tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

28
S t r a t e g y O p e r a t i o n s E x c e l l e n c e P r o j e c t M a n a g e m e n t O r g a n i z a t i o n a l D e v e l o p m e n t 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.

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Page 1: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

S t r a t e g y O p e r a t i o n s E x c e l l e n c e P r o j e c t M a n a g e m e n t O r g a n i z a t i o n a l D e v e l o p m e n t

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.

Page 2: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

2

Contents

1.

2.

Introducing Tefen

Transformations in Quality

Lean Labs Diagnostic Benchmarking Process

Implementation phase

3.

4.

Page 3: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

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

Page 4: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

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

Page 5: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

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

Page 6: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

6

Tefen Clients (Partial list)

Recent Life Science Clients All Sectors

We have worked with 43 of the top 50 life sciences businesses

Page 7: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

7

Contents

1.

2.

Introducing Tefen

Transformations in Quality

Lean Labs Diagnostic Benchmarking Process

Implementation phase

3.

4.

Page 8: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

8

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

Transformation Detailed design

VISION

Performance Practices Impact

PLAN

Costs

Benefits

C A S E

1 2 4

3

Page 9: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

9

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

LEA

N T

OO

LS

CO

MM

ON

TO

OLS

6

S TO

OLS

IMP

RO

VED

EFF

ICIE

NC

Y

& E

FFEC

TIV

ENES

S R

EDU

CED

PR

OC

ESS

VA

RIA

BIL

ITY

Page 10: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

10

Contents

1.

2.

Introducing Tefen

Transformations in Quality

Lean Labs Diagnostic Benchmarking Process

Implementation phase

3.

4.

Page 11: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

11

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

Page 12: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

12

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

Page 13: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

13

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

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14

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

PT

OM

anu

factu

rin

gQ

uality

Opera

tion

Pla

nnin

gW

areh

ouse

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 upWO run

In process data

entryNO

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 correctionRaise

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

ate

in

one

functio

n

Eliminate

Possible automation?Find alternative Eliminate Interface project

Check bag integrity

Find alternativeInterface 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

Page 15: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

15

>60 LS Quality organisations

>60 metrics

2b. Utilise Tefen’s benchmarks to reinforce analysis

Page 16: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

16

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

PT

OM

anu

factu

rin

gQ

uality

Opera

tion

Pla

nnin

gW

areho

use

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 upWO run

In process data

entryNO

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 correctionRaise

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

ate

in

one

functio

n

Eliminate

Possible automation?Find alternative Eliminate Interface project

Check bag integrity

Find alternativeInterface 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

PT

OQ

uality

Operations

Manufa

ctu

rin

gP

lannin

gW

arehouse

NO NO

YES

YES

NO

YES

NO

Possible

automation?

Automation of

printing sequence

Interface

projectCheck 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 correctionOB (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

actionRaise 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

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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

FinancialAdherence 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.

TrainingRhythm time attainment Input into new product planning and development of capital plans

Write Offs ProcessRework

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

Communications Retention and Engagement of key talent

Employee Commitment & Engagement

Actual score on MPS audit

• Provides input review and approval for atypical , observation, and process

capability investigations;

Scores on Empowerment survey

Working Relationships (Internal) • Reviews and approves safety investigations;

Accurate Data

• Identifies quality-related trends and facilitates implementation of corrective

actions

Maintain positive working relationships

Using and sustaining visual management systems for their work area as

appropriate

Improving own business processes

Complying with systems of work SOPs and

guidelines related to your role Safety of self and others

IPT Co-ordinatorFrequency A

Consult / Inform

B C D

Example RACI

Effective role design

Page 18: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

18

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

Page 19: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

19

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

Page 20: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

20

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

Page 21: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

21

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

Page 22: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

22

Contents

1.

2.

Introducing Tefen

Transformations in Quality

Lean Labs Diagnostic Benchmarking Process

Implementation phase

3.

4.

Page 23: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

23

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

Page 24: Tefen feed background_ls lean quality diag_implementation_support_2012 v1.2

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String Diagram – AfterTravel 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 – AfterTravel 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 – BeforeTravel 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 – BeforeTravel 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

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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

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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

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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

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w w w . t e f e n . c o m

www.feedbackground.com

S t r a t e g y O p e r a t i o n s E x c e l l e n c e P r o j e c t M a n a g e m e n t O r g a n i z a t i o n a l D e v e l o p m e n t

Eli Pelleg – Tefen founder & COO Angel Miranda – Business Consultant

Email: [email protected] Email: [email protected] Tel: +972 3 9775151 Tel: +34 934856248 Mobile: +972 74 7211222 Mobile: +34 608 036560