the quality transformation journey · going from product focused to process focused quality tqm •...
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© Copyright Tefen (IL) Israel Ltd.This Document contains data that are proprietary to Tefen (IL) Israel Ltd., and is provided only for limited use in reviewing and evaluating the subject Document. These data shall not
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The Quality Transformation Journey
November 5th , 2013
© Copyright Tefen (IL) Israel Ltd.This Document contains data that are proprietary to Tefen (IL) Israel Ltd., and is provided only for limited use in reviewing and evaluating the subject Document. These data shall not
be otherwise used, copied, or disclosed without the express permission of Tefen (IL) Israel Ltd.
Trends in Quality Management and Methodology
Rotem Greener, Director, Tefen IL
33
Modern quality organizations face challenging requirements
• Quality as part of the
business strategy
• Reduced revenues, share &
margins
• Tightened Regulations
• Demand for reduced Lead
Time
• Increased data
management complexity
x
• Quality at top management
level – no longer a support
function
• Reduce cost of quality
• Zero tolerance for mistakes
• Integrated approach for QA
and QC operations
• Improve QC efficiency
• Effective real time analysis
Trends
Implications
Going from product focused to process focused quality
TQM
• Quality as a
purpose
• Focus on product
quality
1950’s-
1970’s
1980’s
Lean – Quality at the source
• Recognized the
crucial effect of the
process on quality
• Empowers
employees to
achieve “Zero
Defects”
1990’s
-2000
Six Sigma
• Focus on the
variance of the
process
• Strong emphasis
on statistical
thinking and fact
based approach 2010-
Quality Engineering
• “Right First Time”
approach in focus
• Design robust and
forecasted
processes in
various industries
Demand for reducing cost of quality is increasing
55
Quality Management Objectives (LNS benchmark of 500 discrete manufacturing companies 2012)
A clear definition and methodology for measurement & analysis of
quality costs is required in the organization
66
The quality organization is evolving to ensure value
Quality as part of the
Value Stream
Quality as part of the
Value Stream • QC embedded in the value stream organization
Lean QualityLean Quality
• Avoid over-compliance
• QC & QA processes improvement that reduce lead time and increase
efficiency – e.g. batch records, sampling and testing
• Certify non-professional operators to perform QC work on the line
Quality support to
R&D
Quality support to
R&D
• Quality organization involved in defining market requirements
• DFX implementation
Implementing Statistical Thinking
Implementing Statistical Thinking
• Customers suffer mainly from the variance of the process
• The idea – Putting the variance up front as part of the daily analysis
across the organization and not just in the quality department
Statistical Thinking
� The average is just an average
� Make sure you eliminate irregularities
� Always use standard deviation to challenge
your conclusions
� For Lead time analysis it is better to use
median and variance (long tail effect)
� Use SPC to control the process, not
just the product
77
Train your staff to think and act statistics
© Copyright Tefen (IL) Israel Ltd.This Document contains data that are proprietary to Tefen (IL) Israel Ltd., and is provided only for limited use in reviewing and evaluating the subject Document. These data shall not
be otherwise used, copied, or disclosed without the express permission of Tefen (IL) Israel Ltd.
Quality360 Methodology
So what needs to be done?
Effective processes with minimum waste and
minimum variance along the entire value chain of
the product / service
Certification & Standardization
Compliance with regulatory requirements,
certification and standardization of the
product/ service
• Optimal performance level of all product / service abilities
• Compliance with product / service quality targets
Performance & Failures
The ability to identify customer needs and
provide product / service beyond
expectations
Exceeding Customer Expectations
Effective Processes
In order to implement the standards and exceed them over time we have to build an optimal operating model
1010
Creating a quality culture
and continuous improvement
Creating a quality culture
and continuous improvement
Understanding and predicting
customer needs
Understanding and predicting
customer needs
Quality management
and support of core-processes
Quality management
and support of core-processes
Organizational culture and capabilities
building
Organizational culture and capabilities
building
Development and
implementation of quality
methodologies
Development and
implementation of quality
methodologies
Management InfrastructureManagement Infrastructure
The purpose of the operational model is to create a continuous improvement process that will support meeting quality targets
Understanding and predicting customer needs - delivering a product / service with properties that are beyond the customer expectations
1111
Basic
Performance
Excitement
Performing activities correctly will not increase the satisfaction but their absence will cause dissatisfaction
CategoryDefinition
Performing activities correctly will cause high satisfaction and their absence will cause dissatisfaction (satisfaction is proportional to performance level)
Performing activities will cause high satisfaction and perception of the product /service as of high quality (“WOW effect”)
Kano Model
Satisfaction
FulfilledNot fulfilled
Indifference Area
Dissatisfaction
The quality organization needs to develop skills for understanding market and customer behavior
Quality management and support core processes
1212
Organizational culture and capabilities building in the organization - how we build capabilities?
