1. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Implementation of Total
Quality Management Tools in
Cold Supply Chains:
The Case of Drugs
Theodoros Athanasiadis
Dimitrios Aidonis
Petros Ieromonachou

2. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
 Detection of potential problems that may occur in
drugs cold supply chain
 Understanding, evaluation and implementation of
corrective actions in order to eliminate or delete them.
 Improvement of supply chain management by
engaging of principles and tools involved in TQM
Main Scope

3. Main scope
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
TQM
SCM
Drugs cold supply
chain
•Vaccines
•Insulins
•Inhalers
•New biotechnological
products

4. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Drugs peculiarities
•Sort period of life
•Globalization-long distances
•Many products are very expensive or
too cheap
•Large amount of generics
•High sensitivity
•Absolute necessity
•Regulations, laws (local,
international)
•(WHO W. H., Guide to good storage
practices for pharmaceuticals, 2003
•WHO W. H., Model Guidance for the
Storage and Transport of Time and
Temperature-Sensitive
Pharmaceutical Products, 2010
•ΕΜΕΑ 2007 (Declaration of storage
conditions in the product infοrmation
of medicinal products)
•Guidelines of 5 November 2013 on
Good Distribution Practice of
medicinal products for human use
(2013/C 343/01)

5. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Structure of the Study-Research
•Structure of Drugs Supply Chain in Greece
•Analysis of operations of Supply Chain (Flow Chart)
•Detection of faults and problems ( FTA)
•Research Methodology
•Research Data analysis
•FMEA – ( RPN, problems evaluation)
•Corrective actions

6. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Manifacturer-distributor
Consumer
Pharmacy-Hospital-Insurance co.
Wholesaler
Pre-wholesaler
Wholesaler
Drugs Supply Chain Structure in Greece

7. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Seller Transporter Customer``
Start
Specification of
storage
requirements
Comply with
standards
Stop of
procedure
Storage
Temperature
recording
Filling forms
Is process
under control?
Rejection
Specification of
packaging requirements
Packaging
Is process
under control?
Pick up and
transfer by
transporter
Specification of
transportin
requirements
Check and
recording of
temperature
Filling forms Comply with
transporting standards?
Pickup from
customer
Unpackanging
andstorage
Send reference to
supplier
End
No
YES
YES
NO
YES
NO
NO
YES
Drugs cold supply chain Flow Chart

8. Cold supply chain failure
Sellers Failure Distributors Failure Customers failure
or
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Cold supply chain failure
Inappropriate
equipment
Inappropriate handling Inappropriate planning
or
Drugs Cold Supply Chain: FTA

9. Refrigerating
machines
• Non-regular
maintenance
• Bad usage
• Inappropriate
maintenance
• Inappropriate
tools
• Not qualified
workers
Metric system
temperature
control failure
• Damaged
instruments
• Non calibrated
equipments
• Non regular
measurements
• Faults
measurements
• Absence of
software
Handling
problems
• Lack of
knowledge
• Not clear
instructions
• Loading-
uploading
problems
• Workers
negligence
Transportation
means and
procedures
• Inappropriate
vehicles
• Non-regular
maintenance
• Inappropriate
maintenance
• Irresponsible
workers
• Maintenance
by unskilled
people
Planning and
design of
procedures
• Long distances
• Often stop of
vehicles
• Wrong planning
• Non separation of
products
• Lack of
communication
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Main causes of problems in drugs cold supply chain

10. Research Methodology
 Questionnaire
 Research Period : 1-28 February 2015
 Email, Fax, Post, Couriers
 Community pharmacists, Drugs
wholesalers, Pharmaceutical companies
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN

11. Διπλωματική εργασία-Αθανασιάδης Θεόδωρος
6%
17%
35%
36%
6%
Possibility to appear
very
much
very
likely
less likely
unlikely
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
90% consider
problems as serious
58%consider
problems are likely
to occur
Less than10%
consider problems are
unlikely to occur
31%
34%
25%
8%
2%
Problems severity Research Data Analysis

