Kendra Langhans - CBI

UTILIZE SIX SIGMA 

STRATEGIES FOR 

BUSINESS PROCESS 

IMPROVEMENT WITHIN 

MEDICAL AFFAIRS 

September 20, 2012

About Kendra 

2 

BS Pharmacy, University of Kansas, 

MS Organic Chemistry, University of Michigan 

Various leadership roles in Medical Affairs 

including when Lilly established a US Medical 

Affairs group 

Six Sigma Black Belt – 3 years 

About 1.5 years into Lilly’s initiation of Six Sigma 

Currently Bio-Medicines Medical Affairs 

Strategy and Operations Advisor 

Copyright © 2012 Lilly

Definition of Six Sigma 

from Wikipedia 

3 

 

 

 

Six Sigma is a business management strategy, originally developed by Motorola 

in 1986. [1][2] ] Six Sigma became well known after Jack Welch made it a central focus 

of his business strategy at General Electric in 1995, [3] and today it is widely used in 

many sectors of industry. 

Six Sigma seeks to improve the quality of process outputs by identifying and 

removing the causes of defects (errors) and minimizing variability in 

manufacturing and business processes. [4] It uses a set of quality management 

methods, including statistical methods, and creates a special infrastructure of 

people p within the organization ("Black Belts", "Green Belts", etc.) who are experts in 

these methods. [4] Each Six Sigma project carried out within an organization follows a 

defined sequence of steps and has quantified financial targets (cost reduction and/or 

profit increase). [4] 

The term Six Sigma originated i from terminology associated with manufacturing, 

specifically terms associated with statistical modeling of manufacturing processes. 

The maturity of a manufacturing process can be described by a sigma rating 

indicating its yield or the percentage of defect-free products it creates. A six sigma 

process is one in which 99.99966% of the products manufactured are 

statistically expected to be free of defects (3.4 defects per million). Motorola set a 

goal of "six sigma" for all of its manufacturing operations, and this goal became a 

byword for the management and engineering Copyright © 2012 Lilly practices used to achieve it.

How Can Lean Six Sigma 

Help? 

 

 

 

Customer perceptions are driven by how well our products and 

services fulfill their requirements 

Lean Six Sigma focuses on defining those 

requirements and improving speed and quality to 

meet them 

Poor quality increases cost and customer lead time 

A 10% error rate can increase cycle time by 40% 

and reduce available working capacity 

In most value streams, > 95% of customer lead time is spent 

waiting 

Removing Lean Six non-value Sigma optimizes added capacity, time reduces and cycle effort time reduces 

cost performance, and improves and eliminates customer variability perceptions 

in all processes 

4 


How it all started 

5 

Employee Survey Data 

9 

8 

7 

6 

5 

4 

3 

2 

1 

0 

Q1 Q2 Q3 

Our employee survey data says we are not 

managing change well….. 

Can you use Six Sigma to fix this? 


6 

What We Found (during data 

collection) 

 

 

 

What changes were most painful: 

Process changes (new or updated d SOPs, Six Sigma, etc…) 

Re-organizations 

Root causes for poor change implementation: 

Poor communication: no rationale, seems secretive 

Inadequate stakeholder involvement (input) 

Failure to test/pilot before implementing 

Lack of follow-up 

Large number of changes that don't seem coordinated 

• Various Six Sigma and Business projects were ongoing from different sources 

• No one knew what projects were all ongoing! 

• There was duplication and overlap 

• There was re-work and confusion due to multiple projects working on the 

same process 

From a business perspective: 

e 

We didn’t know what resources we were using 

Priorities weren’t clear 


Solutions 

Phase 1 - Address communicating/influencing 

g 

change 

 

Implement new internal internet collaboration to include: 

Centralized coordination for all communications 

 

Collection of input for changes across the organization 

 

Share tools to ensure good Change Management 

Phase 2 – Address the coordination/prioritization 

of change 

Change Advisory Board to review and approve change 

projects (six sigma and non-six sigma) and implementation 

timingi 

Timeline and other Tools 

What projects are going on? 

 

 

 

When are current projects scheduled to roll-out 

out 

Assess capacity 

Combine solution roll-outs 


The “Change” Process….. 

8 

Identify 

Projects 

Prioritize 

Projects 

Implement 

Projects 

Sustain the 

Change 

Communication 


9 

Identify yprojects 

Lots of sources: employees, leaders, other 

projects 

You need to get all the ideas into one place 

Internal website with a simple form is one method 

Identify 

Projects 

Can see if an idea has already been submitted/being worked on 

Allow anyone to submit 

Best Practice - Six Sigma Consultant 

Best Practice -capture all projects, then sort 

out if Six Sigma 


Six Sigma Consultant 

10 

 

 

 

 

 

 

 

 

 

Black Belt assigned to various areas of the business 

Joins team and/or leadership meetings 

Listens for “pain” or problem areas 

Can proactively identify “good” projects 

Can help with charters 

Can help with prioritization iti and scope 

Will know the impact to the business because they are 

part of the business 

For the Belt it is an opportunity to learn more about the 

business and make potential career connections 

Belt may or may not do all the projects coming out of the 

assigned area of business 


11 

Efficiently Prioritize Projects Pi 

Once you have a list……. 

