1.1 INTRODUCTION

The aim of organization study is to gain an organizational

familiarization and in- depth knowledge of the functioning of various

departments. The study was undertaken with the objective of understanding

the working of a business organization. It gives clear idea about the

functions and practices of various department heads, SWOT analysis, porters

five forces model analysis etc. The organizational study is intended to access

and to acquire the knowledge regarding the functional as well as the

management aspects of the firm.

An os study has been conducted at TERUMO PENPOL LTD;

TRIVANDRUM. This study is oriented towards understanding, how the

company functioning. In practice, by interaction with the various

departments in the organization. Blood Transfusion is an integral part of the

Health Care delivery in any country. In fact it is the most important part of

the health care system. Blood bag is a disposable bio-medical device used

for collection, storage, transportation and transfusion of human blood and

blood components. The system consists of a single or multiple bags

connecting with tubing, needle, needle cover, clamp etc. The blood bags are

made of plastic materials which are compatible with blood. Blood Bags can

successfully replace the use of glass bottles for collection, storage,

transportation and transfusion of blood and blood components since bottles

require exhaustive cleaning, rinsing and autoclaving procedures and there

are chances of breakage at any stage. Blood bags are most ostensibly serving

the medical field in crucial hour. As the number of hospitals, nursing homes

are increasing; the demand for the blood bags too is increasing

pg. 1

tremendously. Blood bags cannot be advertised. The USP for these products

is quality.

In March 2011, the company bought U.S. medical device company

CaridianBCT for around $2.6 billion. It is the largest acquisition by a

Japanese medical equipment maker and makes the company to the top of

global blood transfusion market.

1.2 OBJECTIVES OF THE STUDY

The main objectives are:

To the study about the blood bag industry.

To study about the history of the TPL, each department functions, its

vision and mission.

To study the organizational policies, procedures, practices and future

plans of the firm.

To evaluate the strength, weakness, opportunity and threats of the

company.

To analyze PORTER’S five force model of the organization which

leads to the findings, Suggestions and conclusion.

1.3 METHODOLOGY

This study familiarize with general working conditions of the

organization with respect to departments, functions, authority and

responsibility and procedures. The collection of data made through various

methods. These are:

pg. 2

Primary sources

Primary data is the data which is collected by the researcher directly

from his own observations and Interviews.

Sources of primary Data;

Observation

Interview with Managers, office staff and workers.

Secondary sources

Data from a secondary source is any data which has been collected by

another researcher, whether it is a group of people or just one person. The

data may have

originally been used for a different type of research, but we can manipulate

it to fit our research, instead of using it as it was intended to be used.

Sources of Secondary Data;

Data collected from Annual Reports of the company.

Data collected from Department manuals.

Data collected from Journals, Magazines, Brochures, and Websites.

1.4 SCOPE OF THE STUDY

The study helps to develop a practical knowledge about the working

of the organization. It helps to get familiarized with the organizational

procedures and understand company’s strategy for growth, which faces

further expansion of capacity, modernization of processes, follow to strict

quality assurance protocols and to boost efficiency in manufacturing.

1.5 LIMITATIONS OF THE STUDYpg. 3

The information obtained is not complete and accurate, as confidential

matters were not disclosed for the purpose of the study.

The study has limited scope, as it aims an overall organizational study

and not an in-depth study.

The main limitation of the study was time constraint.

Probable bias of the respondents: the secondary data provided for the

study by the authorities may be biased. Errors might have been caused

due to certain biases of the respondent.

Difficulty in meeting with all the top level officials.

2.1 BLOOD BAG INDUSTRY

Blood product belongs to biological products and is a biological

active preparation, which collects healthy blood as the raw material and then

is made through biological process or separation and purification

technologies. Blood products are irreplaceable in the application of medical

emergency and prevention & treatment to some specific diseases. Blood bag

is a disposable bio – medical device used for collection, storage

transportation and transfusion of human blood components. Indian Research

and Development organization is offering technology for the manufacture of

disposable blood bag systems. The system consists of a single or multiple

bags connecting with tubing, needle cover, clamp etc. The blood bags are

made of plastic material, which are compatible with blood. Blood bags can

successfully replace the use of glass bottles for collection, storage,

transportation and transfusion of blood and blood components since bottles

require exhaustive cleaning, rinsing and autoclaving procedures and there

are chances of breakage at any stage. Further, use of disposable bags

pg. 4

eliminates the possibility of any contamination. In recent times the blood

bag has become a conspicuous item and essential need of hospitals and

nursing homes to meet blood infusion emergencies. Blood bags are most

ostensibly serving the medical field in crucial hour. As the number of

hospital, nursing homes are increasing the demand for the blood bags too are

increasing tremendously. A blood bag system comprises of a container

holding an in-activator that inactivates micro – organism contained in blood,

a container holding an anticoagulant and a connecting tube connected liquid

– tightly to the container, wherein the activator contains as a main

component a platinum compound capable of binding to nucleic acid of the

micro – organism or an aqua complex of the platinum compound; and a tube

for introducing a neutralizing agent to neutralize the in-activator which is

connected with the container holding the in-activator.

pg. 5

Fig2.1

Trend of Plasma Volume Collected in China, 2001-2008 

Source: www.researcinchina.com

The increasing trend of Plasma Volume Collected in China

from2001to 2008 is a good example to state the increasing requirement of

blood bags, as blood bag requirement is directly proportional to blood

product requirement.

Advantages of Indian Technologies;

Low capital investment.

High employment potential.

Maximum use of local raw materials and manpower resources.

Adaptable levels of sophistication.

2.2 WORLD SCENARIO

Globally, approximately 75 million blood bags are collected annually

[Source: WHO], Major blood bag manufacturers globally include

Baxter Bioscience, USA; Bayer Corporation, USA and Octapharma AG,

pg. 6

Switzerland. With the increasing global demand for blood bags and growth

rate of its market being 15 percent annually the business for the potential

investor is desirable and is expected to generate high returns from the

business. The investor would need to set up highly standardized plant as the

demand for these products largely depend on their quality. The blood bag

manufacturing industry is now in a growth stage. It is now witnessing high

customer traffic. This particular industry goes hand in hand with new

technology. It also contributes a fair portion of revenue to the economy.

2.3 INDIAN SCENARIO

Terumo Penpol is India's largest manufacturer of Blood Bags. The

company is one of the largest producers of blood bags in Asia, other than

Japan with a capacity of 10 Million Blood Bags. The company has come a

long way since its beginning in 1987.In1985 Peninsular Polymers which was

a pioneer in the field of manufacturing blood bags was set up by Mr.

C.Balagopal, an EX-IAS officer and his brother Mr.C.Padmakumar. In July

1999 the company formally collaborated with Terumo Corporation, Japan.

Terumo Corporation invested in the equity capital of the company and today

it holds 74% with the balance 26% held by the promoters. The name of the

company was changed to TERUMO PENPOL LIMITED on 01/10/99.

The company pioneered the manufacture of Blood Bags in India and

then successfully launched a range of medical electronic products required

for blood transfusion centers. Driven by its strong customer-focus and

innovative spirit, the company has been the market leader ever since it

introduced blood bags in India and then successfully launched a range of

medical electronic products required for blood transfusion centers. Today, it

is more than double the size of any other blood bag manufacturer in India.

pg. 7

Not only does Terumo Penpol offer customers a wide range of Blood Bags

and Blood Bank Equipment, but also offers tailor made products to meet

specific requirements.

3.1 COMPANY PROFILE

Terumo Penpol is India’s largest manufacturer of blood bags. The

company is one of the largest producers of blood bags in Asia, other than

Japan with a capacity of 13 million blood bags. Peninsular Polymer Ltd or

Penpol was established in 1987. On 19th July 1991 Tokyo based Terumo

Corporation has signed a contract to acquire 74% share of Peninsular

Polymers Ltd. The new venture came to be known as Terumo Penpol Ltd.

Terumo Penpol manufactures a wide range of blood collection systems and

medical equipments required for blood banks and component centers.

The company has come a long way since its beginning in 1987. The

company pioneered the manufacture of blood bags in India and then

successfully launched a range of medical electronic product required for

blood transfusion centers. Driven by its strong customer-focus and

innovative spirit, the company has been the market leader ever since it

introduced blood bags in India. Today, it is more than double the size of any

other blood bag manufacturer in India. Not only does Terumo Penpol offer

customers a wide range of blood bags and blood bank equipment, but also

offers tailor made products to meet specific requirements.

Terumo Penpol is part of the multibillion dollar Terumo Corporation,

a Japanese company having its presence in over 150 countries. Terumo has

pg. 8

distinguished itself as a high quality manufacturer of medical products with

13 factories around the world. The company generates annual sales of about

$2 billion and employs 7500 people worldwide. Terumo is pioneering

products of future like implantable left ventricular assist system, artificial

vessels, minimally invasive surgery devices, nano capsules and more.

The Blood Bag Factory (BBF) is situated at Puliyarakonam, a suburb

of Trivandrum, and employees over 600 skilled people. In 1998, the

production capacity was only 1 million bags per year. In 1996, the

production capacity was 3 million bags.

Today TPL has a manufacturing capacity of 24 million bags per year. The

bags are tested against parameter set out in ISO-3826, which provides for

products that ensure safety of blood and blood components. They also offer

resistance to breakage in centrifuge among other parameters. The blood

bags are sold in over 60 countries across the world.

