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(9235-LMT-CT) Fundamental Concepts of

LEAN Process Engineering and Their

Application in the Cellular Therapy

Laboratory

October 13, 2013 2:00 PM - 3:30 PM

Event Faculty List

Event Title:

9235-LMT-CT Fundamental Concepts of Lean Process Engineering and their Application in the Cellular Therapy Laboratory

Event Date:

Sunday, October 13, 2013

Event Time:

2:00 PM to 3:30 PM

Director/Moderator Kevin Bundy, BS, MT(ASCP)SBB, CLS Operations Manager Mayo Clinic bundy.kevin@mayo.edu Disclosures: No

Speaker Erin Brach, BSME, BBSS(ASQ) Systems Engineer II Mayo Clinic brach.erin@mayo.edu Disclosures: No

Speaker Suzanne Dworsky, MBA, BS, MT(ASCP) Administrative Director, Clinical Labs Stem Cell Transplantation and Cellular Therapy The University of Texas MD Anderson Cancer Center sdworsky@mdanderson.org Disclosures: No

Fundamental Concepts of LEAN Process Engineering and Their

Application in the Cellular Therapy Laboratory

Erin Brach, BSME, BBSS (ASQ)

Suzanne Dworsky, MBA, BS, MT(ASCP)The University of Texas MD Anderson Cancer Center

Moderator: Kevin Bundy, BB, MT(ASCP)SBBMayo Clinic

What is LEAN?

What is LEAN?

Definition

• Lean is a methodology of seeking out then removing all the various ‘wastes’ that restrict the flow of getting services or products to their intended customer

Types of Waste

• Overproduction• Waiting• Transport• Extra processing• Inventory• Motion• Defects• Mismanagement of Human Resources

Tools to Eliminate Waste

• Error Proofing• Kanban• Process Mapping• Quick Changeover• Shadowing• Spaghetti Map• Red Tagging• Standard Work• Value Added Map• Waste Walk• Visual Control• Clearly defined position/job descriptions

Error Proofing

– Eliminate tasks

– Replace tasks

– Facilitate tasks

Kanban• Signals the need to move supplies or

product through the process– Used to trigger that a process or supply needs

to be replenished.

Kanban

Kanban

Process Maps

• Flow Chart

Quick Changeover

• A method to minimize setup times (switching form one operation or process to the next).– Identify all steps– Differentiate those steps which are internal to the

process and those that could be performed external to the process

– Standardize– Convert internal tasks to external tasks– Standardize external processes– Examples: Equipment changeover or set up

process for a procedure

Shadowing

• A visual control where an outline or shadow of an object is used as a way to indicate where a tool or other object has been removed and where it should be replaced.

Spaghetti Map – Before Improvements

Spaghetti Map – After Improvements

Red Tagging

• An effective visual method used to identify items designated for removal from a work area.

Red Tagging – Cleanup

Standard Work

• Helps to ensure that everyone will be following standard processes and doing the work the same way– Standard written procedures– Training– Communication– Posting information where possible – visual

ques– Making it difficult to deviate

Process Maps – Value Added Maps

Waste Walk

• An exercise to raise staff awareness of the wastes in the practices environment they work in every day.

Visual Control• The art of placing instruction into the workplace so that anyone knows how to do the right things right, how to keep from doing things wrong, and has the information needed to proceed to the next step.

Human Resource Management

• Are people in the right job titles?

• Are people performing tasks related to their competency levels?

• Do position descriptions clearly define roles/core competencies, education/licensure/certification requirements, experience requirements, working conditions, and physical demands?

References

• The University of Texas MD Anderson Cancer Center Department of Education and Training, Quality Projects and Tools (2013). Lean Tools. Retrieved from mdanderson intranet.

Case Study #1

Using Lean principles to Optimize the Layout of a Flow Cytometry Area in a 

Cellular Therapy Laboratory

Types of Waste

• Overproduction

• Waiting

• Transport

• Extra processing

• Inventory

• Motion

• Defects

• Mismanagement of Human Resources

Project Background

• Flow testing performed in 19ft 6in x 14ft 3in space of lab, isolated from main lab

• Two cytometers located in testing area

– Plan to purchase an additional one, needed to find a home for it

• Space not originally designed for flow testing, current layout not ideal

Project Goals

• Design a new layout to accommodate three cytometers and supporting workbenches, equipment

• Improve efficiency for one person working in the space

• Make it easy for two people to work in the space simultaneously

• Make space easily adaptable for future changes 

Assessing Workflow and Layout using Spaghetti Diagrams

• Method to visually see workflow and movements within a work area

• Documented current testing performed on cytometers and additional filing activities

– Direct observation

– Team consensus verified standard workflow

• Started with the specimen entering the process and followed until it left the process

Spaghetti Diagrams

Discoveries from Assessment

• Excessive movement when one person utilizes second cytometer

– Dependent on workload

– Maintenance of first cytometer

• Centrifuge located away from main workbench/cytometer

• Access to the pass‐through via main area only

– Becomes crowded with two people present

– Excessive movement when utilizing second cytometer

List of Considerations for the New Layout

• Workbench/cytometer in close proximity to refrigerator, freezer and centrifuge

• Need to view cytometer(s) from workbench

• Supplies need to be in work area

• Cytometer specific requirements

• Match future layout to natural flow (from pass‐through, to refrigerator, to workbench, to centrifuge, to cytometer)

