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Continuous Improvement strategies to
become a Lean Company…
March 11, 2014
Cyrille Catel, ASQ CSSBB
Associate Director, Continuous Improvement & PMO Lead

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… versus
Process mapping to determine current
places in your organization in need of
process improvement

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Focus at stake…
 Pros and Cons of a long-term process improvement
strategy compared to a short-term process mapping needs
1
 Strategies in becoming a lean company
– Transformation
– Continuous improvement (CI)
2
 Utilize problem solving to determine improvement needs3

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Grünenthal R&D Operational Excellence goal has been to…
“Institutionalize
continuous improvement
with everyone’s
participation”

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There’s problem everywhere, isn’t it?
Size & frequency
Very few
large
Few
medium
Many small
(daily)
“But how to
identify and
prioritize
them?”

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Starting the journey by end-to-end mapping –
to identify improvement needs and priorities
Example: end-to-end process analysis for clinical trials
SOURCE: workshops with dedicated experts Q4-2013
1

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Can process mapping be the only source?
 Mainly steered by Lean Six Sigma experts
(e.g. MBB, BB, GB)
 Frequently on top of daily business for
people not 100% dedicated to Lean Six
Sigma
 Limited involvement of operational users
during processes redesign
 Implemented solution difficult to sustain and
further improve
 …
While essential, process mapping by itself cannot engage all employees
and institutionalize continuous improvement within the company
 Reasonable effort to create based on
process complexity
 Visual reference easing common
understanding and key stakeholders
alignment
- Improvement needs
- priorities
 Rapid source to constitute a pipeline of
improvement opportunities
 …
LimitationsAdvantages
1

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Strategies in becoming a lean company2
Grünenthal R&D decided to…
 Consider the whole
problem spectrum
Size & frequency
Very few
large
Few
medium
Many small
(daily)
My job =
My tasks + My improvements
 And shift all
employees mindset

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Local transformation approach taking a holistic outlook2
Performance Management
Mindsets and Behaviors
Process Efficiency
Organization & Skills
 Focus on what is required
 Eliminate what does not add value to the
customer
 Adapt organization to best deliver to
customer expectation
 Develop people's skills in order to
achieve overall goals
 Understand and evolve mindsets and
behaviors to realize the organization’s
full potential
 Define objectives
 Analyze performance influencers
 Reveal and resolve problems
Voice of Customer
 Understand, anticipate, and
meet requirements of
customers, partners or
interfaces…

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Continuous
Improvement
 Re-assess priorities
based on last
customer feedback
 Stabilize the lean
system and fine-
tune as required
 Gather regular
customer feedback
 OPEX CI experts on
demand for highly
complex problems
Handover
meeting
3 weeks 8 weeks
Future state
design
 Management and
team articulate
aspiration and
vision
 Define
organizational
enhancement:
- Span of control
- Communication
- Problems
identification and
resolution
 Decide on
countermeasures
for identified gap
 Share aspiration
and vision with
customers
Implementation
 Implement designed
lean system
 Implement quick
wins
 Drive problem
solving
 Execute
implementation plan
 Gather customer
feedback to
consider ongoing
fine-tuning needs
Commit-
ment
meeting
Diagnostic
4 weeks
Preparation
 Define:
- Customers1
- Mix of Services /
products delivered
- Main focus of the
department
 Collect data:
- Customer demand
- Workload
- Performance
 Understand
management views
about the current state
 Collect previous
initiatives / changes
 Interview
customers
 Understand team
views about the
current state
 Map end-to-end
VSM2
 Perform
observation to
assess VA3 time
ratio
 Analyze:
- Gathered data
- Organization
- Lean maturity
- Communication
flow
 Synthetize finding
and articulate
potentials
3 weeks
1 Internal/external customers, interfaces, partners 2 Value Stream Mapping 3 Value Added Time
Structured approach to deploy Lean via stream –
14 weeks transformation before CI
2
Management
Change agent
CI expert

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Managers1 focus on 3 key principles –
to steer continuous improvement and ensure sustainability
Direction
Responding
to Customer
Demand
Power / speed
Performance
Management loop:
continuously improve by
raising and solving
problems
1 Line Managers at functional level and/ or Project Managers at study level
Propulsion
Developing
People and
Standards
2

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Utilize problem solving to determine improvement needs –
the “Performance Management” loop
Project
plan
Standards
Plan
DoCheck
Act
Plan
DoCheck
Act Standards
Time
Continuous
Improvement
Planning of
Deliverables and
Resources
A
Execution
follow-up and
performance
dialogue
B
Problem logging,
Solving and
escalation
C
KPIs /
Performance
Tracking / Impact
tracking
D
Standards
E
3