The Medical Systems Group was established in 1995. Medical

Systems Group is engaged in the design and manufacture of specialized

blood bag equipment and software aimed at improving the blood

management systems and procedures in blood banks.

The manufacturing facility follows an integrated production system from

raw materials to finished products, ensuring strict adherence to Good

Manufacturing Practice (GMP). The production system ensures careful

selection of materials/components, controlled production environment,

comprehensive testing of all inputs, intermediate products and finished

goods.

pg. 9

The main feature of the manufacturing facility is the flexibility it offers:

I. Flexibility in product features.

II. Flexibility in minimum order quantity.

III. Flexibility in delivery schedules.

Terumo Penpol has 700 customers all over India and its blood bags are

sold in over 60 countries across the world and its Medical Equipment

Division has more than 1900 installations to its credit. Terumo Penpol has

its headquarters in Thiruvananthapuram and employs 766 people. The

company has an experienced team of marketing and sales professionals

covering the whole of India. The team is further supported by a well trained

service group.

Terumo Penpol manufactures a wide range of blood collection systems

and medical electronic equipment required for blood banks and component

centers. At Terumo Penpol quality is a way of life. Utmost care and

attention is given to each and every stage of production to ensure strict

adherence to GMP and CE Mark standards.

3.2 TIMELINE OF IMPORTANT EVENTS

1987: Terumo Penpol Ltd launches India’s first single blood bags.

1988: TPL launches India’s first double blood bags.

1993: TPL launches India’s first triple blood bags.

2001: TPL launches the Terumo Automatic Component Extractor

(TACE) which helps to bring down the time required to separate

blood components in blood banks by easy, fast and standardized

method.

pg. 10

2004: TPL launches two products, thawing bath CB 100 and WB

100, for the safe and uniform thawing of fresh frozen plasma. It can

maintain temperature at any set value between 4 degree Celsius and

37 degree Celsius.

2004: TPL launches the improved version of Donor station Compo

safe DC 200, which increases comfort and safety to the donor and the

phlebotomist.

2004: TPL introduced new Deep Freezer Compo safe DF-40, which

is designed for the storage of plasma and preserving the labile factors

during shelf life.

2005: TPL introduces blood bag with safety features that assure

protection from blood borne diseases.

2006: TPL introduces Compo safe Semi- Automatic Expresser SAE

500 that helps standardize the red cells/ packed cells by retaining

selected volume of plasma with RBC in double and triple blood bags.

2006: TPL launches new 80 degree centigrade Deep Freezer, which

is designed as fast freezer for the preparation of fresh frozen plasma

and cryoprecipitate.

2007: TPL won the state level award instituted by PRS( Public

Relation Society of India) for the best company promoting corporate

social responsibility activities among the industries in Kerala

2008: TPL’s new West blood Bag Plant building was inaugurated by

Mr. Kenji Sekine (President Transfusion Business, Terumo

Corporation). With this expansion project, TPL has doubled its

production capacity which is presently 13 million.

2008: TPL organized a mega blood donation camp in association

with All Kerala Blood Donors Society, Club 25, Kerala Sports

pg. 11

Council and SBT as part of the programs in connection with world

health day. Out of the 217 donors who attended the camp, blood was

collected from 107 donors by the blood banks of Medical College

Hospital, Regional Cancer Centre, and SreeChitiraThirunal Institute

for Medical Sciences.

2009: TPL has won the Outstanding Safety Performance Award in

the category of medium size industries other than chemical and

engineering (0.5 million to 1.5 million man hours worked ) instituted

by the Kerala Chapter of National Safety Council of India.

3.3 MISSION

The Mission of TERUMO PENPOL is;

‘Better Ways to Better Healthcare’

Their perception is that today’s best will be replaced by something

still better tomorrow. They mean to go on and on in their quest to create

better ways to better healthcare.

3.4 VISION

To become a world class medical device manufacturer adopting

customer first approach in all business processes.

3.5 QUALITY POLICY

pg. 12

To maintain high quality products meeting customers and

requirements.

To design all products in accordance with international standards.

To ensure high quality at all the stages of the supply chain.

Terumo Penpol will contribute to society through health care.

Terumo Penpol is committed to continuously review and improve the

effectiveness of the quality management systems. The quality management

system of Terumo Penpol is certified according to ISO9001:2000, 1SO

13485, European Standards EN 46001 and European Medical Device

Directive 93/42/EEC.

3.6 QUALITY OBJECTIVES

Ensuring strict compliance to good manufacturing practice.

Improving the product quality through continuous technological up

gradation.

Enhancing the product performance by sustained analysis of customer

feedbacks.

Maintaining high degree of quality awareness among employees

through periodic training programs.

3.7 AWARDS

Awarded the national award for best research and development efforts

in industry from government of India for the year 1995.

Won the top exporters award for medical disposable and surgical

items for the year 1995.

pg. 13

Won the second best award for medical disposable and surgical items

for the year 1996.

Won the top exporters award for medical disposable and surgical

items for the year 1997.

3.8 Voluntary Blood Donation Services

The solution is to increase the number of regular voluntary donors in

India. So their main aims are:

To create awareness and educate the public on the need for regular

and voluntary blood donation

To safe guard the interest and welfare of the blood donors.

To promote voluntary blood donation among all sections of society.

To reach out to peripheral rural areas so as to make them self-

sufficient `rural blood donor forums.

3.9 ACIVITIES

Donor Motivation Seminars, Blood Grouping Sessions.

Publication and Distribution of Promotional Material on Voluntary

Donation.

 Networking of existing Forums and Institutions.

Annual Conferences/Workshops to promote Voluntary Blood

Donation.

3.10 PRODUCT PROFILE

pg. 14

TPL has a wide range of products. It consists of blood bags, urine

bags, blood bag equipment; blood bag management software etc.TPL is an

ISO 9000 company for manufacturing and marketing blood bags. The

most important quality of maintaining the

quality of blood is the container in which it is stored. TPL’s blood bag

reaches a customer after undergoing 41 physical and biological tests that

ensures safety in use. Its product range consists of single bag, double bag,

triple bag, quadruple bag, triple and quadruple bag with SAGM-2.

3.11 PRODUCT CATEGORIES

1. Blood Bags & Accessories

2. MSG (Medical Systems Group) PRODUCTS 

3. Storage Equipment for Blood Banks

4. Blood Collection Devices

3.12PRODUCTS

Blood bag and accessories

Blood bag collection devices

Storage equipment for blood bank

Blood processing devices

Portal ( blood bank management software)

Portable donor couch

Tube scalar

Plasma expresser

Blood weighing scale

Platelet agitator incubator

Safello urine bag

pg. 15

Mini blood storage cabinets

Deep freezers

Terumo automatic components extracting

Refrigerated centrifuge

Limugrated 3 PL

Limugrated 3 PC

Trima Equipment and Accessories.

TrimaDisposibles.

A. BLOOD BAGS

The TERUMO Blood Bag systems are high quality products designed

for optimum blood management during collection, separation, preservation

and transfusion. Various types of blood bag systems with improved storage

period of blood and blood components are available.

A new range of Blood Bags provides the Blood Banks with a large

choice of safety features. Carl Walter and W.P. Murphy, introduced the

plastic bags for blood collection in 1950, a system which replaced the

previously used blood bottles .Terumo Penpol uses K72 PVC (Polyvinyl

chloride) as raw material for blood bags. This contributes to their high

quality, stability and tensile strength. Plasticizers aid in converting highly

brittle PVC resin into softer flexible compounds. The use of plasticizers

for increase in softness and flexibility. DEHP (Diethyl hexyls

phthalate) Preferred plasticizer for medical grade PVC.

Types of Blood Bag

Single Blood Bags

pg. 16

Single bags are mostly used for the collection and transfusion of whole

blood. The anticoagulant used is CPDA

Double Blood Bags

Double bags are primarily used to separate blood into two main

components, packed red cells and plasma. The two bags are called as

primary bag (used to collect blood), and transfer bag (used to transfer the

separated component after centrifugation) respectively.

Triple Blood Bags

They are used for whole blood collection followed by separation into

three components, packed red cells, plasma and platelets. The triple bag kit

contains one primary bag and two transfer bags (for platelet and plasma).

Quadruple Blood Bags

Quadruple bags are used for components reparation into packed red cells,

plasma, platelets. The kit contains one primary bag and three transfer bags

(plasma, platelet, and Buffy).

TAB (Top and Bottom) blood bag

Thus, during component separation process, the top and bottom

components (plasma and packed red cells) move simultaneously into their

respective transfer bags, leaving the Buffy layer in the primary bag.

Penta Blood Bags

The Penta blood bag system contains 5 bags It is designed for pediatric /

multiple

Transfusion it reduces the risk of multiple donor exposure to pediatric

patients.

pg. 17

Top & Bottom BB with Leukocyte filter for CRC

The Inline filter bag is incorporated into the Quadruple bag system . The

filter is encased into a soft plasticized PVC housing which minimizes the

possibilities of bag damage during storage, transport and centrifugation

B. PORTIA (Blood Bank Management Software)

PORTIA significantly improves safety, productivity, quality and cost

effectiveness enabling solution to problems inherent in conventional blood

management methods. It is available in single and multi-user versions. It

also gives the details of

Blood Bags which the company producing. Details regarding the Blood

Bags are available as a database which includes the capacity volume of

blood bags.