Best practices 

Six Sigma Consultant 

Prioritize iti 

Projects 

• Partners with business to understand the project 

• Writes charter (six sigma and non-six sigma) 

• Determines if truly a six sigma project or they just need 

someone to lead the project 

Advisory Board 

• Composed of leaders across the business 

• Owns the resources (team members) 



Meets every 2-3 weeks 

Composed of leaders from the various 

business functions 

Why this works: 

These leaders have accountability for the success of 

their functions and the business unit 

These leaders can make decisions 

These leaders can work together to make better 

prioritization decisions then any tools - JUDGEMENT 



 

 

 

Reviews ongoing projects 

Monitors status t updates and timing 

i 

Reviews new projects 

Decides prioritization 

Determines whether h to use Six Sigma resources 

Evaluates timing to start projects 

Consolidates similar projects 

Approves initiation iti of a project 

Reviews Projects for Implementation 

Approves implementation timing (not actual changes) 

Considers consolidating similar il projects solutions 

Reviews Feedback from Employee Surveys on 

“Change” 

 

Output: t a prioritized iti project list (what is most 

important) ordered by timing for implementation 


Potential Considerations for 

Prioritization 

Relative Benefit to Cost Ratio: 

 

 

 

 

 

 

 

 

Does it align with business priorities or objectives – is it important to 

the organization? 

Does it address a right to operate issue, e.g. a regulatory 

requirement? 

Does it increase productivity or save money? 

The cost or resources needed for the project 

Alignment with other initiatives 

iti Need to work in parallel or in series 

How broad is the impact or scope 

 

How many people does it impact 

Timing 

Something may be the most important project but resources may 

not be available 

Does it lead to transformational or incremental change? 

One may not be better then the other, not everything can be 

transformational! 


When to Use Six Sigma 

 

 

 

 

 

 

You have an important issue or goal 

Problem or goal must be clearly defined! 

You are willing to commit resources 

Your black belt is a precious commodity and will need a 

project team to work on the project 

The answer is not already known 

There is a process involved or a process needs to be 

created 

Six Sigma doesn’t plan resources or budgets but could be used 

to improve processes to free up resources or dollars 

You want a data driven solution 

Customer input is important 


16 

Implement and Sustain Change 

Across an Organization 

Impleme 

 

 

 

 

 

Communication is key 

nt 

Projects 

Early and often 

Collect input and keep broader group informed 

Best Practice: News site on collaboration space 

• Teams create brief updates at key milestones 

• RSS feed creates weekly news synopsis for organization 

Sustain 

the 

Change 

Best Practice: Challenge Teams: non-project team 

members who preview solutions and provide insight and 

challenges 

Best Practice: Pilot before broad implementation 

Best Practice: Advisory Board monitors progress and 

coordinates similar roll-outs 

Validate: 6 months post-implementation team gathers 

data and tweaks if necessary 


Using the Process for 

17 

Transformation 

Identify Prioritize Implement Sustain the 

Projects 

Projects 

Projects 

Change 


Example Capability 

Today 

Trusted 

Information 

• Tailored Dissemination 

Tomorrow 

Make available or disseminate relevant 

Let insights lead 

internal or external data and information in 

an accurate, timely, and preferred manner 

and channel to external customers 

Act in a more 

consultative 

information 

and 

collaborative 

From 

of customer way information into 

• Collection of customer 

• Synthesis and integration 

Information is 

disseminated in an 

accurate but “one 

insights and knowledge 

Tailor • Dissemination our of actions insights 

throughout the torganization 

b t “ 

• Integrated size information fits all” 

generation and organization 

method. 

Lead the change 

To 

Make available or 

disseminate relevant 

data and information 

in an accurate, 

timely, and preferred 

manner and channel 

to all customers. 


Transformation Map 

2010 

2011 2012 

2013 

Strategic Intent: 

Truste ed Source 

Med Letter 

Transformation 

Benefit: Risk Communication 

Manuscpt Cycle 

Time Reduction 

Key Theme 

Key Theme 

Key Theme 


Example Medical Affairs Projects 

Medical Letter 

Revision 

• Use customer input to redesign medical letters 

• Content creation process 

• Fulfillment process 

Medical Website 

• Use DMEDI (Design) to create core content structure 

based on customer input 

• Functionality – Search, Email, Phone, w/enhanced content 

Call Center 

Escalation Process 

• Streamline escalation process from call center to Medical 

Affairs team 

Customer Focused 

Employees 

• Desire to have more customer focused employees 

• Identify what is “good” through VOC 

• Root cause analysis and solutions developed 

Data Integration 

• Data resides in multiple places, hard to integrate 

• Leverage SS to indentify what data the customer needs 

integrated (not all data needs to be integrated) 

• Identify root causes and develop solutions for key data 

integration 


Conclusion 

21 

 

 

 

Medical Affairs is the perfect place to leverage Six 

Sigma 

Medical Affairs organizations must be close to the customer, 

understand the customers needs, and meet those needs in a 

quick and efficient manner; exactly what Six Sigma is 

designed to do! 

Organizations can leverage Six Sigma Consultants t and 

Advisory Boards composed of functional leaders to 

maximize Six Sigma efforts 

Look outside the typical process box, can Six Sigma be 

used for a project you are currently facing?

Kendra Langhans - CBI

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