supply chain risk management guide toolbox & examples

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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!


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


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!


Evolution!

•Little or no guidance QRM

•First interactive fast access electronic guidance document


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


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


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


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.


A Guide for Tomorrow


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


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


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


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.”


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


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


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


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


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


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


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



Content of Part 4

THESE ARE VALUABLE LESSONS FOR YOUR ORGANISATION!



•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



•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


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


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!


Thank You for Listening

Any Questions?

supply chain risk management guide toolbox & examples

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