A few years ago, I was approached by a CEO of a pharmaceutical contract research company to turnaround his sick unit into a profitable enterprise. This company was dealing with the development of solid oral dosage forms. To bring about the necessary change, we initiated several Kaizen campaigns companywide, with 360 degrees focus to overhaul all processes and operational systems. We addressed all key areas across the organization including accounts payable/ receivable, material procurement, order processing, suppliers, R&D, scale-up, production, logistics, product dossiers filings, project management, business development, sales & marketing and PR communication processes.
 
Another key area where Kaizen helped us in a big way was to integrate various client information data sets maintained within different databases on separate systems.​

​At the end of nine months, this company’s books started showing profits, and from there on, it kept going from ‘good to great’. It was an excellent example of a successful transformation.
 
Unfortunately, this contract research company is not alone in the challenges it has faced. Studies indicate that 88% of business owners in North America struggle to maintain consistent cash-flow. Key questions to consider are:

• Can your organization benefit from increased workplace productivity?
• Does your team face challenges with reduced R&D budget?
• Does your organization face challenges because of inconsistent or poor cash-flow?
• Do you need to cut corners as you are forced to do more with less?

 
If you answered ‘yes’ to any of the above questions, then Kaizen should be your mantra…​

​This book is a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device, and biotech companies.
 
It is an invaluable resource, an essential tool for all professionals within the pharmaceutical, medical device, biotech organizations i.e. all life sciences and health care companies, interested in employing Kaizen in their workplaces and their personal lives. This book will also facilitate running Kaizen in a manufacturing company and do it at a world-class level.

​This book doesn’t simply explain Kaizen process features, implementation, and application. The scope of this book is much wide.  

This book is meant for small to medium-size pharmaceutical, medical device and biotech research, manufacturing and contract services companies. This book is to-

• Demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech, and all life sciences organizations, irrespective of their size or workplace culture.
• Apply Kaizen to what really matters, that is, ‘to achieve business expansion along with increased productivity and profits’.  
• Provide practical and useful examples of Kaizen principles that can be executed at various levels: across the organization; within a specific department, business unit or team, as well as for yourself as an individual to further your personal career.
• Improve revenues and create a lasting change using Kaizen principles and techniques.​

Some salient features of this book

• It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, shorten product development times, improve first-to-file rates, conduct successful scale-up and technology transfer to manufacturing sites.

 

• It shows everyone associated with manufacturing, how to use Kaizen to decrease cycle times, work-in-process & quarantine inventories, the cost of distribution & logistics, improve equipment efficiency, facility capacity utilization and shift output.

 

• It shows everyone in Human Resources how to use Kaizen to minimize employee turnover, hire and retain talent, and motivate employees to create a difference.

  

• It shows the company’s senior management, stakeholders, finance and other supporting business units, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address rising competition and counteract fluctuating market economy.

 

• This book presents useful ideas that one can implement immediately, often at no additional cost.

 

• It shows how to transform a business from ‘good- to- great’. True benefits of Kaizen implementation are realized because, it adds value to your products, increases market share, and drives both top line and bottom line of your business.

 
Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap.​

In addition, this book is an excellent resource for Kaizen beginners with a lot of real-life industry examples, case studies and provides several ‘do-it-yourself’ exercises, which is of tremendous value, in absence of a Kaizen coach.


Chapter 1:
 
Pharmaceutical industry growth unlike few other industries viz. retail, banking etc. is not completely determined by ‘value’ it brings to its customer. Frustrated customers can easily walk out of a shop and get their product from some other place. In contrast, pharmaceutical products are unique in the sense, the customer (i.e. patient) doesn’t usually have much say in its purchase. Patients usually buy medicines their doctors prescribe or pharmacist dispense (until such time they don’t experience any adverse effects). For the medicines where adverse effects are well-known or documented on the product label, patients really have no choice but to take bitter medicine (pun intended).
 
Also, a patient on a prescription drug may not always have the option to change medication or brand, because of lack of competing brands due to enforced Exclusivity and Patents laws. Even with the advent of generic medicines which offer price benefits, many patients don’t prefer to change the pill they have been taking over the years.

