Qa assignment

name : thansuh d
roll no : 59

Q1) write a note on personnel records and its importance ?

Personnel Records are records pertaining to employees of an organization. These records are
accumulated, factual and comprehensive information related to concern records and detained. All
information with effect to human resources in the organization are kept in a systematic order.
Such records are helpful to a manager in various decision -making areas.

Personnel records are maintained for formulating and reviewing personnel policies and
procedures. Complete details about all employees are maintained in personnel records, such as,
name, date of birth, marital status, academic qualifications, professional qualifications, previous
employment details, etc.

Types of Personnel Records

1.Records of employment contain applicants past records, list sources, employees

progress, medical reports, etc.

2.Wages and salaries records contains pay roll records, methods of wages and salaries,
leave records, turnover records and other benefit records.

3.Training and development contains appraisal reports, transfer cases, training schedule,
training methods.

4.Health and safety records include sickness reports, safety provisions, medical history,
insurance reports, etc.

5.Service Records are the essential records containing bio-data, residential and family
information, academic qualifications, marital status, past address and employment records

Purposes of Personnel Records

According to the critics of personnel records, this system is called as a wastage of time and
money. According to personnel records, followers of this : Dale Yoder, an economist of Michigan
University, USA has justified the significance of personnel records after making an in-depth study.

1.It helps to supply crucial information to managers regarding the employees.

 2.To keep an update record of leaves, lockouts, transfers, turnover, etc. of the employees.

3.It helps the managers in framing various training and development programmes on the
basis of present scenario.

4.It helps the government organizations to gather data in respect to rate of turnover, rate
of absenteeism and other personnel matters.

5.It helps the managers to make salary revisions, allowances and other benefits related to
salaries.

6.It also helps the researchers to carry in- depth study with respect to industrial relations
and goodwill of the firm in the market.

Q2) explain in brief the design and construction of pharma industry?

When we design a pharmaceutical plant we need to understand and follow the

basic regulatory requirements for the construction of a pharmaceutical plant.
These requirements are mainly divided into two categories namely -
• Requirements related to good manufacturing practices currently followed in
pharmaceutical industry. These are elaborately describe in the various
international cGMP guidelines.
• Requirements related to Factories Acts and Rules, which is a Central Act and
the rules described separately by each state in India, for this work we have
referred the rules specified by the state of Maharashtra.
• In addition to these, there are specific rules and regulations related to
following activities which should be referred separately by the reader e.g.
• Regulation related to water and air pollution.
• Regulation related to handling and storage of inflammable materials etc.

The cGMP requirements are described in the various guidelines which deal
mainly in the following categories, e.g.,
(a) Requirements related to surroundings.
(b) General requirements for pharmaceutical plants.
(c) Requirements related to various departmental areas in the plant and
(d) Requirements related to special products. e.g., sterile products

(a) Requirements Related to Surroundings of the Plant Part I of schedule-

M of Drugs and Cosmetics Act- 1940 states the requirements in the following
words- “The factory building(s) for manufacture of drugs shall be so situated
and shall have such measures as to avoid risk of contamination from external
environment including open sewage, drain, public lavatory or any factory which
produces disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke,
chemicals or biological emissions.” Only Indian cGMP guidelines specifically
talk about “surroundings” of pharmaceutical plant. All other international
guidelines talk in terms of “General Requirements” and “different plant areas.”
In the next section, we will review the “General Requirements” related to
pharmaceutical plants.
Some of the major points to be considered in these cases are - Land cost, water
sources, supply of electric power, extremes of climate like – heavy rain,
extremes of temperature, earthquake proneness, transport facilities and men,
Availability of trained or skilled man power, Labour and industrial legislations,
cost of living, etc.

(b) General Requirements for Pharmaceutical Plants

After reviewing the leading international cGMP guidelines, we can summarize
the same in the following points.
1. Pharmaceutical plants must be located, designed, constructed, adapted and
maintained to suit the operations to be carried out.
2. Their layouts and design must aim to minimize the risk of errors and permit
effective cleaning and maintenance, in order to avoid cross-contamination, built
up of dust or dirt and in general any adverse effect on the quality of the product
and safety of the personnel.
3. The Canadian guidelines are similar to above 1 and 2 but adds one point or
“Orderliness” in the plant and specifically talks about preventing contamination
of drug and addition of extraneous materials to the drug. It also talks about
regular maintenance of the plants to prevent deterioration of the premises and
finally says that the –“Ultimate objective of all endeavours is product quality.”
Duct and filter cleaning procedures must be well defined and documented. The
HVAC system details must be worked out very critically, these include details
like,
• Temperature
• Humidity
• Differential pressure
• Air changes per hour
• Class of air etc.
Even SOPs related to movement of men from one workstation to other
workstation must be clearly defined. The seven zone concept of area planning
may be worth considering while planning the layouts of pharmaceutical
operations. The Dholka plant of Cadila Pharmaceuticals Ltd., was pioneer in
this area.
5. Manufacturing plants should be so constructed that they can always be kept
in clean and sanitized conditions.
6. Manufacturing plants should always be kept in a good state of repair. It
should be so designed, so that the maintenance operations can be carried out
without affecting the product quality. Separate service lanes may be provided.
7. SOPs and records should be kept for cleaning, maintenance, disinfection and
sanitization.
8. Plants should be maintained in order with reference to –
• Electric supply
• Lighting
• Temperature
• Humidity
• HVAC
You should have specifications and records of maintenance about the above
mentioned points.
9. Plants should be so constructed that they avoid the entry of crawling and
flying insects, pests, rodents and other Animals and Birds. A pest and insect
control programme should always be in place. Toxic baits should be carefully
controlled and used in such a way that they should not present a hazard to
product or materials.
Steps should be taken to prevent the entry of unauthorized people. Particularly
no unauthorized person is allowed in the area of production, stores and quality
control departments
11. Waste materials should be continually removed from the premises and
written sanitation procedures available, detailing schedules, methods, materials
and equipment. Responsibility should be assigned in writing. Cleaning and
disinfection should be on going on a regular basis and must include change
rooms, wash rooms toilets and refreshment areas.

