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Optimizing Performance with NexInfo PQM: Webinar Insights
- 1. 1 www.nexinfo.com December 19, 2018 UsingAgile PLM to Get the Best Out of Your Product Lifecycle & Product Quality: Oracle Agile Product Quality Module in Action Presented By: Arun Sharma @NexinfoSolution
- 2. 2 www.nexinfo.com CORPORATE INFO • HQin 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 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) Who Is NexInfo? PARTNERS: CLIENTS:
- 3. 3 www.nexinfo.com Webinar Host: ArunSharma 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. 4 www.nexinfo.com 4 Reminder: SubmittingQuestions Questions?? Reminder: Please submit questions using the questions option on the sidebar
- 5. 5 www.nexinfo.com Setting the Stage 5 Thiswebinar 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 Product Portfolio Management Engineering Collaboration Enterprise Visualization Product Change Control Product Cost Management Product Quality Management Product Governance & Compliance
- 6. 6 www.nexinfo.com Key Challenges forNew Product Introductions • 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? • 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?
- 7. 7 www.nexinfo.com Typical Quality RelatedPain 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. 8 www.nexinfo.com WHAT IS PLM? PLMenables companies to accelerate product innovation and maximize product profitability… …through the management of the information, processes and decisions about their products… …throughout the product lifecycle and across the global product network
- 9. 9 www.nexinfo.com ENTERPRISE PRODUCT RECORD= PLM Manufacturing Data (DMR- ERP/MES Sync) -Bills of Materials -Mfg. Instructions -Revision data Quality Management - Customer Complaints/CAPA - NCMR/Deviations - Audit Management - Voice of Customer Process Data (DHF/DMR) - ECOs/MCOs/Deviations - Change History - Documentation Supplier Data -Approved Vendors -Quality Management -Pricing -Availability Design Data - Design Spec History - Verification/Validation - Lab/Clinical Results - E-Submittals (510K/PMA) DHF Program Data -Schedules -Resources -Constraints -Risk The product record includes all the information required by the extended enterprise to conceptualize, design, source, build, sell, service and disposal of products
- 10. 10 www.nexinfo.com Enabling the Enterprise ProductRecord Manufacturing Information - Bills of Materials - Mfg. Instructions - Tooling - ECR/ECO/ECNs & Revisions Service & Quality Info - Problem Reports - Corrective Actions - Field instructions - Inspection Failures - Service BOMs Purchasing Information - Pricing - Part/BOM Costs - Price History Compliance Information - Regulatory & Standards - Product Compositions - Supplier Declarations - Audits Design Information - CAD Models - Graphics and Artwork - Packaging Specs - Design Reviews Project Portfolio Info - Programs & Projects - Schedules & Resources - Deliverables - Issues & Actions Supplier Information - Approved Vendors - Preference/Status - Availability Customer Information - Requirements - Configurations - Quality Issues The product record includes all the information required by the extended enterprise to conceptualize, design, source, build, sell, service & dispose of products Product Portfolio Management Engineering Collaboration Enterprise Visualization Product Change Control Product Cost Management Product Quality Management Product Governance & Compliance
- 11. 11 www.nexinfo.com Integrated Product Record 11 Historicalrevision control over product structures and BOMS integrated with ERP Integrated document management Approved Manufacturer & Supplier Management Robust configuration management including reference designation support Integrated electronic Change Management Single Version of Truth for all Product Information Multi-Level, graphical BOM management
- 12. 12 www.nexinfo.com Enterprise Value Chain 24/7 Collaboration Program Management Suppliers Artwork Houses Outsourced Partners Customers Regulatory Bodies Testing Facilities Excel LIMS MES ERP SCM ERP QuarkAdobe Marketing Sourcing Managers Quality Product Developers Analyst Pack Manager Specs Test Data Logos Ideas Site AML MES ERP Costs LIMS Complaints Formulas FIN Compliance Documents HCM Concept Briefs CRM HACCP Sample Integrated Product Record A Central Repository with “One Version of the Truth” Product Mgmt. Supplier Management Quality Management © 2008 Oracle Corporation – Proprietary and Confidential
- 13. 13 www.nexinfo.com Agile PLM Modules 13 AgileProduct Governance & Compliance Product & program compliance against standards & regulatory requirements Compliance Office Agile Product Portfolio Management Integrated product, program, resource & portfolio management Executives & Program Office Closed-loop product quality management across the extended enterprise Quality Professionals Agile Product Cost Management Product sourcing and lifecycle cost & risk management Procurement Professionals Agile Enterprise Visualization Native document collaborative visualization across the global enterprise Cross-Enterprise Agile Engineering Collaboration Engineering desktop integration & collaboration Development & Engineering Agile Product Collaboration Eng., Operations & Supply Chain Enterprise product record visibility, management & collaboration Agile Quality Management Product Portfolio Managemen t Engineering Collaboration Enterprise Visualizatio n Product Change Control Product Cost Managemen t Product Quality Management Product Governance & Compliance
- 14. 14 www.nexinfo.com Agile Product Collaboration (PC) 14 CustomerUse 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 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 Most organizations start with PC
- 15. 15 www.nexinfo.com Agile Product Collaboration(PC) Overview: Core Capabilities 15 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. 16 www.nexinfo.com Drug Discovery Process Launch Researchon orphan receptors, ligands, disease- related genes, and orphan enzymes Functional analysis of genes Highthrouput screening Combinatoria l chemistry Estimation of drug efficacy Safety evaluation and pharmacokinet ic Manufacturing process development and quality control Clinical evaluation and new drug application Basic genomic research Identificatio n of target molecules Discovery of seed lead compounds Scrutiny of drug candidates Manufacturing development Clinical Studies New drug application c c
