20140311_Catel 02_CI strategy

GRÜNENTHAL Name der Präsentation DatumGRÜNENTHAL Page 1

Continuous Improvement strategies to become a Lean Company…

March 11, 2014

Cyrille Catel, ASQ CSSBBAssociate Director, Continuous Improvement & PMO Lead


… versus

Process mapping to determine currentplaces in your organization in need ofprocess improvement


Focus at stake…

Pros and Cons of a long-term process improvementstrategy 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


Grünenthal R&D Operational Excellence goal has been to…

“Institutionalize

continuous improvement

with everyone’s

participation”


There’s problem everywhere, isn’t it?

Size & frequency

Very few

large

Few

medium

Many small

(daily)

“But how to

identify and

prioritize

them?”


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


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


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


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…


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

Handovermeeting

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

meetingDiagnostic

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

2Management

Change agent

CI expert


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


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

AExecution

follow-up and

performance

dialogue

B

Problem logging,

Solving and

escalation

C

KPIs /

Performance

Tracking / Impact

tracking

D

Standards

E

3


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

Com

ple

xity

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


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

SDTM stucture

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

CO

RE

STU

DY

TEA

M

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

CO

RE

STU

DY

TEA

MA

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 CSM or 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

raisedChallenge 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 AM review

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

Blo

ckin

g is

sues

Irri

tati

ng

issu

es

C

KPI2

D

1 Performance Management Loop 2 Key Performance Indicators


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


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?


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

Documents

20140311_Catel 02_CI strategy