Tefen is an international management consulting firm with over 350 employees across 7 countries. They have experience improving performance excellence for some of the world's largest companies. The document discusses Tefen's services including strategy, manufacturing, product development, sales and marketing, organizational development, and supply chain. It also introduces their partnership with FeedBackGround to provide clients in EMEA and America with professional consulting services focused on operational excellence. Tefen and FeedBackGround's joint expertise includes manufacturing, automotive processes, and addressing cultural issues in Spanish speaking markets.

1. S t r a t e g y Op e ra ti on s Exc ell en ce Pro je ct Man ag e me nt Org a ni z atio na l D eve lo p me nt
Tefen Management Consulting
Lean Transformations in Quality
Copyright © 2012, Tefen Ltd.
This presentation contains information, which is proprietary to Tefen Ltd. and is provided only for limited use in reviewing and evaluating the
subject matter. This information shall not be otherwise used, copied, or disclosed without the express written permission of Tefen Ltd.

2. 2
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
Appendix
3.
4.
5.

3. 3
 Tefen Management Consulting is a publicly listed, international
consulting company. Tefen is represented in seven countries in North
America, Europe and Asia
 We have more than 350 highly qualified employees with experience
in numerous lines of business.
 Founded in 1982, the company has amassed a reputation for
improving and enhancing performance excellence in some of the
world’s largest and fastest growing companies.
 From strategy through implementation, our hands-on approach has
achieved success in delivering quantifiable and value-driven results.
 Our methods and practical approach mean that we partner with our
clients to ensure a sustainable impact which will become our clients’
knowledge and asset.
Tefen: delivering performance excellence

4. 4
 Business Strategy
 Corporate Strategy
 Supply chain Strategy
 Marketing and Sales Strategy
 M&A and Due Diligence
 International Strategy
 Portfolio management
 PME Process Improvement
 Product launch support
 Training and Coaching
 Process Optimisation
 Value Generation
 Sales and channel management
 Customer lifecycle
 CRM implementation
 Product Launch
 SFE
 Production (Lean-Management, Six
Sigma, etc.)
 Organisational Quality Excellence
 QA/QC optimisation
 Facility design
 OEE improvement
 Capacity & planning
 Benchmarking
Strategy
Manufacturing &
Quality
Product
Development and
PM
Sales and
Marketing
Tefen’s core competences
Delivering Performance Excellence
Organisational
Development
 Operational Excellence
 Customer Service
 Organizational design
 Change management
 People capabilities
Operation and
Organization
 Supply Chain Planning
 Strategy design and implementation
 Inventory management
 Procurement and sourcing
 Green supply chain
 Distribution and Logistics
Supply Chain

5. FeedBackGround
 Tefen is an international Management
Consulting and Business Excellence company
 Tefen has branches across the U.S. and
Europe and its stock is traded on the Tel Aviv
stock exchange
 Tefen’s Customers enjoy the vast experience
accumulated by the firm during 25 years of
management consulting to companies and
major organizations in Israel and worldwide,
including Fortune 500 companies
 More than 60% of TEFEN’s activity is related
to Israel’s 50 leading companies
 The company employs approximately 200
consultants, half of them in Israel and half
worldwide
 FeedBackGround , founded in 2002
(Barcelona-Spain), focused on Operational
Excellence Professional Services
 FeedBackGround has a deep expertise and
knowledge in manufacturing and automotive
processes
 Many projects performed outside Spain, as for
example: Slovakia, Turkey, Vietnam, Egipte,
USA,…
 More than 120 projects executed with big ROI
for our customers. Most part of them repeat
with us. Why?
 All consultants and engineers speak Spanish,
Catalan and English. Some of them French,
too
Tefen and FeedBackGround signed a strategic partnership to help
Spanish companies and Israelite companies in EMEA and America
Tefen
Tefen’s pragmatic and innovative approach - typical of a top western consulting company - joined Allpku
deep knowledge of the Chinese market to provide support to western companies investing in China
5

6. FeedBackGround and Tefen joined to provide their clients with
professional consulting services focused on EMEA and America
Tefen and FeedBackGround can provide our mutual clients better insights to outperform the market and
achieve their specific business goals
• Long term and successful
relationship with ERG
• 3 decades of global professional
consulting experience with a
significant track records of
successes
• Proven methodologies and deep
industry knowledge
• Deep knowledge of the
Manufacturing and Automotive
market
• Pragmatic and direct approach of
the project execution
• Support in addressing cultural
issues with Spanish speaking
countries
Best added-value for Clients
(local and international) in the
EMEA and America
TEFEN + FeedBackGround
parthership
6

