Darshan Patel_final thesis

Achieve Desire Productivity through Effective

Production GAP Analysis

A

Management Internship Program Report

Submitted to

SVKM’s

Narsee Monjee Institute of Management Studies (NMIMS)

M.Pharm (Pharmaceutics) + MBA (Pharma Tech & Healthcare Management)

By

Mr. Darshankumar R. Patel

Under the guidance of

Mr. Haresh Raulgaonkar

School of Pharmacy & Technology Management,

SVKM’s NMIMS,

Vile Parle (W), Mumbai-400056

2015

Statement by the candidate

This is to submit that this written submission in my report entitled “Achieve Desire

Productivity through Effective Production GAP Analysis” represents my ideas in my own

words and where others’ ideas or words have been included, I have adequately cited and

referenced the original sources. I also declare that I have stick to all principles of academic

honesty and integrity and have not misrepresented or fabricated or falsified any idea / data /

fact / source in my submission. I understand that any violation of the above will be cause for

disciplinary action by the School and can also evoke penal action from the sources which have

thus not been properly cited or from whom proper permission has not been taken when needed.

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Assistant Professor

SPP School of Pharmacy & Technology Management,

SVKM’s NMIMS,

Vile Parle (W),

Mumbai - 400056

Certificate

The work described in this report entitled “Achieve Desire Productivity through Effective

Production GAP Analysis” has been carried out by Mr. Darshankumar R. Patel under my

supervision. I certify that, this is his bonafide work. The work described is original and has

not been submitted for any degree to this or any other university.

Date:

Place:

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Assistant Professor

______________________

Chairperson

______________________

Dean

Success is the sweet and succulent fruit of vision, inspiration, guidance and execution.

I earnestly revere The Almighty Lord for his boundless blessings, which accompanied me in

all endeavors of journey. I, therefore take this opportunity to register my acknowledgements to

all who supported me directly and indirectly in this journey.

I express my sincere thanks to Mr. Sunil Chaturvedi for giving me an opportunity to

work with esteemed organization, Novartis Vaccines.

It gives me immense pleasure in expressing my sincere regards and gratitude to Dr. R.

S. Gaud, Dean, School of Pharmacy and Technology management, SVKM’s NMIMS for their

support and constant encouragement for the project.

I am extremely grateful to my guide, Mr. Haresh Raulgaonkar, Assistant Professor,

School of Pharmacy and Technology management, SVKM’s NMIMS for his valuable

guidance, co-operation, affectionate encouragement and moral support throughout the course

of journey without whom it would have been a distant goal. I am greatly indebted towards him.

I have lack of words but I wish to express my warm regards,deep sense of gratitudes

and sincere thanks to Mr. Manoranjan Rayguru (GDSO, Senior Executive Manager) and

Mr. Surajit Pakira (GDSO, Senior Executive Manager) Zydus Cadila Healthcare Pvt Ltd.,

for the enthusiasm and support laid by them during all stages of my work and valuable

guidance, which boosted me to complete my project. I had a great pleasure and sweet

experience for doing my project under them and without whom I would not have got the

opportunity to proceed with this project work in this highly newer complicated field.

I am highly indebted to Mr. Bhavik Siddhpuriya, Mr. Manoj Patil and Mrs. Anuja

Roy for their continuous guidance &constant support.

I am eternally indebted to my Parents, Grand Parents, Brothers and Sisters for their

blessings, inspirations, constant support, faith in me and love throughout my life never tiring

moral support and dedicated efforts to educate me to this level. Which made my dreams comes

true & I promise to come up to their expectation.

This thesis would not have been possible without the support of my friends (Vishal,

Ankit, Brijesh, Yashdeep and Vishal Kulkarni) and my fiancé (Miss Payal). I’ll always

cherish the time spent with them.

Last but not the list I am also thankful to my M.Pharm + MBA classmates Chirag,

Jigar, Navin, Pritesh, Darshak, Sanket, Rudra, Bhavik, Ronak, Maulin & Palak for moral

support & motivation during my curriculum.

To sum up, I would only say that without the association of all the people mentioned,

the blessings of almighty and elders and also the ones whom I might have missed to mention,

this endeavor itself would have been a distant goal.


TABLE OF CONTENTS

I

Sr. No. Title Page No.

LIST OF TABLES III

LIST OF FIGURES IV

ABBREVIATION V

1 ABSTRACT 1

2 INTRODUCTION 2-17

2.1 Production GAP Analysis 2

2.2 GAP Analysis Tools 4

2.2.1 Spreadsheets Analysis 4

2.2.2 Fishbone Analysis 5

2.2.3 McKinsey 7S Model 6

2.2.4 SWOT Analysis 7

2.2.5 Nadler-Tushman Model 9

2.2.6 Force Field Analysis 9

2.2.7 SERVQUAL Model 10

2.2.8 Weisbord’s Six-Box Model 12

2.2.9 Organization Intelligence Model 13

2.2.10 PDCA Cycle 14

2.3 Objective of Production GAP Analysis 15

2.4 Function 15

2.5 Significance 16

2.6 Benefits 16

TABLE OF CONTENTS

II


2.7 Requirements 16

2.8 Research Limitation 16

2.9 Literature Review 17

2.10 Research Methodology 17

3 RESEARCH WORK AND DISCUSSION 18-27

3.1 Production GAP Analysis Tools 22

3.1.1 Spreadsheets Analysis 22

3.1.2 Fishbone Analysis 24

3.1.3 McKinsey 7S Model 25

3.1.4 SWOT Analysis 25

3.1.5 Nadler-Tushman Model 26


4 RECOMMENDATION 28-34

4.1 Kaizen Gemba 28

4.1.1 Common Subjects of kaizen Gemba 28

4.1.2 Implementation 29

4.1.3 Relationship of KAIZEN GEMBA, PDCA and SDCA

Circles 29

4.2 5s Strategy Implementation 31

4.3 Resolve Skilled Manpower Shortage Problem 33

4.4 Other Recommendation 33

4.5 Changes in Current System 34

5 REFERENCES 35

LIST OF TABLES

III


2 INTRODUCTION 2-17

2.1 SWOT Matrix (2x2 matrix using internal/external categories) 8

2.2 2x2 SWOT Matrix (four categories) 8-9

2.3 Details and cause of Service GAP 11


3.1 January-2015 Production Report 19

3.2 February-2015 Production Report 20

3.3 March-2015 Production Report 21

3.4 Monthly Summary Report 22

3.5 List of Reasons behind Production Short Fall 23

LIST OF FIGURES

IV


2 INTRODUCTION 2-17

2.1 McKinsey 7S Model 6

2.2 SERVQUAL Model 10

2.3 Weisbord’s Six-Box Model 12

2.4 Organization Intelligence Model 13


3.1 Monthly Production Overview 22

3.2 Graphical Representation of Reasons behind Production Short Fall 23

3.3 Fishbone Diagram 24

3.4 Schematic Diagram of SWOT Analysis 26

3.5 Schematic Diagram of Force Field Analysis 27

4 RECOMMENDATION 28-34

4.1 Schematic Diagram of PDCA and SDCA - Continuous Improvement 31

LIST OF ABBREVIATION

V

API Active Pharmaceutical Ingredient

GK Gemba Kaizen

OOT Out of Trained

PD Process Development

PDCA Plan Do Check Act

Qty. Quantity

RM Raw Material

Rs Rupees

SAP Systems, Applications, Products in Data Processing

SDCA Standardize Do Check Act

Sr. No. Serial Number

US-FDA United State – Food and Drug Administration

Chapter 1 Abstract

SPP, School of Pharmacy & Technology Management, NMIMS, Mumbai. 1

BSTRACT

Today’s practices in production are faced with volatility in demand, uncertain economy,

