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CHAPTER 1 INTRODUCTION 1

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CHAPTER 1INTRODUCTION

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OBJECTIVES:

• To observe the practices adopted in each department.

• To understand the management activities performed in each department.

• To perceive the insight opportunities of the inter relations between each department.

1. INTRODUCTION

1.1 COMPANY PROFILE:

Malladi Drugs and Pharmaceuticals Ltd is one of India’s most tradition conscious and ethically

sound Pharmaceutical company. Malladi Drugs was founded in 1980 by late Mr. M L N Sastry, a

pioneering microbiologist with expertise in fermentation technology.

Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the cough and

cold segment along with a dominant presence in other therapeutic segments like Anti-histamines,

Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global pharmaceutical industry.

1.2 MALLADI ACHIEVEMENTS:

• The first company in India to manufacture Ephiderine and Pseudophedrine salts through a

fully indigenous process.

• The first Indian company to acquire an API manufacturing facility out of India – Novus

Fine Chemicals in New Jersey, USA.

• Malladi markets their products in over 60 Countries and are supported by highly

motivated and talented partners.

At the heart of this pharmaceutical company there is desire to heal and contribute to the wellness

of mankind. We are constantly innovating; Providing Value added services and always ensure

that we have excellent relationships with everyone which encompasses our businesses and

beyond.

1.3 MANUFACTURING FACILITIES:

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Malladi has six manufacturing units in India and one in the USA. Malladi is the only facility in

the United States of America for manufacturing Pseudoephedrine HCl.

S.No Units/Branches Location1. Corporate Office Chennai2. R&D Poonamallee, Chennai3. Unit-1 Ranipet4. Unit-2 Ranipet5. Unit-3 Ranipet6. Unit-4 Ranipet7. Unit-5 Tirupati8. Unit-6 Hyderabad9. Specialty Chemicals Tiruvallur10. Tantech Agro Ltd Cuddalore11. Novus Fine

Chemicals

United States

TABLE 1.1

Malladi manufacturing units, which are ISO 9001:2000, cGMP compliant, audited by the

USFDA, EDQM, TGA and other big Pharma Majors; establish a benchmark for other

manufacturing units in the Industry.

Malladi has validation capabilities across the Product Development Cycle and facilitate quick

and efficient DMF compilation with dedicated QA and QC teams for identified projects. Malladi

ensures that the manufacturing units are completely safe for the environment as well as our

workers. Our units have Zero effluent discharge and an impeccable safety record.

Malladi undertakes Contract Manufacturing and Custom Synthesis API's, Advanced

Intermediates and Clinical supplies. Malladi reaction conditions range from -70C to +230C.

Malladi also have expertise in Fermentation-based products and can also offer the customers

exclusive project working relationships and utmost confidentiality and protection of IPR.

1.4 NOVUS FINE CHEMICALS:

Not content with resting on its laurels, Malladi decided to spread their business further and better

serve the customers in the west. In 2005, Malaldi became the first Indian company to acquire an

API manufacturing facility outside India , namely, Novus Fine Chemicals in Carlstadt , New

Jersey , a US FDA manufacturing facility.

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Novus was just the right platform that Malladi needed to bridge the gap between the customer’s

requirements and the production capabilities. With Novus, Malladi adopted a unique

Nearshore/Offshore model with USFDA approved API manufacturing facilities in both the India

and USA . Intermediates produced at manufacturing facilities in India are finished at Novus.

Thus Malladi are able to offer US customers, products manufactured in USA at the cost

competitiveness of an Indian Supplier. This arrangement has also helped Malladi cope with the

growing international demand for the products with improved service and better relationships.

Novus has a total manufacturing area of 70,000 square feet and over 50,000 gallons of reaction

capacity in Stainless Steel, Glass and Hastelloy contact surfaces . It also has a pilot plant to scale-

up processes from lab-scale to 500 gallon scale reactor trains. Novus offers total adaptability in

production through flexible manufacturing facilities for development, scale-up and commercial

manufacture of New Chemical Entities (NCEs), mature Active Pharmaceutical Ingredients (API)

and advanced chemical intermediates in a cGMP environment.

1.5 RESEARCH AND DEVELOPMENT:

Research and Development has played a big role in Malladi's success. Our R&D centre has been

recognised by Anna University , a 150-year-old premier institution in Chennai as a center for

doctoral research. The Department of Science and Technology, Government of India has also

recognized Malladi's R&D efforts.

MALLADI has developed an indigenous process for the manufacture of Ephedrine HCl. We also

have global patents on New Chemical Entities and have made great strides.

Non-infringing processes, Synthesis of API's, Complex Advanced Intermediates and

Biosynthesis of APIs, Intermediates and Performance Chemicals. Our research team is staffed

with Scientists and Doctors in Organic Chemistry, Analytical Chemistry, Pharmacology,

Microbiology and Biotechnology.

API- any substance or mixture of substance intended to be used in the manufacture of a drug

(medicinal) product and that, when used in the production of a drug becomes an active ingredient

of the drug product. Such substances are intended to furnish pharmacological activity or other

direct effect in the diagnosis, cure , mitigation, treatment or prevention of disease or to affect the

structure and function of the body.

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1.6 AREA OF FOCUS:

Synthetic Organic Chemistry Reaction capabilities:

Acylation Iodination BrominationBenzoylation Friedel-Crafts AlkylationNitration Diborane Reductions Grignard ReactionEsterification Mannich Reaction Walden InversionTosylation Methylation N-AlkylationBOC Compounds Uracil Derivatives Boronic acid derivatives

TABLE 1.2

1.7 BIOTECHNOLOGY:

• Fermentation

• Biocatalysts

• Enzyme Technology

• Have in-house capabilities from strain screening to Pre-clinical studies for bio-

pharmaceuticals

• Competencies include Bio-analytical Service, Media and Yield Optimization, Process

Scale-up and Fermentation Bio-Process Development

1.8 ANALYTICAL CHEMISTRY:

• Extensive Support to the Synthetic Organic Chemistry and Biotechnology Department

• Evaluates the quality and develops analytical methods for all the products and

intermediates synthesized

• Method development and validations

• Impurity Profiling, Spectral Studies, Stress Testing and Stability Studies

1.9 ACHIEVEMENTS:

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• Received the prestigious Acharya P C Ray Award for indigenous technology

development for the indigenous process Malladi developed to manufacture Ephedrine.

• 6 Successful FDA inspections in 5 years.

• cGMP Compliance as per USDFA, TGA guidelines.

• Certificates of Suitability (COS) from EDQM 8 DMF’s filed with the USDFA.

• International Patent for a NCE.

• Honoured with the Chemexil Award for Exports, for 5 consecutive years.

• Safety Award instituted by the Government of Tamil Nadu.

• Recognition by the Dept. of Science & Industrial Research Ministry of Science and

Technology Govt. of India in the form of the National Award for R&D efforts in industry.

• Indian Drug Manufacturers Association Quality Excellence Award.

1.10 QUALITY POLICY:

The organization is committed to providing Active Pharmaceutical Ingredient and

intermediaries to meet customer needs and expectations and enhance customer satisfaction.

The organization shall achieve this implementing good manufacturing practices,

objectives and conforming to applicable regulatory requirements and continuously improve the

effectiveness of our Quality Management Systems.

1.11 ORGANISATIONAL OBJECTIVES:

• Meeting customer needs and expectations through procurement responsiveness of

customer demands.

• Complying with regulatory requirements through adoption of stringent control and

monitoring measures in the process.

• Attaining maximum yield and reducing waste through dynamic and continual process

improvements.

• Achieve organization goals by enhancing relevant knowledge base of the people through

training.