1313
Provide tools and
knowledge through
training and coaching
Create a unified
language of quality
Use change management
tools with collaboration
of the management
1414
Methodologies and tools
USLLSL
USLLSL
USLLSL
failure!
EliminateDefective
items!
Lower Variance
target
xbar (m)
s
LSL
s s s s s s
USL
σσσσ
Continuous improvementSix Sigma
Variability
reduction
Qu
ali
ty m
eth
od
& t
oo
lsManagement
performance
Root Cause :analysis
5 why’sfishbone
CAPA
Risk management
Summary
The quality organization should no longer act or be considered as a
support function, but as part of the value stream
The process and the product are gradually designed to maximize
robustness and self testing
The quality organization should be involved in analyzing and
understanding of customer needs
© Copyright Tefen (IL) Israel Ltd.This Document contains data that are proprietary to Tefen (IL) Israel Ltd., and is provided only for limited use in reviewing and evaluating the subject Document. These data shall not
be otherwise used, copied, or disclosed without the express permission of Tefen (IL) Israel Ltd.
Lean Transformations in Quality -Case Study
QC Labs operations in a leading pharmaceutical company
Pete Caldwell, Partner , Tefen UK
17
Improvements in Quality impact the whole value-stream
Not a support function…
But an integral part
of the value-stream’s
performance
An integral
part of the
value-stream
Q
Q Q Q
• Improving cost, quality & performance
• Avoiding local optimisation
• Implementing continuous improvement
Continuous improvement drives value stream improvements; not local optimisation
18
Improvements in Quality impact the whole value-stream
Not a support function… Q
Q Q Q
The ultimate
QP QP QP QP QP
19
Improved service
Reduced cost
Superior leaders
Lean Quality: not just cost ............
Highvalue-
added content
Highvalue-
added content
� High proportion of QC
activities adding value
� Minimized waste (OOS,
retests, admin,
documentation)
In pursuitof perfectionIn pursuitof 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
customer
At the pull of the
customer
� Campaigning only within lead-time targets
� Customer does not wait for Quality because of big batches
Speedy product flow
Speedy product flow
� QO in synch with value streams –no queuing
� Speedy deviation and problem handling
Aligned to the customer
Aligned to the customer
� Org structure, planning processes and layouts aligned to the value-streams
� 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
Vision & strategy
Short-term
TransformationImplementation
Transformation journey
� Contribute to the overall strategy
� Understand current performance and ‘blockers’
� Develop a clear vision and commitment
� Address all areas of scope (strategic and operational)
� Build an action plan; gain commitment
� Build a governance process
2-3 years
Programme management & organisational development
Long-term
� 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
Vision & strategy TransformationImplementation
Start with a vision! (and a strategy)
2-3 years
CURRENT
� Costs
� Delivery, lead-time
� Quality
� Productivity
� Headcount
PERFORMANCE
� Strategic approach
� Technology, systems
� Facilities, layout
� Org structure
� Operation processes
PRACTICES
VISION
� Costs
� Delivery, lead-time
� Quality
� Productivity
� Headcount
PERFORMANCE
� Strategic approach
� Technology, systems
� Facilities, layout
� Org structure
� Operation processes
PRACTICES
Impact analysis
STRATEGY
� Between
current and
achievable
performance
BENEFIT
� Action plan, with
investment and
resources required
to achieve vision
COST
Business
case
STRATEGIC PRIORITIES
Tefenbenchmarks
Tefenbenchmarks1 2 4
3
Root cause analysis
BENEFIT
COMPETITIVE
Price
Quality
Service
Uniqueness
CONSTRAINTS
Facilities
People
Supply
Demand
Cash
TRADE-OFFS
Long-term vs short-term
Utilisation vs flexibility
Cost vs risk
Establish strategic priorities, drivers, trade-offs and principles
� Structured interviews to gain understanding of priorities, drivers, constraints and overall philosophy with its principles and trade-offs
� High-level targets for cost, quality and delivery metrics
� Prioritise QA and QC processes for redesign
� Process/function matrix to prioritise the key business processes according to their impact on quality and drivers, such as workload per department, cost, lead-time, customer value etc.