rising process/material costs and intense rivalry. Improving overall productivity and efficiency

at operations level has become an essential not just for margin purposes, but always act in line

with customer needs and achieving long term success. By reducing cost and improving

productivity, we can gain competitive advantage in whole market.1

Operational excellence is the pursuit of conducting integrated business planning (M2M

planning) and continuously improvement in performance at operations level. We can achieve

desire productivity through effective production GAP analysis which can be accomplished by

identify GAP between an optimized allocation of resources and integration of inputs, and the

current level of allocation. This helps provide the company with insight into areas which could

be improved. Once the general expectation of performance in the industry is understood, it is

possible to compare expectation with the company's current level of performance. This

comparison becomes the GAP analysis which can be performed at the strategic, tactical or

operational level of an organization in continuous manner for maintaining flow of operations

without any interruption and achieving expected productivity.

A

Chapter 2 Introduction


NTRODUCTION

Market rivalry is introducing high pressure on cost, quality and responsiveness to

consumer demands. Key challenges in manufacturing firms are lack of visibility and control in

production era and accomplish production operations in a proactive manner. Real time

measuring, monitoring and controlling through managers and production personnel is a tough

job. There is need of documentation, tracking and auditing to ensure compliance. To achieve

desire production, it is important to execute overall plan in an effective manner and evaluated

at fixed interval time for progress report, to provide visibility, of the operations.

Without any planning, we cannot execute process perfectly and cannot achieve desire

outcome. Production planning is a very vast process in which all parts include from starting

resource material management to actual delivery as per required demand on time. Production

planning is one of a technique related to achieve desire productivity. But some of external and

internal factor which affect to manage effectively all-over process of production planning,

Like –

- External factor: availability of funds, power, water, means of transport and

communication, raw and packing materials etc.

- Internal factor:

(a) Static factor: Difficult to change; which includes plant and equipment, raw and

packing materials, energy, products, technology, etc.

(b) Dynamic factor: men, management practices, work methods, systems, work culture

By managing these factors, we can effectively manage production planning process and getting

desire output without any disturbance. But in current scenario, this will not happened. So, by

using of effective GAP analysis, we can address the actual problems for executing planned

production process and solve them. [2-4]

2.1 Production GAP Analysis [8-9]

GAP analysis is a tool for companies to correlate actual performance with potential

performance. By asking two questions: "Where are we?" and "Where do we want to be?” we

can find out era where we are needed to improve. If a company or organization is not creating

the best usage of its current resources or is forgoing investment in capital or technology, then

I



it may be producing or performing at a level below its potential. This concept is analogous to

an economy's being below the production possibilities frontier.

Production GAP analysis addresses gaps where improvisation can be happened. GAP

analysis encompasses determining, documenting, and approving the variance between business

requirements and current capabilities. Production GAP analysis naturally flows from

benchmarking and other assessments. Once the general expectation of Production in the

industry is understood, it is probable to compare that planned production with the company's

current level of production. This comparison turn out to be the Production GAP analysis. Such

analysis can be done at the strategic, tactical or operational level of an organization. Production

GAP analysis is a formal study of what Organization Producing currently and where it wants

to go in the future. It can be conducted, in different viewpoints, as follows:

1) Organization (e.g., Human Resources)

2) Business direction

3) Business processes

4) Information technology

5) Gap in actual foundation for measuring investment of time, money and human resources

required to accomplish a particular outcome.

6) The need for new products or additions to current lines may arise from portfolio analysis,

or the need may arise from the regular process of following trends in the requirements of

consumers. At some point, a gap emerges between what existing products offer and what

the consumer demands. The organization must fill that gap to survive and grow.

7) GAP analysis can recognize gaps in the market. Thus, associating forecast profits to desired

profits reveals the planning gap. This signifies a goal for new activities in general, and new

products in particular. The planning gap can be divided into three main elements:

1) Usage gap

This is the gap between the total potential for the market and actual current usage

by all consumers in the market.

Usage gap = market potential – existing usage

Data for this calculation take account of:

- Market usage

- Existing usage

2) Existing usage

Existing consumer usage makes up the total current market, from which market

shares, for example, are calculated. It usually derives from marketing research, from



panel research and also ad hoc work. Sometimes it may be obtained from figures that

governments or industries have collected. Many, if not most, marketers accept existing

market size—suitably projected their forecast timescales—as the boundary for

expansion plans. Though this is often the most realistic assumption, it may execute an

unnecessary limit on horizons. For example: the original market for video-recorders

was limited to professional users who could afford high prices. Only after some time

did the technology extend to the mass market.

Usage gap is most significant for brand leaders. If a company has a significant

share of the whole market, they may find it worthwhile to invest in making the market

bigger. This option is not generally open to minor players, though they may still profit

by targeting specific offerings as market extensions.

All other gaps relate to the difference between existing sales (market share) and

total sales of the market as a whole. The difference is the competitor share. These gaps

therefore, associate to competitive activity.

3) Product gap

The product gap—also called the segment or positioning gap. This may be

because the market is segmented and the organization does not have offerings in some

segments, or because the organization positions its offerings in a way that effectively

excludes certain potential consumers—because competitive offerings are much

superior positioned for these consumers.

The product gap may be the main element of the planning gap where an

organization can have productive input; hence the weightage on the significance of

correct positioning.

2.2 GAP Analysis Tools

2.2.1 Spreadsheets Analysis

Computer spreadsheets are ideally suited for analyzing gaps in financial outcome. They

let you explore the effects of changes in values you regulate and see the results in the values

that interest to company. For example, if your profits are too low, you can placed all the

individual costs of production and the prices you charge into a spreadsheet. If you practice the

spreadsheet to calculate your profits, changing your prices gives you the effect on profits as

does altering some of the costs. You can govern how much you have to change the prices or

reduce the costs to get the profit you want.



2.2.2 Fishbone Analysis

Fishbone analysis is suited for perceiving at gaps in production results. The analysis

lists the 6Ms: manpower, methods, metrics, machines, materials and minutes and investigate

how they relate to the central problem. You have to inquire what additional people you require,

what processes like automation, what measurements to check for progress, what equipment,

what specific supplies and how much time. Bringing these fishbones together toward the central

bone bridges the gap.

The fishbone diagram is an analysis tool that gives a systematic way of looking at effects

and the causes that create or contribute to those effects. Because of the function of the fishbone

diagram, it may be referred to as "Problem-Analysis Tool" or the "Cause-&-Effect

Diagram". Dr. Kaoru Ishikawa a Japanese Quality Control Statistician developed the Fish

Bone Diagram in the year 1960. This diagram is used to address all the potential causes (during

the input, or process until the output stage) that result in a single effect (output).

