Use of Systematic Continuous Improvement Model to Evaluate and Improve Technology Transfer Michael Murphy, Principal Development Specialist Shire HGT September 2008 The information presented herein represents the views of the presenter, and not necessarily the views of Shire Human Genetic Therapies, Inc.
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Use of Systematic Continuous Improvement Model to Evaluate and Improve Technology Transfer Michael Murphy, Principal Development Specialist Shire HGT September.
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Use of Systematic Continuous Improvement Model to Evaluate
and Improve Technology Transfer
Michael Murphy, Principal Development Specialist
Shire HGT
September 2008
The information presented herein represents the views of the presenter, and not necessarily the views of Shire Human Genetic Therapies, Inc.
Overview
• Why needed?
• Quick intro to Continuous Improvement Model
• Definitions
• Process Overview
• Summary
Why Continuous Improvement??
• Companies grow
+ Departments grow
+ Systems established within departments
+ Links created between individual systems
= Non Value Added Links and Tasks, Systems that work well individually but need improvement as an overall system!
Key Concepts within Continuous Improvement Model
• Data Driven– Knowledge and acceptance of variation!!!
• Systems Driven– People– Equipment– Process
System Perspective
Inputs OutputsValue Added
Understand the System Not Events!
• Must manage the system, not the events– Tech Transfer is never right– PD doesn’t deliver a process that works– We never have enough time to transfer a
process
Must View as an Extended System
SupplierSupplier Value Added
Customer
Measurements
FeedbackFeedback
Another View of System Perspective
Inputs Value Added
Outputs
InputsValue Added
Outputs
Inputs Value Added
Outputs
And So On…….
Net Effect= Greater and Greater Variation (It all Adds up)
Basic Six Sigma Improvement
• Define
• Measure
• Analyze
• Improve
• Control
Define?• Team Charter
– Clarity is important– Charter needs to say what you will try to do
and how you will get there.– Set Up rules– Scope includes do’s and don’t– Set up team rules (resolution and
brainstorming)– Revisit as necessary
Construct a Flow Chart
• Cross Functional Not Independent
• Flag Non Value added steps/links
• Flag where process may be simplified
• Now that the process/system is understood, everyone is on the same page to come up with ideas to improve it.
How to Define Measurements
• Select a Process
• List the Outputs
• List The Users
• List User Needs (terms like good, timely, user friendly, effective, accurate)
• List Key Measures
1) Process
2) Outputs 3) Users/Customers
5) Key Measures 4) Needs
Collect Data
• Tools– Pareto
• Count of the data and then plot• Agree on Classification before starting
Statistical Process Control Charts (Run Charts)
– Determine normal variances, special causes– Is process stable (i.e normal variation)
• Eliminate special causes through root cause analysis
– Is process robust (i.e. does the normal variation satisfy our needs)
• Improve robustness through process improvement
Must be Normal Variance to Use Statistics
Example of a Control ChartControl Chart Individual Measurement of Column 1
-2
0
2
4
6
8
10
12
Colu
mn 1
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34
Sample
Avg=5.20
LCL=-0.31
UCL=10.71
Moving Range of Column 1
-1
0
1
2
3
4
5
6
7
8
Colu
mn 1
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34
Sample
Avg=2.07
LCL=0.00
UCL=6.77
What if There is No Data??
• Vote on the proposed causes
• Each member votes for each proposed cause– Rated scores– Total the scores for most likely candidates for
team to improve
Identify What to Improve
• Highest Pareto
• Highest Vote
• Process Robustness not adequate
• Brainstorm Solutions
Brainstorming Issues
• People calling out ideas as they come to them (Talkative people dominate)
• Arguments against ideas start immediately preventing the generation of new ideas
• When technical experts/higher level people speak the ideas seem like
• Blah Blah Blah• Blah Blah Blah
• Expert’s Idea• Blah Blah Blah• Blah Blah Blah
Organized Brainstorming
• Post topic
• Allow for silent writing
• Give ideas one by one in order– No comments/interruptions allowed– May Pass (doesn’t prevent from joining back
in later)
Assign possible cause/effect
Materials Methods
Machines People
Measurement
Outputs
Track Improvements
• Preferably using same data that was used to identify issue
Basic Process Improvement SystemDefine System To Be Improved
Define Key Measures & Operational Definitions
Check Measurement System Capability
Gather Data
Stable?
Identify Potential System Changes For Improvement
Implement Proposed System Improvement
Monitor System Output For Improvement
Capable?
Institutionalize The System Improvement
Get Local Workforce Input To Attack Special Causes
YES
NO
YES
NO
Flow Chart
BrainstormingPresently Available Data
Data CollectionRun ChartsHistogramsControl Charts
Data Collection Repeatability StudyControl Chart(s)
BrainstormingFishbone DiagramsPareto DiagramsData Collection & Study Force Field Analysis
Data CollectionControl Charts
Process Capability Study
Publish Success Story
• Case Study Examples
• Areas of Opportunity Identifed By Tefen
Team Dynamics
• Current Status:– An ad hoc group of individuals from various disciple
attend meetings– Lack of accountability and ownership of members of
this team– Lack of a joint decision. Individual departments own
the process – Lack of continuity of the members through the life
cycle of the transfer – from initiation to Phase I to Phase III to Commercialization
– Not a team, but a group
Path Forward
• Best practice:– A formal and joint group of individuals who work
towards a common goal that is aligned to the vision of the overall organization is a Team
– Autonomy to make decisions that affect the process but still within the parameters of the Program
– Embrace decisions as a Team – Team leader to manage process and support team
members– Consistent use of action logs– Meeting discipline practices (effectiveness and
efficiency)
Structure
• Best practice:– Single point contact in each organization– Team meets on a weekly basis for an hour– Each member updates the team on progress,
decisions made and changes to process– Project Manager is the facilitator and
coordinator between all departments
Team Leader• Current Status
– Lack of cohesive person for the overall process
– Current leader is acknowledged to be MTS, but with no formal authority
– More of a reactive management than proactive
– Unclear charter of the MTS organization in support of tech transfer activities
Path Forward
• Best practice– Project Manager for a product-specific Tech Transfer– Project Manager is responsible for the Tech Transfer
up to the PVR, and eventually responsible for future Tech Transfers of the product during commercial operations
– Primary role is to ensure that the Tech Transfer process is aligned with the organization’s Tech Transfer vision
Technology Transfer Governance
• No Formal Oversight
• No Direct Link to Other teams (i.e. CMC, Program)