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Dragon Sourcing - 龙 源
Your Tailored Sourcing Approach to Emerging Countries
Blood Collection System
Asia Sourcing Case Study
September 2015
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
2
© 2015 Dragon Sourcing. All rights reserved.
Agenda
Project Objectives
© 2015 Dragon Sourcing. All rights reserved.
Introduction:
• Client is a Special Health Authority in Europe
• Has an ongoing requirement for “Blood Collection Systems” with a value of approximate
€ 29 Million/annum
3
 Objectives:
• To identify who capable Blood Bag System suppliers in Asia, prior to the tender publication.
• To create awareness with the Asian suppliers for the upcoming Official Journal of the European
Union (OJEU) tender and its requirements
• The key MUST criteria:
1. CE marked as Class IIb medical devices against EU Directive 93/42/EEC.
2. EN/ISO 3826- Part 1, 2 & 3
3. Principles of EU Good Manufacturing Practice: EN ISO 13485
 Final deliverables:
• RFI/RFQ analysis report with list of recommended suppliers
• Supplier profiles
Supplier identification process was initiated within the Asian Countries to build long list
of suppliers.
© 2015 Dragon Sourcing. All rights reserved. 4
India
China
Thailand
Vietnam
Pakistan
Malaysia
Indonesia
Singapore
Philippines
South
Korea
Japan
Taiwan
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
5
© 2015 Dragon Sourcing. All rights reserved.
Agenda
© 2015 Dragon Sourcing. All rights reserved.. 6
Approach & Schedule,
No. Step Deliverables
1.
Demand Analysis
Work with client to define and understand the products and requirements (specs, volumes, materials,
production technology requirements, Quality tests, Standards, etc.)
 Project Requirement
Questionnaire
 Kick-Off Report
2.
Supply Market Analysis
Identify long list of potential suppliers in the selected markets by leveraging B2B Websites, DS
Database, Fair catalogues, Chamber of Commerce, Magazines, Network, References.
 Supplier Long List
3.
Telephone Pre-screening
Selection of suppliers to be included in the RFI/RFP process by telephone pre-screening based on
agreed simple criteria (e.g. capability to make the product, minimum company size, interest in
participating)
 Shortlist for RFI/RFQ
4.
Develop RFI/RFQ
Prepare an RFI/RFQ document, with an aligned Balanced Scorecard that has the objective to pre-
qualify the competitiveness and capabilities of the suppliers, including: Background, financial, Client
and product experience, Quality certification & processes, Social Responsibility,
Manufacturing/technology capability)
 RFI/RFQ Template
 Balanced Scorecard
 Introduction Letter
Milestone 1: RFI/RFQ & Scorecard Approved
5.
Conduct RFI/RFQ Administration
The RFI/RFQ is translated to the local languages as relevant, and distributed to the relevant suppliers,
with telephone follow-up to push for maximum participation.
• Completed RFI/RFQs
6.
Analyze RFI/RFQ Responses
Analysis of RFI/RFQ responses, estimation of logistics costs, and preparation of a report which profiles
& objectively ranks the suppliers by capability and competitiveness, including a recommendation for
those to be audited/Sampled.
 RFI/RFQ Report
 Supplier Profiles
 Proposed Shortlist for
Audit/Samples.
Milestone 2: Shortlist for Auditing/Sampling Agreed
Stage 1: Supplier Pre-Qualification
Steps
Duration/week
commencing
Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9
07-13/
07-17
07-20/
07-24
07-27/
07-31
08-03/
08-07
08-10/
08-14
08-17/
08-21
08-24/
08-28
08-31/
09-04
09-07/
09-11
1. Demand Analysis 1
2. Supply Market Analysis 2
3. Telephone pre-screening 1
4. Develop RFI/RFQ 1
5. Administer RFI/RFQ process 5
6. Analyze RFI/RFQ Responses &
submit RFQ report.
1
© 2015 Dragon Sourcing. All rights reserved.
1
2
7
Not started Done
In process Delay
The sourcing process was completed in 9 weeks.
Supplier
recommendations for
auditing/sampling.
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
8
© 2015 Dragon Sourcing. All rights reserved.
Agenda
© 2015 Dragon Sourcing. All rights reserved. 9
Whole Blood Collection Systems including Leucodepletion Filter (nearly € 27 Million in
spend).
System
Whole Blood Collection
Systems including
Leucodepletion Filters
Image Remark
Forecasted Qty
Y3 (Systems)*
1
Top and Top (TAT) Blood
collection system for whole blood
filtration
Nil 1.7 M
2
Bottom and Top (BAT) Blood
collection system for red cell
concentrates (RCC) filtration
Nil XXX
3
Bottom and Top (BAT) Blood
collection system for RCC
filtration with integral plasma filter
(IPF)
Note: This Blood collection system is similar to
System 2 with the exception of having a plasma filter
and an additional (empty) pack to receive plasma
prior to filtration.
XXX
4
Whole blood collection system
without anticoagulant
Note: This Blood collection system is a dry system
which contains no anticoagulant.
XXX
XXXXX
A
B C
D E
F
G
H
A
B
C
D
E
F G
H
A
B
C
F
G
H
D E
I
J
* Y3 is forecasted for use from 01/05/2015 – 30/04/2016
© 2015 Dragon Sourcing. All rights reserved. 10
Ancillary Blood Processing Systems (Primary Components, nearly € 1.8 Million in
spend).