Moreover, Kano’s model may not strictly apply to Life science industries, because unlike other products, a drug product if not proved safe, efficacious and stable, will just not make it to the market. And this applies to all medicinal products- be it Rx (prescription), OTC (over the counter), medical devices etc.​

Pharmaceutical, medical device, and biotech companies are always under federal drug authorities radar for compliance to standards. The very existence of pharma business is based on meeting compliance- be it cGMP, safety, therapeutic efficacy, quality etc.
 
As federal drug regulations change, companies must upgrade to stay in business. Hence, there is an indirect continuous improvement happening all the time. This is probably one of the reasons why the majority of life science companies have not really attempted formal business process improvement methodologies.
 
However, Kaizen is not simply a business process improvement technique. Kaizen doesn’t just focus on cost-cutting or quality improvement. Kaizen is a way of life; of becoming ‘better’ every day; of becoming better than the best- consistently, and taking your business from being good to great with its products, market share, governance, and most importantly, Good to Great with PROFITS!
 
Let’s begin with what is Kaizen?
 
The name ‘Kaizen’ is an adaptation of the Japanese term that stands for continuous improvement. In Kaizen technique, it is believed that employees need to be empowered to enhance various processes of the company. Kaizen utilizes some of the Lean methodology philosophies to plan, implement and evaluate changes in a variety of roles. Kaizen must be integrated into a company’s daily operations to achieve maximum benefits.
 
Kaizen hails from the words, "Renew the heart and make it good." Therefore, an adaptation of Kaizen concept requires changes in the "heart of the business", corporate culture and structure; since Kaizen enables companies to translate the corporate vision in every aspect of its operational practice.​​

Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.
​

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Up to speed with workflow- How to choose business process improvement methodology for your organization and measure the positive change by Dr. Shruti Bhat- book preview

Businesses in US, Canada or in any country worldwide, are governed by five factors, referred as ‘5M’ umbrella- Man, Money, Machine, Material and Methods.
 
Methods or processes, being the most critical out of the five, as, it alone (to a large extent) determines the consequences of the other 4Ms i.e. Man, Money, Machine and Materials. For examples, if the processes in a company were engaging, then employees would stay committed and contribute positively. ‘Machines’ would be productive, costs would go down and ‘Materials’ would be wisely used to generate profitable products, which in turn will help the business thrive, grow and make more money. Therefore, processes drive a chain reaction. ​

Business processes in any organization, can be made more efficient, more effective, and adaptable to changing market and/ or economic needs. However, the biggest problem faced by most companies worldwide, is not its competitors, rather the biggest problems are self-inflicted, that is, created in-house by the management. Therefore, a step further in this direction is to build ‘quality’ and ‘profitability’ into business processes.

 
What will you learn from this book?
 
This book covers the following topics –

• Introduction to business process improvement lifecycle.
• How to strategically design process improvement initiatives to win campaigns.
• Roadmap to process improvement methodology selection including- base lining, change management, organizing business processes within an organization, identifying business process problem areas, various process improvement techniques and process improvement methodologies.
• Decision matrix for selecting process improvement methodology for your workplace.
• Action plan- for doing methodology implementation right!
• Qualifying ‘new’ business process and efficiency measurement metrics.
• Maintaining ‘continued’ operational excellence with the ‘new’ process.
• Illustrative examples of process improvement methodology recommendations for-
  • Healthcare organization.
  • Facility management and maintenance department of manufacturing organizations.
  • IT department of non-profits, technology companies and manufacturing industries.
  • Customer service departments of service organizations.
• Frequently asked questions and tips to maximize output from business process improvement campaigns.

 
Who should read this book?
 
This book is for Agile entrepreneurs and executives, involved in decision-making, directing their organization’s sustainability, profitability, expansion and who wish to apply business improvement methodologies to their work places in most beneficial, effective and practical ways.
​
 
Chapter 1:
​
Management of key business processes is of utmost importance to becoming a high performing organization, as they are the means to executing business strategies, by aligning process results with business goals.
​

​As customer needs change frequently, one has to monitor them continuously and this is the fundamental basis for ‘Business process improvement’ and ‘Continuous improvement’. Those who learn this outperform their competitors because they have a much better understanding of their customers.
 
Business process improvement drives substantial bottom-line increases, customer satisfaction, ultimately accelerating the company’s revenue cycle. In today’s highly dynamic economies, the ones who do not get this mantra eventually have two choices- they get it or they go out.
 