7.  Experienced, large and highly known management consulting companies
 Rich consulting experience taking into account the complementarity of experiences in different
industries and countries
‒ Tefen relevant experience includes: IGCC technical / economical evaluation model; analysis,
risk assessment and implementation plan definition for plant construction; support in
designing IGCC O&M best practices;
‒ FeedBackGround relevant experience includes: support in strategic decision making for
manufacturing companies, and support in Operational Excellence strategy process (Lean,
Kanban, 5S, TOC,…)
 Networking and benchmarking opportunities, e.g.:
‒ Spanish companies with interests in Germany, Israel, Italy, UK, Romania and USA
‒ Israelite companies with interests in Spain and Central and South America
Tefen / FeedBackGround relevant expertise
7

8. 8
Tefen Clients (Partial list)
Recent Life Science ClientsAll Sectors
We have worked with 43 of the top 50
life sciences businesses

9. 9
 Results-driven
 Guaranteed delivery of significant, quantifiable performance improvements
 Systematic, proven approach to sustainability through amassed experience of developing /
embedding a lean quality culture in life sciences businesses
 Cooperation
 By building trust, our partnership and team work ensure continuous, sustainable
improvement
 Building on work already done by you, working where we add most value
 Setting clear roles - this is your programme to own, not ours
 Organizational culture
 Big enough to drive global business transformations, but small enough so that our senior
people are deeply engaged
 Our highly-skilled and professional people are fully committed to equipping you with the
knowledge and tools to support you in reaching your goals
 Experienced LSS trainers, Master Black Belts, Coaches with life sciences backgrounds
 Pragmatic and building on real experiences in the industry
 Getting deeply involved and working at the influencer level where appropriate
What makes us different

10. 10
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
Appendix
3.
4.
5.

11. 11
OperationalStrategic
The scope of Tefen’s Lean Quality programmes
Org structure
(CoE, Value-stream, roles)
Lab layout
(macro, micro, 5S)
Strategic
objectives
Quality philosophy
(PAT, RBA, CofA, sourcing)
Overall performance
(cost, quality, service)
Technology
(IT & assays)
Tier 2
Operational
improvements
Tier 1
Strategy,
performance
Tier 3
Processes and practices
•Financial (QC cost per site, batch & test; batch & test per FTE …)
•Customer (QC & QA lead-times; delivery performance …)
•Process (OOS, OOT, RFT, lab errors, deviations time & workload …)
•Process (Flexibility, productivity, utilisation - human & equipment)
•Org metrics – spans, layers, direct/indirect ratios, absenteeism …)
Data normalised & selected for comparability: type, size, scope, volumes, complexity
Testing and managing
deviations
Measuring & monitoring
Planning & scheduling
Continuously improving

12. 12
Required outcomes for a lean quality transformation
High
value-
added
content
 High proportion of QC
activities adding value
 Minimized waste (OOS,
retests, admin,
documentation)
In pursuit
of perfection
 Leaders drive success
from their teams
 Relentless pursuit of
waste and cost
 CI an integral part of daily
operations
At the
pull of
the cus-
tomer
 Campaigning only within
lead-time targets
 Customer does not wait
for Quality because of big
batches
Speedy
product flow
 QO in synch with value
streams – no queuing
 Speedy deviation and
problem handling
Aligned
to the
customer
 Org structure, planning
processes and layouts
aligned to the value-
streams
Improved service
Reduced cost
Superior managers

13. 13
Strategic
objectives
Tefen’s transformation overview
 Approach tailored to
site needs (size, MPS
maturity, baseline)
 Exploit Tefen
benchmark data from
other sites
 Enhanced preparation
& questionnaires
before each diagnostic
 Use time on site to
develop root causes
and agree action plans
with the teams
 Bringing learnings from
other Quality
Organisations
CURRENT
Performance Practices
STRATEGY
Causes
Benefits
Diagnostic
benchmarking
TransformationDetailed
design
VISION
Performance PracticesImpact
PLAN
Costs
Benefits
C
A
S
E
1 2 4
3

14. 14
 Organisational
change
 Systems change
 Process change
 People change
 Organisation redesign
 Network redesign
 Systems strategy
 Low hanging fruit
 Processes redesign
 Roles redesign
 Improved interfaces &
communication
 Behavioural change
Analysis & Design
Short-term
TransformationImplementation
Transformation journey: typical phases
2-3 years
Programme management & organisational development
Long-term
 Programme level
 Network targets and
performance
 Overall approach
 Governance, resources
 Change plan
 Site level
 As-is performance and
targets
 Site diagnostic
(processes, systems,
org, skills, practices)
 Lean/6S assessment
 Root cause analysis
 Opportunities and
benefits potential
 Site roadmap
 Challenge operating methods and practices
 Facilitate involvement of staff at all levels
 Implement KPIs & reporting tools
 Support pilot / feasibility projects
 Provide lean six sigma training and coaching
Project-driven Way-of-life

