SlideShare a Scribd company logo
Six Sigma and Lean Tools for Validation   Jan C. Crielaard,  Principal, WW Validation  Cordis Corporation,  a Johnson and Johnson Company Pharmaceutical Technology’s Annual Conference July 23-25, 2007  -  Park Hyatt at the Bellevue  -  Philadelphia, PA
Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Learning Objectives ,[object Object],[object Object],[object Object],[object Object]
Validation life cycle and Six Sigma methodologies
FDA’s Initiative GMPs for the 21st Century ,[object Object],[object Object],[object Object]
FDA’s Initiative GMPs for the 21st Century ,[object Object],[object Object]
Continuous Improvement FDA ,[object Object],[object Object],[object Object],[object Object]
Six Sigma ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Measure Analyze Improve Control Define
DMAIC tool overview
Causal thinking y = f(x1, x2,…, xn) Cause-and-Effect Diagram
Risk Based approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Risk Management ,[object Object],[object Object],[object Object],[object Object]
Risk Management
Risk Estimation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
FTA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Identify Hazards Identify all potential failure modes Diagram the fault tree T E A M E F F O R T
FTA
FMEA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Identify component or process steps Identify what can go wrong Determine Effect for user ,[object Object],[object Object],[object Object],[object Object],Evaluate the risk &identify controls and mitigation actions T E A M E F F O R T
Impact Assessment * ,[object Object],[object Object],[object Object],[object Object],[object Object],* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
System Impact Assessment* ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
Component Criticality Assessment* ,[object Object],[object Object],[object Object],[object Object],[object Object],* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
Component Criticality Assessment* ,[object Object],[object Object],[object Object],[object Object],* ISPE, Pharmaceutical Engineering Guides for New and Renovated Facilities
Impact Assessment Commission and  Qualify system
Risk knowledge ,[object Object],[object Object],[object Object],[object Object]
Utilize Lean tools to assess validation system efficacy and efficiency
Overall approach  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Tools ,[object Object],[object Object],[object Object],[object Object]
RACI Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],1 Map current state
RACI Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Group Technology Analysis ,[object Object],[object Object],[object Object]
Group Technology Analysis ,[object Object]
Group Technology Analysis ,[object Object]
Job Standardization ,[object Object],[object Object]
Job Standardization ,[object Object],[object Object]
Group Technology Analysis (Compliance) ,[object Object]
Group Technology Analysis (Compliance) ,[object Object],[object Object]
Value Stream Map (VSM) ,[object Object],[object Object],[object Object]
Current state VSM
Brainstorm improvement opportunities ,[object Object],[object Object],[object Object],[object Object]
VSM – Kaizen Bursts
Future State VSM ,[object Object],[object Object]
Future state VSM
Gauge RnR (Attribute) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Gauge RnR Identify all possible  outcomes of the transactional process
Gauge RnR  Design gauge RnR 2 people  5 scenarios  4 repeats Joe Sally Scenarios 1 2 3 4 5 1 2 3 4 5 repeats 1234 5678 .… .… .… …. 1234 5678 .… .… .… ….
Gauge RnR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Gauge RnR ,[object Object],[object Object],[object Object],[object Object]
Analyze data ,[object Object],[object Object],[object Object],[object Object],2 people  5 scenarios  4 repeats Minitab:  S tat> Q uality Tools>Attrib u te Agreement Analysis
Considerations for an Attribute Gage R&R Study ,[object Object],[object Object],[object Object],[object Object],[object Object]
Control Plans and Validation Metrics
Control Plan - Purpose ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Metrics ,[object Object],[object Object],[object Object],[object Object]
Causal thinking y = f(x1, x2,…, xn ) Causal Driver Hierarchy
Useful Metrics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Balanced Metrics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Balanced Metrics ,[object Object],[object Object],[object Object],[object Object],[object Object],Leading Lagging Effectiveness Efficiency Supplier Input Metrics Customer Output Process Input Output Metrics Process Metrics X X X X X X X
Dashboard Causal driver Hierarchy Linkage / Focus Frequency of review Tactical Strategic More frequent Less frequent
Features of a Well-Dressed Dashboard # of Reviews LCL and UCL Average Benchmark Review iterations Time F M A J J A 2 4 6 8 10 Good Quick reference legend i.e. “Trend down=Good” Clean Data Display: Average and control limits Trend and goal Title X and Y axis Chart legend and update frequency Description This dashboard shows the number of iterations average per month. The benchmark of 2 iterations is the goal. Explanation More then 1 review means rework. Rework is waste. Waste needs to be minimalized. Action plan Descending trend is good. Ascending is bad, requires root cause analysis and  preventive action. Description, Explanation and action plan
Interactive Exercise:  Facilitating a transactional Kaizen initiative 改善
What is Kaizen ,[object Object],[object Object],[object Object],[object Object],[object Object],Kaizen is the lean manufacturing term for continuous improvement and was originally used to describe a key element of the Toyota Production System.
What is Kaizen ,[object Object],[object Object]
What is Kaizen ,[object Object],[object Object],[object Object],[object Object],Tools: Six Sigma and Lean
The benefits to applying Kaizen ,[object Object],[object Object],[object Object],Creativity before capital!
Transactional Kaizen ,[object Object],[object Object],[object Object],[object Object],All these alternatives can be combined in a broad improvement plan.
Scope of transactional Kaizen ,[object Object],[object Object],[object Object]
Event Format ,[object Object],[object Object],[object Object],[object Object],[object Object]
Activity Flow Review Base  Condition Identify Waste Problem Solve Communicate Coordinate Verify  Measure Update Job Standardization Present  Out-Brief Implement Solutions
1 week Kaizen using DMAIC approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Measure Analyze Improve Control Define
1 week Kaizen using DMAIC approach ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Measure Analyze Improve Control Define
Conclusion ,[object Object],Questions?
Contact information ,[object Object],[object Object],[object Object]
References ,[object Object],[object Object]
References ,[object Object],[object Object]
References ,[object Object],[object Object]
References ,[object Object],[object Object]