However, the biggest problem faced by most companies worldwide, is not its competitors. Rather the biggest problems are self-inflicted, that is, created in-house by the management. So how does a company choose the right business process improvement methodology to implement at their organization?
 
This would depend on what problem prevails in the organization, that one is trying to solve and why. For example- is there a design issue? A process issue? A defect issue? A variation issue? Or a combination of them.
 
The success of process improvement directly depends on the process improvement methodology selected to bring on the positive change.
 
It is equally true that choosing a correct process improvement methodology is critical and extremely challenging. This in turn depends on the ‘Process improvement lifecycle’ comprising of following steps-
 
Step 1: Base lining.
Step 2: Identify critical ‘process improvement’ implementation success factors.
Step 3: Organize and centrally locate processes.
Step 4: Standardize processes spread across multiple functions and business units.
Step 5: Re-design ineffective or in-efficient processes.
Step 6: Eliminate work-around or duplicate steps.
Step 7: Automate processes wherever possible.
Step 8: Identify and apply metrics and KPI (key performance indicators).
Step 9: Cross-train employees.
 
‘Identification’ of process improvement methodology stems out of information gathered from steps 1 to 3, while the success of ‘methodology implementation’ is dependent on steps 4 to 9.

​This book highlights salient details about “How to choose a business process improvement methodology for your organization and measure the positive change”.  Further, in the book we will dive into which methodologies might be appropriate for different industry verticals, different processes and different types of companies, as well as few important frequently asked questions.
 
Coming up in the next section- Potential success factors to winning process improvement campaigns…

 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.


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Business Process Improvement for Manufacturing & Service Industry by Dr. Shruti Bhat book preview-

One of the first people to describe business processes was Adam Smith (1776) in his famous example of a pin factory. Since then business processes have evolved and better defined. ​

A business process defines the various activities involved in achieving a particular goal. Business processes briefly describe the chain of events that are involved in an activity or a group of activities. It is common to use a business process if the activities have an effect on current products or data and bring about production. 

 Types of business processes include- 
​

• Management processes such as Corporate governance, Strategic management, planning and implementation.
• Operational processes, which constitute the core business and create primary value stream. Typically, they include Procurement & sourcing, Manufacturing, Marketing, Sales and Customer service.
• Supporting processes, which support the operational processes and include Finance & Accounting, Recruitment & Human Resources Management, Research and Technical support.

Some examples include invoicing, product shipping details, updating information, tracking orders, allocating budgets etc. Business processes used throughout organization, at any level, are outlined in order to improve organization in an effective and efficient way. There can be several inputs in a business process but there is always only one output or specific goal- that is to help business thrive.

Business processes are used practically in any organization and throughout an organization at any level. They are used in a variety of industries such as private, public sector, government, departments, hospitals, charities etc. Business processes are, typically outlined in order to improve an organization in an effective and efficient way.

Various computer software make it possible to create business processes on a computer, however simple business processes are just as effective when written with pen and paper. Some even find it better to jot down the processes on a piece of paper, or on several small ones, in order to kick start their creativity and thinking process. It is up to the professional (and/or organization) to decide whether a software or traditional method will work best for them. Business processes work best when there is input, support and ideas from various people that are involved in the organization (or department).

Key business processes are logically grouped related tasks and activities, independent of the organization’s structure, which utilize the resources of the organization to produce specific results. They possess measurable inputs & outputs, value addition and repeatable activity.

Tip- The effective management of key business process requires- Ownership & planning, performance metrics & control, process qualification, management and improvement methodology.

A business process always begins with a customer’s need and ends with a customer’s need fulfilment.

Customer needs change, technologies change, government policies change, competition changes and what used to be a high level of performance becomes a poor one and it’s time to replace the formerly good process with a new one- only every process cycle should have this capacity of identification, in-built in its charter.

As a practicing Business Transformation expert of many years, I am happy to mention here few case studies, nay success stories. Let me share three examples-

1. A consumer goods manufacturing company redesigned its product deployment process, by means of which, it now manufactures goods and delivers them to its distribution center such that inventory uptake was reduced by 35%, while stock-out goods situation declined by 70%.
2. A pharmaceutical company created a new product development process, which reduced time to market by 75%, development costs by 45% and increased productivity by 30%.
3. An engineering goods manufacturing organization increased its product delivery targets by 350% and reduced its supply chain costs by up to 55%. Something to note in these is the simultaneous achievement of apparently incompatible goals for e.g. reducing inventory while also reducing out –of-stocks.