15. 15
 5S and cell design
 Kanban, one-piece flow
 Level loading
 Mistake proofing
 Visual controls
 TPM
 Org design
 Hypothesis testing
 DOE, Taguchi
 Regression, ANOVA
 Process mapping
 MOS and VA/NVA
 TAKT & lead-time
 OEE and SMED
 Logical maps
 Data collection
 Brainstorming
 5-whys, FMEA
 Role design
 Kaizen
 KPIs design
 Statistics & sigma level
 Process capability
 Yield improvement
 Standard work
 PDCA
 Systems design
 Problem solving
 Investment analysis
 SPC
 Procedures
Use of LSS tools: tailored to the timeframe and problem-type
 Value-stream
mapping
 Chartering
 Interviews and Voice
 Team-building
 Voice of the
Customer
 Stakeholder analysis
 Diagnostic analysis
 Benchmarking
 Cost/benefit
 Project selection
 Critical to Quality
Analysis & Design Implementation Transformation
Value Alignment Flow Pull Perfection
Define Measure Analyse Improve Control
LEANTOOLSCOMMONTOOLS6STOOLS
IMPROVEDEFFICIENCY
&EFFECTIVENESS
REDUCEDPROCESS
VARIABILITY

16. 16
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
Appendix
3.
4.
5.

17. 17
Diagnostic benchmarking to maximise value-stream performance
CURRENT
 Costs
 Delivery
 Flexibility,
 Lead-time
 Inventory
 Quality
 Productivity
 Headcount
 Layers, spans
PERFORMANCE
 `
`
PRACTICES
VISION
 Costs
 Delivery
 Flexibility,
 Lead-time
 Inventory
 Quality
 Productivity
 Headcount
 Layers, spans
PERFORMANCE PRACTICES
COMPETITIVE
Price
Quality
Service
Uniqueness
Ethics
CONSTRAINTS
Facilities
People
Supply
Demand
Cash
TRADE-OFFS
Long-term vs short-term
Utilisation vs flexibility
Cost vs risk
ROADMAP
 Gap between
current and
achievable
performance
BENEFIT
 Action plan, with
investment and
resources required
to achieve vision
state
COST
Business
case
STRATEGIC PRIORITIES
Tefen
benchmarks
Tefen
benchmarks
1 2
4
3
 Strategic approach
 Technology, systems
 Facilities, layout
 Org structure
 Planning, scheduling
 QA & QC processes
 KPIs, mgt &routines
 Culture, leadership
 Strategic approach
 Technology, systems
 Facilities, layout
 Org structure
 Planning, scheduling
 QA & QC processes
 KPIs, mgt & routines
 Culture, leadership
Impact analysis
Root cause analysis

18. 18
1a. Establish strategic priorities, drivers, trade-offs and principles
 Quality by Design
 Building quality into the product, processes & systems
 QbD during Pharmaceutical Development (ICH Q8) as well as during
Commercialization and In-Line supply
 Right First Time
 Straight through operation
 Eliminate non-value add
 Drive simplicity and error avoidance
 Decision making based on science, facts, data
 Application of principles of Quality Risk Management (ICH Q9)
 Application of principles of Competitive Decision Making
 Continue to ensure robust quality systems
 Establish and maintain a state of control that ensures a quality drug product
 Facilitate continuous improvement over the life cycle of a drug product (ICH
Q10 in development)
Functional principles
 Structured interviews to gain
understanding of priorities,
drivers, constraints and overall
philosophy
 Set high-level targets for cost,
quality, delivery metrics
1
2
3
4
5
Price Quality Delivery
performance
Uniqueness Responsibility Structural
management
Infrastructural
management
Supply-chain
management
Demand
management
Cash-flow Strategy
The criteria which could win orders The areas that could constrain the business
Drivers, constraints
Organisational principles

