Innovation in the pharma Industry
Contents
• Objective
• Scope of the Study
• Introduction
• History of Lean
• Wasteful practices
• Tools in Lean
• Application of Lean in our company
• Analysis
• Conclusion
Scope of this project
This project is about the benefit in output when applying the Lean Principles to XXX Company (my previous company) which I worked for three years (due to confidential agreement I could not reveal that name of the company here).
Introduction
The company XXX was a well-known pharmaceutical company. It is always giving its customers a very good quality product (drug). Currently the company uses traditional ways to achieve good quality product such as cGMP refers to the Current Good Manufacturing Practice as per the US Food and Drug Administration (FDA). Though this process guarantees the products are steadily produced and meet the standards, but took a lot of time and produce huge amount of inventory piling on the go down. Sometimes the production took a lot of time and the product didn’t get on time to the customers. This will lead the demand of the product in the market. This irregular supply cost lot of money as well. The quality and quantity of the products also fluctuated a lot and that leads to lot of waste in terms of work in progress time, finished good waiting etc. Hence the company is looking for overall efficiency.
There are two methods available to improve the quality and overall efficiency namely Lean and Six sigma. Our company chooses the Lean method to improve the overall efficiency and quality mainly due to its waste elimination and reducing the amount of time between activities events and cycles. Because of the Lean process implementation, our productivity increased manifolds.
In this report, will describe effect of applying lean in our company and how it effectively reduced our wastes by using lean methodology.
History
What is lean?
Lean is nothing but minimising the waste and maximize the customer wealth by using systematic procedure. It gives the more values to the customers with zero waste or minimal waste. Henry ford was the first innovator of lean method in 1913. Ford transformed the industrial workshop with this approach to maximize the production. Toyota is the world leader in this methodology today due to their endless search for perfection. Their continued success for the past 20 years created huge demand for lean knowledge. Toyota slightly modified the ford system and gets the full benefit of this lean methodology called as Toyota production system (TPS) (Ref1). Lean can be implemented in all industries ranging from manufacturing, Automobile, chemical industries, health care industry, service sector etc. There are number of books, periodicals available to explain lean principles. Because of the benefits it give, most of the companies taking this in all sectors of the industry such manufacturing, logistics, services etc.
A company wants to apply lean principles must have a defined set of processes to be followed to a produce a product. This could be product, process or service oriented. The lean is about the complete and through elimination of wasteful practices". Unfortunately many companies understand this as "elimination of waste "(MUDA in Japanese) and will address only one of the three wasteful practices.
Wasteful Practices
There are three types of waste full practices available. 1 Muda 2. Mura and 3 Muri
Muda:
It is an activity or a process that doesn’t add value and it is waste of our time, resources and money. Specially focus on waste elimination.
Mura: Everyone in these processes has two types of activities 1. Valuable activities (VA) and 2 NVA (non-valuable activities). Each of them in a team add value to the product and to find out their Non value added activities as well. It also deals with work load volatility. Input materials/compounds supplied less than the demand and in some cases final product produced in excess.
Muri: it is actually over burden. It addresses the workflow to the employees in peak demand and in less demand period. In the TPS system, the lean activity is at the foundation of a house as given below
Just in time (JIT) Continuous improvement & Jidoka
Flow & Pull Waste Elimination Build in Quality and error
Prevention
Fig1. Lean House
The principles of lean represented in the "House of Lean". The roof represents the goals of the lean and pillars are the "lean practices" required to achieve the goals. The groundwork blocks are the important doers to practice the lean methodology in the company. Hence it is not only waste elimination pillar to build the lean house but also other pillars which lead to volatility in the product. We also had taken to consider "the seven muda wastes" which is noticeable and spontaneous.
Lean methodology is based on the following principles
Waste removal is the most important
Operational performance improvement
Reduce the operational variance
Safety aspects of employee and the customer
Employee confidence improvement
Decrease errors while developing new product
Financial savings
Reduce the waiting time to produce the final product to the market.
Lean Manufacturing process
The process has 3 important steps
Identify the waste
As per lean, there is always some waste is there in every process. To identify the waste we use the Value Stream map (VSM). It is a flow diagram mentioning each and every step elaborately.
This gives an idea of how the material and processes flow through the organization.
i. Analyse the waste and find out the reason for it
ii. Each waste we recognised in step 1, has to find out the reason for that waste
iii. Solve the root cause and repeat the cycle
Using appropriate method, we can solve that issue and decide what we will do to avoid this waste kin future and apply it in our process.
Tools used in Lean
The following tools can be used to reduce the waste in each and every step in the production process
Just In Time (JIT)
This is the most important method used in Lean process based on the "Pull" model. Purchase inventories as and when needed. It means making "only what is required and when it is, and in the amount required."
Kanban
This tool is focused on overproduction and minimise the overproduction. We have to produce to the correct quantity and correct size to the customers.
Zero defects
This deals with the correct product in the beginning itself rather than a defective product and spend some time on it to fix the bugs at a later time.
5S technology
There are five 5S phases translated from the Japanese as "sort", "straighten", "shine", "standardise", and "sustain".
Sort
The sort involves eliminating the unnecessary items not needed for our current operations. If we remove all these wastes, we can save time, money, energy and other resources can be managed effectively. When you are in doubt whether the item is essential or not, just throw it out.
Set in order/straighten
Arrange the items necessary for the operation so that they can be used as and when needed.
