Using the DMAIC Process to Direct the Sequencing of Lean/Six Sigma Tools for Successful Project Outcomes

Jim Ellis Certified Master Black Belt J&J Process Excellence Director – US Sales Strategic Accounts [email protected] Intent:

The purpose of this presentation is to share with the attendees my experience over the past 5 years using the DMAIC Process how to determine what Lean and/or 6 Sigma tools is the best to use when for assuring successful outcomes of your projects.

Learning Objectives: 1.) Clear understanding of DAMIC Process 2.) Clear understanding of which common Lean and 6 Sigma Tools are best used in what stage of DMAIC 3.) Clear understanding of how to assess success for a project and know if you have achieved it.

After Attending the attendees will: 1.) Know what the DMAIC process is and how it is applied in project planning 2.) Understand which Lean and 6 Sigma tools are used in what sequence to assure successful project outcomes

Declining Resources $29.9 Space Vacancy Capital Funds billion Skilled Labor Rates Medicare/Medicaid Reimbursement Laboratory Techs 5.9% Shortfall Imaging Techs 5.9% Pharmacists 8.1% RNs 8.1%

Inpatient Admissions2 ED Visits2

Volume New Technology Market Pressures

“I need to transform my lab!”

Why?

• 2X Volume

• ½ the Labor

• ½ the Skill

• ½ the Reimbursement

• New Medical Content

“Help Me!”

• Testing thru-put (TAT) reduced by 50%

• Productivity improvement >40% (Billables per FTE)

• Labor hrs per 24 hrs reduced by >40%

• Cost reduction at 28%

• Space savings of >30%

• Standardized work practices

• Reduction in Errors and Error Potential

• Improved Customer Satisfaction

• Elimination of excess unused inventory

• Elimination of visual noise

• 100% cross-training of staff

• Improved Employee Job Satisfaction

• Current State • DOE • 5 S • Value Stream • DMADVV • Kano • Muda • DMAIC • DESIGN EXCELLENCE • Stakeholders • Null • FMEA • Fishbone • Future State • CTQ • LEAN • DMAIC • Affinity • Push/Pull • Pareto • Regression • Flow • 6 SIGMA • Mistake Proofing • Y=f(x) • Charter • VOC • Kaizen • Gauge R&R • SIPOC

Improve an Create a New Create a New Existing Process Product Process

• DMAIIC • DMADVV • DESIGN EXCELLENCE Define Measure I See Analyze Innovative Improvement What I will do & How it compares Control

How I will make it last

• Charter Document

• Business Case

• Gathering the Voice of the Customer (VOC)

• Defining Success – measureable and time bound

• Stakeholder commitment

• High level Current Process map – the SIPOC

© 2008 Ortho Clinical Diagnostics Title: Process Improvement Opportunity for XYZ Distribution Center resulting in reduced labor costs, reduced packing costs, Define reduced customer defects, and reduced square footage.

Phase - Problem Statement: Today XYZ is spending too much on labor, packaging and storage for its products at its main distribution center. Also, end user Charter customer defects are too high. Improvements must be made within the next 12 months.

Rev: 09/02/08 Stakeholder approval 9/02/08

Scope: XYZ Products, from order entry to unpacked and receipted into customer’s inventory. Includes up stream into Marketing and Product specifications.

Duration: Immediate through next 12 months

Key Stakeholders: VP’s, CFO’s, Line Managers, HR

Steering Team: To Be Named and type and frequency of communications to be determined following first month of work.

Project Teams: List all functioning team s

Goals: 1.) Reduce labor hours needed in picking and packing process from Current State for both domestic & international. 2.) Reduce packaging total costs (cartons, corrugate, gel card staging & obsolescence) from Current State. 3.) Reduce end-user customer defects from Current State. 4.) Reduce square footage (footprint).

Resources Needed: Work this out for all resources needed

Expense Funds: Detail out and get approval

Methodology: PE – Lean primarily following a DM AIIC roadm ap with use of Value Streams for documenting Current and Future States.

