Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector.

For example- Regulations, customer demands, competitor landscape, product criteria, facility needs, EHS (environmental, healthy & safety) needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry.

Moreover, auto industry manufacturing is 'assembly-based' while in pharmaceuticals and other life sciences companies, manufacturing is 'batch production-based'. Additionally, pharma industry 4.0 have automated and/or automatic production processes popularly known as 'continuous manufacturing' techniques. Therefore, Kaizen practices 'as is' from auto sector won’t work for pharmaceutical, medical device, and biotech organizations. Kaizen concepts must be customized for life science industries, to achieve its full benefits. So far, there is no book on Kaizen that is customized for pharmaceuticals and other life sciences industries.

For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 450 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals and healthcare sectors and felt it will be beneficial to share those techniques and her experiences, thus this book.

In addition to explaining the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen campaigns and its strategic implementation for pharmaceutical, medical device and biotech companies.

This book demystifies Kaizen and helps business leaders in pharma and all life sciences organizations, irrespective of their size or workplace culture. It provides practical and useful EXAMPLES and CASE STUDIES of Kaizen that can be executed at various levels across the organization as well as for an individual to further his/her personal career.

This book will help business leaders to immediately improve corporate revenues, increase market share, improve manufacturing productivity and product quality. Moreover, this book helps you customize Kaizen to your company; this book is not a ‘vanilla generic’. Also, this book presents useful ideas that one can implement immediately, often at a meager additional cost and reap rich returns.


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​
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Presented a talk at ASQ Quality Continuous Improvement Conference Vancouver, May 26, 2016 …
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​Dr. Shruti Bhat presenting a talk on 'Applying Design For Six Sigma (DFSS) and Lean to Build Quality in Products Manufactured via 3D Printing (aka Additive Manufacturing) technique …

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There are seven main tools that help identify quality problems. These techniques are the most commonly used and most effective tools for overcoming problems in terms of quality. The best tools are ones that can easily be understood and implemented by a variety of personnel, which these seven are. They also offer the best solutions to a number of quality-type problems. The main tools used for identifying quality problem include: check sheet, cause-and-effect diagram, control chart, Pareto chart, histogram, flow chat and scatter diagram. 
 
A check sheet is a tool that allows for the collection of information regarding quality issues. Check sheets for quality  problems scores the amount of problems for a number of predetermined defect causes. Once the check sheet is complete, the total score of problems for individual causes can then be used to make a Pareto chart or a histogram. 
 
Cause-and-effect diagrams, also known as fishbone diagrams, depict the causes of individual events and the connection between the events. These diagrams are used to pinpoint the cause of a specific quality problem in order to fix the issue. It is common for these types of diagrams to be constructed by several team members in order for discussion to take place on the legitimacy of the causes. 
 
Control charts are made up of a horizontal line that represents the norm of the process. There is also a line above and below, to represent upper and lower regulation boundaries. Various samples are gathered over a period of time and added to the chart. It is clear that there is a quality problem, or one that should be looked into, when there are measurements that extend above or below the norm line. 
 
Pareto charts contain line graph and bars in order to graph data. It is a method of finding out where the sources for defects come from and pinpointing the source of largest reoccurring defect. It is easy to understand due to its simply detailed visual presentation. 
  
Histograms are used to give a rough assessment for the probability of a source of a problem. It shows the occurrences of observations that occur amongst the subject focus point. Flow charts, otherwise known as run charts and stratification, depicts the stages involved in a process. They allow viewers to easily identify and solve issues of quality problems by clearly showing the details of a certain procedure. 
 
Scatter diagrams depict the connection between variables. By comparing two variables, it is easy to see where there is a correlation or where one is lacking. 

About the Author: Shruti Bhat PhD, MBA
 
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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CAPA, otherwise known as Corrective Actions Preventive Actions, is a vital key to a management system of high quality.  Correction actions are required in order to figure out the reason for problems whilst preventive actions are actions that are required in order to prevent the problems from reoccurring and aims to figure out the problems before they occur at all. There are paper and electronic versions of CAPA processes. 
  
The reason that CAPA is an important tool to incorporate into an organization is because it demands high quality management. In order to deal with the processes involved in CAPA the organization needs to be accurate and flexible. Organizations that typically implement CAPA include automotive, sciences, manufacturing and aerospace operations. It is typically linked with other improvement processes such as Lean and Six Sigma methodology.  
  
Corrective action processes are made up of several stages. The first is to identify and document the reason for the problems occurrence. After this, the whole systems processes need to be viewed and analyzed in order to confirm that similar problems will not occur. The effect of the problem has to be analyzed by finding out when the problem was realized and the impacts it had on the product or service itself. 
 