19. 19
1b. Prioritise QA and QC processes for redesign
Function
HR Mfg Packaging QC Engineering R&D Exec Mgt Finance Planning Logistics Purchasing Sales Mkt'ing
Level 1 Processes Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT Lab LT
Payroll 0.5 1 1.5 0
Recruitment 1 1 2 0
HR Policy 1.5 1 2.5 0
Training 2 2 1 1 1 7 0
Employee Issues 0.5 0.5 0
Works Council 0.5 0.5 0
Manufacturing & Release 88 54 3 54 19 2 1 1 3 1 0 148 78
Shipping 0 0 3 0 1 0 0 4
Purchasing 0 0 0 0 0 5 2 5 2
Supply Chain Mgt 1 1 0
R&D 6 6 0
NPI 4 4 7 2 17 0
Strategy-making 1 4 5 0
Sales 4 4 0
Promotion 1 1 3 5 0
Pricing 1 1 4 6 0
Packaging 1 44 45 0
Planning 1 1 0.5 2 5 9.5 0
Scheduling 0 0
QA policy 14 14 0
CapEx 2 2 0
Process Eng. 1 4 5 0
Maintenance Eng. 3 3 5 11 0
TOTAL 6 0 101 54 49 3 73 22 21 0 12 0 7 0 2 0 6 1 3 2 6 2 9 0 3 0 298 84
 Using PFM (process/function matrix) to map major business processes
within scope
 Impact on business drivers estimated per process
 Workload per department established
 Including impact on cost, lead-time, customer value, other drivers
 Processes prioritised according to impact on drivers
Example processes
 Sample management, Testing, Scheduling, Planning,
Deviation management, Documentation, Batch release,
QRM processes (PAT, RBA, etc), Equipment
management, Vendor certification, Test strategy,
Validation, CAPA, change control, Inspection readiness,
Calibration, Compliance management, SOP
management, Archiving, Customer management,
Escalation, RCP/RNP etc
Example PFM

20. 20
 Establish current state and impact on performance
 Workshops to identify the process steps, inputs and outputs
 Clarify accountabilities
 Calculate volume, inventory, flexibility correlations
 Challenge the way things are done
2a. Analyse processes and assess wastes, delays & rework
MANUFACTURING
PTOManufacturing
Quality
Operation
PlanningWarehouse
Weekly
meeting for
scheduling
Detailed
Product Line
scheduling
Manuf Supervisor
asks Manuf Admin
for WO opening
Batch Book -
(LIBRO
MASTRO)
filling (manual)
FPO in D3?
Ask planning
for FPO
confirmation
MPD approved
and OB
recipes
installed?
Planner
confirms FPO
in D3
FPO
transformed in
WO # (D3)
OK to Data
transfer from
D3 to PMX
Material list
and Analysis
request
printing
Material list
sent to
Warehouse
Analysis
request
attached to BR
MPD printing
(PMX)
Batch record
attachments
printing
Check material
allocation
(impegni)
WO trasfer
from D3 to
MHCS
(78880)
OB (CBS &
DBS)
inizialization
Product
managed by
Upper disp?
Material
delivered to the
line
Manual
material
inizialization in
MHCS
Batch record
ready to be
processed
Phisical
material check
Product
managed by
Upper disp?
Logical
material check
Material
consumption in
MHCS
(manual)
Logical
material check
(auto)
Start up and
line set up
WO run
In process data
entry
NO
YES
Reconciliation
and MHCS
charge to stock
Documentation
check
Check Manuf date in D3
Equipment hours
Labors Hours Check
Notes (Yield in Kg - EtOH)
Manufacturing
Date in D3
WO closure in
D3 (9250)
MANDATORY FIELDS
Yield
Labors Hours
YES
NO
YES
WO summary
print out
ARP Material
consumption
Sample
delivered to
QO
Bring Doc to
Release
Pharmacist
(2 days)
Is doc OK?
QA perform
doc check
Doc correction
Raise
investigation
action
is there a
process
problem?
Tablet weight
in DMS
Batch releaseTest bulk
NO
YES
NO
YES
Material
dispensing
Weekly
meeting for
scheduling
Weekly
meeting for
scheduling
WO raised in
D3
WO & MPD
check
MPD approval
and OB recipes
installation
NO
Weekly
meeting for
scheduling
File excel
Consolid
atein
one
function
Eliminate
Possible automation?
Find alternative Eliminate Interface project
Check bag integrity
Find alternative
Interface project?
Possible automation
with charge stock?
Possible automation
with charge stock?
Possible automation
with charge stock?
Possible automation
with charge stock?
Auto filling with
theoretical weight
Batch Record
Redesign
Batch record
archival
Envelope change
Batch record
redesign
Batch record
redesign
Example: deviation management
 Use Tefen benchmarks to
compare performance and
practices with others
 Observations within QC
labs to examine working
practices such as planning,
scheduling, testing,
documentation, layout,
management and
organisation, etc
 Quantify the impact on
performance (lead-time /
FTEs / Other costs)
Tefen LS Quality benchmark

21. 21
>60 LS Quality
organisations
>60 metrics
2b. Utilise Tefen’s benchmarks to reinforce analysis

