5/11/2015
Keynote Speaker
Increasing Product Confidence –
Shifting Paradigms
Ms. Marla Phillips
Director of Xavier Health
Increasing Product Confidence –
Shifting Paradigms
ExcipientFest Americas April 28, 2015
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5/11/2015
Xavier Health
Medical Device Industry
Pharmaceutical Industry
• FDA/Xavier University MedCon Conference
• FDA/Xavier University PharmaLink Conference
• QARA Institute (professional development and certification)
• Xavier/PwC Metrics Initiative
Cross‐Industry
Initiatives
• Integrity of Supply
 Good Supply Practices (GSP)
• Support for CDRH “Case for Quality”
Patient Safety
Everything we do must be of high quality
To make a meaningful difference to patient health
Warning Letters
Save and improve lives around the world
Risks
To help people do more, feel better, live longer
We develop medicines that improve lives around the world
Improve the Product quality of life for patients and Failures
caregivers
Help patients prevail over serious diseases
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5/11/2015
Table Discussion
What are some actions you would take as a result of having a high risk supplier in your supply chain?
Discuss in groups
With the End in Mind
GSP
GMP
Increase Product Confidence
GIP
GDP
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5/11/2015
Governance Team
Helge Batz
Mike King
Gwyn Murdoch
Rafiqah Williams
Director
Boston Scientific
Director
J&J
Director
Eli Lilly
VP
Eli Lilly
Dale Carter
Michael Landberg
Mark Paviglianiti
Steve Wolfgang
Global Director
Huber
Global Sourcing
Boston Scientific
Director
Merck
Acting Assoc. Director
CDER
Tami Frederick
Hank Llamas
Marla Phillips
Exec. Director
Perrigo
VP
J&J
Director
Xavier University
Dale Huff
David Lowndes
Susan Rolih
Exec. Director
Merck
SVP
Shire
EVP
Meridian Bioscience
Al Kentrup
Will Mitchell
Michelle Smith
WW Director
P&G
Corp. Quality
P&G
Sr. Director
Meridian Bioscience
Integrity of Supply GSP
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Problem Statement
We are unable to reliably and consistently ensure the supply of incoming materials used in products to serve the Pharmaceutical and Medical Device industries
Therefore, we need greater assurance that suppliers can reliably and consistently supply safe and quality materials/products to limit adverse impact on end‐
user safety and brand equity
Natural Tendencies
“If”
We are unable to reliably and consistently ensure the supply of incoming materials
“So of course that means”
We need to “fix” our Suppliers
“and”
“Then obviously” We need greater assurance that suppliers can reliably and consistently supply safe and quality materials/products Our Suppliers are causing the Problems
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Mission Statement
To determine the source of dysfunction affecting the Integrity of Supply, and to implement sustainable solutions that can be tied to Return on Investment ‐
such as increased safety, improved quality and enhanced reliability – commensurate with the need.
Integrity of Supply GSP
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5/11/2015
Cause/Effect and Pareto
Product and Process Theme
1. We are not setting the right specifications to begin with
2. We rely on compendial testing rather than determine if other tests are needed for our product and process
3. We are not able to detect changes or deficiencies in in‐coming material 4. We do not have a feedback loop for specification effectiveness
5. We do not have a robust change management system in place
6. We are not involved in setting the specifications beyond Tier 1
Cause/Effect and Pareto
Supply chain Theme
1. We are unable to verify GMPs with a certain base of our suppliers
2. We have no real understanding of how the supply chain is managed beyond Tier 1
3. We do not have enough resources to monitor entire supply chain
4. We are not involved in selecting our supplier’s suppliers
5. We lack leverage with a certain base of our suppliers
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Cause/Effect and Pareto
Behaviors Theme
1. Our supplier approval process is not robust
2. We do not adequately share information with our suppliers
3. We do not engage cross‐functional colleagues in the process, or not at the right time
4. We don’t follow our own supplier selection process
Paradigm Shift
“Our Suppliers
Are Causing Problems”
August
2012
July
2013
We are Causing
Problems
• August 2012: we wanted to focus on certifying our suppliers
• July 2013:
top data is pointing to ourselves as the root cause
Key Takeaway Disciplined process will focus on true root cause
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Action‐Provoking!
