blood collection system - asia sourcing
TRANSCRIPT
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
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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
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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 & 33. 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.
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India
China
ThailandVietnam
Pakistan
Malaysia
IndonesiaSingapore
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
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Approach & Schedule,
No. Step Deliverables
1.Demand AnalysisWork 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 AnalysisIdentify 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-screeningSelection 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/RFQPrepare 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 AdministrationThe 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 ResponsesAnalysis 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
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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
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Whole Blood Collection Systems including Leucodepletion Filter (nearly € 27 Million in spend).
SystemWhole Blood Collection
Systems including Leucodepletion Filters
Image Remark Forecasted Qty Y3 (Systems)*
1Top and Top (TAT) Blood
collection system for whole blood filtration
Nil 1.7 M
2Bottom 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
XXXX
X
AB C
D EF
G H
A
B
C
D
E
F G
H
A
B
C
F
GH
D E
I
J
* Y3 is forecasted for use from 01/05/2015 – 30/04/2016
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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
Suppliers identified Failed phone screening Passed phone screening
5547
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
Indonesia
Thailand
Vietnam
Philippines
Singapore
South Korea
Pakistan
Malaysia
Taiwan
Japan
China
India
116
DS identified 142 suppliers in 12 Asian Countries,
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26
142
116 suppliers failed phone screening process
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29
52
32
7
9
68
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• OthersYour 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 infoConfidential
DS Contact Person Mr Pankaj TutejaEmail [email protected] number +91- 22- 26365009Mobile + 91- 9867602535
Company Name Address Town Province Company Website
Contact Person Title Email Tel Fax Mobile phone
Detailed specifications are showed in Annex 1 and Annex 2
4. Quality Management: Information requested about Certification, Quality control etc.. 5. Factory Pictures: Please provide recent pictures of your factory. 6. RFQ: Request for quotation.
This RFI/RFQ contains a total of 9 worksheets detailed below:0. Introduction & Instructions: presentation of the objectives and timetable of the 1. Contact Information: General and contact information about your company. 2. Company Profile: Key business and financial information.3. Production: Manufacturing capability, Production capacity, etc.
COMPANY INFORMATION
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 detailinformation
Productioninformation
© 2015 Dragon Sourcing. All rights reserved.
RFI-RFQ sent Intend To Respond
Don’t Intend to respond
Only RFI Received
RFI-RFQ received
14
4
10
4
8
2
6
2
1
1
1
1
1
1
1
1
1
Singapore
South Korea
Pakistan
Japan
India
China
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
ShaanxiAnhui
Fujian
Inner Mongolia
Shanxi
Xizang
Sichuan
Yunan
Guizhou
Henan
Jilin
Liaoning
Guangdong
Gansu
Shanghai
Hong Kong
Taiwan
Heilongjiang
Sichuan
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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
Similarly other Countries suppliers location were highlighted.
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
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- Logistics Process: DDP Price Calculation- From FOB China & India to DDP Europe destination.
EXWPrice
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.
DDPPrice
FOBPrice
Delivered price until client warehouseChinese & Indian suppliers quotation
Country Supplier Product #
Supplier DDP Price
(Euro/System)Supplier Annual
spendSupplier 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 MFigure 2 € 3.02 xxxFigure 3 € 0.21 xxxFigure 4 € 0.23 xxx
China# DSCN/BB30
Total annual saving € 3.91 M
Figure 1 € 2.03 1.7 MFigure 2 € 1.47 xxxFigure 3 € 0.25 xxxFigure 4 € 0.16 xxx
China# DSCN/BB28
Total annual saving € 0.24 M
Figure 1 € -1.77 1.7 MFigure 2 € -1.49 xxxFigure 3 0.04 xxxFigure 4 0.20 xxx
China# DSCN/BB27
Total annual saving € 0.18 M
Figure 1 € -4.90 1.7 MFigure 2 € -8.03 xxx
Figure 4 € 0.18 xxx
India # DSIN/BB31 Figure 1 € -16.33 1.7 M
India# DSIN/BB26Total annual
saving € 0.19 M
Figure 1 € -10.22 xxxFigure 2 € -11.62 xxx
Figure 4 € 0.19 xxx
© 2015 Dragon Sourcing. All rights reserved. 19
Supplier with highest annual saving was about € 6 millionHighest Annual Saving
CO
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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
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Highest Annual Saving
CONFIDE
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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
# DSCN/BB24
# DSCN/BB30
# DSIN/BB31 # DSCN/BB28
# DSCN/BB27
# DSIN/BB26 # DSSK/BB25China China India China China India South korea
0
10
20
30
40
50
60
70
80
90
14.933333333333316.066666666666713.0666666666667 9.75 10.533333333333310.68333333333339.03333333333334
24.5 27.526.5
24.75 24.125 18.5 18.25
18.7517.5 21.25
18.75 18.7521.25
17.5
12 8 612
4 4
4.33333333333333 3 5 4.33333333333333
2 3.33333333333333
3
5 5 5 5
5 3.75
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
Page 1-5
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
TestUV-visible range spectrophotometerTotal organic carbon analyzerHigh performance liquid chromatographyElectronic analytical balanceAutomatic optical rotationcentrifugal machinemould 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.
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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
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Page 5 - 5
• Section: Factory Pictures
© 2015 Dragon Sourcing. All rights reserved.
PotentialSavings
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%