Document

Report
Introduction to the
Supply 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…..
PLANNED
October 2007
UPDATED
REVIEWED
FEEDBACK
Cycle
reiterated
3 times
DEVELOPED
CONSULTED
January 2010
The Guide at a glance…..
Supply Chain focus…..
• Consideration of
controls
• Impact of complex
systems
• Supplier lifecycle
approach
Understand your business!
•
•
Look internally as well as externally
Internal may involve different sites / locations
Internal Support Services (examples): Quality, EHS, Engineering, Facilities, IT
Supplied
materials /
products
Product /
service Design
& Development
Manufacturing
& Testing
Packaging
Warehouse &
Distribution
End user /
customer
External Contracted Services
E.g. manufacturing, testing, artwork & origination, packaging, warehousing & distribution, calibration etc
Supply Chain tiers
End customer / patient
• Know your supply
chain
• What activities are
critical to the
product?
• Identify potential
hazards &
associated risks
Supplier A
Transport / Distribution
Wholesale / retailer /
pharmacy
Transport / Distribution
Pharmaceutical and Medical
Device Industry
Brokers / Distributors /
Transport companies
Tier 1 suppliers
Tier 2 suppliers
Supplier B
Tier 3 suppliers
Brokers /
Distributors /
Transport companies
Supplier C
• Communication
• Understanding
requirements
• Shared agreement
Tier 4 suppliers
Supplier D
See the “big picture”.…..
Focus too much
on one source of
information……
And you might just
miss something
important!
17
Using the PQG Guide…..
• Designed for use by organisations & their suppliers
• Quality Risk Management (QRM) is important to:
o You
o 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
– Communicated
– Reviewed
ICH Q9
Supply Chain Risk Management
•
Foundations
Improvement
Risk Management
Monitoring
•
SCRM
Evaluation
•
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)
Selection
•
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?
Thank you for listening!
• We hope that you will find the PQG Guide to SCRM a
useful resource that you will use & share widely

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