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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Manufacturing process qualification can be explained as collecting and evaluating data from the beginning stages to final production in order to find out how a product or service can be offered consistently. It encourages the use of current principles of manufacture, improvement of processes, the use of science, assessment of risks and modernization. 
 
It works on the understanding that is not possible to guarantee high-quality and consistent products or services by only inspecting at random stages or by only inspecting the final result. It is necessary to create a product or service that is effective, safe and of high quality to begin with.

The entire process of manufacturing is moderated and organized in such a way that the end result complies with all the necessary characteristics. In relation to the quality of a product, manufacturing process qualification states that the performance of a product does not differ regardless of the amount of batches involved, but remains consistent. 
 
There are three stages of implementing manufacturing process qualification: process design, process qualification and continued process verification. The first stage, process design, is when the process is outlined due to the data that is acquired during various activities leading up to it. Process qualification refers to the evaluation of the design outlined in stage one in order to assess whether the process has the capability required. Stage three, continued process verification, implies the continuous assertion is a norm due to the standards of production, which are constantly monitored.
 
Manufacturing process qualification shows whether or not the process that has been created can handle reproducing consistent manufacturing. There are two key attributes involved with process qualification. The first is the design of the processes and the types of tools used. The second is the procedure used to validate the performances. It is necessary to undergo manufacturing process qualification before a product or service is made available to the public. 
  
If all goes well then the products that are a result of the manufacturing process are accepted for distribution. The qualification shows that the tools that are required are able to perform the job and will help reach the performance level that is required. Qualification of the various tools typically includes appropriate selection, confirmation that they are built for their intended purposes, risk assessment, confirmation that they can perform in the conditions required, comparing various tool options and performing a variety of tests and studies. 


Shruti Bhat PHD MBA Certified Lean Six Sigma Black Belt is an Enterprise Strategist and Business Process Improvement Mastermind.
Connect with Shruti me on Twitter https://twitter.com/ShrutiUBhat
#ShrutiBhat  #ContinuousImprovement  #LeanSixSigma  #LeanInnovation #TQM #Kaizen #PharmaceuticalR&D  #Innoworks   #LifeScienceIndustry

While there are many benefits to implementing 55 workplace organization methodology, it is good to be aware of its potential limitations as well. The most common problems when implementing 5S include, but are not limited to, workplace problem misaddresses, struggles to change, deficiency of moral backing and misunderstanding the methodology in itself. 

It is not easy to create change in the workplace and 5S is known to cause large changes to occur. People get used to their way of things and routines, which can be difficult to change, especially if there is resistance to doing so. Therefore, it is necessary to introduce and implement 5S in increments, or at a slow pace, in order to allow people to get used to the idea of doing things in a different way. It is best to allow them to incorporate aspects of 5S into their daily habits without completely disrupting their norm in one go. 
 
Another way that this limitation can be overcome is to introduce 5S methodology’s concept during meetings and seeing their reaction. If the employees are interested in making the change, it will be that much easier to keep it going and to receive the necessary support. 
  
5S methodology is also largely customizable and each company needs to find how it will benefit them in the best way. Therefore, it is not ideal to use a pre-existing 5S plan from another company in hopes that it will reap the same results. Generally speaking 5S gets rid of unnecessary things in the workplace, but the framework that is used must be altered to suit each unique situation. Some workplaces may find that frequently used materials need to be brought closer to their areas, whereas others may need to clean out and reorganize their primary work space. 
 
5S has difficulty in excelling if it is not backed with moral support of the management and employees alike, regardless of the type of organization or industry vertical. Management is required to monitor, evaluate and provide an example as to how 5S should work, as well as provide adequate staff and financial support. Some organizations implement methodologies such as 5S and expect it to turn things around on its own. But this is not accurate, they are needed to be carefully implemented and monitored, even after success has been reached. It is also necessary to know exactly how 5S can benefit the company and not give it more expectations than it can fulfill. 

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