Visualizing Customer Delivery
Kent M. Payne, Ph.D.Catalent Pharma Solutions
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Lean Simply Stated
Lean is…“Getting the right things to the right place at the right time in the right amount, while minimizing
waste and being open to change.”
James Womack, Chairman and CEO of Lean Enterprise Institute
Lean System For Managing (LSFM)Catalent Pharma Solutions – RTP FacilityCase Study
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Who we are: The basics
• $1.7 billion in annual revenue
• 9,000 employees worldwide
• 29 facilities on 5 continents
• Comprehensive provider of proprietary, best-in-class solutions:
— Oral
— Injectable
— Respiratory
— Advanced drug packaging
…to the clinic…
…to the market
From the laboratory…
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Who we are: By the numbers
Number of doses made or packaged annually100,000,000,000
Patents and patent applications1,400
Quality and regulatory experts1,100
Number of customer countries100
Portion of “Top 200” selling drug compounds we support80%
Years experience in serving pharma industry75
Number of the top 50 pharmas we serve49
Portion of recent new drug approvals supported by Catalent40%
Number of the top 100 biotechs we serve90
Ratio of scientists to overall employee base1 in 10
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Our Company
Right offerings
Speed
Right investment
Process excellence
World Class Provider
…had a vision…
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Visualizing the Current State
$-$20,000$40,000$60,000$80,000
$100,000$120,000$140,000$160,000$180,000$200,000
Wat
ers
Cor
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cien
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ogie
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heno
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exN
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Wel
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Mill
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orp
Bio
Mer
ieux
Hac
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ltra
Ana
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umA
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Rem
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Dio
nex
Cor
p
RT
Cor
p
0%10%20%30%40%50%60%70%80%90%
Spend Cum % Spend
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Time Well Spent?
Non-Value Add Activities
Business Value Add Activities
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Quote Pre-PhaseProtocol
Analysis Data Review QualityAssurance
NVABVAVA
Value Add Activities
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Project Delivery Tied to Month EndSite Wide Projects Submitted by Week
0
10
20
30
40
50
60
5/4/2007
5/11/2007
5/18/2007
5/25/2007
6/1/2007
6/8/2007
6/15/2007
6/22/2007
6/29/2007
7/6/2007
7/13/2007
7/20/2007
7/27/2007
8/3/2007
8/10/2007
8/17/2007
8/24/2007
8/31/2007
9/7/2007
9/14/2007
9/21/2007
9/28/2007
10/5/2007
10/12/2007
10/19/2007
10/26/2007
11/2/2007
11/9/2007
11/16/2007
11/23/2007
11/30/2007
12/7/2007
12/14/2007
12/21/2007
12/28/2007
Week
# P
roje
cts
Project activity was reactive and batched at month end, not proactively planned and leveled across the month.
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BusinessDevelopment
General Manager
Contract Management
StabilityLab
AnalyticalR&D Lab
StructuralLab
To theCustomer
…to complete the Testing Process…
Pre-phase/Protocol Data Review
MaterialManagementLaboratory
QualityAssurance
Lab OperationsFinance QAHR
BusinessDevelopment
Functionally, We Were Silos
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Even with customer data, many remained skeptical of the need for change.
We needed to learn to see.
Opening our Eyes
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Lean System For Managing (LSFM)
Vision
Objectives
Team Goals
Objectives Objectives
Key Performance Indicators (KPIs)
Team Goals Team GoalsTeam GoalsTeam Goals
Plan Communicate
Implement
Review/Adjust
Report Daily Rigor
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Our Plan for Implementation
Phase I – Core Lab Teams with Consultant Support
Phase II – Remaining Lab Teams and Support Functions
Phase III – Rollout to Sister Site
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We Defined Key Improvement Objectives And Established A Balanced Scorecard
Metric Site Level Description Actual Goal Status
On Time Delivery (OTD)% of external customer deliverables (from operations) delivered on or before commitment date vs total number of projects delivered.
