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Copyright © Siemens Healthcare Diagnostics 2010. All rights reserved. Lean Six Sigma - the Industr ial Approach to Quality also applicable to drive Quality in Healthcare 10-11February 2011 Labquality Days Helsinki Tom M Pettersson. PhD [email protected] Lean Laboratory Medicine 
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Page 1: Lean lab 2

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Copyright © Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean Six Sigma - the IndustrialApproach to Quality also applicable

to drive Quality in Healthcare

10-11February 2011Labquality Days Helsinki

Tom M Pettersson. [email protected]

Lean 

Laboratory Medicine 

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Page 2Copyright © Siemens Healthcare Diagnostics 2010. All rights reserved.

Lean is part of Industrial Quality Development

Bill Smith(Motorola)

Carl Friedrich Gauß(1777- 1855)

QC RulesLab Medicine

SixSigma(DMAIC)

The 7Wastes(TPS -QCDM)

Value

Engineering Customer Focus

ISOCEN

StandardizationISO 9001/2008

ISO 17025ISO 15189

M Imai

Kaizenlow Cost

Continuous

Improvement

Dr Carl Henrik de VerdierUppsala

Benjamin

Franklin

”Waste Nothing”

Henry Ford

Short and fastProcess

”Waste Nothing”

Frederick Taylor

Scientificapproachto work

Walter Shewart

StatisticsTQM

Joseph Juran

Improvementthrough projectsPareto Principle

The man whodiscovered Quality

Edward Deming

James Westgaard

Taiichi Ohno

Toyoda Larry Miles

NoriakiKano

1706 - 1790

Jim Womack

(LEI)

LeanManufacturing

LeanServices

John

Seddon

Lean Laboratory Medicine 

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Lean is part of Industrial Quality Development

Bill Smith(Motorola)

Carl Friedrich Gauß(1777- 1855)

QC RulesLab Medicine

SixSigma(DMAIC)

The 7Wastes(TPS -QCDM)

Value

Engineering Customer Focus

ISOCEN

StandardizationISO 9001/2008

ISO 17025ISO 15189

M Imai

Kaizenlow Cost

Continuous

Improvement

Dr Carl Henrik de VerdierUppsala

Benjamin

Franklin

”Waste Nothing”

Henry Ford

Short and fastProcess

”Waste Nothing”

Frederick Taylor

Scientificapproachto work

Walter Shewart

StatisticsTQM

Joseph Juran

Improvementthrough projectsPareto Principle

The man whodiscovered Quality

Edward Deming

James Westgaard

Taiichi Ohno

Toyoda Larry Miles

NoriakiKano

1706 - 1790

Jim Womack

(LEI)

LeanManufacturing

LeanServices

John

Seddon

Lean Laboratory Medicine 

System Thinking

No Wastein Process

QCDM ValueProcess/ProductStability

No Errors

QMS

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Imai

Work Decision Work/Decision

Decision separated from Workequal to Six Sigma approach

Decision integrated with Workin Lean System approach

´Two Ways of Thinking – Two Ways of Management

Weber Taylor

Deming Ohno Womack Seddon

Command

and Control

Lean

System ThinkingSmith

Experts Lead

Lean 

Laboratory Medicine 

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The TPS Approach

Taiichi OhnoFather of the Toyota Production System

He called the Toyota system

“profit-making industrial engineering”.

”- in Lean all we do is to reduce the timeit takes from when we commit money to

the raw materials to when we collectmoney from our customers”

”We design for best quality tolowest price”

”We mobilize all intelligence in theorganization to meet our purpose”

Lean 

Laboratory Medicine 

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Lean Focus

Yet the most powerful aspectof LEAN

is not what participants do toadd to improve a process but what

they remove from the processto improve it

Lean 

Laboratory Medicine 

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Value added Activities of total Process LEAD time

ValueAdded Time

Non ValueAdded Time

Organizations adopting LEAN as a continuous improvement metodology typically find 95% of all process lead time is non value added 

Lean 

Laboratory Medicine 

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The 7 + 1 Wastes

12

5

3

4

7

6 8

Over production

Inventory

Motion

WaitingTransportation

Over processing

Not Right First Time –Scrap, Rework, Devects

Untapped Human

Potential

Lean 

Laboratory Medicine 

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Lean Laboratory Medicine 

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Process Focus1. Process is the problem2. Helping to get things done3. How my job fits in total process4. Measure processes5. Change the process

