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All materials contained herein are the sole property of Value Innovation Partners, Ltd. and unauthorizeduse is strictly prohibited without the expressed written consent of Value Innovation Partners, Ltd.
VIP VIP
VIP
VIP
Chicago
1537 Hazelnut CrossingMundelein, IL 60060001 (847) 910-0830
Boston
14 Willowdale DrMerrimac, MA 01860001 (617) 801-1325
Europe
12 Monti Di VillaRioloLucca Italy
Singapore
28 Simei Street 1#01-13 Singapore 529948
Lean EnterpriseASQ Illiana Section 1213
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Who We Are
Value Innovation Partners, Ltd. was founded by a group of business practitioners with offices in Boston, Chicago, Lucca Italy and Singapore.
• Professionals with an average of 20 years of industry experience• Clients in all major business sectors• Recognized leaders in Lean Enterprise, Lean Supply Chain, ABC Analysis,
Pharmacovigilance, Six Sigma, Lean Office and Lean Healthcare
• Participate in the analysis and implementation of solutions• Deliver innovative, hands-on, creative approach • Establish long-term relationships
• Quantifiable and sustainable benefits• Transfer critical skills • Improve customer satisfaction, working capital, revenue and processes
ExperienceExperience
ResultsResults
InvolvementInvolvement
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Partial Client ListBiotechsBayer GanedenPharmaceuticalJohnson & Johnson Roche MedevaPfizer Eli Lilly McNeil Pharmacia & Upjohn Parke-Davis Wyeth Bayer AllerganCyberonicsFood & Beverage•Kerry Foods, Ltd. •Parco Foods •Frito Lay •Flying FoodsEducationMerrimac College LormanIIE NQA APICS
Medical DevicesBBraunMedtronic, Inc. Innovative Surgical Products FabConJohnson & Johnson Ethicon, Inc Cochlear, Inc. ManufacturingDentsplyAvery Dennison Films Avery Dennison Fasteners Oleo International ICI DuluxMuntersM/A-Com Automotive/ElectronicsHorton, Inc DG Obrien Multina, Inc. AssociationsAssociation for Manufacturing Excellence Institute of Industrial Engineers Northern Illinois Quality Conference National Manufacturing Association American Society for Quality
Building Products•ICI Dulux•Avery Dennison •James HardyDistribution•Avery Dennison STD •Graphic Packaging Print/PackagingAvery Dennison Graphic Packaging CCL Labels Keller Crescent Cardinal Health, Inc. Oil & GasChevron Texaco ServiceUnderwriters Laboratory Rail and MarineTrinity Industries
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Patrick Lucansky, CSSMBB, CLS, MBA, CMC, BBA
• BIO:Mr. Patrick Lucansky is an Executive Director of Value Innovation Partners, Ltd. and the Midwest President of AME. Mr. Lucansky has held a variety of positions in the past including Production Manager and Director of Operations. He holds a BBA from the University of Iowa, an MBA from Illinois Institute of Technology, a CMC from Institute of Management Consultants and Teaches at the BA/MBA level in the Chicago area. He is a Certified Lean Sensei and a Certified Six Sigma Master Black Belt. Mr. Lucansky has co-authored dozens of articles published in International journals and has presented on many Lean topics to IIE, AME, ASQ, Lincoln Foundation, NAM, NIQC, & IMC.