More Related Content

What's hot

Risk based quality management
Risk based quality managementRisk based quality management
Risk based quality management
selinasimpson2301
 
Risk management in pharmaceutical Industry
Risk management in pharmaceutical IndustryRisk management in pharmaceutical Industry
Risk management in pharmaceutical Industry
Mahesh shinde
 
Project Quality management
Project Quality managementProject Quality management
Project Quality management
Karishma Chaudhary
 
Chapter 6 Tool Support for Testing
Chapter 6 Tool Support for TestingChapter 6 Tool Support for Testing
Chapter 6 Tool Support for Testing
Zetryan Satria
 
Howtocreate capa template
Howtocreate capa templateHowtocreate capa template
Howtocreate capa template
Do Thanh Hoan
 
Test Planning and Test Estimation Techniques
Test Planning and Test Estimation TechniquesTest Planning and Test Estimation Techniques
Test Planning and Test Estimation Techniques
Murageppa-QA
 
Quality management system sample
Quality management system sampleQuality management system sample
Quality management system sample
selinasimpson321
 
STATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROLSTATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROL
Vivek Thorve
 
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk ManagementICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
Seetharam Kandarpa ASQ CMQ/OE, CPGP, CQA
 
L07 quality management
L07 quality managementL07 quality management
L07 quality management
Asa Chan
 
Risk Based Testing: Deferring the Right Bugs
Risk Based Testing: Deferring the Right BugsRisk Based Testing: Deferring the Right Bugs
Risk Based Testing: Deferring the Right Bugs
indus329
 
Analytical control strategy 2
Analytical control strategy 2Analytical control strategy 2
Analytical control strategy 2
Chandra Prakash Singh
 
Introduction To Statistical Process Control
Introduction To Statistical Process ControlIntroduction To Statistical Process Control
Introduction To Statistical Process Control
Gaurav bhatnagar
 
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk ManagementICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
muna_ali
 
Corrective & Preventive Action
Corrective & Preventive Action Corrective & Preventive Action
Corrective & Preventive Action
Praneet Surti
 
How to Create a Risk-Based CAPA Process
How to Create a Risk-Based CAPA ProcessHow to Create a Risk-Based CAPA Process
How to Create a Risk-Based CAPA Process
Greenlight Guru
 