6. Can always improve the process7. Remove barriers8. Develop people9. We are in it together10. What allowed the error to occur11. Reduce variation12. Customer driven

The Process is the Problem - Not the People

Traditional Focus1. Employees are the problem2. Doing my job3. Understanding my job4. Measure individuals5. Change the person

6. Can find a better employee7. Motivate people8. Control employees9. Distrust10. Who made the error11. Correct errors12. Bottom-line driven

Lean Laboratory Medicine 

Lean

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Team BasedCommunication

The Information

Highway Of TheOrganization

Individuals Accessto The InformationHighway

Non-Team BasedCommunication

First Line ManagerCommunication

Selfsustainable Lean team

First Line Manager

Lean in Practice – Brain is bigger than Tools

Lean LeadershipVision Goals Strategy

Motivate and Empower

Staff understand ProcessesContinuously improveDeliver results

Awareness and Commitment

Visualize processesMeasure to prove value

Short ”Gemba” Meetings

Behavior and Procedures

Kaizen BoardsTrack Ideas

Choose ImprovementsGo and do it !

Share Knowledge

Lean ToolsMetrics

Value Stream Mapping8 Wastes, 5S, 5 WhyKaizen Blizes (PDCA)

Management by Science

The Lean Team

Communication

Lean Coach /

Facilitator

Lean Laboratory Medicine 

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Lean Design and Management

Understand

Present Process

Design of

Future Process

Staff ParticipationLean Transformation

Lean LeadershipLean CultureLean “Teams”Lean Micro/Macro ProcessesLean A3-LearningLean ToolsLean Metrics

Adopt IT förProcess Control

”Lean IT”

Structured Implementation

PDCA, DMAIC, DFSS

Lean Laboratory Medicine 

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BusinessValue(Cost)

Quality

in Process(Quality)

CustomerValue

(Delivery)

Value

For staff(Motivation)

Growth

Competitiveness

Cost efficiency

Margin (Profit)

Satisfaction

Commitment

Joy

Best Quality

Lowest Price

Shortest Delivery

No Waste

No Error

Simplicity

Create the right Value

Lean Laboratory Medicine 

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Growth 

Increased Profitability 

More Customers 

Better Products 

More Efficient 

Processes 

Reduced Waste 

Lean 

Lean 

Reduced Waste 

More Efficient Processes 

Better Customer Service 

Spare Capacity 

Headcount reduction    H

  e  a

   d  c  o  u  n   t   R  e   d

  u  c   t   i  o  n  s

M o t  i  v a t  i   on

Established Processes

 C  u s t   om

 er  S  a t  i   sf   a c t  i   on

   R  e  v  e  n  u  e   /

   M  a  r  g   i  n

Sustainable Success

Yes ! No !

Lean Laboratory Medicine 

Lean is a Growth Strategy

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Lean Proven Success

US Automotive

Japan automotive

1920 1940 1960 1980 2000 2010

Japanelectronics

USelectronics

Deming visits

US Automotive

Japan automotive

1920 1940 1960 1980 2000 2010

Japanelectronics

USelectronics

Deming visits

Lean Laboratory Medicine 

Taiichi Ohno

Quality in Process

Cost is lowest

Delivery is best

Motivated Staff

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Lean Production - Build on Demand not for Stock

Lean Laboratory Medicine 

Mass Production ( variety is separated, many production lines, work force specialization)

Maximize Speed

Defect Repair Area

Build for Stock ( Make and sell Mass)Defects or problems = Fix at the End of the Line

= High Rework

Lean Production, Variety is integrated (one production line, one work force constructing all varieties

Build on Demand (Sense and Respond Lean)Defects or problems = Stop the whole Line

= No Rework

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Lean Production - Build on Demand not for Stock

Lean Laboratory Medicine 

Mass Production ( variety is separated, many production lines, work force specialization)

Maximize Speed

Defect Repair Area

Build for Stock ( Make and sell Mass)Defects or problems = Fix at the End of the Line

= High Rework

Lean Production, Variety is integrated (one production line, one work force constructing all varieties

Build on Demand (Sense and Respond Lean)Defects or problems = Stop the whole Line

= No Rework

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Lean Healthcare – End to End Flow Design

Elective Surgery (on demand )

Emergency Surgery

High Care Medical

Outpatients

Obstetrics

Low Care Medical

   L   i  n  e   M  a  n  a  g

  e  r  s

   P  r  o   d

  u  c   t   i  o  n   L   i  n  e  s   i

  n   H  o  s  p   i   t  a   l

Lean Laboratory Medicine 

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Shared Departments (large – no small dept)