(c) Regulatory Related To Various Departmental Areas The regulatory

requirements related to various departmental areas cover following points. The
regulatory guidelines cover requirements related to the following departments.
viz.,
(i) Storage and weighing areas
(ii) Production areas
(iii) Q.C areas
(iv) Sterile – products areas
(v) Ancillary areas covering following :
(a) Rest, refreshment rooms and smoking areas.
(b) Change rooms and storing of linen, toilets and washrooms.
(c) Maintenance workshops.
(d) Animal houses.
(e) Now let us briefly look at the regulatory requirements regarding the above
mentioned departmental areas.
Q3)different types of plant layouts in pharma industry with advantages?

pharmaceutical plant layout

pharmaceutical plant layout/ factory layout refers to the allocation of space and
the arrangement of machines, furniture and other important administration and
necessary services needed in a production process within a factory building in
other to perform the various unit operations involved in the manufacturing
process of dosage forms in a cost effective manner and with the least amount
of handling in processing the product from the receipt of raw material through
the distribution of the finished product.

Features of a good pharmaceutical plant layout

A good pharmaceutical plant layout should possess the following
characteristics
•There should be adequate floor space for machines installation and utilization
•The machines should be properly arranged to facilitate minimum material
handling is necessary for low cost processing.
•The layout should facilitate smooth and continuous flow of production process
from one point to another without any form of delay
•It must incorporate adequate health, safety and security features such as first
aid box, fire extinguisher, emergency exit and access point
•A good layout should allow effective supervision, coordination and control of
the production processes
•There should be room for adjustment and modifications whenever the need
arises.

Advantages of a good pharmaceutical plant layout

The advantages of a good pharmaceutical plant layout includes but are not
limited to
•Optimum use of available floor space for production operations
•Improved quality of product due to reduced chances of cross contamination
•Efficient arrangement for receipt, transportation, storage, and delivery of raw
material and finished goods.
•Low cost of material handling
•Minimized loss due to waste and spoilage
•Conducive working conditions resulting in improved efficiency.
•Increased productivity with reduced risk of human error
•Minimized risk of occupational hazards/ low incidence of occupational hazards
•Minimized cost and efforts in supervision of production processes.
•Provision of control and supervision operations at appropriate points
Four Main Types of Plant Layout
Keeping in view the type of industry and volume of
production, the type of layout to be selected is to be decided
from the following:

1. Product or Line Layout

2. Process or Functional Layout.
3. Fixed Position Layout.
4. Combination type of Layout.

1. Product or Line Layout:

If all the processing equipment and machines are arranged according to
the sequence of operations of the product, the layout is called product
type of layout. In this type of layout, only one product of one type of
products is produced in an operating area. This product must be
standardized and produced in large quantities in order to justify the
product layout.
The raw material is supplied at one end of the line and goes from one
operation to the next quite rapidly with a minimum work in process,
storage and material handling. Fig. 8.3 shows product layout for two
types of products A and B.

Advantages offered by Product Layout:

(i) Lowers total material handling cost.
(ii) There is less work in processes.
(iii) Better utilization of men and machines,
(iv) Less floor area is occupied by material in transit and for temporary
storages.
(v) Greater simplicity of production control.
(vi) Total production time is also minimized.
Limitations of Product Layout:
(i) No flexibility which is generally required is obtained in this layout.
(ii) The manufacturing cost increases with a fall in volume of production.
(iii) If one or two lines are running light, there is a considerable machine
idleness.
(iv) A single machine break down may shut down the whole production
line.
(v) Specialized and strict supervision is essential
2. Process or Functional Layout:
The process layout is particularly useful where low volume of production
is needed. If the products are not standardized, the process layout is
more low desirable, because it has creator process flexibility than other.
In this type of layout, the machines and not arranged according to the
sequence of operations but are arranged according to the nature or type
of the operations. This layout is commonly suitable for non repetitive
jobs.
Same type of operation facilities are grouped together such as lathes will
be placed at one place, all the drill machines are at another place and so
on. See Fig. 8.4 for process layout. Therefore, the process carried out in
that area is according to the machine available in that area.

