Mastering PQM with NexInfo: A Webinar on Performance Optimization

1. Using Agile PLM to Get the Best Out of Your Product Lifecycle & Product Quality: Oracle Agile Product Quality Module in Action December 19, 2018 Presented By: Arun Sharma @NexinfoSolution

2. Who Is NexInfo? SUMMARY • Consulting company focused on helping clients achieve Operational Excellence via an optimal blend of Business Process & Software consulting services • Deep domain expertise, including: Integrated Business Planning, Sales & Operations Planning, Supply Chain, Product Lifecycle Management, Predictive Data Analytics, Security & Compliance, and Business Transformations • Founded in 1999 and managed by computer industry & business process professionals • Clients include emerging companies and Fortune 1000 corporations • Recognized in the industry, including features in Gartner Reports, The Silicon Review (50 Smartest Companies of the Year 2016 and 10 Fastest Growing Oracle Solution Providers 2017), and CIO Review (100 Most Promising Oracle Solution Providers 2015) PARTNERS: CLIENTS: CORPORATE INFO • HQ in Orange County, CA with offices in Redmond, WA, Chicago, IL, Bridgewater, NJ, Dublin, Ireland, Chennai & Bangalore, India • Operations across the United States, Europe (Ireland, UK, Switzerland, Belgium) & India

3. Webinar Host: Arun Sharma Director of Analytics & Information Management Experience: Arun Sharma is a Product Innovation leader with expertise in Product Management and Product Lifecycle Management. His deep domain expertise in the High Technology Industry combined with innovative experience in the Life Sciences & Pharmaceuticals industry provides clients with solutions that provide a high quality user experience and enhancing business value. With over 18+ years of industry experience, Arun Sharma engages with client on identifying compelling business problems and Solution Development, Business Process Reengineering, Business Strategy and Business Analytics needs. Education: MBA, KELLOGG SCHOOL OF MANAGEMENT MSEE, IIT KANPUR Presenter Details

4. Reminder: Submitting Questions Questions?? Reminder: Please submit questions using the questions option on the sidebar

5. Setting the Stage Product Governance & Compliance Product Portfolio Management Product Quality Management Engineering Collaboration Product Cost Management Enterprise Visualization Product Change Control This webinar is focused on discussing Product Collaboration & Product Quality on the Agile 9.x platform Agile 9.x – On Premise PLM Cloud There are multiple Oracle options for Product Quality

6. Key Challenges for New Product Introductions • Which products have the most changes in pilot / product ramp phases? • What is the Mean Time Between Design Failures & Change per Product Line? • How can we improve the engineering change cycle time metrics? • How many new parts have been introduced into the new products? • How many parts in the new products lack price, compliance data? • How many single-source parts have been designed into each new product? • Who are the most leveraged manufacturers in current products? • How will the Top-50 Manufacturers change with the new product introductions • Do any of the top Manufacturers have Quality issues? Are any due for an audit? • Who are the high risk manufacturers in the new products? • What is the level of part obsolescence risk? • How do we manage these manufacturer and/or supply risks?

7. Typical Quality Related Pain Points • Product and quality related data reside in different systems • Managing supplier quality issue management is a time consuming and manual process • Difficult to comply to regulations and standards involving service of products • Not clear on how product quality impacts total product costs • Products often fail to meet customer or operational requirements

8. WHAT IS PLM? PLM enables companies to accelerate product innovation and maximize product profitability… …through the management of the information, processes and decisionsabout their products… …throughout the product lifecycle and across the global product network

9. ENTERPRISE PRODUCT RECORD = PLM DHF Program Data • Schedules • Resources • Constraints • Risk Quality Management • Customer Complaints/CAPA • NCMR/Deviations • Audit Management • Voice of Customer Design Data • Design Spec History • Verification/Validation • Lab/Clinical Results • E-Submittals (510K/PMA) Manufacturing Data (DMR-ERP/MES Sync) • Bills of Materials • Mfg. Instructions • Revision data Supplier Data • Approved Vendors • Quality Management • Pricing • Availability Process Data (DHF/DMR) • ECOs/MCOs/Deviations • Change History • Documentation The product record includes all the information required by the extended enterprise to conceptualize, design, source, build, sell, service and disposal of products

