Six Sigma7 Management

1Revised: mmvi

Six Sigma7 ManagementA Tool for Implementing ISO 15189:2003

Six SigmaSix Sigma77 ManagementManagementA Tool for Implementing ISO 15189:2003A Tool for Implementing ISO 15189:2003

Marlies Ledford-Kraemer, MBA, BS, MT(ASCP)SH

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Topics for Discussion

What is Quality?

ISO 15189:2003 Standard

ProcessesSix Sigma7 Management

Lean Six SigmaImpact of Quality Management

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What is Quality?What is Quality?

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Definitions of QualityCynical approach– An external business constraint– A “given” just like the air we breathe, therefore if everybody

has quality, it does not give us a competitive advantage– The only level of quality that we need is the level that prevents

us from being suedProgressive view– The extent to which health services … increase the likelihood of

desired outcomes and are consistent with current professional knowledge.” (Institute of Medicine-1990)

– “Predictable degree of uniformity and dependability, at low cost and suited to the market”

• Dr W Edwards Deming (American statistician who revitalized the Japanese economy in the 1950s)

– How closely a product or service meets the expectations set forth by the “customer”

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Scope of Quality Issues

Three types of quality problems decrease likelihood of desired outcomes– Overuse

• Providing services even though “risk” exceeds benefit– Giving antibiotics to a person with the common cold– PT/APTT as part of pre-operative screen

– Underuse• Failure to provide effective care that would improve outcomes

– Taking an inadequate patient history that leads to incomplete bleeding or thrombotic work-up

– Misuse• Providing appropriate care without requisite skill thereby

increasing risk of complications– Protein C / Protein S testing on patients receiving warfarin

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ISO 15189:2003ISO 15189:2003Medical Laboratories Medical Laboratories ––

Particular Requirements Particular Requirements for Quality & Competencefor Quality & Competence

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What is ISO?

Name is taken from Greek meaning equalISO is world's largest developer of standardsNetwork of national institutes of standards representing 150 countries– Secretariat for USA is American National Standards

Institute (ANSI) who in turn delegates responsibility to CLSI (Clinical Laboratory Standards Institute-formerly NCCLS)

Preparation of standards is done through ISO Technical Committees (TC)– ISO/TC 212, Clinical Laboratory Testing and in vitro

Diagnostic Test Systems, developed ISO 15189• First proposed in 1999 and published in 2003

ίσος

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Are ISO 15189 & 9000 Related?

ISO 9000 is a generic management system standard– ISO 9001:2001 is concerned with "quality management“ (QM)

• QM is what an organization does to enhance customer satisfaction by meeting both customer & applicable regulatory requirements whilecontinually improving its performance in pursuit of these objectives

– “Generic” implies its use for any product or service– “Management system” refers to what the organization does to

manage its processes or activities– If an organization wishes to establish a quality management

system, then salient features of such a system are found in relevant standards of ISO 9000

ISO 15189 is based upon ISO 9000– ISO 15189 standard denotes particular requirements for quality

and competence uniquely related to medical (clinical) laboratories

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ISO 15189 and CLSI Guidelines

CLSI guidelines related to quality management parallel efforts of ISO 15189– HS1-A2 A Quality Management System Model for Health

Care; Approved Guideline-Second Edition– GP26-A3 Application of a Quality Management System

Model for Laboratory Services; Approved Guideline-Third Edition

– GP22-A2 Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline-Second Edition

Slides 12-18 show relationship between ISO 15189 elements and the 12 CLSI Quality System Essentials (QSE)

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Impact of IS0 15189An institution’s management system that has been independently audited by a third party agency and confirmed to be in conformity with ISO 9001:2000 is certified by the third party agency (not ISO)Laboratories in the US are accredited through CAP, JCAHO, or COLAPotential adoption by US accrediting agencies and others worldwide would establish ISO 15189 as the standard for guiding and harmonizing the accreditation process of clinical laboratories– Standard has been endorsed by the International Laboratory

Accreditation Cooperation as an acceptable alternative for accreditation of medical laboratories