Corrective and preventive action plan CAPA report form
Corrective and preventive action plan  CAPA report formCorrective and preventive action plan  CAPA report form
Corrective and preventive action plan CAPA report form
Connie Dello Buono
 
STATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROLSTATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROL
Vivek Thorve
 
Statistical Process Control
Statistical Process ControlStatistical Process Control
Statistical Process Control
Alishap
 
Statistical Process Control
Statistical Process ControlStatistical Process Control
Statistical Process Control
Tushar Naik
 

What's hot (20)

Risk based quality management
Risk based quality managementRisk based quality management
Risk based quality management
 
Risk management in pharmaceutical Industry
Risk management in pharmaceutical IndustryRisk management in pharmaceutical Industry
Risk management in pharmaceutical Industry
 
Project Quality management
Project Quality managementProject Quality management
Project Quality management
 
Chapter 6 Tool Support for Testing
Chapter 6 Tool Support for TestingChapter 6 Tool Support for Testing
Chapter 6 Tool Support for Testing
 
Howtocreate capa template
Howtocreate capa templateHowtocreate capa template
Howtocreate capa template
 
Test Planning and Test Estimation Techniques
Test Planning and Test Estimation TechniquesTest Planning and Test Estimation Techniques
Test Planning and Test Estimation Techniques
 
Quality management system sample
Quality management system sampleQuality management system sample
Quality management system sample
 
STATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROLSTATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROL
 
ICH Q9 Quality Risk Management
ICH Q9 Quality Risk ManagementICH Q9 Quality Risk Management
ICH Q9 Quality Risk Management
 
L07 quality management
L07 quality managementL07 quality management
L07 quality management
 
Risk Based Testing: Deferring the Right Bugs
Risk Based Testing: Deferring the Right BugsRisk Based Testing: Deferring the Right Bugs
Risk Based Testing: Deferring the Right Bugs
 
Analytical control strategy 2
Analytical control strategy 2Analytical control strategy 2
Analytical control strategy 2
 
Introduction To Statistical Process Control
Introduction To Statistical Process ControlIntroduction To Statistical Process Control
Introduction To Statistical Process Control
 
ICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk ManagementICH Guideline Q9 - Quality Risk Management
ICH Guideline Q9 - Quality Risk Management
 
Corrective & Preventive Action
Corrective & Preventive Action Corrective & Preventive Action
Corrective & Preventive Action
 
How to Create a Risk-Based CAPA Process
How to Create a Risk-Based CAPA ProcessHow to Create a Risk-Based CAPA Process
How to Create a Risk-Based CAPA Process
 
Corrective and preventive action plan CAPA report form
Corrective and preventive action plan  CAPA report formCorrective and preventive action plan  CAPA report form
Corrective and preventive action plan CAPA report form
 
STATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROLSTATISTICAL PROCESS CONTROL
STATISTICAL PROCESS CONTROL
 
Statistical Process Control
Statistical Process ControlStatistical Process Control
Statistical Process Control
 
Statistical Process Control
Statistical Process ControlStatistical Process Control
Statistical Process Control
 

Viewers also liked

Risk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life CyclesRisk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life Cycles
Institute of Validation Technology
 
Seminário Aese - Implementar um processo de LSS
Seminário Aese - Implementar um processo de LSSSeminário Aese - Implementar um processo de LSS
Seminário Aese - Implementar um processo de LSS
PedrodosSantos
 
Black Belts Programa 2010
Black Belts Programa 2010Black Belts Programa 2010
Black Belts Programa 2010
Luis Fernandes
 
Aula de qualidade lean - unoesc videira
Aula de qualidade lean - unoesc videiraAula de qualidade lean - unoesc videira
Aula de qualidade lean - unoesc videira
Luiz Felipe Cherem
 
+++2010 Profitability Engineers (Pt)
+++2010 Profitability Engineers (Pt)+++2010 Profitability Engineers (Pt)
+++2010 Profitability Engineers (Pt)
Luis Fernandes
 
