1. Creating the Case for Quality

2. Define EQMS In Your Context Tailor the EQMS Map for Your Organization 2 3. Extended, Mobile Quality Enterprise 3 Mobile Employees Mobile Devices Suppliers, Contractors, CMOs, Distributors Quality R&D Commercial Manufacturing Regulatory Affairs Preclinical/ Clinical EHS Incidents Investigations Audits Commitments Product Complaints Supplier Defects Deviations Corrective Actions Change Control Trends Approvals Reports Status Audits NCs Commitments Audit Observations Corrective Actions Deviations Product Complaints Certifications Emerging Requirements & Capabilities External Vendor Quality 4. Post Market Operating Outside The Four Walls 4 Supplier Quality Management Supplier Audit Supplier Qualification EOL Text Goes Here Lab Issues & Nonconformances Deviations & Incidents Audit Management Investigations Risk Evaluation Root Cause Analysis Complaint Handling CAPA Change Control Batch / IT / Process / Document Material / Equipment Supplier Nonconformance Supplier Corrective Action Supplier Change Control Electronic Reporting Registration Tracking Change Management Commitment Tracking Recall Management Creating the connected quality enterprise! Effectiveness CheckEffectiveness Check 5. Poor quality impacts - Consumers / patients - Product availability - Lost revenue - Brand image / morale - Stock price / shareholders Quality management involves everyone in the company and the extended supply chain - Top executives are concerned - But they cant connect the dots The Organizational Dynamics of Quality 5 Quality Management QA RA Ops R&DMfg EHS IT Suppliers Suppliers Suppliers 6. A Quality System in Basic Terms Being able to answer: What happened? Why did it happen? What did we do about it? Were we effective? Did we follow through on commitments? What can we do better? 6 If you dont document it it didnt happen! Lack of visibility means things wont get done! Tracking Visibility Enterprise Control 7. Assess the Current State Pick your facts wisely The 80-20 rule applies 7 8. What is the Result? What happened? What did we do? Were we effective? How did we do as a company? Why did it happen? 9. The Future State Transition 9 PLM CRM LIMS EQMS Processes Incidents CAPA Deviations Auditing Complaints Change Control Functions Mfg. - Int. Mfg. - Ext. R&D Clinical Suppliers Facilities Locations Country Region Business Unit Site Department Other ERP as the foundation & core of intersystem communications EQMS is an integral pillar system providing seamless interaction of all quality processes across all locations & functions Brand protection Less quality events & recalls Increase operating margins Variety of quality point solutions Separate implementations Manual process integration Quality information not shared Global compliance challenges ERP ERP PLM CRM LIMS Q Q Q Q Q Fragmented Pillar Systems Trust. Safety. Efficiency. Current State Compliance Desire Future Operational State Effectiveness 10. Local excellence emphasis Fragmented quality systems Manual corporate reporting Limits our assessment of global process capability Global and local blind spots Will lead to regulatory findings Creates global brand risk Lower share price w/ Opx budget Current State Summary 10 Very difficult to clearly understand: How are we really doing globally? Where are we at risk? What can we be doing better? 11. Quantify the Future State Gap Remember to avoid the curse of knowledge! Less is more? 11 12. The Future State Transition 12 Compliance-driven Project-centric Approach Strategic Effectiveness Platform-centric Approach Global brand risk Local process visibility Missed opportunities Reactive corrections Higher operating costs Global brand integrity Enterprise compliance Global transparency Proactive change Speed to results 13. Reporting Efficiency & Effectiveness Process Efficiency & Effectiveness Consolidation Into Platform Global Visibility Enterprise Transparency The Future State Impact 13 Concrete Emotional Tactical Strategic 14. Eliminate 90% non-value- added reporting - Pulling data out of disparate systems - Resolving and aggregating corporate metrics - Distributing results for review and reporting - Publish results 10-20 days after end of cycle Reporting Efficiency & Effectiveness 14 Average # of processes: 8 Supplier audit, internal