Gap Analysis (setup elements)
� Quality philosophy:
� Error-proofing?
� 100% testing?
� Risk management?
� Testing at source?
� Raw material pre-approved?
� Organizational structure:
� QC reports to manufacturing?
� QC structure aligned to product-streams of functional?
� Empowerment? Culture of improvement?
� Technology:
� Test methods?
� Information management?
� Layout:
� Proximity? Co-location?
� Functional layout? Or product-streams?
� Workplace organisation & 5S?
Gap Analysis (operational elements)
� Planning:
� Time-standards?
� Capacity models?
� Skills matrix?
� Processes for matching capacity with demand?
� Scheduling and doing the core testing operations:
� Daily scheduling?
� Time-standards?
� “Standard work”
� Simple processes
� Checking and managing:
� Getting data from the IS system
� Time-standards
� Leading, and balanced, metrics
� Continuously acting on learnings:
� Improvement processes
� Spare resource
� Culture and rewards
A lean quality vision
Aligning resources to customer needs
Capacity plans + flexibility = amount and skills of people needed
�Skills gaps identified and prioritised
according to resources modelled
�Allowing training and resourcing
strategies to be defined to meet
demand
Resource modelling based on standards Training strategy
Activity standards to
plan resources and meet demand
Skill gaps assessed for each resource
Align
QUALITY CONTROL ORGANIZATION
BIOCHEMISTRYGENERAL
CHEMISTRYTISSUE CULTURE MICRO-BIOLOGY
EARLY SHIFT
DAY SHIFTEARLY SHIFT
LATE SHIFT
DAY SHIFT
UPSTREAM DOWNSTREAM PACKING
NIGHT SHIFT
GENERAL
SAMPLE MGT
LATE SHIFT
LAB HELPERS
QC SUPPORT
CHECK & VALIDATE
Recognising the problems with functional organisations Align
As s performance was poor
� Poor on-time delivery of QC before lean quality programme:
� Typically 20% - 40%
� Causes delays in manufacturing
� Prevents effective planning
� Lead-times too long:
� Typically 1 month for ½-finished product
� Manufacturing must wait for results before continuing.
� Costing millions of Euros per year.
� Two functional labs testing samples for one customer
� Lead-time excessive in non-chrom:
14 days!
� Takes too long to start (though test-
time is shorter)
� Coordination between activities
hindered by the org. structure
QUALITY CONTROL ORGANIZATION
RAW MATERIALS IN-PROCESS RELEASE MICRO-BIOLOGY
EARLY SHIFT
LATE SHIFT
NIGHT SHIFT
DAY SHIFT
EARLY SHIFT
LATE SHIFT
DAY SHIFT
LAB HELPERLAB HELPER
UPSTREAM DOWNSTREAM
LAB HELPER
PACKING
QC SUPPORTQC SUPPORTQC SUPPORT
LAB HELPER
QC SUPPORT
CHECK & VAL CHECK & VAL CHECK & VAL CHECK & VAL
HIGH-VOL PRODUCT
DAY SHIFT
High Vol Product
QC SUPPORT
LAB HELPER
CHECK & VAL
The beginnings of a process-centric organisation Align
Analysts' added-value content extremely low
� Analysts adding value only 21% of the time
� Benchmark for standard labs is 45%
� Best-in-class is 72%
0%
5%
10%
15%
20%
25%
30%P
erc
en
t o
f ti
me
de
dic
ate
d t
o a
cti
vit
y
0%
5%
10%
15%
20%
25%
30%P
erc
en
t o
f ti
me
de
dic
ate
d t
o a
cti
vit
y
Waste
MICROBIOLOGY
IN PROCESS CONTROL
IN PROCESSCONTROL
RAWMATERIALS
SAMPLEMICRO
BIOLOGY HPLC IPC REAGENT STORESSTORES
Example: HPLC set-up
Paying analysts to walk 3 km per day
� Travel distance: 300 m per test
� Heavy travel between sample room & lab, reagent room & lab
� Heavy travel within lab itself
� Can be minimized by workplace organization and cellular layout
Waste
Process simplification reinforced by work cells
Waste
MICROBIOLOGY
IN PROCESS CONTROL
IN PROCESSCONTROL
RAWMATERIALS
SAMPLEMICRO
BIOLOGY HPLC IPC REAGENT STORESSTORES
Process simplification to increase analyst productivity by 10%
� Lean layout includes:
� Workplace organization, process simplification & method standardization
� Travel distance reduced to 55 m per test
Example: HPLC set-up
Waste
Analysts' added-value content extremely low
� Added value: 40%.