+++Six Sigma & Pat
+++Six Sigma & Pat+++Six Sigma & Pat
+++Six Sigma & Pat
Luis Fernandes
 
Seminário Aese - Definição das ferramentas do LSS
Seminário Aese - Definição das ferramentas do LSSSeminário Aese - Definição das ferramentas do LSS
Seminário Aese - Definição das ferramentas do LSS
PedrodosSantos
 
Tablets 2017
Tablets 2017Tablets 2017
Tablets 2017
Juan M. Irache
 
Trailer Estadistica avanzada, aplicada a la industria farmacéutica
Trailer Estadistica avanzada, aplicada a la industria farmacéuticaTrailer Estadistica avanzada, aplicada a la industria farmacéutica
Trailer Estadistica avanzada, aplicada a la industria farmacéutica
Fernando Tazón Alvarez
 
Final year project report on Value stream mapping and Smed
Final year project report on Value stream mapping and SmedFinal year project report on Value stream mapping and Smed
Final year project report on Value stream mapping and Smed
Umar Yazdani
 
Seminário Aese - Conceitos teóricos do LSS
Seminário Aese - Conceitos teóricos do LSSSeminário Aese - Conceitos teóricos do LSS
Seminário Aese - Conceitos teóricos do LSS
PedrodosSantos
 
Kanban e seis sigma v1.1
Kanban e seis sigma v1.1Kanban e seis sigma v1.1
Kanban e seis sigma v1.1
vicfigui
 
Apresentação fatec inteiro
Apresentação fatec   inteiroApresentação fatec   inteiro
Apresentação fatec inteiro
Paulo Bandeira
 
Mapeamento do processo Lean 6 Sigma
Mapeamento do processo Lean 6 SigmaMapeamento do processo Lean 6 Sigma
Mapeamento do processo Lean 6 Sigma
Actio Lean Consulting
 
Six Sigma Metodologia DMAIC
Six Sigma Metodologia DMAICSix Sigma Metodologia DMAIC
Six Sigma Metodologia DMAIC
CLT Valuebased Services
 
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
Diego Pacheco
 
Measure phase lean six sigma tollgate template
Measure phase   lean six sigma tollgate templateMeasure phase   lean six sigma tollgate template
Measure phase lean six sigma tollgate template
Steven Bonacorsi
 
Ferramentas Qualidade e Lean Six Sigma Hospital
Ferramentas Qualidade e Lean Six Sigma HospitalFerramentas Qualidade e Lean Six Sigma Hospital
Ferramentas Qualidade e Lean Six Sigma Hospital
Rubia Soraya Rabello
 
Analyze phase lean six sigma tollgate template
Analyze phase   lean six sigma tollgate templateAnalyze phase   lean six sigma tollgate template
Analyze phase lean six sigma tollgate template
Steven Bonacorsi
 
G Liegois Lean France Sqop09 Afeit
G Liegois Lean France Sqop09 AfeitG Liegois Lean France Sqop09 Afeit
G Liegois Lean France Sqop09 Afeit
AFEIT
 

Viewers also liked (20)

Risk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life CyclesRisk-Based Approaches in GMP’s Project Life Cycles
Risk-Based Approaches in GMP’s Project Life Cycles
 
Seminário Aese - Implementar um processo de LSS
Seminário Aese - Implementar um processo de LSSSeminário Aese - Implementar um processo de LSS
Seminário Aese - Implementar um processo de LSS
 
Black Belts Programa 2010
Black Belts Programa 2010Black Belts Programa 2010
Black Belts Programa 2010
 
Aula de qualidade lean - unoesc videira
Aula de qualidade lean - unoesc videiraAula de qualidade lean - unoesc videira
Aula de qualidade lean - unoesc videira
 
+++2010 Profitability Engineers (Pt)
+++2010 Profitability Engineers (Pt)+++2010 Profitability Engineers (Pt)
+++2010 Profitability Engineers (Pt)
 
+++Six Sigma & Pat
+++Six Sigma & Pat+++Six Sigma & Pat
+++Six Sigma & Pat
 
Seminário Aese - Definição das ferramentas do LSS
Seminário Aese - Definição das ferramentas do LSSSeminário Aese - Definição das ferramentas do LSS
Seminário Aese - Definição das ferramentas do LSS
 