Setting up of Blood Banks

Setting up or modernizing a blood bank requires a lot of time,

investment and effort on the part of the person in-charge. It spans across a

wide range of complex activities starting from preparation of the project

proposal to ensuring uninterrupted day-to-day functioning of the Blood

Bank. Each of the activities requires expertise without which the cost and

time involved can shoot up to very high levels. TERUMO PENPOL Limited

has over 17 years of experience in Blood Banking. During these years the

company has interacted with many Blood Bank professionals and

manufacturers from across the world; and understands the operations of a

Blood Bank. This knowledge, combined with the expertise of a team of

highly trained managers, engineers and blood bank professionals, help

pg. 18

Terumo Penpol in providing the best solution to the blood banking needs.

Terumo Penpol helps to set up a fully functional blood bank that not only

conforms to Drug Rules but also to GMP as well as International Standards.

SAMPLING AND SAFETY FEATURES

Occupational exposure to blood remains a serious concern during the

blood donation process. In order to address the safety issues concerning the

blood bank personnel, we have introduced a range of features in our blood

bags. The sampling and safety features are available on all configurations of

blood bags.

Blood Sampling Arm

This simple design eliminates the need for cut and drip sampling.

Needle Injury Protector

Reduces the risk of needle stick injury from both donor and sampling

needles .It provides immediate shielding of needle on withdrawal from vein.

Luer Adapter and Tube Holder

Facilitates safe in-line sampling. The unique LUER adapter needle

provides for a safer sample collection using vacuum tubes. It reduces the risk

of needle stick injury from sampling needle.

Pre-donation Sampling Bag 

Our skin houses millions of bacteria commonly called as skin flora

which can cause contamination of the collected blood on entering through

the needle during Phlebotomy. Ideally 25ml of blood to be diverted to

achieve.

pg. 19

A. Fig 3.1Process at Blood Bank

Source: http://www.terumopenpol.com

C. MSG (Medical Systems Group) PRODUCTS

Tube sealer

Radio frequency sealing quality, easy separation of tube segments after

sealing procedures as hermetic seal hence no contamination , no warm up

time required.

XS1010

The XS1010 model heavy-duty radio frequency bench top sealer

provides wide, reliable, snap-apart seals. This lightweight compact tube

sealer conserves space in the

pg. 20

work area and has international safety certification of EN61010-1.It

produces hermetic seal by waves minimizing contamination and haemolysis

of blood and blood components and the sealing head is easy to clean.

Features

Heavy duty radio frequency bench top sealer ensures wide, reliable,

snap-apart seals.

Minimizes haemolysis of blood in tube segments.

Produces a hermetic seal preventing chances of contamination.

No warm up time required.

Compatible with the tubes of various manufacturers.

No variation in seal quality due to voltage fluctuation.

Splash guard provided (optional).

Plasma Expresser

Highly sensitive electronic sensor to prevent contamination uniquely

designed clamp mechanism ensures fast clamping at reduced power;

micro-processor based automatic collaboration for different type of tube

and bag.

Features

Uniquely designed compression plates exert uniform pressure on

the blood bag ensuring minimum layer disturbance for efficient

separation.

Same efficiency of separation across different brands of blood bags.

Powder coated mild steel cabinet.

Optimum performance ensured by Switch Mode Power Supply.

pg. 21

No contamination in separated components due to voltage fluctuation.

Compliance with international safety standards ensuring safety to

users.

Platelet Agitator Incubator

Ensure agitator at constant speed of 70+/-5 cycles/min .digital

temperature monitor, unique airflow system maintains uniform

temperature range. The Compo safe PA/PI200 is designed to meet all

international safety requirements of EN60601-1. This product stores

platelet concentrates in continuous motion at controlled temperature.

Digital temperature control monitor coupled with a unique air circulation

system maintains. Incubator at a uniform temperature of 22+- 2ºC within

the Incubator chamber as per FDA recommendation. There are visual

indications and audio alarms for temperature variation, open door and

agitator failure.PA/PI200 Platelet Agitators come in two options: 24 and

48 bag capacities.

Features

The flat bed agitator stores platelet concentrates in continuous motion

at controlled temperature.

Helps increase platelet viability, post transfusion recovery and

preservation of platelet morphology.

Agitation at constant speed of 75 +/ - 5 cycles/min.

No need for periodic calibration due to the digital temperature sensor

used.

pg. 22

Provision for connecting external remote alarm.

Visual indications and audio alarms for abnormal conditions like

temperature deviation, door open and agitator failure.

Compliance with international safety standards ensuring safety to

users.

Mini blood storage cabinets

Small capacity which is ideal for small-450ml blood bags power saver

ideal for remote location with frequent power failure.

Deep Freezer

Two models available- 400c and 800c high durability due to high impact

epoxy coating to resist scratches and rusting. Insolating sub lids to minimize

cold or during lid opening, clean fitter indicator light warns of fitter

clogging. Audible and visual power failure claims CFC free refrigerants and

insulation.

Refrigerated Centrifuge

Programmable memory for standard runs, Reduced maintenance

with brushless induction drive, Acceleration and declaration profiles.

Limuguard III-PL

pg. 23

To remove leukocytes and micro aggregates from up to ten units

platelet preparation. Only polyurethane fitter is used for highest bio-

compatibility. Unique air vent for convenient air removal.

Terumo Automatic Component Extractor

A highly flexible automatic blood component extractor for the

standardized processing of centrifuged blood according to good

manufacturing process. The device is designed to be used with all

common standard bag systems. Its top angled press with press position

detection ensures high stability of layers during extraction. It gives high

quality, non contaminated products with maximum component yield and

viability with a reduction in leukocytes through Buffy method.

Donor couch

It is designed for the comfort of the donor and the phlebotomist. Design

is based on haemoid dynamic principles (head high foot low position into

head low foot high position).

Blood collection monitor

Ensures better quality blood than that collected using manual mixing

methods. Clamp programmed volume, uniformed oscillation for optimum

mixing ensuring higher yield of components.

Safello urine bag

pg. 24

Conformity to ISO-8669 international standard for urine bag. Leak

proof no return value to prevent back flow of urine to minimize the risk

of infection.

Portable donor couch

Puts the voluntary donor where it belongs. Easy conversion from head

high foot low position to head low foot high position, no power

requirements.

Fig 3.2 Fig3.3

Donor Station (DC200) BLOOD COLLECTION MONITOR - D601

Making blood donation a safe Blood Collection and comfortable experience… made simpler .

…

pg. 25

Fig3.4 Fig3.5

TUBE SEALER- XS 1010 Portable Tube Sealer – LM100

Fig 3.6 Fig 3.7

Plasma Expresser – E300

Portable Sealer – LM100

BLOOD COMPONENT

SEPERATION…

pg. 26

Fig 3.8 Fig 3.9

Compo Scale CS300 E300 Interface with CS300

Fig 3.10 Fig 3.11

Cryo Bath (CB 100) PLATELET AGITATOR

WITH INCUBAT

4.1 ORGANIZATION STRUCTURE

The organization is working in three regions which includes corporate

office and logistics office at Sasthamangalam, blood bag manufacturing unit

pg. 27

at Puliyarakonam, and medical systems group at General hospital Jn:,

Trivandrum.

The organization has the following department that functions

effectively with a vibrant group of employees with the help of whom the

organization is able to shape up its future. The different departments that

functions are:

1. Production Department

2. Production & Engineering Department

3. Production Planning & Control Department

4. New Product Development Department

5. Maintenance Department

6. Accounts and Finance Department

7. Purchase Department

8. Stores Department

9. Quality Assurance Department

10.Export Department

11.Logistic Department

12.Marketing Department

13.Personnel and Administration Department

14.Human Resource Development Department

15.Corporate Social Responsibility

16.Medical System Group

Fig 4.1Organization structure

pg. 28

Chairman

5.1 PRODUCTION DEPARTMENT

pg. 29

Managing Director

Strategic planning

Corporate Admin

HR Legal Complianc

Executive Director

Corporate HR

Finance

GM MarketingVP Manufacturing

National Marketing Manager

Head Government Business

DGM Operation

PAD

Head of BBF

Materials

QA/QC

R&D

Technical Resource Manager

Administration and Accounts

Production

NPD

Safety

Maintenance

Application Specialist

Production

QA

Development

Purchase

Snr. Manager Institutional

National Sales Manager

All India Service Manager

Regional Manager

Area Manager

Sales and Service Engineer

The policy of production department is to manufacture

medical product as per the international standards strictly in compliance with

specifications laid down in the standard operating procedures with

minimum possible wastage of resources.

Production Process involves;

Selection of raw materials

Formulation

Processing

A .Raw materials used:

PVC

Plasticizers

Deoxidized oils

Stabilizers

Lubricants

Other additives

B. Formulation

This is a critical aspect that involves careful selection of raw materials

and proportions to be used to achieve the range of desirable properties. It can

be done by experiments followed by various studies.

C. Processing

Blood bags are made by welding together extruded plastic sheets. The

bags are subjected to autoclave sterilization at high temperatures and

pressures and freezing temperatures in the blood banks. They should also

pg. 30

withstand processes like centrifuging, used to separate the various

components of blood. Various parts like connecting tubes,

needles, outlet ports, special flow-regulating valves, filters, safety features

and sampling ports go into these bags, which are filled with an anticoagulant

solution that prevents blood from clotting.

Processing Steps:

1. PVC Sheet Extrusion

The raw materials for sheet extrusion are compounded PVC pellets. A

single screw extruder is used for the continuous process. The major zones of

the extruder are feed zone, meeting zone, recompression zone, adapter zone

and the dry zone.

