled Yield

.9331
.9331 .7581

.9999966
.9999966 .9999864

CALCULATING SIGMA - YIELD

YIELD DECREASES WHEN COMPLEXITY INCREASES
Yields thru Multiple Steps/Parts/Processes Zst
(distribution shifted 1.5)

Yields thru Multiple Steps/Parts/Processes Zst

(distribution shifted 1.5)

# of parts, steps, or processes 1 5 10 20 50 100 200 500 1000 2000 10000

3 93.32% 70.77% 50.09% 25.09% 3.15%

4 99.38% 96.93% 93.96% 88.29% 73.24% 53.64% 28.77% 4.44% 0.20%

5 99.9767% 99.88% 99.77% 99.54% 98.84% 97.70% 95.45% 89.02% 79.24% 62.79% 9.76%

6 99.99966% 99.9983% 99.997% 99.993% 99.983% 99.966% 99.932% 99.830% 99.660% 99.322% 96.656%

# of parts, steps, or processes 1 5 10 20

3 93.32% 70.77% 50.09% 25.09%

4 99.38% 96.93% 93.96% 88.29%

5 99.9767% 99.88% 99.77% 99.54%

6 99.99966% 99.9983% 99.997% 99.993%

50
100 200 500 1000 2000 10000

3.15%

73.24%
53.64% 28.77% 4.44% 0.20%

98.84%
97.70% 95.45% 89.02% 79.24% 62.79% 9.76%

99.983%
99.966% 99.932% 99.830% 99.660% 99.322% 96.656%

Remedy 1: Reduce Parts/Steps

Remedy 2: Improve Sigma per Part/Step

THE FUNDAMENTAL MSA QUESTION

Is the variation (spread) of my measurement system too large to study the current level of process variation?

Product Variability Process Variability

Variation in the measurement process

(Observed Variability) Total Variability

POSSIBLE SOURCES OF VARIATION

Observed Process Variation

Actual Process Variation

Measurement Variation

Long-term Process Variation

Short-term Process Variation

Accuracy

Repeatability

To address actual process variability, the variation due to the measurement system must first be identified and separated from that of the process.

Reproducibility

Stability

Linearity

LEVELS OF ANALYSIS
Measure Measure Analyze 1 2 3 Individual Experience Group Experience Graphical Interpretation of Observed Data

Analyze
Improve Improve

4
5 6

Statistical Interpretation of Observed Data

Graphical Interpretation of Experimental Data Statistical Interpretation of Experimental Data

Think Directional

THE ANALYSIS TOOL DEPENDS ON THE QUESTION AND THE DATA TYPE
Y
Continuous Data Continuous Data
How does change in X affect change in Y ? Statistical: Correlation /Regression Graphical: Scatter Plots Means Different ? Statistical: t-test; ANOVA Graphical: Histogram(s) Variance Different ? Statistical: Test of Equal Variances Graphical: Stratified Box Plots

Discrete Data
How does change in X affect change in Y ?

X
Discrete Data

Statistical: Logistic Regression

Are the outputs different ? Statistical: Chi Square, Proportion tests Graphical: Stratified Pareto Diagrams

HYPOTHESIS TESTING DESCRIPTION

Allows us to answer the practical question: Is there a real difference between Dr. A and

Dr. B

A practical process problem is translated into a statistical hypothesis so that we may answer the question above. Data vs. Gut Feeling
In hypothesis testing, we use relatively small samples to answer questions about large populations. There is always a chance that we selected a sample that is not representative of the population - a weird sample. Therefore, there is always a chance that the conclusion obtained is wrong. With some assumptions, inferential statistics allows us to estimate the probability of getting a weird sample. Hypothesis testing quantifies the probability (P-Value) of a wrong conclusion.

ALPHA & BETA RISK

a is the risk of finding a difference when there really isnt one. b is the risk of not finding a difference when there really is one.

Truth Ho Fail to Reject Ho Ha Type II Error

Also called: Type II error Consumers Risk

Correct Decision Type I Error

m1

m2

Reject Ho

Correct Decision

a b

Also called: Type I error Producers Risk