22. 22
 Workshops to eliminate waste
 Eliminate NVA work
 Remove overlap/duplication
 Redesign accountabilities
 Improve QC activities such as planning,
scheduling, testing, documentation, layout,
management and organisation, etc
 Predict the benefits identified (lead-time / FTEs
/ Other costs)
 Create a list of ‘enabling projects’ required to
deliver the future state
3a. Create a vision: redesigned processes to eliminate waste & delay
MANUFACTURING
PTOManufacturing
Quality
Operation
PlanningWarehouse
Weekly
meeting for
scheduling
Detailed
Product Line
scheduling
Manuf Supervisor
asks Manuf Admin
for WO opening
Batch Book -
(LIBRO
MASTRO)
filling (manual)
FPO in D3?
Ask planning
for FPO
confirmation
MPD approved
and OB
recipes
installed?
Planner
confirms FPO
in D3
FPO
transformed in
WO # (D3)
OK to Data
transfer from
D3 to PMX
Material list
and Analysis
request
printing
Material list
sent to
Warehouse
Analysis
request
attached to BR
MPD printing
(PMX)
Batch record
attachments
printing
Check material
allocation
(impegni)
WO trasfer
from D3 to
MHCS
(78880)
OB (CBS &
DBS)
inizialization
Product
managed by
Upper disp?
Material
delivered to the
line
Manual
material
inizialization in
MHCS
Batch record
ready to be
processed
Phisical
material check
Product
managed by
Upper disp?
Logical
material check
Material
consumption in
MHCS
(manual)
Logical
material check
(auto)
Start up and
line set up
WO run
In process data
entry
NO
YES
Reconciliation
and MHCS
charge to stock
Documentation
check
Check Manuf date in D3
Equipment hours
Labors Hours Check
Notes (Yield in Kg - EtOH)
Manufacturing
Date in D3
WO closure in
D3 (9250)
MANDATORY FIELDS
Yield
Labors Hours
YES
NO
YES
WO summary
print out
ARP Material
consumption
Sample
delivered to
QO
Bring Doc to
Release
Pharmacist
(2 days)
Is doc OK?
QA perform
doc check
Doc correction
Raise
investigation
action
is there a
process
problem?
Tablet weight
in DMS
Batch releaseTest bulk
NO
YES
NO
YES
Material
dispensing
Weekly
meeting for
scheduling
Weekly
meeting for
scheduling
WO raised in
D3
WO & MPD
check
MPD approval
and OB recipes
installation
NO
Weekly
meeting for
scheduling
File excel
Consolid
atein
one
function
Eliminate
Possible automation?
Find alternative Eliminate Interface project
Check bag integrity
Find alternative
Interface project?
Possible automation
with charge stock?
Possible automation
with charge stock?
Possible automation
with charge stock?
Possible automation
with charge stock?
Auto filling with
theoretical weight
Batch Record
Redesign
Batch record
archival
Envelope change
Batch record
redesign
Batch record
redesign
Manufacturing
PTO
Quality
Operations
ManufacturingPlanningWarehouse
NO NO
YES
YES
NO
YES
NO
Possible
automation?
Automation of
printing sequence
Interface
project Check bag
integrity only
Batch Record
Redesign
MANDATORY
FIELDS
Yield
Labors Hours
Manufacturing
date in D3
Batch Record
Redesign
Batch Record
Redesign
Release
pharmacist near
to manuf area
SMED and
TOP
Doc correction
OB (DMS)
inizialization
Doc to Release
Pharmacist
(2 days)
Material
dispensing
Batch release
MPD approved
and OB
recipes
installed?
Weekly
meeting for
scheduling
Is doc OK?
WO summary
print out
Product
managed by
Upper disp?
WO runWO & MPD
check
Reconciliation
and MHCS
charge to stock
Raise
investigation
action
Raise WO
Start up and
line set up
is there a
process
problem?
MPD printing
(PMX)
Phisical
material check
Material
delivered to the
line
QA perform
doc check
Sample
delivered to
QO
Manual
material
inizialization in
MHCS
Improved
Batch record
archival (no
env change)
Scheduling and
planning WO
MPD approval
and OB recipes
installation
In process data
entry
Test bulk
Batch record
attachments
printing
Weekly
meeting for
scheduling
ARP Material
list check
Documentation
check
FPO confirmed
in D3 and
transform in
WO
WO trasfer
from D3 to
MHCS
(78880)
Weekly
meeting for
scheduling
WO closure in
D3 (9250)
OK to Data
transfer from
D3 to PMX
1.Weekly meeting for scheduling
2. Detailed Product Line scheduling
3. Ask for WO opening
performed by one function (Planner/Buyer)
1. Assign and track WO #
2. Raise WO # in D3
performed by one function (Planner/Buyer)
 Sign off future
state with
process owners
 Escalate major
conflicts to
steering
committee