Lean Healthcare – End to End Flow Design

Elective Surgery (on demand )

Emergency Surgery

High Care Medical

Outpatients

Obstetrics

Low Care Medical

Emergency Surgery MedicalObstetrics

Pediatric

Intensive

Care

Oncology Imaging Labs

   L   i  n  e   M  a  n  a  g

  e  r  s

   P  r  o   d

  u  c   t   i  o  n   L   i  n  e  s   i  n   H  o  s  p   i   t  a   l

Lean Laboratory Medicine 

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http://maps.google.com/maps/ms?ie=UTF8&hl=en&msa=0&msid=117519194103230134041.000470e737b7696a23930&ll

=39.909736,-95.009766&spn=63.368016,112.5&z=3&source=embed

Lean Healthcare Worldwide

Capio StGöran

2005 Learning Organization

Ryhov JönköpingMicrosystem Approach

Lean Laboratory Medicine 

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Personnel Room Patient Monitoring Tests Individualround

Planning Coordination

RedTeam

17 P.O-66 MIDA Trop-I 10 11

19:1 GE-40 MIDA 10 Angio

19:2 S.S-26 T-metri

20:1 K.K-23 Leave at 11

20:2 W.O-40 Leave afterbreakfast

Blue Team

14 E.R-45 MIDA

15 T.Y-29 Leave at 13

16 U.I-34 A-kabel Waiting dept. 37

21:1

21:2 K.K-22 MIDA

Beh rum

IVA

Personnel Room Patient Monitoring Tests Individualround

Planning Coordination

RedTeam

17 P.O-66 MIDA Trop-I 10 11

19:1 GE-40 MIDA 10 Angio

19:2 S.S-26 T-metri

20:1 K.K-23 Leave at 11

20:2 W.O-40 Leave afterbreakfast

Blue Team

14 E.R-45 MIDA

15 T.Y-29 Leave at 13

16 U.I-34 A-kabel Waiting dept. 37

21:1

21:2 K.K-22 MIDA

Beh rum

IVA

Visualization and teamwork key parts of LEAN improvementExample: Process work at cardiac ward - Overview of white-board

Individual Planning – No Classical Rounds

Capio StGöran

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Time Thieves – Capio StGöran

• Radiology

• Laboratory Medicine• IT

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The Lean T – Stream Model for Customer Value

