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
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
Main scope
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
TQM
SCM
Drugs cold supply
chain
•Vaccines
•Insulins
•Inhalers
•New biotechnological
products
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)
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
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Manifacturer-distributor
Consumer
Pharmacy-Hospital-Insurance co.
Wholesaler
Pre-wholesaler
Wholesaler
Drugs Supply Chain Structure in Greece
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
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
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
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
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
 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
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
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
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
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
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
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
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
CORRECTIVE
ACTIONS
Clear designed procedures
Communication
Intervention of
administration
Employees involvement
Internal evaluation
Occurrence Detection
√ √
√ √
√ √
√ √
√ √
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Thank you
for your attention!!!

Drugs cold supply chain presentation

  • 1.
    3RD INTERNATIONAL CONFERENCEON 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 CONFERENCEON 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 INTERNATIONALCONFERENCE ON SUPPLY CHAIN TQM SCM Drugs cold supply chain •Vaccines •Insulins •Inhalers •New biotechnological products
  • 4.
    3RD INTERNATIONAL CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON SUPPLY CHAIN Manifacturer-distributor Consumer Pharmacy-Hospital-Insurance co. Wholesaler Pre-wholesaler Wholesaler Drugs Supply Chain Structure in Greece
  • 7.
    3RD INTERNATIONAL CONFERENCEON 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 chainfailure 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 • Badusage • 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% Possibilityto 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 toappear 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 CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON 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 CONFERENCEON SUPPLY CHAIN CORRECTIVE ACTIONS Clear designed procedures Communication Intervention of administration Employees involvement Internal evaluation Occurrence Detection √ √ √ √ √ √ √ √ √ √
  • 20.
    3RD INTERNATIONAL CONFERENCEON SUPPLY CHAIN Thank you for your attention!!!

Editor's Notes