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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

All rights reserved VIPGroup 2014

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


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


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


AGENDA

• Lean overview

• Tools and techniques

• Case studies


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


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


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


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.


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


THE GOAL…

QUALITY

DELIGHTING THE CUSTOMER

CONTINUOUS &RAPID IMPROVEMENT

COSTSERVICE

LEADTIMEFLEXIBILITY

through

in

& INNOVATION


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


AGENDA

• Lean overview

• Tools and Techniques

• Case studies


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


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


Lean Solutions are Achieved Through…

Automating………. Utilizing IT functionality and connectivity

Simplifying……………………...Processes

Integrating…………....…Across Organizations


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


LEAN OBJECTIVE

. . . A Continuous & Rapid Flowof Value Added Activities


WASTE

that delivers NO Value to the Customer. . . Any Resource consuming Activity


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


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?


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%


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


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


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


What is a Process?

?


We’ve taken a simple process...

Supplier CustomerPRODUCE SHIPASSEMBLERECEIVE

Basically…


. . . & 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


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


x\x\

BUSYNESsQALITY IS OUR

Q


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


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


Everyone must have ownership of quality

End

Self

Source

Towards Lean ‘Inspection’

Successive

Type of ‘inspection’


FINISHED FILES ARE THE RESULT OF YEARS OF SCIENTIFIC STUDY COMBINED WITH THEEXPERIENCE

OF MANY YEARS.

How many F’s are there?


FINISHED FILES ARE THE RE -

SULT OF YEARS OF SCIENTIF -

IC STUDY COMBINED WITH THE

EXPERIENCE OF MANY YEARS.


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


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


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


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


If We Do Nothing. . .We Cannot Assume That

The Business Will Stay The Same.


AGENDA

• Lean overview

• Tools and techniques

• Case studies


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


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


• 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


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



• 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



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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