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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
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
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
3.
4.
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
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
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
Tefen Clients (Partial list)
Recent Life Science Clients All Sectors
We have worked with 43 of the top 50 life sciences businesses
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
15
>60 LS Quality organisations
>60 metrics
2b. Utilise Tefen’s benchmarks to reinforce analysis
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
17
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
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
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
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
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
22
Contents
1.
2.
Introducing Tefen
Transformations in Quality
Lean Labs Diagnostic Benchmarking Process
Implementation phase
3.
4.
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
24
String Diagram – AfterTravel distance – 50m2
Microbiology IPC, VPT QC LAB Bio Image lab Raw Materials Array