Success Defined: At the end of the 12 months time, XYZ Corp. is delighted with the transferable, replicable process improvements from the project that have substantially reduced the amount of labor hours needed to perform the process, substantially reduced the cost of the packaging used in the process, substantially reduced the number of end user defects produced by the improved process and substantially reduced the square footage to store products. Magnitude of improvement for each of the 4 Goals is expected to be at least 20% . Environmental Impact: Improvements consistent with movement towards “Green”

DMAIIC High Level Project Plan 8/1/08 9/1/08 10/1/08 1/1/09 4/1/09 6/1/09

Charter Bus Case Project Plan Control Charts Generate SIPOC Process Map FMEA Possible Control Charts VOC Deployment Affinity Diagram Solutions Flowchart Control Plan CTQ’S Casual Tree Diagram Prior Matrix Value Streams Implement Plan Team Regression/DOE Pilot / 5 S Stakeholders Prior. CTQ’s

Define Measure Analyze Inn. Impr. Control

VOC Process Pred. Equation Implement Sustain the Gain Capability Solution

NEED ------DRIVERS ------CTQ’S

Demand Units Shipped per 24 hrs

1 of 4 Goals

Reduce Sq. Inventory Req. Total Units Required including safety stock/24 hrs Footage of Products in Warehouse by at least 20%

Footprint of Product Cubic ft/SKU

SS II PP OO CC

Physicians Offices Booking Admission Physicians Information / Date Physicians Patients Estimated Discharge Discharged Patient Patients Date Insurance Co.

Insurance Co. Special Discharge Nurses Needs Nurses Case Manager

Case Manager Social Worker

Social Worker Senior Management

Physician’s Nursing MD discuss MD issues Case Manager Decision to Completes Patient is Discharge Discharge and Social Worker Discharge makes discharge Discharge Discharged With Patient Order arrangements Patient Instructions

• Charter Document

• Business Case

• Gathering the Voice of the Customer (VOC)

• Defining Success – measureable and time bound

• Stakeholder commitment

• High level Current Process map – the SIPOC

• Value Stream

• Process Map

• Data Collection Plan – how much is enough?

• Is Current State in Control? – Control Charts

• Is Current State Capable? – Specs (VOC) vs. Control Limits

• Funneling – the trivial many X’s – FMEA

Ref “Learning to See” Rother & Shook

Hotel Check-out Process Process Name

• Activity flowcharts are 1 2 YES Is there 3 Approach front desk Wait specific about what a line? Clear direction of happens in a process. NO flow (top to bottom or Numbered 4 They often capture steps Step up to desk left to right) decision points, rework

5 loops, complexity, etc. Clerk NO available? 6 Wait Key of symbols YES

7 Consistent Give room number Start/End level of detail Action/Task 8 Check bill

Decision

9 Charges NO 10 Sequence correct? Correct charges

People or groups listed across the top Invoicing Process

Sales Billing Shipping Customer Elapsed •Deployment flowcharts Time show the detailed steps in a Steps listed in 1 Time flows Delivers goods process and which people column of person or down the

group doing step or 2 8 page or groups are involved in Notifies sales of Receives in charge completed delivery delivery each step. 5 days 9 3 Records receipt and Sends invoice to claims against this •They are particularly useful customer delivery 10 days

4 10 in processes that involve Notifies billing Receives invoice the flow of information of invoice 11 5 Checks invoice between people or Files invoice against receipt functions, as they help 12 highlight handoff areas. Pays bill

6 Receives and records payment Horizontal lines

7 clearly identify Reviews weekly handoffs report of overdue accounts

Being clear about your question will help you make sure you collect the right data.

Data Operational Definition and Procedures What Measure How Related Sampling How/where type/ Data measured1 conditions to notes recorded (attach type record2 form)

Recording what data you are going to collect reminds you what you want to An operational definition defines accomplish. exactly how you will go about Noting the type of data collecting and recording the data. helps you decide how you should analyze the data. © 2008 Ortho Clinical Diagnostics Measure: Control Chart Features (In Control?)

Basic features same as a time plot 100 UCL 90 80 70 60 50 40 30 20 LCL 10 0 JASONDJFMAMJJASONDJFM

On Target and Target Capable of Meeting Customer Needs

Lower Upper Spec. Spec.

Not Capable Even if On Target Target Target too many Defects on both ends Lower Upper Spec. Spec. Lower Upper Off Target but Spec. Spec. Otherwise Capable if a small % of Defects is acceptable

• FMEA identified 3-5 Input Variables that were causing the majority of the concerns within the process

Input X's from In what ways might the What is the effect of each How can the failure occur? What are the existing controls and Process Map process potentially fail to failure mode on the outputs Describe in terms of something procedures (inspection and test) that meet the process and/or customer requirements? that can be corrected or either prevent failure mode from requirements and/or design The customer could be the next controlled. Be specific. Try occurring or detect the failure should intent? operation, subsequent identify the causes that directly it occur? Should include an SOP operations, another division or impacts the failure mode, i.e., root number. the end user. causes. SEV x OCC x DET How often does the cause or or cause the does often How failure mode occur? How well can you detect FM? or cause How Severe is the effect to the to the effect the is Severe How cusotmer? Not Global Not look at all parameters Departments cannots Process to obtain feedback None of the process that might improve process to have an only focuses on one part of the effect customer impact to customer 9 process from lead to audit, 9 9 729 satisfaction ratiing satisfaction thus data is not global.