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1.12 COMPETITORS:

1) MLN Biotech at Mahad, Maharastra

2) KREBS, Hyderabad.

3) AVON Organics at Sholapur, Maharastra.

1.13 FOREIGN RELATIONS:

The product produced from the organization is an ingredient for bronchial and cough oriented

problems. About 80% of the product are exported to foreign countries like Japan, Mexico ,

Pakistan , Srilanka , U.S.A etc. Demand is more during winter and less during summer.

1.14 CORPORATE SOCIAL RESPONSIBILITY:

It is a part and parcel of any organization to be socially responsible for the welfare of the public.

MALLADI is one among them to incorporate CSR and they are:

1) EMERALD Park constructed and maintained by MALLADI at Emerald Nagar in

Ranipet, Vellore.

2) Donated Rs.3 lac to chettithangal village through TWAD for water supply to the

surrounding villages.

3) Donated centralized washing unit for primary health centre at Lalapet, Manavaram.

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CHAPTER 2STRUCTURE OF MALLADI

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2.1 ORGANISATION STRUCTURE:

FIGURE 2.1

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2.2 ORGANISATION CHART:

FIGURE 2.2

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2.3 PLANT LAYOUT

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2.4 PROCESS LAYOUT:

FIGURE 2.4

2.5 PRODUCT LAYOUT:

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CHAPTER 3VARIOUS DEPARTMENTS IN MALLADI

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3.1 SYSTEM DEPARTMENT:

In MALLADI, ERP is being used. Here three department are centralized through ERP. Main

server and recovery centre is placed at UNIT 1, RANIPET. BSNL broad band is used for

connecting MALLADI. The departments centralized through ERP are:

• Production

• Stores

• Finance

3.2 STORES DEPARTMENT:

Organization Structure of stores department:

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FIGURE 3.1

Stores department is responsible for purchase of raw material, spare parts, packaging materials,

labels, office requirements, warehouse, transportation, and planning. Stores department divided

the raw material into two categories for their purchase schedule

• Major Raw Material

Molasses, Toluene, methanol, benzaldehyde are the major raw materials which can be

purchased with help of annual schedule. This is annual schedule based on the forecasting

of previous year or month.

• Minor Raw Material

Spare parts, Packaging materials, Labels and office stationeries are the minor raw

materials which can be purchased as per the requirement on weekly or monthly basis.

Purchase request is send from head of respective department to commercial department

Raw Materials Used In MALLADI:

1) Molasses

2) Benzaldehyde

3) Toluene

4) Mono methyl Amine

5) Caustic Soda

6) Hydrochloric acid

7) Methanol

8) Acetone

9) Activated Carbon

10) Hydrogen Gas

11) Ethyl Acetate

12) Isopropyl Alcohol

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13) Hyflow supercell

14) Raney Nickel Catalyst

15) Mono Ethanol Amine

16) Para toluene sulphonic acid

17) 10% Palladium on Carbon

3.2.1 PROCESS INVOLVED IN PURCHASING:

The organization requires raw materials from vendors to manufacture the ingredients and

thus it ensures the raw material obtained is of good quality for the supplier to be in the market in

the long run.

For new vendors questionnaire is set based on the turn over and their number of years in

the market and their rapport with other industries is monitored. The new vendors after filling the

questionnaires, sends three set of samples for testing with analytical report and submitted to

quality assurance department. The three sets of samples are tested and if the standards are met

then the organization approves the vendor and now the vendor becomes the approved vendor.

Moreover the approved vendor’s 5 suppliers are monitored. Approved vendor list is sent to

purchase department and procurement of raw materials is ordered.

3.2.2 ORDERING OF RAW MATERIALS:

Purchase department sends quotation to approved vendors and details of the raw materials

including the quality and quantity is mentioned. Order is placed based on the price, supply and

accessibility.

3.2.3 TRANSPORTATION:

After ordering of raw materials the next basic step is to transport them from the vendor to the

organization. Trucks are used for transportation. Since raw materials like molasses and methanol

are statutory, they are government bonded and thus require permission from the government to

transport since misuse of these two materials can lead to disaster. For instance, use of methanol if

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added with contaminants can be used as a cheap alcohol drinks which leads to blindness,

immediate death and loss of lives. This has happened earlier and therefore the government of

Tamil Nadu has rules and regulations while transporting them. It is mandatory for the truck

drivers to hold ML4 and ML6 license with them, since it is considered as an acknowledgement

from the government. Purchase, transportation, storage of raw materials are the three stages

involved and individual licenses for the three stages are mandatory. When the truck enters the

Tamilnadu check post, the Inspector of Police is provided with an authentication letter to escort

the raw materials to the company for delivery. While unloading the raw materials from the truck,

the District Revenue Officer verifies the bill number, receipt number, the material content and

gives the consent for further processing.

Check list for the truck when it enters the company

1) Approved vendor

2) Weight is checked

3) Muffler is fitted with spark arrester

4) Combustible items are seized from driver

5) Bill number, Receipt number is verified and checked

3.2.4 WAREHOUSE:

The company has a warehouse to store the raw materials and finished goods. There is

underground warehouse for the storage of solvents which are maintained at a temperature of -23

degree Celsius. For raw materials like molasses it’s a seasonable product and is ordered earlier

and requires ageing. Material ageing is necessary for raw materials like molasses.

3.2.5 PACKAGING:

Packaging is an important factor for any organization because the finished product delivered to

the end user should be safe and attractive. Packaging is divided into two

• Primary

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Primary packing involves polythene bag in which the ingredient is present and based on

the customer’s requirements it is packed in various sizes. There is 25 kg, 50 kg capacity

polythene bags. The polythene bag is tied with pilfer which does not allow air, moisture

and has to be cut open for unpacking. Aluminum foil in form of bags are used to maintain

temperature.

• Secondary

Secondary packing involves the final packing of the primary packed content. Usually

drums are used and based on customer’s requirements various sizes of drums are used.

Dimensions of 14*19 for 5 bed drum, 16*30 and 28*50 for 50 kg drum. Inner labels and

outer labels are pasted for proof seal, box strapping is done. Tech lock sealing is an anti

theft device which is done at the end. The central government embeds a excise seal on the

drum for shipping to other countries. To accommodate more than one drum, a wooden

pallet or fumication pallet is used which can hold six drums and a polythene wrapper is

used to envelope around it. This is done to be lifted easily by the JCP.

3.2.6 PRINTING:

Printing is an essential and significant part of any organization. This function of printing is

almost inevitable in the various departments of the organization. In Malladi it is incorporated

almost in all departments and its utility is of most importance beyond any doubts and questions.

A label distinguishes the different components and makes it easier for the end user to identify the

component. Labels contain the name, code number, color, date of packing, method of packing

and hazards identification. The printing is outsourced to reputed and approved offset printers.

Intimation for printing is given if labels are out of stock. The labels are verified with master

labels and if found faulty it is rejected.

3.2.7 PLANNING:

Planning in a stores department is essential since forecasting the demand for raw materials in a

production company makes it to run for longer time and if proper planning is not implemented

then the production is shut down. Inventory control is maintained by proper planning and

forecasting. There are five levels of inventory and they are

a) Maximum stock

b) Re-order level

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c) Minimum stock

d) Critical stock

e) Dead stock

3.3 FINANCE DEPARTMENT:

Organization structure of finance department:

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FIGURE 3.2

3.3.1 The functions performed in the accounts department:

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a. Vendor Payment:

• Firstly, enter the advance amount in SAP and obtain the Goods Receipt Note (GRN)

from stores and Goods Inspection Note (GIN) from Quality.