10. Enabling the Enterprise Product Record Product Governance & Compliance Product Portfolio Management Product Quality Management Engineering Collaboration Product Cost Management Enterprise Visualization Product Change Control Customer Information • Requirements • Configurations • Quality Issues Project Portfolio Info • Programs & Projects • Schedules & Resources • Deliverables • Issues & Actions Compliance Information • Regulatory & Standards • Product Compositions • Supplier Declarations • Audits Service & Quality Info • Problem Reports • Corrective Actions • Field instructions • Inspection Failures • Service BOMs Design Information • CAD Models • Graphics and Artwork • Packaging Specs • Design Reviews Purchasing Information • Pricing • Part/BOM Costs • Price History Manufacturing Information • Bills of Materials • Mfg. Instructions • Tooling • ECR/ECO/ECNs & Revisions Supplier Information • Approved Vendors • Preference/Status • Availability The product record includes all the information required by the extended enterprise to conceptualize, design, source, build, sell, service & dispose of products

11. Integrated Product Record Multi-Level, graphical BOM management Historical revision control over product structures and BOMS integrated with ERP Single Version of Truth for all Product Information Integrated document management Approved Manufacturer & Supplier Management Robust configuration management including reference designation support Integrated electronic Change Management

12. Excel Product Mgmt. Adobe Quark 24/7 Collaboration Supplier Management Value Chain Quality Management ERP Specs ERP Enterprise MES Program Management LIMS SCM Integrated Product RecordA Central Repository with “One Version of the Truth” Testing Facilities Artwork Houses Outsourced Partners Suppliers Customers Regulatory Bodies Marketing Analyst Logos Complaints Ideas CRM Concept Briefs Quality Pack Manager Product Developers Sourcing Managers LIMS Test Data Costs Compliance Documents HCM Formulas FIN Sample HACCP Site AML MES ERP © 2008 Oracle Corporation – Proprietary and Confidential

13. Agile Product Portfolio Management Executives & Program Office Agile Product Governance & Compliance Compliance Office Integrated product, program, resource & portfolio management Product & program compliance against standards & regulatory requirements Quality Professionals Closed-loop product quality management across the extended enterprise Agile Product Cost Management Procurement Professionals Product sourcing and lifecycle cost & risk management Agile PLM Modules Agile Engineering Collaboration Development & Engineering Engineering desktop integration & collaboration Agile Enterprise Visualization Cross-Enterprise Native document collaborative visualization across the global enterprise Product Governance & Compliance Product Portfolio Management Product Quality Management Engineering Collaboration Product Cost Management Enterprise Visualization Product Change Control Agile Quality Management Agile Product Collaboration Eng., Operations & Supply Chain Enterprise product record visibility, management & collaboration

14. Agile Product Collaboration (PC) Agile Product Collaboration™ provides enterprise visibility, management and collaboration of new and changing product record information across the product lifecycle and the extended supply chain Customer Use Cases • Basis for all other Agile modules • Create and Manage Documents, Parts and BOMs • Manage the Review/Change/ Release Process • Work with Vendor/Manufacturer related data and processes • Interact with customers Capabilities • Product Definition Item, Part & BOM Management • Document Management • Revision and Version Control • Change Collaboration • Reviews, ECR/ECO, Deviations • Manufacturer/Supplier Management • External Collaboration Most organizations start with PC

15. Agile Product Collaboration(PC) Overview : Core Capabilities Product Definition • Create, share and maintain product record Change Collaboration • Create and approve product changes in systematic way • Internal teams, partners and customers collaboration in real time Document Management • Store, organize and search across all document types • Full version control with a detailed audit trail Manufacturers Management • Define, share and manage the manufacturer part information and approved manufacturer list (AML) Sites & Distributed Manufacturing • Supports globally distributed design and manufacturing organizations • Provides visibility and control over site specific product information