Integrity of Supply GSP
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Functional Background
Food
Drug
23% 9%9%
17%
17%
Device
20%
30%
10%
58%
8%
20% 20%
59%
Business Development
Customer Service
Quality Operations/Assurance
Technical Operations
Other
Location of manufacturing facilities
Food
Drug
Device
7% 2%
8%8%
12%
8%
48%
16%
1%
19%
34%
36%
8% 15%
1%
2%
51%
24%
Africa
Asia
Australia
Europe
N. America
S. America
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# of different “types” of products/materials
# of different “types” of products/materials
Food
Drug
34%
Device
15%
32%
41%
58%
8%
52%
33%
27%
<10
10‐50
>50
% of supplier’s product/material is specialty
% of supplier’s product/material is specialty
Food
Drug
Device
10%
10%
33%
17%
17%
19%
38%
10%
33%
19%
14%
10%
61%
9%
<10
10‐25
51‐75
>75
26‐50
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Total Respondents
Food
Drug
Device
12
22
128
7%
14%
Food
79%
Drug
Device
% of time willing to share process capability data and/or composition of material with customers
Food
Drug
Device
6%
5%
18%
25%
9%
59%
8%
8%
45%
14%
9%
4%
12%
8%
13%
57%
<10
10‐25
26‐50
51‐75
>75
Not Sure
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5/11/2015
% of customers who ask to see your process capability data and/or composition of material information
Food
Drug
Device
10%
5%
12%
17%
32%
27%
41%
16%
27%
25%
18%
17%
16%
9%
9%
19%
<10
10‐25
26‐50
51‐75
>75
Not Sure
% of customers ask for your input on specifications for your product/material
Food
Drug
Device
6%
5%
9%
8%8%
8%
18%
4%
34%
13%
23%
30%
15%
34%
8%
23%
27%
27%
<10
10‐25
26‐50
51‐75
>75
Not Sure
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5/11/2015
% of time you have enough info about customer needs and process to know when it is important to report changes Food
Drug
8%
9% 14%
Device
6%
25%
4%
9%
5%
10%
17%
8%
16%
14%
45%
59%
42%
9%
<10
10‐25
26‐50
51‐75
>75
Not Sure
% of time given access to representatives from your customers who have the responsibility, competency, and authority to make decisions
Food
8%
Drug
Device
6%
8%
10%
9% 14%
25%
23%
9%
40%
25%
34%
6%
9%
11%
27%
36%
<10
10‐25
26‐50
51‐75
>75
Not Sure
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Quality Agreement in place with what % of customers
Food
Drug
Device
6%
25%
50%
8%
14%
5%
13%
27%
9%
38%
23%
21%
27%
17%
17%
<10
10‐25
26‐50
51‐75
>75
Not Sure
% of customers who involve cross‐functional representatives in the due diligence process
Food
Drug
Device
4%
25%
9%
16%
5%
14%
25%
17%
17%
19%
23%
32%
8%
14%
34%
20%
18%
<10
10‐25
26‐50
51‐75
>75
Not Sure
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5/11/2015
% of time changes in scheduling from your customer communicated w/ enough notice and with regard to the commitments you have with other customers
Food
17%
Drug
23%
33%
25%
9%
25%
Device
9%
7%
8%
18%
17%
16%
14%
27%
25%
27%
<10
26‐50
>75
10‐25
51‐75
Not Sure
Paradigm Shift #2
Suppliers
are
Suppliers
August
2012
Suppliers
are
Customers First
July
2013
• Suppliers = Customer: our specifications, requirements and expectations are the “products” we deliver to our suppliers
• Suppliers = Suppliers: the incoming material is the product we then receive from our suppliers
Suppliers ≠ “Lesser” En
es
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Action‐Provoking!
