Protecting The Global Supply Chain Through An Effective Audit Program Rev B

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Supplier audits are a critical component of ensuring the integrity of the Pharmaceutical Ingredient Supply Chain. However, evolving supply chains are outpacing traditional audit program methods. Today, effective supplier audit programs require a fresh look at the people, processes and technology involved. The new global standard for supplier audit programs is an agile, multi-faceted model that comprises a disciplined process, optimized key resources, versatile tools and complete stakeholder visibility. This presentation will help business leaders evaluate their supplier quality operations and create a foundation for greater supply chain integrity and improvement.

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Protecting The Global Supply Chain Through An Effective Audit Program Rev B

  1. 1. Protecting the Global Supply Chain Through an Effective Audit Program<br />Gerard Pearce<br />
  2. 2. TODAY’S LEARNING OBJECTIVES<br />Assess the forces influencing your supplier quality organization<br />Establish and maintain the foundations of a strong, versatile and organizationally visible supplier quality function<br />Monitor and manage critical aspects of supplier quality for consistency, efficiency and effectiveness<br />Anticipate and adapt to the changing supplier environment<br />
  3. 3. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  4. 4. FORCES ON SUPPLIER QUALITY<br />New Decade, Old Challenges<br />Challenges inside your company<br />Challenges inside your supply chain<br />Challenges outside your company<br />
  5. 5. FORCES ON SUPPLIER QUALITY<br />Challenges inside your company<br />Resources Vs Requirements<br />More travel<br />More detective work/chasing<br />Connection<br />Standard Tools<br />Greater detail, number and frequency<br />
  6. 6. FORCES ON SUPPLIER QUALITY<br />Internal Connection?<br />organizational boundaries<br />Supplier<br />Supplier<br />Supplier<br />Supplier<br />Supplier<br />Supplier<br />Supplier<br />functional boundaries<br />system boundaries<br />quality results<br />OK<br />marginal<br />OK<br />OK<br />OK<br />incomplete<br />poor<br />OK<br />poor<br />OK<br />OK<br />?<br />
  7. 7. FORCES ON SUPPLIER QUALITY<br />Challenges inside your supply chain<br />Moving Target<br />Distance<br />Can’t go, shouldn’t go<br />Mergers, acquisitions, splits and spinoffs<br />Global Financial Crisis<br />Cultural and local knowledge factors<br />CAR Sickness<br />PDA Web Seminar<br />Protecting the Global Supply Chain Through an Effective Audit Program <br />
  8. 8. FORCES ON SUPPLIER QUALITY<br />Evaluating an increasingly global supply chain:<br />volume<br />safety<br />language<br />expertise<br />travel expense<br />visibility<br />follow-up<br />
  9. 9. FORCES ON SUPPLIER QUALITY<br />Challenges outside your company<br />Regulatory and Industry pressure<br />Global Financial Crisis<br />Environmental Factors<br />Economically Adulterated Medicine<br />Political Climate<br />…factors not usually considered in audit scope<br />
  10. 10. FORCES ON SUPPLIER QUALITY<br />So how does a better audit program help?<br />Best use of most valuable resources<br />Can address broader scope<br />Can cover new geography<br />Keeps up with supply chain changes<br />
  11. 11. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  12. 12. STRONG FOUNDATIONS<br />Focus<br />Planning and Staffing<br />Process<br />Tools<br />Training<br />Automation<br />
  13. 13. STRONG FOUNDATIONS<br />Focus<br />Supplier Audits are only one aspect of Supplier Quality<br />Regulatory Obligations (ICH Q7: 7.11, ICH Q10: 2.7a, 21 CFR 820.50, etc.)<br />Business Sense (reduced cost of quality, supplier improvement, etc.)<br />
  14. 14. STRONG FOUNDATIONS<br />Planning and Staffing I<br />Goals<br />Defined and aligned with corporate strategy<br />Alignment with strategic goals and other functions<br />Low or no Purchasing-Quality ‘Distance’<br />
  15. 15. STRONG FOUNDATIONS<br />Planning and Staffing II<br />Resources<br />Wise use of finite resources<br />Based on good data (target hot-spots)<br />Rethink roles and responsibilities (and create new ones for people behind the scenes)<br />Think global, act regional (hubs)<br />Upgrade tools, techniques and systems<br />
  16. 16. STRONG FOUNDATIONS<br />Planning and Staffing III<br />Prioritization<br />Strategic Partners<br />Strategic Stinkers<br />Risk Management<br />Regional Coverage<br />risk<br />low<br />medium<br />high<br />high<br />medium<br />performance<br />low<br />
  17. 17. STRONG FOUNDATIONS<br />Planning and Staffing IV<br />Standardization<br />Target organizational, system and functional boundaries<br />Leverage organizational quality network<br />Aim for synergy in Supplier Quality Management<br />Develop ‘Best of Breed’ tools and processes<br />Share results and critical data<br />
  18. 18. STRONG FOUNDATIONS<br />Process I<br />‘Manufactured’ Supplier Evaluation<br />Consistency Vs Redundancy<br />Consider all the moving parts and control them<br />Map all activity<br />Free up high-value resources for high-value tasks<br />Invite self-serve visibility rather than reports<br />Steal ideas with pride<br />
  19. 19. STRONG FOUNDATIONS<br />Process II<br />‘Bigger Picture’ Supplier Evaluation<br />View evaluation as part of a larger process<br />Increase the evaluation scope to add value (counterfeit risk, process capability)<br />Exploit ‘Administrative Intelligence’<br />