No. Ancillary Blood Processing Systems (Primary Components) Forecasted Qty (Sets) Y3
1 Figure 1 - Quadruple transfer system for the storage of platelets for neonatal use. 6,000
2 Figure 2 - Quadruple transfer system for the storage of frozen plasma for neonatal use. XXX
3 Figure 3 - Quadruple transfer system for the storage of red cells for neonatal use. XXX
4 Figure 4 - Sextuplet transfer system for the storage of red cells for neonatal use. XXX
5 Figure 5 - Single transfer pack for the handling of waste material or storage of plasma components. XXX
6 Figure 6 - Cryoprecipitate pooling system. XXX
7 Figure 7 - Single plasma filter system. XXX
8 Figure 8 - Double plasma filter system. XXX
9 Figure 11 - Platelet storage system. XXX
10 Figure 13 - Platelet pooling filter system. XXX
11 Figure 14 - Platelet pooling filter system with integral sampling device. XXX
* Y3 is forecasted for use from 01/05/2015 – 30/04/2016
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
11
© 2015 Dragon Sourcing. All rights reserved.
Agenda
55
47
8
47
33
14
6
5
1
5
5
5
5
5
4
1
5
4
1
4
3
1
3
3
3
3
3
3
1
1
Suppliers identified Failed phone screening Passed phone screening
Indonesia
Thailand
Vietnam
Philippines
Singapore
South Korea
Pakistan
Malaysia
Taiwan
Japan
China
India
116
DS identified 142 suppliers in 12 Asian Countries,
© 2015 Dragon Sourcing. All rights reserved. 12
26
142
116 suppliers failed phone screening process
© 2015 Dragon Sourcing. All rights reserved. 13
29
52
3
2
7
9
6
8
Traders/importer only, not a manufacturer
Manufacturing secondary components only, Unable to supply complete blood
bag system.
Manufacturing (products) do not comply with ISO 3826 part 1, 2 & 3
Products not comply with CE marked as per medical devices directive
Only subsidiary or factory, Requested to contact parent Company or Parent
company, requested to contact subsidiary special for blood bag.
Contact details not valid/not responding
Suppliers already in contact directly with the client
Stopped making blood bags and/or Company shutdown
ISO 9001
ISO 14001
ISO13485
CE marked as Class IIb medical devices against EU Directive 93/42/EEC.
EN/ISO 3826- Part 1: Plastic collapsible containers for human blood and blood
components
EN/ISO 3826- Part 2: – Graphic symbols for use on labels and instruction leaflets
EN/ISO 3826- Part 3: – Blood bag systems with integrated features.
Principles of EU Good Manufacturing Practice: EN ISO 13485 (Medical devices-
Quality management systems)
FDA Approved
Manufacturing QMS
What international/domestic product
certification do you have?
Do you have below certificates ?
Do you currently manufacture, or do you have experience of
manufacturing blood packs?
If yes, What type of blood bags do you manufacture?
Can you provide high quality transparent medical grade PVC film?
Whole Blood
collection
Transfusion
system
Disposable blood
Bags, Tubes &
Ports
Optimal additive
solutions
Needles
manufacturing
Sample site
coupler, Filters.
Base Label
Does your company do all production steps in house? If no, please
elaborate.
Type of machinery,
• Fully Automatic
• Semi-Automatic
• Others
Your outsourcing partner (material sub-contractor) comply to EN/ISO
3826- Part 1, 2 & 3?
Your outsourcing partner comply to CE marked as Class IIb medical
devices against EU Directive 93/42/EEC?
Can your company design according to client's requirement?
Yes/No Quantity
Assembly lines (semi-automated)
labelling equipment
Assembly lines (typically automated)
Please list production equipment you will use (others, please specify)
Accurate solutions filling equipment,
validated sterilization plant (typically steam
autoclaves),
ProducerEquipment or Production line
Do you offer following manufacturing process?
Please provide answer with,
• Yes
• No
RFI/RFQ - Contact info
Confidential
DS ContactPerson MrPankajTuteja
Email pankaj.tuteja@dragonsourcing.com
Tel number +91-22-26365009
Mobile +91-9867602535
CompanyName
Address
Town
Province
CompanyWebsite
ContactPerson
Title
Email
Tel
Fax
Mobile phone
Detailed specificationsare showed inAnnex1 and Annex2
4.Quality Management: Informationrequested aboutCertification,Qualitycontroletc..
5.Factory Pictures: Please provide recentpicturesofyourfactory.
6.RFQ: Requestforquotation.
This RFI/RFQcontains a totalof9 worksheets detailed below:
0.Introduction & Instructions: presentationofthe objectivesand timetable ofthe
1.ContactInformation: Generaland contactinformationaboutyourcompany.
2.Company Profile: Keybusinessand financialinformation.
3.Production: Manufacturing capability,Productioncapacity,etc.
COMPANYINFORMATION
CONTACT PERSON INFORMATION
Dragon Sourcing
© 2015 Dragon Sourcing. All rights reserved.