Shine
It deals with the workplace and machine maintenance and tells about the benefit of clean bright place where everyone enjoying his work. Machines that do not receive sufficient maintenance tend to break down and cause defects.
Standardize
It incorporates sort, set in order and shine into a single whole.
Sustain
It deals with the consequences of not keeping the records in order. It also deals with creating a habit of properly maintaining correct procedures for a process.
5S methodology benefits the company in many ways such as increasing quality, cost reduction, safety enhancement, rise in customer confidence, increasing production time, and minimize repair costs.
Fig2. 5S methodology
Applying Lean in our company
We applied the Lean process in our company in Laboratory and production departments.
Waste identification:
Waste not only involved in products, inventory but also the time delay in each and every step in a production cycle and is a loss for the development of a drug and it leads to loss of money. We found that lack of integration of lab work flows/informatics system among the teams. It involves lot of non-value added steps in the laboratory and variability in products.
Large number of printed documents needs to be carried in all process throughout the production cycle of a drug. There is always a chance of missing the document which is very important especially to file a patent.
Due to this, Unnecessary delays in each and every stage and product development and the speed is so slow.
Lack of coordination among the scientist among the data to be shared.
If anyone wants particular information about a chemical, he has to search physically to all the company documents. Hence maintaining those types of documents is very challenging and this also lead to the process very slow.
Lot of complexity in all stages
Low efficiency due to duplication efforts and data loss due to manual data transfer processes
Lean enabled Laboratories
If we choose the right tools and technique we can eliminate waste at the right time. If we choose the best work flow practice in the laboratory, that will remove the Variability in our processes.
We choose E-notebook (Electronic Lab Notebook), LIMS (Laboratory Information Management System) to eliminate the wastes. First we introduced Electronic Lab Notebook in QC and R&D labs at different sites. The Electronic Lab Notebook in general used by scientists and technicians to file their research, experiments and procedures.it is often used as evidence in a court as a legal document.
Abstract Overview
The typical flow of a drug development is shown in this diagram (VSM). The drug first developed in the Research and development lab has to be patented. For that process we have to give solid proof of evidence showing that we are the first to produce the drug. Enotebook will be accepted as evidence.
A typical E-Notebook is given below. E-Notebook is a secure, multi-user Electronic Laboratory Notebook .it is easily searchable, configurable and auditable. It gives lot of information at one place. Any user can have all the required data in his lab. Anybody can share their work with other research groups across the world.
Fig2. E-Notebook overview
E-Note book characteristics
This facilitates daily record-keeping for scientists (managing data, organizing information, streamlining workflow…)
• Allows searching by substructure, key word, date, and so on.
• Is highly configurable.
• Creates a valuable resource for the sharing and re-using of information amongst research scientists.
• Allows us to set up templates, to avoid reentering information that you often use
• Fully automates stoichiometry calculations
A typical user homepage of the E-Notebook is given below. It includes various sub section such as word, excel, ChemDraw, reaction section, sample management section etc.
Uses of lean
FIG.3 E-Notebook user Homepage
We also implemented a total knowledge management system as given below. It covers all aspects of research and development, quality and sample management in all areas.
Fig4. Integrated flowchart (VSM) in the process in a Lab
When we analyse the output we found a lot of improvements in terms of time, quality, waste reduction, potential knowledge sharing and research sharing across the globe.
Hence we implemented this E-Notebook, and another tool to improve the process called LIMS (Laboratory Information Management System).LIMS gives an idea to share all the laboratory informatics among those scientists. We put all the information in one place such as LIMS, E-Notebook, SDMS (Scientific Data management System) and analysis etc. This gives us huge amount of savings time and energy. Hence the variability decreased a lot.
Because of the above implementations we can reduce many manual steps and huge amount of money also saved.
Lean value estimated
Table1. Lean values saved
Task/Transfer steps cost saved
Task/Transfer
LIMS → CDS 68 several thousands*
Paper Notebook → CDS lot of variations several thousands*
CDS→Paper Notebook Highly varied several thousands*
LIMS → Paper Notebook 8 several thousands*
SDMS → LIMS 18 several thousands*
CDS→ SDMS 53 several thousands*
*The amount of money saved is highly confidential hence I put several thousands
Fig 5. Lean uses
Benefits of LEAN implementation
Issuing, tracking and archival of a research paper is very now.
Searching, data, structure, spectra is much easier. We almost remove the time waste in this process completely.
Easily clone the experiment whenever and wherever required
LIMS, E-NOTEBOOK and CDS (compound data sheet) is integrated.
Easily generate templates, crete and export lists of reactions, compounds. Products, inventories etc.
Minimise or almost nil errors in file transfer, compound data transfer such as compound registration, physical properties etc.
CONCLUSION
Our company is one of the famous pharmaceutical companies in the world. We already have many patents in our name. More than 50000 workers working globally. Using lean method, we have achieved the following things
50% of time reduction in documenting the compounds in a month.
Our operational performance has to be increased significantly
Fluctuations in the product output has been minimized
Quality of the product improved a lot
Reduce waste significantly in terms of raw material available for production, storage and supply
Work in progress (WIP) time has been maintained as minimal
QA and QC check time reduced enormously
Communication and collaboration improved
Errors reduced
Based on the above reasons, we now implemented this "Lean method" to all our branches across the world.
References:
1. http://www.toyota-global.com/company/vision_philosophy/toyota_production_system/
2.
Acknowledgements