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Managing Quality Across the Enterprise

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Manufacturing companies today are challenged by mounting pressures to meet extreme demands such as market demand, cost and recall reduction and coordinating communication across a complex supply chain to ensure quality and compliance.

In this presentation, Sparta Systems displays the quality issues faced today, and the best practices leading manufacturers are leveraging to manage quality across the enterprise, standardizing processes to improve efficiencies, reduce costs and ensure better business outcomes.

Published in: Business
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Managing Quality Across the Enterprise

  1. 1. Enterprise Quality Management Solution for Medical Device Companies Managing Quality Across the Enterprise
  2. 2. 2 Why Is Quality Important to Your Business Ecosystem? R&D PRODUCT INTROEXPANDING MARKETS GROWTH & MATURITY LIFE SCIENCE INDUSTRY Brand protection Globalization $ Cost, Price & Margins Vendor Network Speed to Market Consistent Delivery Compliance Sparta Systems Proprietary
  3. 3. The Challenge 3 Company Develops products to satisfy the needs of consumers Finance & Purchasing Focused on performance management and reducing costs Suppliers Supplies safety and high quality raw materials and packaging NO QUALITY VISIBILITY Issue Resolution Cost:  CAPA 2  Change Control 2  Deviations 2  CAPA 3  Change Control 3  Deviations 3 DISPARATE PROCESSES  CAPA 1  Change Control 1  Deviations 1 ConsumerDistributor WALL ST 1x 10x 100x 1000x… Contract Manufacturers & Packagers Handles outsourced manufacturing and packaging for brand owner NO QUALITY VISIBILITY Sparta Systems Proprietary
  4. 4. Addressing the Challenge 4 Path to Success ERP $ End-to-End Quality Management Internal Facility  Worldwide Facilities  Vendor Facilities Functional Area  Internal Manufacturing  External Manufacturing  R&D  Supplier Management Geography  Country  Region  Business Unit Quality Process  CAPA  Deviation/ Incident  Auditing  Complaint Handling  Change Control  OOS/OOT Sparta Systems Proprietary
  5. 5. The Proven Quality Solution 5 Company Finance & Purchasing ConsumerDistributor WALL ST EQMS: Harmonized Global Processes Contract Manufacturers & Packagers Suppliers  500k Global Users  700 (+) Implementations  Best Practice EQMS Workflows  Top 35 Pharmaceutical companies  Top 13 out of 15 Med Device Companies  Meets FDA & global regulatory requirements Sparta Systems Proprietary
  6. 6. Sparta Systems’ Customers 6 Sparta Systems Proprietary
  7. 7. EQMS Value Pillars 7 Business Value  Protect Brand Image & Liability Measure  Brand Valuation EQMS Benefit  Reduce Consumer Facing Events Business Value  Reduce Event Cycle Times EQMS Benefit  Continuously Improve Processes Measure  Increased Resource Efficiency EQMS Benefit  Connect All Solutions & Processes Business Value  Single integrated platform Measure  Reduced Technology Costs IT EFFICIENCY OPERATIONAL EFFICIENCY Business Value  Reduce Global Production Problems Measure  Reduced Waste Costs EQMS Benefit  Pinpoint and Contain Issues SUPPLY CHAIN MGMT RISK/COMPLIANCE MANAGEMENT Sparta Systems Proprietary
  8. 8. Executive Dashboards Analytics Analytics: Actionable Insights Business Insights Pre-structured Analyses Finance & Purchasing EQMS Visibility 8 Company ConsumerDistributor WALL ST Contract Manufacturers & Packagers Suppliers Sparta Systems Proprietary
  9. 9. 9 SPEED QUALITY INTELLIGENCE Addressing the Visibility Challenge: What’s Broken? Role Business Questions Today Executive What quality events are happening across the global business environment by product, process, region and function? Quarterly Consumer: Senior Manager What’s preventing us from shipping product/filling orders? Monthly Consumer: QA Manager What is the origination of our problems? How deep are our problems? Weekly/ Monthly Consumer: Auditor What is the root cause of our issues and how deep is the issue? How can we be more proactive in managing our product quality? (i.e. SOPs, training, change management) Days/ Weeks Monthly/ Quarterly Analyst Are there any positive or negative trends that impact product quality (i.e. waste, warranty, recall costs, etc.) Weekly/ Monthly Business Needs Insights needed for fact-based decisions Current Reporting Paradigm Current Output Self-service analytics users were 85% more effective in finding the information in the required amount of time. (Aberdeen Group, April 2012) Companies that inject