– From a regulatory perspective, laboratories would be accredited by agencies that use ISO 15189 as a guideline

• Laboratories could still obtain ISO 9000 certification• Management & technical requirements of ISO 15189 would be

complemented by the complete management system provided by ISO 9001:2000

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ISO 15189 Document1 Scope2 Normative references3 Terms and definitions4 Management requirements4 Management requirements5 Technical requirements5 Technical requirementsAnnex A (normative)– Correlation with ISO 9001:2000 and ISO/IEC 17025:1999

(General Requirements for the Competence of Calibration and Testing Laboratories)

Annex B (informative)– Recommendations for protection of laboratory information system

(LIS)Annex C (informative)– Ethics in laboratory medicine

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Management Requirements-1

4.1 Organization and management

Laboratory should• Be legally identifiable• Meet needs of patient and clinical personnel• Meet ISO requirements• Identify personnel conflicts of interest• Be responsible for design, implementation,

maintenance, and improvement of quality management system

Aligns with CLSI QSE: Organization

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4.2 Quality management system

Laboratory should have• Policies & procedures that are documented,

communicated, understood, and implemented• Internal quality control and participate in external

quality assessment schemes• A quality policy statement• A quality policy manual• A program that regularly monitors & demonstrates

proper calibration of instruments, reagents, and analytical systems


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4.3 Document control

Laboratories should• Control all documents that form a laboratory's quality

documentation• Have procedures to ensure that quality management

documents are reviewed by authorized personnel, identified as current, amended & so noted, and removed if obsolete

• Maintain documents on any appropriate medium (that may or may not be paper)

Aligns with CLSI QSE: Documents and Records

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Management Requirements-44.4 Review of contracts– Laboratories which enter into contracts with clients to whom they

provide medical laboratory services should• Establish & maintain procedures for review of contracts• Ensure that laboratory has capability to meet contractual requirements• Document contract reviews, changes, or discussions• Include, in contract, work referred to other laboratories• Inform clients if deviations from the contract occur• Communicate contract amendments to all parties

4.6 External services and supplies– Laboratory should

• Document procedures for selection & use of external services such as equipment & consumables

• Verify that equipment & consumable supplies comply with standardspecifications

• Maintain an inventory control system• Evaluate suppliers of critical reagents & document evaluations and

approvals Aligns with CLSI QSE: Purchasing and Inventory

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4.15 Management review

Laboratory management should• Review laboratory's quality management system to

ensure continuing effectiveness & introduce necessary improvements

• Record findings from reviews, forward those on to staff, and implement new actions in a timely fashion


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Remaining elements are covered by CLIA and laboratory accrediting programs with deemed status such as CAP– 4.5 Examination by referral laboratories– 4.7 Advisory services– 4.8 Resolution of complaints– 4.9 Identification & control of nonconformities– 4.10 Corrective action– 4.11 Preventive action– 4.12 Continual improvement– 4.13 Quality and technical records– 4.14 Internal audits

QSE: Purchasing and Inventory

QSE: Service and Satisfaction

QSE: Occurrence Management

QSE: Assessments

QSE: Process Improvement

QSE: Documents and Records

QSE: Assessments

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Technical Requirements

CLSI QSEElement

5.8 Reporting of results

5.7 Post-examination procedures (post-analytical testing phase)

5.6 Assuring quality of examination procedures (quality control)

5.5 Examination procedures (analytical testing phase)

Process Control

5.4 Pre-examination procedures (pre-analytical testing phase)

Equipment5.3 Laboratory equipment

Facilities and Safety5.2 Accommodation & environmental conditions

Personnel5.1 Personnel

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How to Use ISO 15189

ISO 15189 is a guideline (a “what to do”) that provides laboratories with specific managerial and technical requirementsImplementation of ISO 15189 requires specific tools or roadmaps– CLSI standards and guidelines

• GP22-A2, GP26-A3, and HS1-A2

– Lean enterprise (or Lean Thinking)• Eliminating muda (waste)