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Building problems solving agility –
to involve and engage all employees in CI
Problem solving & Continuous Improvement
Type
Example
Resolution
process
Work preparation
‘Question’ / ‘Clarification’
 Who is the contact
person?
 How shall I perform…?
 Not an issue / normal
Q&A process
Other blocking or irritating points
Complexity
1 structured fire fighting 2 What? Who? When? Where? Why? How? How many? 3 Plan-Do-Check-Act/ Adjust
 Pending signatures
delaying CA/EC
submission
 5W2H2
 5 Whys
 Temporary
countermeasure or
complete solution
Simple issue
and/ or short
term resolution1
Complex issue
and/ or long term
resolution
 Broken process
 New regulation
 SOP missing or to
be improved
 5W2H2
 Advanced problem
solving tools such
as:
- Fishbone
- Affinity diagram
- Data analysis
tools
 PDCA3
Straight
forward
(Quick fix)
 Missing input
 ‘just do it’
3
Small daily problems Medium and large
problems
Problem
board
Long term
issue board
C

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PM loop1 implementation and visual management example –
to support problem solving at core study team level
Project
plan
(MSP)
Project
plan
Weekly commitments
Team resource
overview
CW49
Team Commitment Status Commitment Status Commitment Status Commitment Status Commitment Status Commitment Commitment Commitment Commitment
15 random subjects
/week Newsletter
CA submission of AM2 in
remaining countries
EC submission of AM2 in
ES and AT
Respond to incoming
deficiency letters (validation
of submission package)
Respond to incoming
deficiency letters
Respond to incoming
deficiency letters
Investigator Meet in HU
Adapt CRF to AM2
Update Lab specs
Final presentations for
CRA meeting
Motivate CRAs to
enhance recruitment
(Meeting in FFM)
Final CAPA plan Dr.
Veenendaal
Review Safety Plan
Update
CAPA Plan Dr.
Veenendaal
Motivate CRAs to
enhance recruitment
(Meeting in FFM) MVR review MVR Review MVR Review
Status Report
Update of Paper process
for IMP return PD DEVA2 update
Follow-up on TMF QC check
Follow-up on recruitment
enancement activites
Follow-up on TMF QC
check
Create and provide to
Operations the Missing
Pages and Open Queries -
Reports
Findings from PK-, PG,
IVRS-Reconciliation
providing to Operations
Feedback to Update of
SDTMstucture
Max Flow - Invoice
tracking for Accovion
GB Migration to new eCRf
acc. to amendment 1
Completion Guidline for
review to Operations
Clarification of the
finding: MRL- ECG unable
to evaluate
instruction for
unscheduled ECG
reporting
by country and dropout
analysis Accovion clarifications
SAP finalization -PPS
definition
MRL #9
PD DEV A1 updated draft
PD DEV A1 discussion with
team
newsletter review and
substantial rewrite
central TMF update
Accovion clarifications for
answered queries
DEVA1 update alignment
within project SAP comments alignment
DEVA1 update final for
next steps at Accovion
Review update specifica6tions
central lab after AM1 MRL #9
instruction for
unscheduled ECG
reporting
Review eCRF update after
AM1
PPS definition
Review eCRF completion
guideline update after AM1
CW50 CW51 CW1
Study
deliveries
CORESTUDYTEAM
CW2
Mon Tue Wed Thu Fri
CW50 CW51 CW52
Mon Tue Wed Thu Fri Mon Tue Wed Thu Fri Mon Tue Wed Thu Fri
Team Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence Presence
A A A A A P P P P A P A A A A
P P P HO P P P P A A A A A A A
P P P P A P P P P A A A A A A
P P P P P P P A P P A A A A A
A A P P P P P P P P A A A A A
P P P P P P P P P P A A A A A
A P P A P P P P P P P A A A A
CORESTUDYTEAMA
No. Item Category Root cause/consequences/impact 1. Action I
2. Action II …
Owner Start date End date Priority Status CO-team
1 Site audit findings allocated to GOSL, why not to CSM?
(GGP)
Process JKu JKu 23-May-2013 medium open GOSL
2 Review + approval local ICF (NGa) Process not done by CSMor no CSM
appointed
meeting JKu - how to progress? GGP 13-May-2013 open GOSL
4 Questionnaires (NMH) Process versioning not harmonized
trial identifier missing
finding JTyrell: email AEsser
10Jun
1. follow-up by STM, MZ, QS (Elke
Ufer) - done
2. request questionnaire issues
from all CO's (done)
3. PSS (done 30Sep2013)
GGP 29-May-2013 high 75% GOSL
5 Protocol deviation reporting Process Protocol deviation plan, fraud &
misconduct
1. PSS 5 Sep - done
3. PSS 11 Nov - done
3. FU PSS scheduled for 28 Nov
(and furhter bi-weekly until
resolution)
VK 23-May-2013 high 25% GOSL