Subjective Vs. Inaccurate data In ability to impact Not a universal or objective None Objective satisfaction 9 measurement system 9 9 729

BIAS Inaccurate Data Collected Cannot improve process Not collected by 3rd party; None Results impacted by current 9 system operations, such as 9 9 729 uptime Not understood Not clear on the process minimal impact to No proper explanation of the Review with internal customer of by the customer satisfaction 5 process 5 data 5 125

Measurement Not measuremd Do not know impact Lack of interval established None Interval consistently 5 5 5 125

No Standardized Inconsistent data Inaccurative corrective Different resources using None Measurement actions 2 different collecton collection 2 28 tool methods

Alignment to Not relevent to Not relevent to organizatoins No alignment None Strategic organizations goals goals 2 2 28 Imperiaives NPS Incldued/not included Not included in satisfaction Incorporate into rating None rating 1 1 11

Total 2454

• FMEA identified 3-5 Input Variables that were causing the majority of the concerns within

the process How often does or does not occur Severity Ranking

90% Highest probability does not occur 9

Input X's from In what ways might the What is the effect of each How can the failure occur? What are the existing controls and 50% Moderate probability it does not occur 5 Process Map process potentially fail to failure mode on the outputs Describe in terms of something procedures (inspection and test) that meet the process and/or customer requirements? that can be corrected or either prevent failure mode from requirements and/or design The customer could be the next 10% controlled. Be specific. Try Lowoccurring probability or detect it does the failure not shouldoccur 1 intent? operation, subsequent identify the causes that directly it occur? Should include an SOP operations, another division or impacts the failure mode, i.e., root number. the end user. causes. SEV x OCC xDET How well can you detect you detect can well How FM? or cause How Severe is the effect to the theeffect is Severe How cusotmer? or cause the does often How occur? mode failure Not Global Not look at all parameters Departments cannots Process to obtain feedback None of the process that might improve process to have an only focuses on one part of the effect customer impact to customerProbability of9 failureenGen process from lead to 9 Occurrence 9729 Ranking satisfaction ratiing satisfaction audit, thus data is not global. 90% High probability of failure most of the time 9 Subjective Vs. Inaccurate data In ability to impact Not a universal or objective None Objective satisfaction measurement system 50%9 Moderate9 probability of failure most of the time9729 5

BIAS Inaccurate Data Collected Cannot improve process Not collected by 3rd party; None 10% Results impacted by current Low probability of failure most of the time 1 9 system operations, such as 9 9729 uptime Not understood Not clear on the process minimal impact to No proper explanation of the Review with internal customer of by the customer satisfaction 5 process 5 data 5125

Measurement Not measuremd Do not know impact Lack of interval established None Interval consistently 5 5 5125 Detection Detection Ranking No Standardized Inconsistent data Inaccurative corrective Different resources using None Measurement actions 2 different collecton collection 2 28 90% tool methods Highly likely will not detect 9

Alignment to Not relevent to Not relevent to organizatoins 50% No alignment ModeratelyNone likely will not detect 5 Strategic organizations goals goals 2 2 28 Imperiaives 10% Low probability it will not detect 1 NPS Incldued/not included Not included in satisfaction Incorporate into rating None rating 1 1 11

Total 2454

• Value Stream

• Process Map

• Data Collection Plan – how much is enough?

• Is Current State in Control? – Control Charts

• Is Current State Capable? – Specs (VOC) vs. Control Limits

• Funneling – the trivial many X’s – FMEA

• The “Holy Grail” – the predictable equation – Y=f(x1, x2,…xn)

• Root Cause Identified

• Fishbone Diagram

• Regression Analysis

• Design of Experiments (DOE)

