Drugs cold supply chain presentation

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


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


TQM

SCM

Drugs cold supply chain

•Vaccines•Insulins•Inhalers•New biotechnological products


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)


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


Manifacturer-distributor

Consumer

Pharmacy-Hospital-Insurance co.

Wholesaler

Pre-wholesaler

Wholesaler

Drugs Supply Chain Structure in Greece


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


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


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


Διπλωματική εργασία-Αθανασιάδης Θεόδωρος

6%

17%

35%

36%

6%

Possibility to appearvery much

very

likely

less likely

unlikely


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%


Research Data Analysis


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



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


unlikely000

010

020

030

040

050

damaged instrumentsnon calibrated equipmentnon regular messurmentsfauls messurementsabsence of software Percentage

distribution of handling problems causes

very much


unlikely000005010015020025030035040045

lack of knowledgenot clear instructionsloading problemsworkers negligence Percentage

distribution of handling problems causes



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


unlikely000005010015020025030035040045050

long distncesoften stop of vehicleswrong planning products separationcommunication

Percentage distribution of inadequate planning

>67%

>75%



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


3,77 Lack of communication

3,05 Re-evaluation 2,72 31,28

Inadequate planning


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


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


Products demolition

3.52 Not calibrated instruments

2.67 Check 2.08 19.71


Products demolition

3.52 Damaged instruments

2.67 check 2.08 19.52


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


CORRECTIVE ACTIONS

Leadership

Strategic planning

Funding increase

Employees involvement

Business culture

Information and uncertainty

Costumers Focus

Structural changes

Inventory management


CORRECTIVE ACTIONS

Clear designed procedures

Communication

Intervention of administration

Employees involvement

Internal evaluation

Occurrence

Detection

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Thank you for your attention!!!

Drugs cold supply chain presentation

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Transcript of Drugs cold supply chain presentation