analytics into their operations show productivity rate and profitability that are 5-6% higher than their peers. (Harvard Business Review, October 2012) VOLUME Role Business Questions TWA Executive What quality events are happening across the global business environment by product, process, region and function? Minutes / Hours Consumer: Senior Manager What’s preventing us from shipping product/filling orders? Minutes / Hours Consumer: QA Manager What is the origination of our problems? How deep are our problems? Minutes / Hours Consumer: Auditor What is the root cause of our issues and how deep is the issue? How can we be more proactive in managing our product quality? (i.e. SOPs, training, change management) Minutes / Hours Analyst Are there any positive or negative trends that impact product quality (i.e. waste, warranty, recall costs, etc.) Minutes / Hours Speed to Insights and Volume of Insights Business Needs TWA Enabled Insights needed for fact-based decisions Sparta Systems Proprietary
  10. 10. ROI Benefits to Quality Management Value Pillar Examples
  11. 11. 11  From multiple project solutions/data to a single platform  All processes connected to a single data source EFFICIENCIES GAINED FROM….. Platform Consolidation  Infrastructure/Hardware  Integration  Development and Support Organizational Efficiencies  Process effectiveness  Reporting effectiveness  Aggregated KPIs  Distribution  NVA efforts Maintenance & Support  Hardware  Software  Data backup  Upgrades + + Key Reasons to Implement an EQMS IT Efficiency ERP $Fragmented Pillar Systems Q Q Q Q Q = VALUE Point Solution # Quality ProcessesX XSites Sparta Systems Proprietary Sparta Systems Proprietary
  12. 12. 12 Key Reasons to Implement an EQMS Operational Efficiencies Role Key Responsibilities EQMS Benefit Executive • KPI • Critical information • Real-time Info • Push Report Visibility Regulatory Affairs • Regulatory filing • Risk assessment • Safety/Compliance • Visibility • Signaling • Timely reporting to Regulatory Bodies QA Manager • Task prioritization • Problem areas • Audit management • Continuous improvement • Resource efficiency • Holistic Quality management Manufacturing/ Operations • Tasks list, completion, and priorities • Ops reporting • Critical Issues detection • Business rules based workflow • Visibility 35% − Cost of Managing a growing number of Records Cost of Managing Records Today Cost of Managing Records Today Reducing Number of Records Given 35% Efficiency Gains− VS Sparta Systems Proprietary
  13. 13.  Product Quality and Value directly correlates to Brand - Affects brand integrity - Corporate Reputation - Profitability (market share) - Depends on the recall management Key Reasons to Implement an EQMS Brand Image Protection RECENT EVENTS AND BRAND IMAGE 13 iPhone antenna issues/ Foxconn Labor Issues B787 Li-Ion Battery Fires ICD (defibrillator) recalls Microscopic design error (Sandy Bridge) 83% 78% 59% 70% 17% 22% 41% 30% Pre-Recall Recall 1 Recall 2 Post-Recall Positive Perception Negative Perception Brand Sentiment Sparta Systems Proprietary Sparta Systems Proprietary
  14. 14. RECALL COST ELEMENTS  Recalls due to quality issues, product safety, regulatory bodies • Undermines trust and customer confidence • Long time to recover reputation, goodwill and equity • Proactive recall – minimal negative impact Key Reasons to Implement an EQMS Recall Costs Costs of Customer Dissatisfaction Operational Costs Regulatory Fines & Penalties Litigation Costs Long-Term Impact on Brand Sparta Systems Proprietary14 Sparta Systems Proprietary
  15. 15. Product Recalls A Threat to Brand Protection and Consumer Safety 15 Senior Team members manage recall risk through supplier indemnification 2 58% RECALL RISK MANAGEMENT 1 FDA Enforcement Statistics Summary, Fiscal Year 2012 2 Recall Execution Effectiveness Report. Deloitte, GMA, FMI and GS1. May 2010 3 Capturing Recall Costs: Measuring and Recovering Losses. Ernst & Young, GMI, Oct. 2011 Recalls: Class I, II and III 5,585 5,778 8,065 9,361 9,288 9,469 07 08 09 10 11 12 Recalled Products 2007-20121 10.7 7.8 8.4 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 ImpactofRecall onSharePrice2 Days from Recall Announcement 21% 52% of Recalls were due to supplier and contract manufacturer issues2 High Medium Low Recall Costs Scale X $90,000,000 $35,000,000 $10,000,000 Sparta Systems Proprietary
  16. 16. 16 For additional information on Sparta Systems, please visit: www.spartasystems.com Or contact us at: marketing@spartasystems.com

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