Advantages of Process Layout:

(i) There will be less duplication of machines. Thus, total investment in
equipment purchase will be reduced.
(ii) It offers better and more efficient supervision through specialization
at various levels.
(iii) There is a greater flexibility in equipment and man power thus load
distribution is easily controlled.
(iv) Better utilization of equipment available is possible.
(v) Break down of equipment can be easily handled by transferring work
to another machine/work station.
(vi) There will be better control of complicated or precision processes,
especially where much inspection is required.
Limitations of Process Layout:
(i) There are long material flow lines and hence the expensive handling
is required.
(ii) Total production cycle time is more owing to long distances and
waiting at various points.
(iii) Since more work is in queue and waiting for further operation hence
bottle necks occur.
(iv) Generally, more floor area is required.
(v) Since work does not flow through definite lines, counting and
scheduling is more tedious.
(vi) Specialization creates monotony and there will be difficult for the
laid workers to find job in other industries

3. Fixed Position Layout:

This type of layout is the least important for today’s manufacturing
industries. In this type of layout the major component remain in a fixed
location, other materials, parts, tools, machinery, man power and other
supporting equipment’s are brought to this location.
The major component or body of the product remain in a fixed position
because it is too heavy or too big and as such it is economical and
convenient to bring the necessary tools and equipment’s to work place
along with the man power. This type of layout is used in the manufacture
of boilers, hydraulic and steam turbines and ships etc.
Advantages Offered by Fixed Position Layout:
(i) Material movement is reduced
(ii) Capital investment is minimized.
(iii) The task is usually done by gang of operators, hence continuity of
operations is ensured
(iv) Production centers are independent of each other. Hence, effective
planning and loading can be made. Thus total production cost will be
reduced.
(v) It offers greater flexibility and allows change in product design,
product mix and production volume.
Limitations of Fixed Position Layout:
(i) Highly skilled man power is required.
(ii) Movement of machines equipment’s to production centre may be
time consuming.
(iii) Complicated fixtures may be required for positioning of jobs and
tools. This may increase the cost of production.
4. Combination Type of Layout:
Now a days in pure state any one form of layouts discussed above is
rarely found. Therefore, generally the layouts used in industries are the
compromise of the above mentioned layouts. Every layout has got
certain advantages and limitations. Therefore, industries would to like
use any type of layout as such.
Flexibility is a very important factory, so layout should be such which
can be molded according to the requirements of industry, without much
investment. If the good features of all types of layouts are connected, a
compromise solution can be obtained which will be more economical
and flexible
Q4) whatis sanitation? Add a note on environmental maintainance in
industry?
The sanitation of clean areas is particularly important. They should be
cleaned thoroughly in accordance with a written programme. Where
disinfectants are used, more than one type should be employed.
Monitoring should be undertaken regularly in order to detect the
development of resistant strains.
The vacuum cleaning lines laid down in plants with connections at
suitable points may be a fast and easy method of cleaning. These can
at least be planned for major corridors and if well planned with a
powerful central vacuum system other workstations may also be
connected to this. The dry dust may be collected by this way at few
selected points in the plants, eliminating physical transfer of collected
dust from the plant. Suitable trash collection systems may also be
planned. Trash collection points may be planned in each section or
subsection. Each such trash collection point may have recycled
plastic bags put in a suitable wire meshed containers and these bags
may be collected along with collected trash at least twice in a shift of
8 hours or whenever required.
Sanitization SOP and records must be in place and followed.
Sanitization SOPs should be clearly described for different areas e.g.,
corridors, engineering service areas, wash places, change rooms,
linen rooms, non-sterile processing areas, primary and secondary
packaging areas and sterile processing areas. Aseptic operations areas
must have vacuum cleaners made up of at least S.S.304 and fitted
with additional HEPA filters. The people doing sanitation work in
aseptic areas must be specifically trained in entry and exit from the
aseptic area, and method of handling sanitation equipment and other
materials like detergents and disinfectants etc for this purpose
substances like cresol with soap, (Lysol) which are highly caustic and
can result into physical accidents because of its contact to skin or eye
etc people must be trained in safety procedures for using such
materials and methods of dealing with accidental injuries by such
caustic substances. U.S.F.D.A. consider the role of sanitary
supervisor as one of the important positions and its detailed job
description is demanded by F.D.A. inspectors during their plant
audits, hence well experienced and suitably qualified people should
be put in charge of this position. Records of sanitary work carried out
as per laid down SOPs must be maintained.