An RFI/RFP process was administered to filter out most capable suppliers,
Quality Management
Contact detail
information
Production
information
14
4
10
4
8
2
6
2
1
1
1
1
1
1
1
1
1
RFI-RFQ sent Intend To
Respond
Don’t Intend to
respond
Only RFI
Received
RFI-RFQ
received
Singapore
South Korea
Pakistan
Japan
India
China
© 2015 Dragon Sourcing. All rights reserved. 15
26
7
19
7 suppliers responded to the RFI-RFQ
6
South Korean supplier submitted only
the Company profile (RFI) & will
submit RFQ during the OJEU tender
process as they need contact the their
outsourcing US partner for providing
Leucodepletion filter
1
Identify Suppliers Pre-screen suppliers Administer RFI/RFQ
Analyse RFI/RFQ
received
Xinjiang
Gansu
Jiangxi
Tianjin
Jiangsu
Guangxi
Hunan
Hubei
Qinghai
Ningxia
Shaanxi
Anhui
Fujian
Inner Mongolia
Shanxi
Xizang
Sichuan
Yunan
Guizhou
Henan
Jilin
Liaoning
Guangdong
Gansu
Shanghai
Hong Kong
Taiwan
Heilongjiang
Sichuan
© 2015 Dragon Sourcing. All rights reserved. 16
Zhejiang
Shandong
Hebei
# Supplier name City Province Website
1 XXX XXX Sichuan XXX
2 XXX XXX Shandong XXX
3 XXX XXX Guangdong XXX
4 XXX XXX Jiangsu XXX
Beijing
Location of the suppliers responded to the RFI-RFQ
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
17
© 2015 Dragon Sourcing. All rights reserved.
Agenda
© 2015 Dragon Sourcing. All rights reserved. 18
- Logistics Process: DDP Price Calculation
- From FOB China & India to DDP Europe destination.
EXW
Price
 Loading on container on
manufacturing site
 Container transportation to
China sea port “Shanghai” &
Indian sea port “Nhava Sheva”.
 Export documents expenses,
transportation & other taxes
 Handling & loading of the
container on the vessel
 Loading cost on
truck
 Haulage cost to final
destination
 Fuel taxes
 Import duty
 XXX port handling cost
& terminal charges
 Clearance Charges
Port Security, etc.
 Port Infrastructure
fees
 Sea freight from China &
India FOB port to XXX in
Europe.
 Additional fees (BAF &
CAF)
 Insurance cost based on
the CFR value.
DDP
Price
FOB
Price
Delivered price until client warehouseChinese & Indian suppliers quotation
Country Supplier Product #
Supplier DDP
Price
(Euro/System)
Supplier Annual
spend
Supplier Annual
saving (+/-)
Client Current
DDP
(Euro/system)
Client annual
volumes
Client annual
spend
Based on 20
FCL'
Euro (Millions) Euro (Millions) 20' Systems (units) Euro
China
# DSCN/BB24
Total annual
saving € 6.06 M
Figure 1 € 2.60 1.7 M
Figure 2 € 3.02 xxx
Figure 3 € 0.21 xxx
Figure 4 € 0.23 xxx
China
# DSCN/BB30
Total annual
saving € 3.91 M
Figure 1 € 2.03 1.7 M
Figure 2 € 1.47 xxx
Figure 3 € 0.25 xxx
Figure 4 € 0.16 xxx
China
# DSCN/BB28
Total annual
saving € 0.24 M
Figure 1 € -1.77 1.7 M
Figure 2 € -1.49 xxx
Figure 3 0.04 xxx
Figure 4 0.20 xxx
China
# DSCN/BB27
Total annual
saving € 0.18 M
Figure 1 € -4.90 1.7 M
Figure 2 € -8.03 xxx
Figure 4 € 0.18 xxx
India # DSIN/BB31 Figure 1 € -16.33 1.7 M
India
# DSIN/BB26
Total annual
saving € 0.19 M
Figure 1 € -10.22 xxx
Figure 2 € -11.62 xxx
Figure 4 € 0.19 xxx
© 2015 Dragon Sourcing. All rights reserved. 19
Supplier with highest annual saving was about € 6 million
Highest Annual Saving
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
Country Supplier Product #
Supplier DDP Price
(Euro/System)
Supplier Annual
spend
Supplier Annual
saving
Client Current DDP
(Euro/system)
Client annual
volumes
Client annual
spend
20' Euro Euro 20' Systems (units) Euro
China
# DSCN/BB24
Total annual
saving € 0.63 M
Figure 1 € 21,795 6,000
Figure 2 € 15,621 xxx
Figure 3 € 15,621 xxx
Figure 4 € 25,769 xxx
Figure 5 € 25,131 xxx
Figure 6 € 64,722 xxx
Figure 7 € 71,014 xxx
Figure 8 € 54,951 xxx
Figure 11 € 49,832 xxx
Figure 13 € 238,528 xxx
Figure 14 € 49,622 xxx
China
# DSCN/BB30
Total annual
saving € 0.36 M
Figure 1 € 20,960 6,000
Figure 3 € 6,625 xxx
Figure 5 € 23,488 xxx
Figure 7 € 163,215 xxx
Figure 8 € 143,297 xxx
China
# DSCN/BB28
Total annual
saving € 1.30 M
Figure 1 € 30,534 6,000
Figure 2 € 24,487 xxx
Figure 3 € 25,901 xxx
Figure 4 € 52,220 xxx
Figure 5 € 26,394 xxx
Figure 6 € 153,818 xxx
Figure 7 € 170,604 xxx
Figure 8 € 170,604 xxx
Figure 11 € 92,880 xxx
Figure 13 € 462,338 xxx
Figure 14 € 93,956 xxx
India
# DSIN/BB31
Total annual
saving € 0.024 M
Figure 1 € 8,145 6,000
Figure 2 € (4,455) xxx
Figure 3 € (4,455) xxx
Figure 4 € (32,264) xxx
Figure 5 € 16,227 xxx
Figure 6 € (130,759) xxx
20
©2015DragonSourcing.Allrightsreserved.