Cause-and-Effect Diagram

Not Global Strategic Subjective Vs. Bias Imperatives Objective

Not Measurable

Not understood NPS No Standardized Measurement Interv al by customer Measurement

4-AM Skills 3-Mktng. 2-Sales 1B-Mngm't 1A-Org. & Programs Training Practices Structure J. Ellis Inability to flex with product Attributes 5/12/2003 Simple & Easy & Tools Instr Skills Lack of alignment with life cycle stages & portfolio product life cycle stages Time in The Dept. Territory Std & Proff # of Distractions that take Stability of territory boundaries Funds AM from Gr 3 Selling Ability to build Eff. Sales Tools Capacity Base vs. Gr 3 Ability to remove sales trusting Org Structure Not built on a process for effective "Right" Ones barriers to making it easy to relationship MARS Specific Gr 3 selling Opt for Funnel Movement convert quickly Courses Eff. Mktng. Not conducive for Team Alignment of Goals Programs Duration & Selling Demonstrated Timing Aligned with MARS Specific Varied Alignment Not conducive for training mentors historic success Sales Goals Incentive Comp in the field in Gr 3 Exp Center Format Capacity for Requirements & Opportunities Correctly Timed Students Program No one position responsible for the Gr 3 Selling "Right People" execution of a complete Gr 3 sale Measure of AM Input for Gr 3 Quota Wow factor Effectiveness Who & What No separation of groups or Ability to apply SPIN On-the-Job Silo goals vs. goals departments for Gr 3 customers & Strategic Selling Product Portfolio Training aligned with the process vs Base customers Total knowledge of Team Selling & a successful output Follow-up account & competition Effective Management at Mix Ability to Stage Mentoring the territory level for demonstrate to Integra table & Students executing a successful Gr 3 customer a Economies of Scale territory plan Feedback & Metrics Hiring Profile compelling reason to Lack of metrics & SOP's to switch Y Contracting monitor Gr 3 Selling Limited Portfolio Training Static or I know you Cycle time of SME's Evergreen Only by What Others Have each MARS Channel/s Standardized? Told Me By Product OCD too Internal & External What makes Sales Mgmt Available AM Inherited expensive Gr 3 Database Can't do high MARS Mentor Cardinal is Primary volume Happen? AM Format OCD not enough menu Training Relationship Accuracy Sr Sales You Will Be with Dist Rep Frequency of Team Selling Different Contact with Timely /Usable Remove Barriers Adds Capacity Gr 3 during Gr 3 Market Cost per Bill sales cycle After Sales Research Info Monthly Ship Ease of Use Simpler by Territory What I am Internal & External Static or Cycle Time for Contract Doing today Removes Evergreen Group 3 Sale Lack of Inside Mktng Owns is "Right" "distractions" Standardized Rep for AM Batch Operation AM's Working AM Capacity Information Gr 3 Database for Group 3 What's happening in Customer's Minimize Account Usable Sales account Perception Change Identification Integra table $ at AM level to fund No Group 3 Gr 3 promo activities Relationship I'm not paying Metrics in AM's Strategy with Customer anymore place today for each Gr 3 5-AM Account Price vs Cost Available Info in format to share Resources 6-Distribution 7-Information 8-Cust 9-Metrics Expectations

These 10 “branches” were deemed the “Vital Few X’s” since they represented all the © 2008 AffinityOrtho Clinical Groupings Diagnostics and the Top 15 High RPN’s were embedded within the “branches”. Analyze: Regression Analysis Quantifies the Relationship Between X and Y

Regression analysis generates an equation (represented graphically by a line) that quantifies the relationship between X and Y.

Y (output)

012345678910 X (input) The line, or regression equation, is represented as

Y = bo + b1X y = mx + b

BRAINSTORM LIST OF WAYS TO IMPROVE MPG: Change brand of gas Change octane rating Drive slower Tune-up car PROBLEM: Gas prices have been skyrocketing. The fuel Wash and wax car economy of the company car is 20 Buy new tires MPG. Management would like an increase to 30 MPG Change tire pressure

QUESTIONS: How can you “rule in” or “rule out” these possible causes? How would you know if these possible causes act alone or if they interact with any of the others?

•A full factorial involves all possible Std. Factor Factor Factor combinations For 3 factors, each at 2 levels, there are 2 x 2 x 2 = 8 Order 1 2 3 combinations of factor settings 2 x 2 x 2 is often written as 23 The superscript 3 indicates the number of 2’s multiplied 1 – – – together For 3 factors there are 23 = 8 possible combinations 2 + – – of factor settings 3 – + – 4 + + – After I am done with 5 – – + this I should have a Predictable Equation 6 + – + for my Y/Y’s. Be 7 – + + sure to test Predictability! 8 + + +

• The “Holy Grail” – the predictable equation – Y=f(x1, x2,…xn)

• Root Cause Identified

• Fishbone Diagram

• Regression Analysis

• Design of Experiments (DOE)