The potential causes could be due to any of the 6(M's), 8 (P's), & 4 (S's)

6M's - Machines, Method, Material, Maintenance, Man & Mother Nature

8P's - Price, Promotion, People, Process, Place, Policy, Procedure, Product

4S's -Surrounding, Suppliers, Systems, Skills

The causes are organized according to their level of importance to recognize the root

cause of a problem (effect).This diagram is valuable for identifying and organizing the

known or possible causes of quality or the lack of it.

Steps to a Fishbone Diagram and to Identifying Those Causes

The fishbone diagram is a simple tool that permits quick and effective root causes to be

understood, in the taking of corrective actions.

Often referred to as a cause and effect diagram, or Ishikawa, it is a simple root cause analysis

tool that is used for brainstorming issues and causes of particular problems and consumed

in conjunction with the 5 Whys tool.

In a fishbone diagram, the various causes are clustered into categories and the causes

cascade from the main categories, flowing towards the effect, forming what bear a

resemblance to a fishbone appearance.

The prime concern is to brainstorm all the possibilities that could cause the problem and

then drill down to the factor(s) that are causing this issue. Once found, eliminate them. It

enables the team to focus on why the problem occurs, and not on the history or symptoms



of the problem, or other topics that digress from the intent of the session. It also exhibits a

real-time 'snap-shot' of the collective inputs of the team as it is updated.

2.2.3 McKinsey 7S Model

We can use the McKinsey 7S framework when a particular part of the company is not

living up to expectations. The seven aspects McKinsey examines are strategy, structure,

systems, shared values, skills, style and staff. The analysis looks at the characteristics of the

company in terms of each of these aspects and examines how the target group, where the gaps

are, doesn't fit. Once it is clear that the reason for the gaps is a lack of skills, for example, or a

different structure, you can address the problem in a focused way.

Definition of 'McKinsey 7S Model': A model of organizational effectiveness that postulates

that there are seven internal factors of an organization that need to be aligned and reinforced in

order for it to be successful.

Investopedia explains 'McKinsey 7S Model': The 7S Model specifies seven factors that are

classified into "hard" and "soft" elements. Hard elements are easily identified and influenced

by management, while soft elements are fuzzier, more intangible and are influenced by the

corporate culture. The hard elements are: strategy, structure and systems. The soft elements are:

shared values, skills, style and staff.

Figure No 2.1: 'McKinsey 7S Model'



2.2.4 SWOT Analysis

SWOT analysis works well when the company has a specific problem and is

looking for ways to solve it. The GAP analysis identifies where the gaps are that

characterize the overall problem. SWOT analysis asks what are the company's strengths,

weaknesses, opportunities and threats. Describing the problem in these terms often

points the way toward a solution by showing you how to avoid potential threats while

using strengths to exploit an opportunity.

The SWOT analysis is an extremely beneficial tool for understanding and decision-

making for all sorts of situations in business and organizations. SWOT is an acronym for

Strengths, Weaknesses, Opportunities, and Threats. Information about the origins and inventors

of SWOT analysis is below. The SWOT analysis headings provide a good framework for

reviewing strategy, position and direction of a company or business proposition, or any other

idea. Completing a SWOT analysis is very simple, and is a good subject for workshop sessions.

SWOT analysis also works well in brainstorming meetings. SWOT analysis is often interpreted

and used as a SWOT Analysis 2x2 Matrix, especially in business and marketing planning.

In addition to this 2x2 matrix method, SWOT analysis is also a widely recognized

method for gathering, structuring, presenting and reviewing extensive planning data within a

larger business or project planning process.

If you use SWOT Analysis as a 2x2 matrix method, then technically Strengths and

Weaknesses are internal factors, whereas Opportunities and Threats are external factors.

The SWOT 2x2 'internal/external' matrix method thus only considers external threats and

opportunities.

A SWOT analysis is a subjective assessment of data which is organized by the SWOT

format into a systematic order that helps understanding, presentation, discussion and decision-

making. SWOT analysis can be used for all sorts of decision-making, and the SWOT template

enables proactive thinking, rather than relying on habitual or instinctive reactions.

Strengths and Weaknesses, are 'mapped' or 'graphed' against Opportunities and

Threats. To enable this to happen cleanly and clearly, and from a logical point of view anyway

when completing a SWOT analysis in most business and marketing situations, Strengths and

Weaknesses are regarded distinctly as internal factors, whereas Opportunities and Threats

are regarded distinctly as external factors. Here is the explanation in more detail:



Table No 2.1: SWOT Matrix (2x2 matrix using internal/external categories)

Strength and

Weakness

The internal

environment- the

situation inside the

company or

organization

For example, factors relating to

products, pricing costs, profitability,

performance, quality, people, skills,

adaptability, brands, services,

reputation, processes, infrastructure, etc.

Factor tend

to be in the

present.

Opportunities

and Threats

The external

environment – the

situation outside

the company or

organization

For example, factors relating to markets,

sectors, audience, fashion, seasonality,

trends, competition, economics, politics,

society, culture, technology,

environmental, media, law, etc.

Factors

tend to be in

the future.

Here is a typical extension of the basic SWOT analysis grid into a useful ‘action based’

2x2 SWOT matrix. The SWOT analysis in this format acts as a quick decision-making tool,

quite aside from the more detailed data that would typically be fed into business planning

process for each of the SWOT factors.

Here the 2x2 matrix model automatically suggests actions for issues arising from the SWOT

analysis, according to four different categories:

Table No 2.2: 2x2 SWOT Matrix (four categories)

Strength (Internal) Weakness(Internal)

Opportunities

(External)

Strengths/Opportunities

Apparent priorities likely to

produce greatest ROI (Return On

Investment). Probably justifying

immediate action – planning or

feasibility study. Executive

focusing on unmet areas and

prioritizing them.

Weakness/opportunities

Potentially attractive options Likely

to produce good returns if capability

and implementation are viable.

Executive focusing on parameters

which are actually stopping us doing

desire things and try to sort out

obstacle.



Threats

(External)

Strengths/Threats

Easy to defend and counter Only

basic awareness, planning and

implementation required to meet

these challenges. Investment in

these issues is generally safe and

necessary.

Executive concentrate on gathering

properly information and organized

to deal with these issues which is

hidden surprises. Try to convert

these threats into opportunities.

Weakness/Threats

Potentially high risk assessment of

high crucial.

Where risk is low, we must ignore

these issues and not be distracted by

them. Where risk is high, we must

assess capability gaps.

Executive focusing on specific

controlled reliable plans to

avoid/avert/defend high risk area.

2.2.5 Nadler-Tushman Model

The Nadler-Tushman model looks at how the whole company works together. It

practices the concept of congruence to analyze gaps that affect the operational efficiency of the

entire organization. It treats the company as a social system made up of elements that work

together to transform inputs into outputs. It looks at how inappropriate inputs can lead to gaps;

how a failure to work together in the transformation functions can produce gaps; and how you

can trace back gaps in outputs. Characterizing company operations in this way can lead to

insights about which parts of the company don't work well together or are not congruent. Such

insights let you recognize specific problems and fix the resulting gaps.