16. Drug Discovery Process c c Identification of target molecules Discovery of seed lead compounds Scrutiny of drug candidates Basic genomic research Manufacturing development Clinical Studies New drug application Highthrouput screening Estimation of drug efficacy Manufacturing process development and quality control Research on orphan receptors, ligands, disease-related genes, and orphan enzymes Functional analysis of genes Clinical evaluation and new drug application Launch Safety evaluation and pharmacokinetic Combinatorial chemistry

17. Business Processes Impacted by PLM Packaging and Labeling Supply Chain Planning Supplier Qualification PLM Business Process Commercial Manufacturing Purchasing Controls Clinical Manufacturing

18. Agile Product Quality Management (PQM) Overview : Core Capabilities Agile Product Quality Management drives improved product quality and customer satisfaction by tightly integrating customer, product, and quality information within a closed-loop corrective action system Customer Use Cases • Supplier quality tracking and management • Full CAPA process implementation • Quality process integration with engineering change management Capabilities • Quality Event Management • Problem Reports & Issues Management • Nonconformance Reports • Quality Action Management • Corrective Actions, Audits • Flexible Relationships, tied to product and documents • Decision Support & Reporting • Quality Dashboards • Out of the box Reports

19. Agile PQM Solution Overview Act Aggregate Analyze Customer Call Center Design QA Supplier Mfg. Mfg Ops Supplier Field Service Field Proactive & Holistic

20. Closed Loop Quality Process Quality Processes integrated into ECO process, leveraging PQM and PC Problem (Issue) Process 5. Closed 1. Pending 2. Owner Review 3. Containment 4. Open Quality Action Process (CAPA) 1. Pending 2. Submitted 3. In Queue 4. Root Cause 6. Solution Proposed 8. Closed 5. Solution Design 7. Validate Failure Analysis Process 1. Pending 2. Submitted 3. In Process 4. Closed ECO Process 1. Pending 2. Review 3. Submitted 4. Pre CCB 6. Released 7. Implemented 5. CCB

21. Closing The Gaps on Quality Pain Points Problem Impact Solution Integrate Product Quality and Engineering Processes Continuous analysis of current and historic quality issues Design Higher Quality Products Going Forward • Recurring Product Quality Issues . . . . • No Tie Between Quality Data and Engineering Changes • Higher Warranty Costs • Greater Inventory • More Recalls • Delay Between Problem Identification & Resolution . . . . • Multiple Systems and Locations • No Aggregate View of Issues and Resolutions Integrate Customer and Product Issues to Engineering Changes Faster, Consistent Resolution Processes Lower Cost of Service • Loss of Productivity • Slower Response • Higher Service Costs • Higher Scrap and Rework Costs

22. System DemonstrationCAPA Workflow

40. Agile PQM Experiences Implementation • Typically 3-5 months, depending on size of organization • If you are an existing Agile PLM user, has same exact look and feel • UI looks and behaves same exact way • Training end-users on PQM is half a day/ one day max • Admin side, similar to PC, set-it and forget-it • Will have no impact on existing Product Collaboration or other modules that are live • Minimal retraining for existing users for new quality tab in PC where impacted • PQM can be implemented prior to PC • No additional hardware needed (unless going in the direction of Analytics) • Allow small budget for PX development

41. WHY NEXINFO FOR AGILE PQM Solution Based • We understand your industry and will help you to define the problems you are trying to solve • We deploy best practices • We engage our clients to create a sustainable model • We are the ‘Enablers behind the Leaders’ • We Train the Trainers • We streamline business processes and define future state before aligning with Agile PQM • We benchmark current state and set measurable process improvement goals • We can support you as you Go Live • We deploy a structured knowledge transfer approach

42. Contact Us Dublin, Ireland Bellevue, WA HEADQUARTERS Bridgewater, NJ Orange, CA Santa Ana, CA 615 W Civic Center Drive, Suite 350 Santa Ana, CA 92701 Chicago, IL Bangalore, India EMAIL Chennai, India LetsTalk@nexinfo.com TELEPHONE (714) 955-6970

43. Q&A