managing efficiency in quality operation -...
TRANSCRIPT
cResults / ERD confidential 1
Continuous Improvement Platforms
Resource Planning, Scheduling, Cost of Quality and Efficiency
Management for QC Laboratorieswww.smart-qc.com
Batch Record Release Management and Overall QA Scheduling &
Efficiency Managementwww.cmanageefficiency.com
Value Added
Compliance
By cResults an IPS Affiliate
Effic
ienc
y, c
ost
and
Cycle
Tim
ewww.cresultsconsulting.com
KPIKPI
Boosting Operating Performance
For
Managing Efficiency in Quality OperationNovember 14, 2008
cResults / ERD confidential 2
Smart-QC
Managing Your Labs’ Resources and Overall Efficiency
By an IPS affiliate
(3) Cost of Quality (COQ)
(1) Robust capacity planning for both analysts and instruments
(2) Test allocation to analysts across various laboratories & Efficiency Management Platform
Smart-QC composes of three major modules:
cResults / ERD confidential 3
AGENDA
Introduction
Objectives
Smart-QC: Approach to Resource Modeling and Scheduling in QC Laboratories
Smart-QC Demonstration
Implementation Approach
Case Study
Summary and Q&AReduce Cost
Efficiency
cResults / ERD confidential 4
Mission
To Control Cost of Goods and Improve Turn Around Time in QC Labs
Implementing proactive Resources Planning and Scheduling usingSmart-QC application, can effectively help achieve this mission
Areas impacted by Resource Planning and Scheduling:
Efficiency & Financial (Cost of Quality)
Customer Service (On-Time Delivery, Throughput)
Compliance (Stability On-Schedule)
Right First Time (No Re-test & Improved span of control)
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Detailed Labs’ standards as a foundation for effective planning and Scheduling of the Labs’ resources
Operation Excellence – QC Laboratories
Systems: LIMS / Data Acquisition / Planning / Daily Scheduling / Test Allocation / Training
The R
oad
Map T
owar
d QC
Opera
tion
Exce
llenc
e
Impr
ove
Sam
ples
’Tur
n A
roun
d Ti
me,
On-
Tim
e D
eliv
ery
and
redu
ce C
ost o
f Tes
ting
Impr
ove
Sam
ples
’Tur
n A
roun
d Ti
me,
On-
Tim
e D
eliv
ery
and
redu
ce C
ost o
f Tes
ting
Meaningful KPI –measuring the progress
Meaningful KPI –measuring the progress
An effective labs’ structure that support the business goals
An effective labs’ structure that support the business goals
Efficient Layout / Material Flow and Work Method / Make or Buy
Efficient Layout / Material Flow and Work Method / Make or Buy
An effective coordination & alignment with Mfg. / Planning / purchasing
An effective coordination & alignment with Mfg. / Planning / purchasing
Automation and adequate resources level (Instruments and Analysts)
Automation and adequate resources level (Instruments and Analysts)
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5 Types of demand forecasts -Planning Complexity
Identifies capacity expansion needs
Scheduling
Variation
Planning
Time
Avg.
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Scheduling Complexity
Example:Example:20 samples a day (all labs)6 tests per sample10 day turnaround time
The number of tasks that need to be scheduled and scheduled and
managed managed are: 1,200 !!!1,200 !!! ((20*6*10)20*6*10)Cost Model
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Campaigning Effect on QC Efficiency
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Smart-QC can address the following challenges:
What is the impact of volume changes, mix changes, new product introduction on the QC laboratories?What is the training road map to best meet future demands?What is the expected work-load based on the new schedule?What is the impact of a second and third shift?What percent of time does the analyst spend on admin., preparation, set-ups, calculations?Which automation project has a significant ROI?What is the analyst value added vs. non value added percentage?What is the campaign effect on QC efficiencies?Who should perform these tests ,when, in what order, and grouping?What is the expected overtime / backlog this month?How many tests were completed, what was my analyst’s efficiency, what was my turn-around time and schedule adherenceWhat are my KPIs showing me?What is the resource cost of quality?
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Determine Resource Requirements for a given Forecast (Week, Month, Quarter, Year).
Additional Resources, Shift Structure, Allocation (internal / External), Cross Training, Special Project, Campaign Optimization etc.
(1) Do I Have Sufficient Resources ?
(3) Monitoring / Reporting / KPI and Cost of Quality
Optimized Lab Performance based on Sample Arrival, Due Dates & Resources availability.