In 1951, Kurt Lewin developed a model for analyzing and managing organizational

problems which he has termed Force Field Analysis. This model is relatively simple to

understand and easy to visualize. A depiction of the model identifies both driving forces and

restraining forces within an organization. These driving forces, such as environmental factors,

push for change within the organization while the restraining forces, such as organizational

factors (e.g., limited resources or poor morale), act as barriers to change. To understand the

problem within the organization, the driving forces and restraining forces are first identified



and, hence, defined. Goals and strategies for moving the equilibrium of the organization toward

the desired direction can then be planned.

The model relies upon the change process, with the social implications built into the

model (e.g. disequilibrium is expected to occur until equilibrium is reestablished). The general

goal of this model is to intentionally move to a desirable state of equilibrium by adding driving

forces and eliminating restraining forces. These changes are thought to occur simultaneously

within the dynamic organization.

2.2.7 SERVQUAL Model 12

The marketing research team of Parasuraman, Zeithamel, and Berry created this service

quality measuring tool in 1988.

Has been used in a wide range of studies including fields such as health care, banking,

appliance repair, and many other professions.

SERVQUAL is not a measurement to compare and rank separate companies but only to provide

a measure for managers to determine actions needed in their own services

Figure No 2.2: SERVQUAL Model



Five Gaps include

Customer expectations vs. managerial perceptions

Manager’s expectations of quality vs. quality specs

Communication with customer at point of service or sale

Service delivery vs. communication

Perceived services vs. expected services

Table No 2.3: Details and cause of Service GAP

GAP Problem Cause(s)

1. Consumer

expectation – Mgmt.

perception

The offered service features

don’t meet customer needs

Lack of marketing research;

inadequate upward communication;

too many levels between contact

personnel and management

2. Management

perception – Service

quality specification

The service specifications

defined do not meet

management’s perceptions of

customer expectations

Resource constraints; management

indifference; poor service design

3. Service quality

specification –

Service delivery

Specifications for service

meet customer needs but

service delivery is not

consistent with those

specifications

Employee performance is not

standardized; customer perceptions

are not uniform

4. Service delivery –

External

communication

The service does not meet

customer expectations, which

have been influenced by

external communication

Marketing message is not consistent

with actual service offering;

promising more than can be

delivered

5. Expected service

– Perceived service

Customer judgments of

high/low quality based on

expectations vs. actual

service

A function of the magnitude and

direction of the gap between

expected service and perceived

service



2.2.8 Weisbord’s Six-Box Model 13

Weisbord (1976) proposes six broad categories in his model of organizational life,

including purposes, structures, relationships, leadership, rewards, and helpful mechanisms. The

purposes of an organization are the organization’s mission and goals. Weisbord refers to

structure as the way in which the organization is organized; this may be by function – where

specialists work together – or by product, program, or project – where multi-skilled teams work

together. The ways in which people and units interact is termed relationships. Also included in

the box of relationships is the way in which people interact with technology in their work.

Rewards are the intrinsic and extrinsic rewards people associate with their work. The leadership

box refers to typical leadership tasks, including the balance between the other boxes. Finally,

the helping mechanisms are the planning, controlling, budgeting, and information systems that

serve to meet organizational goals. The external environment is also represented in Weisbord’s

model, although it is not represented as a “box”

Figure No 2.3: Weisbord’s Six-Box Model

The shape of the model was also designed to illustrate the interdependency of the

variables; the illustration of the model has been termed the “Managerial Molecule.” While the

authors thought that other variables existed within complex organizations, the variables

represented in the model were considered to be of crucial importance to managers and

practitioners.



2.2.9 Organization Intelligence Model 14

By evaluating environmental inputs (Leadership, Culture and Strategy) and Key indices

related to organizational capability & execution, we can analyze our actual situation and actual

performance in form of output. So, we addressing a real GAP in system by comparing actual

vs planned allover situation in organization.

Figure No 2.4: Organization Intelligence Model



2.2.10 PDCA Cycle 15

PDCA cycle comprising of four systematic steps for

continues improvement.

Plan - A change aimed at improvement

Do - Carry out the change

Check - Evaluate the results

Act - Adopt, adapt, or abandon

Plan: The purpose of this phase is to investigate the current situation, fully understand the

nature of any problem to be solved, and to develop potential solutions to the problem that will

be tested.

Identify and prioritize quality improvement opportunities.

Develop an AIM statement

Describe the current process

Collect data on the current process

Identify all possible causes

Identify potential improvements

Develop an improvement theory

Develop an action plan

Do: The purpose of this phase is to implement the action plan.

Implement the improvement.

Collect and document the data.

Document problems, unexpected observations, lessons learned and knowledge

gained.

Check: This phase involves analyzing the effect of the intervention. Compare the new data to

the previous data to determine whether an improvement was achieved and whether the measures

in the aim statement were met. Pareto charts, histograms, run charts, scatter plots, control charts

and radar charts are all tools that can assist with this analysis.

Reflect on the analysis, and consider any additional information that emerged as

well. Compare the results of your test against the measurable objective.

Document lessons learned, knowledge gained, and any surprising results that

emerged.

Plan

DoCheck

Act



Act: This phase marks the culmination of the planning, testing, and analysis regarding

whether the desired improvement was achieved as articulated in the aim statement, and the

purpose is to act upon what has been learned. Options include:

Adopt

Adapt

Abandon

PDCA offers a data-based framework based on the scientific method. This simple yet powerful

format drives continuous and ongoing efforts to achieve measurable improvements in the

efficiency, effectiveness, performance, accountability, outcomes, and other indicators of quality

in services or processes.

2.3 Objective of Production GAP Analysis

The objective of Production GAP Analysis is to find out the GAP and to clearly elicit

the requirements to bridge the GAP, estimate the timelines to address them and perform a

comprehensive impact analysis. It required making no GAP for the business organization and

making more efficient Production in terms of quantity, quality and revenue through adapting

effective approaches in organization, like :-

Maximum the use of all resources of organization and gaining a greater share of the

Market. (Achieve desire productivity)

Maintain flow in production process with minimum waiting and setup time

Maintain inventory level

2.4 Function

The function of GAP analysis is to ask upper management two basic questions about

the organization: Where are we now? Where do we want to be in the future? To make the move

towards the future desired state, a company must develop and implement quantifiable and

measurable success factors that reflect the difference between success and failure of the

organization. If accomplished, a solid critical success factor should establish a competitive

advantage over the competition in the marketplace.



2.5 Significance

GAP analysis looks to improve inefficient business processes by optimizing allocation

of all resources and inputs. Many companies are performing below their potential because they

either misuse resources or lack the correct investment in technology or capital. GAP analysis

highlights these inefficiencies and offers recommendations for improvement.

2.6 Benefits

Correct GAP analysis should increase an organization’s production and performance,

resulting in higher-quality products at a lower total cost - that means enhancing overall

productivity. GAP analysis also measures the amount of time, money and resources needed to

fulfill an organization’s potential and reach the desired state.

2.7 Requirements

The fundamental requirement of GAP analysis is consistent, proactive and effective

management throughout the planning, implementation and transformation stages of the

analytical process. The planning stage and the extensive research required during this stage is

the foundation of successful GAP analysis. The research needs to focus on both the internal

operations of the organization as well as the external business environment. This research

provides the necessary knowledge about the current state of internal operations as well as

information about aspects such as market trends, consumer demands and competition, through

the process of benchmarking. Benchmarking is a useful tool companies use to compare

themselves to companies similar in nature that provides information and guidelines to what is

a realistic desired state for the business.