– Six Sigma with myriad of process improvement tools• SIPOC (Suppliers, Inputs, Process, Outputs, Customer): Define• FMEA (Failure Modes and Effects Analysis): Measure• Flow diagrams: Analyze

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A Comparison

Hierarchical Level Activities Performed

Total Quality Management Total management approach centered around customer satisfaction

Quality Cost Management Activity to identify, measure, & control cost of quality

Quality Management System Systematic process-oriented approach to meet quality objectives

Quality AssuranceOrganized activities to provide confidence that organization meets requirements for quality

Quality ControlOperational process control techniques to meet requirements for quality & regulatory compliance

Stages of Quality (CLSI HS1-A2:2004)

ISO

900

1

CLIA

/CAP ISO

151

89

Six

Sigm

a M

anag

emen

t To

ol

New

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ProcessesProcesses

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How is Quality Measured?

First step in quality consciousness is to recognize that a defect existsAssess processes– Measure variation using control charts– Determine process capability

Assess outcomes– Should relate to a process that can be modified to improve

an outcome• Example: Phlebotomy (pre-analytical process)

– Improper technique leads to PF4 release, causing in vitro heparin neutralization that falsely shortens the APTT used to monitor heparin therapy (outcome)

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What is a Process?

Transformation of inputs (X) into outputs (Y)– Example: Patient specimen is an “input” that is transformed by

the laboratory into a Prothrombin Time (“output”)

A process can be:

Defined

Measured

Analyzed

Improved

Controlled

Brushing one’s teeth, preparing breakfast

Admitting a patient, administering chemotherapy, serving meals to patient

Phlebotomy (pre-analytical phase of testing)

Performing a PT (analytical phase)

Reporting PT test result (post-analytical)

Examples

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Defining & Documenting a Process

Every process must have an owner– Owner is Courier who delivers specimen tubes to laboratory

Objective of a process must be clearly stated– For the Courier, the objective is to deliver tubes to laboratory

Each process must have a beginning & end point (boundary) in order to identify where one process ends and another begins– Process for Courier begins when phlebotomist gives him labeled

specimen tubes and process ends when Courier gives (signs in) tubes to laboratory technologist

Data collected from a process must be valid– Everyone involved in the process (courier delivery of

specimens) must be in agreement as to how process data is to be collected so that data is useful and can lead to action

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Data Collected from a Process

Attribute data– Classification of items into categories– Example

• Proportion of requisition slips not “clocked-in” when received by laboratory

• Number of typographical errors (post-analytical) inputted into LIS during January for all coagulation laboratory testing

Variables data– Measurement of a characteristic– Example

• Turn-around time for STAT coagulation tests (PT, APTT, Thrombin Time, and D-dimer)

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Attribute Data

Attribute data aids in preventing defects and moving to a zero percent defective rate–– DefectDefect is an imperfection of some type that does not

necessarily render the product or service as unusable whereas defectivedefective implies that the item is non-conforming and needs to be re-worked.

Data does not provide specific information as to cause of the defectControl charts plot attribute data based on conforming or non-conforming to some specification

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Attribute Control Chart

Requisition Slips "Clocked-in"

0

0.02

0.04

0.06

0.08

0.1

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day (50 Requisitions per Day)

Frac

tion

Non

-Con

form

ing

1 of 50 defective

2 of 50 defective

zero defective

Special Cause Variation

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Variables DataVariables data control charts allow for reduction of unit-to-unit variation by quantifying information obtained from attribute data– Of those slips identified as

“defective” (not “clocked in”), how many came between the hours of 0:00 to 8:00, 8:00-16:00, 16:00-24:00?