2. PVC Tube Extrusion

The raw materials for tube extrusion are PVC compounded materials.

The inner diameter of tube is 3mm and outer diameter is 4.5mm. After

extrusion serial number is printed on the tube.

3. Injecting molding

The outlet port is manufactured through injection molding. The raw

material used is PVC pellets.

4. In process testing of sheet

pg. 31

This is done to confirm quality before being used in manufacture of

blood bags .The test on tube involves chemical test and element test. The

test on sheet also includes chemical test and element test.

5. Tube and compounding assembling

In tube assembling component of tube are broken off at junction

which have cuts provided at the stumping stage. Breaking of component is

done as per the specifications for each capacity and type of bag.

6. Welding\bag sealing

  First the sheet is assembled with one embossed surface and plane

surface facing the inside of the bag to be made. Thus both the inside and

outside are embossed as well as plane surface, then between the parallel

arranged sheet. Then tube and sheet are ready for sealing.

7. New Process

This stage is relatively new in the TPL’s blood bag production

process. Two major reasons contributed to the creation of new process stage-

sticking and leakage. Leakage is tested by passing filtered air with the help

of specially designed machine. To avoid sticking of bag air is injected into

the bag as per the standard set by Q.A. Less amount of air leads to sticking

and more air effects the smooth flow of blood. Care is taken to ensure right

quantity of air is injected. This stage provided an added advantage by

different bags of different thickness and volume to be produced at same

time.

8. Labeling of bags

pg. 32

  The labeling should be perfect. There are two types of labels Pressure

Sensitive Plastic Label (PSPL) and Heat Sensitive Plastic Label (HSPL).

The latter one has certain advantages over the other. It has a plastic coating,

which prevents shrinkage after sterilization. HSPL is exposed to 118 C and

therefore is not destroyed during centrifugation. PSPL is provided only to a

few old customers, who prefer it as it is cheaper. Majority of the labels are

HSPL. Prior to use the batch number are printed.

9. Preparation of anti coagulant solution

Anticoagulant solution is the one, which prevents clouting of blood.

Every blood bag should contain this solution in the required quantity, i.e.,

14% of the net capacity of the bag. The solution is prepared at TPL by using

inspected chemical like adenine (preservator), citric acid, citro phosphate,

etc. from the QC Department. Four types of

solutions are prepared, namely- CPDM, CPD, SAGM, ACD. CPDM

preserves blood for 35 days, CPD for 42 days. SAGM preserves blood for

42 days and has an additive to preserve blood cells.

10. Filling

The solution in collection tank is re-entered to sub tanks of capacity of

50liter each. From this the solution is channeled to blood bags via nozzles.

Sample of the solution from nozzle is taken for testing. During the process

of mixing, filtration, collecting, filling, the solution is least exposed to air to

prevent contamination. The bags filled with the solution are sent for packing.

11. Packing

pg. 33

  Polypropylene covers are used for PVC blood packing. Packing is

done manually. Bags are inserted and the tube with needle, holding

assembly and donor tubes are coiled into the packet. Coiling is different for

Single, Double and Multiple bags. Packing of bag is followed by sealing.

Sealing is done manually or automatically.

12. Sterilizing

Packed bags are now brought in for sterilization. It consists of two

processes.

Auto claving

Drying

13. Final inspection

Pinch off, leak, weld leak stopper leak, transfusion leak, needle blend

damages, label rejection, CPDA stain \ color change and other defects are

checked.

14. Foil packing, Cartooning and Dispatching

The foil package for the blood bag is three layer packs;

External polyester

Middle aluminum

Internal polyethylene

pg. 34

Sheet Extrusion

Break off Value and Cover Tube

Tube ExtrusionInjection Molding

Printing

pg. 35

Assembling of Outlet

Ports

Outlet Caps & Inner Tube

Labeling

Sheet

Bag Sealing In Fully-automatic Sealing Machine

Bag Sealing In Semi-automatic Sealing Machine

Tube Assembly for Multiple

Tube Sleeve

Outlet Ports & Transfer

Y connector

Break off Value

Filling of Bag with Solution

Individual

Autoclaving

Bag Drying

Foil Packing & Cartooning

Polypropylene Covers

Dispatching

Fig 5.1Production Flow Chart

5.2 PRODUCTION AND ENGINEERING DEPARTMENT

Production and engineering department is concerned with the

introduction of new machines and new technologies for manufacturing in the

pg. 36

Chief Production Manager

Production Manager

Deputy Production Manager

Plant Manager

Foreman

Supervisors

Assistant Plant Manager

Work Assistance

factory. The introduction of machines, technologies is done carefully so as to

minimize risk involved.

New machine introduction

PED refers 3 processes before introducing new machines;

Installation Qualification

Operational Qualification

Performance Qualification

Kaizen

It is a Japanese term with the meaning continuous improvement. It

followed in Terumo Penpol for improving the quality of finished product. It

is practiced in PED with participation of employees in production

department.

5.3 PRODUCTION PLANNING AND CONTROL DEPARTMENT

Production Planning and Control can be viewed as the nervous system

of the production operation. This function aims at efficient utilization of

pg. 37

VP Manufacturing

DGM MSE

Head BBF

Deputy Manager (PED)

Executive (PED) Executive (PED)

materials resources, people and facilities in any undertaking through

planning, co-ordination and controlling the production activities that

transforms the raw materials into finished products or components as a most

optimum manner. Production planning and control comprises the planning,

routing, scheduling, dispatching and follow up function in the productive

process. Terumo Penpol has a blood bag manufacturing plant at

Puliyarakonam with a capacity of 11 million. The present capacity

utilization is 10.5 billion. Terumo Penpol

has a well functioned production planning and control department.

The major function of production planning department are:

Coordination with marketing activities.

Production planning i.e. preparation of yearly, monthly, weekly

and daily production schedules.

Finalize production planning

Preparation of work order system

Revise plan when production activities cannot confirm to original

plans and when revisions in scheduled production are necessary

because or rush orders.

Keeping up-to-date records scheduled and in process.

The important production control functions are:

1. Inventory control

2. Reduction of idle time

5.4 NEW PRODUCT DEVELOPMENT DEPARTMENT

pg. 38

The future of every organization depends upon the successful launch

of new innovative products and services although new product development

is a key competitive capability for manufacturers worldwide, many

companies are unable to launch a new product on a timely basis. They have

a well functioning NPD department it is the policy of NPD division to

enhance customer satisfaction by designing, developing, and manufacturing

products meeting quality standards and making them available to customers

on schedule.

Functions

Designing and developing products meeting quality standards

Empowering personnel’s with the right knowledge, technique and

tools

Put together a working environment conducive to creativity,

efficiency and team work.

Developing business through products and services which are new

i.e. not in existence now.

pg. 39

Chief Manager

Assistant Manager

Deputy Manager

Manager

5.5 MAINTENANCE DEPARTMENT

The policy of maintenance department is to upkeep all production

machines and utility equipments by periodic maintenance and providing

utility services.

Quality Assurance Procedure

Preventive Maintenance

Breakdown Maintenance

Environmental Maintenance

Preventive Maintenance

Purpose to conduct preventive maintenance of utility equipment to

support daily production activities. Operating procedure of all the preventive

maintenance other than GMP requirement are detailed and recorded in each

department.

Planning

Preventive Maintenance is planned on the basis of the following:

Machinery manufacturer’s recommendations available with the

firm in the form of instruction manual.

Analysis of Breakdown.

pg. 40

Assistant Executives

Junior Executives

Chemists

Experience gained by maintenance staff.

Maintenance Department prepares schedule for the Preventive

Maintenance of utilities equipment for a period of one year. At the end of

one year and considering the information received from breakdown analysis,

if necessary changes are incorporated in the maintenance procedure. For

carrying out certain Breakdown and Preventive

Maintenance activities, services are sought from external agencies. Service

done to equipments are filed equipment wise.

Breakdown Maintenance 

The purpose of bring down the machine/equipment to efficient working

condition in the shortest possible time. According to information received

from various departments find out the machine/equipment on which

Breakdown Maintenance is to be carried out. All maintenance activities are

recorded in respective machine history records. Frequency of maintenance

requirement is also recorded. Breakdown Maintenance which cannot be

attended on regular working days and which are not so critical shall be

postponed to holidays.

Environmental Monitoring

Control of environment in a clean room area is essential to keep the

bio-burden at a low level, so that the microorganism can be excluded during

processing and packaging of sterile products. Sterile products is of high

quality standards and purity, must be free from microorganism, particulate

matter, etc. All components and processes involved in the preparation of this

should be clean and selected to eliminate, as far as possible, contamination

of all type. Environmental cleanliness is of primary importance to control

pg. 41

microbes and particulate matters in air. Thus conditioned monitoring of

operating environment is essential. Following procedure outline the method

to be followed for testing – filters, UV lamp efficacy, fumigation, pest

control, painting of all the manufacturing areas and factory premises.

Fig 5.3

Maintenance Department

5.6 ACCOUNTS AND FINANCE DEPARTMENT

Finance is the life blood of any business. Organizations should

understand the importance of finance as a component of the strategic

decision-making process. TERUMO PENPOL has a well functioning

finance department.

pg. 42

Executive Director

VP Manufacturing

Head BBF

Head Plant Engineering

Executive Maintenance

Executive Maintenance

Executive Maintenance

Executive Maintenance

Department policy

The policy of Finance Department is” to ensure provisions of timely

finance to various departments, without any delay and as per plan and to

exercise necessary financial controls and to maintain and record all financial

transactions of the organization accurately, systematically and to provide all

statutory reports and returns to concerned statutory agencies, and to provide

internal information reports on time to management and measuring

organization performance and for decision making.”