Highest Annual Saving
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
C
O
N
F
I
D
E
N
T
I
A
L
Supplier with highest annual saving for the ancillary system was € 1.3
million
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
21© 2015 Dragon Sourcing. All rights reserved.
Agenda
© 2015 Dragon Sourcing. All rights reserved. 22
15 16 13 10 11 11 9
25
28
27
25 24
19 18
19
18 21
19 19
21
18
12 8 6
12
4
4
4 3 5 4
2
3
3
5
5 5
5
5
4
0
10
20
30
40
50
60
70
80
90
# DSCN/BB24 # DSCN/BB30 # DSIN/BB31 # DSCN/BB28 # DSCN/BB27 # DSIN/BB26 # DSSK/BB25
China China India China China India South korea
Business information 20% Production 30% Quality system 25%
RFQ 15% Cooperation 5% Corporate Responsibility 5%
Balance Score card used to rank the suppliers
India
80 77 77 75 64 62 48
Submitted
only RFI
Average RFI scoring: 69 from 100
1. Introduction & Project Objectives
2. Approach & Schedule
3. Demand Analysis
4. Supply Markey Survey
5. Price analysis
6. Supplier Assessment
7. Supplier Profile Example
23© 2015 Dragon Sourcing. All rights reserved.
Agenda
© 2015 Dragon Sourcing. All rights reserved. 24
RFI Score 80
RFI Ranking 1
Willing to offer DDP price Yes
Payment terms
30 days from
invoice
COMPANY INFORMATION
Company Name DSCN/BB24
Address XXX
City XXX
Province XXX
Company Website XXX
CONTACT PERSON INFORMATION
Contact Person XXX
Title Marketing Manager
Email XXX
Tel XXX
Fax XXX
Mobile phone XXX
BUSINESS INFORMATION
Year Founded 1994
Nature of the Company Private
Company type (manufacture, trader) Manufacture
Registration Capital (Euro)
Total Employees
Main production items
Factory size (m²)
Export License
Years of export experience
Participated directly in the "OJEU"
Subsidiary in Europe, Australia &
New Zealand
Have Account Manager able to
communicate effectively in English
BUSINESS INFORMATION
Turnover
Million in Euro
2015 (till date) 2014 2013
Percentage of
turnover
distributed to: (%)
Domestic Europe U.S.
Rest of the
world
Top 5 Customers?
Customers Industry Country % of sales
XXX Medical China 8%
XXX Medical China 7%
XXX Medical Cuba 6%
XXX Medical Germany 5%
XXX Medical China 3%
Ever exported any
of
these items
Whole Blood Bag
System
Ancillary Blood
Systems
Secondary components like
needles, sample site
coupler,etc.
Yes Yes Tes
CORPORATE RESPONSIBILITY & POLICIES
Policies your
organization
hold. (Yes/No)
Health & Safety Policy Yes
Environmental Policy Yes
Quality Policy Yes
CSR (Corporate Social Responsibility) Yes
• Section: Business Information
© 2015 Dragon Sourcing. All rights reserved. 25
• Section: Quality Control
QUALITY CONTROL
Certified with Yes / No
Date of
Certificate
Certifying Org.
Manufacturing QMS
ISO 9001
ISO 14001
ISO13485
Others
International/domestic product certification
CE marked as Class IIb medical devices
EN/ISO 3826- Part 1:
EN/ISO 3826- Part 2
EN/ISO 3826- Part 3
Principles of EU GMP: EN ISO 13485
FDA Approved
Quality control equipment in-house
Test
UV-visible range spectrophotometer
Total organic carbon analyzer
High performance liquid chromatography
Electronic analytical balance
Automatic optical rotation
centrifugal machine
mould Incubator
Have daily in line quality inspection
Type of inspection for finished goods
Performance achieve on average in out going quality measures
Internal rule for advising time of quality claim
Research and development department in-house
Accept 3rd party QC
Contract Management: Attend the Supplier Liaison Meetings
Contract Management: Attend the Framework Review Meetings
Test company do with an external supplier
Have testing methodology of EN ISO 3826 parts 1 and 3 for the specific chemical,
biological and physical tests that must be carried out to validate the production process
and batches of blood bags.
26
Factory overview from outside Office Raw Material/Finished Goods warehouse
Production Floor Production Floor Accurate solutions filling equipment
Assembly lines (semi-automated) Assembly Floor R&D/Lab
© 2015 Dragon Sourcing. All rights reserved. Page 5 - 5
• Section: Factory Pictures
© 2015 Dragon Sourcing. All rights reserved.
