Webinar: Justifying a Paperless Solution Building a Compelling Business Case

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1 Pharma&Biotech Webinar: Justifying a Paperless Solution Building a Compelling Business Case Jeremy Tanner / Lonza Wayne Inc., Wayne, PA / April 2017 Lonza

Lonza Informatics Lonza Informatics empowers its

control rather than the clerical management and

We deliver: Compliance through Data Integrity

2 Lonza Informatics Lonza Informatics empowers its customer to focus on the science of quality control rather than the clerical management and paperwork of nonvalue added activities. We deliver: Compliance through Data Integrity Paperless efficiency and automation Unparalleled analysis and insight 2

Today s Presenter Jeremy Tanner, Lonza Bioscience Informatics Account & Business Development Representative 10+ years of industry experience spanning QC, Manufacturing, and Quality

3 Today s Presenter Jeremy Tanner, Lonza Bioscience Informatics Account & Business Development Representative 10+ years of industry experience spanning QC, Manufacturing, and Quality Information Systems Lean Six Sigma Green Belt Multiple successful internal CAPEX project business cases Led workshops for multiple MODA-EM customers to build compelling business cases 3

4 Agenda I have a solution, where do I start? Utilizing Value Stream Mapping (VSM) to visualize and collect data Using data from VSM to create a Return on Investment (ROI) summary Creating a presentation/document for upper management 4

5 Where Do I Start? Pain Points Understand Solution Benefit Link to Pain Points Identify Efficiencies Risk of No investment Monetary Quality Strategic Goals Link to Corporate Goals Business Case Put it all Together Concise 5

6 Value Stream Mapping Helps to visualize Non-Value added work vs. Value Added Work Helps to collect data to quantify benefit Pain Points Understand Includes both process mapping and data analysis 6

7 Value Stream Mapping Process No Judgement! Management must be supportive of process Have Subject Matter Experts (SME) on each segment of the process Pain Points Understand Have an external to the process person lead the discussion/questioning Don t discuss solutions or improvements during mapping Capture Methods Paper/Sticky Notes Visio/Excel 7

8 Value Stream Mapping Choose a starting point and ending point Starting point should be start of overall process End point should include an output Pain Points Understand Data Capture for each Step How long does it take? Per Hour Per Day Per Week Per Sample Per Report Generation How many people are performing that step? Cycle time to next step? How long does it take from sample completion to report generation? 8

9 Value Stream Mapping Create Weekly Schedule Autoclave Review Weekly Delivery to Cleanroom Weekly Meeting To Discuss Schedule Print Forms Fill Out Autoclave Sheet Deliver to Autoclave Group Pain Points Understand Pain Points Understand Assign Work Create Sample Labels Verify Against Schedule Travel to Cleanroom Check Media Expiry Check Equipment Calibration Label Samples Record Master Data on Paper Collect Samples Record Sample Data on Paper Exit Cleanroom Submit Samples to QC Complete Sample Delivery Log Start Incubation Record Data on Forms File Paperwork Stop Incubation Record on Forms Read Samples Record on Form Review Forms Record in LIMS/ Excel Verify Correct Entry Compile for Trending 9

10 Value Stream Mapping Data Process Step Create Weekly Schedule Review Weekly Schedule Amount of Time Per Unit # of People 1 Hour Week 1 0 Cycle Time 1 Hour Week 1 1 day Print Forms 1 hour Day 5 0 Pain Points Understand Create Labels 1 hour Day 5 0 Take Samples 2 hours Day

Solution Benefit Link to Pain Points Time spent scheduling and reviewing weekly Time spent on corrections to missing data, incorrect data or legibility on paper forms Lengthy, time-consuming review

11 Solution Benefit Link to Pain Points Time spent scheduling and reviewing weekly Time spent on corrections to missing data, incorrect data or legibility on paper forms Lengthy, time-consuming review process Time spent performing & reviewing data entry from paper to LIMS/Excel Compiling information for trending Performing trending Pain Points Understand Solution Benefit Link to Pain Points Identify Efficiencies 11

Solution Benefit VSM Future State Create Weekly Schedule Autoclave Assign Work Review Weekly Delivery to Cleanroom Create Sample Labels Weekly Meeting To Discuss Schedule Verify Against Schedule

12 Solution Benefit VSM Future State Create Weekly Schedule Autoclave Assign Work Review Weekly Delivery to Cleanroom Create Sample Labels Weekly Meeting To Discuss Schedule Verify Against Schedule Print Forms Travel to Cleanroom Fill Out Autoclave Sheet Check Media Expiry Deliver to Autoclave Group Check Equipment Calibration Pain Points Understand Solution Benefit Link to Pain Points Identify Efficiencies Label Samples Record Master Data on Paper Collect Samples Record Sample Data on Paper Exit Cleanroom Submit Samples to QC Complete Sample Delivery Log Start Incubation Record Data on Forms File Paperwork Stop Incubation Record on Forms Read Samples Record on Form Review Forms Record in LIMS/ Excel Verify Correct Entry Compile for Trending 12