� Through process simplification, optimization and standardization
� A good start, but a long way to go!
Multi-Observational Study of Analysts
0%
5%
10%
15%
20%
25%
30%
Pe
rce
nt
of
tim
e d
ed
ica
ted
to
acti
vit
y
March 2012
Waste
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
8 - 9 9 - 10 10 - 11 11 - 12 12 - 1 pm 1 – 2 pm 2 – 3 pm 3 – 4 pm
Hours
Acti
vit
y
ABSENT
BREAK
IDLE
SAMPLING
REAGENT PREP
TRAINING
TEST SUPPORT
LIMS
PAPERWORK
TEST 4
TEST 3
TEST 2
TEST 1
4 – 5 pm
Analysts wasting time at the beginning and end of the day
� Green blocks (added value) account for 20% of time
� Two hours at start of day with very low added-value
Waste
� Value-stream mapping (internal) to dispel complexity
� Shows major bottlenecks and their impact on flow
� Required QC processing time: 0.1 days
� Actual lead-time: 5 days
� ‘X-FACTOR’ = 100 (benchmark: 4 - 10)
� Lean scheduling and bottleneck management increase speed
Silo-organisations & poor bottleneck management hinder flow
47 minutes
15
minutes
6
minutes
10
minutes
WIP
0 days
Validate
Karl FischerAppearanceCollect Sample
WIP
2 daysWIP
1 day
65 minutes
Bromine
WIP
0 days
30 minutes
Typing Results
WIP
2 days
WIP
0 days
WIP
2 days
Speed
� Many tests benefit from campaigning
� Typical batch size is 20 (optimum batch size is 5)
� Huge delays to lead-time through unnecessary (default)
campaigning
� The essence of “pull” is to do the work only when it’s needed
Silo-organisations & poor bottleneck management hinder flow
Pull
Achieve strategic objectives by laying a strong foundation
Improve
these
metrics...
...to achieve
thisperformance
Predictive lead-time
Right first time
ImproveKPIs
CHECK: predictive indicators prevent poor performance
Pre
dic
tiv
e le
ad
-tim
eR
igh
t F
irs
t T
ime
An
aly
st
Fle
xib
ilit
yO
n-tim
e D
eliv
ery
Ac
tua
l lea
d-tim
eP
rod
uc
tivity
(Co
st)
KPIs drive active management – not just a reporting structure
By focusing on leadingindicators
Performanceis improved
Improve
4040
Transformation : KPIs owned by the people and easy to use
� Simple, automatic KPI reports
� Help people see what actions to
take, quickly and easily
� Well-defined escalation procedures
Simple reports & reporting structures ensure speedy resolution of issues
Improve
RESULTS
Cycle time & productivity have improved; quality unaffected
Cycle time has decreased
by 10 days to 17 days
Productivity has doubled since
implementation of KPI structure
Pilot is now 7th best lab in Tefen benchmark; up from 17th
� Through implementation of strong KPI structures and appropriate actions, pilot has seen dramatic improvements in productivity
� CT has also decreased due to increased analyst activity
� Quality of performance has not been effected, and is consistently above 97%
� By driving these actions towards site goals and strategy, PDCA structure and KPIs ensures performance is improved, aligned with product stream and owned by analysts
Aligned vision and holistic programme gives good results!
The future in now…
Robust process
and embedded
testing
Q
Q Q Q
Value Stream
P&Q P&Q P&QP&QP&Q
© Copyright Tefen (IL) Israel Ltd.This Document contains data that are proprietary to Tefen (IL) Israel Ltd., and is provided only for limited use in reviewing and evaluating the subject Document. These data shall not
be otherwise used, copied, or disclosed without the express permission of Tefen (IL) Israel Ltd.
Thank you!