Potential
Savings
Whole Blood Collection
Systems including
Leucodepletion Filters,
Identified suppliers with annual
savings of € 6 million
Ancillary Blood
Processing Systems
Identified suppliers with annual
savings of € 1.3 million
Savings from both Chinese & Indian
In summary, a savings potential of 25%

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Blood collection system - Asia Sourcing

  • 1. Dragon Sourcing - 龙 源 Your Tailored Sourcing Approach to Emerging Countries Blood Collection System Asia Sourcing Case Study September 2015
  • 2. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 2 © 2015 Dragon Sourcing. All rights reserved. Agenda
  • 3. Project Objectives © 2015 Dragon Sourcing. All rights reserved. Introduction: • Client is a Special Health Authority in Europe • Has an ongoing requirement for “Blood Collection Systems” with a value of approximate € 29 Million/annum 3  Objectives: • To identify who capable Blood Bag System suppliers in Asia, prior to the tender publication. • To create awareness with the Asian suppliers for the upcoming Official Journal of the European Union (OJEU) tender and its requirements • The key MUST criteria: 1. CE marked as Class IIb medical devices against EU Directive 93/42/EEC. 2. EN/ISO 3826- Part 1, 2 & 3 3. Principles of EU Good Manufacturing Practice: EN ISO 13485  Final deliverables: • RFI/RFQ analysis report with list of recommended suppliers • Supplier profiles
  • 4. Supplier identification process was initiated within the Asian Countries to build long list of suppliers. © 2015 Dragon Sourcing. All rights reserved. 4 India China Thailand Vietnam Pakistan Malaysia Indonesia Singapore Philippines South Korea Japan Taiwan
  • 5. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 5 © 2015 Dragon Sourcing. All rights reserved. Agenda
  • 6. © 2015 Dragon Sourcing. All rights reserved.. 6 Approach & Schedule, No. Step Deliverables 1. Demand Analysis Work with client to define and understand the products and requirements (specs, volumes, materials, production technology requirements, Quality tests, Standards, etc.)  Project Requirement Questionnaire  Kick-Off Report 2. Supply Market Analysis Identify long list of potential suppliers in the selected markets by leveraging B2B Websites, DS Database, Fair catalogues, Chamber of Commerce, Magazines, Network, References.  Supplier Long List 3. Telephone Pre-screening Selection of suppliers to be included in the RFI/RFP process by telephone pre-screening based on agreed simple criteria (e.g. capability to make the product, minimum company size, interest in participating)  Shortlist for RFI/RFQ 4. Develop RFI/RFQ Prepare an RFI/RFQ document, with an aligned Balanced Scorecard that has the objective to pre- qualify the competitiveness and capabilities of the suppliers, including: Background, financial, Client and product experience, Quality certification & processes, Social Responsibility, Manufacturing/technology capability)  RFI/RFQ Template  Balanced Scorecard  Introduction Letter Milestone 1: RFI/RFQ & Scorecard Approved 5. Conduct RFI/RFQ Administration The RFI/RFQ is translated to the local languages as relevant, and distributed to the relevant suppliers, with telephone follow-up to push for maximum participation. • Completed RFI/RFQs 6. Analyze RFI/RFQ Responses Analysis of RFI/RFQ responses, estimation of logistics costs, and preparation of a report which profiles & objectively ranks the suppliers by capability and competitiveness, including a recommendation for those to be audited/Sampled.  RFI/RFQ Report  Supplier Profiles  Proposed Shortlist for Audit/Samples. Milestone 2: Shortlist for Auditing/Sampling Agreed Stage 1: Supplier Pre-Qualification
  • 7. Steps Duration/week commencing Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 07-13/ 07-17 07-20/ 07-24 07-27/ 07-31 08-03/ 08-07 08-10/ 08-14 08-17/ 08-21 08-24/ 08-28 08-31/ 09-04 09-07/ 09-11 1. Demand Analysis 1 2. Supply Market Analysis 2 3. Telephone pre-screening 1 4. Develop RFI/RFQ 1 5. Administer RFI/RFQ process 5 6. Analyze RFI/RFQ Responses & submit RFQ report. 1 © 2015 Dragon Sourcing. All rights reserved. 1 2 7 Not started Done In process Delay The sourcing process was completed in 9 weeks. Supplier recommendations for auditing/sampling.