Improve an Create a New Create a New Existing Process Product Process

• DMAIIC • DMADVV • DESIGN EXCELLENCE Define Measure I See Analyze Innovative Improvement What I will do & How it compares Control

How I will make it last

• Solution Prioritization Matrix

• Effort vs. Impact Graph

• Kaizen on Current State Value Stream to Create Future

• 5S (Sort, Set in Order, Shine, Standardize, Sustain)

• Mistake Proofing

• Flow

• Pilot

• Retest Process Capability

• Revisit FMEA (calculate new RPN’s for improved process)

• Quick and Dirty Techniques: • More Involved Techniques: – Think Like a Kid – Channeling – Challenge the Rules – Anti-Solution (‘Evil – Set a Deadline Twin’) – Get Rid of Excuses –Analogy – Musical Chairs • Alternatives to – SCAMPER – Slice and Dice • Face to Face: – Idea Box – Chain Letter – Brutethink – Billboard

3 5

1 6

4 7 2

Ref “Learning to See” Rother & Shook

g i 10

o 452

f 6

9 78

o 3 1

Low Impact High

This is a team exercise! Has to be collective alignment of your project team!

Cheap Quick Compat. Cheap to Satisfies Criteria> Implem. Implem. Technol. Operate CTQs Weight> 45 2 1 8SUM Alt. A 1 5 15 9108

Alt. B 5 1751 56

Alt. C 9 1 99 176 Solutions Alternative Alt. D 5 9 55 5120

Pictures of Lean examples:

• 5S (Sort, Store, Shine, Standardize, Sustain)

• Mistake Proofing

• Flow

Take the best solution/s and run a pilot!

On Target and Target Capable of Meeting Customer Needs

Lower Upper Spec. Spec.

Not Capable Even if On Target Target Target too many Defects on both ends Lower Upper Spec. Spec. Lower Upper Off Target but Spec. Spec. Otherwise Capable if a small % of Defects is acceptable

• FMEA identified 3-5 Input Variables that were causing the majority of the concerns within the process

Input X's from In what ways might the What is the effect of each How can the failure occur? What are the existing controls and Process Map process potentially fail to failure mode on the outputs Describe in terms of something procedures (inspection and test) that meet the process and/or customer requirements? that can be corrected or either prevent failure mode from requirements and/or design The customer could be the next controlled. Be specific. Try occurring or detect the failure should Reclassify the intent? operation, subsequent identify the causes that directly it occur? Should include an SOP operations, another division or impacts the failure mode, i.e., root number. the end user. causes. severity, SEV x OCC x DET occurrence, How well can you detect FM? or cause How Severe is the effect to the the is effect Severe How cusotmer? or cause the does often How failure mode occur? Not Global Not look at all parameters Departments cannots Process to obtain feedback None of the process that might improve process to have an only focuses on one part of the and detection effect customer impact to customer 9 process from lead to audit, 9 9 729 satisfaction ratiing satisfaction thus data is not global. ratings with Subjective Vs. Inaccurate data In ability to impact Not a universal or objective None Objective satisfaction 9 measurement system 9 9 729 the new

BIAS Inaccurate Data Collected Cannot improve process Not collected by 3rd party; None improvements Results impacted by current 9 system operations, such as 9 9 729 uptime to get a new, Not understood Not clear on the process minimal impact to No proper explanation of the Review with internal customer of by the customer satisfaction 5 process 5 data 5 125 lower RPN.

Measurement Not measuremd Do not know impact Lack of interval established None Proving that Interval consistently 5 5 5 125

No Standardized Inconsistent data Inaccurative corrective Different resources using None the improved Measurement actions 2 different collecton collection 2 28 tool methods process is Alignment to Not relevent to Not relevent to organizatoins No alignment None Strategic organizations goals goals 2 2 28 quantifiably Imperiaives NPS Incldued/not included Not included in satisfaction Incorporate into rating None better. rating 1 1 11

Total 2454

• A Gantt chart is a diagram that shows the timing, duration, and interrelationship of steps in a plan. See sample below, made in Microsoft Project software:

Rearrange Machine Controls

MAY JUNE ID Task Name 5/31 6/7 6/14 6/21 6/28 1 Redesign Control System

2 Develop new wiring schematic Calvin, Max, Sheryl

3 Conduct Changes Maria 4 Revalidate System Maria 5 Train Operators Calvin 6 Update documentation Team, TBD 7 Develop Training Plan Team, TBD 8 Train operators