2.8 Research Limitation

Research reached at its aims for production GAP analysis. Although this research was carefully

prepared, I am still aware of its limitations and shortcomings. First of all, the research was

conducted in 4.5 months and for 25 products. Twenty weeks is not enough for the researcher to

observe the entire GAP. It would be better if it was done in a longer time. Second, Gap Analysis

can be goes to depth of the product processes by which the Gap can be identified but the

Pharmaceutical sectors are avoiding to share the product process as per there business concern.



2.9 Literature Review

Patil R. P. and Shakthi P. M. R., (2011) [1], reported critical problems which are faced by

company and how to enhance productivity and measure in pharmaceutical industry.

Other Reference gives idea related to problems which are faced by current manufacturing

facility, what is actual GAPs in Manufacturing firms, methods which are going to use for actual

GAP analysis and key improvement strategy used for achieving desire productivity and

fulfilling GAPs. [2-15]

2.10 Research Methodology

The GAP analysis also can be used to analyze GAPs in processes and the GAP between the

existing outcome and the desired outcome. This step process can be summarized as below:

1) Literature review and Discussion related finalization of project and all key aspects.

2) Identify and understanding of know-how of overall existing process for production in plant.

3) Identify the existing outcome from Production.

4) Identify and document desired outcome & process to achieve the desired outcome.

5) Identify GAP, document the GAP.

6) Develop the means to fill the GAP.

7) Develop and prioritize requirements to bridge the GAP.

8) Try to collect survey regarding readiness of accept key means to fulfilling GAP which

improve productivity. (Survey collect from line manager)

9) Compilation of data and result interpretation.

10) Deliver presentation regarding key recommendation which helps to meet desire output

without any disturbance in execution of planned production. (Improve productivity)

Chapter 3 Research Work and Discussion


PRODUCTION PROCESS IN ZYDUS CADILA HEALTHCARE LTD.

The company production is based upon the forecasting by business

development team. After getting the forecast the production targets are decided in monthly

basis by production planning meeting (the gathering of all supporting departments).all the

products are manufactured in batch process which are fixed as per the research development

team and filed as drug masters.

Let us take some current and earlier production figures to analyze the production variations

as well as reasons behind production variations.



r

Total 1942.62 2030.28 87.7

Sr.

No

Product

Name

Rate

(Rs)

Plan

Qty

Plan

Value

(lacks)

Actual

Qty

Actual

Value

(lacks)

Difference

(Positive /

Negative)

Reasons

1 Xx01 250,000 13 32.50 11.6 29.00 -3.5 Yield Loss

2 Xx02 10,858 2,400 260.59 2421 262.86 2.27

3 Xx03 13,816 1,296 179.06 1315 181.68 2.62

4 Xx04 14,045 640 89.89 507.2 71.24 -18.65 Under Test

5 Xx05 24,600 150 36.90 152.3 37.47 0.57

6 Xx06 3,998 1,980 79.16 957 38.26 -40.9 Under Test

7 Xx07 2,815 1,480 41.66 1427 40.17 -1.49 Skilled Manpower

Shortage

8 Xx08 58,427 105 61.35 112.3 65.61 4.26

9 Xx09 16,500 1,200 198.00 0 0.00 -198 Change in Plan

10 Xx10 37,000 10 3.70 0 0.00 -3.7 Quality Issue

11 Xx11 10,000 63 6.30 0 0.00 -6.3 Process Delay

12 Xx12 887,000 3 26.61 0 0.00 -26.61 Analysis Delayed

13 Xx13 8,427 1078 90.84 1159 97.67 6.83

14 Xx14 7,500 1125 84.38 1198 89.85 5.47

15 Xx15 3,229 1680 54.25 2526 81.56 27.31

16 Xx16 9,225 1280 118.08 1295 119.46 1.38

17 Xx17 6,757 4480 302.71 5057 341.70 38.99

18 Xx18 9,225 450 41.51 472 43.54 2.03

19 Xx19 5,342 2300 122.87 2302 122.97 0.1

20 Xx20 5,342 2300 122.87 2302 122.97 0.1

21 Xx21 5,342 2300 122.87 2302 122.97 0.1

22 Xx22 5,342 2300 122.87 2302 122.97 0.1

23 Xx23 5,342 2300 122.87 2302 122.97 0.1

24 Xx24 5,342 2300 122.87 2302 122.97 0.1

25 Xx25 3,820 9620 367.48 9620 367.48 0

26 Xx26 10,787 2538 273.77 1903 205.28 -68.49 Change in Plan

27 Xx27 6,088 2210 134.54 2240 136.37 1.83

28 Xx28 28,681 300 86.04 307 88.05 2.01

29 Xx29 9,115 780 71.10 798 72.74 1.64

30 Xx30 23,971 475 113.86 529 126.81 12.95



Table No 3.2: February-2015 Production Report

Total 3491.5 3234.62 -256.88

Sr.

No

Product

Name

Rate

(Rs)

Plan

Qty

Plan

Value

(lacks)

Actual

Qty

Actual

Value

(lacks)

Difference

(Positive /

Negative)

Reasons

1 Xx01 8446.20 520 43.92 479.80 40.52 -3.40 Yield Loss

2 Xx02 3246.25 1980 64.28 1208.93 39.24 -25.03 Manufactured

at Cp-2 With

Less Quantity

3 Xx03 27882.50 38 10.60 39.40 10.99 0.39

4 Xx04 6320.25 1000 63.20 78.20 4.94 -58.26 RM Shortage

5 Xx05 4797.38 875 41.98 1132.32 54.32 12.34

6 Xx06 2984.56 848 25.31 1428.07 42.62 17.31

7 Xx07 13693.94 1300 178.02 1495.74 204.83 26.80

8 Xx08 6545.36 600 39.27 511.72 33.49 -5.78 Change in Plan

9 Xx09 9412.79 520 48.95 527.51 49.65 0.71

10 Xx10 6196.53 1000 61.97 1049.09 65.01 3.04

11 Xx11 9225.00 1200 110.70 1258.40 116.09 5.39

12 Xx12 23751.46 750 178.14 664.48 157.82 -20.31 Small Batch

Due to Lack of

Other

Intermediate

13 Xx13 13351.58 400 53.41 1301.00 173.70 120.30

14 Xx14 3925.55 5460 214.34 5421.00 212.80 -1.53 Skilled

Manpower

Shortage

15 Xx15 5393.28 2514 135.59 2850.60 153.74 18.15

16 Xx16 337080.00 8 26.97 0.00 0.00 -26.97 RM Failed in

PD Trial

17 Xx17 14606.80 230 33.60 0.00 0.00 -33.60 Seeding

Material Not

Available

18 Xx18 36900.00 140 51.66 191.40 70.63 18.97

19 Xx19 6749.01 3000 202.47 4754.00 320.85 118.38

20 Xx20 112360.00 13 14.61 28.70 32.25 17.64

21 Xx21 1544.95 90 1.39 80.40 1.24 -0.15 Yield Loss

22 Xx22 0.00 21 0.00 0.00 0.00 0.00

23 Xx23 9831.50 156 15.34 112.71 11.08 -4.26 Change in Plan

24 Xx24 5018.00 165 8.28 140.15 7.03 -1.25 Yield Loss

25 Xx25 100000.00 10 10.00 8.75 8.75 -1.25 Yield Loss

26 Xx26 0833.73 1200 130.00 933.70 101.15 -28.85 Delayed to Get

Process

27 Xx27 2823.39 396 11.18 371.00 10.47 -0.71 Yield Loss

28 Xx28 0.00 0.7 0.00 0.76 0.00 0.00

29 Xx29 13861.96 945 131.00 299.50 41.52 -89.48 Quality Issue

30 Xx30 2813.97 1295 36.44 2329.50 65.55 29.11



Table No 3.3: March-2015 Production Report

Total 2483.38 2292.31 -191.07

Sr.