23. 23
3b. Redesign roles and interfaces
 RACI to determine responsibilities and
communication
 Use principles of effective roles (team-
supportive, process-centric, span, size,
leadership roles, plan-do-review
embedded, responsibility for CI, etc)
Accountabilities BBSC Responsibilities On Yr Q M W D H C I C I C I C I
Financial
Adherence to Budget
Labour • Participates in development of profit plan and EAs;
Overtime
Identify and facilitate Continuous Improvement opportunities that result in
cost savings
Maintenance Spend including spares used
but not holding of spares • Assures IPT headcount meets production and company needs.
Training
Rhythm time attainment Input into new product planning and development of capital plans
Write Offs Process
Rework
Material Variance • Serves as liaison between shifts, teams, IPTs, and COEs;
Energy • Participates in Daily Walk Through of IPT, and in plant tours as needed
Right First Time - Product & Documentation • Approves IQ/OQ/PQ/CC documents ;
On time Delivery - Product & Documentation
Product Quality
OEE (Inc Change-over time)
Manages adherence to MPS metrics using tracking, trending and visual
management
Yields • Participates in Event Management and Renewal
Cycle Time Internal Maintain internal inventory system (Kanban levels)
Compliance & HSE SOP adherence training and Revision
Equipment Ownership Systems expert - FDA, MHRA
Number of Atypicals
• Coaches operators and mechanics in an Employee Involvement Culture
with the goal of achieving total empowerment utilizing a “STAR” model
approach;
Atypical close-out time
Assists the team with development of objectives and ensures alignment with
site goals and provides feedback to direct reports
Maintenance of PIR
Develop new & Maintain SOPs
Assesses employee training/development needs to enhance team
performance;
Training • Recognizes and addresses direct report performance
Performance management Responsible for ensuring all Safety and Quality compliance in all areas
People Development Empowerment - Tools, Knowledge/ Skills & Accountability
Attendance Management Facilitates cross-training
IPT Co-ordinator
Frequency A
Consult / Inform
B C D
Example RACI
Effective role design

24. 24
Example QA
3c. Redefine any beneficial changes to org structure
•Authorization of BOM’s
and Artwork approval
•Inspection management
• (agency, customers, divisional)
•Annual Reviews
•Third Party Quality Management
Regulatory requests / RAS-CMS liaison
•Quality Validation oversight
•Stability program management
•Change control management
•DMF-SMF licenses
•Management of SOP system
•GMP training oversight
•Final batch disposition
•Real-time batch record review
•Atypical guidance and support
•Significant atypical investigations,
• fact findings and management of
•market actions
•Direct testing, or coordination thereof,
•for products that are included in IPT
•Annual Reviews
 Organization with autonomy
necessary to optimize
supply-chain processes
 Built around the process
and value stream
 Driving end-to-end
responsibility
 Minimize management
layers; optimum team size
approx. 8 people
 Preserve functional
excellence
 Maintain critical mass in
COE and global interactions
 Rotation and development
between COE and Ops
 Core functions in value-
streams without excess
duplication

25. 25
3d: Set new performance targets
 Quantify new performance levels (workload, throughput, delivery
performance, lead-time), and analyse further opportunities to combine/
add activities to the role using
 Simulation & time study data
 Activity-based models / management estimations
 Tefen benchmarks

26. 26
Action-planning & costing
Gap analysis (benefits)
4. Create action plan
 Action-planning workshops to agree the future state and how to reach it
 Gaining consensus amongst the Quality Leadership and Management teams
Business case

27. 27
Deliverables and benefits from Tefen’s Quality Diagnostic
Deliverables
 A feedback report, delivered within the
context of local strategies
 An evaluation of the scale and priority of
requirements with a quantified analysis
of any trade-offs
 Data collected and analysed against
benchmarks (cost, quality, delivery,
inventory, flexibility …)
 Major reasons for performance gaps,
across the entire lab’s operations
 An assessment of potential improvement
benefits and a balanced set of targets
based on the requirements
 A proposed engagement approach to
support the site to reach the defined
targets, if appropriate or necessary
Benefits
 Secures a clear, common, objective and data-
driven understanding of true lab performance
 Proven to support
 reduction in cost per test
 reduction in lead time
 elimination of backlogs
 increase in OTD
 reduced investment needs (space, equipment)
 Supportive of CI culture

28. 28
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
Appendix
3.
4.
5.