• Solution Prioritization Matrix

• Effort vs. Impact Graph

• Kaizen on Current State Value Stream to Create Future

• 5S (Sort, Store, Shine, Standardize, Sustain)

• Mistake Proofing

• Flow

• Pilot

• Retest Process Capability

• Revisit FMEA (calculate new RPN’s for improved process)

Improve an Create a New Create a New Existing Process Product Process

• DMAIIC • DMADVV • DESIGN EXCELLENCE Define Measure I See Analyze Innovative Improvement What I will do & How it compares Control

How I will make it last

• Visual Controls

• Production Metrics

• Audits

• SOP’s

• HR Performance Measures

• Huddles

• Kaizens

Pictures of Lean examples of Visual Control in the Workplace

Rating Scale Guide

Score Description of Score

No apparent attempt to institute/enforce &/or 1 adhere to the principle

Principle has been instituted, but no apparent 2 attempt to enforce or sustain

Principle has been instituted and displays signs 3 of sustainability and enforcement

Principle is being sustained and enforced, and 4 there are positive signs of a plan to track performance

Principle is sustained and enforced. Kaizen 5 events occur frequently.

Main Menu 5S Operations Metrics Supply Chain

Auditor's Checklist

1 WORK SCHEDULE WITHIN HEPATITIS TESTING AREA 2 SCHEMATIC DIAGRAM OF HEPATITIS WORK CELL 3 SCHEMATIC DIAGRAM OF PRODUCT / OPERATOR FLOW 4 SOP OF HEPATITIS WORK CELL OPERATIONS 5 SOP FOR HEPATITIS TESTING AND / OR REPEATS 6 DOCUMENTATION OF PREVENTATIVE MAINTENANCE 7 DOCUMENTATION OF QUALITY CONTROL LOG 8 DOCUMENTATION OF PRODUCTION METRICS 9 EXAMPLE OF "RACK PRINT REPORT/RELEASE" Example of LIS Printout 10 DIGITAL CAMERA

2.1 FLOW

2.1.1 Tubes received into ID testing area are batched according to assay family? Yes No

2.1.2 Defects are being detected and documented throughout the process? - Pre-Analytical Area Yes No

- Analytical Area Yes No

- Post-Analytical Area Yes No Not Applicable

2.1.3 Each person(s) is only working on one process at a time and completing the Yes No process prior to moving to next tube - Flow of Operator adheres to schematic diagram Yes No

2.1.4 Flow of Product adheres to schematic diagram Yes No

2.1.6 VISUAL MANAGEMENT CONTROL 2.1.6.1 Are tubes presented visually for processing? Yes No

Is there a specific area designated for the activity above? Yes No 2.1.6.2 Are repeats / defects presented visually for corrective action? Yes No

Is there a specific area designated for the activity above? Yes No 2.1.6.3 Are tubes presented vis ually for cold storage racking? Yes No Is there a specific area designated for the activity above? Yes No

Quest - St. Louis, MO Section 5: Integrated Supply Chain

5.1 VISUAL MANAGEMENT CONTROL - 5S RATING 5.1.1 Are supplies and reagents neatly organized and labeled properly? Yes No 2

5.1.2 Is there method standardization for storing and stocking of supplies and Yes No reagents? 2

5.1.3 Evidence of Re-Order points and/or Kanban cards? Yes No 1

5.1.4 Evidence of Product Stock rotation - FIFO Methodology? Yes No 1

5.1.5 Evidence of Poka-Yoke system for new lots received? Yes No 1

5.1.6 Evidence of Poka-Yoke system for product replenishment at Hepatitis Yes No Not applicable 1 work cell?

Sales Mgm’t SOP’s 1, 2, Field Sales 6, 7, 8, & 9 SOP’s 1 & 8 HR SOP 4 Sales Success

Sales Train. SOP’s 5, 8, Marketing & 9 SOP’s 3, 6, Sales 7, 8, & 9 Admin. SOP’s 7 & 9

• Visual Controls

• Production Metrics

• Audits

• SOP’s

• HR Performance Measures

• Huddles

• Kaizens

Improve an Create a New Create a New Existing Process Product Process

• DMAIIC • DMADVV • DESIGN EXCELLENCE Define Measure I See Analyze Innovative Improvement What I will do & How it compares Control

How I will make it last

Using the DMAIC Process to Direct the Sequencing of Lean/Six Sigma Tools for Successful Project Outcomes

GOOD LUCK!!

Jim Ellis Certified Master Black Belt J&J PE Director – US Sales Strategic Accounts [email protected]