Integrity of Supply GSP
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Good Supply Practices (GSPs)
Three over‐arching themes
1. Product and Process Knowledge and Development
2. Supply Chain Development and Management
3. Driving Ideal Behaviors
End Goal
Development and implementation of pragmatic Good Supply Practices (GSPs) related to the three over‐arching themes that include standardized practices based on cross‐industry best practices
Anchor to SCM Process
Group GSPs under Supply Chain Management Phases
Link to process‐specific
steps
Planning
Requirements and Risk
Implementation
Supplier Identification
Qualification
Lifecycle Management
Monitor/
Feedback
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5/11/2015
Matrix of Input
Planning
Team
Requirements and Risk
Implementation
Supplier Identification
Qualification
Lifecycle Management
Monitor/
Feedback
Product and Process
Supply Chain
Ideal Behaviors
Marla
Product and Process Group
Product and Process Knowledge and Development
First
Last
Christopher
Claeboe
Product Manager
Title
Albemarle
Company
Matthew
Deacon
Director ‐ API Manufacturing
Eli Lilly
Elaine
Jai
Supply Chain and Procurement
Eli Lilly
Siek Meng
Khor
QA Director
Teleflex
Viliam Kovac
Head of Global Compliance
Roche
Glenn
Muldoon
Manager, materials procurement
Shire
Mike
Oleksa
Senior Director
Steris
Stelios
Tsinontides
Sherry
Warren
Sr. Director, Mfg. Sci & Technology Shire
President WLS Enterprises
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5/11/2015
Supply Chain Group
Supply Chain Development and Management
First
Last
Title
Company
M.
Bhupathy
Senior Director
Shire
Hanna
Paul
Shonte
David
Edstrom‐Valsinger
Nelson
Pettiford
Rothenberger
Sourcing Process Leader
Exec. Dir., Supply Chain
Quality Program Manager
Consultant ‐ QA Procurement
GE Healthcare
Auxilium
Abbott
Eli Lilly
Gerard
Sheehan
Quality/ Regulatory Affairs Director Tornier
Jack
Ken
Andre
Jean Pierre
Don
Solomon
Stopar
Warren
Zajac
Zgoda
Practice Leader, Supply Chain
Director Supplier Quality
Vice President
General Mgr., Sourcing EMEA
CQA Supplier Quality Management
Core Risks Ltd
Baxter
WLS Enterprises
GE Healthcare
P&G
Ideal Behaviors Group
Driving Ideal Behaviors
First
Last
Title
Company
Dave
Gault
Sr. Manager Risk, Compliance & Security
CPKelco
Harry
Gill
Vice President
Patheon
Christine
Gladwell
Quality Director ‐ Global Supply Chain
Baxter
Patrick
Henry
Director of Business Development
Puritan Products
Tim
Johnson
Sr. Director, Quality
J&J
Stephanie Leonardos President & CEO
Amerikam
Diana
Lewis
Senior Specialist – Quality
Merck
Ben
Locwin
Director
Biogen Idec
Kristen
Geert
Lyons
Van Acker
Quality Engineer
VP of Purchasing
Cook
Baxter
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5/11/2015
Swim Lanes
R&D
Quality
Supply
Chain
Reg
Affairs
Suppliers
Step 1. Internal Risk Based Assessment
Step 2. Development of Product and Process
Step 3. Finalization of Requirements
Action Provoking!
• Understanding our Product/Process
• Developing our Supply Chain
• Establishing Ideal Behaviors
Increased Product Confidence
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Action Provoking!
Transparency actually builds trust, inspires creative problem solving, and engenders ownership of outcomes
Accurate forecasting and harmonizing (“I’ll take a #1”) reduces risk of error
Action Provoking!
Supplier Qualification
Compliance, Resources, Stability, Product Knowledge
Forecasting Ability, Internal Alignment
Capacity, Location, Risk of Material
Compliance, History
Self Qualification
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Suppliers Rate Clients
25 650 Specification
25 670 Tender Process
KEY:
 Maximum
18 650 Bid Clarification
score within
group
20 672 Purchase Order / Contract Docs
 Purchaser
position within
group
16 623 Communications
12 261 Manufacturing/Service Supprt
 Average score
of group
24 692 Quality Control
25 590 Change Control
 Minimum score
within group
25 594 Documentation
23 630 Delivery
21 629 Commercial Management
14 300 Interfaces with Client Systems
12 220 Post Delivery Experience
18 614 Co-operation & Relationships
Poor
2
Mediocre 4
Adequate 6
Good
8
Excellent 10
Table Discussion
Remember this slide?
What are some actions you would take as a result of having a high risk supplier in your supply chain?
How would your response change?
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5/11/2015
With the End in Mind
GSP
GMP
Increase Product Confidence
GIP
GDP
Integrity of Supply GSP
Xavier Health Contact:
Marla A. Phillips
Director, Xavier Health
Xavier University
phillipsm4@xavier.edu
513‐745‐3073
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