• The balance payment can be made direct or through Bill of Exchange (B/E). In case

of B/E, it can either be discounted with the bankers, with a commission of maximum

11.5% or with the company itself (MALLADI Discount) at a rate of 14%.

b. Fixed Asset:

• A request is first obtained from the department seeking the asset in the prescribed

format . Next check for the approved budget and get the approval from the CFO and

MD.

• The Purchase Order (PO) is raised by the purchase department, and the asset is

capitalized under the respective heads.

• The Fixed asset register is updated thereon and the amount of depreciation is

calculated.

c. Mis – Daily Bank Balance and Reconciliation:

• The daily bank balance is generated through SAP and the same is verified with the

company’s cash register.

• This includes all the cash transactions throughout India because all receipts and

payments are directed to the head office.

• This report will be sent to the CFO at Chennai through the manager on a daily basis.

d. Action on Delivery Orders:

• After receiving the delivery orders from the commercial department, the

financiers of the customers will be contacted and the invoices will be sent

to them.

• After delivery of products, the follow-up of the payments need to be made

as per the terms

agreed upon.

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• When the payments are received, entry for the same will be passed and the

deal will

be closed.

e. Follow-up of Collections:

• The ageing schedule of SAP shows the details of payments overdue, at

various stages and using different signs.

• Accordingly reminders will be prepared and sent to the respective

branches and the customers.

• If payment is due more than 90 days, the customer account will be blocked

and further transactions to him will barred.

f. Service Tax:

• The service tax due and payable for the different branches are extracted and the

payments for the same are arranged, after the approval of CFO.

• The service tax returns are prepared and filed on a half yearly basis.

g. Cash:

• The receipts of cash are through cash withdrawal from bank, scrap sales and service

income.

• The physical cash is tallied with the SAP on a daily basis and reported to the deputy

manager.

• Payment advice and collection of bills are done for the following:

Travel/Tour Advance

Mobile charges Reimbursement

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Conveyance

Medical Claim.

h. Travel:

• Approval of the travel through the Travel Authorisation Form (TAF)*.

• The tickets and the advances are paid against the TAF no.

• After the tour is completed, a Travel Expense Statement (TES)* is submitted.

• After approval of the TES, the advances are knocked off against the expenses and

the balance amount is recovered or paid, as the case may be.

i. Sales Tax:

• The sales tax accounts are maintained by the respective branches, and a request for

payment of VAT is received from the branches.

• After verification, cheques are prepared and sent to the branches and follow up is made

on the payment.

• A sales tax return for Tamilnadu is prepared and filed.

j. Inventory Reconciliation:

• The stocks are physically verified at the plants and the branches and also at the Sub-

contractor’s place.

• The physical stock is then verified against the SAP accounts and the difference

entries are made and the books are reconciled.

k. Tax Deducted at Source (TDS):

• The TDS accounts are maintained by the respective branches and it gets segregated into

various heads as per the codes maintained.

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• The returns are filed on a Quarterly basis and the stamped challans from the banks are

filed.

• The TDS certificate is issued on an annual basis.

l. Payroll:

• Finance department will assist the administration department in preparing the payrolls for

the employees.

• It ensures that the adherence to all eligibilities and deductions are done in preparing the

payrolls.

m. Audit:

• Various audits like Internal, External and Tax Audit are co-ordinated and the necessary

data are provided.

• The system is being reviewed and made such that the procedures are made easy to

generate information in the future.

• The changes in the legal and other regulations are kept track of and complied.

3.3.2 Sales tax on various scrap items

S.No Item Sales Tax Surcharge1.

2.

3.

4.

M.S Scrap

Cast Iron Scrap

Empty M.S Barrels

200 litre capacity

4%

4%

12%

12%

Nil

Nil

5%

5%

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5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

Empty HDPE Crabuoys

Damaged plastic scraps

Condemned aluminum scrap

Waste Gi scrap

Copper Scrap

S.S Scrap

Waste oil scrap

Waste wooden scrap

Condemned Machinery

Waste, contaminated

chemicals

Spent acetic acid(by product)

Waste fibre drums

12%

4%

4%

12%

4%

4%

12%

12%

12%

12%

12%

12%

5%

5%

5%

5%

5%

5%

5%

5%

5%

5%

5%

5%

TABLE 3.1

3.4 HUMAN RESOURCE:

The organization Structure Of Human Resource Department:

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FIGURE 3.3

For any organization, Human Resource is an asset. The more efficient the human resources the

more successful the industry would be. Such an efficient human resource is needed to be

governed by a healthy planning. The HR department of MALLADI Drugs and Pharmaceuticals

Ltd has a very rigid structure. This entire management is divided into levels of organization

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structure thus making the entire organizations structure a transparent one. The HRD apart from

appointing and recruiting also functions in employee appraisal, welfare activities of employee

etc.

3.4.1 WELFARE SCHEMES:

1. The department takes care of the various benefit schemes and welfare activities of the

employees. They maintain the employees ESI, PF records and contractors attendance and

wage records.

2. The benefits given are soap, horlicks, safety shoes, uniform, rain coat and towel.

3. The facilities provided are medical treatments and rest rooms.

4. Best employee scheme- Every month, from each department a best employee is chosen on

performance based on productivity, housekeeping initiation and attitude towards work

and performance allowance is rewarded to them. A batch process report is maintained for

each employee.

5. An attendance award of Rs.1500/- is awarded to the employees who have a 100%

attendance.

6. Special Events:

a) Festival Advance: It is given in a financial year for one festival. The amount has to be

repaid in equal monthly intervals.

b) Safety Day: Every year March 4 is celebrated as safety day in which various events

are conducted for the employees. The importance of safety is emphasized in this

event.

7. The other benefits and schemes are travel allowance, funeral expenses, group personnel

accident policy (GPA), group insurance (GI), group saving linked insurance (GSLI), PF,

gratuity benevolent fund.

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3.4.2 INSURANCE SCHEME:

Employee GPA GI Med claimTraining Applicable Not applicable Not applicableProbatitioner Applicable Applicable Not applicableConfirmed Applicable Applicable Applicable

TABLE 3.2

3.4.3 SHIFT TIMINGS:

Shift From To Break timeA 06:00 hrs 14:00 hrs 10:00 hrs to 10:30 hrsB 14:00 hrs 22:00hrs 18: 00 hrs to 18:30 hrsC 22:00 hrs 06:00 hrs 02:00 hrs to )2:30 hrsG 09:00 hrs 17:30 hrs

TABLE 3.3

3.4.4 WORKER’S OVERTIME:

HR is in charge of keeping the Time Office functions. They get the OT details from all the

departments, maintain the records and advise the Accounts department for payment.

Wage and Salary Administration:

• They prepare the appointment orders of worker-trainees and maintain their monthly

attendance and salary.

• Calculation of leave encashment and advise the accounts department.

• Preparations of salary, recovery sheets and advise the accounts department for payment

through HDFC cheques.

• Generating pay-slips and distributing to all the employees.

3.4.5 TRAINING:

An exclusive training centre has been created to train 50 persons at a time. This training centre

imparts primary and advanced courses on Operation and maintenance, course on safety , machine

owner course on testing for quality products for deriving the best benefits out of MALLADI

DRUGS AND PHARMACEUTICALS PVT LTD. A training calendar is distributed to

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employees in the beginning of the year and programs are conducted as per schedule. Special

programs by various eminent trainees are organized.

3.5 PRODUCTION DEPARTMENT:

The organization structure of Production Department

FIGURE 3.4

The production department manager is assisted by a team to coordinate, control, co-operate and

maintain quality standards. The company continues to follow current Good Manufacturing

Practice (cGMP) in order to lower cost of production and enhance performance on quality and

delivery parameters.