Track you COQ & Efficiency Improvements Opportunities
(2) How do we allocate tests to analysts ?
Managing Labs Operation: Strategic Level and Daily Operation
Action Plan
What if Analysis
ResourcePlanning
Daily / Weekly Schedule
KPI / ReportCOQ
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SAP / Other ERP
Samples IP/FG/Stability
Forecast /Manufacturing / API / Components
Dispatch List
LIMS
Strategic Planning
Smart-QC –Resource Planning & Scheduling
Resources Workload & Requirement
Key Performance Indicators
Smart-QC: LIMS – ERP Overview
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QC Scheduling Complexity – Smart-QC
Product A – FG (Typical Bill of Tests)
Test-1Test-2Test-3Test-4
Test-n
Test-2Test-3
Test-n
Traditional Execution
Test-1
Product A - FGLS
LS
LS
LS
Critical Path Focus – Desired Execution
Test-1Test-2Test-3Test-4
Test-n
LS – Latest Start
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Scheduling Parameters
Service Level focused on on-time delivery
Cycle Time & Critical Path focus
Utilization Work load balancing between analysts
Efficiency - Campaign samples/tests to improve efficiency based on pre-defined parameters
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(3) Cost of Quality (COQ)
(1) Robust capacity planning for both analysts and instruments
(2) Test allocation provides a platform to deliver daily test allocation to analysts across the various laboratories
Smart-QC composes of three major modules:
SMART-QC - DEMO
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SMART-QC - DEMO
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SUMMARY: Key Value Add by Smart-QC to Laboratories
Resource Capacity Planning for both analysts and instruments (per site(s) / network)A fully integrated QC lab budget with Resource Planning leveraging advanced allocation methodology.Detailed work centers / labs, products and tests costAutomated Test Allocation and work load balancing for analysts across various labs to maximize campaigning opportunities and improve service levelManage lab / analyst weekly efficiencyProductivity losses tracking for Lean / Six Sigma process improvement initiativesManage your Cost of quality (COQ) and identify cost enhancement opportunities (Make or Buy analysis)Robust Reporting tool with powerful What If Analysis capabilitiesUpgrade your lab visibility and overall span of control
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Implementation Approach
Initial Phase Initial Data
Collection Test Pareto-1
and Test Pareto-2
Study Preparation
Standards Development:
Data Collection –Direct Time Study (selected groups)
Standards Verification -Modeling:
Forecast sources mapping Load data into Smart-QC Data Verification – by using
recent actual volume and resources vs. standards
Model enhancements / finalization
Training Knowledge
transfer
1 Week 1 Week 1 Week 2-3 weeks
Test Allocation Parameters
setting Training Pilot Deployment to
other labs
3-4 Weeks
PARETO 1 - ALL TESTS
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
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APPEARANCE
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ime
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Test Group Name
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ime
Managing Your Labs’ Resources and Overall Efficiency
LIMS ERP Integration if applicable
cResults / ERD confidential 18
Implementation Approach
FG and Stability Lab Resource Requirements (Hrs / Week)
Raw Materials Lab Resource Requirements (Hrs / Week)
Week-# Focus / Main Activity Manager Supervisor Senior
Analyst(s) Manager Supervisor Senior Analyst(s)
Total
Week-1 Preparation / Set-up 4 8 16 4 10 16 58
Week-2 4 16 40 4 16 60 140
Week-3 Test Grouping & Standards development 4 8 40 4 10 60 126
Week-4 Finalize Standards & Initial Model population 4 8 20 4 10 20 66
Week-5 Model Verification & Road map 4 8 4 4 8 8 36
Week-6 Model Enhancements / Training and Knowledge Transfer -Planning
4 8 4 4 8 4 32
Week-7 Scheduling Pilot area, Set-up 4 16 10 4 16 8 58
Week-8 4 8 4 4 8 4 32
Week-9 4 4 4 4 4 4 24
Week-10
Initiate the Pilot for scheduling / Parameters enhancements / additional training 4 4 3 4 4 4 23
TOTAL (hrs) 40 88 145 40 94 188 595
Planning 4-6 weeks, Scheduling for ALL labs 2-4 weeks
cResults / ERD confidential 19
Case Studies
Case Study-1: Par Pharmaceutical Enhancing its QC
Operation Efficiency
Case Study-2: Reduce Cycle Time and Improve On-Time
Delivery
cResults / ERD confidential 20
Case Study-1: Par Pharmaceutical Enhancing its QC Operation Efficiency
The main goals were to develop standards, reduce the overall cost of quality, reduce / eliminate RM backlog, improve visibility and establish a continuous improvement infrastructure.Among the building blocks to achieve operational excellence, resource planning and scheduling is one of the key contributors to reach these goals.