DUTIES AND REPONSIBILTY

Plan and manage fund flow, cash flow to cover critical expenses,

purchases and statutory obligation of the company.

Attend to all bank matters liaison with bank and financial institutions.

To scrutinize all payments and approve the same.

To collect dues to the company in time.

Compliance of internal audit report.

Preparation of balance sheet and monthly profit and loss account.

Effective financial control.

Budget preparation & Preparation of annual accounts.

Attending to income tax, central excise and sales tax.

Accounting executive general capital accounting, depreciation

statement.

Maintenance of updated capital asset register check, verify and ensure

proper and correct purchase accounting and journal accounting.

Analysis of creditors accounts to check out various unsettled

advances.

pg. 43

Functions

The various functions of finance department are:

To provide financial assistance to the various departments.

Relation with bank and financial institutions.

To collect money from debtors.

To maintain accounting records.

To comply with various statutory formalities.

To provide management information.

pg. 44

Document Preparation

Transaction

Fig 5.4Process of Accounts and Finance Department

FINANCE DEPARTMENT

pg. 45

Filing of Documents

Accuracy Checking

Document Verification

Transaction Approval

Transaction Accounting

Finance Advisor

Finance Manager

5.7 PURCHASE DEPARTMENT

An average commercial enterprise disposes of more than half of its

income on materials, supplies and services. A five percent saving in material

costs in a business organization can thus equate with an increase in turnover

of 25%. Effective purchasing is therefore the key to the overall profitability

of a business. The Purchase department in TPL coordinates all purchasing

activities. The policy of the purchase department is to provide

materials/services to the quality and the delivery as acceptable to the

requisitioned, procuring them at economical or convenient terms and to

maintain good professional business relationship with sub-contractors.

The main activities of Purchase Department include:

Purchase order execution

Receipt of materials

Bill passing and release of payment

Purchase Order

pg. 46

Deputy Finance Manager

Assistant Finance Manager

Section Officers

Based on the approval of subcontractor the purchase executive

prepares the purchase order in favor of the selected subcontractors with all

relevant purchase date. PO is prepared in six copies. The requisitioned is

expected to check his copy of the PO and if any discrepancies are observed

regarding specifications, quality, delivery dates in the order purchase

department is to be notified. PO is maintained in three series for raw

materials, consumables and capital goods. The orders are normally send by

post but to local subcontractor it may be handled over personally.

Receipt of materials

After the PO is placed the sub contractor are contacted through phone,

fax or letter to confirm the receipt order. The subcontractor dispatches the

materials are agreed. If deemed necessary remainders are end a week before

due date of dispatch. The dispatch

details are entered in material dispatch register. This is maintained for

a period of two years. To cover transit insurance, weekly statement of

dispatch is prepared and sent to insurance companies. Dispatch documents

are obtained from the subcontractors if the payment is through bank. Prior to

taking delivery the consignment are checked for any damage or loss. If any

damage or loss occurred the insurance company will immediately informed

and the insurance survey is arranged. A claim is lodged on insurance

company if there is any actual damage. Then the consignment is collected

and delivered to the stores.

Bill passing and release of packing

The particulars in the invoice are compared with that of purchase

order discrepancies, if any is noted on the reverse of the invoice then

pg. 47

concerned purchasing executive is informed comparing the invoices\bill

with the purchase order and it is ensured that the bill can be passed on the

receipt of accepted GRN. Such invoices is recorded in the Invoice Catalogue

Register and kept in pending bill file. As soon as GRN copies are received

from stores it is in warded in GRN Control Register. The information of

purchase invoices no: and bill amount is registered on the reverse of the

invoice having appropriate GRN. Endorsement for passing the bill is made

on the reverse side of the bill. Such passed bill and corresponding GRN are

forwarded to finance department as per agreement mentioned in the

purchase order the request for the payment are duly signed by purchase

executive and is

sent to finance department, to the release of payment on the due date.

After releasing the payment the finance department returns the second copy

of the request for filling in the payment details.

5.8 STORES DEPARTMENT

Sound stores management is a key to the running of every profitable

and efficient organization. The policy of the store is to store and preserve

materials in good condition by maintaining optimum level of inventory,

issue the same to the user and manage the finished goods till it is dispatched

to the customer.

Functions

Receipt and storage of materials

Issue of materials

Preservation

pg. 48

Receipt and sale of scrap

Packaging of finished goods

Issue of materials

All the sections in various departments are given separate requisition

book. Based on the requirement the requisition is made by the concerned

department. The stores assistant based on FIFO approves all the requisition.

The items kept for issue will be verified by the stores clerk and signed by the

stores in charge. After taking store copy of receipt note material is

transferred to the plant by stores assistant. Items to outsiders are given with a

material movement pass.

Dispatch of finished goods

Junior executive who intimates the marketing office regarding daily

stock position by fax generates daily stock position of finished goods from

computer. Marketing office furnishes in return the details of finished goods

to be distributed by dispatch advice note. The superior directs the head load

worker to load goods batch wise as per Performa invoice. Goods are taken to

the lorry – base by trolley and thereafter manual loading into

the truck should be done. The vehicles in which bags are loaded should be

free from dust and should be clean. Goods loaded are counter checked by

invoice. A non-returnable

material pass is prepared for the quantity to be dispatched by superior.

Materials movement pass is handed over to the security

pg. 49

Deputy Manager

Fig 5.5Stores Department

5.9 QUALITY ASSURANCE DEPARTMENT

In manufacturing, quality control or quality assurance is a set of

measures taken to ensure that defective products or services are not

produced, and that the design meets performance requirements. It includes

the regulation of the quality of raw materials, assemblies, products and

components; services related to production; and management, production,

and inspection processes.

The policy of the QAD department is to ensure quality by adopting

high standard of testing with respect to pharmaceutical standards. ISO

Department policy

standards in house specification and to develop the implement system

for imposing quality as per quality objectives of the company. The firm has

pg. 50

Supervisor

Junior Executive

Data Entry Operator

TechnicianStores Assistant Store Clerk

a well equipped QAD at the factory assuring the quality of finished goods as

well as raw materials.

Functional areas of QAD Quality control Quality assurance

Quality control: This section deals with final inspection of goods i.e.

whether the finished goods passed or failed the quality checks.

Their inward inspection includes:

Inspection of PVC pellets

Inspection of PP cover 

Inspection of blood bags labels

Their pharmaceutical inspection includes:

Inspection of water for injection

Inspection of citric acid and Inspection of adenine

Inspection of mono basic sodium phosphate

Inspection of sodium citrate

QC checks sample of raw materials and they have to approve its

quality before production. Inspection of solution is done before they are

filled into the bags.

Quality Management System

Terumo Penpol has implemented QMS considering all aspects of

personnel inputs, apt technology and machinery for various operations.

Functions such as NPD, production engineering, purchase and stores, QAD,

pg. 51

production, maintenance, HRD and marketing are smooth functioning. QMS

is applicable for any sourced operation or process that Terumo Penpol may

engage from time to time.

5.10 EXPORT DEPARTMENT

More than 65% of Terumo Penpol sales come from the export market.

Terumo’s market share comes around 20-25% of the world market Terumo

Penpol exports goods to more than 82 countries of the world.99% of the

export constitute blood bags and 1% constitutes equipments.

 

Achieve excellence in customer service by providing

Timely and accurate information

On time deliveries for all orders

Technical and promotional support

Means of export

pg. 52

Executive Director

VP Manufacturing

Head BBF

Deputy Manager QA/QC

Deputy Manager

Deputy Manager

Executive QA

Executive QC

Assistant Manager

Assistant Manager

95% of the company’s export is through Sea and the rest is

through air.

Export incentives

The practice of giving export incentives is virtually universal, and

India is no exception. Terumo Penpol enjoys a number of export incentives

such as:

DEPB (Duty Entitlement Pass Book)

EPCG (Export Promotion Capital Goods)

ADVANCE LICENSESales return

Sales return owing to quality complaint is taken as per procedure for

product recall. For sales return other than quality complaint prior approval

from Executive director is obtained.

Customer complaint handling

Complaints related to product should be communicated to quality

assurance department or export department. Complaint is forwarded to the

quality assurance department for blood bags for the study of

complaints .within 24 hours of the receipt of

complaint DM is authorized to replace defective bags free of cost to the

customers immediately on receipt of the complaint. If the complaint is of

biological nature QAD should arrange four testing of bags in house / by

external agencies if necessary. If the analysis of the quality complaint shows

that there is a batch problem. QAD should within 24 hours inform LC for the

pg. 53

product recall .Market returned products are delivered to the store fresh

stock will be supplied free of cost to the customer.

Service complaint

All the customer complaint other than product quality complaint is

termed as service complaint. All this include:

1. Short supply 2. Dispatch of wrong products 3. Non receipt of dispatch

document

4. Discrepancies in invoicing /dispatch documents 5. Damages in outer

packing over 

6. Delay in delivery

Export Department Fig 5.7

pg. 54

Executive Director

Assistant Manager (Export)

Executive ExportExecutive Export

5.11 LOGISTIC DEPARTMENT

DUTIES OF LOGISTIC COORDINATOR 

Order processing

Delivery status updating to customers.

