Transcript Document

Supply Chain Risk Management Guide
Toolbox & Examples
RPSGB, London 23rd February 2010
Justin Ahern - PQG
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Why are we here today?
Evolution!
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Evolution!
•No
•No
•No
•No
GMP
Regulation
Standards
Guides
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•Dunlop Committee
•MCA/MHRA
•FDA
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•ISO
•ICH
•BROMI
•MLX 345 Risk Based
Inspection
•FDA GMP for 21st
Century
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Evolution!
•Do as you
like!
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•Do as we
say!
•Say what
you do and
do what
you say!
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•Do it
scientifically
on a risk
basis!
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Evolution!
•Little or no
guidance
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QRM
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•First interactive
fast access
electronic guidance
document
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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
•
•
•
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Implications
Costs
Competitiveness
Continuity
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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
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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
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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.
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A Guide for Tomorrow
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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
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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
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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
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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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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
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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
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Guide Toolbox
Benefits
•
•
•
•
•
•
•
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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
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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
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Supply Chain Examples
Content of Part 4
THESE ARE VALUABLE LESSONS FOR YOUR
ORGANISATION!
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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
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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
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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
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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!
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Thank You for Listening
Any Questions?
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