Introduction to the Supply Chain Risk Management Guide RPSGB, London 23 rd February 2010 Jill...
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Transcript of Introduction to the Supply Chain Risk Management Guide RPSGB, London 23 rd February 2010 Jill...
Introduction to theSupply Chain Risk Management
Guide RPSGB, London 23rd February 2010
Jill Jenkins - Pharmaceutical Quality Group
Today…..
• You will:
– Hear about the development of the PQG Guide, its content, structure & benefits
– Learn from MHRA & key industry speakers who will share their experiences on Risk Management & Supply
– Gain a good understanding of why Supply Chain Risk Management is so important & take away key messages
• We hope that you will find the PQG Guide a useful resource that you will use & share widely
Wave of change….
The combination of:– Emerging low-cost suppliers– Global sourcing beyond traditional
boundaries– Variation in standards & control
has meant that Supply Chain Management is
an increasingly risky business!
Areas highlighted….• Supplier approval & ongoing compliance issues:
– Uncommunicated changes– Inconsistent QC or yield rates– Unknown impurities
• Continuity of Supply:– Single sourcing– Suppliers ceasing business
• Lack of full Supply Chain transparency:– Not knowing original source of materials– Shipper integrity & on time delivery
• Distribution & logistics concerns:– Security (counterfeiting/theft), cross-mixing, mislabelling, poor
storage, temperature issues, delays,
ISO 9001:2008 …..
• Reference (4.1) states:
– “where an organisation chooses to outsource any process that affects product conformity to requirements, the organisation shall ensure control over such processes
– The type and extent of control to be applied shall be defined within the Quality Management System
– Ensuring control over outsourced processes does not absolve the organisation of the responsibility of conformity to all customer, statutory & regulatory requirements.”
ICH Q10…..
• Defines the “accountable organisation” as being ultimately responsible for ensuring that processes are in place to assure control of outsourced activities and quality of purchased materials
• It requires:
– Assessment prior to outsourcing / selection
– Defined responsibilities & communication processes
– Monitoring & review of performance
– Confirmation of incoming materials against agreed supply chain
Regulatory expectations…..
• Expect manufacturers & authorisation holders to ‘‘do the right thing’’:
−Know where the Risks are
−Know how big the Risks are
−Be Proactive, Plan to Control and if possible, Reduce these Risks
−Communicate these Risks to stakeholders & groups who can act accordingly, and
−Stay in Control
The project team….
• Richard Smalley• David Cock• Justin Ahern• Sharon Shutler• Sharon Hooper• Jill Jenkins
What we set out to do……..
• Develop a freely available, downloadable Supply Chain Risk Management Guide (SCRM) based on the ICH Q9 quality risk management model
• Provide a resource of information to help organisations & their suppliers adopt a common approach to Risk Management across the Supply Chain.
Target audience…..
• Pharmaceutical & Medical Device
organisations
• Suppliers / contractors to the above
industries
Purpose of PQG Guide…..
• Encourage all organisations to apply the principles of Risk Management to minimise supply chain risks & assure quality & continuity of supply
• Emphasise to the pharmaceutical & medical device industries & their suppliers the need to:
– Apply Risk Management when making sourcing decisions or changes
– Involve the relevant people
– Communicate proactively
• Provide information that will help supply organisations understand the regulatory requirements & expectations of the pharma & medical device industries
Development…..
UPDATED
PLANNED
DEVELOPED
CONSULTEDREVIEWED FEEDBACK
October 2007
January 2010
Cycle reiterate
d 3 times
Supply Chain focus…..• Consideration of
controls• Impact of complex
systems
• Supplier lifecycle approach
Understand your business!
Supplied materials / products
Manufacturing & Testing
PackagingWarehouse & Distribution
Internal Support Services (examples): Quality, EHS, Engineering, Facilities, IT
External Contracted ServicesE.g. manufacturing, testing, artwork & origination, packaging, warehousing & distribution, calibration etc
End user / customer
Product / service Design & Development
• Look internally as well as externally• Internal may involve different sites / locations
Supply Chain tiers
• Know your supply chain
• What activities are critical to the product?
• Identify potential hazards & associated risks
End customer / patient
Wholesale / retailer / pharmacy
Pharmaceutical and Medical Device Industry
Brokers / Distributors / Transport companies
Supplier A Supplier B
Supplier C Supplier D
Tier 1 suppliers
Tier 2 suppliers
Tier 3 suppliersBrokers /
Distributors / Transport companies
Transport / Distribution
Transport / Distribution
Tier 4 suppliers
• Communication• Understanding
requirements• Shared
agreement
17
See the “big picture”.…..
Focus too much on one source of information……
And you might just miss something important!
Using the PQG Guide…..
• Designed for use by organisations & their suppliers
• Quality Risk Management (QRM) is important to:
o Youo Your customers and o Your suppliers
• QRM is a business process that:
– Provides a common language for communication
– Assists in defining the scope and rationale for decisions within the supply chain
Getting started?
• Firstly, understand how Risk Management works
• Define the overall approach
• Focus on areas where it makes obvious sense & there will be a better chance of success
• Decide what specific goals you want to achieve
• Train /coach people in the relevant tools
• Don’t try to run before you can walk
Structured approach…..
Key messages:• Cover product
life-cycle • Should be:
– Pro-active– Re-iterative– Communicat
ed– Reviewed
ICH Q9
Supply Chain Risk Management
Sel
ecti
on
Mo
nit
ori
ng
Imp
rove
men
t
Risk Management
Eva
luat
ion
Foundations
• Supports continuous improvement:– Proactive not reactive– Ongoing cycle of risk
reduction• Enables more effective
prioritisation & efficient use of resources
• Reduces risk to business & lower overall cost
• Improve overall customer satisfaction (regulator / purchasing company)
SCRM
Final thought!
• Our customers include the:• Regulators• Healthcare professionals• Patient
• They expect our products to meet regulatory, Safety, Quality & Efficacy requirements!
• How secure is your supply chain?