Sometimes appropriate action is required in order to handle the situation, which can involve telling the customer, recalling products or discarding products completely. The follow up is an important last stage because it allows the organization to assess whether the problem was handled effectively and if the possibility of it reoccurring has been eliminated. 
 
Preventive action processes involve taking  the necessary actions in order to guarantee that an error will not occur. It is often necessary to have an analysis performed of the system and its processes, which will help determine the requirements for changes involved so that the problem does not occur. 
 
This is typically performed by assigning a team to a project that focuses on improvement, which can include plans for progress, discussions about change, the resources that will be required and then evaluating their findings. Preventive actions require a set program of activities that allow for change to be implemented and monitored. It is best to space out the stages of the set over a longer period of time in order to note the progresses and to make evaluation more meaningful. It is important to communicate the ideas about what has taken place and what has been done to help team members communicate in a productive way.  

About the Author: Shruti Bhat PhD, MBA
 
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
 
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A RACI matrix defines the contribution from different roles when it comes to finishing tasks in a process of business. It is a beneficial tool for making sure that roles and role responsibilities are clearly understood in a process. A RACI matrix is commonly made by creating rows and columns that depict the processes and the roles relating to the processes.
 
It is important to have a clear understanding of the roles and responsibilities in project management, especially in large teams with members from various departments. RACI matrix provides a good tool for eliminating confusion and allowing those involved to fulfill their roles in a more timely and effective manner, which leads to project completion at a more desirable rate. 
 
RACI is an acronym for Responsible, Accountable, Consulted and Informed. Responsible refers to the individual that is executing the activity. Accountable refers to the person who makes authority decisions and approves work. Consult refers to the individuals that are consulted when activities or decisions are being made or analyzed. Inform refers to the group of people who must be updated on the actions or decisions in a process. 
 
A RACI matrix is advantageous to an organization because it clearly shows if there are not enough, or too many, responsibilities in relation to each role. It also allows those involved to be aware of the responsibilities and the accountability of each activity. It makes it easier to inform all the right people and often allows for better communication to take place instead of misunderstandings. It also saves a significant amount of time by only involving those that are necessary at the appropriate times. 
 
The best way to implement a RACI matrix is to confirm that each task has a designated individual fulfilling the role. It is possible that more than one role is given to the same individual but this should only be limited to roles that are not vital and are not difficult to complete. In order to keep things stress-free and simple, each task should only have one person in the “accountable” section, despite the fact that it is okay to share responsibilities if it is necessary. 
 
If many individuals are involved in the “consulted” category, it is essential to evaluate and confirm whether or not all the individuals are necessary. Those that are not vital to the “consulted” category can be moved to the “informed” category in order to save time in communication. A RACI matrix is an excellent tool to use for project management that makes it easier for teams to communicate and complete a project at a much faster pace.

About the Author: Shruti Bhat PhD, MBA
 
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
 
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Value steam analysis is a tool used to record, evaluate and enhance information flow that is necessary in order to produce a service or product. It is a technique that solely uses pen and paper in order to gain insight and understanding of the movement of information or materials through the value stream that contributes to the production of a service or product. It is a tool that is most frequently used in Lean approaches, which is slightly different from the process mapping tool that is commonly used in Six Sigma. 

Value stream analysis differs from process mapping since it collects and shows a much larger range of information, involves more processes, used in wider circumstances and is used to find out where the focus of future events should be placed. Also referred to as an “end-to-end” map, value stream analysis does not only use the information regarding various activities leading up to a product or service, but also incorporates other elements of the entire process such as information and management methods.
 
It is an excellent tool for lowering time within a sequence since it allows us to find out valuable information regarding the process of making decisions as well as the actual process itself. 
  
The two main stages of constructing a value stream analysis is to map out the various stages in the process itself and conclude that information by placing a map above with the flow of information that is involved in the process. 
 
All the activities involved in the creation of a service or product are listed in a value stream analysis. This makes it easier to view the difference between meaning and necessary activities against those that are a waste of time or are prone to error. A good example of a value stream analysis makes it easy to separate the time by dividing activities that are deemed valuable and non-valuable. The analysis will make it clear as to which processes can be improved and can also be used to solve a specific problem, such as to find out where further efforts can be made to enhance production. 
 
It is meant to be used a tool for continuous improvement. Instead of jumping into value stream analysis in one go, it is wiser to start implementing it in segments instead. This can also help to reduce the initial costs that it can take to start implementing the changes involved in a value stream analysis. 

About the Author: Shruti Bhat PhD, MBA
 
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
 
#ShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #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