No

Product

Name

Rate

(Rs)

Plan

Qty

Plan

Value

(lacks)

Actual

Qty

Actual

Value

(lacks)

Difference

(Positive /

Negative)

Reasons

1 Xx01 10000.00 150 15.00 153.21 15.32 0.32

2 Xx02 7704.83 650 50.08 692.11 53.33 3.25

3 Xx03 3257.09 3060 99.67 3061.9 99.73 0.06

4 Xx04 19840.00 280 55.55 0 0.00 -55.55 Quality Issue

5 Xx05 20000.00 90 18.00 85.13 17.03 -0.97 Skilled Manpower

Shortage

6 Xx06 125000.00 28 35.00 0 0.00 -35.00 RM Shortage

7 Xx07 22630.00 360 81.47 259.53 58.73 -22.74 One Batch OOT

8 Xx08 26000.00 230 59.80 0 0.00 -59.80 OOT Batches

9 Xx09 44506.90 70 31.15 37.61 16.74 -14.41 Analysis Delayed

10 Xx10 7500.00 440 33.00 454.3 34.07 1.07

11 Xx11 30298.26 400 121.19 450.66 136.54 15.35

12 Xx12 9597.48 590 56.63 582.38 55.89 -0.74 Under Test


Shortage

14 Xx14 6051.33 1820 110.13 1835 111.04 0.91

15 Xx15 9300.00 2578 239.75 2578 239.75 0.00

16 Xx16 23971.36 270 64.72 309.8 74.26 9.54

17 Xx17 8531.20 2300 196.22 2502 213.45 17.23

18 Xx18 50000.00 22 11.00 0 0.00 -11.00 Analysis Delayed

19 Xx19 400000.00 8 32.00 8.2 32.80 0.80

20 Xx20 62000.00 45 27.90 0 0.00 -27.90 Manufacturing

Delay/ Lack of

Planning

21 Xx21 3400.00 8060 274.04 8003.14 272.11 -1.93 Quality Issue

22 Xx22 9600.00 2350 225.60 2386.7 229.12 3.52

23 Xx23 2542.68 2590 65.86 2420 61.53 -4.33 Yield Loss

24 Xx24 12500.00 1536 192.00 1540 192.50 0.50

25 Xx25 22526.67 150 33.79 153.7 34.62 0.83

26 Xx26 13112.77 1512 198.27 1494 195.90 -2.37 Skilled Manpower

Shortage

27 Xx27 200000.00 2 4.00 0 0.00 -4.00 Under Test

28 Xx28 2500.00 15 0.38 0 0.00 -0.38 Production Hold

for Licenses Issue,


Shortage

30 Xx30 25000.00 5 1.25 5.49 1.37 0.12



3.1 Production GAP Analysis Tools

3.1.1 Spreadsheet Analysis

The Summary of loss of productions during three months are as below

Table No 3.4: Monthly Summary Report

There are several obstacles for production short fall like - Quality failure, planning

fluctuation, Delayed processes, Yield loss, Manpower shortage, Breakdown, Raw material

shortage, Equipment shortage / planning failure, Environment effect and unexpected

problems. As the production quantities are as per customer requirements so it needs to

nullifying by indenting the root cause, let us start analyzing to rectify the reasons for which

production get hampered.

During January production the production short fall is for 300.83 Lacks which is

recovered by 388.53 lacks by another product production. But in case of February and March

production, plant achieve less production compared to earlier planning. These will happened

due to some obstacles. Depending upon weightage on production short fall and frequency of

occurrence, critical reasons (GAP) were find out.

Jan-2015 Feb-2015 March-2015

Planned Value 1942.62 3491.5 2483.38

Achieve Value 2030.28 3234.62 2292.31

Variance 87.7 -256.88 -191.07

Jan-15

Feb-15

Mar-15

Planned

Value

Achieve

Value

Variance

1942.62 2030.28

87.7

3491.53234.62

-256.88

2483.38 2292.31

-191.07

Monthly Report

Jan-15 Feb-15 Mar-15

Figure No 3.1: Monthly Production Overview



Table 3.5: List of Reasons behind Production Short Fall

From table no 2, we have to focused on mainly three reasons (GAP). Above 70% of short fall

in production due to these three reasons.

So, Area to be concentrated:

Quality issue

Change in Plan

Process delayed

Figure No 3.2: Graphical Representation of Reasons behind Production Short Fall

Reasons Short Fall Amount

% of Short Fall Amount

Frequency of Reason Occurrence

Quality Issue 280.53 32.63 5

Change in Plan 177.63 20.66 5

Process Delayed 157.25 18.29 4

Yield Loss 68.05 7.92 4

Analysis Delayed 52.02 6.05 3

Under Test 42.86 4.99 3

RM Shortage 42.36 4.93 3

OOT Batches 29.04 3.38 2

Skilled Manpower Shortage 9.96 1.16 7

Grand Total 859.7



3.1.2 Fishbone Analysis

Here, "Cause-&-Effect Diagram was drawn on base of central problem (Production short

fall) and analysis/investigate lists the 6Ms: Man, Machine, Material, Methods, Measurement

and Mother Nature based on how they relate to the central problem. Try to subcategories in

all possible cause and find out critical route cause related to final effect.

Here, critical route cause are

Quality Issue ( Due to poor housekeeping issue, lesser stability of intermediate)

Change in Plan (Due to shortage of RM/machine availability, volatility demand)

Process Delayed (Due to manpower/RM shortage, change in plan schedule)

Figure No 3.3: Fishbone Diagram

Prioritization

Issue

Lack of

nurturing

environment

Poor Maintenance

Lack of Responsibility

and Seriousness

Wrong Attitude

toward Work

Forecast

Accruing

Failure

Planning

OOT

Batches

Personal Issue

Process

Issue

High Market

Rivalry

Volatility of

Demand

Uncertainity

of Demand

Shortage of

RM/Reactor

Availability

Miscommunication

between department

Transportation

Issue

Plan for late

production

Delayed process of

undertaking decision

based on OOS analysis

Change in Plan

Schedule

Manpower /

RM Shortage

Government

Restriction

< 30% - Local

worker

Overburden Work

Lack of skill and

proper training Poor Storage

condition Lesser stability

of intermediate

Poor

Housekeeping

Equipment

overused

Utility

Problem

Delayed

Analysis

Skilled Quality

Manpower

Shortage

RM Shoratge

(Reagent/ Column)

Stop Production Due to

Discontinuation of Chemical

Wastage Removal Process

Change in Forecast

Leading to More

Stock at Site

Clashes planned

Schedule of

Different Product

Process

Delayed

Change in

Plan

Production of

Small Batches

Due to

Shortage of

Intermediate Availability of

restricted Stock

Mismatch

On-System and

Practical Stock

Raw

Material

Shortage

Under

Test

Quality

Issue

Yield

Loss

Improper

Availability

of Reactor

Utility

Problem

Breakdown

of Machine

Higher

Attrition

Rate

Low

Moral

Effect

Production

Short Fall

MAN MACHINE MEASUREMENT

MATERIAL METHOD

Breakdown

of Machine

Lack of continuous

tracking/audit system

MOTHER

NATURE



3.1.3 McKinsey 7S Model

The analysis looks at the characteristics of the company in terms of two aspects (Hard and

Soft Elements) and examines how the target group, where the gaps are, doesn't fit. Here, we

have capability to improve and control the hard elements which are identified and influenced

by management. So, our main target era is hard elements. (System, Structure, Strategy)

Target era:-

Quality era, Planning and process design era for easily compatible with fluctuating planning

environment.

