Creating a Lean R&D System: Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations, 1st Edition (Hardback) book cover

Creating a Lean R&D System

Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations, 1st Edition

By Terence M Barnhart

Productivity Press

267 pages | 13 B/W Illus.

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Description

The ability to find and remove barriers between people and their systems in R&D can almost guarantee a doubling in performance, and often delivers multiples of that. R&D teams that have smooth handoffs deliver 100 percent of the required knowledge at those handoffs. As a result, such teams do not lose critical information, have unexpected knowledge gaps appear in their projects, or have uncoordinated knowledge transfers that waste minutes, days, and even months every year.

Creating a Lean R&D System: Lean Principles and Approaches for Pharmaceutical and Research-Based Organizations lays out the logic of whyLean implementation isn’t strictly for manufacturing and describes why it can be just as effective in R&D organizations. Terence Barnhart, former senior director of continuous improvement at Pfizer R&D, describes the theoretical and physical underpinnings of creating a Lean transformation in any R&D organization, as exemplified by the Lean transformation initiated within the R&D division of a global pharmaceutical company.

Describing how to merge Lean principles with the cultural virtues inherent in R&D, the book presents Lean approaches that can be easily applied in pharmaceutical and research-based organizations. It takes a strategic approach to solving two problems unique to the Lean field. The first is in noting the key distinctions between R&D and manufacturing, and developing a Lean approach specific to the R&D environment. The second is that it proposes a systematic middle-out (merger/maneuver) strategy to help you initiate and sustain a Lean culture within your pharmaceutical R&D organization that will help you immediately engage all stakeholders involved.

Table of Contents

Seeing and Removing Barriers in the R&D Environment

Mental Models

Removing Barriers to Innovation

Impact on R&D Innovation

Physical Barriers

Emotional Barriers

Observational and Thinking Barriers

Lean and the Removal of Barriers

Lean in Research and Development

Purpose

Continuous Improvement in Manufacturing and R&D

The Purpose of Lean

What Lean Is

Lean R&D

Implications

Connection with People

Conclusions

The Individual in the Lean R&D Community

The Individual/Community Continuum in R&D

An Example of the Lean R&D Community

Qualities of the Individual in a Lean Environment

Commitment

Commitment to Craft

Commitment to the Team

Awareness of the Community

Skill at Learning

Pulling It Together

Lean Exercises for the R&D Professional

Seeing

Skill-Building Exercise 1: Seeing without Prior Mental Context

Skill-Building Exercise 2: Seeing Beliefs

Reframing to Innovate

Deconstruction and Synthesis to Increase Value Content

Making Snowmobiles

The Role of Language in Reframing for Innovation

Skill-Building Exercise 3: Reframing by Converting Statements into Questions

Skill-Building Exercise 4: Seeing and Reframing through Value Stream Mapping

Skill-Building Exercise 5: Reframing by Making Snowmobiles

The Value of Experience in Innovation

Skill-Building Exercise 6: Improving Innovation Experience through Daily Experimental Practice

Growing Yourself and Your Environment

Practice to Grow

Pulling It Together—Seeing, Reframing, Experiencing, and Growing: A Learning Loop for Innovation

Integrated Exercises

Skill-Building Exercise 7: The A3 Format

Skill-Building Exercise 8: Good-Better-Best

Skill-Building Exercise 9: Mapping

Apply Liberally

Apply in Your Work, Start Small, Grow in Scale, and Spread Outward

The A3 in Developing R&D Thinking

Description of the A3

Purpose of the A3

Section 1: Problem Statement, Business Value, Performance Goals—Defining the Problem and the Terms for Its Successful Resolution

The First Step in Creating Thought Clarity—Separating Problem and Solution with a Well-Constructed Problem Statement or Valuable Question

Business Value—Creating a Stage for Buy-In

Goals—Defining Criterion for Successful Completion, a.k.a. "When Do I Stop?"

