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

2. 23/02/2010Justin Ahern – PQG 2 Why are we here today? Evolution!

3. 23/02/2010Justin Ahern – PQG 3 Evolution! No GMP No Regulation No Standards No Guides Dunlop Committee MCA/MHRA FDA ISO ICH BROMI MLX 345 Risk Based Inspection FDA GMP for 21 st Century

4. 23/02/2010Justin Ahern – PQG 4 Evolution! Do as you like! Do as we say! Say what you do and do what you say! Do it scientifically on a risk basis!

5. 23/02/2010Justin Ahern – PQG 5 Evolution! Little or no guidance QRM First interactive fast access electronic guidance document

6. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 7 Visions of Tomorrow FDA – “GMP’s for the 21 st 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. 23/02/2010Justin Ahern – PQG 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 expected to take overall responsibility for the quality of its output.” Gerald W Heddell, Director Inspection, Enforcement & Standards Division, MHRA – Foreword to PQG SCRM Guide

9. 23/02/2010Justin Ahern – PQG 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 their suppliers 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. 23/02/2010Justin Ahern – PQG 10 A Guide for Tomorrow

11. 23/02/2010Justin Ahern – PQG 11 Why is this Guide Different? Guide is an interactive pdf Can be viewed FREE online at PQG Website Can be downloaded FREE to your own PC for sharing or personal use In colour Incorporates a Toolbox, Worked Examples, Real Industry Examples that provide valuable Risk Management learning points

12. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 14 Guide Toolbox Purpose (Section 3.1) “This toolbox is to provide the user with basic information on some relevant, commonly available tools and techniques and demonstrate how they are applicable to Risk Management. The tools and techniques discussed in this section are proven, effective methods that are commonly used in a variety of industries.”

15. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 16 Guide Toolbox Structure Contains 6 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. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 18 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 Guide Toolbox

19. 23/02/2010Justin Ahern – PQG 19 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 Guide Toolbox

20. 23/02/2010Justin Ahern – PQG 20 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 Guide Toolbox

21. 23/02/2010Justin Ahern – PQG 21 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 Supply Chain Examples

22. 23/02/2010Justin Ahern – PQG 22 Supply Chain Examples Content of Part 4 THESE ARE VALUABLE LESSONS FOR YOUR ORGANISATION!

23. 23/02/2010Justin Ahern – PQG 23 Supply Chain Examples 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 The Examples

24. 23/02/2010Justin Ahern – PQG 24 Supply Chain Examples 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 The Examples

25. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 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. 23/02/2010Justin Ahern – PQG 27 Thank You for Listening Any Questions?