Dispatch orders.

Exports shipmen of documentation.

Export incentives.

Verification and passing of freight bills.

Manager In logistics

Overall responsibility for sourcing of all products marketed by

Terumo Penpol.

Overall responsibility for warehousing and distribution.

Handling of service complaints.

Effecting delivery to customer on schedule.

Develop and establish genuine alternative subcontract for supply

and servicing and to evaluate them appropriately

Monitoring and implementing corrective action at depot.

Preparation and submission of tender document.

Issue of intends and convening contract review.

Updating information on sales on a daily basis.

pg. 55

Senior Executives

Updating of stocks of traded goods in the computer.

Maintaining the depots stock record.

Submitting of weekly and monthly stock statement and total

stock statement on time.

Registering purchase requisitions.

Maintaining purchase order register, bill passing register, checking

of all purchase bills and passing them arranging payments and

maintenance of 

all registers and reports concerned Collection of dates and

calculation of incentives

Preparation of tender document and arranging to send them on

time

Registering purchase orders customers and maintaining records

Preparation of statement relating to monthly marketing review

meetings

Typing of all kinds of correspondence statements and mailing them

on a daily basis.

Communication with customers/depots.

pg. 56

Fig 5.8

Logistic Department

5.12 MARKETING DEPARTMENT

The policy of marketing department is to achieve excellence in

customer service by providing timely and accurate information, on time

deliveries of all orders, technical and promotional techniques.

Major functions of marketing department

Deciding price and discount revisions as appropriate from time to

time.

Handling of the enquiries (both domestic and export) generated.

pg. 57

Executive Director

Senior Executives

Manager Logistics

Senior Executives

Senior Executives Junior Executives

Issuing of the delivery order.

Coordinating with various other departments (finished products,

finance, and quality) for the proper execution of the order received.

Collection of payment towards of the order executed.

Conducting regular customer surveys.

Domestic market is divided into six zones

South 1(Kerala, Tamil Nadu)

South 2( Andhra Pradesh, Karnataka)

East

West

North

Gujarat

Manager Marketing. The products of Terumo Penpol can be sold only

to 3000 licensed blood banks of the country. Out of these 3000 blood banks

490 blood banks do component separation. Now the company’s major focus

is on them because they use multiple bags, which is profitable to the

company. Not only that the competition for multiple bags are very less

compared to single bags

Fig 5.9 Supply Chain of TPL

pg. 58

Terumo Penpol Ltd.

Depots

Direct Customers

Distributor

Sub-Distributor

Terumo Penpol has depots in five major cities of India including

metros. The depots are located at:

Delhi Chennai Kolkata Gujarat Thiruvananthapuram

From these depots goods are transmitted to distributors and from there

to final customers. These depots may sometimes have sub depots.

Sales promotion techniques

Development follows the various sales promotion techniques such as

direct mail campaigns, website, sales persons and also market research. But

the most important techniques are medical exhibitions and conferences

Product Group Blood Bags Blood Equipments(MSG) Equipments directly import from Terumo

Main competitors

At present the main competitor of Terumo Penpol is J Mithras

Industries, Delhi. The other competitors are HLL, Polimedicure, Eastern

Medi Kit, and certain local companies of North. But the competitors are not

matches for Terumo Penpol on account of its high quality.

Market Share

pg. 59

TPL is concentrating on both International and Domestic market.

Once TPL was the leaders in Market Share, but now they are concentrating

on profitability

Fig 5.10 Marketing Department13. PERSONNEL AND ADMINISTRATION DEPARTMENT

The work force is an instrument in the organization and the personnel

manager provides and shapes that instrument. This instrument work force

consists of human beings of varying types with complex and changing needs

and values. The personnel manager assists the organization in adapting

changes in mix and values. He searches for programs that have overlapping

interest for both the employees and the organization. Production department

is functioning in an organization under an efficient personnel manager.

Functions

To meet the manpower requirement.

pg. 60

Manager Institutional

Business

GM Marketing

Regional Managers

Technical Resource Managers

Sales & Service Engineers

Area Managers

National Sales Manager

All India Service Manager

To carry out the administrative function of the factory in

asystematic manner.

Preparation of payroll document.

Salary disbursement.

Responsible for company vehicle.

Handling of inward and outward letters.

Selection of security staff.

CLASSIFICATION OF WORKMEN

Permanent: - Whose work is permanent in nature and whose

appointment is duly confirmed by the management after he has

completed his probationary period.   Probationers: - Is one who is

provisionally employed with the view to give permanent employment

by the company management

Temporary: - Temporary workmen include a person who is

employed for work which is temporary in nature and likely to be

ended with in a limited period.

Substitute: - Is a workmen who is appointed in the post of permanent

workman

or probationer who is temporarily absent on account of any reason.

Casual:-Is a person who is on a work of casual in nature, irrespective

of the length of the period of work.

Apprentice Trainee: - Is one who is engaged for any length of period

for the purpose of learning any work with or without stipend or any

allowances as maintained in the contract of appointment.

pg. 61

INDUSTRIAL RELATION

Industrial relation means the relation between any employee and

management. In Terumo Penpol a good industrial relations is maintained

through negotiations between management and group of employees,

commonly known as collective bargaining, that determine the conditions of

employment. The result of collective bargaining procedure is called

collective bargaining agreement. These agreements contain settlements

regarding wage structure, allowance; leave facility, rights and

responsibilities of employees, disciplinary procedure etc….

There have been four collective bargaining agreements in TPL. They

are from

1990 ---- 1992

1992 ---- 1995

1995 ---- 2001

2001 ---- 2006

2006 ---- 2011

There are four trade unions they are:

TP Employees Union (TPEU)

TP Employees Sang (TPES)

TP Employees Association (TPEA)

TP Employees Congress (TPEC)

TPEU was the first in the company, this was split into three unions TPES,

TPEA, TPEC.

pg. 62

PROBATION

Every workmen recruited by the management shall unless otherwise

specifically mentioned in the appointment order, be on probation for a

period which shall be 12 months initially subject to extension for a

maximum period of 12 months if demand specific for any reason which shall

be communicated in writing to the workman not less than 30 days from the

date of expiry of initial probation.

WORKING TIME

The working time will be as per the notice exhibited on the respective

notice board. The period and hours of work for all workmen for each shift

shall be exhibited on notice board. The management or the competent

authority has the right to require a workman or a group of workmen to work

extra time during any day beyond the prescribed hours of work during any

week beyond the 48 hour subject to the provision of any law and on payment

of overtime wages.

ATTENDANCE

It is the duty of every employee that he/she should attend the office

5min before the office time starts. The working time is fixed at 09.00hrs to

17.30hrs with 30minlunch break between 13.00-13.30hrs. It is the duty of

every staff to endorse there porting time and sign the attendance register at

the front office.

pg. 63

WORK SHIFT

There are two types of shifts ie, general and relay shift. As most of the

employee is ladies the general shift is from 8.30 am to 05.00pm. The relay

shifts are for gents from 6am to 2 pm, 2pm to 10pm and 10pm to 6am.

Inspections are carried from 4pm to 12

midnight. The workers are provided with transportation facilities at early

morning and night. Attendance is registered through punch card system.

WORKERS’ PARTICIPATION IN MANAGEMENT

The thought that participation of workers in management is inevitable

in the process of decision making for higher productivity in micro and macro

level and for the smooth functioning of industrial democracy has gained

much strength. It is because of the realization that labor is not only the factor

of production, but also the sensitive human element. In TPL workers

participation in management is through the following:

Works committee

Safety committee

Canteen committee

Recreation committee

Welfare fund committee

Grievance procedure

All grievances shall be handled in accordance with the procedure laid down:

The workman in person will first take up grievance with his

immediate supervisor.

pg. 64

If the workman is not satisfied with decision of the immediate

supervisor or fails to receive an answer from him within 7 days, he

will take the grievance to the next immediate superior officer.

If the decision of the officer is not satisfactory the workman will

present his grievance to the department head in writing in the

grievance note duly signed by the worker.

If the decision of the head of the department is not satisfactory the

workman will present a copy of the grievance to the head of the

personnel department.

The head of the personnel department or any person

authorized by him or by the management will take the final decision and

inform the in written format. Any representation regarding a grievance

which does not comply with the provision of these rules shall not be

considered.

Welfare facilities

The workers are granted with all statutory welfare facilities as per Factories

Act1948, Drugs Act and ESI. There is a highly subsidized canteen which

gives 75%subsidy for the workers. Festival allowances provided to workers

during festivals.

Canteen Facility

A fully-fledged canteen is functioning within the factory premises.

External team on contract basis undertakes the canteen. The contract is

usually for one year, which is decided on the basis of quotation, which is

fixed by management. Building, furniture, utilities, water, gas, etc are

pg. 65

provided by the organization. The payment is made as two sections,

payment of 1stto 15thon 20thof current month and payment of 16thto 30thon

10th of next month. Other allowances like P.F, E.S.I, V.R.S, etc are

also provided to the team. Employees are provided coupons, which are

available atRs.2.50, Rs.40 and Rs.50. The coupons are provided on

Mondays, Tuesdays and Saturdays unto 25th of each month. An employee’s

price menu is fixed and displayed in canteen. Employer’s contribution is

3/4thand employee’s contribution is 1/4th.

