1. Lean Six Sigma in
Laboratory Management Systems
Arta Doci

2. Agenda
a) Plan
• 9 Step Process
a) Do – Execute Plan
b) Study
• Execute follow-up plan
• Is outcome acceptable to Standardize?
a) Act - Establish Standard Process
Laboratory Information Management
Systems
1
Case Studies3
Framework - Process Methodology2
a) What is LIMS?
b) What is Workflow?
• Sequential Workflows
• State Machine Workflows
a) Why Workflow analysis and optimization?
a) Assess Microbiology System
b) Redesigning workflows for LIMS

3. Goals
Use a Systematic Framework for
Implementing Lean Six Sigma Workflow
Analysis in Laboratory Information
Management Systems and:
1.Analyze and improve complex workflow
systems
2.Learn the Lean Six Sigma tools used in
these contexts
3.Learn that the laboratory resulting
analysis will be consistent, accurate, and
impartial

4. Laboratory Information Management Systems

5. What is LIMS?
• LIMS is a system that is designed for the analytical
laboratory and administers samples, acquires and
manipulates data and reports results via a database
• LIMS acts as an environment that interacts with
analytical instruments, laboratory data systems and computer
systems, e.g., chromatography data systems, scientific data
management systems, electronic laboratory notebooks, and
applications outside of the laboratory, e.g., enterprise resource
planning systems.

6. What is LIMS?

7. LIMS Workflow Examples
•Register work requests & schedule work
•Print analytical worksheets
•Monitor and communicate sample/technique backlogs
•Acquire and store analytical data
•Monitor the quality for all analytical work

8. What is Workflow and Benefits?
•Workflows are systems that manage the execution of a business process and
manage the flow of work among individuals, offices, departments, or merge of
different systems with other companies.
•Business processes can be overly complex with multiple paths and complex
routing. Identifying and managing the decisions within a process and
automating those using workflows simplify complex business processes.
•Benefits of Workflows:
– Add efficiencies
– Increase productivity
– Add consistency
– Improve quality by automating and coordinating business processes.
– Help bring together the power of human collaboration with the power of software to
improve communication and task management
– Allow you to route specific tasks to different actors and systems. Therefore, you can
streamline business processes while greatly increasing business efficiency.
– Are good at managing parallel processes or multiple instances of work running at the
same time

9. Sequential workflow
The steps within the workflow execute sequentially,
one after another. A sequential workflow always
progresses forward, never going back to a previous
step.
Example:
LIMS Sample Registration Workflow (Process):
•Add Samples
•Enter Sample Shipping
•Scan Sample
•Select Sample Type
•Enter Sample Receipt Information
•Enter Client / Patient Information
•Assign Samples to Storage

10. State Machine Workflow
Moves from one state to another until the logic concludes the
workflow has completed.
Example:
Defect tracking workflow that tracks defects in Sample Data
Analysis.
When the workflow starts, the defect may be placed in a pending
state, where it waits for an analyst to be assigned to the defect
and begin working on the defect. Thereafter, the analyst starts
working on the defect and fixes it, putting the defect into a fixed
state. When a defect is fixed, a second data analyst reviewer tries
to confirm the resolution. If they find that it was not fixed, they
place the defect back into a pending state. This ability to go back
in time or to a previous state is only available with state machine
workflows.

11. Why Workflow Analysis and Optimization?
• Workflow Analysis and Optimization ensure:
– Maximization of throughput,
– Waste reduction,
– Optimization of turnaround times,
– Efficient resource laboratory utilization,
– Reporting accuracy and efficiency using vast amount of data,
regulatory compliance,
– Adherence to quality standards, dashboards, and streamlining of
processes across company.

12. Framework - Process Methodology

13. 5 Principles of Lean
Continue the cycle until all waste is
eliminated and all activities create value
and quality for the customer
Work to
Perfection
Define Value
From the customer’s perspective, and
express value in terms of a specific
measurement
Map the Value
Stream
Map all the steps, value added, non
value-added, which bring a product or
service to the customer
Est. Flow &
Create Stability
& Predictability
The continuous movement of materials,
services, or information from end to
end through the process
Nothing is worked on by the upstream
process until the customer signals the
need
Implement
Pull

14. What is Lean?
• Create more value for
customers
• Create more value for
customers
• Less human effort
• Less space
• Less capital
• Less time to make products
& services at far less costs &
with much fewer defects
• Less human effort
• Less space
• Less capital
• Less time to make products
& services at far less costs &
with much fewer defects
Maximize customer value
while minimizing waste
A Lean organization
understands customer
value & focuses its key
processes to continuously
increase it
Changes the focus from
optimizing separate
technologies, assets, &
vertical departments (silos)
to optimizing the flow of
products & services
through entire value chain
(horizontal)
• Ultimate goal is to provide
perfect value to the
customer through a perfect
value creation process that
has zero waste
• Ultimate goal is to provide
perfect value to the
customer through a perfect
value creation process that
has zero waste
Companies are able
to respond to
changing customer
desires quickly with
high quality, low
cost, & high
flexibility

15. 5 Principles of Lean
Continue the cycle until all waste is
eliminated and all activities create value
and quality for the customer
Work to
Perfection
Define Value
From the customer’s perspective, and
express value in terms of a specific
measurement
Map the Value
Stream
Map all the steps, value added, non
value-added, which bring a product or
service to the customer
Est. Flow &
Create Stability
& Predictability
The continuous movement of materials,
services, or information from end to
end through the process
Nothing is worked on by the upstream
process until the customer signals the
need
Implement
Pull

16. Plan – Do – Check - Act
Take actions to continually improve
process performance
The “Plan, Do, Check, Act”
(PDCA) cycle methodology is
applied to all processes
Plan
Act
Do
Chec
k
Establish the objectives and processes
necessary to deliver results in accordance
with customer requirements and the
organization's policies
Implement the processes
Monitor and measure processes and
product against policies, objectives and
requirements for the product and report
the results

17. Process Methodology

18. Tools:
Suppliers-Inputs-Process-Controls-Resources-Outputs-Customers

19. Tools: Force-Field Analysis
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20. Tools: Map Value Stream
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21. Case Studies

22. Case Study: Assess Microbiology System
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23. Automation
Automate mass spec data reviews:
– Success QC Fail Pre Align Peaks Less than <threshhold> Positive Control
– Success QC Fail Pre Align Peaks Less than <threshhold> Negative Control
– Success QC Fail Pre Align Peaks Less than <threshhold> <sample id>
– Success QC Fail Pre Align Peaks Equal <threshhold> Positive Control
– Success QC Fail Pre Align Peaks Equal <threshhold> Negative Control
– Success QC Fail Pre Align Peaks Equal <threshhold> <sample id>
– Success QC Fail Tolerance <GreaterThan / Equals> <threshhold>
<negative / positive/ sample>
– Success QC Fail Used Align Points <GreaterThan / Less than>
<threshhold> <negative / positive/ sample>
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24. Case Study: Redesigning workflows for LIMS
05/06/15 24

25. Future:
Laboratory Information Management Systems

26. Future Developments
– Mobile device integration
• Wireless barcode scanners
• Sample Delivery Scheduling (example, Verizon
Field Force)
• Provide mobile LIMS version for technicians who
need access but can't be in the laboratory
• Regulatory / Quality Approvals
– External monitoring
• Monitor the status of sample batches, test results
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