Managing Efficiency in Quality Operation -...

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

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ost

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KPIKPI

Boosting Operating Performance

For

Managing Efficiency in Quality OperationNovember 14, 2008


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:


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


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)


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

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oad

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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)


5 Types of demand forecasts -Planning Complexity

Identifies capacity expansion needs

Scheduling

Variation

Planning

Time

Avg.


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


Campaigning Effect on QC Efficiency


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?


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


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


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


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


(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


SMART-QC - DEMO


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



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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Managing Your Labs’ Resources and Overall Efficiency

LIMS ERP Integration if applicable



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


Case Studies

Case Study-1: Par Pharmaceutical Enhancing its QC

Operation Efficiency

Case Study-2: Reduce Cycle Time and Improve On-Time

Delivery


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


3

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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

0

50

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150

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300

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LITE

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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

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10

7

9

8

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Glassware

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FG LAB

Stability

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MEDIA

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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

0

50

100

150

200

250

# S

ampl

es R

elea

sed

Calc. Efficiency Samples Released

# of samples released by Lab

0

20

40

60

80

100

120

140

160

180

200

WW-35 WW-36 WW-37 WW-38 WW-39

# of

sam

ples

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


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


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

20

30

40

50

60

70

80

90

100

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%


THANK YOU

Web Site: www.smart-qc.comEmail: [email protected] Web Site: www.cresultsconsulting.comContact Info: Rafi Maslaton; 1-732-748 1990 ext. 250

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