Further the introduction of batch processing has helped in reducing WIP, throughput time and

increasing on time delivery.

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Investments are targeted at creating application specific capabilities, based on customer

requirements. Investments are made to upgrade existing machinery equipments to be an area of

focus. The company is planning more such investments in future with a view to retaining its

competitive edge.

Increasing infrastructure activity, booming construction and a flourishing economy in India

brings with it signs of robust demand. Globally, the focus on cost cutting and value for money

sourcing will enable Indian companies to establish a strong foothold. In order to capitalize on the

growth opportunities, there are plans to have a presence in China and the Middle East.

The introduction of VAT is likely to benefit the company as product pricing will be more

standardized across the country. The VAT regime would also help to curb grey market activities

to a large extent. Malladi with its vertically integrated operations, strength in manufacturing

process, stringent quality controls and wide distribution reach will maintain its domestic

leadership and also emerge as a more visible force in the global market.

TOTAL PRODUCTIVE MAINTENANCE:

The TPM department is classified in two departments:

• Quality Control

• Quality Assurance

The following objectives at MALLADI are:

• Avoid wastage in a quickly changing economic environment.

• Producing goods without reducing product quality.

• Reduce cost.

• Produce a low batch quantity at the earliest possible time.

• Goods send to the customers must be non defective.

ROLE OF TPM:

Achieve “ZERO EFFECT” by identifying all the upstream factors of equipment causes of defects

and implementing fool-proofing techniques to eliminate man and materials- caused defects.

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1. Identify all the Q-components.

2. Implement fool-proofing techniques to prevent man and materials- caused defects.

3. Eliminate all chronic effects.

QUALITY CONTROL:

The organization structure of quality control department:

FIGURE 3.5

The organization requires raw materials like molasses and methanol which are highly

volatile and need protection to avoid mishap and theft for illegal activities. For this a quality

check is made by the quality control department and assurance is provided to the organization for

further processing of the raw materials. A sample of the raw material is analyzed based on its

qualitative and quantitative. After analysis the sample is tested through twelve analytical tests.

During the process of analysis and testing it is called the quarantine stage where a yellow label is

stuck on the product to differentiate from others and to the employees that it is under quarantine.

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If the tested sample shows expected results then it is accepted and a green label is pasted on the

sample to indicate that it could be processed to obtain the value added product and the raw

material is unloaded from the container On the other hand if the results are negative and do not

reach the quality standards then a red label is pasted to indicate that the raw material is rejected

and sent back to the corresponding vendor.

QUALITY ASSURANCE:

The organization structure of quality assurance department:

FIGURE 3.6

Quality Assurance is a wide ranging concept which covers all the matters that the collectively or

individually influence the product quality. The system of Quality Assurance appropriate to the

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manufacturing of pharmaceutical products should ensure that the pharmaceutical products are

designed and developed in a way that it takes account of requirements of GMP, GDP, and GCP.

The steps taken at quality assurance department:

• To train in the cGMP for API’s

• To introduce general principles of quality management system

• Maintenance of quality system.

• Documentation process.

• Batch number is noted.

• System checking is done based on the performance.

• Standard operating procedures complies the specification.

• Calibration of the instruments is checked.

TOTAL QUALITY MANAGEMENT:

Total Quality Management department is headed by Mr.V.Sampath Kumar. The department

heads for a new approach to improve product quality and increased customer satisfaction on a

continuous basis by restructuring traditional management practices.

Features of TQM:

• Customer driven quality.

• Strong quality leadership.

• Continuous improvement.

• Actions based on facts, data and analysis.

• Improved two way communication systems.

It concentrates more on:

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• Operating procedures.

• Financial performance.

• Employee relations.

• Customer satisfaction.

TQM is a fundamental shift from what has gone before. The systematic analysis pre planning and

blue printing of operations remains essential but the focus switches froma process driven by

external control through procedure compliance and enhancement to a process of habitual

improvement where control is embedded within and is driven by the culture of the organization.

TQM is an approach for continuous improving the quality of goods and services delivered

through the participation of all levels and functions of their organization.

5S Concept in MALLADI

The organization is concentrated on 5S concept implementations. Every month they conduct an

audit in the entire modules in all the units.

5 S is a methodology to get the whole plant clean, bright and in order. It’s a Japanese model of

housekeeping, which is very popular in the country today. It includes:

• SEIRI meaning ‘Sort’.

• SEITON meaning ‘Set in Order’.

• SEISO meaning ‘Shine’.

• SEIKETSU meaning ‘Standardize’

• SHITSUKE meaning ‘Sustain’

KAIZEN Technique:

KAIZEN means “change for good”. It’s a Japanese model of change management which calls for

continuous improvements in our working life. Here problems are not shunned out but welcomed

and solved. This is practiced in the plant for Quality Maintenance, in order to minimize defects.

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The systematic identification and elimination of waste to produce enhanced quality product with

reduced time and cost to deliver product on time considering the safety and morale of employees

is practiced at MALLADI.

3.6 MAINTENANCE DEPARTMENT:

The organization structure of maintenance department

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FIGURE 3.7

The maintenance department is headed by Mr. S. Elumalai and is in charge of engineering

services department for three sections namely fitter, electrician, and boiler operator. There are

two boilers namely thermax and wood boiler which have capacity to produce steam 6 ton/ hr and

3.5 ton/hr respectively. Steam is sent as energy to the vapour absorption machine (VAM) .There

are four cooling towers for the fermentation section and exhaust fans which are used to transfer

heat to synthetic and extraction section. The boiler runs for 364 days throughout the year and is

shut down only once a year. It takes time for the boiler to start after complete shutdown. The

HOD of the maintenance ensures that motion work is reduced in all the three sections in case of

any failure of the machines. The maintenance department is the most crucial and important

department for the whole organization.

3.6.1 EFFLUENT TREATMENT PLANT:

The effluent from the bulk drug industries generally consists of high organic content

thereby making the effluent as high COD effluent. For the purpose of treating this effluent,

Evaporation and Drying methods are used. A combination of Industrial Evaporators like Flash

Evaporator, Falling film Evaporator, Forced Circulation Evaporator and the Industrial Dryers like

Agitated Thin Film Dryer, Fluid Bed Dryer etc are used. Other auxiliary techniques such as

centrifuging, filtration, incineration are also employed. But the condensate water generated after

condensation of the vapours formed in evaporation process of this particular effluent tends to

carry the volatile organic compounds thereby increasing the COD of condensate water and

making it unfit for use/disposal. The COD of the condensate water can be brought down by

rectification/ carbon treatment or aeration with a high pressure blower for prolonged periods.

The effluent containing high amount of organics is preheated and then high heated using steam as

heating media and then it enters into flashing chamber where due to flash evaporation, the

maximum quantity of low boiling organics leave the effluent stream and their vapours are

condensed into a condenser. This condensed vapours can be incinerated in an incinerator for

making the facility a complete zero pollution plant.

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The output liquid stream from the flashing chamber enters the multiple effect falling film

evaporator for further concentration. After concentration in the falling film evaporator, we get a

concentrated stream of effluent which can be then further concentrated or dried in different types

of evaporators and dryers depending upon the actual composition of the individual stream.