audit, Deviations, Nonconformance, Complaints, CAPA, RFC/CC, Effectiveness, Commitment Tracking 15. Reduce process cycle time - # days from OPEN to CLOSE Improve right first-time - Eliminate rework / cycling Improve on-time completion - Due date extensions and overdue record management Process Efficiency & Effectiveness 15 Category Change % Change # Records +25,000 60% Average Cycle Time -90 days 65% Right First Time N/A 9% Open Record Inventory -5,000 50% On-time N/A TBD Note: A recent TrackWise example (3 year change) 16. Processing time reductions - Amount of touch time per record to move from OPEN to CLOSED - Elimination of non-value- added data assembly from multiple systems Largest efficiencies include - Initiation, initial review, and assignment - Investigations and analysis - CAPA and effectiveness planning Process Efficiency & Effectiveness 16 Process Processing Time Reduction Deviations 55% Complaints 65% Internal Audits 20% Investigations 50% CAPA 50% Change Control 35% Tracking, Visibility & Control Streamline Processes 17. Reduces infrastructure complexity Reduces integration complexity Reduces development and support costs Enables process and reporting effectiveness System Consolidation 17 Average # of processes: 8 Supplier audit, internal audit, Deviations, Nonconformance, Complaints, CAPA, RFC/CC, Effectiveness, Commitment Tracking 18. Best-in-class enterprise quality management - People & process changes institutionalized with a TrackWise platform Accelerating knowledge transfer & results - Share local results globally - Share global results locally Global Visibility 18 Category Benefit Summary # Quality Events 70% Gross Margins 2-3% # Recall Events >60% Serious Injury Rate >30% Quality Event Backlog >90% Results attained in 3+ years 19. Streamlined communications inside & outside the company Efficient operations Effective oversight Systematic follow through Efficiencies gained in dealing with quality outside your 4 walls Enterprise Transparency 19 Average # of processes: 4 Annual update/audit, supplier nonconformance, supplier corrective action, supplier change control Assumes 150 events per supplier per year 20. Create a Compelling Story The science of making your case stick 20 21. Making It Stick Simple - Avoid the Curse of Knowledge Unexpected - Surprise draws attention, focus and retention Concrete - Examples and analogies are memorable Concise - Avoid providing too much information (TMI)! Emotional - This is core to stickiness Story - People remember a good story! 21 22. The Opportunity Our brand image is dictated by supplier performance Over 60% of our recalls and withdrawals are supplier-related Our supplier interactions are slow, cumbersome and ineffective Future State / Benefits A centralized management tool with supplier access eliminates all paper Duplicate efforts, data copying, and costly delays will be eliminated Resolutions will occur 40% faster. Recalls will be reduced by at least 50% Example 1 Supplier Quality Management 22 Current State All supplier interactions are paper, email, phone call and FAX based Last year there were an estimated 20,000 supplier interactions The # of suppliers & interactions is growing at least 10% each year Requested Action One less recall is a $10M savings A supplier quality management solution is a small fraction of 1 recall This approach enables key suppliers to become part of our R&D and quality teams 23. Example 2 EQMS Consolidation 23 The Opportunity Our quality tools resemble 1990s MRP A recent IT audit revealed 43 critical Excel, Access and SQL tools to release product beyond 2 that IT knew about We have successfully grown through acquisition to 25 sites Future State / Benefits A more centralized approach will save at least $10M per year More importantly, benchmarks show that we can reduce quality events by 70% and improve gross margins 2-3% This can be done in 3 years Current State We have duplicate audit, deviation, complaint, NC, CAPA and change tools We estimate a redundant spend in excess of $10M annually across sites A recent audit uncovered consistent compliance gaps despite redundancy Requested Action Our brands & stock price are at risk Quality needs an enterprise platform Each quarter, Excel is used for event cycle counting & reconciliation An enterprise solution costs