Brings process or product closer and closer to intended specifications

99.73% of all data falls within +/- 3 Standard Deviation (sigma units or F)of an average value (mean or µ)

68.26%

99.73%

95.46%

-3σ −2σ −1σ µ 1σ 2σ 3σ 68.26%68.26%68.26%

99.73%99.73%99.73%

95.46%95.46%95.46%

-3σ −2σ −1σ µ 1σ 2σ 3σ -3σ −2σ −1σ µ 1σ 2σ 3σ

Normal Gaussian Distribution

Carl Frederick Gauss

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Variables Data Control Chart

R Bar Chart: TAT in Hours for Four Lab Tests Within Each Subgroup

02468

101214161820222426

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Subgroups

Ave

rage

TAT

in h

ours Ave TAT = 5 hours (PT = 3 + APTT = 3

+ TT = 4 + DD = 10 hours)

All points due to Common Cause Variation

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Process Variation

Sources to which variation can be attributed: human, equipment, methods, materials, or environmentProcess variation is due to either common causes or special causes– Control charts are statistical tools that aid in distinguishing

between these two types of variationGoal is to control and reduce variation, stabilize a process, and improve the process– Process improvement continuously modifies currently used

methods so as to reduce the difference between “customer” needs and process performance

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Common Cause Variation

Inherent in a process– Always present and affects all components of a process

Laboratory perspective– Systematic error or bias

• Incorrect value (120% v 100%) for reference plasma entered into coagulation analyzer for FVIII assay calibration curve

– Relates to accuracyManagement perspective– Managers are responsible for a system and hence are

responsible for common causes of variation• Coagulation analyzer has not undergone quarterly preventive

maintenance because Supervisor failed to renew contract

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Special Cause Variation

Special causes come from outside the systemLaboratory perspective– Random error

• Reagent arm on coagulation analyzer does not dispense correct amount for one sample due to obstruction in probe

– Relates to precisionManagement perspective– Variation should be identified and studied

• May be shown to be detrimental and therefore must be removed– Samples accessioned incorrectly by a new technologist on first day of

job

• May be shown to be beneficial and therefore implemented– Western blots for VWF multimers are far superior when performed by

one technologist versus other co-workers

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Process Stabilization & Improvement

Control charts allow for process stabilization wherein a process exhibits only common cause variation and by that has a known capabilityOnly a stabilized process can be continually improved upon– Stabilized attribute chart shows zero percent defective

(Example: achieve conformance in that all requisition slips contain an ICD9 code)

– Variables data chart may still show deviation from a “standard” and allow for continuous reduction in variation from this center

• For example, conformance with noting ICD9 codes on all requisition slips does not imply that correct ICD9 codes were used

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Deming PDSA Cycle

Quality

Never-ending

Improvement

P (Plan)

A (Act)

D (Do)

S (Study)

Model for process standardization

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Commonly Used “Cycle"

P (Plan)

P (Plan)

D (Do)

D (Do)

“p,p,do,do cycle”Quality

Never-ending

MESS

Is this your laboratory’s process improvement model?

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Six Sigma Management Six Sigma Management Relationship Between Voice of the

Customer and Voice of the Process

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What is Six Sigma®?Process improvement initiative– A registered trademark of the Motorola Corporation who

initiated this management strategy in the 1980s– Designed to set tolerance limits for manufacturing, service, and

administrative processes such that fewer than 3.4 defects occur per million opportunities (<3.4 DPMO)

“Relentless and rigorous pursuit of the reduction in variation of critical processes in order to achieve continuous and breakthrough improvements that impactthe bottom line and/or top line of the organization and increase customer satisfaction” (Dr Edward Popovich)From a non-technical perspective it represents a corporate culture, philosophy, or business/management strategy

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Six Sigma® Focus

Meet needs of the customer (external such as a patient or internal such as another department)Align Voice of the Customer with Voice of the Process– Customer wants high quality goods and services at a

reasonable price– Reducing variability in processes improves performance

• Process variation decreases quality and adds cost

Top down management– Approach must be supported at all levels of an

organization

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Six Sigma® ls About Processes!

