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

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