Tablets 2017
Tablets 2017Tablets 2017
Tablets 2017
 
Trailer Estadistica avanzada, aplicada a la industria farmacéutica
Trailer Estadistica avanzada, aplicada a la industria farmacéuticaTrailer Estadistica avanzada, aplicada a la industria farmacéutica
Trailer Estadistica avanzada, aplicada a la industria farmacéutica
 
Final year project report on Value stream mapping and Smed
Final year project report on Value stream mapping and SmedFinal year project report on Value stream mapping and Smed
Final year project report on Value stream mapping and Smed
 
Seminário Aese - Conceitos teóricos do LSS
Seminário Aese - Conceitos teóricos do LSSSeminário Aese - Conceitos teóricos do LSS
Seminário Aese - Conceitos teóricos do LSS
 
Kanban e seis sigma v1.1
Kanban e seis sigma v1.1Kanban e seis sigma v1.1
Kanban e seis sigma v1.1
 
Apresentação fatec inteiro
Apresentação fatec   inteiroApresentação fatec   inteiro
Apresentação fatec inteiro
 
Mapeamento do processo Lean 6 Sigma
Mapeamento do processo Lean 6 SigmaMapeamento do processo Lean 6 Sigma
Mapeamento do processo Lean 6 Sigma
 
Six Sigma Metodologia DMAIC
Six Sigma Metodologia DMAICSix Sigma Metodologia DMAIC
Six Sigma Metodologia DMAIC
 
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
INTEGRANDO A ESTRATÉGIA DE PRODUÇÃO COM A TEORIA DAS RESTRIÇÕES, LEAN MANUFAC...
 
Measure phase lean six sigma tollgate template
Measure phase   lean six sigma tollgate templateMeasure phase   lean six sigma tollgate template
Measure phase lean six sigma tollgate template
 
Ferramentas Qualidade e Lean Six Sigma Hospital
Ferramentas Qualidade e Lean Six Sigma HospitalFerramentas Qualidade e Lean Six Sigma Hospital
Ferramentas Qualidade e Lean Six Sigma Hospital
 
Analyze phase lean six sigma tollgate template
Analyze phase   lean six sigma tollgate templateAnalyze phase   lean six sigma tollgate template
Analyze phase lean six sigma tollgate template
 
G Liegois Lean France Sqop09 Afeit
G Liegois Lean France Sqop09 AfeitG Liegois Lean France Sqop09 Afeit
G Liegois Lean France Sqop09 Afeit
 

Similar to Sslean Validation 20070622

Quality Management
Quality ManagementQuality Management
Quality Management
Joanmaines
 
QM-026-Quality Management
QM-026-Quality ManagementQM-026-Quality Management
QM-026-Quality Management
handbook
 
FMEA and FMECA
FMEA and FMECAFMEA and FMECA
FMEA and FMECA
Sjur
 
Managing Quality
Managing QualityManaging Quality
Managing Quality
Ali BARAN
 
Measure Phase
Measure PhaseMeasure Phase
Measure Phase
jay68
 
Six Sigma Glossary
Six Sigma GlossarySix Sigma Glossary
Six Sigma Glossary
Ossama Ismail
 
K 10716 mukesh beniwal(basic quality tools in small companies)
K 10716 mukesh beniwal(basic quality tools in small companies)K 10716 mukesh beniwal(basic quality tools in small companies)
K 10716 mukesh beniwal(basic quality tools in small companies)
shailesh yadav
 
Quality risk management
Quality risk managementQuality risk management
Quality risk management
RavindraKumarGoyal
 
Quality assurance
Quality assuranceQuality assurance
Quality assurance
RajThakuri
 
Quality Management
Quality ManagementQuality Management
Quality Management
Joshua Miranda
 
Capa ‘Bellwether’
Capa ‘Bellwether’Capa ‘Bellwether’
Capa ‘Bellwether’
Victoria V. Lander, MA
 
