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Supply Chain Risk Management Guide Toolbox & Examples. RPSGB, London 23 rd February 2010 Justin Ahern - PQG. Why are we here today?. Evolution!. Evolution!. No GMP No Regulation No Standards No Guides. ISO ICH BROMI MLX 345 Risk Based Inspection FDA GMP for 21 st Century. - PowerPoint PPT Presentation
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Supply Chain Risk Management Guide
Toolbox & ExamplesRPSGB, London 23rd February 2010
Justin Ahern - PQG
223/02/2010 Justin Ahern – PQG
Why are we here today?
Evolution!
323/02/2010 Justin Ahern – PQG
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 21st Century
423/02/2010 Justin Ahern – PQG
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!
523/02/2010 Justin Ahern – PQG
Evolution!
•Little or no guidance QRM
•First interactive fast access electronic guidance document
623/02/2010 Justin Ahern – PQG
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
723/02/2010 Justin Ahern – PQG
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
823/02/2010 Justin Ahern – PQG
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
923/02/2010 Justin Ahern – PQG
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.
1023/02/2010 Justin Ahern – PQG
A Guide for Tomorrow
1123/02/2010 Justin Ahern – PQG
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
1223/02/2010 Justin Ahern – PQG
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
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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
1423/02/2010 Justin Ahern – PQG
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.”
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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
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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
1723/02/2010 Justin Ahern – PQG
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
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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
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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
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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
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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
2223/02/2010 Justin Ahern – PQG
Supply Chain Examples
Content of Part 4
THESE ARE VALUABLE LESSONS FOR YOUR ORGANISATION!
2323/02/2010 Justin Ahern – PQG
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
2423/02/2010 Justin Ahern – PQG
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
2523/02/2010 Justin Ahern – PQG
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
2623/02/2010 Justin Ahern – PQG
Essential Messages
Communicate, Communicate ,Communicate
Use Risk Management – Educate Your Supply ChainAnd Your Business Will Benefit
Use This Guide and Together We Will Serve the Patient Well!
2723/02/2010 Justin Ahern – PQG
Thank You for Listening
Any Questions?