Disinfectants and detergents should be monitored for microbial

contamination; dilutions should be kept in previously cleaned containers and
should only be stored for defined periods unless sterilized. Disinfectants and
detergents used in Grades A and B areas should be sterile prior to use.
Fumigation of clean areas may be useful for reducing microbiological
contamination in inaccessible places.
Environment management system

An Environmental Management System (EMS) is part of an

organization’s overall management system. Itis a systematic
approach dealing with the environmental aspects of an
organization. EMS is a 'tool' thatenables an organization of any
size or type to control the impact of its activities, products or
services on the natural environment.
It provides a framework to help the organization identify those
aspects of its business that have a significant impact on the
environment, toset objectives and targets to minimize the impacts
and to develop programme to achieve targets and implement other
operational control measures to ensure compliance with the stated
environmental policy . A set of international standards brings a
worldwide focus to the environment, thus encouraging a cleaner,
safer, healthier world for us all. The existence of the standards
allows organizations to focus on environmental efforts against
internationally accepted criteria.
The ISO 14000 series of standards developed by ISO/TC 207 effectively
address the needs of organizations worldwide by providing a common
framework for managing environmental issues. They promise to effect a
broadly based improvement in environmental management, which in turn can
facilitate trade and improve environmental performance worldwide.
The ISO 14000 series embodies a new approach to environmental
protection for organizations in the global marketplace.
It challenges an organization to
• Take stock of its impact on the environment;
• Establish its own objectives and targets;
• Commit itself to effective and reliable processes,
prevention of pollution and continual improvement;
Bring all employees and managers into a system
of shared and enlightened awareness and personal
responsibility for the organization’s performance with
reference to the environment.
ISO 14001 “Environmental Management systems – Specification with
guidance for use”

BENEFITS OF EMS:-

• The company emphasizes pollution

prevention rather than pollution creation and
• It can provide evidence of regulatory compliance
• Improving market access;
• Assuring customers of commitment to demonstrate
environmental management;
• Adopting a process of continual improvement;
• Improved environmental performance;
• Adopting a preventive approach to ensure compliance
with statutory and other requirements applicable to
the company;
• Enhancing image and market share;Preventing
pollution by conserving resources like electricity,water,
coal;
• Improved operating efficiency;
• Enhanced employee morale in a safe working
environment;
• Credibility with stakeholders;
• Competitive market advantage;
• Improving cost control;
• Meeting vendor certification criteria;
• Legal compliance and facilitating the attainment of
permits and authorizations;
 • Better image and maintaining good relations with the
public, regulators, shareholders, investors;
• Heightened employee awareness of, and responsibility
towards,the environmental aspects of their activities;
• Competitive advantage in research;

Q5) what is sterile area ? Explain in brief on

maintenance of sterile area?

Sterile area: Clean areas for the manufacture of sterile

products are classified according to the required
characteristics of the environment. Each manufacturing
operation requires an appropriate environmental cleanliness
level in the operational state in order to minimize the risks of
particulate or microbial contamination of the product or
materials being handle.
In addition to the general requirements for the facilities,
sterile-products manufacturing areas should give attention to
following points:
• All premises should as far as possible designed to avoid the
unnecessary entry of supervisory or control personnel. Grade
“B” areas should be designed so that all operations can be
observed from outside.
• In clean areas all exposed surfaces should be smooth,
impervious and unbroken in order to minimize the shedding or
accumulation of particles or micro-organisms and to permit the
repeated application of cleaning agents and disinfectants
used.

• To reduce the accumulation of dust and to facilitate cleaning

there should be no unchangeable recesses and a minimum of
projecting ledges, shelves, cupboard and equipment. Doors
should be carefully designed to avoid unclean-able recesses;
sliding doors are undesirable for this reason.
• False ceilings should be sealed to prevent contamination
from space above them.
• Pipes and ducts should be installed so that they do not
create recesses that are difficult to clean.
• Sinks and drains should be avoided where ever possible and
should be excluded from areas where aseptic operations are
carried out. Where installed they should be designed, located
and maintained so as to minimize the risk of microbial
contamination, they should be fitted with effective, easily
cleanable traps with air break to prevent back flow. Any floor
channel should be open and easily cleanable and be connected
to drains outside the area in a manner that prevents ingress of
microbial contamination.
• Changing rooms should be designed as airlocks and used to
provide separation of the different stages of changing, so
minimizing microbial and particulate contamination of
protective clothing. They should be effectively flushed with
filtered air. The use of separate changing rooms, for entering
and leaving clean areas is sometimes desirable.
• Hand washing facilities should be provided only in the first
stage of changing rooms, not in areas where aseptic work is
done. The final stage of the changing room should in the at
rest state, be the same grade as the area into which it leads.
• Air lock doors should not be opened simultaneously. An
interlocking system and a visual and / or audible warning
system should be operated to prevent the opening of more
than one door at time.
• A filtered air supply should maintain a positive pressure and
an air flow relative to surrounding areas of a lower grade under
all operational conditions and should flush the area effectively.
Adjacent room of different grades should have a pressure
differential of 10-15 pascals (General Guidelines) particular
attention should be paid to the protection of the zone of
greatest risk, that is, the immediate environment to which the
product are exposed clean components which contact the
product are exposed.
The various recommendation regarding air supplies and
pressure differentials may need to be modified where it
becomes necessary to contain some materials e.g.,
pathogenic, highly toxic, radioactive or live viral or bacterial
materials or products. Decontamination of facilities and
treatment of air leaving a clean area may be necessary for
some operations.
• It should be demonstrated that air flow patterns do not
present a contamination risk e.g., care should be taken to
ensure that air flows do not distribute particles from a particle
generating person, operations or machine to a zone of higher
product risk.
• A warning system should be provided to indicate failure in
the air supply. Indicators of pressure differences should be
fitted between areas where these differences are important.
These pressure differences should be recorded regularly or
otherwise documented.
• In addition to above points discussed from various regulatory
guide lines following points must also be considered. These are
discussed in “Annex-1” of orange guide under the title of
“Manufacturing of sterile medicinal products.”
• The manufacturer of sterile products should be carried out in
clean areas, entry to which should be through air locks for
personnel and / or for equipment and materials. Clean areas
should be maintained to an appropriate cleanliness standard
and supplied with air which has passed through filters of an
appropriate efficiency.
• The various operations of component preparation product
preparation and filling should be carried out in separate areas
within the clean area. Manufacturing operations are divided
into two categories, firstly those where the product is
terminally sterilized, and secondly those which are conducted
aseptically at some or all stages.
• Clean areas for the manufacture of sterile products are
classified according to the required characteristics of the
environment. Each manufacturing operation requires an
appropriate environmental cleanliness level in the operational
state in order to minimize the risk of particulate or microbial
contamination of the product or material being handled.
In order to meet “In Operation” conditions these areas should
be designed to reach certain specified air cleanliness levels in
the “at rest” occupancy state. The “at rest” state is the
condition where the installation is complete with production
equipment installed and operating but with no operating
personnel present. The “In Operation” state is the condition
where the installation is functioning in the defined operating
mode with the specified number of personnel working.