Other Types of Stop-Gap Goals

Section 1 Summary

Section 2: Current State

Section 2 Summary

Section 3: Analysis/Synthesis—Finding the Root Cause of a Problem and Developing Countermeasures to Address Root Cause

Considerations in Analysis/Synthesis

Section 3 Summary

Section 4: The Learning Plan

Learning Plan Structure

Predicting Plan Timing

Building Fast Learning into Our Planning Process

Thinking and Cadence in the Learning Plan

Thoughts on the Learning Plan

Section 4 Summary

Section 5: Results and Future Considerations

Pulling It Together to Get the Most from the A3

The Lean R&D Manager

Skills a Lean Manager Must Possess

Seeing Exercises

Skill-Building Exercise 1: Seeing Group and System Dynamics in an External Setting

Skill-Building Exercise 2: Letting the Environment Tell You Its Problems

Skill-Building Exercise 3: Observing the Internal Environment (Walking the Gemba)

Skill-Building Exercise 4: Seeing and Reframing through Mapping

Reframing Exercises

Skill-Building Exercise 5: Disbelieving Your Own Beliefs

Skill-Building Exercise 6: Identifying Other Possible Beliefs

Experience

Skill-Building Exercise 7: Small-Scale/High-Velocity Experimentation

Growth

Skill-Building Exercise 8: Setting Targets

Skill-Building Exercise 9: Assessing Performance and Reflecting on Results

Pulling It Together

Removing Barriers within the R&D Community

Noninnovation Work

Supporting Basic Work Requirements

Supporting Interfaces

Supporting Management Systems

Seeing the Noninnovation Work

Creating Purpose

Seeing without Prejudice

Group Exercise 1: Seeing without Prejudice, the Current-State Value Stream Map

Issues in Value Stream Mapping in R&D

Group Exercise 2: Seeing Team Assumptions

Group Exercise 3: Bypass Assumptions Entirely—Critical Question Mapping

Reframing Exercises

Building Group Experience

Pulling It Together to Remove Barriers

Critical Question Mapping

The Emergence of Critical Question Mapping

Developing Critical Question Maps

Step 1: Defining a Strategic Problem

Step 2: Brainstorming

Step 3: Arranging the Questions and Flow

Steps 4 and 5: Review and Iteration

Managing Creative and R&D Projects Using Critical Questions

CQM in the Real World

Value Stream Mapping in the R&D Space

Scoping to Define Direction and Performance Level

The Design (Value Stream Mapping) Workshop

Current-State Mapping (Day 1)

Analysis (Day 1)

Analysis (Day 2)

Future-State Mapping (Day 2)

Creating the Learning Plan (Day 3)

Management Intervention during Design and Planning

Implementation and Fast Learning

Learning and Review

Fast Learning and Strategies for Fast Learning

The Next Level: Linking the Project to Lean Strategy and the Learning Process

Implementation Strategy

Using a Critical Question Map to Define a Strategic Thinking Structure

Flow and Learning Loops

Filling Gaps in the Questions

Methodology/Philosophy (Barrier Removal) Section of the Map

Converting the Critical Questions into a Strategy

Design of the First and Subsequent Projects

Selecting Lean Practitioners

Identifying That First Project

Spreading Lean through Fast Learning: The Wildfire Strategy

Learning as Its Own Strategy

The Implications of a Learning Strategy

Implementation Strategy Summary

The Formation of Lean R&D Communities: A Case Example

Case Study: Formation of a Lean Community

The SPOT Project

Project Management in a Lean R&D Community

The Value of Point-to-Point Communication

Results of the SPOT Experiment

Conclusions

Reflections

Index

About the Author

Dr. Terence Barnhart has worked as an academic and industrial research scientist, a strategy consultant, a plant engineer, and a project manager for some of the largest and best-known companies in the world, including Pfizer, McKinsey and Company, and General Electric. His professional passion is researching, developing, and implementing strategies to help people create environments in which they and others can flourish.

Dr. Barnhart holds a PhD in inorganic chemistry from the University of Wisconsin and a bachelor of science degree and post-doctoral fellowship in chemistry from the University of Michigan.

Subject Categories

BISAC Subject Codes/Headings:
BUS053000
BUSINESS & ECONOMICS / Quality Control