Finally, whole of the effluent is converted into solid/sludge form so that it can be disposed and

used as land filling and manure which is mixed with urea for trees and plant in MALLADI

EFFLUENT TREATMENT PLANT

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FIGURE 3.8

3.6.2 Eliminate wastage:

The organization identifies and eliminates wastage by 3W from:

1) Overproducing

2) Time on hand (waiting)

3) Transporting

4) Processing itself

5) Unnecessary stock on hand

6) Unnecessary motion

7) Producing defective goods

The organization in order to make dramatic improvement, 3D’s is removed at work place and

they are:

1) It is dirty. The possibilities of being dirty it could be dusty, leaky, noisy and the solution

is repetitive work or re-work.

2) It is difficult. The possibilities are heavy to handle, can’t/ access reach, steps hard to

follow, no standard and difficult to read(sense).

3) It is dangerous. The possibilities unsafe to work, for health, loose connections,

deteriorated parts, no ‘fit - to - finish’

3.7 DOCUMENTATION:

3.7.1 Certificate of Inspection:

For a number of products notified under the exports (Quality control and Inspection) Act 1962. It

is obligatory for an exporter of specified products to obtain an inspection certificate. The scheme

is administered by the Export Inspection Council of INDIA (EIC).

3.7.2 Certificate of Quality and Quality control:

The importer of any one of the following reason may require these certificates.

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1) Assessment of customs duty.

2) Required document in the process of authorizing foreign exchange.

3.7.3 Specimen Copy for Permit Vessel Entry:

Fill in the appropriate boxes. Be specific while filling the report. Permit is issued only for a

specific job and time. In case of any change it must be revalidated and reissued suitably. Permit

cancelled during any emergency in the plant needs reauthorization.

1. Originating Department Date

a) Permit issued to Dept / Contractor…………….

b) Nature of work to be done………………….

c) Exact Location………………..

d) Work / involved: ………. Vessel Entry / Others

2. The following preparation have been made

The equipment to be worked upon has been prepared as follows

Pipe Line Disconnected Yes/No Drained Yes/No

Isolate/ Blanked Yes/No Valve Closed Yes/No

Purged or washed with water/steam Yes/No Aeration Given Yes/No

SECTION IN CHARGE PRODUCTION HEAD

3. Maintenance

a) Required personnel protective equipments like safety belt, life rope, nose mask, full

face mask are confirmed.

b) Work has been explained to the person doing the job.

SECTION IN CHARGE MAINTENANCE HEAD

4. Electrical

• Power supply to the vessel disconnected………………..

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• Electrical isolation of the equipment done and tagged.

• Fuse removed.

ELECTRICAL SUPERVISOR MAINTENACE HEAD

5. Safety

Oxygen level in the equipment …………………………. % (Temp )

• Required PPE’s were made available Yes/No

• Surveillance frequency by safety

Dept…………………………………..

Recommendations……………………………

SAFETY HEAD

6. PERMIT EXTENSION

Permit extended up to………………….. Hrs on…………………. / Not extended

SAFETY HEAD HEAD OPERATIONS

7. Job completed ………………………………..

Time……………………………. Signature………………………

“SAFETY FIRST WORK NEXT”

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3.7.4 Specimen copy for Quarantine label stock register

FIGURE 3.9

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3.7.5 Specimen copy for goods receipt for printing form, labels and registers:

FIGURE 3.10

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3.7.6 Specimen copy for Inward Register:

FIGURE 3.11

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3.7.7 Specimen copy for Material Dispensing Register:

FIGURE 3.12

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3.8 SAFETY:

The safety department is well organized and coordinated by Mr. A.Subramanian, Manager of

safety department. In a drugs manufacturing company safety is an important factor to be

considered since raw materials are easily combustible and the employees in particular require

safety while pre and post handling the operations of the machine.

When truck drivers enter at the gate with the raw materials, a flame arrester is provided on the

muffler at the security gate to avoid spark from the engine when the accelerator is raised. Truck

drivers travel from far distances and have their own stove and cooking accessories with them to

cook food, thus these combustible items are removed from them to avoid fire break out. The

truck drivers are frisked for cigarettes, lighters, mobiles, other miscellaneous items if found are

seized in order to maintain safety for any mishaps.

Solvents like toluene, acetone while unloading in the container also require safety. First of all the

ignition of the engine is switched off. The trucks are fitted with gas pipelines to transfer them

into the container and during the flow of solvents static electricity is developed in the pipelines

due to high velocity which causes explosion, to avoid the static electricity the trucks are body

earthed to the earth iron. In front of the tires a wooden block is placed in front of the tires to

avoid the movement of vehicle to pull away from the pipeline which causes wastage of the

solvents. The driver should be near by the truck till the whole transfer process is over since in

any case of emergency, the truck should be driven out.

For the employees personal protective equipments like gloves, helmet, goggles, face masks, nose

masks and safety shoes are provided to ensure safety protection from hazardous materials and

harmful chemicals like acids and bases. It is ensured the personal protective equipments are of

the ISI quality standards. A register is maintained for each employee to keep a record of all the

equipments issued to the employees and the usage of the equipments is verified by the

supervisors when inspection is done. Color code is provided for pipelines to differentiate the flow

of solvents and combination color code is provided for nut, bolts and other joints. Similarly

numbers for reactors, storage tanks and labels are also present. Temperature and pressure gauge

are fitted to monitor and necessary actions are taken if needed. There is an underground storage

for solvents and they are maintained at a temperature of -23 degree Celsius. There is a big

lightning arrester to allow the flow of charges to the ground when the lightning strikes and wind

sac on roof. In case of any accidents, there is an ambulance which is operating 24*7 and the

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organization has a tie-up with Ida Scudder Memorial hospital, Vellore. The employees are

ordered to follow the Standard of Procedures (SOP) only before handling the machine. Every

year National Safety Day is celebrated on March 4 and various events like essay writing, poems,

caption writing and prizes are awarded for the winners.

3.8.1 ENVIRONMENTAL POLICY:

We commit ourselves to maintain a clean environment through constant improvements in

methods and trials. We provide a framework for setting and reviewing environmental objectives

and targets. We strive to limit, control and prevent all the spheres of pollution based on scientific

understanding.

3.8.2 SAFETY AND HEALTH POLICY:

a) We believe that safety and Health of our employees and safe working environment are

fundamental to our operations. We will ensure this by providing and maintaining safe

working conditions, continuous education and training.

b) We also consider the performance of the employees, with regard to their usage of PPE,

following safety procedure and eleiminating unsafe condition in the work place, during

their annual appraisal for increments and career advancement.

c) All contractors and our customers including transporters are educated and trained to

strictly follow the safety procedure of our organization.

d) The safety and Health policy report will be part of the annual report of our organization.

e) We shall conduct safety Audit, do hazard and risk analysis, and take preventive actions to

eliminate the accident potential in the work place. We shall record the accidents then and

there, investigate and initiate corrective actions. We shall also discuss the same in the

safety committee meetings.

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3.8.3 MATERIAL SAFETY DATA SHEET:

A material safety data sheet (MSDS) is a form containing data regarding the

properties of a particular substance. An important component of product stewardship and

workplace safety, it is intended to provide workers and emergency personnel with procedures for

handling or working with that substance in a safe manner, and includes information such as

physical data (melting point, boiling point, flash point, etc), toxicity, health effects , first aid,

reactivity, storage, disposal, protective equipment and spill handling procedures. The exact

format of an MSDS can vary from source to source within a country depending on how specific

is the national requirement. MSDS can be found anywhere chemicals are being used.

There is also a duty to properly label substances on the basis of physio-chemical, health and/or

environmental risk. Labels can include hazard symbols such as European Union standard black

diagonal cross on an orange back ground, used to denote a harmful substance.

An MSDS for a substance is not primarily intended for use by the general consumer, focusing

instead on the hazards of working with the material in an occupational setting.