6 GxP relevant issues (GGP)
confidential information which needs to be
exchanged within the study team but not with all
(budget, TMP documents, status reports, QC
monitoring reports)
Process where to file? 1. fu with GOPLs wrt status
reports -done, waiting for answer
2. meeting with H. Netz, GOSL,
STM
new eroom will be established
for complete GCD
3. where to file STM minutes?
(question CBe)
GGP 14-May-2013 75% GOSL
7 GCP online training (CL, NGa) Training Infonetica: test too difficult,
questions too complex,
ambiguous questions
short-term solution for affected
trial found, analysis ongoing
IS 16-Apr-2013 16-May-2013 high interim-
solution
GOSL
7 GCP online training Training approval of access to Infonetica
done via 2 persons in CO but
insufficient; not all countries
covered by Infonetica nor by local
language trainings
alignment with GGP, PSS with IS BS 5-Jun-2013 14-Jun-2013 high solved GOSM
3 CTA: RA preparation (BSt) Process no preparation by RA meeting with T. Hujbers (JKu) TH high 75% GOSL7-May-2013
Problem board (short term)
Long term issue
Date
raised
Challenge description
(clear description to nail the particular challenge down)
Proposed countermeasure Status Owner
Target
Date
before
escalation
GOPL ICL OVM GECD GLCD CO GBM GRA Others
11-Nov-13
Protocol deviation meeting needed to discuss PD category 3 -
difficult to find timeslot with Core STM PPS slot used SO 20-Nov-13
13-Nov-13
Gisela on sick leave (duration unknown) - Potentially blocking SAP
finalization/TLD definitions none Cla 18-Nov-13
25-Nov-13
Potentially blocking: definition of PDs and DEVA1 discussion
blocking the PD process
Several PSS took place to define the PD
definitions Ach, SO 11-Dec-13
25-Nov-13
CI signatures on amendment 1 delay CA/EC submission of
amendment 1 (DK) none Cla 29-Nov-13
27-Nov-13
Science colleagues have limited capacities due to high amount of
unplanned alerts; this endangers the medical review and protocol
deviation review
Develop recovery plan, e.g. consider to
have one person concentrating on the day-
to day issues?
Cla to escalate to DR and Ahä Cla 03-Dec-13 13-Dec-13
11-Nov-13 High amount of regular meetings reduces overall working time
Undergo pilot phase; escalate if this issue
remains Ach 13-Dec-13
13-Nov-13 Gisela on sick leave (duration unknown) -affects AMreview
Forward amendment to Giacomo
(combined review planned) MW 13-Nov-13
21-Nov-13
MRL #8 time line 20Nov not met due to workload, therefore queries
could not be sent to Accovion
new timeline of 26 Nov 2013 was chosen
to be acceptable without bloking other
deliverables SO, Ach 26-Nov-13
25-Nov-13 FI003 randomizing subjects that do not meet IN/EX Visit of Lead CRA at site FI003 Cla, Ach 29-Nov-13
28-Nov-13 Availability of team and vendors over X-mas period
Cla addressed issue in meeting on 28 Nov;
ME and DR will act as coverage; others to
be determined Cla 13-Dec-13
Line escalationProject escalation
BlockingissuesIrritatingissues
C
KPI2
D
1 Performance Management Loop 2 Key Performance Indicators

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Core study team visual problem board example
Pre-defined escalation path
Problems are
categorized based on
the urgency of their
resolution
Problem
transferred to long
term resolution are
marked
GCP relevant
problems are
marked
If too many open
problems, manager1
picks the challenge of
the day to be solved
1 Line Managers at functional level and/ or Project Managers at study level
C

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Simple problem solving framework –
Problem sheet template
Page 1 of 2 Page 2 of 2
Root cause
analysis
Action plan
Evaluation of
solution
Adjust or Ensure
sustainability
Possible
countermeasure
per cause
Countermeasure
prioritization
(Impact / Feasibility)
ACT
CHECK
DO
PLAN
PLAN
5W2H1
1 What? Who? When? Where? Why? How? How many?

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As a recap…
 Long-term process improvement vs. short-term process map
– Use short-term process map for urgent fixing needs
– Deploy long-term CI1 strategy to avoid the trap…
1
1 Continuous Improvement
Product or
Service
Hey folks, what
about improving?
Wish we could… but
we are too busy to
deliver to customers!!
 To become a lean company
– Use a holistic approach
– Implement mechanism to steer CI1 and ensure sustainability
2
 Utilize problem solving to
– Involve and engage all employees
– Determine improvement needs
3