How to contact pat• Email [email protected]• Phone 847-910-0830
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AGENDA
• Lean overview
• Tools and techniques
• Case studies
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EVOLUTION OF LEAN
TQC
EmployeeInvolvement
TQM
Waste Elimination
Supplier DevelopmentJIT
Competitive Product & Services(DFM/A; Concurrent Engineering: Innovation)
Cost Management
Structured Management Approach(Vision; Goals; Strategy; Measurements)
Business Process Re-Engineering
(ABC)
WORLDCLASSMFG
LEANENTERPRISE
BPM
1970's 1980's 1990's 2000's
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The Origins of the Lean Approach
Lean Manufacturing – Total Employee Involvement
– responsibility & accountability– line stop authority
– Total Quality Ethic– quality at source, right first time– customers + suppliers =
partnerships – Poka Yoke or fail-safing
– Elimination of Waste– cellular layout– set up and lead-time reduction
– Kaizen or Continuous Improvement– Simplify, Integrate, Automate
TotalQualityEthic
Total Employee
Involvement
Eliminationof Waste
EffectiveManagement
LEANENTERPRISE
Lean Basics
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Lean Approach• Positive, clear communications.• Ensure “no-blame” culture.• Work through cross functional teams.• Staff involvement at every stage.• Process maps on display for comments.• Remove non-value added steps, hand-off`s, rework loops.• Agree design principles with All. • Fix the root cause not the symptom.• Ensure solution supports departmental interfaces.• Incorporate Continuous Improvement
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The Definition of Lean EnterpriseA Group of individuals, functions, and sometimes legally separate but operationally synchronized organizations. The value stream defines the Lean Enterprise. The objectives of the Lean Enterprise are to:
• correctly identify and specify “value to the ultimate customer / consumer” in all its products and services
• analyze and focus the value stream so that it does everything form product development and production to sales and service in a way that activities that do not create value are removed and actions that do create value proceed in a continuous flow as pulled by the customer.
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The Definition of Lean Production
“Lean production is “lean” because it uses less of everything compared with mass production: half the human effort in the factory, half the factory space, half the investment in tools, half the engineering hours to develop a new product in half the time. Also it requires far less than half of the needed inventory on site. Results in fewer defects, and produces a greater and ever growing variety of products.”
John Krafcik: The Machine that Changed the World
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THE GOAL…
QUALITY
DELIGHTING THE CUSTOMER
CONTINUOUS &RAPID IMPROVEMENT
COSTSERVICE
LEADTIMEFLEXIBILITY
through
in
& INNOVATION
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Lean Will Take You…
From• Push or MRP based execution• Thinking as a Functional
Organization• Long lead times (weeks)• Large inventories (months)• Increased space needs• High concentration of Low Value
Activities
To
• Pull or build to order• Thinking as a Process or Team
Based Organization• Short lead times (days)• Small inventories (weeks)• Optimal space utilization• Minimal concentration of Low
Value Activities
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AGENDA
• Lean overview
• Tools and Techniques
• Case studies
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Lean concepts include many disciplines
STATISTICALPROCESSCONTROL
ENLIGHTENED PHILOSOPHY OF
WORK
STATISTICAL PROCESS CONTROL
SMED
TPM JIT
VISIONARY&
SUPPORTIVELEADERSHIP
CONSENSUSDECISION
MAKING AT ALLLEVELS
KANBANEMPOWERED,WELL-
TRAINEDEMPLOYEES
CONCURRENT ENGINEERING
ONE-BY-ONE FLOW
POKA-YOKE
KAIZEN
DOE
TQM
PROCESS REENGINEERING
CELLULAR MFG
Six Sigma
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PEOPLE
TYPESOF
WASTE
Processing
Motion
Waiting
FixingDefects
Making TooMuch
MovingThings
Inventory
QU
ALITY
QUANTITY
TAIICHI OHNO, ARCHITECT OF THE TOYOTA PRODUCTION SYSTEM
Lean Operations: Means Identifying & Eliminating Waste
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Lean Solutions are Achieved Through…
Automating………. Utilizing IT functionality and connectivity
Simplifying……………………...Processes
Integrating…………....…Across Organizations
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BENEFITS TO THE BUSINESS
SPACE
INVENTORY
QUALITY
UNIT COSTS
LEAD TIME
Increased Worker Motivation
Improved Industrial Relations
Improved Customer Service
Improved Market Responsiveness
50%
50-90%300- 400%
30%
95%$$$
100% On TimeEvery Time
RECOGNITION / AWARDS
For Rent
50%
Absenteeism
X
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LEAN OBJECTIVE
. . . A Continuous & Rapid Flowof Value Added Activities
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WASTE
that delivers NO Value to the Customer. . . Any Resource consuming Activity
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The analysis and redesign requires a clear understanding of…Value Added, Non Value Added, and Sustaining Activities
The value related attribute of an activitycan only be assessed in the context of the process, never in isolation–Considering other activities upstream and downstream
Value Added activities are those absolutelynecessary to deliver the customer’s requirements–These are colored green on the flowcharts–They are later re-designed into the new process
Non Value Added activities are those that are not necessary to deliver the customer’s requirements and can be eliminated in the re-design–These are colored red on the flowcharts
Sustaining activities are those that are not necessary to deliver the customer’s requirements but are either: –absolutely necessary to sustain the business or:–cannot be eliminated due to known severe constraints (often external)
–These are colored blue on the flowcharts–They are later re-designed into the new process
Sustaining activities are targeted for gradual elimination during the Continuous Improvement process
NVAVA SNVA
VANVA
Sustaining Activities
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Necessaryto Produce
Output?