Chemicals are widely used in industry. Many of them are toxic, corrosive or flammable.

However, they can be safely handled if information on their physical, chemical and hazardous

properties together with the necessary precautions to take is made available to users.

Chemical or material safety data sheets (MSDS) are used in many countries to provide the

information necessary for the safe handling of hazardous substances. Therefore, MSDS play an

important role in the comprehensive approach to the control of chemical hazards in the work

place

There is a need to ensure that Material Safety Data Sheets are produced to meet certain minimum

standards of acceptability.

3.8.3.1 Standard format of MSDS:

There is currently no international standard for the preparation f MSDS. Manufacturers/ suppliers

of chemicals may have different formats of presenting the information required in the MSDS.

Nonetheless, the information provided by MSDS must be adequate and accurate. In general,

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information provided in MSDS is the responsibility of the producer of the MSDS. All

information should be based on verifiable sources, for example documented studies, reports and

reliable databases.

The MSDS is not a fixed length document. The amount of information provided (in each sheet)

may vary according to the amount of relevant information available.

No information items should be left blank. If the information is not relevant or not available, it

should be clearly stated.

3.8.3.2 Role of MSDS

The material safety data sheet has a number of roles for managing the safe use of

chemicals.

• It should first be used to ensure that the product is being used as intended by

the manufacturer or importer. Other use may be possible, but particular care

should be taken when the product is being put to a ‘new’ use – it may give rise

to unforeseen hazards.

• It is the key tool for risk assessment as it includes detailed hazard information.

• The options for appropriate controls included in the MSDS may be 48ehavior for

the design and improvement of control measures and procedures.

• Workplace monitoring and health surveillance strategies may often be based

on advice contained in the MSDS.

• Sufficient information should be provided to select the necessary safety

equipment and to develop necessary emergency procedures.

• The MSDS may be used as the basis of a training program for workers as it

covers hazards, precautions and emergency procedures.

3.8.3.3 Information provided by MSDS:

A wide range of information is provided in an MSDS. It is the most comprehensive source of

information available to a chemical user.

Identification information:

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The name of the product is clearly specified together with classifications appropriate to the

product- United Nations substance number, dangerous goods class and subsidiary risk, hazardous

substance status, poisons schedule etc.

The manufacturer’s or importer’s name, address and telephone number is provided, often with a

24 hour-a-day telephone contact for emergencies.

The name (and CAS number) of hazardous ingredients is given together with their approximate

proportion in the product composition.

Specific chemical properties:

Chemical and physical properties are listed below:

• Boiling point and vapour pressure, which give an indication of the potential to generate

significant vapour concentrations. Low boiling point and high vapour pressure materials

will generate higher vapour concentrations.

• Vapour density(VD)- the ratio of the density of the vapour to that of air. This determines

the behavior of the gas or vapour in air. Substances with a VD<1 will rise in air.

Substances with VD>1 will tend to sink in air and flow along horizontal surfaces and

down stairs drains etc.

• Solubility of the substance in water and other solvents expressed in a variety of units or

descriptive terms (insoluble, dispersible, slight, partial, soluble, miscible).

• Specific gravity of a liquid- the ratio of the density of the substance compared to that of

water. This enables a determination of whether the substance will float on or sink in

water.

• The Ph of the product gives an indication of acidity( if Ph<7) or alkalinity (if Ph>7).

• Fire safety data such as:

Flammability range, the range of concentrations of fuel in air between the

lower flammability limit (LFL) and the upper flammability limit (UFL),

over which a mixture of a material.

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Flash point (fp), the lowest temperature of a liquid at which the vapour

above it can be ignited.

Auto-ignition temperature (AIT), the lowest temperature (of a potential

ignition source) at which a flammable mixture in air can be ignited.

3.8.3.4 The information content of MSDS are listed as follows:

1) Identification of the substance and of the company

2) Composition/information or ingredients

3) Hazards identification

4) First-aid measures

5) Fire-fighting measures

6) Accidental release measures

7) Handling and storage

8) Exposure controls/personal protection

9) Physical and chemical properties

10) Stability and reactivity

11) Toxicological information

12) Ecological information

13) Disposal considerations

14) Transport information

15) Other information

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CHAPTER 451

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INNOVATIVE PROCESS IMPROVEMENT

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INNOVATIVE PROCESS IMPROVEMENT

4.1 SKILL MATRIX FOR MAINTENANCE DEPARTMENT:

Problem:

The problem persisting in the organization is that Human Resources department is not

aware of the skills within employees of maintenance department and how they perform.

They are recruited based on their previous experiences. The minimum education

qualifications are ITI and higher secondary which form a category of low skilled and semi

skilled employees.

Solution:

In order to know how the employees perform and usage of their skills in job, the Human

Resources can adopt a skill matrix to evaluate and based on the results , the management

can train them and enhance the development for the organization with skilled labors.

The objective of skill matrix are:

• To identify the work related skills of the employees.

• To identify the training imparted to the employees.

• To verify whether the initial training met the employee’s expectations.

• To compare the skills of the employees with the skills of the machine.

• To define the gap between the number and level of competencies that the

employees possess in comparison with the number and level of competencies

required by the organization according to their job role.

Questionnaire has been evaluated by the head of department maintenance for operators.

The questionnaire contains details about work, performance and total employee

involvement. As a result of this the gap in employees is found out and can be reduced.

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Blue Print of the Questionnaire for the employees:

Name: M/F:

Age: Working Experience:

Job Description: Number of years inMallady:

Educational Background: Machine name:

1) What are the tools used to assemble?

2) Availability of the tools.

3) How much time does it take for you to assemble?

4) What is your role?

5) Did you have knowledge about the machines before entering the company,

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a) If yes, Where did you learn about it

b) If no,

• What is the training imparted to you by organization? (hands on /

theory)

• Did the training meet your expectations?

• What do you expect from training?

• How much benefit did you obtain after training?

• Were you able to perform after training?

If yes, how much time it took for you to apply your knowledge?

If no,

• Did you observe from your seniors

• Asking your seniors when you are facing a new problem

• Getting training before facing a new problem

6) If given a new machine are you confident to try it out.

7) How much time does it take for you to learn a new machine?

8) What do you expect from the present technology?

9) Is technology enough for the prevailing situation?

10) If you are able to train others how much time is required?

11) If fault occurs, you discuss with your co-workers or call the management to

resolve it.

12) What is the most common complaint in the machine?

13) Is regular maintenance in terms of service there for the machine?

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14) If a machine fails, is there an alternate or substitute machine to do the particular

job?

15) When do you shutdown the system?

Blue Print of the questionnaire to the Head of Department

S.NO STATEMENTS 4 3 2 11. Clarity in his job description and job satisfaction.

2. Proficiency in handling the machine operations.

3. Alertness & readiness in work situation is satisfactory.

4. Adoptiveness & flexibleness in work environment.

5. Feedback about the job to his superior in a regular basis.

6. Record maintenance about the details of the work in a

daily basis.

7. Capability to tackle the situation without the superior.

8. Listening, observation and communication skills.

9. Ability to detect the faults in the operations

10. Knowledge about the company’s product and its vision

& mission.

11. Ability to understand & execute the instructions of the

superior in a proper manner.

12. Self- responsibility in work situation.

13. Regularity.

1- Can perform under guide lines.

2- Can perform independently.

3- Can perform independently and trouble shooting

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4- Can perform independently, trouble shooting and train others.

