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Supply Chain Risk Management Guide Toolbox

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Supply Chain Risk Management Guide Toolbox & Examples RPSGB, London 23rd February 2010 Justin Ahern - PQG Why are we here today? Evolution! No GMP No Regulation No ... – PowerPoint PPT presentation

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Title: Supply Chain Risk Management Guide Toolbox


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

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

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

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 GMPs 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 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
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
A Guide for Tomorrow
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
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 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
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
  • 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
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
Supply Chain Examples
The 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

24
Supply Chain Examples
The 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

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?
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