Goal is to reduce spread in variation and to center processIn turn, customer receives a high quality product/service

with a high degree of certainty

Goal is to reduce spread in variation and to center processIn turn, customer receives a high quality product/service

with a high degree of certainty

On Target&

Less Variation

xxxxxx

x

Off Targetxxxx xxx x

Variation

x

x xx

xx

x

x

x

x

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Six Sigma® Technically Speaking

Measures the degree to which any process deviates from its goal– A metric

Applies statistical tools to identify, quantify, and eliminate/control variation– Typical value of an output is measured by the mean– Variability of an output (process) is measured by the

standard deviation• As the standard deviation of a process decreases, the “sigma

level” of a process increases– With Six Sigma7 performance, 6 process standard deviations fit

between process mean and specification limits

Allows for benchmarking

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“Goal Post View” of Process Capability

Nominal area is based upon perceived needs & wants of customers

Nominal “Loss” or Defects

“Loss” or Defects

LSLLower Specification Limit

USLUpper Specification Limit

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Process Distribution

-6σ -5σ -4σ -3σ -2σ -1σ µ 1σ 2σ 3σ 4σ 5σ 6σ99.73% of processes are nominal3F

Voice of the Process

Voice of the Process

Voice of the Customer

99.9999998% of processes are nominal (fall within specification limits)6F

Voice of the Customer

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What’s the Point?USLLSL

µ

Define process capability

µ

USLLSL

Optimize process capability

USLLSL

µ

LSL* USL*

Improve process capability and do so continually

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Focusing on X (Not Y)

Six Sigma tools focus on understanding and improving the upstream X’s versus monitoring the downstream Y variablesBy understanding how variation in X’s impact variation in Y’s, the need for inspection & rework is dramatically reduced/eliminated

Y = f (X1, X2, X3,…Xn)Y = f (X1, X2, X3,…Xn)

Inputs (X) Process Outputs (Y)

Feedback Loop

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DMAIC Approach toProcess Improvement

DefineDefine OpportunityOpportunity

MeasureMeasure PerformancePerformance

AnalyzeAnalyze OpportunityOpportunity

ImproveImprove PerformancePerformance

ControlControl PerformancePerformance

Opportunity: chance for a defect to occur

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DMAIC Approach toProject Management

DefineDefine goals & scope of projectgoals & scope of project

MeasureMeasure X’s & Y’s and determine baseline process capability

X’s & Y’s and determine baseline process capability

AnalyzeAnalyzerelationships between X’s & Y’s and determine

which X’s are critical in order to detect & eliminate noise (variation)

relationships between X’s & Y’s and determine which X’s are critical in order to detect &

eliminate noise (variation)

ImproveImproveprocess by manipulating key X’s to

achieve desired changes in Y variable of interest

process by manipulating key X’s to achieve desired changes in Y variable

of interest

ControlControlnew & improved process

in order to sustain the gain

new & improved process in order to sustain the

gain

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What is Measured?

Unit: any item that is produced or service rendered

Defect: an imperfection of some type that fails to meet a customer’s requirement

Opportunity: chance for a defect to occur

Calculate Defects per Million Opportunities (DPMO)

Total # defects x 1,000,000DPMO =(# of Opportunities for Error) x (# of units)

Sigma calculators are available on-line to determine sigma levels

Met

rics

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Six Sigma® Allows for 1.5σ shift

1.5σ offset was described by Harry & Schroeder as the “fudge factor” that accommodates unexpected errors or movement over time and allows for a robustness in the product that is impervious to unavoidable sources of variationShort-term capability of a process is 6σ but long-term capability is only 4.5σ– Voice of the Process should be no more than half of

tolerance allowed for Voice of the CustomerAdvantage is that small shifts in the process mean are tolerated without increasing the defect rate significantly (6σ = 3.4 DPMO v 4.5σ = 6.8 DPMO)

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Short v Long Term Process Capability

1.5 Sigma Shift

LSL USL

Centered

LSL USL

Three Sigma Process

USLLSL

Centered

1.5 Sigma Shift

USLLSL

Six Sigma Process

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What Do the Numbers Mean?