For the manufacture of sterile products normally 4 grades can

be distinguished.
Grade A: The local zone of high risk operations e.g., filling
zone, stopper bowls, open ampules and vials making aseptic
connections. Normally such conditions are provided by a
laminar-air-flow work station. Laminar air flow systems should
provide a homogeneous air speed of 0.45 met/sec. ±20% (i.e.
72 to 108 feet /min) (Guidance Value) at the working position.

Grade B: In case of aseptic preparation and filling the

background environment for grade A zone.

Grade C and D: Clean area for carrying out less critical stages
in manufacturing of sterile products.
The airborne particulate classification for these grades is given
in the following table.

(b) The guidance given for maximum permitted number of

particles in the “at rest” condition corresponds approximately
to US federal standard. 209E and the ISO classifications as
follows:
Grades A and B - Corresponds to class 100, M3.5, ISO5 Grade
C - Corresponds to class 10000, M5.5, ISO7
Grade D - Corresponds to class 100000, M6.5, ISO8
(c) The requirement and limit for this area will depend on the
nature of the operations carried out. Examples of operations to
be carried out in the various grades are given in the table
below.
Grade Examples of operations for terminally sterilized products
A Filling of products, when unusually at risk.
C Preparation of solutions, when unusually at risk filling of
products
D Preparations of solutions and components for subsequence
filling

Grade Examples of operations for aseptic preparations

A Aseptic preparation and filling
C Preparations of solutions to be filled
D Handling of components after washing

Maintenance of Pharmaceutical sterile Area: FDA Recommendation:

1.Maintenance of pharmaceutical clean area has its importance in sterile
manufacturing. Sterility of the sterile products is the most important factor for
the product quality and it can be achieved only by the proper maintenance of
the manufacturing area.
2. Areas surrounding the core manufacturing area are known as supporting
areas. These supporting areas have different functions as storage of in-process
materials, cleaned equipment, material transfer etc. These areas should be
designed to minimize the particulate and microbial contamination in the core
manufacturing area where the product is exposed to the air.
3. Different activities in surrounding areas should be conducted according to
the cleanliness class of the area. Less critical activities such as equipment
washing should be done in the 1,00,000 class area. The adjacent area to the
aseptic area (class 100) should be maintained at least at class 10,000. The
manufacturer can maintain it as class 1000 or 100 depending upon the
activities done in the pharmaceutical clean area.

Q6) explain in detail the location design and layouts of industry?

