Date post: | 16-Dec-2015 |
Category: |
Documents |
Upload: | christian-dawson |
View: | 221 times |
Download: | 4 times |
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?