  20. 20. STRONG FOUNDATIONS<br />Tools<br />Consensus on what the tools are and how to use them<br />More than a checklist (templates, notifications, gold samples, lessons learned)<br />Feedback loop through review<br />Share with pride<br />
  21. 21. STRONG FOUNDATIONS<br />Training<br />Not all auditors created equal<br />Flexible, team-oriented people<br />How to use the tools<br />Role play<br />What-if scenarios<br />Culture awareness<br />Lessons learned & regular briefing<br />Critique focus<br />
  22. 22. STRONG FOUNDATIONS<br />Automation<br />Support the process, not just the results<br />Align with IT strategy and existing infrastructure<br />Eliminate manual steps<br />Monitoring and alerts<br />Facilitate exchanges (beyond Outlook)<br />View towards business intelligence<br />‘Careful what you wish for…<br />alert!<br />
  23. 23. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  24. 24. PRODUCTION<br />Execution<br />Closing the loop<br />Continuous Improvement<br />
  25. 25. PRODUCTION<br />Execution<br />Constant monitoring and action<br />Expanding the scope<br />Measure, then measure some more<br />
  26. 26. PRODUCTION<br />Closing the loop<br />Opportunity presented by corrective action<br />Different levels of corrective action<br />‘CAR sickness’<br />Managing effective corrective action to close the loop<br />
  27. 27. PRODUCTION<br />Continuous Improvement<br />Acknowledge sources of variation<br />Monitoring ‘Production’ (resource utilization, turnaround time, days-to-x, responsiveness)<br />Don’t inspect quality in<br />Lessons learned<br />Feedback into “Use, Improve or Lose” Supply Management mantra<br />
  28. 28. PRODUCTION<br />Business Intelligence: program automation and stakeholder visibility<br />Real-time Dashboard<br />Filtered Program Data<br />Detailed Event Status<br />Deployed Team<br />Process Controlled<br />Data Export<br />Complete Results<br />Email Alerts<br />Relational Events<br />
  29. 29. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  30. 30. ADAPTING<br />Optimization and Exception Handling<br />Sharing responsibility<br />Outsourcing<br />Data Sharing<br />it Procedure – Revision 17<br />Confidential<br />establish a system<br />conducting,<br />quality<br />XYZ Co<br />Quality Management System<br />
  31. 31. ADAPTING<br />Optimization and Exception Handling<br />Naturally follows a well-defined process<br />Escalation<br />Why not a FMEA?<br />Reduces roadblocks and ‘too-hard’ cases<br />
  32. 32. ADAPTING<br />Sharing Responsibility<br />Obtain commitment up front<br />Data: do it once, do it fast, do it right<br />Develop two-way visibility<br />Buy-in eliminates redundancy, errors<br />Establish ‘Controlled Connection’ through organizational boundaries<br />Opportunities beyond simple transactions<br />Promote a collaborative, time-saving environment<br />www.sqaservices.com - "Global Quality on Demand"<br />
  33. 33. ADAPTING<br />“Where is the Quality Manager who can afford so to cover his entire supply base as that a thousand suppliers might not do an infinite deal of mischief?” – apologies to Benjamin Franklin<br />Outsource<br />Acknowledge ‘commoditized’ activities<br />Target necessary, but non-critical activity<br />Adopt ‘co-sourcing’ for specialist or regional skills<br />Use risk-based approach<br />
  34. 34. ADAPTING<br />Outsourcing<br />Not responsibility, or the relationship<br />A supplement, not a silver bullet<br />They must be you<br />You still need to be involved<br />
  35. 35. ADAPTING<br />Data Sharing:<br />Rx-360 Mission <br />Create and monitor a global quality system that meets the expectations of industry and regulators, that assures patient safety by enhancing product quality and authenticity throughout the supply chain<br />Patient safety must never be compromised as a competitive advantage<br />
  36. 36. ADAPTING<br />Data Sharing:<br />Fair Factories Clearinghouse <br />Apparel industry<br />Monitors supplier practices to ensure social responsibility is upheld<br />CHWMEG, Inc <br />Manufacturing and other "industrial" companies, many Pharmaceutical companies<br />Efficiently audit waste management. 217 member companies have saved $27M<br />Learning from other organizations <br />in order to accelerate Rx-360<br />
  37. 37. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  38. 38. RECAP & TAKE-AWAY<br />Forces on Supplier Quality<br />New decade, old challenges - inside your company, your supply chain, and outside your company<br />Strong Foundations<br />Focus, Planning and Staffing, Process, Tools, Training, Automation<br />Production<br />Execution, Closing the loop, Continuous Improvement<br />Adapting<br />Optimization and Exception Handling, Sharing responsibility, Outsourcing, Data Sharing<br />
  39. 39. TODAY’S LEARNING OBJECTIVES<br />Assess the forces influencing your supplier quality organization<br />Establish and maintain the foundations of a strong, versatile and organizationally visible supplier quality function<br />Monitor and manage critical aspects of supplier quality for consistency, efficiency and effectiveness<br />Anticipate and adapt to the changing supplier environment<br />
  40. 40. THIS SESSION<br />Focus on effective system for evaluating suppliers<br />Agenda:<br />90<br />30<br />60<br />intro<br />forces on supplier quality<br />strong foundations<br />production<br />adapting<br />recap<br />q&a<br />
  41. 41. Questions and further information:Gerard Pearce310-802-4448gpearce@sqaservices.com<br />

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