Making the Difference: Process Improvement Expectations in Todays Changing Environment

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Making the DifferenceProcess Improvement
Expectations in Todays Changing Environment

• MARSQA Membership Meeting
• June 2008

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Agenda

• Process improvement
• Business today
• HLS approach

3
What is Process Improvement?

• Identify, analyze, improve processes
• Improve to impact
• Efficiency
• Productivity
• Quality
• Profitability

4
Methods and Tools

• Six Sigma
• Motorola 1986
• Reduce defects to 3.4 per million
• Statistically driven
• DMAIC/DMADV
• Lean
• Toyota Production System
• Value stream mapping, kanban (pull), poka- yoke
  (error proofing)
• Reducing waste improving flow

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Methods and Tools

• Total Quality Management (TQM)
• Similar tools to SS
• Continuous improvement
• Organizational quality awareness
• Capability Maturity Model (CMM)
• Maturity of an organization
• Chaos to optimized, deliberate processes

6
Todays Environment

• Rapidly changing environment
• Population, diversity, age range
• Changing jobs more frequently
• Technology
• Exponential technology growth
• Need for unified systems
• Generational attitudes
• Managing younger generations today
• Preparing tomorrows leaders

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Todays Environment

• Client expectations
• Quality and compliance
• Scientific competence
• Financially competitive positioning
• PI expectations via RFIs, audits, business
  relationship meetings
• Outsourcing
• Increased levels of outsourcing
• Battle for capacity
• Dedicated space agreement
• Preferred provider agreement
• Competitive pricing

8
Todays Environment

• Opportunity and challenge for CROs
• Capitalize on experience, expertise,
  infrastructure, speed
• Maintain competitive edge

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Our Old Approach

• Is it working?
• Slow progress but progress nonetheless
• Driven by technology/automation
• Kick-started some with natural talents
• Supplemented by existing metrics
• Well-documented financial success

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Our Old Approach

• Could it be better?
• Reviewed ongoing activities
• Fractured
• Redundant
• Considered reasons for failure
• Resource
• Leadership
• Poorly publicized successes

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The Birth of HLS Delta
Customer Feedback
Rees
DMS
CUSTOMER SERVICE
Etc
etc
etc
PRODUCTION DEVELOPMENT PROJECTS
ACCOLADES ERRORS
Primavera
CSQA
Liberate
CAPA
BUSINESS SYSTEMS
QUALITY ASSURANCE
Audits
Delta
Quality Metrics
HuBS
HARMON- ISATION
PROCESS IMPROVEMENT GROUPS
Finance
Local PI groups
SCIENTIFIC DEVELOPMENT
TRAINING DEVELOPMENT
Archives
PI Reporting
IT
PI Network
PI Projects
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HLS Delta objectives

• Harnesses existing internal systems and processes
  designed to achieve improvements in productivity,
  quality and profit
• Demonstrates for external viewers, HLS
  commitment, via focused investment, to
  improvement activities
• Key deliverable is on-time, quality reports that
  help our customers to take safe and effective
  products to market faster

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HLS Delta focus

• Focuses existing resources on
• Process refinement
• Quality improvement
• Error reduction
• Productivity enhancement
• Drive improvement across HLS
• Share success and failures
• Go beyond operational areas to finance, HR,
  marketing, sales, QA

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HLS Delta engaging management

• Define realistic expectations
• Detail resource needs
• Staff
• External resource
• Training needs
• Publication and buy-in
• Document expected returns
• Manhour or cost savings
• Targets for company and by site, by department

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HLS Delta methods and tools

• Delta makes use of
• Selected tools and principles of Lean and Six
  Sigma, aligned to the Product and Business model
  of HLS - focus on efficiency
• Traditional (TQM) quality improvement tools and
  methodologies - to improve selected aspects of
  operations
• CAPA and audit processes for effective evaluation
  and feedback of issues - to monitor progress and
  learn from mistakes
• Project management for initiation and
  implementation of major automation programs

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HLS Delta measuring change

• Delta metrics will provide
• Where we were - historical insight critical to
  interpreting and effecting solutions
• Where we are - ongoing monitoring of KPIs to
  ensure a successful solution has been attained
  and to document sustainability
• where we want to be - goals for future that
  ensure continuous ongoing incremental improvement
  for all processes

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HLS Delta deliverables

• Process. Continuous improvement, harmonization,
  sharing best practices to achieve efficiency
• Performance metrics. Documented quantification
  and improvement with SCD cascading to balanced
  scorecard
• Proficiency. Constantly reviewed and upgraded,
  strongly linked to customer service, focused
  error reduction and product improvement
• Productivity. Process re-engineering, automation,
  greater competence, less rework and higher
  capacity utilization
• People. People-centric model reinforced via
  appraisal and reward system encouraging
  competence in Delta skills
• Project management. Effective management and good
  leadership drive positive outcomes
• Profitability. Outcome of the 6Ps above, RoI is
  measurable in increased profits

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Delta Metrics
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Summary

• Engage management
• Capitalize on existing activities
• Commit the resources
• Choose leadership wisely
• Publish successes and learn from failures
• Evolve with our changing world!!!