A canteen committee is functioning at Terumo Penpol, which

constitutes 4trade union representatives, 2 management representatives and

representatives of Personnel and Administrative Department. Committee

checks the functioning of the canteen, employee satisfaction, etc. A

complaint register is maintained at the canteen, for employee’s to register

complaints. The canteen committee does monthly review of complaint

register.

Healthy measures inside the factory

The company provides certain dress codes to worker in which they are

covered from head to toe except eyes. The dress is usually blue in color and

consists of pajamas, jubbahs, masks, Glovers, and rubber slippers. The

quality of personnel and administration department enhances the reputation

of the organization so far as its external stakeholders are concerned. Terumo

Penpol has a well managed personnel and administration department.

pg. 66

VP Manufacturing

Executive Director

Head BBF

Fig 5.11 Personnel and Administration Department

5.14HUMAN RESOURCE DEVELOPMENT DEPARTMENT

Organizations have proclaimed their human resources to be their

"most valued asset”. Human capital is a critical factor in promoting

competitiveness as it provides the required knowledge, skills and capabilities

for developing competitive strategies. The role of the human resource

function is to deliver the human competencies i.e. the internal capability

required to achieve the organization’s objectives. TERUMO PENPOL has a

well functioning HRD department. The main function of HRD department is

hiring, induction, training and performance appraisal in resonance with the

quality policy and organizational goals.

DUTIES AND RESPONSIBILITIES

Head of the Department

Recruitment of executives/managerial categories as authorized by

the management.

Administration of performance appraisal awarding increments,

performance rewards, promotion and grievance redresses of

employees.

pg. 67

Personal Manager

Deputy Manager Personal Officer

Planning, organizing and conducting training as per the training

plan and policy.

Initiating organizational development activities to bring the

manpower in line with the management vision.

Executive HRD

Responsible for generating all the MIS reports

Preparation of appointment orders and other office orders.

Coordinating with placement consultant and other internal and

external customers of HRD department as and when needed.

Assisting HOD (HRD) in day to day functions.

pg. 68

Fig 5.12Source: Department Journal

 The major functions of HRD departments are:

Recruitment, Training, Performance appraisal

RECRUITMENT

Recruitment means searching for and obtaining potential candidates

insufficient numbers and quality so that the organization can select the most

appropriate people to fill its job needs. The two main aims of recruitment are

the attraction and retention of the interest of suitable applicants, and the

projection of a positive image of organization to those who comes to contact

with it.

Purpose 

To ensure that the organization has adequate competencies in all

functional areas to meet its objective and goals. The sources of

recruitment are:

Notification press or advertisement

Campus interviews

pg. 69

Natural transfer and promotion

Reference by consultancy or professional bodies  Employee referrals

Procedure

Recruitment is one of the most important activities of HRD.

Recruiting the right person for the right job ensures better productivity and

lesser hassles. Recruitment will be done on the basis of manpower budget.

Manpower budget for a financial year will be prepared by HOD (HRD) at

the time of preparation of business plan of the organization.

HOD (HRD) will consult the divisional head and the budget

and planning department for preparation of manpower budget. HOD should

forward the number of requisitions and initiate the process of recruitment if

the position is budgeted. If it is not special approval from the management

should be obtained. Recruitment will be done through internal database,

recruitment agencies, campus recruitment, advertisement etc. Selection

process involves written test, group discussion and interview. After short

listing the candidates, an interview panel will be determined and they will

conduct the interview. Interview panel contain s subject expert, department

head, HR representative

and divisional head. HRD dept will send the interview details along with

names, proposed salary and responsibility to the MD through ED for the

comments or approvals. The appointment order will be prepared and issued

based on this. On resignation an exit interview is conducted by the HOD

(HRD).

TRAINING

pg. 70

  Training is very important for learning and development. HR

department should plan, organize and conducting training programs as per

the training plan, policy and needs.

Purposes

Identify the training needs.

Upgrade knowledge and skills.

Build up a line of competent confident people and to prepare them for more

responsible jobs.

Procedure

Training is done based on the identified training needs by the

reporting officer and by the associates. Training is done through

administering psychometric tests. Training calendar is prepared on the basis

of the identified training needs and cultural needs of the organization. The

training calendar depicts the training plan for the year. Based on this a

monthly calendar is prepared. Mainly there are two types of training:

Internal Training External Training

Internal Training

Induction training is an internal training. It is given to newly appointed

employees. In this training they provide details regarding company products,

market, and demand trends, marketing strategies, quality policies,

administrative policies and rules etc. Internal training is given to executives

on periodically. The main methodologies used are case studies brain

storming, debates group discussions, lectures and illustrations etc.

External Training

pg. 71

It includes overseas training and training conducted by training institutes.

Overseas training is a part of company’s business. Duration of training can

be from one week to one year. Good manufacturing practice training is

imparted to all the employees once in every six month recruited for

manufacturing activities. During these training personnel

will be made avail of general GMP requirements observed in

the pharmaceutical industry. Training imparted covers the requirements,

personal hygiene and behaviors, entry procedures after training a feed back

is collected. It gives an idea about the program, faculty, and the way the

program conducted. Training officer maintains training history card. Once

the training program is over, after one month the concerned reporting officer

of each program will provide a feedback to HRD dept. concerning his

assessment about individual improvement of performance after attaining the

training program.

ProbationAppointed workmen, unless specified in the order will be on

probation for a period of 12 months. The duration can be extended if seemed

necessary, but to be communicated to the workmen in writing not later than

30 days from the expiry of initial probation. No payment of compensation on

account of such termination is necessary. When a permanent workman is

promoted to another post he will be on probation of a minimum of 12 month

with a possible extension of 6 months which will be communicated to the

concerned person within 30 days of expiry of the initial probation.

pg. 72

Promotion

It is management’s discretion to decide as to a vacancy should be

filled in by promotion or by fresh outside recruitment. If promotion is

decided, the criteria for promotion will be suitably for the post, efficiency,

skill conduct, seniority etc... Of the workman in the lower post.

Record of service

The management maintains a record of each workman. Separate

records are maintained for permanent and temporary workman, staff and

executives. The company maintains the record of service will workman is

terminated or leaves the job.

Transfers

Every workman is liable to be transferred from one post to another,

from one branch to another, or from one place to another place, etc.

Workman may also be transferred to other subsidiary establishment of the

company whether at present existing or that may be established in future.

Resignation

Subject to the terms and conditions in the order of appointment,

workmen may resign his job, but the resignation can come into effect only

on accepting the same by the management or company without prior notice

given in writing to the competent authority.

pg. 73

Retrenchment

The management under such a situation issues a notice of

retrenchment to the workman on prescribed time before the actual process.

This process is however not practically possible due to clauses in the

industries that safeguard a workman’s labor. Also the political scenario here

is not flexible enough to stern actions against the labor community.

Termination of employees

A workman may be discharged of terminated from work at anytime

by the management if he is found physically or mentally unfit for the job he

is engaged in.

Dealing with cases of misconduct

Written charge sheet issued to worker as well as put on notice

board

A chance is given to each worker to explain his part.

If the worker has no explanation within the stipulated time the

management proceeds with the course of action.

If the worker has explanation, it is submitted and seen if it is

satisfactory

If not satisfactory, action is taken.

It is satisfactory, the punishment is withdrawn.

Management may entrust an enquiry committee for the same.

Then the committee is liable to furnish an enquiry report having

the proof of incidents under concern.

The management takes action according to the findings in the

enquiry report.

pg. 74

PERFORMANCE APPRAISAL

Purpose 

To know the performance level of each person to the required level.

This help to reward or to take corrective measures.

Procedure 

Performance appraisal is done for all executives and managers.

Assessing the performance of associates is very important for the associates

and reporting officers to know where he stands in performance. A midyear

review will be done in the month of September and final assessment will be

done in the month of March. Performance of trainee and probationers will be

assessed once in every six month. All the associates will be assessed

annually. The decision related to training, rewards, promotion etc will be

decided based on this assessment. For this process key result area will be

fixed for every executive. Competencies or potential of associate also will be

measured during end year assessment. The rating of associates should be

based on guidelines. Based on the marks there are four types of rating such

as outstanding, very good, good and below average.

Exit Management

When an employee decided to exit, detailed exit interview is

conducted by HRD and recorded in a form. Exit interview is conducted

mainly for analyzing the reasons of resignations and issues regarding salary.

This helps the employer to improve the working conditions

pg. 75

Fig 5.13Human Resource Development Department

5.15 CORPORATE SOCIAL RESPOSIBILITY PRACTICE

TERUMO PENPOL Limited business units have Environment,

Health, Safety and People policies that are appropriate to their

operations.TPL serves the community by complementing the growth &

success of business with contribution towards the social, environmental and

financial aspects of the society. At TPL, CSR is targeted for-Feel good

factor for Employees, customer satisfaction, brand visibility, recognition and

awareness and environmental sustainability.

Statutory compliance is also fulfilled. It includes-Employees State

Insurance, Provident Fund, Gratuity Scheme, Round a clock canteen with

75-percentage subsidy, etc. Safety is a high priority for the Company.

Electrical Safety audit, Weekly internal safety audit, Mock Drills, Safety

pg. 76

MD

Assistant Manager HR

Executive HR Executive Payroll

training programs and installation of Safety equipment were some of the

actions taken. In addition to this TPL also provides social services to

employees, pollution control measures, environmental protection measures,

customer welfare programmes, etc

Events organized by TPL for a cause-

World Health Day - 7thApril

World Blood Donors Day - 14thJune

National Blood Donation Day - 1stOctober 

World AIDS Day - 1stDecember

5.16 MEDICAL SYSTEMS GROUP (MSG)

Medical Systems Group is a manufacturing unit of Terumo

Penpol.Marketing department interacts with MSG to assert the capability of

meeting specification of customer requirements and the delivery schedule

prior to acceptance of an order along with regulatory requirements.