Adds Valueto Customer?
Non-ValueAddedSustainingCustomer
Value Added
YesYes
No
NoYes
ActivityActivity
No
Review & ApprovalReworkFilingCopyingReconciliation
Agree SpecificationsManufacturing
VA SNVA NVA
Contributesto Business
Effectiveness?
PayrollTestingDevelopment ActivityBack-up Data BaseChangeoversRegulatory
How to Determine VA/NVA/SNVA?
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Approaches to Improvement
Accept Imposed QualityRequirements
LEAN APPROACH
Focus on the 95%Non-Value AddedResources Through . . .
• Total Quality Control
• Total WasteElimination
• Enforced ProblemSolving
• Total Involvement
Challenge/Reduce the Need forImposed Quality Requirements
TRADITIONAL APPROACHFocus on Value AddedResources through . . .
• Time Study• Work Study• Piecework• Utilization• Automation
5%95%
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Lead Time Analysis. . . Office Processes
TYPICALLY . . . 75% PLUS OF LEAD TIMES ARE NON-VALUE ADDED
NON-VALUE ADD
- Corrections
- Filing
- Retrieving
- Recording
- Reconciliation
- Sorting
- Copying
- Etc
- Counting
- Tracking
VALUE ADD
- Purpose25%
75%
$BIN
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Which of These Add Value?
Please Please IndicateIndicate:
VA
NVA
MRP
Planning Purchasing Suppliers
Expediting
GRN’sReceiving
Inspection
Materials Handling
Stores/ Kitting
Manufacturing
Direct Operator
WIPSupervision
ConveyorsRobot
Automated Warehouse
Distribution
Customers
CAD System
Production Engineering
Accounts
Shop Floor Data Collection
Management
Start
End
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TODAY'S BUSINESS is . . . Organized along Functional Lines
LEADS TO A MAJOR PROBLEM . . .
ISLANDS OF LEAD TIME !
Marketing Finance Engineering HR Production Cust-Service Sales
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What is a Process?
?
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We’ve taken a simple process...
Supplier CustomerPRODUCE SHIPASSEMBLERECEIVE
Basically…
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. . . & Complicated it!