  • 8. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 8 © 2015 Dragon Sourcing. All rights reserved. Agenda
  • 9. © 2015 Dragon Sourcing. All rights reserved. 9 Whole Blood Collection Systems including Leucodepletion Filter (nearly € 27 Million in spend). System Whole Blood Collection Systems including Leucodepletion Filters Image Remark Forecasted Qty Y3 (Systems)* 1 Top and Top (TAT) Blood collection system for whole blood filtration Nil 1.7 M 2 Bottom and Top (BAT) Blood collection system for red cell concentrates (RCC) filtration Nil XXX 3 Bottom and Top (BAT) Blood collection system for RCC filtration with integral plasma filter (IPF) Note: This Blood collection system is similar to System 2 with the exception of having a plasma filter and an additional (empty) pack to receive plasma prior to filtration. XXX 4 Whole blood collection system without anticoagulant Note: This Blood collection system is a dry system which contains no anticoagulant. XXX XXXXX A B C D E F G H A B C D E F G H A B C F G H D E I J * Y3 is forecasted for use from 01/05/2015 – 30/04/2016
  • 10. © 2015 Dragon Sourcing. All rights reserved. 10 Ancillary Blood Processing Systems (Primary Components, nearly € 1.8 Million in spend). No. Ancillary Blood Processing Systems (Primary Components) Forecasted Qty (Sets) Y3 1 Figure 1 - Quadruple transfer system for the storage of platelets for neonatal use. 6,000 2 Figure 2 - Quadruple transfer system for the storage of frozen plasma for neonatal use. XXX 3 Figure 3 - Quadruple transfer system for the storage of red cells for neonatal use. XXX 4 Figure 4 - Sextuplet transfer system for the storage of red cells for neonatal use. XXX 5 Figure 5 - Single transfer pack for the handling of waste material or storage of plasma components. XXX 6 Figure 6 - Cryoprecipitate pooling system. XXX 7 Figure 7 - Single plasma filter system. XXX 8 Figure 8 - Double plasma filter system. XXX 9 Figure 11 - Platelet storage system. XXX 10 Figure 13 - Platelet pooling filter system. XXX 11 Figure 14 - Platelet pooling filter system with integral sampling device. XXX * Y3 is forecasted for use from 01/05/2015 – 30/04/2016
  • 11. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 11 © 2015 Dragon Sourcing. All rights reserved. Agenda
  • 12. 55 47 8 47 33 14 6 5 1 5 5 5 5 5 4 1 5 4 1 4 3 1 3 3 3 3 3 3 1 1 Suppliers identified Failed phone screening Passed phone screening Indonesia Thailand Vietnam Philippines Singapore South Korea Pakistan Malaysia Taiwan Japan China India 116 DS identified 142 suppliers in 12 Asian Countries, © 2015 Dragon Sourcing. All rights reserved. 12 26 142
  • 13. 116 suppliers failed phone screening process © 2015 Dragon Sourcing. All rights reserved. 13 29 52 3 2 7 9 6 8 Traders/importer only, not a manufacturer Manufacturing secondary components only, Unable to supply complete blood bag system. Manufacturing (products) do not comply with ISO 3826 part 1, 2 & 3 Products not comply with CE marked as per medical devices directive Only subsidiary or factory, Requested to contact parent Company or Parent company, requested to contact subsidiary special for blood bag. Contact details not valid/not responding Suppliers already in contact directly with the client Stopped making blood bags and/or Company shutdown
  • 14. ISO 9001 ISO 14001 ISO13485 CE marked as Class IIb medical devices against EU Directive 93/42/EEC. EN/ISO 3826- Part 1: Plastic collapsible containers for human blood and blood components EN/ISO 3826- Part 2: – Graphic symbols for use on labels and instruction leaflets EN/ISO 3826- Part 3: – Blood bag systems with integrated features. Principles of EU Good Manufacturing Practice: EN ISO 13485 (Medical devices- Quality management systems) FDA Approved Manufacturing QMS What international/domestic product certification do you have? Do you have below certificates ? Do you currently manufacture, or do you have experience of manufacturing blood packs? If yes, What type of blood bags do you manufacture? Can you provide high quality transparent medical grade PVC film? Whole Blood collection Transfusion system Disposable blood Bags, Tubes & Ports Optimal additive solutions Needles manufacturing Sample site coupler, Filters. Base Label Does your company do all production steps in house? If no, please elaborate. Type of machinery, • Fully Automatic • Semi-Automatic • Others Your outsourcing partner (material sub-contractor) comply to EN/ISO 3826- Part 1, 2 & 3? Your outsourcing partner comply to CE marked as Class IIb medical devices against EU Directive 93/42/EEC? Can your company design according to client's requirement? Yes/No Quantity Assembly lines (semi-automated) labelling equipment Assembly lines (typically automated) Please list production equipment you will use (others, please specify) Accurate solutions filling equipment, validated sterilization plant (typically steam autoclaves), ProducerEquipment or Production line Do you offer following manufacturing process? Please provide answer with, • Yes • No RFI/RFQ - Contact info Confidential DS ContactPerson MrPankajTuteja Email pankaj.tuteja@dragonsourcing.com Tel number +91-22-26365009 Mobile +91-9867602535 CompanyName Address Town Province CompanyWebsite ContactPerson Title Email Tel Fax Mobile phone Detailed specificationsare showed inAnnex1 and Annex2 4.Quality Management: Informationrequested aboutCertification,Qualitycontroletc.. 