Supply Chain Risk Management Guide Toolbox & Examples

1. Supply Chain Risk Management Guide Toolbox & Examples RPSGB, London 23rd February 2010 Justin Ahern - PQG

2. Why are we here today? Evolution!

3. Evolution! • No GMP • No Regulation • No Standards • No Guides • ISO • ICH • BROMI • MLX 345 Risk Based Inspection • FDA GMP for 21st Century • Dunlop Committee • MCA/MHRA • FDA

4. Evolution! • Do as you like! • Do it scientifically on a risk basis! • Do as we say! • Say what you do and do what you say!

5. Evolution! • Little or no guidance • First interactive fast access electronic guidance document QRM

6. A Changing World • Globalisation • complex supply chains • sourcing from less developed parts of the world • Transportation and Storage • long distances • increased transport time • varied climates • security • Counterfeits • Threat to patient safety • Threat to business continuity and brand confidence • Business Implications • Costs • Competitiveness • Continuity

7. Visions of Tomorrow • FDA – “GMP’s for the 21st Century” • Integration of Quality Systems & Risk Management • Use of science and analysis • Targeting resources to important quality issues • ICH – “Create a single, harmonised global quality standard and interpretation based on good science and risk management principles” • ICH Q9 is one building block of this vision

8. Visions of Tomorrow • MHRA – “Risk Based Inspection” • “Anti-counterfeiting strategy” • “Better Regulation Initiatives” • “The MHRA has implemented a risk based approach to the inspection of pharmaceutical operations as a key element of its Better Regulation initiative. This approach recognises to a greater degree the ownership of pharmaceutical companies of the quality assurance of their total manufacturing and supply processes. The industry, therefore, is being expectedto take overall responsibility for the quality of its output.” • Gerald W Heddell, Director Inspection, Enforcement & Standards Division, MHRA – Foreword to PQG SCRM Guide

9. Visions of Tomorrow • PQG Guide - • User-friendly and easy to navigate – rapid information access • Supports understanding of current Risk Management requirements • Consistent with current regulatory guidance • Appropriate to all organisations and theirsuppliers involved in the supply chain • Encourages the user to evolve • Gives examples to support understanding and awareness • Encourages improved communication and cooperation between all parties in the Supply Chain.

10. A Guide for Tomorrow

11. Why is this Guide Different? • Guide is aninteractivepdf • Can be viewedFREEonline at PQG Website • Can be downloadedFREEto your own PC for sharing or personal use • Incolour • Incorporates aToolbox, Worked Examples, Real Industry Examplesthat provide valuable Risk Management learning points

12. How to Navigate • Individual pages display text, graphics and links • Index always displayed on left – always know where you are • Click on index section title to go instantly to that section

13. How to Navigate • Within a main index section - subsections become display on the side bar • Hyperlinks in the text of the document - Click to go will to jump to another part of the document or to an external website

14. Guide Toolbox • Purpose(Section 3.1) • “This toolbox is to provide the user withbasic informationon some relevant, commonly available tools and techniques and demonstrate how they areapplicable to Risk Management. The tools and techniques discussed in this section areproven, effectivemethods that are commonly usedin a variety of industries.”

15. Guide Toolbox • Please Note! • Not intended to be definitive – does not substitute need for training and developing further understanding and expertise! • There will be tools and techniques that are not mentioned which may be appropriate to use! • Section 3.2 – Guidance on Implementing Risk Management • Project Management • Pointers and Pitfalls

16. Guide Toolbox • Structure • Contains6 subsections and 3 Appendices • Subsections 3-6 cover a selection of tools that can be used for the applicable stage of the Risk Management Process • Each Appendix is a worked example of a tool discussed in the main sections

17. Guide Toolbox • Subsection Structure • Introduction • Applicable to the Risk Management Stage • List of Tools • List may be sub-divided into simple and complex tools • May be some comments on some special cases e.g. tools that are defined in a particular sub-section but may have application in other subsections

18. Guide Toolbox • Subsection Structure • Individual Tool • Overview – Brief background, function and applicability • Advantages/Disadvantages – will provide the user information on where tools strengths and weaknesses are • How to Use the tool • Illustrations • Links – to references, diagrams, websites

19. Guide Toolbox • Example Appendices • Provides a worked example of a tool • Risk Ranking and Filtering Appendix 1 • Risk Assessment (FMEA) Appendix 2 • Priority Risk Assessment Appendix 3 • Provide templates that you can adapt to your use • Useful as a training aid • Illustrate use & facilitate understanding

20. Guide Toolbox • Benefits • Provides basic knowledge of a vast range of tools • Enables you to start simply and evolve toward more complex tools • Gives a common language for communication • Provides clear examples • Provides Templates • Provides Training Material • Fast Access • Comprehensive Bibliography Section giving references to further knowledge

21. Supply Chain Examples • Content of Part 4 • 19 real world examples • YES THESE ALL HAPPENED! • Sub-divided into: • Scenario – what happened – tells you the story • Learning Points – highlights the lessons learned and the effects of poor or good risk management

22. Supply Chain Examples • Content of Part 4 • THESE ARE VALUABLE LESSONS FOR YOUR ORGANISATION!

23. Product Contamination Management of Second Tier Suppliers Verification of Artwork Warehouse Operations & Pest Control Temperature Controlled Transportation Change Control - Process Fraudulent Activities in the Supply Chain Errors in Proof Reading Change Control – Source of Material Supply Chain Examples The Examples

24. Implementation of a New Process Multiple uses of a Material High Bio-burden Inconsistent Analytical Results Continuity of Supply Lack of Formal Contracts Effect of Global Supply Chains Effect of not knowing all the links in a Transport Chain Raw Material Source of Origin Reuse and Potential Infection Supply Chain Examples The Examples

25. Essential Messages • Risk Management is Not New Science But it is Good Science • Learn to Walk before You Learn to Run • Guide is Packed with Information • Clear • Concise • Fast Access at Your Fingertips • Designed for You

26. Essential Messages • Communicate, Communicate ,Communicate • Use Risk Management – Educate Your Supply Chain • And Your Business Will Benefit • Use This Guide and Together We Will Serve the Patient Well!

27. Thank You for Listening Any Questions?