Some of the key achievements of the 6 months of implementation were:More than 20% efficiency gain in the QC labs, which translates into major cost reduction / avoidance (i.e., reduced temp; over time). More than 1 million dollars per year in total savings compared to the previous year.Raw materials backorder was greatly reduced due to reengineered business processes and improved visibilityWalking distance was reduced by 25% (~1,250 miles per yr.)Improved on-time delivery and delivery consistency (i.e., NO Backlog due to lab performance)Planning standards, scheduling strategy and Dashboard became the core of the continuous improvement infrastructure
cResults / ERD confidential 21
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1817
Disso bay-1
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1211
620
Glassware Main
Storage
Pair-1
Pair-2
Disso bay-2HPLCFG/RM
B
Common Area
Stability old Chamber
Not to Scale
STORAGE
B
KF
Offices
Our previous layout
Decentralizing the glassware
Released16%
On-Schedule72%
Potential Behind Schedule
0%
Sample Not Here12%
LATE0%
Our Raw Material Service Level: 100% last WeekImproving our
samples visibility and requested release date
Tools to improve
our visibility
COMMERICAL SUMMARY # %Released (Commercial) 8 16.0%On-Schedule 36 72.0%Potential Behind Schedule 0 0.0%Sample Not Here 6 12.0%LATE 0 0.0%TOTAL Commercial 50 100%Non Commercial 13Released (Non Commercial) 9
Eliminate Raw Material backlog
Improving our on-time delivery ~
above 95%
Bulk Solution Preparation
Mobile Phase Request Sheet (For Quantities > 20 Liters)
Product:____________________________________________ Monograph Number _______________________________ Mobile Phase _____________________________________ QTY____________Liters Mobile Phase _____________________________________ QTY ____________Liters Requested By_________________________ Date___________________ Date Needed ______________________ Please place in Media Request Tray
Our GOAL: Centralize and prepare solutions in large volume to reduce sample prep.time and making our analysts focus more on the science
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LITE
RS P
REP
ARED
Dissolution Media Mobile Phase
BULK SOLUTION PREPARTATION
1-Sep9/89/159/229/2910/6
We have made significant amount of media and mobile phase since we have started our implementation
(1) Request F
orm
(2) Media and M
obile phase
Ready to use
E-Logs to Manage and Track QC Samples
Standards are applied to calculate expected work load
Automatic calculations keep running totals of weekly and
monthly performance
Incoming samples are entered into E-
logs for easy tracking
Improving our samples visibility and improving our
campaigning at stability and with finish good lab
Our MissionTo provide our customers the highest service level and quality standards in a cost effective
manner
Lab Continuous Improvement Board
Our story so far …
Our Continuous Improvement Initiatives: Establish an accurate standards and develop a
resource planning tool to become more proactive
Improve our campaigning and overall efficiency
Centralized Media to reduce set-up and to focus our
analysts more in the science
Improve our layout to reduce walking distance
Establish tools / systems to improve labs visibilities,
reduce Lab’s backlog and improve service level
Create an additional KPI and a dashboard to help us
measure our progress
3
6
4
512
1413
1817
Disso bay-1
10
7
9
8
1211
620
Glassware
Glassware
Glassware Main
Storage
Pair-1
Pair-2
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Disso bay-2
HPLC-1
HPLC-2
HPLCFG/RM
B
Offices
Common Area
FG LAB
Stability
Stability old Chamber
Not to Scale
1516
MEDIA
B
KF
Key Movements
Careful Planning for a successful layout implementation
Our layout is changing
Some of the changes:
• HPLC moves –Stability and Finish Good
• Centralized Media
• Glassware decentralization
• Offices relocations
• Dissolution 2 bays
• UV / Oven to be closer to the analysts
Reduce Walking distance by ~%25%
Our New Layout
~ 25% reduction in walking distance.
