Project Management: Doing Business Using Lean Principles

Transcription

1 Project Management: Doing Business Using Lean Principles Jennifer Hellberg Sr. Director, Operational Excellence Thermo Fisher Scientific Clinical Trials Division Linda Kaer Director, Compliance Officer GHH Compliance/Sample Accountability Merck & Co., Inc.

2 Agenda Practical Process Improvement (PPI ) Definition & Process Overview Representative Analysis Tools Six Sigma Similarities / Differences Impact on Project Outcomes PPI In Action Case Study Bell&Zunich 2

3 What is Practical Process Improvement (PPI) Business System Operational discipline it s the way we do business Drives sustainable growth A culture of employee engagement and continuous process improvement Operational Benefits Drives efficiency increased capacity and/or cost savings Supports quality structured approach to process/problem analysis Enhances compliance framework to solve complex issues for effective Corrective Action/Preventative Action 3

4 Cultural Benefits Drives ownership by engaging people in solving problems impacting them every day Improves collaboration by focusing on process and data, not emotion Reduces stalled out teams by providing a clear next step Teaches people to see waste and problems Energizes employees by enabling visible incremental improvement Builds a mindset of continuous improvement 4

5 Representative Projects Minimize FDA/regulatory agency reporting cycle time Increase annual ethics training completion Improve inventory records accuracy Eliminate repeat internal control audit findings Decrease employee complaints 5

6 Three Strategic Principles Apply Logical Simplicity Utilize Practical Methods and Tools Involve Everyone Step by Step Improvement Correct problems at their source Make step-by-step improvements Repeat the cycle of improvement many times 6

7 PPI 8-Step Problem-Solving Process Bell&Zunich 7

8 Application of PPI Tools & Process 8

9 4Ms and an E 9

10 Fishbone Diagram 10

11 Fishbone Diagram 11

12 Pareto Charts 12

13 Is PPI the same as Six Sigma? Smaller, tightly defined projects & processes Less emphasis on extensive measurement & statistical analysis Greater focus on quick hits with actionable plans Problems are solved by individuals doing the work Supports culture of problem solving and continuous improvement 13

14 How Does PPI Improve Project Outcomes? The Importance of Good Upfront Planning Appropriate scoping Solving the right problem Setting appropriate goals Witness the Current Process Don t design in a vacuum Data-Based Decisions Identifying and eliminating true root cause Monitoring Implementation Management Boards & Standup Meetings 14

15 Case Study Problem Statement: Last year, replacement label requests attributable to in room damage were too high averaging 72 labels per month. 30,000ft and 500ft process flows Pareto Chart (Level 2) 15

16 Wrong Application Location Root Cause: Different interpretation of directions between personnel or shifts Solution: Usage of label placement verification packet Test Results: 1. Personnel felt that the packet would give consistency throughout the job series and add to the comfort level that the label is correct 2. Prefer hand on or actual photo instead of mechanical drawings Actions: Wrong Application Location Actions for Standardization Person Responsible Planned Start Create protocol and pilot label placement verification packet Planned Completion Status Implement long term label placement verification packet

17 Manual Removal from Backing Root Cause: Removing labels manually too quickly from backing Solution: Utilize new, automated label dispenser for all manual label jobs on rolls Test Results: 3 operations personnel tested dispenser and concluded that removal speed could be controlled and replacement labels eliminated. All replacement label occurrences were provided on rolls and could run on this machine. Actions: Manual Removal from Backing Actions for Standardization Person Responsible Planned Start Planned Completion Status Take label dispensers to production floor after WI is Pilot usage of label dispensers effective Evaluate effectiveness (usage & replacement label reduction) of label dispensers and determine additional dispensers should be deployed

18 Adhered to Glove Root Cause: Blue gloves do not have texture and are thin which cause tearing Solution: Use green gloves in secondary Test Results: 5 minute test demonstrating blue gloves build up adhesive and damage label, green gloves do not Actions: Adhered to Glove Collect feedback on green gloves from Operations Actions for Standardization Person Assigned Planned Start Remove blue from stock room and replace with green gloves, replace in the hallway & communicate Planned Completion Status Modify glove holders to support green gloves Evaluate the sourcing of non-extended gloves

19 Proposed Benefits Problem Solution Benefit Hard/Soft Savings Wrong Application Location Implementation of label placement verification procedure Downtime and potential of 6 replacement labels per month Manual Removal from Backing Automated Label Dispenser 6 replacement labels per month Skewed Application Implementation of Skew Specification Downtime due to evaluation of skewed label Roll Change 1) Lexan Label Guide 2 replacement labels per month 2) 610 Card Sleeve 3) Repack Cleaning Adhered to Glove Usage of Green Gloves 3 replacement labels per month Adhered to Bubble Wrap 2.5 replacement labels per month BAM Trays Potential savings of ~20 replacement labels per month (28% reduction within 6 months, goal can be met!)

20 Questions / Discussion 20

21 Helpful Resource 21

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