IT Support processesRIS/PACS/LIS/Middlewares

ServiceProcesses

•Radiology•Physiology•Lab Medicine

“End to End” Patient Value Stream

IT Support process

HIS/EMR/RaR

Shared HC Functions

Patient flow

Lean Laboratory Medicine 

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CC / Ser / Imm

Trans Med

Bact

Pathol

Molec. Biol

Hem, Coag

Integration of Functions

Phys Rad

“Patient Journey”- Disease oriented Process- create Flow

Treat

Patient

HIS /

EMR /

PMS

RaR

MW

1

MW

2

MW

3

MW

4

Healthcare IT

C5LIMS

Lab IT

MeetDr

RIS /

PACS

Core

POCT

RRL

Lean Laboratory Medicine 

Bact

Pathol

Molec. Biol

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CC / Ser / Imm

Trans Med

Bact

Pathol

Molec. Biol

Hem, Coag

ImproveTiming

Integration of Functions

Phys Rad

“Patient Journey”- Disease oriented Process- create Flow

Treat

Patient

HIS /

EMR /

PMS

RaR

MW

1

MW

2

MW

3

MW

4

Healthcare IT

C5LIMS

Lab IT

MeetDr

RIS /

PACS

Core

ImproveTiming

POCT

RRL

Lean Laboratory Medicine 

Bact

Molec. Biol

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CC / Ser / Imm

Trans Med

Bact

Pathol

Molec. Biol

Hem, Coag

ImproveTiming

Integration of Functions

Phys Rad

“Patient Journey”- Disease oriented Process- create Flow

Treat

Patient

HIS /

EMR /

PMS

RaR

MW

1

MW

2

MW

3

MW

4

Healthcare IT

C5LIMS

Lab IT

MeetDr

RIS /

PACS

Core

ImproveTiming

Integrated Information Flow and Process Control

POCT

RRL

Lean Laboratory Medicine 

Bact

Pathol

Molec. Biol

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CC / Ser / Imm

Trans Med

Bact

Pathol

Molec. Biol

Hem, Coag

ImproveTiming

Integration of Functions

Phys Rad

“Patient Journey”- Disease oriented Process- create Flow

Treat

Patient

HIS /

EMR /

PMS

RaR

MW

1

MW

2

MW

3

MW

4

Healthcare IT

C5LIMS

Lab IT

MeetDr

RIS /

PACS

Core

ImproveTiming

Integrated Information Flow and Process Control

POCT

RRL

Lean Laboratory Medicine 

Network

Result Harmony

Bact

Pathol

Molec. Biol

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CC / Ser / Imm

Trans Med

Bact

Pathol

Molec. Biol

Hem, Coag

ImproveTiming

Integration of Functions

Phys Rad

“Patient Journey”- Disease oriented Process- create Flow

Treat

Patient

HIS /

EMR /

PMS

RaR

MW

1

MW

2

MW

3

MW

4

Healthcare IT

C5LIMS

Lab IT

MeetDr

RIS /

PACS

Core

ImproveTiming

Integrated Information Flow and Process Control

POCT

RRL

Lean Laboratory Medicine 

Network

Result Harmony

Bact

Pathol

Molec. Biol

From Batch to AutomatedLean Single Unit Processing

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Återförslutning

Buffer

Inmatningsmodul

Utmatningssmodul

Centrifug

Centrifug

Avproppning

Alikvotering&

märkning

Återförslutning

Buffer

Inmatningsmodul

Utmatningssmodul

Centrifug

Centrifug

Avproppning

Alikvotering&

märkning

Återförslutning

Buffer

Inmatningsmodul

Utmatningssmodul

Centrifug

Centrifug

Avproppning

Alikvotering&

märkning

IMMULITE 2000

ADIVA CENTAUR XP ADIVA CENTAUR XP

ADVIA 1800 ADVIA 1800

ARCHITECT

LSM

Second LineProcesses

Third Line

Processes

First Line CC/Ser/Imm

Automated Process

SIEMENS /Thermo WorkCell Maximizing Analytical

Consolidation

•Biochemistry

• Pharmacology (TDM)

• Drugs Of Abuse (DOA)

• Proteins

• Trad. Clin. Chem.

Immunochemistry

• Allergy

• Infection Disease Serology

• Autoimmunity

Lean Bacteriology Lean Cellular Pathology

Lean Molecular Biology

Common Customer Service

Healthcare Processes

LIS

DELTRIX

EPR1 EPR2 HIS PMS

Parallel processes•Hematology•Coagulation•Transfusion medicine

MW

Common

SampleReception

Lean Process Automated Core Lab

Lean Innovation – Big Leap (ref Unilabs Skaraborg)

Lean Laboratory Medicine 

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Lean for QA/QC

Pre-, Pre analysis Preanalysis, Analysis, Postanalysis Post-, Post analysis

USL

T

LSL

Correct Order

Correct Sample Correct Delivery

Correct

Medical Decision

Target

Bias

• Establish TEa max/min Specs / Method - LSL/USL

• Consider Biological Variation, Medical Need

• Eliminate Bias for Result Harmony

• Perform Adequate Risk Analysis (FMEA)• Revise QC Procedures in Production

• Consensus Reference Intervals (NORIP)

Cons. Ref

Intervals

Process Capability

Lean, Six Sigma Product Control

Sigma (TEa – Bias) / CV

Lean Laboratory Medicine 

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Form Batch processing to Single Unit Processing

Accessioning data +Sample

Grosssing/Orientation

Tissue Processing

Stainings

HistochemistryIHC

ISHSpecial

InterpretationMicroscopy

Imaging

Embedding

Cutting

LEAN

WS A

LEAN

WS B

LEAN

WS C

LEAN

WS D

E-Request

Middle Ware for Lean Process Control

Man WS Man WS

LIS (Discipline integrated) E-Report

Man WS

Automation

No Connectivity

AutomationNo Connectivity

AutomationConnectivity

AutomationConnectivity

P a p e r l e s s P r o d u c t i o n

Reorganize

staff

Arch

Lean Process Histopathology

Lean Laboratory Medicine 

• Old Process VAT < 2%,• High Risk for Errors• Work Cell Automation

Design for Single Unit Flow• Goal 80 % delivery within

same day

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Form Batch processing to Single Unit Processing

DirectIdentificationon MALDITOF MS

MolecularBiology directHybridization

PCR-Semi /FullAutomationRandom

Liquid

Plates

Tubes

Slides

Primary Sample:

Secondary Samples:

Colony

IdentifyBiochemistry

Auto-Work Cell I Auto-Work Cell II

Cultivation

Fast tracks

UniqueLabelingPlate, TubesFrom Store

Inoculate -Streak out

Direct appl.