5.Factory Pictures: Please provide recentpicturesofyourfactory. 6.RFQ: Requestforquotation. This RFI/RFQcontains a totalof9 worksheets detailed below: 0.Introduction & Instructions: presentationofthe objectivesand timetable ofthe 1.ContactInformation: Generaland contactinformationaboutyourcompany. 2.Company Profile: Keybusinessand financialinformation. 3.Production: Manufacturing capability,Productioncapacity,etc. COMPANYINFORMATION CONTACT PERSON INFORMATION Dragon Sourcing © 2015 Dragon Sourcing. All rights reserved. An RFI/RFP process was administered to filter out most capable suppliers, Quality Management Contact detail information Production information
  • 15. 14 4 10 4 8 2 6 2 1 1 1 1 1 1 1 1 1 RFI-RFQ sent Intend To Respond Don’t Intend to respond Only RFI Received RFI-RFQ received Singapore South Korea Pakistan Japan India China © 2015 Dragon Sourcing. All rights reserved. 15 26 7 19 7 suppliers responded to the RFI-RFQ 6 South Korean supplier submitted only the Company profile (RFI) & will submit RFQ during the OJEU tender process as they need contact the their outsourcing US partner for providing Leucodepletion filter 1 Identify Suppliers Pre-screen suppliers Administer RFI/RFQ Analyse RFI/RFQ received
  • 16. Xinjiang Gansu Jiangxi Tianjin Jiangsu Guangxi Hunan Hubei Qinghai Ningxia Shaanxi Anhui Fujian Inner Mongolia Shanxi Xizang Sichuan Yunan Guizhou Henan Jilin Liaoning Guangdong Gansu Shanghai Hong Kong Taiwan Heilongjiang Sichuan © 2015 Dragon Sourcing. All rights reserved. 16 Zhejiang Shandong Hebei # Supplier name City Province Website 1 XXX XXX Sichuan XXX 2 XXX XXX Shandong XXX 3 XXX XXX Guangdong XXX 4 XXX XXX Jiangsu XXX Beijing Location of the suppliers responded to the RFI-RFQ
  • 17. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 17 © 2015 Dragon Sourcing. All rights reserved. Agenda
  • 18. © 2015 Dragon Sourcing. All rights reserved. 18 - Logistics Process: DDP Price Calculation - From FOB China & India to DDP Europe destination. EXW Price  Loading on container on manufacturing site  Container transportation to China sea port “Shanghai” & Indian sea port “Nhava Sheva”.  Export documents expenses, transportation & other taxes  Handling & loading of the container on the vessel  Loading cost on truck  Haulage cost to final destination  Fuel taxes  Import duty  XXX port handling cost & terminal charges  Clearance Charges Port Security, etc.  Port Infrastructure fees  Sea freight from China & India FOB port to XXX in Europe.  Additional fees (BAF & CAF)  Insurance cost based on the CFR value. DDP Price FOB Price Delivered price until client warehouseChinese & Indian suppliers quotation
  • 19. Country Supplier Product # Supplier DDP Price (Euro/System) Supplier Annual spend Supplier Annual saving (+/-) Client Current DDP (Euro/system) Client annual volumes Client annual spend Based on 20 FCL' Euro (Millions) Euro (Millions) 20' Systems (units) Euro China # DSCN/BB24 Total annual saving € 6.06 M Figure 1 € 2.60 1.7 M Figure 2 € 3.02 xxx Figure 3 € 0.21 xxx Figure 4 € 0.23 xxx China # DSCN/BB30 Total annual saving € 3.91 M Figure 1 € 2.03 1.7 M Figure 2 € 1.47 xxx Figure 3 € 0.25 xxx Figure 4 € 0.16 xxx China # DSCN/BB28 Total annual saving € 0.24 M Figure 1 € -1.77 1.7 M Figure 2 € -1.49 xxx Figure 3 0.04 xxx Figure 4 0.20 xxx China # DSCN/BB27 Total annual saving € 0.18 M Figure 1 € -4.90 1.7 M Figure 2 € -8.03 xxx Figure 4 € 0.18 xxx India # DSIN/BB31 Figure 1 € -16.33 1.7 M India # DSIN/BB26 Total annual saving € 0.19 M Figure 1 € -10.22 xxx Figure 2 € -11.62 xxx Figure 4 € 0.19 xxx © 2015 Dragon Sourcing. All rights reserved. 19 Supplier with highest annual saving was about € 6 million Highest Annual Saving C O N F I D E N T I A L C O N F I D E N T I A L C O N F I D E N T I A L C O N F I D E N T I A L