1.The pharmaceutical industry is a major global economic force, which

increasingly relies on the safe and efficient production of technically advanced
products. This environment challenges the facilities professional who is
charged to plan, design ,construct, validate, and operate complex
manufacturing facilities that meet world class pharmaceutical standards. The
facilities professional must master the many dynamic, interacting industry
forces and understand how they influence pharmaceutical manufacturing
facilities, and must apply prudently good design practices in response to these
challenges
[2] PLANT LOCATION:-
Plant location means the establishment of an industry at a particular place. The
performance of an enterprise is considerably affected by its location. The
selection of site for any enterprise mainly depends on its size and nature.
Sometimes, The nature of the product itself suggest some suitable location.
A Small scale industry mainly select the site where in accordance with its
capacity, the local market for the product is available. It can easily be shifted to
other place, when there is any change in the market.
But in the case of Large scale industries, Where huge amount of investment
has already been done the selection of proper site is very important.
IMPORTANCE OF PLANT LOCATION:
The selection of appropriate location is important due to the following
reasons :--
 Location of plant partially determines operating and capital costs. It
determines the nature
of investment costs to be incurred and also the levels of operating costs.
Location fixes some of the physical factors of the overall plant designs. e.g.
heating and
ventilation requirements, storage capacity of raw material taking into
consideration their local availability, transportation need for raw materials and
finished goods, power needs ,cost of labours, taxes, land construction, fuel, etc.
Each prospective location implies a news allocation of capacity to
respective market area.
Government sometimes plays an important role in the choice of location
keeping in view
the national benefits.
FACTORS RESPONSIBLE FOR THE PLANT LOCATION CHOICES:
The choices of the plant location is based on the following factors :------
Availability of Raw material: An ideal location is one where the main raw
material required
to manufacture the product is adequately available. This will ensure regular
supply of the material and will reduce the transportation costs.
Nearness to the potential market: marketing of finished goods efficiently is
an important function of an enterprise. If the plant is located near the market,
then the management can keep close touch with their changes in market
environment and formulate its production policies accordingly. Moreover, the
transportation and other overhead expenses are reduced.
Location should be near to source of operating power: in some industries,
continuous and adequate power supply is needed.
There are certain industries for which cheap electricity may be very important.
In such situation, location of the plant near to the hydel-power situation will
provide cheap electricity.
Supply of labour: labour is one of the most important inputs in any
industrial enterprise. There should be regular and cheap supply of labour,
specifically the unskilled labour. If there is adequate supply of local labour near
the plant, then naturally it will be available at cheaper rates.
Transport and communication facilities: Transport is very important for
bringing raw materials, fuel from different places, marketing of finished
products etc. The region well connected with rail, road, water and air transport
system is considered to be more appropriate for the location of the plants.
Similarly good communication facilities, such as, postal and
telecommunication links are of great significance towards the success of an
enterprise. Regions with good communication system should be given priority
for the selection of the sites.
Similarly, industries producing goods for exports may be located near ports or
airports.
Suitability of land and climate: sub-soil of the location should be able to
support the load likely to be placed on it. Similarly, climatic conditions viz
humidity, temperature and other atmospheric conditions should be favourable
for the plant. For the example, humid atmosphere is not suitable for the
formation of pharmaceuticals.
Integration with other group of companies: new enterprise owned or
operated by a single group of companies should be so located that its work can
be integrated with the work of the associated establishments.
Availability of housing, other amenities and services: good housing facility,
adequate shopping centre, theatres, cinema halls, restaurants, local transport
facilities, rail services and sufficient availability of gas, water supply, drainage,
disposal of waste, can easily attract good staff.
Local building and planning regulations: proposed location should not be
infringe local regulations and bye-laws. A discussion with survey department
of the local authority is most desirable. Laws for the construction of buildings,
local taxes etc. should be taken into consideration for the selection of site.
Safety requirements: industries likely to cause pollution or processes
explosives in nature should be located in remote areas.
Miscellaneous considerations: The consideration like low interest on loans,
special grants, low rentals, attitude of residents, towards the industry, living
standards etc. helps in locating in the site of plants.
SELECTION OF SITE:
Once an appropriate area is chosen for certain plant, next step is location
analysis to choose suitable site in that area. The choice of site is important both
for objective and subjective reasons.
The following points should be kept in mind for the selection of the site:-
1. It should be well connected with rail, road and river transports.
2. There should be efficient sewage system for the disposal of water and waste
materials.
3. The surroundings should be good and peaceful.
4. The sub-soil should be capable of bearing the load of the building plant and
equipment.
5. There should be sufficient land to meet the present as well as the future
space
requirements of the plant. There should be provision for the parking of
transport and sufficient space for residential accommodation for staff and
labour.
Site can be selected both in urban or rural areas.
Urban area can provide better transport and communication system with
sufficient labour
supply. There can also be adequate security arrangements as well as other
social services like medical, entertainment, restaurants, educational etc. But in
urban area, cost of land and labour wages are likely to be on higher side.
Rural area can provide cheaper land and labour with scope for further
expansion. The local taxes and expenditure on other amenities is likely to be
very low. The main shortcomings of rural plant site lies in scarcity of skilled
labour, good shopping complexes, entertainment facilities, school and colleges
and other amenities. In general, rural location is good for large plants.
PLANT LAYOUT:-
Once a decision about location of the plant has been taken, next important
problem
before the management is to plan suitable layout for the plant. Efficiency and
performance of good machines and sturdy building depend to a great extent on
the layout of a plant.
Plant layout is the method of allocating machines and equipment, various
production processes and other necessary service involved in transformation
process of a product with the available space of the factory, so as to perform
various operations in the most efficient and convenient manner providing
output of high quality and minimum cost.
Planning the layout of a plant is a continuous process as there are always
chances of making improvements over the existing arrangement. The
disposition of the various parts of a plant along with all the equipment used is
known as plant layout. It should be so designed that the functioning of plant
would become very efficient.
A good layout results in comforts, convenience, safety, efficiency, compactness
and profits. A poor layout results in congestion, waste, frustration and
inefficiency.
ADVANTAGES OF A GOOD LAYOUT:
A good layout can provide a number of advantages to workers and