AntibioticDiscs forAST

Incubate InterpretImage orig.Image AST

Pick out

NegativesFlowcytometry

Antigen

Tests

Middle Ware (Steering Automation, Data Concentrator - Images, MALDI TOF and AST data)

LIS DELTRIX (Common for CC/Ser/Imm/Bact/Path)Order

in

Report

out

Incubate andEvaluate AST

Identify

MALDI TOF MS

Auto-Work Cell III

P a p e r l e s s P r o d u c t i o n

Lean Process Bacteriology• Work Cell Automation

Design for Single Unit Flow• New Technology (MALDI ToF)

disrupts old Process• Potential within Day Reporting

Lean Laboratory Medicine 

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Designing the Integrated Lean LaboratoryLean Laboratory Medicine 

Patient

Flow

IntegratedSample Flow

Nucleic acidsTissuesCultivations

BiologicalLiquids

Harmonized Value StreamsDesign ”Single Unit Processing”

P r  o c  e s  s  C 

 on t  r  ol  

I  n t   e gr  a t   e d I  nf   or m a t  i   on

 O  C 

Molecular Biology ProcessHistopathology / Cytology Process

Bacteriology process

Parallell Processes

Primary Automation Process

Secundary Processes

Tertiary Processes

”Send outs”

Lean IT

Staff design Processes

Staff continuously improve ProcessesIVD Industry listens to the Customer for Innovation

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Lean System Thinking

Lean is CultureContinuous Improvement /InnovationRespect for PeopleFocus on Processes

Clarity on Purpose

Lean Laboratory Medicine 

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Rational and Creative – Select Improvements

Vital

Few

Closing

GapsWorking

together

Learn bydoing

Doing

new things ImaginationInspirationIntuition

Lean Laboratory Medicine 

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QMS hampers Continuous Improvement

ISO9000/17025/15189

DEFINE

MEASURE

ANALYZE

IMPROVE

CONTROL

ACT

PLAN

DO

CHECK ACT

PLAN

DO

CHECKACT

PLAN

DO

CHECK

Factsdrive

development”Customer Pull”

• Patient• User• Payer

LEAN /

SixSigma

Business and ProcessChallenges

 Q  M S

Lean Laboratory Medicine 

Does not promotea culture of

Continuous QualityImprovement (CQI)

Quality Management System(QMS)

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QMS must support Continuous Improvement

ISO9001/17025/15189

 Q  M S

DEFINE

MEASURE

ANALYZE

IMPROVE

CONTROL

ACT

PLAN

DO

CHECK ACT

PLAN

DO

CHECKACT

PLAN

DO

CHECK

Factsdrive

development”Customer Pull”

• Patient• User• Payer

Business and ProcessChallenges

 Q  M S

Lean Laboratory Medicine 

+ CQILean SixSigma

Stabilizes

and puts Focus onImprovements

Quality Management System(QMS)

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Customer pulls the Value – Organization delivers

Quality in Process

Cost is lowest

Delivery is best

Motivated Staff

Medical ExcellencePatient SafetyCorrect

Fast / TimelyCoordinatedReproducibleOperational Excellence

Customer Value

Patient / User / Payer

Lean Value

Dimensions

Continuously Improve, Innovate, Change for Value

Lean, Six Sigma, ISO 15189

Lean Laboratory Medicine 

DeliveryWindow30 min

to24 hours(80-90%)

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Meeting increasing Demand

and Limitation in Resourceswith

Lean Value Stream Design

Manage the Healthcare Dilemma

ValueAdded Time

Non ValueAdded Time

Lean Laboratory Medicine 

I i Ab P l

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It is About PeopleThere is No Such Thing as Operator Error

It is PROCESSES – not PEOPLE that Fail.

This maps to one of Deming’s 14 Points for Management :“ DRIVE OUT FEAR”.

Focus on Processes implies that people are not accused,but rather, that they are able to investigate processes and

be “part of the solution.”http://www.1000advices.com/guru/quality_tqm_14points_deming.html

Lean Laboratory Medicine