Designing the New Layout

• Brainstormed ideas using scaled paper models of the room and equipment

• Identified 10+ options for new layout– U‐shape / L‐shape layouts following natural flow of work

• Generated pro’s / con’s list for each option

• Down‐selected to best option for future layout

• Generated 3‐D model to confirm layout details and better illustrate planned future layout

The Selected New Layout

flow

flow

bench low bench

Flow Entrance/Hallway

small

freezer

main ben

chbench‐top

centrifuge

ben

ch

fridge

flow

shelving

The Selected New Layout

Spaghetti Diagrams of New Layout

Feedback on the New Layout

• Favorite changes:– View both instruments at the same time, reducing movement

– New refrigerator with greater on‐hand storage, eliminating  extra trips to auxiliary storage

• Least favorite changes:– Limited walkway when technologists seated at workstations

Successful Completion of Goals

New layout accommodates three cytometersand associated benches/equipment

Improve efficiency for one person working in the work space

Easier for two people to work in the space simultaneously due to two work spaces that can access the pass‐through

Mobile work benches make the area more adaptable for future changes 

Outcomes from the Project

• Space avoidance of approximately 46 ft2

– Space required for third flow cytometer

• Cost avoidance estimated at $54,000 saved

– Estimated difference to remodel the support area versus a larger remodel of the entire laboratory

• Improved efficiency

– Access of pass‐through

– Work area matches workflow needs

Lessons Learned

• Clearly document and communicate requirements with others

• Be flexible with plans and adjust as needed

Additional Resources

• http://www.mayomedicallaboratories.com/education/whitepapers/index.html– “Efficient Laboratory Space Design”

– “Special Coagulation Laboratory Layout Improvements”

• http://www.qualitytrainingportal.com/resources/lean_manufacturing/lean_manufacturing_layouts.html

• http://www.six‐sigma‐material.com/Workcells.html

Many Thanks

• Amy Mohr

• Sarah Wittwer

• Jen Glejf

• Mike Gustafson

• Mike Deeds

• Kevin Bundy

• Dennis Gastineau, MD

• Allan Dietz, PhD

Case Study #2

Staffing to Workload in a Cellular Therapy Laboratory

Types of Waste

• Overproduction

• Waiting

• Transport

• Extra processing

• Inventory

• Motion

• Defects

• Mismanagement of Human Resources

Project Background

• Clinical volumes increasing, expected to continue increasing over the next 1‐2 years

• R&D workload growing and must be supported to advance the future of cellular therapy

• Two clinical technologists lost over 6 month period, need to understand if positions need to be replaced

Project Goals

• Determine if current staffing can cover the workload

• Identify open capacity throughout the week, utilize that capacity to assist R&D

• Develop a tool for the future to help assess staffing levels required as workload changes

Measuring Current Staffing

• Divided lab into three categories: management, R&D and clinical

• Reviewed current staffing schedule to measure available staff for each category

– By day of week and time of day

• Management performs some clinical duties

– Portion of management time assigned to clinical

• “On Call” excluded from model but noted

Measuring Current Workload

• Grouped tasks/processes

– By category (i.e. clinical, R&D, management)

– By work bench

• Aid in analysis of required staffing for each category or work bench

Measuring Current Workload

• Collect process timings and calculate average process time for each activity

• Time study over 4 week period

• Multiple technologists participated in time study

Measuring Current Workload

• Collect volumes

– Retrospectively over eight month period

– By day of week and time of day

– When work available (not necessarily when completed)

Measurements Input into Tool

Graphical Output - Day of Week

Graphical Output - Time of Day

Findings from Analysis

• Current clinical staff cannot cover workload 

– Two clinical replacement positions requested

– Analysis used to support the staffing request

• Specific days/times identified where clinical staff would be available to assist R&D

– Wednesday, Thursday and Friday

– Best times from 10AM ‐ Noon and 3PM ‐ 5PM

Flexibility of the Tool

• Staffing to Workload model built for future staffing analysis and planning

– Workload changes input into the tool and the tool automatically updates to see staffing impact

• Ex: volume increases with rWBC testing or R&D patients

– Use for volume projections

Successful Completion of Goals

Determined current staffing did not cover the workload; this meant that work was “carried‐over” from day to day, overtime was required and management covered the bench more frequently

Identified open capacity throughout the week, shared findings with R&D to aid in future planning

Developed a tool that can be updated in the future to help assess staffing levels required as workload changes

Lessons Learned

• Make sure to include the following when calculating staffing needs:

– Planned time away (i.e. PTO, FMLA, etc.)

– Indirect work such as process improvement projects or continuing education

• Identify when work is available, not when it is currently performed

Additional Resources

• http://www.mayomedicallaboratories.com/education/whitepapers/index.html

– “Staffing to Workload: How to use Indirect Work to Avoid Hiring More FTE and Meet the Demand”

Many Thanks

• Courtney Liwski

• Jason Fohr

• Dave Majewski

• Doug Padley

• Adam Armstrong

• Kevin Bundy