U20
U20U20
Basic Six Sigma Presentation
Basic Six Sigma PresentationBasic Six Sigma Presentation
Basic Six Sigma Presentation
vivekissar
 
ICH Q9 QUALITY RISK MANAGEMENT(QRM)
ICH Q9 QUALITY RISK MANAGEMENT(QRM)ICH Q9 QUALITY RISK MANAGEMENT(QRM)
ICH Q9 QUALITY RISK MANAGEMENT(QRM)
saimsoleja
 
Review on Quality Management using 7 QC Tools
Review on Quality Management using 7 QC ToolsReview on Quality Management using 7 QC Tools
Review on Quality Management using 7 QC Tools
Government engineering College- Banswara,Rajasthan
 
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
 Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ... Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
Seapine Software
 
The 5 core tools are recognized as standard quality tools for the automotive ...
The 5 core tools are recognized as standard quality tools for the automotive ...The 5 core tools are recognized as standard quality tools for the automotive ...
The 5 core tools are recognized as standard quality tools for the automotive ...
arvindsinghrathore6
 
Statistical_Quality_Control esp.ppt
Statistical_Quality_Control esp.pptStatistical_Quality_Control esp.ppt
Statistical_Quality_Control esp.ppt
Oswaldo Gonzales
 
Ancora 6Sigma - 3. la metodologia DMAIC
Ancora 6Sigma - 3.  la metodologia DMAICAncora 6Sigma - 3.  la metodologia DMAIC
Ancora 6Sigma - 3. la metodologia DMAIC
Manager.it
 
Risk Management Training
Risk Management TrainingRisk Management Training
Risk Management Training
Quality Improvement Consulting
 

Similar to Sslean Validation 20070622 (20)

Quality Management
Quality ManagementQuality Management
Quality Management
 
QM-026-Quality Management
QM-026-Quality ManagementQM-026-Quality Management
QM-026-Quality Management
 
FMEA and FMECA
FMEA and FMECAFMEA and FMECA
FMEA and FMECA
 
Managing Quality
Managing QualityManaging Quality
Managing Quality
 
Measure Phase
Measure PhaseMeasure Phase
Measure Phase
 
Six Sigma Glossary
Six Sigma GlossarySix Sigma Glossary
Six Sigma Glossary
 
K 10716 mukesh beniwal(basic quality tools in small companies)
K 10716 mukesh beniwal(basic quality tools in small companies)K 10716 mukesh beniwal(basic quality tools in small companies)
K 10716 mukesh beniwal(basic quality tools in small companies)
 
Quality risk management
Quality risk managementQuality risk management
Quality risk management
 
Quality assurance
Quality assuranceQuality assurance
Quality assurance
 
Quality Management
Quality ManagementQuality Management
Quality Management
 
Capa ‘Bellwether’
Capa ‘Bellwether’Capa ‘Bellwether’
Capa ‘Bellwether’
 
U20
U20U20
U20
 
Basic Six Sigma Presentation
Basic Six Sigma PresentationBasic Six Sigma Presentation
Basic Six Sigma Presentation
 
ICH Q9 QUALITY RISK MANAGEMENT(QRM)
ICH Q9 QUALITY RISK MANAGEMENT(QRM)ICH Q9 QUALITY RISK MANAGEMENT(QRM)
ICH Q9 QUALITY RISK MANAGEMENT(QRM)
 
Review on Quality Management using 7 QC Tools
Review on Quality Management using 7 QC ToolsReview on Quality Management using 7 QC Tools
Review on Quality Management using 7 QC Tools
 
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
 Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ... Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
Use the Windshield, Not the Mirror Predictive Metrics that Drive Successful ...
 
The 5 core tools are recognized as standard quality tools for the automotive ...
The 5 core tools are recognized as standard quality tools for the automotive ...The 5 core tools are recognized as standard quality tools for the automotive ...
The 5 core tools are recognized as standard quality tools for the automotive ...
 