management. Some of these are given below:-----

I.To the worker:
1.There are lesser number of operation and material handling.
2.There is reduction in length of hauls and motions between operations, which
minimize production time as well as the activities of workers.
3.There is more labour productivity i.e. more output per man hour.
4.There is more safety and security to workers from accidents.
5.Better working conditions resulting in improved efficiency.
II.In manufacturing costs:
1.Maintenance and replacement costs are reduced.
2.Loss due to waste and spoilage is minimised.
3.Improved quality of product with reduction in handling w.r.t. movement, time
and cost. Better cost control.
4.In production control and supervision:
5.It provides more space for production operation.
6.There is efficient arrangement for receipt, transportation, and delivery of raw
material and finished goods.
7.The cost and efforts in the supervision of production are minimized.
8.There is a better and convenient storage facility.
Control and supervision operations are provided at appropriate points.
FEATURES OF A GOOD LAYOUT:
The good layout should possess the following basic characters:--
1. There should be sufficient space for the workers as well as for the equipment
to perform
their functions. This will ensure smooth and continuous flow of production
process.
2. It must provide adequate safety and security to workers against accidents or
injury. For
example, provision of fire fighting equipment, first aid boxes, etc.
3. The arrangement of machines and equipment should be such that minimum
material
handling is necessary for low cost processing.
4. The store for in-process material should be such that minimum material
handling is
necessary for low cost processing.
5. The supervision, coordination and control of the activity should be
effectively and easily
executed.
6. There should be sufficient scope for making adjustment and modifications
whenever any
need arises.

PLANNING:-
A plan is a course of action to be taken in future. It is a prescribed course of
action.
Planning is the process of deciding in advance what to do, how to do it,
when to do it and
who is to do it.
 It involves the selection of objectives, policies, procedures, and programmes
from among
alternatives.
Planning is a mental exercise that requires imagination, foresight and sound
judgments.
It is thinking before doing.
SALIENT FEATURES OF PLANNING:
The following points highlight the nature of planning:
1. Planning is goal oriented : planning is done to achieve certain objectives and
all plans are
linked with the goals of the organization. Planning identifies the action that
would lead to the desired results quickly and economically.
2. Planning is future oriented : planning seeks to manage future events to the
best advantage of the organization. Scientific anticipation of future events is
called forecasting which serves as the basis of planning. For example,
manufacturer prepares the production plan of the next year after forecasting the
demand.
3. Planning is intellectual process : planning is a mental exercise and it
involves the creative thinking and imagination. Management can prepare sound
plans only when it has sound judgment, foresight and vision. Planning requires
mental predisposition to think before acting. Planning is not mere guess work
but involves logic and systemic thinking.
4. Planning is a primary function of management : planning serves as the basis
for all other functions of management. It precedes organizing, staffing,
directing and controlling. Allthese function are preformed within frame work
of plans. Thus planning is the most basic function.
5. Planning is pervasive : planning is required in all types of organization and
at all levels of management. Every department prepares plans. However, the
scope of planning may differ from one level to another. For example, top
management plans for the whole of the organization, middle management
prepares departmental plans, whereas the lower management prepares day to
day operational plans.
6. Planning is continuous : planning is ongoing process. Plans are prepared for
a specified period say for one year. At the end of that period, new plans have to
be prepared. Similarly, existing plans are required to be changed, if the
conditions are changed. Thus planning is never ending exercise.
7. Planning involves choice : planning is essentially the process of choosing
from among alternatives course of action. If there is only one possible
alternatives, there is no need for planning as there is no choice. The planning is
needed when there are various alternatives to reach to a definite goal.
8. Planning aims at efficiency : plans are prepared to achieve the objectives in
the best way. Sound planning helps to achieve desired objectives at the
minimum possible cost. It helps in optimization of resources. A good plan
should provide maximum satisfaction to those responsible for its execution.
ADVANTAGES:
1. Planning makes goals clear and specific. Plans serves as a guide for deciding
what actions should be taken. With clear goals, activities become meaningful.
2. Planning helps the organization to keep on the right path.
3. Planning reduces the risks and uncertainly. Business enterprises operate in
an uncertain
environment. Planning enables to predict future events and prepares to face the
unexpected events.
4. It improves the efficiency of operation because planning involves selection
of the best
possible course of action.
5. It provides basis of control. Planning provides the standard against which the
actual
performance can be measured and evaluated.
6. It promotes creativity, because only sound planning encourages creative
thinking. This leads
to growth and expansion of business.
7. It facilitates decision making. Planning involves forecasting of future
conditions and helps
the management to take correct decision.
8. It helps in coordinations. Planned targets and programmes serves as the basis
of
harmonizing the efforts of different departments, sections and individuals to
achieve it.
LIMITATIONS :
1. Planning is an expensive process. Money is involved in forecasting,
collection of information
The cost of planning should not exceeds the gain expected from it.