TOTAL EMPLOYEE INVOLVEMENT

S.NO STATEMENTS 5 4 3 2 1

1. 5S

2. TPM

3. Safety

4. Small group activity

5. Team work

1- Very poor

2- Poor

3- Good

4- Very good

5- Excellent

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Skill Matrix- Engineering Services

FIGURE 4.1

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4.2 IMPLEMENTING SAP HR FOR PERSONNEL

ADMINISTRATION AND RECRUITMENT

Technology plays a major role in today’s business environment. So many companies and

corporations have adopted information technology on a large scale by using Enterprise

Resource Planning (ERP) systems to accomplish their business transaction and data

processing needs. And in this technology SAP R/3 plays a significant role when

compared with other similar tools.

ERP system takes a lead role because of some of the following reasons:

Many large corporations use several different and separate information systems, often

because they have merged with and/ or acquired other companies with varied systems. An

ERP system integrates these separate information systems and results in improved data

reliability and processing efficiency. ERP systems are not only used by large corporations

but becoming popular with small to mid-sized companies also.

In MALLADI, SAP B1 is implemented in three departments and they are:

• Production Department

• Stores Department

• Accounts Department

Problem:

SAP Business One (B1) module is implemented in MALLADI. There is a need to

implement SAP in Human Resource Department since the related functions are entered in

MS-EXCEL for pay roll and Microsoft Office for other functions.

Solution:

SAP R/3 is one of the options that can be used in Human Resource Department. SAP R/3

is also called SAP ERP. If SAP R/3 is implemented it can be used in four areas of human

resources, financial, supply chain management and marketing. R/3 is scalable and highly

suited for many types and sizes of organizations and runs on six different platforms. R/3

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is also an international product, and meets the local fiscal, language, and tax requirements

of most countries.

Using R/3 in Human Resources department many functions can be adopted and provides

for a “single entry data point” where the data entered from any location is instantly sent to

all other appropriate modules in the ERP system. SAP sells its R/3 product on a ‘price per

user basis’. The actual price is negotiated between SAP and the customer and therefore

depends on numerous factors which include number of users and modules. The major

drivers of the total implementation cost are the Timeframe, Resource Requirements and

Hardware.

• Timeframe – the absolute and quickest implementation is 45 days since

MALLADI is a small manufacturing industry with 186 employees.

• People – the smallest of SAP implementations can get done on a part- time basis

without outside help.

• Hardware – the smallest SAP implementations probably uses only three instances

one for the production system, one for test, and one for development.

IMPLEMENTING SAP HR

To implement SAP HR it includes product definition, project definition, deliverables and

materials, purchased services, responsibilities, payment type, payment plan, laws, validity

and several other similar items depending on the project and scope. The implementation

starts with the project preparations, business goals are determined; expectations from the

project are defined. There are some specific software packages to replace their existing

Human Resources and Payroll systems. MySAP is one of the packages built for SAP HR.

To have better control over implementation time and costs, mySAP HR can be

implemented in phases. Approaching an implementation step by step, users have time to

get familiar with the system before launching the next module, which will ultimately

reduce implementation time. When implementing HR and payroll, the following phases

would be a good solution:

Phase1: Master Data, Time Management, Payroll, Benefits Administration,

Organizational Management and Payroll.

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Phase 2: Personnel Development, Recruitment, Training and Events, Travel

Management and Compensation Management – this phase can be broken down

further.

Phase 3: Employee Self Service, Manager’s Desktop Costs of Employees on the

Project Team not able to perform their normal jobs.

MySAP HR provides timely information, helps to spot levels of absenteeism, low

retention, career progressions etc. The organization can implement mySAP HR with

minimal costs within an optimum time frame. This new technology will make the

organization more efficient, strategy focused and ultimately more profitable.

Some of the functions that can be done in SAP HR Personnel Administration are:

a) Personnel Development Skills:

In this info type the HR can store the skills of the employees and it can be used to

• Create development plan for the employee.

• Compare the competencies of a person and his current position.

• Find the best candidates if the HR si trying to fill a position.

• Career planning.

• Succession planning.

b) Insurance:

In this info type the HR can maintain data of insurance taken by the employees

and it can be used to store:

• Insurance type

• Insurance company

• Insurance number

• Insurance tariff

c) Disciplinary Action and Grievances

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In this info type the HR can store disciplinary action and grievances of employees

and the HR can have access to:

• Grievance number- The HR can assign a three digit number to identify

specific grievance.

• Date entered

• Supervisor

• Policy-related

• Grievance status

At the end of the day the employee may be exonerated, warned or dismissed. In

the case of grievances, the grievance may be dismissed, or redressed.

d) Wage type

• Wage type is the vehicle of payments and deductions in SAP payroll.

• Wage types have multiple properties and they are:

Payment to/ deduction from employees

Financial posting

Taxability

• Wage types are printed on payslips

e) Basic pay

• Payments or deductions are specified in wage types.

• It contains all wage types, which are to be paid regularly to an employee,

except reimbursements and time wage types.

• When an employee leaves a company the HR is not permitted to delimit

regular payments. Basic payroll must remain in the system. This is to

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ensure the accuracy of any retroactive accounting runs that need to be

performed.

f) Loans

This info type is used for creating loans for employee. The loans in SAP come

under one of the following categories which determine their behavior:

• Annuity loan( Fixed periodic repayment. The interest is recovered first,

balance goes towards principal repayment0

• Installment loan (fixed principal repayment + variable interest)

• Recurring advance(no repayment, no interest)

• When a loan is created, the system checks whether the employee is eligible

to get his/her loan. There are several checks that the HR can build in the

system whether a loan is to be granted or not, depending on the following

factors:

Maximum number of loans at a time.

Maximum number of loans till date.

Maximum outstanding amount.

Minimum service period.

Upper limit on age.

Minimum gap between current and previous loan.

• Based on the properties of the loan, the system recovers installment and

interest during payroll run. It also computes imputed income.

• If there is balance for a loan even after the end date of a loan record, the

payroll processing stops. In that case the HR has to extend the end date.

Similarly, if there is no balance but the loan record is valid, the system

displays a message in the payroll log. In that case the HR to bring forward

the end-date.

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• Since Payroll is run for a period, the HR has to decide the date on which

the payment of loan, or recovery of installment, has happened. SAP lets

HR decide whether it is the first day of the payroll period, the last day, in

the middle of the period, or the payment date. This impact interests

computation

g) Additional Off-cycle payments

If the HR wants to pay some employee in between the payroll period, SAP allows

the user to run an off cycle payroll and the important fields are:

• Wage type

• Amount and currency- The user can enter the amount to be paid or

deducted.

• Number/Unit- The user can enter the number and its unit. This field can be

used to convert number in amount during payroll run. It can be used to

keep related information, which can be printed in the payslip.

• Payment date

• Payroll type

If SAP is correctly implemented there is nothing to fear. The organization should

not be afraid of implementing mySAP HR by avoiding certain pitfalls and paying

attention to crucial factors such as clearly defining the project scope, having the

whole company fully committed, supportive line managers, a fast decision making

policy, a competent project team and well trained users. The organization can

implement mySAP HR with minimal costs within an optimum frame. This new

technology will make the organization more efficient, strategy focused and

ultimately more profitable, fit for today and tomorrow’s economy.

4.3 WAREHOUSE AUTOMATION:

Warehouses are facilities that provide a proper environment for the purpose of storing

goods and materials that require protection. The design of the warehouse space should be

planned to best accommodate business service requirements and the products to be

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stored/handled. Warehouse is a crucial link between a manufacturing facility and its

suppliers, as it governs the flow of materials and ultimately affects productivity.

In MALLADI there are two types of warehouses:

a) General warehouse which provides space for bulk, receiving and shipping space,

packing and crating space.

b) Refrigerated warehouse which includes freeze and chill space to preserve the quality

of perishable goods that require refrigeration.