0.00034%99.99966%3.40.0026.0320.0385.5

0.0233%99.9767%2330.575.01,3506.84.5

0.621%99.379%6,210634.022,7504653.5

0.27%99.73%66,8072,7003.0158,68612,4192.5

4.56%95.44%308,53745,6002.031.74%68.26%691,462317,4001.0

TailAUCDPMO with Shift

DPMOCenteredSigma

AUC: area under the curveDPMO: defects per million opportunities

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A Product Involves Many Processes

A product or service is composed of many processesExample: a product such as a Prothrombin Time may require 20 processes (phlebotomy, transport of specimen, specimen processing, test performance, reporting of results, and so forth) – Industry standard is ~4σ or 6,210 DPMO

• (1.0-0.00621)20 x 100 = 88.286% likelihood of delivering a defect free product (correct PT)

– If industry standard were 6σ or 3.4 DPMO• (1.0-0.0000034)20 x 100 = 99.99932% likelihood of

delivering a defect free product

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Lean Lean Six SigmaSix Sigma

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Lean Philosophy

Toyota manufacturing system (1988)– Taiichi Ohno, a Toyota executive, identified seven types of

muda (waste) that absorb resources but create no value• Defects (mistakes that require rework)• Overproduction (producing items that no one wants)• Inventories (goods awaiting further processing or consumption)• Unnecessary processing (performing steps that are not needed)• Unnecessary movement of people• Unnecessary transport of goods from one place to another without

any purpose• Waiting by employees in a downstream activity because an

upstream activity has not delivered on time

Womack & James (1996) added an eighth muda: design of goods or services that do not meet users’ needs

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Lean ThinkingEffectiveness of any process is reflected by a product’s value– Value is defined by the CUSTOMER and not the producer

Types of process steps– Value-added

• Steps directly contributing to a product characteristic that is desired and valued by the customer

• Activities should be retained and are opportunities for improvement thereby enhancing value and reducing costs

– Non-value-added• Work, which according to the customer, does not add value to the

product• Considered as WASTE and must be minimized/eliminated

– Business-value-added• Includes administrative, regulator, and business functions• Also considered as non-value-added steps by the customer• Processes can not be eliminated but can be improved

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Combining Lean and Six Sigma7

Lean Six Sigma improves processes and allows for quality improvement to occur at a quicker pace– Lean approaches processes from a “waste management” point of view

hence, steps that create waste are initially eliminated– Six Sigma7 tools can subsequently be applied to only those

steps/processes that provide value to the customer• Time is not wasted by applying tools to processes that are not value-

added (with the exception of business-value-added process steps)

Lead time and process cycle efficiency are key components of Lean Six Sigma– Lead time: how long it takes to deliver a product or service once it

has been requested by a customer– Process cycle efficiency: proportion of time spent on value-added

work compared to total process time

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What is the Impact of What is the Impact of Quality Management?Quality Management?

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99.99966% Good (6 F)99% Good (3.8 F)

Six Sigma® in Practice

16,000 lost articles of mail per hour

22,000 checks deducted from the wrong bank account each hour

500 incorrect surgical operations per week

2 unsafe plane landings per day at O’Hare International Airport in Chicago

50 newborn babies dropped at birth by doctors each day

5.4 articles lost per hour

7.5 checks deducted from the wrong bank account each hour

1.7 incorrect operations per week

1 unsafe plane landing every four years

1 newborn baby dropped at birth by doctors every 2 months

Eckes G. Six Sigma Revolution. New York: John Wiley & Sons, Inc, 2003, p 37.

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Industry Examples of Six Sigma®

Domestic airline fatalities– 0.43 DPMO (better than 6σ)

Airline baggage handling & restaurant billing– 4,000 DPMO or 4.15σ

Firestone production of tires for Ford Explorer– ~5σ (remember the public outcry?)

1% hospitalized patients injured through negligence– ~10,000 DPMO or 3.8σ

Inappropriate prescribing of antibiotics by doctors– 210,000 DPMO or 2.3σ

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Laboratory Capabilities in 2000

Nevalainen D, et al. Arch Pathol Lab Med 2000:124;516-9

4.8533Laboratory reporting errors

Post-analytical3.99,000Laboratory proficiency testing

4.7726Laboratory testing error

Analytical2.4207,140Therapeutic drug monitoring timing

3.619,053Specimen redraws

4.15,625Patients without ID bands

4.33,123Correction of errors on ordered tests

2.8100,259Missing information on Pap requisitions

Pre-analyticalSigmaDPMOQuality Indicator

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Health Care v Other Businesses