Statistical_Quality_Control esp.ppt
Statistical_Quality_Control esp.pptStatistical_Quality_Control esp.ppt
Statistical_Quality_Control esp.ppt
 
Ancora 6Sigma - 3. la metodologia DMAIC
Ancora 6Sigma - 3.  la metodologia DMAICAncora 6Sigma - 3.  la metodologia DMAIC
Ancora 6Sigma - 3. la metodologia DMAIC
 
Risk Management Training
Risk Management TrainingRisk Management Training
Risk Management Training
 

Recently uploaded

Authentically Social Presented by Corey Perlman
Authentically Social Presented by Corey PerlmanAuthentically Social Presented by Corey Perlman
Authentically Social Presented by Corey Perlman
Corey Perlman, Social Media Speaker and Consultant
 
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdfModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
fisherameliaisabella
 
The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...
Adam Smith
 
Best Forex Brokers Comparison in INDIA 2024
Best Forex Brokers Comparison in INDIA 2024Best Forex Brokers Comparison in INDIA 2024
Best Forex Brokers Comparison in INDIA 2024
Top Forex Brokers Review
 
The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...
Adam Smith
 
Part 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 SlowdownPart 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 Slowdown
jeffkluth1
 
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
my Pandit
 
-- June 2024 is National Volunteer Month --
-- June 2024 is National Volunteer Month ---- June 2024 is National Volunteer Month --
-- June 2024 is National Volunteer Month --
NZSG
 
How MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdfHow MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdf
MJ Global
 
Creative Web Design Company in Singapore
Creative Web Design Company in SingaporeCreative Web Design Company in Singapore
Creative Web Design Company in Singapore
techboxsqauremedia
 
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta MatkaDpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
➒➌➎➏➑➐➋➑➐➐Dpboss Matka Guessing Satta Matka Kalyan Chart Indian Matka
 
Training my puppy and implementation in this story
Training my puppy and implementation in this storyTraining my puppy and implementation in this story
Training my puppy and implementation in this story
WilliamRodrigues148
 
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
Kirill Klimov
 
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
bosssp10
 
Chapter 7 Final business management sciences .ppt
Chapter 7 Final business management sciences .pptChapter 7 Final business management sciences .ppt
Chapter 7 Final business management sciences .ppt
ssuser567e2d
 
Structural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for BuildingsStructural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for Buildings
Chandresh Chudasama
 
2022 Vintage Roman Numerals Men Rings
2022 Vintage Roman  Numerals  Men  Rings2022 Vintage Roman  Numerals  Men  Rings
2022 Vintage Roman Numerals Men Rings
aragme
 
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel ChartSatta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
➒➌➎➏➑➐➋➑➐➐Dpboss Matka Guessing Satta Matka Kalyan Chart Indian Matka
 
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfThe 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
thesiliconleaders
 
ikea_woodgreen_petscharity_dog-alogue_digital.pdf
ikea_woodgreen_petscharity_dog-alogue_digital.pdfikea_woodgreen_petscharity_dog-alogue_digital.pdf
ikea_woodgreen_petscharity_dog-alogue_digital.pdf
agatadrynko
 

Recently uploaded (20)

Authentically Social Presented by Corey Perlman
Authentically Social Presented by Corey PerlmanAuthentically Social Presented by Corey Perlman
Authentically Social Presented by Corey Perlman
 
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdfModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
ModelingMarketingStrategiesMKS.CollumbiaUniversitypdf
 
The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...
 
Best Forex Brokers Comparison in INDIA 2024
Best Forex Brokers Comparison in INDIA 2024Best Forex Brokers Comparison in INDIA 2024
Best Forex Brokers Comparison in INDIA 2024
 
The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...The Influence of Marketing Strategy and Market Competition on Business Perfor...
The Influence of Marketing Strategy and Market Competition on Business Perfor...
 
Part 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 SlowdownPart 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 Slowdown
 
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
 
-- June 2024 is National Volunteer Month --
-- June 2024 is National Volunteer Month ---- June 2024 is National Volunteer Month --
-- June 2024 is National Volunteer Month --
 
How MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdfHow MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdf
 
Creative Web Design Company in Singapore
Creative Web Design Company in SingaporeCreative Web Design Company in Singapore
Creative Web Design Company in Singapore
 
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta MatkaDpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
 
Training my puppy and implementation in this story
Training my puppy and implementation in this storyTraining my puppy and implementation in this story
Training my puppy and implementation in this story
 
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
 
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
Call 8867766396 Satta Matka Dpboss Matka Guessing Satta batta Matka 420 Satta...
 