12.  Probability to appear
000
010
020
030
040
050
060
1 2 3 4 5
machines
problems
metric system
handling
transpostation
structure
>30%
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Research Data Analysis

13. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
33.3% consider
moderate or little
possibility to detect
>40%
000
010
020
030
040
050
060
uncertain less possib. moderate pos. quit certain certain
machines problems
metric system
handling
transpostation
structure
4%
13%
18%
37%
28%
Possibility of detection
uncertain
little pos.
moderatte pos
quite certain
certain
Research Data Analysis

14. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
000
010
020
030
040
050
060
very much very likely less likely unlikely
non-regular maintenance
bad usage
inapropriate maintenance
inappropriate tools
inapropriate workers
Percentage distribution of
causes that create problems
in refrigerating machines
000
010
020
030
040
050
very much very likely less likely unlikely
damaged instruments
non calibrated equipment
non regular messurments
fauls messurements
absence of software
Percentage distribution of
handling problems causes
000
010
020
030
040
050
very much very likely less likely unlikely
lack of knowledge
not clear instructions
loading problems
workers negligence
Percentage distribution of
handling problems causes
Research Data
Analysis

15. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
000
005
010
015
020
025
030
035
040
045
050
very much very likely less likely unlikely
inapropriate vehicles
non regular maintenance
inapropriate maintenance
maintenance by incompeted
people
irresposnible workers
Percentage
distribution of
transportation
problems causes
>67%
000
005
010
015
020
025
030
035
040
045
050
very much very likely less likely unlikely
long distnces
often stop of vehicles
wrong planning
products separation
communication
Percentage distribution of
inadequate planning
>67%
>75%
Research Data
Analysis

16. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Probable
problem Severity Probability Detect ability
RPN
Problems in
machines 4,03 2,69 1,74 18,90
Failure of
metric system 3,52 2,28 2,08 16,65
Handling
errors 3,97 3,31 2,44 32,02
Problems in
transportation 3,90 3,13 2,44 29,70
Inadequate
plans 3,77 2,64 2,72 27,06
FMEA: Main Problems categories

17. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Process step Potential
Failure Mode
Potential
Failure
Effect
SEV Potential Causes OCC Current
Process
Controls
DET RPN
Inadequate
planning
Omissions Products
demolition
3,77 No separation of
products
3,23 Re-evaluation 2,72 33,12
Handling Ignorance of
procedures
Products
demolition
3,97 Loading-
unloading
problems
3,28 Inspection 2,44 31,77
Inadequate
planning
Omissions Products
demolition
3,77 Lack of
communication
3,05 Re-evaluation 2,72 31,28
Inadequate
planning
Omissions Products
demolition
3,77 Faults in routes 3,05 Re-evaluation 2,72 31,28
Handling Ignorance of
procedures
Products
demolition
3,97 negligence 3,21 Inspection 2,44 31,09
Process step Potential
Failure Mode
Potential
Failure Effect
SEV Potential
Causes
OCC Current
Process
Controls
DET RPN
Refrigerating
machines
Stop of
procedure
Products
demolition
4.03 Conservation by
wrong people
2.95 Inspection 1.74 20.69
Metric system Wrong
temperature
estimation
Products
demolition
3.52 Wrong
measurement
2.74 Check 2.08 20.09
Metric system Wrong
temperature
estimation
Products
demolition
3.52 Not calibrated
instruments
2.67 Check 2.08 19.71
Metric system Wrong
temperature
estimation
Products
demolition
3.52 Damaged
instruments
2.67 check 2.08 19.52
Refrigerating
machines
Stop of
procedures
Products
demolition
4.03 Use of improper
tools
2.74 Inspection 1,74 19.21
FMEA: Main causes of problems in Drugs Cold supply chain

18. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
CORRECTIVE ACTIONS
Leadership
Strategic planning
Funding increase
Employees involvement
Business culture
Information and uncertainty
Costumers Focus
Structural changes
Inventory management

19. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
CORRECTIVE
ACTIONS
Clear designed procedures
Communication
Intervention of
administration
Employees involvement
Internal evaluation
Occurrence Detection
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20. 3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Thank you
for your attention!!!