Traditional organizations view these as conflicting goals and trade off against another. While process managed organizations, recognize that such payoffs, are achieved by improving business processes and continually maintain their business process efficient. So how do we go about bringing on a process change?

Three main categories of business process improvement techniques, have been found to be extremely effective in managing, expanding and /or transforming businesses worldwide including USA, Canada, Latin America and the emerging economies. They are – Breakthrough improvement, Streamlined improvement and Continuous improvement. The 18 methodologies described in this book belong to one or many of these three main categories.

​
In this book, you will learn about: 
​

• What is a business process? What are different types of business processes? Why improve a business process?
• 18 different business process improvement methodologies including Lean, ISO, Kaizen, Six Sigma, Capability maturity model integration (CMMI) etc.
• Advantages of each business improvement methodology. Precautions needed before implementing a methodology at your workplace.
• Strategic planning and risk assessments involved prior to implementing a business process improvement methodology.
• References of their use by startups, small companies who later on became big corporate houses and Fortune 500 companies.
• Tips to maximize positive results from executing business process improvement methodologies for your organization.

This book presents a practical way to build and improve business processes, and assists professionals whether they are learning the basics of business process improvement, planning their first improvement project, or evangelizing process-oriented thinking throughout their organization.

Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

​

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Therefore, for a business to survive and grow, its business processes must evolve appropriately, to make running the business both affordable and profitable. This constant adaption is brought about by Continuous Improvement.

For Continuous Improvement efforts to be meaningful, cost-effective, realistic and sustainable, one must use effective and accurate tools that will facilitate- identification of the business problems, augment strategic decision-making & implementation, help problem-solving, support measuring the change & sustaining process excellence.
 
This book provides deep insights into thirty vital tools necessary to meet success with your Continuous Improvement campaigns.

 
What will you learn from this book?
 
This book covers the following topics –

• Thirty important Continuous Improvement tools.
• How to construct and strategically use these tools during all the phases of a Continuous Improvement campaign.
• Advantages, limitations and applicability of each tool at your workplace.
• Illustrative examples of using these tools during your Continuous Improvement campaigns and post face.
• Possible roadblocks on Continuous Improvement highway that champions needs to watch out for, how to tap into these tools as a vital resource to overcome roadblocks and/or prevent detours.

 
​
Who should read this book?
 
This book presents practical ways to build and improve business processes and assists professionals whether they are learning the basics of Continuous Improvement, planning their first improvement project, or evangelizing process-oriented thinking throughout their organization.
 
This book is for all professionals involved in decision-making, directing their organization’s sustainability, profitability, and expansion. If you want some new and effective ideas for improving your organization's efficiency, then this business management book is for you.
​
 
Chapter 1:

​Things do not improve on their own. There is a mechanism for improvement- PDCA (Plan, Do, Check, Act) or DMAIC (Define, Measure, Analyze, Improve, Control) or DMADV (Define, Measure, Analyze, Design, Verify). The whole process is then repeated continuously, which means Continuous Improvement!
 
The Deming’s quality cycle is never ending. It is a strategy used to achieve Breakthrough and Continuous Improvements in safety, quality, morale, delivery cost and other critical business objectives. The completion of one cycle continues with the beginning of the next.
 
The success of any Continuous Improvement campaign relies on following four types: tools for data gather, tools for problem-solving, tools for decision-making, tools for strategic implementation of the campaign, tools for measuring the change and assessing ‘change is indeed an improvement’. This book presents tools belonging to all these four types.
 
Before exploring the specific tools, let us start by having a quick look at what is involved in improving a business process.
 
A business process can be anything from a process of procuring material, at the production line or serving a customer. There are three principal or key areas for process improvement, which contribute to the profitability and effectiveness of an organization. These are-

1. Reduce waste (for a manufacturing company) and/or reduce time taken to see a customer (for a service organization).
2.  The way a job is done.
3. The way any process is under taken.

 
To improve any one of these we need to:

1. Observe all our actions and the consequences.
2. Record what is observed in detail.
3. Analyze the results and take corrective and preventive actions for errors.

 
Business management team in any organization, worldwide, has two sets of problems: those of today and those of tomorrow on the supposition that there is a tomorrow for the company that hopes to stay in business.
 