Q7 ) what are the personnel responsibilities and training employees in

industry ?

Training of employees takes place after orientation takes place. Training is the process of
enhancing the skills, capabilities and knowledge of employees for doing a particular job. Training
process moulds the thinking of employees and leads to quality performance of employees. It is
continuous and never ending in nature.
Importance of Training

Training is crucial for organizational development and success. It is fruitful to both employers and
employees of an organization. An employee will become more efficient and productive if he is
trained well.

Training is given on four basic grounds:

1.New candidates who join an organization are given training. This training familiarize
them with the organizational mission, vision, rules and regulations and the working
conditions.

2.The existing employees are trained to refresh and enhance their knowledge.

3.If any updations and amendments take place in technology, training is given to cope up
with those changes. For instance, purchasing a new equipment, changes in technique of
production, computer implantment. The employees are trained about use of new
equipments and work methods.

4.When promotion and career growth becomes important. Training is given so that
employees are prepared to share the responsibilities of the higher level job.

The benefits of training can be summed up as:

1.Improves morale of employees- Training helps the employee to get job security and
job satisfaction. The more satisfied the employee is and the greater is his morale, the
more he will contribute to organizational success and the lesser will be employee
absenteeism and turnover.

2.Less supervision- A well trained employee will be well acquainted with the job and will
need less of supervision. Thus, there will be less wastage of time and efforts.

3.Fewer accidents- Errors are likely to occur if the employees lack knowledge and skills
required for doing a particular job. The more trained an employee is, the less are the
chances of committing accidents in job and the more proficient the employee becomes.

4.Chances of promotion- Employees acquire skills and efficiency during training. They
become more eligible for promotion. They become an asset for the organization.

5.Increased productivity- Training improves efficiency and productivity of employees.

Well trained employees show both quantity and quality performance. There is less
wastage of time, money and resources if employees are properly trained.

Ways/Methods of Training
Training is generally imparted in two ways:

1.On the job training- On the job training methods are those which are given to the
employees within the everyday working of a concern. It is a simple and cost-effective
 training method. The inproficient as well as semi- proficient employees can be well
trained by using such training method. The employees are trained in actual working
scenario. The motto of such training is “learning by doing.” Instances of such on-job
training methods are job-rotation, coaching, temporary promotions, etc.

2.Off the job training- Off the job training methods are those in which training is
provided away from the actual working condition. It is generally used in case of new
employees. Instances of off the job training methods are workshops, seminars,
conferences, etc. Such method is costly and is effective if and only if large number of
employees have to be trained within a short time period. Off the job training is also called
as vestibule training,i.e., the employees are trained in a separate area( may be a hall,
entrance, reception area,etc. known as a vestibule) where the actual working conditions
are duplicated.

The Duties and Responsibilities of an Employee

Employee roles depend on the scope of the job as defined by the employer's
manual and training and as they are explained when the employee accepts
the position. It is the job responsibility of human resources personnel to
provide all relevant information about the requirements of a position during a
new employee's onboarding process. It is the employee's responsibility to
listen and to read and absorb this information to prepare for employment with
the company.
An employee's role may change over time as a company's products and
processes evolve. Although these changes often happen under the radar, it is
good form for managers and human resources personnel to proactively and
explicitly redefine the employee's role and the new duties and responsibilities
that come along with it. This clarity and communication gives employees the
tools and information they need to step up and meet these evolving
expectations.

Employee Safety Responsibilities

It is the employer's responsibility to provide a safe workplace, but it is the duty
of each employee to listen and to read and understand the information
provided about how to work safely and comply with company and federal
safety requirements. Some of these safety requirements are based on rules
and regulations coming from the Occupational Safety and Health
Administration, which crafts safety rules that are industry specific as well as
those that are applicable to all sectors.
Employers are responsible for posting relevant safety rules and responsibilities
in the workplace, and employees are responsible for reading and
complying. OSHA may require that employees working with hazardous
chemicals wear safety goggles, and the employer is usually responsible for
providing these goggles, but employees are responsible for wearing these
goggles during each shift even if a manager isn't present to enforce the rule.
This compliance is in the best interest of employees, who minimize the risk of
eye injuries, and employers, who lessen the odds of injuries that interfere with
work flow, hurt employee morale and expose the business to potential fines
and citations.
Moral and Professional Responsibilities

The actions of an employee reflect on that employee's company, so employees

are responsible for behaving in ways that are beneficial to the companies that
employ them and, at the very least, they should not do any unnecessary
damage to their employer's reputation.
An employee who processes customer transactions will handle sensitive
banking and credit card information and is responsible for only using this
information to complete the specified transactions. Employees of a business
that installs security systems may learn about customer vulnerabilities but are
bound by duty to not exploit these weaknesses for personal gain.
Employees are also responsible for acting professionally, even when their
managers are not watching their work closely. This professional behavior can
include dressing appropriately, speaking civilly to customers and providing
quality products and services. Acting and working professionally fulfills the
employee's responsibilities to the employer .