  • 20. Country Supplier Product # Supplier DDP Price (Euro/System) Supplier Annual spend Supplier Annual saving Client Current DDP (Euro/system) Client annual volumes Client annual spend 20' Euro Euro 20' Systems (units) Euro China # DSCN/BB24 Total annual saving € 0.63 M Figure 1 € 21,795 6,000 Figure 2 € 15,621 xxx Figure 3 € 15,621 xxx Figure 4 € 25,769 xxx Figure 5 € 25,131 xxx Figure 6 € 64,722 xxx Figure 7 € 71,014 xxx Figure 8 € 54,951 xxx Figure 11 € 49,832 xxx Figure 13 € 238,528 xxx Figure 14 € 49,622 xxx China # DSCN/BB30 Total annual saving € 0.36 M Figure 1 € 20,960 6,000 Figure 3 € 6,625 xxx Figure 5 € 23,488 xxx Figure 7 € 163,215 xxx Figure 8 € 143,297 xxx China # DSCN/BB28 Total annual saving € 1.30 M Figure 1 € 30,534 6,000 Figure 2 € 24,487 xxx Figure 3 € 25,901 xxx Figure 4 € 52,220 xxx Figure 5 € 26,394 xxx Figure 6 € 153,818 xxx Figure 7 € 170,604 xxx Figure 8 € 170,604 xxx Figure 11 € 92,880 xxx Figure 13 € 462,338 xxx Figure 14 € 93,956 xxx India # DSIN/BB31 Total annual saving € 0.024 M Figure 1 € 8,145 6,000 Figure 2 € (4,455) xxx Figure 3 € (4,455) xxx Figure 4 € (32,264) xxx Figure 5 € 16,227 xxx Figure 6 € (130,759) xxx 20 ©2015DragonSourcing.Allrightsreserved. Highest Annual Saving C O N F I D E N T I A L C O N F I D E N T I A L C O N F I D E N T I A L C O N F I D E N T I A L Supplier with highest annual saving for the ancillary system was € 1.3 million
  • 21. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 21© 2015 Dragon Sourcing. All rights reserved. Agenda
  • 22. © 2015 Dragon Sourcing. All rights reserved. 22 15 16 13 10 11 11 9 25 28 27 25 24 19 18 19 18 21 19 19 21 18 12 8 6 12 4 4 4 3 5 4 2 3 3 5 5 5 5 5 4 0 10 20 30 40 50 60 70 80 90 # DSCN/BB24 # DSCN/BB30 # DSIN/BB31 # DSCN/BB28 # DSCN/BB27 # DSIN/BB26 # DSSK/BB25 China China India China China India South korea Business information 20% Production 30% Quality system 25% RFQ 15% Cooperation 5% Corporate Responsibility 5% Balance Score card used to rank the suppliers India 80 77 77 75 64 62 48 Submitted only RFI Average RFI scoring: 69 from 100
  • 23. 1. Introduction & Project Objectives 2. Approach & Schedule 3. Demand Analysis 4. Supply Markey Survey 5. Price analysis 6. Supplier Assessment 7. Supplier Profile Example 23© 2015 Dragon Sourcing. All rights reserved. Agenda
  • 24. © 2015 Dragon Sourcing. All rights reserved. 24 RFI Score 80 RFI Ranking 1 Willing to offer DDP price Yes Payment terms 30 days from invoice COMPANY INFORMATION Company Name DSCN/BB24 Address XXX City XXX Province XXX Company Website XXX CONTACT PERSON INFORMATION Contact Person XXX Title Marketing Manager Email XXX Tel XXX Fax XXX Mobile phone XXX BUSINESS INFORMATION Year Founded 1994 Nature of the Company Private Company type (manufacture, trader) Manufacture Registration Capital (Euro) Total Employees Main production items Factory size (m²) Export License Years of export experience Participated directly in the "OJEU" Subsidiary in Europe, Australia & New Zealand Have Account Manager able to communicate effectively in English BUSINESS INFORMATION Turnover Million in Euro 2015 (till date) 2014 2013 Percentage of turnover distributed to: (%) Domestic Europe U.S. Rest of the world Top 5 Customers? Customers Industry Country % of sales XXX Medical China 8% XXX Medical China 7% XXX Medical Cuba 6% XXX Medical Germany 5% XXX Medical China 3% Ever exported any of these items Whole Blood Bag System Ancillary Blood Systems Secondary components like needles, sample site coupler,etc. Yes Yes Tes CORPORATE RESPONSIBILITY & POLICIES Policies your organization hold. (Yes/No) Health & Safety Policy Yes Environmental Policy Yes Quality Policy Yes CSR (Corporate Social Responsibility) Yes • Section: Business Information
  • 25. © 2015 Dragon Sourcing. All rights reserved. 25 • Section: Quality Control QUALITY CONTROL Certified with Yes / No Date of Certificate Certifying Org. Manufacturing QMS ISO 9001 ISO 14001 ISO13485 Others International/domestic product certification CE marked as Class IIb medical devices EN/ISO 3826- Part 1: EN/ISO 3826- Part 2 EN/ISO 3826- Part 3 Principles of EU GMP: EN ISO 13485 FDA Approved Quality control equipment in-house Test UV-visible range spectrophotometer Total organic carbon analyzer High performance liquid chromatography Electronic analytical balance Automatic optical rotation centrifugal machine mould Incubator Have daily in line quality inspection Type of inspection for finished goods Performance achieve on average in out going quality measures Internal rule for advising time of quality claim Research and development department in-house Accept 3rd party QC Contract Management: Attend the Supplier Liaison Meetings Contract Management: Attend the Framework Review Meetings Test company do with an external supplier Have testing methodology of EN ISO 3826 parts 1 and 3 for the specific chemical, biological and physical tests that must be carried out to validate the production process and batches of blood bags.
  • 26. 26 Factory overview from outside Office Raw Material/Finished Goods warehouse Production Floor Production Floor Accurate solutions filling equipment Assembly lines (semi-automated) Assembly Floor R&D/Lab © 2015 Dragon Sourcing. All rights reserved. Page 5 - 5 • Section: Factory Pictures
  • 27. © 2015 Dragon Sourcing. All rights reserved. Potential Savings Whole Blood Collection Systems including Leucodepletion Filters, Identified suppliers with annual savings of € 6 million Ancillary Blood Processing Systems Identified suppliers with annual savings of € 1.3 million Savings from both Chinese & Indian In summary, a savings potential of 25%