To thrive, succeed and grow, the business must constantly improve productivity, product/ service quality and overall organizational effectiveness. Moreover, it is vital to note that, Productivity improvement should not be more production at the cost of more people losing jobs. Rather, productivity improvement should be win-win scenario for the business and its employees and the whole community.

​Productivity improvement should actually change the character of departments. New way of doing things should mean, more work gets done by the same number of people now trained to do their jobs better, new skills.
 
Similarly, Quality comes not from inspection, but from improved business, production and/or service processes. Total quality control means- quality of work, quality of service, quality of products, quality of information, quality of process, quality of division, quality of people, quality of company, quality of objectives and quality function deployment. Quality tools cannot remedy every quality problem, but they certainly facilitate problem solving.
 
There is increasing recognition that Continuous Improvement offers more than just operational improvement in performance. If Continuous Improvement efforts can be sustained over the long term, the opportunity exists for considerable strategic advantage, as organizations move on from bringing and maintaining their processes in control to improving them and developing totally new ones.
 
Recent survey data suggests that 65% of companies consider Continuous Improvement to be strategic importance and around 50% have instituted some form of systematic program to apply these concepts.
 
A further 19% claim to have a widespread and sustained process of Continuous Improvement in operation and of those firms using Continuous Improvement, 89% claim it has had an impact on productivity, quality, delivery performance or a combination of these- such is the power of Continuous Improvement !
 
To improve a process, you need to have a clear picture of what is ‘actually’ happening, not what you ‘think’ is happening or what is happening in ‘theory’; but how the process is actually working.
 
Therefore, tools are essential ingredients of a process and basic instruments for the success of a business process Improvement program. Many companies have used tools without giving enough thought to their selection and have then experienced barriers to progress.
 
So, how do you choose the correct tool?  Choice of tool will depend on-

• What do you want to measure?
• What do you want to achieve?
• What form does the data take?
• What do you want to do with the results? 

Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.


​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
 


​#DrShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ProcessExcellence  #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement  #Speaker  #KaizenTrainingAcademy

Kaizen for Leaders: A Continual Improvement Tool to Increase Profit & Organizational Excellence is the eighth book of ‘Business Process Management Systems and Continuous Improvement Executive Guide Series.

What will you learn from this book?

This book covers the following topics:

• Business process improvement lifecycle.
• How to win process improvement campaigns.
• Roadmap to process improvement methodology selection
• Business process mapping, process modeling, process redesign/ reengineering.
• Decision matrix for selecting process improvement methodology for your workplace.
• Action plan- for doing methodology implementation right!
• Qualifying ‘new’ business process and efficiency measurement metrics.
• Maintaining ‘continued’ operational excellence with the ‘new’ process.
• Illustrative examples of process improvement methodology recommendations for- Healthcare organization, Facility management of a manufacturing company, IT department of non-profits, manufacturing and technology companies, Customer service department of a service organization
• Frequently asked questions and tips to maximize output from continuous improvement campaigns.

​
Who should read this book?

This book presents practical ways to build and improve business processes and assists professionals whether they are learning the basics of business process improvement (or Continuous improvement), planning their first improvement project, or evangelizing process- oriented thinking throughout their organization.

This book is for Agile entrepreneurs, Leaders, QA (Quality Assurance) managers, Management consultants, Production supervisors, Manufacturing heads, CEOs, Directors and all Managers involved in decision-making, directing their organization’s sustainability, profitability, and expansion.
This book answers questions on business process management, which would help managers improve business situations in their new role as a Business Analyst, Project Manager, Change Management or Process Improvement Expert.

This book is for “all business readers” who wish to apply these methodologies to their workplace, like to read, and self-develop to become ‘better’ at whatever they are doing.


About the author:

Shruti Bhat PhD MBA Certified Lean Six Sigma Black Belt
Over the past eighteen years, Shruti has successfully led over 450 Continuous Improvement projects in big & small organizations world wide. She specializes in business transformation of sick units. Shruti has proficiency in Continuous Improvement for Innovation management, Research & Development, Human Resources (HR), Manufacturing, Quality, Intellectual Property, Sales and Service functions; additional case studies on Shruti's blog www.DrShrutiBhat.com. Shruti has helped build enterprise teams and coached more than 12000 employees worldwide.

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