Department policy

It is the policy of MSG of Terumo Penpol Ltd to enhance

customer satisfaction by designing, developing and manufacturing products

meeting quality standards (in- house) and making them available to

pg. 77

MD

PR & CSR Manager

Department Manager

customers on schedule. They supply the products to the hospitals and blood

banks. Penpol is India’s largest manufacturer of Blood Bags. The products

of MSG are commonly known by the brand name “Compo Safe TM”.

Penpol offers comprehensive range of equipments intended to make

operations at the Blood Bag, blood transfusion activities safer and more

effective. The “Compo Safe TM” range of products includes equipments

for collection and storage of blood and a software package for blood bank

management.

MSG manufactures three types of devices:

Collection devices-donor couch, blood collection monitor, tube

sealer etc 

Processing devices –plasma separator, centrifuge etc

Storage device-refrigerator, defreeze, platelet agitator, incubator

etc

MSG consists of the following functional areas:

Production

Quality control

Purchase

Store control

MSG quality objectives

Designing and manufacturing of products meeting quality

standards.

Empower personnel with right knowledge, technical tools.

pg. 78

Put together a working environment conducive to creativity,

innovation and team effort.

Fig 15 Medical Systems Group

6.1SWOT ANALYSIS

A scan of the internal and external environment is an important part of

the strategic planning process. Environmental factors internal to the firm

usually can be classified as Strength or Weakness and those external to the

firm can be classified as Opportunities or Threats. Such an analysis of the

strategic environment is referred to as a SWOT Analysis. The Overall

evaluation of company’s strength, weakness, opportunities and threats is

called as SWOT analysis. It can do so by using a form which is called

marketing memo or an outside consultant can be hired. but it is always better

that then companies do their own SWOT analysis and accept their weakness

pg. 79

DGM Operations

VP Manufacturing

Accounts & Administratio

n

Purchase Departme

nt

Development

Production Department

QA Stores

and threats and review the marketing, financial, and organizational

competencies and rates each factor as a single strength, minor strength,

neutral factor ,minor weakness and major weakness.

Clearly, the business does not have to correct all its weakness nor

should it focus about its strengths. The big question is whether the business

should limits itself to those where it posses the required strength or should it

explore better opportunities might have to acquire or develop certain

strengths.

Sometimes a business does poorly not because its departments lack

the required strength but because they do not work together as a team. Every

year the company asks each department to rate its own weakness and those

of other department with which it interacts. Once each department’s

weakness are identified, work can be undertaken to correct them.

Strengths

1. Stable managementTPL has a well- mannered team of highly

qualified, experienced and dedicated management professionals.

Almost all of the managers possess an industrial experience of over 10

years. All the top level executives are serving the company for more

than ten years.

2. Sound financial position

Since inception, the firm enjoys a sound financial capability as it

enjoys an association with the MNC Terumo co-operation. All financial

pg. 80

matters are handled by a team of highly qualified and experienced

professionals. 

3. Product quality and standard with Terumo Penpol brand image

TPL’s products have high quality and standard because they came

across highly sophisticated quality checks. TPL always ensures quality to

its products in all stages.TPL has got ISO Certifications and CE

("Conformity European) marking.

4. Maximum range of products – product mix

TPL is mainly dealing with blood bags and its variants like single,

double, triple, quadruple and Penta bags and its systems. 

5. Good sales network of branch

TPL has a well equipped sales network covering both domestic and

international market. The department concerned is handled by a team

of professionally qualified, experienced and competent workforce.

6. Higher number of installations with strong customer base

TPL’s products enjoy a strong customer loyalty than the others. They

manufacturer’s products as per the customer’s need.

7. Very good after sales service with own service networks

TPL provides an appreciable after sales services to their customers

with the assistance of highly skilled technicians.TPL ensures effective

handling customer queries after sales. 

8. Experienced financial services and strong customer relations

pg. 81

The firm is equipped with eminent and experienced financial

services professionals and the firm maintains strong relations with their

customers.

Weakness

1.High prices of blood bags compared to indigenous product and certain

imported brands 

The prices of TPL’s products are comparatively more when compared

to the other market players. The other companies provide the same product

for fewer prices with warranties and offers.

2. Lack of complete product range – refrigerated centrifuge and cell

separator

TPL’s main product is blood bag and it lags some of the allied

products in the range. At this time the competing firms possess them.

3. Organized lobby by foreign companies

The market witnesses an organized effort from the part of certain

forces to capture market share for the foreign companies. These sort of

activities affects TPL’s product performance.

4. Servicing difficulties of blood bank equipment

The equipment used in this industry are highly sophisticated, it faces

servicing difficulties because of its complexity.

5. Servicing delays and additional cost in closing complaints

Servicing is a complex activity it is not an easy task and it requires

more time, effort and money to close them all. Some times the cost incurred

for complaint handling may be heavy.

Opportunities

pg. 82

1. High demand for products in domestic and international market

The product enjoys a high rate of demand both in domestic and

international market. This is a great opportunity for TPL because they rely

on delivering high quality and standardized product to the customers.

2. up gradation of blood banks

The blood bank services are to be upgraded to stay tuned with the

environment changes.

3. New blood bank projects

New blood bank projects are to be initialized to get more acquaintance

with the industry.

4. Value added features in blood bags

The products must be provided with value added features.

5. Large unexplored territory – blood bank equipments

This industry is now witnessing changes in connection with blood

bank equipments it throws a great opportunity to use.

Threats

1. Quality complaints of blood bags

Sometimes it may happen due to carelessness from the part of

employees.

2. Competition from Indian companies

Competition from the part of domestic firms like HLL is a real threat.

3. Free equipment as package along with projects by major competitors

TPL’s major competitors provide free equipments along with the

product this may affect the firm’s performance.

4. Centralized purchase plan by NACO for blood bags and blood banks

pg. 83

The centralized purchase plan by NACO for blood bags and

blood banks may reduce TPL's sales because of the price difference between

competitors.

7.1 FINDING

1. Terumo Penpol is the India’s largest manufacturer of Blood Bags and

its part of the Terumo Corporation.

2. They offer customers a wide range of Blood Bags and Blood Bag

Equipments and also products to meet specific requirements.

3. The company has a sound financial position and a stable management.

4. The product quality and standard is in line with Terumo Penpol brand

image.

5. The company believes in innovation, and produces a wide range of

products.

6. The products of Terumo Penpol have high demand in domestic and

international market.

7. The company has good sales network of branch and higher number

of installations with strong customer base.

8. It maintains very good after sales service with own service networks.

9. Terumo Penpol enjoys experienced financial services and strong

customer relations.

10.The company has a lack of complete product range – refrigerated

centrifuge and cell separator.

11.Terumo Penpol blood bags are highly priced compared to indigenous

product and certain imported brands.12.There is servicing difficulties

of blood bank equipments because the unavailability of Technicians.

pg. 84

12.The company faces servicing delays and additional cost in closing

complaints.

13.TPL serves the community by complementing the growth & success

of business with contribution towards the social, environmental and

financial aspects of the society.

14.14. TPL serves the community by complementing the growth &

success of business with contribution towards the social,

environmental and financial aspects of the society.

SUGGESTIONS

1. Measures like adoption of new technology, which reduces the cost

of prodction, can in turn reduce the price of product.

2. Improvised services to blood bank equipments can reduce the

exporting difficulties for the same.

3. Proper implementation of company’s quality policy may help to

reduce complaints based on quality of products.

4. Counter offers to that of competitors and reduced price may help to

with stand the competition in the domestic as well as international

markets

5. Timely servicing and smooth handling of customer complaints can

reduce additional cost in closing complaints.

6. Innovative and value added features in the products might contribute

to an increase in the existing potential market.

7. The appointment of technicians will reduce the servicing difficult

pg. 85

CONCLUSION

Terumo Penpol is the India’s largest manufacturer of Blood Bags and

its part of the Terumo Corporation a Japan Company having its presence

over 150countries. The company is one of the largest producers of blood

bags in Asia, other than Japan with a capacity of 13 million Blood Bags.

Terumo Penpol Ltd (TPL) has opened its new factory premises on 28 th May

2008 and this will enable the company to double its production capacity

from the existing 13 million. A significant portion of this output is exported.

The company’s strategy for growth envisages further expansion of capacity,

modernization of processes, adherence to strict quality assurance protocols

and a drive to boost efficiency in manufacturing. TPL has successfully

launched a whole range of medical electronic products for use in blood

transfusion centers and blood banks designed to significantly enhance safety,

quality and efficiency of blood transfusion

BIBLIOGRAPHY

BOOKS

1. Aswathappa K. 1999, Human Resource & Personnel Management,

Newdelhi,

Tata McGraw – Hill

Publishing Co. Ltd.

2. Kothari C.R. 2004, Research Methodology Methods & Techniques,

Newdelhi, 

pg. 86

New Age International

Publishers.

3. Kotler Philip 2002, Marketing Management, Newdelhi,

Prentice – Hall of

India Pvt. Ltd.,

WEBSITES

www.terumopenpol.com

www.terumo.com

www.wikipedia.com

MANUALS

Annual reports, Department Manuals

pg. 87