Chapter 7 Final business management sciences .ppt
Chapter 7 Final business management sciences .pptChapter 7 Final business management sciences .ppt
Chapter 7 Final business management sciences .ppt
 
Structural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for BuildingsStructural Design Process: Step-by-Step Guide for Buildings
Structural Design Process: Step-by-Step Guide for Buildings
 
2022 Vintage Roman Numerals Men Rings
2022 Vintage Roman  Numerals  Men  Rings2022 Vintage Roman  Numerals  Men  Rings
2022 Vintage Roman Numerals Men Rings
 
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel ChartSatta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
Satta Matka Dpboss Matka Guessing Kalyan Chart Indian Matka Kalyan panel Chart
 
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfThe 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
 
ikea_woodgreen_petscharity_dog-alogue_digital.pdf
ikea_woodgreen_petscharity_dog-alogue_digital.pdfikea_woodgreen_petscharity_dog-alogue_digital.pdf
ikea_woodgreen_petscharity_dog-alogue_digital.pdf
 

Sslean Validation 20070622

  • 1. Six Sigma and Lean Tools for Validation Jan C. Crielaard, Principal, WW Validation Cordis Corporation, a Johnson and Johnson Company Pharmaceutical Technology’s Annual Conference July 23-25, 2007 - Park Hyatt at the Bellevue - Philadelphia, PA
  • 2.
  • 3.
  • 4.
  • 5. Validation life cycle and Six Sigma methodologies
  • 6.
  • 7.
  • 8.
  • 9.
  • 11. Causal thinking y = f(x1, x2,…, xn) Cause-and-Effect Diagram
  • 12.
  • 13.
  • 15.
  • 16.
  • 17. FTA
  • 18.
  • 19.
  • 20.
  • 21.
  • 22.
  • 23. Impact Assessment Commission and Qualify system
  • 24.
  • 25. Utilize Lean tools to assess validation system efficacy and efficiency
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31.
  • 32.
  • 33.
  • 34.
  • 35.
  • 36.
  • 37.
  • 39.
  • 40. VSM – Kaizen Bursts
  • 41.
  • 43.
  • 44. Gauge RnR Identify all possible outcomes of the transactional process
  • 45. Gauge RnR Design gauge RnR 2 people 5 scenarios 4 repeats Joe Sally Scenarios 1 2 3 4 5 1 2 3 4 5 repeats 1234 5678 .… .… .… …. 1234 5678 .… .… .… ….
  • 46.
  • 47.
  • 48.
  • 49.
  • 50. Control Plans and Validation Metrics
  • 51.
  • 52.
  • 53. Causal thinking y = f(x1, x2,…, xn ) Causal Driver Hierarchy
  • 54.
  • 55.
  • 56.
  • 57. Dashboard Causal driver Hierarchy Linkage / Focus Frequency of review Tactical Strategic More frequent Less frequent
  • 58. Features of a Well-Dressed Dashboard # of Reviews LCL and UCL Average Benchmark Review iterations Time F M A J J A 2 4 6 8 10 Good Quick reference legend i.e. “Trend down=Good” Clean Data Display: Average and control limits Trend and goal Title X and Y axis Chart legend and update frequency Description This dashboard shows the number of iterations average per month. The benchmark of 2 iterations is the goal. Explanation More then 1 review means rework. Rework is waste. Waste needs to be minimalized. Action plan Descending trend is good. Ascending is bad, requires root cause analysis and preventive action. Description, Explanation and action plan
  • 59. Interactive Exercise: Facilitating a transactional Kaizen initiative 改善
  • 60.
  • 61.
  • 62.
  • 63.
  • 64.
  • 65.
  • 66.
  • 67. Activity Flow Review Base Condition Identify Waste Problem Solve Communicate Coordinate Verify Measure Update Job Standardization Present Out-Brief Implement Solutions
  • 68.
  • 69.
  • 70.
  • 71.
  • 72.
  • 73.
  • 74.
  • 75.