NexInfo PQM Webinar

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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 _at_NexinfoSolution
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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

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Presenter Details

• 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

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Reminder Submitting Questions
Questions??
Reminder Please submit questions using the
questions option on the sidebar
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Setting the Stage
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
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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?

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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

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WHAT IS PLM?
PLM enables 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
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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
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Enabling the Enterprise Product Record

• 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
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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
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Integrated Product RecordA Central Repository
with One Version of the Truth
Artwork Houses
Testing Facilities
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
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Agile PLM Modules
Product Portfolio Management
Product Governance Compliance
Product Quality Management
Engineering Collaboration
Enterprise Visualization
Product Cost Management
Product Change Control
Agile Quality Management
Agile Product Collaboration
Eng., Operations Supply Chain
Enterprise product record visibility, management
collaboration
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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
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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

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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
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Business Processes Impacted by PLM
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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

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Agile PQM Solution Overview
Act
Aggregate
Analyze
Customer
Call Center
Design
QA
Supplier
Mfg Ops
Mfg.
Supplier
Field Service
Field
Proactive Holistic
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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
8. Closed
6. Solution Proposed
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
7. Implemented
6. Released
5. CCB
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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

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System Demonstration CAPA Workflow
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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

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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

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Contact Us
Dublin, Ireland
Bellevue, WA
Bridgewater, NJ
Orange, CA Santa Ana, CA
Chicago, IL
Bangalore, India
Chennai, India
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QA