Clear the space
Preparation
The move
PAR Laboratories 2RR - Dashboard
RangesLab / Area KPI Goal
WW-35
WW-36
WW-37
WW-38
WW-39
Ranges
Green Yellow <>
Red
Financial Overtime [%] 6% 7% 10% 12.9% 16.7% 15.9% 10.7%
Efficiency All Labs [workload] 85% 80% 60% 101% 61% 107% 125% 145%
Compliance OOS # 2 3 5 1 2 7 5
OOS Closure [days] 20 22 30 23 39
Stability Late 0 0 2 1 0 4 2
FG Backlog [weeks] N/A N/A N/A 4.7 4.8
Calc. Work load 85% 80% 60% 116% 41% 37% 351% 298%
Earn FTE (35 Hrs) 15.1 1.2 5.2 24.6 26.8
# of FTE Avail. (12) 13.0 3 13.8 7 9
Released 28 25 15 31 3 13 53 61
Cycle Time [days] 12 14 20 16.6 23 33
RM Backlog [weeks] 1 week 2 3 0.9 0.97 0.87 0.67 0.92
Calc. Work load 85% 80% 60% 23% 30% 135% 79% 88%
Earn FTE (35 Hrs) 2.8 3.6 16.25 9.5 10.61
# of FTE Avail. (12) 12.0 12.0 12.0 12.0 12.0
Released 25 20 10 8 9 27 17 26
Cycle Time [days] 25 20 30 52.7 89.6 98
IPT Backlog [weeks] N/A N/A N/A N/A 1.4
Calc. Work load 85% 80% 60% 142% 91% 123% 132% 216%
Earn FTE (35 Hrs) 5.7 5.5 9.8 5.3 8.6
# of FTE Avail. (4) 4 6 8 4 4
Released 25 20 10 23 29 45 19 51
Cycle Time [days] 3 4 6 5.7 2.6 7.8
Stability Backlog [weeks] N/A N/A N/A N/A 3.0
Calc. Work load 85% 80% 60% 56% 81% 136% 105% 104%
Earn FTE (35 Hrs) 12.4 16.3 20.1 18.9 18.8
# of FTE Avail. (20) 22.0 20 14.8 18 18
Released 45 40 30 38 33 45 44 45
Validation Backlog [weeks] 4 week 5 8 16.6 3.3 1.0 26.0 19.7
Calc. Work load 85% 80% 60% 1660% 46% 186% 11% 100%
Earn FTE (35 Hrs) 16.6 4.1 1.9 0.7 5.0
# of FTE Avail. (3) 1 9 1 6 5
Released 8 6 2 0 5 1 2 15
Weekly Calc. Efficiency for All Labs
54%
92%
109%
131%
0%
20%
40%
60%
80%
100%
120%
140%
WW-36 WW-37 WW-38 WW-39
Cal
c. %
Effi
cien
cy
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# S
ampl
es R
elea
sed
Calc. Efficiency Samples Released
# of samples released by Lab
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WW-35 WW-36 WW-37 WW-38 WW-39
# of
sam
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rel
ease
d
Validation Stability IPT RM FG
Our new Dashboard shows our improvements and help us being more proactive
Our New Dashboard
Our efficiency is improving
Our implementation team leaders
Case Study
cResults / ERD confidential 22
Case Study-2: Reduce Cycle Time and Improve On-Time Delivery
Initial Situation Inefficient communication between QC, Mfg & Planning Supply planning did not consider QA capacity in
determining loads Labs were constantly fire-fighting Less than optimal lab operations
Improving Customer Service Needed to improve: Communication b/w QC & Mfg Organization & scheduling of work in the labs QC’s planning capabilities
cResults / ERD confidential 23
Jan Feb Mar Apr May Jun Jul Aug Sep
Month
Cyc
le T
ime
(in D
ays)
4346
67
8589 89
95 9396 96.5
0
10
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90
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Perc
ent c
ompl
ete
56.1% cycle time reduction in the raw material lab
On-Time delivery went up from 43% to 96.5%
Throughput significantly improved over 6 months
Over time level went down from 20% to close to 0
QC were no longer the bottleneck for the site
Raw material inventory level is reduced significantly (20-30%) due to the reduction of the RM cycle time and improvement in the on-time delivery performance
Case Study-2: 56% Cycle Time Reduction
On-Time DeliveryFrom 43% to 96.5%
CT by 56%
cResults / ERD confidential 24
THANK YOU
Web Site: www.smart-qc.comEmail: [email protected] Web Site: www.cresultsconsulting.comContact Info: Rafi Maslaton; 1-732-748 1990 ext. 250