FUNCTIONAL MEASURES
• Efficiencies• Finance Related
• Utilization• Variances
OperationsPurchasing Finance& Admin
Sales &Marketing
Design &Develop Quality Customer
Service
DEPARTMENTAL BARRIERS
SYSTEMS BARRIERS
CustomerOrder
CustomerDelivery
• Bureaucracy• Delays
• Island of Autonomy• Aligned to Functions
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KEY PROCESS IMPROVEMENT
ELIMINATE NON-VALUE ADDED ACTIVITIESTARGET IS A PROCESS CONSISTING OF ONLY
VALUE ADDED ACTIVITIES
IDEAL PROCESS
VAVAVA VA VA VAVANVA NVA NVA NVA NVA NVACURRENT PROCESS
VA = VALUE ADDED ACTIVITIESNVA = NON-VALUE ADDED ACTIVITIES
VANVA
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x\x\
BUSYNESsQALITY IS OUR
Q
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LEAN TOTAL QUALITY. . . Techniques in Manufacturing
RIGHT FIRST TIME
POKA YOKE
TOTAL PRODUCTIVE MAINTENANCE (TPM)
MANAGEMENT BY SIGHT- the Visual work place- Quality Charts- SPC
WORKPLACE ENVIRONMENT
DETECTION, CORRECTION & PREVENTION- Cause & Effect- Structured Analysis and Control of Variables- Pareto Analysis
. . . ALL REQUIRE A COMMITMENT TO WASTE ELIMINATION& TOTAL EMPLOYEE INVOVEMENT
. . . ALL REQUIRE A COMMITMENT TO WASTE ELIMINATION& TOTAL EMPLOYEE INVOVEMENT
THE GOAL
To Delight the Customer withthe Quality of our Product or
Service
THE GOAL
To Delight the Customer withthe Quality of our Product or
Service
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QUALITY AT SOURCEQUALITY AT SOURCE
THE SOURCE OF GOOD QUALITY LIES IN PREVENTION . . . . through :-
•PRODUCT DESIGN
•PROCESSES
•MATERIALS
•PEOPLE
. . . NOT IN INSPECTION & CORRECTION
MAKE IT RIGHT FIRST TIME, EVERY TIME
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Everyone must have ownership of quality
End
Self
Source
Towards Lean ‘Inspection’
Successive
Type of ‘inspection’
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FINISHED FILES ARE THE RESULT OF YEARS OF SCIENTIFIC STUDY COMBINED WITH THEEXPERIENCE
OF MANY YEARS.
How many F’s are there?
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FINISHED FILES ARE THE RE -
SULT OF YEARS OF SCIENTIF -
IC STUDY COMBINED WITH THE
EXPERIENCE OF MANY YEARS.
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Daily PreventionDaily Prevention MeasurementMeasurement VaccinationVaccination
Increase Manufacturing Reliability Through TPM
Early equipment
maintenance
Early equipment
maintenance
Establish a system of autonomous
maintenance to be performed by
operators.
Establish a system of autonomous
maintenance to be performed by
operators.
Create a planned maintenance program for the maintenance
department.
Create a planned maintenance program for the maintenance
department.Training courses to increase skills
of workers.
Training courses to increase skills
of workers.Improving equipment
effectiveness
Improving equipment
effectiveness
Routine Service Lubricate Clean Adjust Inspect
Monitoring & Prediction
Timely PreventativeMaintenance
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A SAFE, CLEAN, TIDY ENVIRONMENTHELPS PREVENT PROBLEMS
A SAFE, CLEAN, TIDY ENVIRONMENTHELPS PREVENT PROBLEMS
• THE ABILITY TO SEE WHERE THINGS ARE GOING WRONG• Constantly updated charts• Using SPC for Critical measures
• SPC - THE WORLD CLASS APPROACH• Simple• Easy to Understand• Train employees in its use• Empowerment
• EVERYTHNG IN ITS PLACE• Equipment• Materials• Paperwork• Clearly labeled, owned and accountability assigned.
MANAGEMENT BY SIGHT
Pareto Analysis
Cause & Effect
SPC Charts
Taguchi
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QUALITY AT SOURCE. . . Employee Involvement
. . . PEOPLE ARE THE KEY TO TOTAL QUALITY MANAGEMENT. . . PEOPLE ARE THE KEY TO
TOTAL QUALITY MANAGEMENT
RESPONSIBILITY
AUTHORITY
SKILLS
TEAMWORK
Total QualityControl
EmployeeInvolvement
TOTALQUALITY
MANAGEMENT+ =PRINCIPLES &
TECHNIQUES- SPC- Cause & Effect- Taguchi- etc
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LEAN OPERATIONS. . . is extremely Intolerant of Failure!
. . . FAILURE OF
SUPPLIERS TO SUPPLY
PEOPLE TO PERFORM
EQUIPMENT TO WORK
. . . VARIABILITY, NOT LEVEL OF PERFORMANCE IS THE ISSUE
TECHNIQUES GET YOU THEREPRINCIPLES KEEP YOU THERETECHNIQUES GET YOU THEREPRINCIPLES KEEP YOU THERE
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If We Do Nothing. . .We Cannot Assume That
The Business Will Stay The Same.