- 17. 17 www.nexinfo.com 17 Business Processes Impactedby PLM PLM Business Process Supply Chain Planning Purchasing Controls Clinical Manufacturing Supplier Qualification Commercial Manufacturing Packaging and Labeling
- 18. 18 www.nexinfo.com Agile Product QualityManagement (PQM) Overview : Core Capabilities 18 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 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 Customer Use Cases 🞂Supplier quality tracking and management 🞂Full CAPA process implementation 🞂Quality process integration with engineering change management
- 19. 19 www.nexinfo.com Agile PQM SolutionOverview 19 Aggregate Analyze Act Supplier Field Call Center Mfg Ops Field Service Supplier Mfg. Design QA Proactive & Holistic Customer
- 20. 20 www.nexinfo.com Closed Loop QualityProcess 20 1. Pending 2. Owner Review 3. Containment 4. Open 5. Closed Problem (Issue) Process 1. Pending 2. Submitted 3. In Queue 4. Root Cause 8. Closed Quality Action Process (CAPA) 5. Solution Design 6. Solution Proposed 7. Validate 1. Pending 2. Submitted 3. In Process 4. Closed Failure Analysis Process 1. Pending 2. Review 3. Submitted 4. Pre CCB 7. Implemented ECO Process 5. CCB 6. Released Quality Processes integrated into ECO process, leveraging PQM and PC
- 21. 21 www.nexinfo.com Closing The Gapson Quality Pain Points 21 • Recurring Product Quality Issues . . . . • No Tie Between Quality Data and Engineering Changes • Delay Between Problem Identification & Resolution . . . . • Multiple Systems and Locations • No Aggregate View of Issues and Resolutions Problem • Higher Warranty Costs • Greater Inventory • More Recalls Impact • Loss of Productivity • Slower Response • Higher Service Costs • Higher Scrap and Rework Costs Solution Integrate Product Quality and Engineering Processes Continuous analysis of current and historic quality issues Design Higher Quality Products Going Forward Integrate Customer and Product Issues to Engineering Changes Faster, Consistent Resolution Processes Lower Cost of Service
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- 40. 40 www.nexinfo.com Agile PQM Experiences 40 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. 41 www.nexinfo.com ✔ We understandyour 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 Solution Based WHY NEXINFO FOR AGILE PQM
- 42. 42 www.nexinfo.com Contact Us HEADQUARTERS 615 WCivic Center Drive, Suite 350 Santa Ana, CA 92701 EMAIL LetsTalk@nexinfo.com TELEPHONE (714) 955-6970 Bellevue, WA Orange, CA Santa Ana, CA Bridgewater, NJ Chicago, IL Dublin, Ireland Chennai, India Bangalore, India
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Editor's Notes
- #8 Agile customer aggregate definition of PLM
- #9 One location for all med dev product information
- #12 What does enterprise PLM solution look like – how can one address all the shortcomings on the earlier slide?
- #23 What you see here is that customer complaint and you can see all the information on it. This is an out of the box form . . . The fields here also come out of the box, standard best practices information Going to scroll down . . .
- #24 Same customer complaint and you can see the flex fields on Page 3 which are customer specific. Configuring the fields do not require coding experience
- #25 On that same Customer Complaint, we went from the Cover Page tab to the Affected Items. Here you see all the Affected items on this customer complaint which is the PDA
- #26 On the Workflow tab of the Customer Complaint and you can see the steps this process needs to go through before there is closure.
- #27 We’re scrolling down and here you can see the history of this complain, who created and reviewed.
- #28 On the relationships tab you can see if this customer complaint is associated to any other items. Here you can see that this complaint is related to this corrective action. What you’re seeing is that this customer compliant is addressed by this Corrective Action If you look further you’ll see how they’re tied together. When the Corrective Action is set to Close and Notify, it automatically closes this customer complaint since they’re linked. . . . Attachments tab . . Attach anything including a picture sent by the customer of the item or anything else.
- #29 History tab automatically tracks anything done to this item. Standard functionality.
- #30 Here is a look at that Corrective Action we saw on the Customer Complaint. There are the standard fields out of the box and you get the key information right up front. We’re going to go to the Affected Items tab . . .
- #31 On the Affected Items tabs what you’re seeing is all the logged product service requests. You’re seeing a series of complaints all related to the same top level assembly. This CAPA was sent to Engineering, they looked into it and pinpointed the problem which you can see in the Affected Items section. We’re going to go to the Workflow tab
- #32 Here on the workflow tab is the process or the steps this Corrective Action will go through. It scrolls to the right so the next slide will show the extended process . .
- #33 Here you can see the rest of the process and where it currently is in which is Investigated. It’s waiting for approval to go into the next status. If you scrolled down you’ll see the entire history of this Corrective Action. Going to the Relationships tab . .
- #34 Here are all the customer complaints related to this corrective action. When this corrective action gets closed, it will close these corrective actions.
- #35 Here you can see the related Engineering Change that’s been put in place. By clicking on the link you’ll be taken right to the Engineering change
- #36 Here is the Engineering Change to change the display. Cover page information is standard out of the box fields. If you go to the Affected Items tab that PDA will show up . . We saw that in the Product Collaboration demo And If click on it, you’ll go to the PDA product record . . .
- #37 Here is that PDA product record . . And we’re going to click on the Quality tab . .
- #38 On the Quality tab you can see all the Quality issues related to that product record. Lets go to the BOM tab . .
- #39 On the BOM tab you’ll see very quickly which items have a Quality related item against it You can scroll up and down the entire BOM and quickly see which items have issues