13 Solution Benefit Quantify Process Step Create Weekly Schedule Review Weekly Schedule Amount of Time Per Unit # of People Cycle Time Annual Time Spent 1 Hour Week Hours 1 Hour Week 1 1 day 52 Hours Print Forms 1 hour Day hours Create Labels Take Samples 1 hour Day hours 2 hours Day Hours Solution Benefit Link to Pain Points Identify Efficiencies Savings of 2652 hours annually 13

14 Solution Benefit Quantify Determine Total Annual Savings Ask Finance for fully-burdened cost per hour for your department Multiply out total annual benefit Determine monthly benefit Determine Return on Investment (ROI) Solution Benefit Link to Pain Points Identify Efficiencies 14

15 Solution Benefit ROI Date Benefits/Month Cost Savings per Month 1-Jun-17 $ 22, $ 200, $ (177,900.00) 1-Jul-17 $ 44, $ 200, $ (155,800.00) 1-Aug-17 $ 66, $ 200, $ (133,700.00) 1-Sep-17 $ 88, $ 200, $ (111,600.00) 1-Oct-17 $ 110, $ 200, $ (89,500.00) 1-Nov-17 $ 132, $ 200, $ (67,400.00) 1-Dec-17 $ 154, $ 200, $ (45,300.00) 1-Jan-18 $ 176, $ 200, $ (23,200.00) 1-Feb-18 $ 198, $ 200, $ (1,100.00) 1-Mar-18 $ 221, $ 200, $ 21, Apr-18 $ 243, $ 200, $ 43, May-18 $ 265, $ 200, $ 65, Jun-18 $ 287, $ 200, $ 87, Jul-18 $ 309, $ 200, $ 109, Aug-18 $ 331, $ 200, $ 131, Sep-18 $ 353, $ 200, $ 153, Oct-18 $ 375, $ 200, $ 175, Nov-18 $ 397, $ 200, $ 197, Dec-18 $ 419, $ 200, $ 219, Jan-19 $ 442, $ 200, $ 242, Feb-19 $ 464, $ 200, $ 264, Mar-19 $ 486, $ 200, $ 286, Apr-19 $ 508, $ 200, $ 308, May-19 $ 530, $ 200, $ 330, Jun-19 $ 552, $ 200, $ 352, Jul-19 $ 574, $ 200, $ 374, Aug-19 $ 596, $ 200, $ 396, Year Benefit $ 1,126, month ROI Solution Benefit Link to Pain Points Identify Efficiencies 15

16 Solution Benefit ROI $ ,00 $ ,00 $ ,00 $ ,00 $ ,00 Breakeven Analysis Solution Benefit Link to Pain Points Identify Efficiencies $- $( ,00) $( ,00) $( ,00) Jun 17 Jul 17 Aug Sep Okt 17 Nov Dez Jan Feb 18 Mrz Apr Mai Jun Jul 18 Aug Sep Okt 18 Nov Dez Jan Feb 19 Mrz Apr Mai Jun Jul 19 Aug 19 16

17 Risk to Business of No Investment Costs will continue to rise Scalability for growth will be adding headcount Compliance concerns Data Integrity guidelines Deviations Reactive decision making Audit Readiness Risk of No investment Monetary Quality 17

18 Strategic Goals Use the Strategic Goals set by your company/department Look for statements on Quality Efficiency Delivery Employee Satisfaction Strategic Goals Link to Corporate Goals Align the project to a strategic goal This project will help us to provide a better quality environment to manufacture our products designed for our patients. 18

19 Building a Business Case Define the problem Determine how the problem does not allow you to meet strategic goals Concisely discuss the VSM process Show the Current State VSM Business Case Put it all Together Concise Discuss the Solution Link to Pain Points Show the Future State VSM Utilize graphical representation benefits Savings (ROI) 19

20 Building a Business Case Discuss the Risk of No Investment Align Solution/Benefit to Strategic Goals Business Case Put it all Together Concise Without data you re just another person with an opinion. W. Edwards Deming, Data Scientist 20

21 Summary Pain Points Understand Solution Benefit Link to Pain Points Identify Efficiencies Risk of No investment Monetary Quality Strategic Goals Link to Corporate Goals Business Case Put it all Together Concise 21

22 MODA-EM QC Microbiology Software More science. Less paper. Purpose-built QC Microbiology platform Quickly move from paper-intensive QC monitoring/analysis Measurable gains in operational efficiency, improved quality, reduced costs 22

23 Any Questions? Please submit your questions using the questions pane on the right hand side of your screen 23

24 Wrap-Up: More Information Jeremy Tanner Sales & Business Development Representative, Lonza Informatics Learn more about the MODA-EM Solution Website:

25 Thank You All trademarks belong to Lonza or its affiliates or to their respective third party owners. BioTek is a registered trademark of BioTek Instruments, Inc. The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of these products. 25

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