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AGENDA
• Lean overview
• Tools and techniques
• Case studies
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Process Steps
QC Steps
Reg Steps
S&DS Steps
Total Steps
Error Loops, F/U's & Cosuspect
Total Steps
Report Type
Process structure
US-CT 47 11 29 0 87 17 104 15 day IND ParallelNon US-CT 35 11 22 0 68 9 77 15 day IND ParallelNon US-Spont 32 13 21 19 85 45 130 15 day NDA ParallelUS-Spont 79 12 21 19 131 35 166 Spont Sequentia
477
Example – Pharmacovigilance Process
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Actual redesigned process
Process Steps
QC Steps
Reg Steps
S&DS Steps
Total Steps
Error Loops, F/U's & Cosuspect
Total Steps NVA VA SNVA
All 17 0 0 0 17 0 17 0 8 9
Example - Pharmacovigilance
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• 4560 cases times .5 miles/case = 2780 miles traveled/year.
• The distances result in increases in:
• lead times• batching• process
delays
MD MD
MD
MDAdmin Temp
Admin
Admin
MD
MDTemp
Temp
Regulatory
Data Mgt
Corp
FilesFDA
2nd Floor
1st Floor
Garden Level
While, the current layout leads to a case travelling about 1/2 mile from case receipt to submissionWhile, the current layout leads to a case travelling about 1/2 mile from case receipt to submission
Example – Pharmacovigilance
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Serious Case Path Sequence
1. Receive case by fax and sentto hub-bin
2. Initial Triage of case and place in appropriate hub-bin
3. Assessment and data entry4. Submission and printing of
required documents5. File Pending awaiting further
action6. File Archive awaiting further
action7. Offsite storage
DSS
DSC
Archive FilesArchive Files
Hub-Bin
Faxes FU’s
1
3
4
6
5
Off-sitestorage7
Distance traveled reduced by 96%
Approx. 100 ft/case2
Example - Pharmacovigilance
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• Case travel distances will be reduced
• Internal data entry will reduce lead-times and work in process
Source:Client Process Mapsincludes rework loops
Number of process steps and hand-offs
NVA78%
VA3%
SNVA19X%
104
15
0
20
40
60
80
100
120
140
160
180
Non Us-CT
1025
Pilot
SNVA55%
VA
45%
Before
Pilot
76%After
Steps
Handoffs
The “centrally approved” Pilot case handling process is simpler, with fewer steps and less hand off’s The “centrally approved” Pilot case handling process is simpler, with fewer steps and less hand off’s
Example - Pharmacovigilance
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DefinitionsBottleneck Any resource whose capacity is equal to, or less than the demand placed on it.
Kaizen Continuous improvement through incremental improvements. [Same as Process Kaizen]
Muda Any human activity which absorbs resources, but creates no real value. [See Non-Value Added, Waste]
Non-Value Added Activities or actions taken that add no real value to the product or service, making such activities or action a form of waste.
Process The flow of material in time and space. The accumulation of sub-processes, or operations that transform material from raw material to finished products.
Quick Changeover The ability to change tooling and fixtures rapidly (usually minutes), so multiple products can be run on the same machine.
Right-size Matching tooling and equipment to the job and space requirements of lean production.
Sensi An outside master or teacher that assists in implementing lean practices.
Single Minute Exchange of Dies (SMED) The reduction in die set-up time. Set-up in a single minute is not required, but used as a reference.
Standard Work Specifying tasks to the best way to get the job done in the amount of time available while ensuring the job is done right the first time, every time.
Takt Time Daily production number required to meet orders in hand divided into the number of working hours in the day.
Theory of Constraints (TOC) A lean management philosophy that stresses removal of constraints to increase throughput while decreasing inventory and operating expenses.
Throughput The rate the system generates money through sales.
Value Added Activities or actions taken that add real value to the product or service. [See Non-Value Added]
Value Stream The set of specific actions required to bring a specific product through three critical management tasks of any business: Problem-solving, Informationmanagement and physical transformation.
Visual Controls Displaying the status of an activity so every employee can see it and take appropriate action.
Waste Anything that uses resources, but does not add real value to the product or service.
Yield Produced product related to scheduled product.
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Thank You for Your Participation
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