Require to emphasis on -

Lacking in Continuous Improvement systems

Mainly focused on onetime target achievement rather than process improvement.

Continuous co-ordination between top manager, line manager and worker must require.

Poor housekeeping system (Remaining to implement complete 5s strategy).

Increasing manpower in quality control staff.

3.1.4 SWOT Analysis

Analyzing and describing production short fall problem in the terms which points

different way toward a solution by showing you how to avoid potential threats while using

strengths to exploit an opportunity. Here, the company's strengths, weaknesses, opportunities

and threats are described. Depending upon these, company gets idea to fulfilling the GAPs.



Figure No 3.4: Schematic Diagram of SWOT Analysis

3.1.5 Nadler-Tushman Model

Characterizing company operations in such a way which can lead to insights about which

parts of the company don't work well together. In plant,

Parts to be concentrate:-

Poor Housekeeping (Remain to implement complete 5S strategy)

Lack of up-to mark performance in quality department.

Delayed Analysis

(Due to manpower issue, RM shortage, breakdown of machine, utility problem, etc…)

Shortage of skilled worker

3.1.6 Force Field Analysis

In organization, require intentionally move toward a desirable state of equilibrium by

deploying driving forces and eliminating restraining forces. These changes are thought to

occur simultaneously within the dynamic organization and forces are described below.

• US – FDA approved plant

• Better management staff

• Better communication between all plants through

effective technology platform (SAP).

• Better supportive and teamwork culture

SWOT Analysis

Harmful

• Shortage as well as high attrition rate of skilled labor

• Quality Issue • Process delayed • Delayed analysis • Yield loss • Sometime RM/intermediate shortage leads to

stop in production process.

• Continuous co-ordination of cross functional team

leads to better handling of complicated issue in plant.

• Involvement and getting feedback from everyone

who linked with directly or indirectly to particular

operations.

• Implement completely 5S strategy in Plant.

• By continuous improvement in operations, easy to

handle situation effectively.

• Change in forecast leading to more stock at site

• Forecast accruing • Chances of discontinuation in removal

process of chemical wastage & also government pressure.

• Lots of rivalry in current API Market

• Shortage as well as high attrition rate of skilled

labor

• Quality Issue

• Process delayed

• Delayed analysis

• Yield loss

• Sometime RM/intermediate shortage leads to stop

in production process.

• Change in forecast leading to more stock at site

• Forecast accruing

• Chances of discontinuation in removal process of

chemical wastage & also government pressure.

• Lots of rivalry in current API Market

SWOT Analysis

Helpful Harmful

Strength Weakness

Opportunity Threat



Figure No 3.5: Schematic Diagram of Force Field Analysis

- Green Field –Business

(High growth rate)

- Better management

staff

- Better technology

platform(SAP).

- Better supportive and

teamwork culture

- Quality Issue

- Delayed analysis

- Limited resources

(RM, Manpower)

- Breakdown of machine

- Utility issue

Dri

vin

g F

orc

eR

estrain

ing F

orce

Chapter 4 Recommendation


ECOMMENDATION

Zydus Cadila Healthcare API production shortfall is mainly caused by major three critical

issues according to production GAP analysis study. (71.58% of Total Production Short Fall

Amount in three month)

Quality Issue ( Due to poor housekeeping issue, lesser stability of intermediate)

Change in Plan (Due to shortage of RM/machine availability, volatility demand)

Process Delayed (Due to manpower/RM shortage, change in plan schedule)

Key Recommendation/Solution to Achieve Desire Productivity

Kaizen Gemba

Complete 5s Strategy Implementation

Resolve Skilled Manpower Shortage Problem

4.1 Kaizen Gemba 5

Kaizen means ‘improvement’ and Gemba means ‘Workplace’.

Definition: “Systematic organized effort to continuously improve the performance at the

work area by individual efforts in a group who assemble periodically to discuss their

work related problems.”

To achieve desire productivity the service and management departments should provide

the appropriate actions in a continuous manner. Management also focused on mainly

process oriented rather than result oriented. Improvement is not a trigger event but it’s an

ongoing process in which require to track and standardize process continuously. When

the processes become an error proof then it will be easy to adopt any complicated

situation and achieve desire output automatically.

4.1.1 Common Subjects of kaizen Gemba

Major focus areas are as follows:

Improvements in methods, work content, workshop quality.

Reduction in wastage, defective, rework, errors.

Saving in energy, fuel, space, time.

Use of improved tools.

R



Machine maintenance.

Inventory control.

Housekeeping etc.

4.1.2 Implementation

Quality council decides to implement the kaizen gemba, done by ‘pareto analysis’.

Supervisor in charge of problematic departments are chosen as ‘kaizenees’.

Each kaizenee form a group of ten workers from his department, train them on principles

and guidelines of kaizen gemba.

Gather once a while in a month for an hour, speaks of regarding the improvements done

in preceding month and its results.

It must be ensured that there must be an honest give and take of ideas, thoughts and

experiences.

All kaizenees submit the monthly scores of their members to the kaizen gemba

coordinator, who’s responsible for submitting further to quality council.

Quality council tracks the progress of companywide kaizen gemba activities.

4.1.3 Relationship of KAIZEN GEMBA, PDCA and SDCA Circles

I. Definition of Gemba Kaizen (GK)

Need of improvement

Value stream mapping (VSM)

All important processes and their operations, lead time, cycle times WIP, setup time are

included.

Gemba Kaizen opportunities are spotted and GK workshop is planned

II. 1st Pre-GK (minimally 2 – 4 weeks before GK workshop)

Owner of the process with lean specialist will lead that GK from the methodologist

perspective

They discuss about expectations and define targets, basic resources material, labor, etc.

Plan



III. 2nd Pre-GK (minimally 1 – 2 weeks before GK workshop)

Leader and his deputy are the key participants

Whole GK team is defined in two groups.

First group contains operators, store keepers, line technicians, maintainers, etc

Second group supports GK according to their needs

Check everything is prepared for GK workshop or not then go for further step.

IV. Gemba Kaizen workshop (x days of teamwork)

Workshop is officially started with targets and team presentation in the presence of plant,

production and lean managers.