99% >95%
Right First Time (RFT)% notebooks with no major defects and fewer than 5 minor defects as noted during technical review
96% >95%
Safety # of days with no recordable incidents 7 days 7 days
Sales WonWeekly revenue dollars signed versus dollars planned
95% >100%
Projects Completed to PlanNumber of projects actually completed versus number of projects planned for the week
131% >100%
ARROW COLOR ARROW DIRECTION
100% or more of Goal Better than last report period
90% to 99% of Goal No change from last report period
Below 90% of Goal Worse than last report period
RTP SITE DASHBOARD
Legend
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We Developed Team-Owned Metrics
Rev 9/4//07
R
For the week of:
CUSTOMER PLEASING METRICS
Mon Tues Wed Thur Fri Wkly
# Projects Sent: (Goal is Qty Planned for Week)
# (%) Projects On Time: (Of the Sent Projects, Qty of Projects On Time / Total Qty of Projects Sent)
# (%) Notebooks Right First Time: (Of the Tech Reviewed Notebooks, Qty of Notebooks Right First Time / Total Qty of No tebooks Reviewed)
# In-Process Projects Past Dues: (Qty of RED Projects / Total Projects Tracked On VCB)
# In-Process Projects At Risk: (Qty of BLUE Projects / Total Projects Tracked On VCB)
OUR GOAL =
OUR GOAL =
OUR GOAL =
OUR GOAL =
OUR GOAL =
Daily Metrics recorded directly from Visual Control Boards
Trended at team and Site Level
ALL LABS Metrics - Rolling Four Week Avg.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
15-O
ct-07
22-O
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29-O
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5-No
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12-N
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19-N
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26-N
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3-De
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10-D
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17-D
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24-D
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31-D
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7-Ja
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14-J
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21-J
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28-J
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4-Fe
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11-F
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3-M
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17-M
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24-M
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31-M
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7-Ap
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5-M
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Week
ALL LABS %Notebooks RightFirst TimeALL LABS % On-Time Delivery
ALL LABS %Projects Past Due
Linear (ALL LABS% Projects PastDue)
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And Engaged Teams in LSFM
Name Larry Lab
Date Tuesday, May 13, 2008
10.5 10.5
7:00 AM Admin/email 0.5 0.5 g7:30 AM Compliance 1 1 g8:00 AM
8:30 AM DR CSA-aminolysis 2 0.5 r Awaiting for updated Excel sheets to be added to notebook9:00 AM
9:30 AM LSFM 0.25 0.25 g10:00 AM
10:30 AM
11:00 AMTTP-VJO-C0005 assay LIR writeup & PR complettion/revision 1.5 1.5 g
11:30 AM lunch 0.5 1 y took longer than planned12:00 PM
12:30 PM TTP-VJO-C0005 RS LIR writeup & completed PR 1.5 y Unplanned1:00 PM TTP-IPC-C0001 investigation ?? 4.25 0.5 r Priority change see line 211:30 PM
2:00 PM DR TTP-VJO-C0005 RS 6 month retest 1.75 y Priority change 2:30 PM
3:00 PM DR TTP-VJO-C0005 LOD 6 month retest 1 y Priority change 3:30 PM
4:00 PMDR pH calibration record and microbalance calibration 0.5 y Unplanned
4:30 PM Admin/email 0.5 0.5 g5:00 PM
5:30 PM
6:00 PM
6:30 PM
7:00 PM
7:30 PM
Total Time
Barrier Description (Required for Yellow and Red flag)Plan Time TASK Description
Task Status Red
Yellow Green
LEAN SYSTEM FOR MANAGING WORK PLAN
Est. Hours
Act. Hours
IT = Systems / Technology issue; U = Underestimated Time/Task; IN = Internal Interruption; X = External Interruption; IA = Instrument not Available; IR = Instrument Rework; I = Instrument/Machine not Working OR = Operator Rework; DR = Data Review; G = Supplies; SR = Science / Protocol; P = Priority Change; C = Customer caused delay; O = other
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Teams Trained on Identifying and Removing Barriers
Plan WorkIdentify Barriers
Analyze Barriers
Engage Barrier Remover
Manage Removal
Confirm Improvement
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Team Leaders Resisted
This will go away...I already
have a process that
works!
My customers are happy!
I don’t have time for a daily team meeting.
The Consistent Message…
This is the way we do business! Period!
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Leaders Walked the Walk
Management Involvement
Team Success
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We Began to Reward and Recognize
Team-Based insteadof Individual
Rewards Based on Performance and Trajectory
Candy Bars-show up on time-complete work plans
Gift Cards-Week with all projects delivered on time
2 days off-Exceeded Site’s Quarterly Target
TeamCelebration-3 months meeting OTD goal
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And Then the Consultants Left…
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“LSFM works for them, but We are Different”
Labs SupportFunctions
Manufacturing
Phase II Brought Challenges
The principles of LSFM apply to every team!
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Sustaining the Gains is Paramount
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Barrier Removal Takes Disciplined Action
Barriers
Improvements
Projects
- Identified daily at VCB by team members
- Every team has at least one active barrier removal project at all times
Teams continually identify and eliminate waste.
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Barrier Blitz Workouts
Focused Teams Yield Results
Teams Identify Barriers…
…and Make Improvements
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We Continue to Monitor Progress
Mentor Audits Formal Assessments
Frequent Observations by Management
Consistent, Frequent
Engagement at multiple levels
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Have We Changed?
Project Lead Time
20
25
30
35
40
45
50
55
Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Jun-08 Jul-08
Month
Lead
Tim
e (d
ays)
Just making work visible drives down lead times!
LSFM Implemented Here
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Have We Changed?
LSFM has led to significant improvementsin performance!
Since LSFM…
< 5%37%Projects Past Due
> 95%76%Reports Right First Time
> 95%63%On Time Delivery
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Have We Changed? The Signs are Everywhere!
Metrics
Control Boards5S Boards
Event Posters
We arebecoming a
Visual Workplace
Trending
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A Growing Coalition…
5S Boards
Employees at all level are engaged
ProjectTeams
Mentor
Table Leads
KaizenLeader
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Takeaways
• Define a clear vision and demonstrate that vision through consistent, unwavering actions
• Outline Key Performance Indicators and communicate/establish expectations of performance
• Align every individual’s and team’s objectives to KPIs and Goals
• Commit to daily rigor and PDCA cycles - extinguishing old habits is hard
• Make the work visible
• Reward and recognize desired behaviors
• Share and communicate successes
• In the words of Deming, “You have to manage the system. The system does not manage itself.” Stay the course.
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“Without changing our patterns of thought, we will not be able to solve the problems that we created with our current patterns of thought.”
- Albert Einstein
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Questions?
. . .