Problem:

In MALLADI, the warehouse is quite small and it requires expansion and moreover the

stock of goods present in warehouse is monitored manually by humans which are tedious

and time consuming.

Solution:

It is possible for the organization to automate their warehouses. Warehouse automation is

an upcoming technology in INDIA. It is limited to large players, while most small scale

industries can adopt it. In a article in Economic Times “Storing Success for SMEs”,

dated 4 August 2009 says ‘Indian SMEs automating their warehouses can improve their

inventory accuracy and save significantly on labor costs.’

Warehouses automation requires considerable investment in the beginning while the

benefits are only realized after a while. Some modules have been introduced for

warehouse automation and they are:

a) Automated Storage Retrieval System(AS/RS)

AS/RS is an automation system with high-rise racks that are loaded and unloaded

using automatic storage machines within the aisle.

b) Automatic Guided Vehicles(AGVs)

These can be used to transport, store and retrieve loads for warehouses which are

mainly associated with the manufacturing industries.

Advantages of using warehouse automation:

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• Can save the costs spent on managing inventory, as warehouse automation

systems enhance inventory control through computerization.

• Ensures higher accuracy and efficiency in inventory tasks.

• Important tool for saving on the costs incurred in material replacement and

manpower

Implementing Automation:

Warehouse automation requirements are individual and one of the successful approache is

to develop a Warehouse Strategic Master Plan(WSMP). It is a blueprint for warehouse

automation, to be implemented over the next eight to ten years. WSMP considers aspects

such as facilities, manpower, machinery, and inventory required as per business plan.

AS/RS warehouses are used for maximum storage and minimum personnel on site.

Automated order picking will employ minimal human labour, and will be more flexible,

sensitive, modular, and improve their inventory accuracy.

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CHAPTER 5

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COMPARISON OF THEORY AND PRACTICE

1) 5S Concept:

It’s a Japanese model to keep the whole plant clean, bright and in order and the

observation which I observed in the organization is:

a) SEIRI in office:

• Unused or broken pen.

• Irrelevant or useless papers, notebooks, files.

• Old diaries.

• Broken furniture.

• Unused paper weights.

• Expired short hand note book(memo pads) carbon paper and scribbling pads.

• Outdated and obsolete vouchers, slips etc.

b) SEITON in office:

• Files not clearly identified.

• Tables, drawers are cluttered with papers, keys, pens.

• Lack of proper indexing system in cupboards file cabinets.

• Papers heaped on the table of keeping urgent trays.

c) SEISO in office:

• Dust and grime in type writers, photocopier machines. Telephones, fax machines.

• Computers and printers.

• Dirty windows, ventilators.

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• Dirty fans, tube lights, air conditioners.

• Dirty tables, chairs, cupboards, drawers and cards.

d) SEIKETSU in office:

• Toilet and washbasins are disinfected.

e) SHITSUKE in office:

• Self discipline.

2) KAIZEN:

• Steps for continuous improvement.

• Providing leadership from the top.

• Establishing Vision and policies.

• Establishing and development quality goals.

• Establishing measurement.

• Rewarding the reward system.

3) ABC Analysis:

Always Better Control (ABC) analysis based on cost criteria helps to exercise selective

control when confronted with large number of items, it rationalizes the number of orders,

number of items and reduces the inventory. This is practiced in the stores department

when order is placed and is an important management tool for materials management.

4) Storage:

The stores department has a storage area to store materials in a correct way by arranging

them in group wise and alphabetical order which helps the workers for identification,

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traceability and retrieval. First in first out principle is followed to avoid stock out and

minimum reorder level is always maintained in order to reduce lead time.

5) Batch Process Report:

In accordance with the performance appraisal of the employees, the Human Resources

has a Batch Process Report for each employee. In this report the employee’s good or bad

incidents are noted and during the period under consideration for appraisal have to be

acknowledged by the immediate superior or the reporting officer. This ensures that none

of the activities of the employee gets unnoticed before appraisal.

6) Training and Creating awareness:

The Human Resource department plans at the beginning of every year a training schedule

for the employees. The HR takes immense effort to train the employees and other senior

employees also give lectures on current environment issues which creates awareness

among them to protect our surrounding.

7) Approval for vendors:

The quality control and quality assurance department function is to approve the raw

material received from the vendors (supplier). They perform various standards to verify

whether the product meets the quality standards. If it does not meet the standards then

they stick a red label to reject it.

8) Traceability and Identification:

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In this method the stores department arranges the materials with unique number for easy

traceability and identification. This method reduces motion time and increases

productivity.

9) Welfare Schemes:

For the better prosperity and well being of the employees, from each department a best

employee is chosen based on performance in productivity and attitude towards work and

rewards for their work is given. Medical treatments are provided in case of emergency.

10) Employee Participation:

Employee Participation is important in any organization and can be in the form of

suggestions and quality circle meetings. Effective suggestions are rewarded in the form of

cash rewards, recognition or merit certificate. It is one of the methods for motivating

employees to participate more for the welfare of the company.

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CHAPTER 6

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BENEFITS OF UNDERGOING THE TRAINING:

The benefits of the 53 days long Institutional Training Program that I underwent is as follows:

1) It gave me an insight into the production department where I observed the processes of

fermentation, synthesis, and extraction.

2) I had an opportunity to view the two different types of boilers and their functions at each

stage in the maintenance department.

3) It gave me a mind experience to study the activities performed in the stores department

like order level, traceability, identification, purchase, transportation, and warehouse.

4) I had hands on experience in interviewing some maintenance workers for the skill matrix

in the human resources department.

5) It provided me a platform to interact with various people from different industrial

background and experience.

6) I learnt a lot about the interpersonal communication between the staffs in and between

departments for activities and transaction.

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CHAPTER 7

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7.1 CONCLUSION:

The organization has more concern towards the environment, employees, union by following the

global principles and put forward its thoughts by promoting environment friendly business to the

world by its new products. It coined profit making and environmental commitments which are

part of their success.

The organization follows international standards to achieve the utmost customer satisfaction by

its timely response and meets the customer requirements by resolving their problems.

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7.2 REFERENCES:

BOOKS and ARTICLES:

1. SAP HR- PERSONNEL ADMINSTRATION AND RECRUITMENT- P.K. AGRAWAL

Published by ASOKE K.GHOSH, Prentice Hall of India Private Limited, New Delhi.

2. Agut, S. and Grau, R. (2002), “Managerial competency needs and training requests: the

case of the Spanish tourist industry”, Human Resource Development Quarterly, Vol. 13 No.

1,pp. 31-51.

3. Barber, C.S. and Tietje, B.C. (2004), “Competency requirements for managerial

development in manufacturing, assembly, and/or material processing functions”, Journal of

Management Development, Vol. 23 No. 6, pp. 596-607.

WEBSITES:

www.malladi.co.in

www.wbdg.org/design/warehouse.php

ANNEXURES:

1. SKILL MATRIX- ENGINEERING SERVICES DEPARTMENT FOR BOILER

OPERATORS.

2. SKILL MATRIX- ENGINEERING SERVICES DEPARTMENT FOR

ELECTRICIANS.

3. SKILL MATRIX- ENGINEERING SERVICES DEPARTMENT FOR FITTERS.

4. SPECIMEN COPY OF PERMIT WORKIN AT HEIGHT.

5. SPECIMEN COPY OF PERMIT OF VESSEL ENTRY.

6. SPECIMEN COPY OF ACCIDENT/INCIDENT REPORT.

7. SPECIMEN COPY OF ACCIDENT/INCIDENT INVESTIGATION REPORT.

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