Lean specialist presents and teaches GK team about lean philosophy and important tools

and methods which can be used during Kaizen event.

Analyze the problems and possibilities how to solve them.

Each employee has assigned a task for which takes responsibility.

V. Visualization of GK results, trainings, etc. (1 week after GK)

Results are visualized directly on Gemba

Employs are shown changes

VI. 1st Post-GK (maximally 2 weeks after GK)

Review the status and sustainability of changes/improvements on place where Kaizen was

performed.

Plus at this meeting has to be checked action plan from workshop

Process owner, lean specialist and leader of GK attend this meeting.

VII. 2nd Post-GK (maximally 4 week after GK)

Similar to the 1st meeting

It is held if the problems still persists

Check results which are sustainable or not then go for further step.

Do

Check



VIII. Certified GK, Routine management receives new standard

Standardization is a process that helps to maintain achieved improvement.

Within standardization is prepared standard, in which are included all changes and whole

staff is trained based on it. Standard is defined as the best way to do the job.

IX. Managerial visit (“Gemba walk”)

X. Act correctly to guarantee sustainability of the results

Sustainability depends not only on standards, but also on regular system of trainings,

discipline and morale of employees, etc.

XI. Lean committee should evaluate and act in necessary case

If any problem persist, lead committee should take action

Figure No 4.1: Schematic Diagram of PDCA and SDCA - Continuous Improvement

4.2 5s Strategy Implementation [6,7]

First 2 step of 5S strategy was already implemented in plant

I. SEIRI (SORT)

II. SEITON (SET IN ORDER)

Act



Require to proper and complete implementation of 5S strategy with all employers &

employees support.

III. SEISO (CLEAN) - “Cleaning with meaning”

Everyone should equally participate in cleaning activity.

Benefits:

Defects are easier to identify in clean environment.

A work area (clean of debris) is less likely to cause a tripping hazard

Machines which are clean and maintained work more efficiently with less occurrence of

break down.

A clean work area promotes improved morale and instills pride in the team members

Implementation:

Determine the shine targets: what are we going to clean?

Set a schedule and assign individuals

Create procedures for continued daily shine processes

Set periodic machine inspection and maintenance targets

IV. SEIKETSU (STANDARDIZE) - “Make the best way, the easiest way”

Action Step

Brainstorm ideas for making 5S changes

Update documentation to reflect changes

Make sure all stakeholders are aware of the new standards - inform and educate

Resources

Support from those who can create documentation, job aids, and visual aids

Information and approval for maintaining company procedures

Poster-making supplies for posting new standards in work areas

V. SHITSUKE (SUSTAIN) – “A workplace that automatically restores order,

regulates activity, and continuously improves”

Action Step

Monitor processes established

during S4 - Standardize



Expand 5S efforts to other work areas

Evaluate 5S effectiveness and continuously improve

Recognize and reward strong efforts

Resources

Management audit forms

Newsletters, Displays, Awards

Presentation tools for sharing best practices with other work areas

Management commitment and focus on maintaining the new standards

4.3 Resolve Skilled Manpower Shortage Problem

In vacation and festival season – more attrition rate

Require to decrease attrition rate and try to attract worker/operator through giving better

nurturing working environment. (Try to develop symbiotic relationship)

Require to organize continuous skill development program with scoring system based on

key performance indicator and reward system.

Powerful continuous training program require as per worker/operator needed

In kaizen Gemba, try to involve and getting feedback for improvement

Giving some importance and try to feel out as a their own workplace

Make them more responsible and confident about their work

Try to avoid much more load in workplace by organizing systematic refreshing and

replacement system. (At every plant – 2 extra manpower require)

4.4 Other Recommendation

Resolve problem of on system and practical stock mismatch by taking regular feedback

and continuous inspection.

Try to develop day to day planning with day to day tracking system. That helps in

Finding right focus era where we are lacking in performance

Making uninterrupted scheduling process

Effectively implementation of Kaizen Gemba system

Chemical wastage of API production system are managed effectively by taking some

preventative steps or measurement against removal process.



Improve in attitude of employees.

(More responsibility and more seriousness toward own work.)

4.5 Changes in Current System

1 Implementation of Daily based tracking system

Benefits:

Helps in future planning as well as inventory management system and there will be no

delay in production due to non- availability of Raw material.

2 Complete 5S Implementation in QC Department.

Benefits:

Make effective and efficient QC process & make an error proof processes.

The QC labs achieved zero observations in following their most recent internal and

US-FDA audit.

3 Increasing manpower in plant operator, worker as well as in QC department.

Benefits:

Reducing burden in work

Increase in output as well as completing work on time.

Chapter 5 References


EFERENCES

1. Patil R. P. and Shakthi P. M. R., “Productivity enhancement and measurement in

pharmaceutical industry”, International Journal of Pharma. Research and Development,

March 2011; 3(1): 193-198.

2. Robert J. B. and Chase R. B. Operations and Supply Management: The Core. 2nd Ed. New

York: McGraw-Hill/Irwin, a business unit of The McGraw-Hill Companies, Inc., 2010.

3. Silver E. A., Pyke D. F., and Peterson R. Inventory Management and Production

Planning and Scheduling. 3rd Ed. New York: John Wiley Inc., 23th January 1998.

4. Graves S. C. A Review of Production Scheduling. Operations Research. July-August 1981;

29(4): 646-675.

5. Masaaki Imai. Gemba Kaizen – A Commonsense Approach To A Continuous Improvement

Strategy. 2nd Ed. New York: McGraw-Hill/Irwin, a business unit of The McGraw-Hill

Companies, Inc. 1st July 2012; 1-78.

6. Khanna V. K. 5”S” and TQM status in Indian organization. TQM J. 2009; 21: 486-501.

7. Gapp R., R. Fisher and K. Kobayashi. Implementing 5S within a Japanese context: An

integrated management system. December 2008; 46: 565-579.

8. http://smallbusiness.chron.com/tools-gap-analysis-46456.html

9. http://www.mindtools.com/pages/article/gap-analysis.htm

10. http://www.batimes.com/articles/do-we-need-a-mature-gap-analysis.html

11. http://www.mindtools.com/pages/article/newTED_06.htm

12. http://www.12manage.com/methods_zeithaml_servqual.html

13. http://reflectlearn.org/discover/the-marvin-weisbord-six-box-model-

weisbord%E2%80%99s-model

14. http://www.oi-institute.com/organizational-intelligence-model-skyline

15. http://asq.org/learn-about-quality/project-planning-tools/overview/pdca-cycle.html

R

http://smallbusiness.chron.com/tools-gap-analysis-46456.html

http://www.mindtools.com/pages/article/gap-analysis.htm

http://www.batimes.com/articles/do-we-need-a-mature-gap-analysis.html

http://www.mindtools.com/pages/article/newTED_06.htm

http://www.12manage.com/methods_zeithaml_servqual.html

http://reflectlearn.org/discover/the-marvin-weisbord-six-box-model-weisbord%E2%80%99s-model

http://reflectlearn.org/discover/the-marvin-weisbord-six-box-model-weisbord%E2%80%99s-model

http://www.oi-institute.com/organizational-intelligence-model-skyline

http://asq.org/learn-about-quality/project-planning-tools/overview/pdca-cycle.html

Documents

Darshan Patel_final thesis