Most healthcare services show process capabilities between 2.7σ – 4.7σ– Notable exception is deaths caused by anesthesia during

surgery (5.4 DPMO or ~5.9σ)If other industries deteriorated to our antibiotic practices at 2.3σ– 9 million errors per day would occur in the credit card

industry– 36 million checks per day would be deposited in the

wrong accounts– Deaths from airline crashes would increase by nearly

500,000 fold

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Benefits of Six Sigma®

Improves process flowsReduces total defectsImproves efficiencyImproves effectiveness (checklists to prevent missing critical steps)Results in higher levels of customer & employee satisfactionIncreases value of product/service

Decreases costs & increases revenueDecreases costs & increases revenue

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Using ISO 15189 as a guide, laboratorians should look beyond quality control and quality assurance of individual procedures by extending their QC/QA culture to process improvement throughout the workflow– Use Six Sigma7 management as a tool to improve quality

Be proactive and embrace quality initiatives in order to raise laboratory outcomes to those that we as consumers demand of other industries– We have the capacity to deliver the finest health care but

must do so with regularityAs providers of healthcare services we can not continue to defend our level of mediocrity

Improving processes is just not another thing to do but makes us do things right

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ReferencesCastellani WJ. ISO 15189-taking laboratory accreditation to the next level. CLMA/ASCP LabThink 2005.Chassin MR. Is health care ready for Six Sigma quality? The Milbank Quarterly 1998;76(4):565-91.Becher EC, Chassin MR. Improving quality, minimizing error: making it happen. Health Affairs 2001;20(3):63-81.Clinical and Laboratory Standards Institute (CLSI). Application of a quality management system model for laboratory services; Approved Guideline GP26-A3, 2004.CLSI. A quality management system model for health care; Approved Guideline HS1-A2, 2004.CLSI. Continuous quality improvement: integrating five key quality system components; Approved Guideline GP22-A2, 2004.Gitlow HS, Oppenheim A, Oppenheim R. Quality Management: Tools and Methods for Improvement, 2nd

ed. Boston: Irwin McGraw-Hill, 1995.Gitlow HS, Levine DM. Six Sigma for Green Belts and Champions. Upper Saddle River: Pearson Prentice Hall, 2005.International Organization for Standardization (ISO). Medical laboratories – Particular requirements for quality and competence; International Standard 15189, 2003.ISO. Medical laboratories - Guidance on laboratory implementation of ISO 15189:2003; Technical Report 22869, 2005.Jacobson JM, Johnson ME. Lean and Six Sigma: not for amateurs. Lab Medicine 2006;37(2):78-83 (Part 1) and Lab Medicine 2006;37(3):140-5 (Part 2).Ledford-Kraemer MR. The Clotting Times. 2005;5(1):6-9. http://www.clot-ed.com/edit/documents/CTApr2005.pdfLedford-Kraemer MR. The Clotting Times. 2005;5(2):5-7. http://www.clot-ed.com/edit/documents/CTJul2005.pdfNevalainen D, et al. Evaluating laboratory performance on quality indicators with the Six Sigma scale. Arch Pathol Lab Med 2000;124:516-19.South SF. Achieving breakthrough improvements with the application of Lean Six Sigma tools and principles within process excellence. Lab Medicine 2005;36(4):240-2.WomackJP, Jones DT. Lean Thinking, 2nd ed. New York: Free Press, 2003.

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Internet Resourceswww.clsi.orgwww.iso.orgwww.westgard.com (excellent web site for Quality Control, Quality Assurance, and Six Sigma)www.sixsigmatutorial.com (Six Sigma tutorial) www.isixsigma.com (iSixSigma)– http://healthcare.isixsigma.com/ (iSixSigma Healthcare)

www.ge.com/sixsigma/ (General Electric)http://mu.motorola.com/sixsigma.shtml (Motorola University)http://www.6sigma.us/ (Six Sigma.us)

Six Sigma7 Management

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