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Digg It - Preparation for Lean Manufacturing
It seems that every manufacturing company is now trying to adapt the Lean Philosophy, invented and mastered by Toyota Corporation. Lean manufacturing has also spilled over into non manufacturing industries. Unfortunately, many companies don’t completely understand the true meaning of Lean Manufacturing. Lean Manufacturing, simply put,
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
is “continuously improving your processes to eliminate waste”. This sounds simple, but many companies will fail to become truly Lean because they don’t have an environment to implement and maintain Lean.
Most people believe Lean is just a set of tools (One Piece Flow, JIT, Kan-Ban, 5S, Six-Sigma, Kaizen Teams, Push / Pull Systems, etc
Most people believe Lean is just a set of tools (One Piece Flow, JIT, Kan-Ban, 5S, Six-Sigma, Kaizen Teams, Push / Pull Systems, etc
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
.) that can be used to cut waste. However, Lean is not only a set of tools, it is a culture. If a company has severe issues with employee turnover, employee morale, product quality, product delivery, equipment uptime, plant housekeeping, etc., it will be extremely difficult to shift the employees to a new way of thinking and conducting
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
business. In other words, if your employees are in constant fire fighting mode, they will not be able to properly implement Lean.
Fix the obvious problems first
To prepare for Lean, you must “fix the obvious problems first”. Many times employers will know exactly what the problems and solutions are. They just don’t have the ti
Fix the obvious problems first
To prepare for Lean, you must “fix the obvious problems first”. Many times employers will know exactly what the problems and solutions are. They just don’t have the ti
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
me, resources, or incentive to fix them. If you have an automobile that is constantly breaking down because of a bad transmission, then fix it! Repair or replace the transmission. Do not implement a Lean Strategy to fix the car. Just fix it. Lean is not used to fix broken processes. Lean is used to continuously improve working processe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to eliminate waste. When all the obvious problems are fixed on that vehicle, it’s then time to fine tune it to become more efficient. It’s time to look at ways to cut waste (cost) to ultimately save money!
A Word about Six-Sigma
Some companies now mandate that Six-Sigma be used to fix problems. Unfortunately, Six-Sigma isn’t
A Word about Six-Sigma
Some companies now mandate that Six-Sigma be used to fix problems. Unfortunately, Six-Sigma isn’t
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
always used correctly. Six-Sigma is intended to solve complex problems that have numerous variables that cause variation in a process, which ultimately cause defects. Six-Sigma uses statistics to systematically identify what the different variables are doing in the process and points to potential solutions. It eliminates guessing as to
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
what’s causing the variations. Again, fix the obvious problems first. Many problems don’t have to be analyzed to detect solutions. In many instances, the solutions are obvious: i.e., If the light bulb is blown, then, change the light bulb.
Value Your People
Society generally refers to companies as entities. We speak of IBM, G
Value Your People
Society generally refers to companies as entities. We speak of IBM, G
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
, and Microsoft as entities; however, they are really groups of people. GM doesn’t build cars, the employees of GM build cars.
To develop that culture as successfully as Toyota Corporation has, companies must first realize that they have to develop, nurture and value their employees. In order to build a culture of people wanting to co
To develop that culture as successfully as Toyota Corporation has, companies must first realize that they have to develop, nurture and value their employees. In order to build a culture of people wanting to co
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ntinuously improve, people have to be engaged in their jobs. They have to feel valued by the company. They have to feel they are noticed and rewarded for their contributions. Ultimately, the company has to value having low employee turnover to create consistency. A company with high employee turnover cannot maintain a successful Lean e
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
vironment.
To foster this type of environment in today’s business world isn’t easy. There is low loyalty between U.S. companies and their employees for a variety of reasons. Some companies look at employees as an expense rather that an asset that can be easily cut. If employees of a company do not feel the company values them, they wi
To foster this type of environment in today’s business world isn’t easy. There is low loyalty between U.S. companies and their employees for a variety of reasons. Some companies look at employees as an expense rather that an asset that can be easily cut. If employees of a company do not feel the company values them, they wi
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ll find other jobs. With today’s business world, it’s difficult to implement a long term Lean strategy. Yes, a company can dictate to it’s employees to use Lean tools to cut waste, however, to sustain that ideology long term require an engaged, loyal, consistent, work force.
Develop and Retain Strong Leaders
Good managers are
Develop and Retain Strong Leaders
Good managers are
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
coaches, poor managers are dictators. A good manager will believe in the team concept where every member of the team is important and his/her opinions are valued. A good manager will value his/her employees and realize that for him/her to be successful, the team has to be successful. A poor manger will dictate to his/her employees, whi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
h creates havoc! A good, efficient, business unit with high employee morale will fall apart within weeks if a poor manager has taken over. Poor managers fail because they don’t have strong leadership skills. They lack people skills, communication skills, decision making skills, and delegation skills necessary to develop and maintain ef
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
fective teams. A strong leader must sell the Lean Strategy and realize that ultimately the employees as a team are the ones to make it happen.
Think and act World Class (even if not there yet!)
To become Lean is to become World Class. When walking into a facility that has an unclean, unorganized work environment, one knows he/
Think and act World Class (even if not there yet!)
To become Lean is to become World Class. When walking into a facility that has an unclean, unorganized work environment, one knows he/
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
he haven’t walked into a World Class facility. There is no need to look at the productivity numbers to determine whether or not the facility is World Class. If a plant is World Class, it looks World Class as soon as you walk into the door.
A Lean facility is thoroughly organized. Every process is clearly defined via standards. Product
A Lean facility is thoroughly organized. Every process is clearly defined via standards. Product
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ion is operated via very clear Visual Management. A true World Class facility has the discipline to sustain organization. Outside auditors, potential customers and employees will be turned off if the work environment isn’t clean and organized. Keeping a work area clean and organized is simple; however, many companies overlook this simp
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
le task.
Make Decisions Based on Logic and Not Politics
Most of the time decisions made senior management are implemented without questioning regardless if the decisions make sense or not. Too many times, decisions are made by senior management without them fully understanding the process and issues. Lower-level managers ultim
Make Decisions Based on Logic and Not Politics
Most of the time decisions made senior management are implemented without questioning regardless if the decisions make sense or not. Too many times, decisions are made by senior management without them fully understanding the process and issues. Lower-level managers ultim
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
tely implement ideas and strategies that are not based on logic but politics. They will implement ideas even if they themselves do not believe in them. This can create numerous problems which makes implementing Lean Strategies difficult.
Decisions should be made throughout the organization through effective communication. Senior manag
Decisions should be made throughout the organization through effective communication. Senior manag
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ement should not just mandate, but sell their ideas and be open to questioning and suggestions from lower-level managers. Senior management should fully understand the issues and processes by effectively communicating with the managers at the different levels. Major decisions whenever possible should be made as a team vs. an individual
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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