29. 29
A joint workplan will be developed collectively to schedule meetings and sessions
Client Tefen
 To drive the design for programme
/ roadmap design in a structured
fashion
 Set the momentum and sense of
urgency to get the programme
underway
 Facilitate appropriate approaches,
principles, techniques and learning
from benchmarks and experience
 To own and lead the programme
 To sponsor and drive results
 To define the guiding principles
 To resource the projects
 To engage in training at all levels
 To resolve issues as they arise
 To empower your employees
 To set up programme structure / PMO
 To identify appropriate projects and roll out strategy
 To customise approach to site needs
 To agree the right operating partnership framework
How we typically work during implementation

30. 30
Lean Quality – typical features in implementation

31. 31
String Diagram – After
Travel distance – 50m2
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
String Diagram – After
Travel distance – 50m2
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
Process and productivity
String Diagram – Before
Travel distance – 300m2
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
String Diagram – Before
Travel distance – 300m2
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array
Sampling Speciation HPLCs LAL Weighing Stores AutoclaveStores
Isotopes
Incubators
DOKA
String Diagram- Before
Travel distance- 300m
String Diagram- After
Travel distance- 50m
 Reduce documentation
 Improve macro and micro layout
 Implement work cells
 Improve discipline (breaks, etc)
 Ensure sufficient equipment
 Maximize time spent testing

32. 32
Planning and scheduling
 Using value-stream scheduling principles
 Aligned to the lean org structure
 Cycle-planning for common test types
 Increasing visibility of workload plan
 Supported by software (if required)
 Supported by visual management tools

33. 33
Leadership and KPIs
 Coaching of Lab management and Team Leaders to enhance
leadership performance
 Short interval control (KPIs) to drive improvement activities
 Clear, relevant team and personal objectives
 Focusing on what QC can affect (cost per test, delivery
performance, lead-time, efficiency, retest rate, skills, CI
activities, etc)
 Supported by management processes (action meetings,
walkthroughs, PDCA)
Growing the
organisation
Leaders need
to give:
1. Means
2. Ability
(how and why)
3. Holding to
account

34. 34
Org development and change management
 Practical change management method
 Heavy focus on kaizens, workshops, etc
 Supported by training and coaching
 Knowledge transfer a key element for rollout
Change management Workshops Training and coaching
Lean
Council
Lean Experts to
train Champions
and employees
Lean Champions full
training champion per area
over 3-6 months
Project Team Members Lean
Awareness Training Entire area
over the next year
Successful
change
Understand
The need
Facilitate
Communication
Create
The vision
Show
Management
commitment
Measure
and reward
Provide
tools

35. 35
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
Appendix
3.
4.
5.

36. 36
Making lean six sigma transformations stick
Your
culture
Roles, skills,
experiences
Systems &
processes
Programmes
& projects
Well
aligned
Standard
methods
Proactive,
empowered

37. 37
 Organisation structured around processes
 Departmental  process structure
 Cross-functional teams working on process improvement
 Optimising value-stream performance (not local departmental silos)
 Clear, process-based performance objectives
 True understanding of customer needs (internal / external)
 High quality decision-making within each process
1. Well-aligned: with customers and the organisation
 Clear accountability and authority to make change
 Local metrics linked to customer and
organisational objectives
 Work planned, executed and monitored at process
level
Mills et al, 1995

38. 38
2. Feeling empowered: held accountable for change
 Managers devote time and energy to teams and individuals
 Encouraged and required to grow in responsibility
 Teams trained, coached, supported, given the tools
 Consistent approach to reward and criticism
 Moving towards self-managed value-streams
 Performance measures within direct control of team
members
 Process-execution team includes all required roles
 Building team confidence

39. 39
 Culture of visual management
 A3 & whiteboards to encourage ownership & resolution
 Leaders engaging face-to-face with problems in highly visible way
 Short feedback loop, encouraging can-do and trust
3. Standard work: culture of visual management
 Culture of good standard practices
 Good management practices infused
 Daily review meetings
 Weekly review and planning meetings
 RACIs and DITLO (day in the life of)
 Knowledge managed centrally
 Good practices pushed from mature to
immature sites

