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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 chainUnderstanding, 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 requirementsPackagingIs 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• Inappropriat
e 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 MethodologyQuestionnaire
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 appearvery 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 than 10% consider problems
are unlikely to occur
31%
34%
25%
8%
3%
Problems severityResearch Data
Analysis
Probability to appear
1 2 3 4 5000
010
020
030
040
050
060
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%
uncertain less possib. moderate pos.
quit certain certain000
010
020
030
040
050
060
machines prob-lems
metric system
handling
transpostation
structure
4%13%
18%
37%
28%
Possibility of detectionuncertain
little pos.
moderatte pos
quite certain
certain
Research Data Analysis
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
very much
very likely less likely
unlikely000010020030040050060
non-regular maintenancebad usageinapropriate maintenanceinappropriate toolsinapropriate workers
Percentage distribution of causes that create problems in refrigerating machines
very much
very likely less likely
unlikely000
010
020
030
040
050
damaged instrumentsnon calibrated equipmentnon regular messurmentsfauls messurementsabsence of software Percentage
distribution of handling problems causes
very much
very likely less likely
unlikely000005010015020025030035040045
lack of knowledgenot clear instructionsloading problemsworkers negligence Percentage
distribution of handling problems causes
Research Data Analysis
3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
very much very likely less likely unlikely000005010015020025030035040045050
inapropriate vehiclesnon regular maintenanceinapropriate maintenancemaintenance by incompeted peopleirresposnible workers
Percentage distribution of transportation problems causes
>67%
very much
very likely less likely
unlikely000005010015020025030035040045050
long distncesoften stop of vehicleswrong planning products separationcommunication
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 CHAINProcess step Potential
Failure ModePotential 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
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3RD INTERNATIONAL CONFERENCE ON SUPPLY CHAIN
Thank you for your attention!!!