40. 40
2009 2010 2011 2012
€/unit
27
26
26
25
OvH
Nr.
innov
5
10
20
25
UVI
BN %
65
75
80
83
OEE
€/unit
1.4
1.4
1.3
1.3
Mat
€/unit
143
156
162
169
Lab
days
122
66
55
50
LT
Nr.
event
s
<3
0
0
0
CSR
%
91
94
96
97
OTD
€K%%
1310
1690
1500
1500
CoGS
red’n
82 90
7872
7169
8479
OrgCF
€/unit
27
26
26
25
OvH
Nr.
innov
5
10
20
25
UVI
BN %
65
75
80
83
OEE
€/unit
1.4
1.4
1.3
1.3
Mat
€/unit
143
156
162
169
Lab
days
122
66
55
50
LT
Nr.
event
s
<3
0
0
0
CSR
%
91
94
96
97
OTD
€K%%
1310
1690
1500
1500
CoGS
red’n
82 90
7872
7169
8479
OrgCF
NPI
EVS
IVS
CM
Global
Local
Shared
MakevsBuy
VSM
PFM
PAT
Portfolio efficiency
RRS
Process mapping
Programme Mgt DFM
Kanban
QAS
TCO
VMI
SRM
RCM
OAC
M
ate
rialwaste
reduction
OEE
Variability reduction
SM
ED
SM
ED
Rhythm
wheel
Process streamliningStock levelling
Visual m
anagem
ent
OEMaturityAudit
OrgSurvey
BSCCIStructure
PCO
Kaizen
CIevents
Line balancing
W
arehouse
optimisation
5S
T&D
T&D
NPI: New Product Introduction
IVS: Internal Value Stream
CM: Change Management
EVS: Extended Value Stream
NPI: New Product Introduction
IVS: Internal Value Stream
CM: Change Management
EVS: Extended Value Stream
LEVEL 5 value-stream maturity
4. Programmes and projects to stimulate momentum
 Top-down initially
 Site Leadership Team translate strategy into manufacturing objectives
 Teams and leaders trained in problem solving approach and tools (LSS…)
 Strategy, plans and successes consistently communicated through cascaded communication
and awareness training process.
 Sites generate their own OpEx roadmaps to deliver strategy & goals
 Projects selected with line-of-sight to site goals (OEE, cost, delivery, FCAs)
 Clear understanding of site improvement pathway
and project interdependence to deliver strategy
 Initial projects used to learn, coach and celebrate
success
 Momentum sustained through communication
process delivering reinforcement and consistent
messages
Kaplan & Norton, Porter, 1992, 1994

41. 41
 Performance management
 Cascaded KPI system – relevant, understandable, measurable.
 Team and individual performance review process: easy to use, benefits individuals, balance of
outcomes and team working
 Capabilities building
 Right blend of formal education and coaching on the job
 Skills matrix; personal development plans
 Comprehensive training curriculum
 Recognition for advancing capabilities
5. Systems and processes to support culture change
 PMO and governance processes
 Clear accountabilities for programme delivery
 Robust project selection and chartering – A3 and
project portfolio management.
 Plan-do-review process at all levels: getting results,
resolving issues, learning
Kaplan & Norton, 1992

42. 42
6. Roles and skills transformed to meet new needs
 RACI defined for each process and participant
 Process outcomes driven accountabilities
 End to end view to avoid redundancy and omission
 All understand their role and the fit with the whole
 Management and Leadership expectations
 Accessible leadership and management training curriculum
 Clearly defined expected competency levels defined for all levels of leadership and
management
 Regular assessment processes and support coaching
 Roles, knowledge, skills and attributes defined for each profile
 Purpose and impact
 Accountabilities, expectations and measures
 Skills and capabilities needed: technical, general and leadership

43. 43
QC diagnostic benchmarking - linking performance to practices
Tier 2
Tier 1
Tier 3
1. Financial, Customer, Quality performance outputs
 including QC cost & FTEs per site; cost per batch & test;
batch & test per FTE / direct FTE; QC & QA lead-time for
test and release; delivery performance / schedule
adherence; OOS, OOT …
 Data split by raw material, IPC, bulk, finished, packaging,
microbiology, stability
2. Quantified metrics enabling Tier 1 performance
 including direct to indirect ratios, value-added content,
equipment OEE, RFT, lab errors, investigations, time spent
on investigations and retests, analyst flexibility / skills
cover…
3. Detailed operational practices
 including org structure, roles, span, analyst & support staff
activities, availability, absenteeism, space per analyst and
test, workplace organisation, travel time, LIMS utilization,
planning and scheduling tools, use of technology,
maintenance practices, outsourcing, reduced testing,
CofAs, training practices, CI processes and culture, use of
KPIs, management routines…
Data normalised & selected for comparability: type, size, scope, volumes, complexity

44. 44
Tier 1 – Performance outputs (selected graphs)

45. 45
Tier 2 – Enablers (examples)

46. 46
Tier 3 – Detailed operational practices (examples)
4.

47. w w w . t e f e n . c o m
www.feedbackground.com
S t r a t e g y Op eratio n s Ex ce ll en ce Proj ec t Ma n ag emen t Org an i za ti on al De ve lo pmen t
Eli Pelleg – Tefen founder & COO Angel Miranda – Business Consultant
Email: Elip@tefen.co.il Email: angel.miranda@feedbackground.com
Tel: +972 3 9775151 Tel: +34 934856248
Mobile: +972 74 7211222 Mobile: +34 608 036560