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Digg It - Leaning Your Organisation
The Institute of Certified Public Accountants recently published its first tracking research report – CPA Business Barometer – on the state of the economy and the issues facing Irish business. Some real concerns emerged around costs and competitiveness for all European Businesses. There was specific evidence that subsidiaries of foreign companies are under significant scrutiny regarding costs that they incur. There is also concern in European political circles about the pace of growth in labour costs and productivity versus the emerging states in Europe a
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
nd the Far East. These are big issues in assessing competitiveness.
The impact of all of this is clearly seen in the reduction of manufacturing jobs in the old Europe. Company closures have largely been brought about as a result of Central Europe’s high cost base and a change in global trading conditions. These factors will have an ever-increasing impact on Small and Medium Enterprises (SME’s) servicing the manufacturing sector in the old EU.
Public and semi-state sectors are also coming under increased competition as a result of EU regulatory changes.
The impact of all of this is clearly seen in the reduction of manufacturing jobs in the old Europe. Company closures have largely been brought about as a result of Central Europe’s high cost base and a change in global trading conditions. These factors will have an ever-increasing impact on Small and Medium Enterprises (SME’s) servicing the manufacturing sector in the old EU.
Public and semi-state sectors are also coming under increased competition as a result of EU regulatory changes.
; 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
Some operations in these sectors are run on traditional and outmoded practices. Increased competition both within Ireland and across the EU will have a significant impact on the viability of these concerns.
Financial Controllers and Managers in SMEs and service sectors are, however, successfully fighting back through a number of initiatives that include:
- Moving business activities up the value chain
- Developing and marketing ‘knowledge centres of excellence’ within their own organizations
- Initiating programs for streamlining their core pr
Financial Controllers and Managers in SMEs and service sectors are, however, successfully fighting back through a number of initiatives that include:
- Moving business activities up the value chain
- Developing and marketing ‘knowledge centres of excellence’ within their own organizations
- Initiating programs for streamlining their core pr
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ocesses
These organizations have embarked on what we term Lean improvement initiatives using concepts and tools associated with the Lean Thinking philosophy.
What is Lean?
Lean Thinking was introduced by Toyota in the 1960’s as a systematic approach to identifying and eliminating waste or non-value-add activities in an organization through continuous improvement with the goal of creating value.
The term “Lean” is used because a Lean organization or business:
Optimizes human effort
Uses less space
Reduces the need for capital investm
These organizations have embarked on what we term Lean improvement initiatives using concepts and tools associated with the Lean Thinking philosophy.
What is Lean?
Lean Thinking was introduced by Toyota in the 1960’s as a systematic approach to identifying and eliminating waste or non-value-add activities in an organization through continuous improvement with the goal of creating value.
The term “Lean” is used because a Lean organization or business:
Optimizes human effort
Uses less space
Reduces the need for capital investm
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ent
Decreases amount of raw materials/supplies bought and consumed
Uses less time to produce and deliver products and services
Lean is therefore a strategy or system for remaining competitive through identifying and eliminating wasteful steps in products, services, or processes. The key principles of Lean are based on identifying 'waste' from the customer perspective, and determining how to eliminate it. Waste is defined as the activity or activities that a customer would not want to pay for and do not add value to the product or service fr
Decreases amount of raw materials/supplies bought and consumed
Uses less time to produce and deliver products and services
Lean is therefore a strategy or system for remaining competitive through identifying and eliminating wasteful steps in products, services, or processes. The key principles of Lean are based on identifying 'waste' from the customer perspective, and determining how to eliminate it. Waste is defined as the activity or activities that a customer would not want to pay for and do not add value to the product or service fr
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
om the customer's perspective. Once waste has been identified in the current or existing state, a plan is formulated to eliminate this waste and attain a desired future State in as effective and efficient a manner as possible.
Types of Wastes
Wastes can be typically divided into the following:
The 7 Wastes Examples
1. Waiting Employee or equipment idle time
2. Transportation Any movement that does not add value
3. Processing Itself Doing more work than necessary
4. Motion Wasted walking or movement
5. Poor “Quality” Errors or r
Types of Wastes
Wastes can be typically divided into the following:
The 7 Wastes Examples
1. Waiting Employee or equipment idle time
2. Transportation Any movement that does not add value
3. Processing Itself Doing more work than necessary
4. Motion Wasted walking or movement
5. Poor “Quality” Errors or r
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
ework
6. Inventory Storing excess inventory
7. Overproduction Producing more, sooner, faster than required by the next step in the process
Lean Tools and Techniques
There are a number of techniques and tools available to achieve the objectives associated with Lean Thinking. The most popular and effective of these include Value Stream Mapping, Kaizen, and 5S.
Value Stream Mapping (VSM):
Value Stream Mapping (VSM) follows a product or service from beginning to end, and draws a visual representation of every step in the process that the pro
6. Inventory Storing excess inventory
7. Overproduction Producing more, sooner, faster than required by the next step in the process
Lean Tools and Techniques
There are a number of techniques and tools available to achieve the objectives associated with Lean Thinking. The most popular and effective of these include Value Stream Mapping, Kaizen, and 5S.
Value Stream Mapping (VSM):
Value Stream Mapping (VSM) follows a product or service from beginning to end, and draws a visual representation of every step in the process that the pro
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
duct or process goes through, from receipt of raw materials or source of information from your supplier; to the processing of that product or service; to its final distribution to the end customer. A value stream encompasses all the value-add and non-value-added actions required to bring a product or service to a customer.
VSM provides a means for identifying non-value-add activities within a value stream and a platform to improve quality, efficiency, and productivity. As a result, process flow for that product or service is improved, while also inventor
VSM provides a means for identifying non-value-add activities within a value stream and a platform to improve quality, efficiency, and productivity. As a result, process flow for that product or service is improved, while also inventor
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y and floor space requirements are optimized.
The initial step in the VSM exercise is the development of a current state map that provides a detailed account of how a selected process works. Based on the findings of this current state analysis, a future state map is generated. This map provides a vision of what the organization could aspire to in improving flow, efficiency, and productivity. The future state map is subsequently implemented through a detailed plan that is tied to the organization’s business objectives.
Example of a Future Value Stream Ma
The initial step in the VSM exercise is the development of a current state map that provides a detailed account of how a selected process works. Based on the findings of this current state analysis, a future state map is generated. This map provides a vision of what the organization could aspire to in improving flow, efficiency, and productivity. The future state map is subsequently implemented through a detailed plan that is tied to the organization’s business objectives.
Example of a Future Value Stream Ma
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
p
Source: Stryker Orthopaedics, Limerick
Kaizen:
Kaizen is a philosophy focused on problem solving to achieve gradual, orderly, and continuous improvement throughout all the elements of a process. It is based on analyzing a process or system with a view to developing an understanding of how it works, and working out how it can be continually improved. Kaizen activities are aimed at adding value to every operating step in a process, and eliminating any waste from that process.
A Kaizen Event is a carefully planned, well structured team-based activity f
Source: Stryker Orthopaedics, Limerick
Kaizen:
Kaizen is a philosophy focused on problem solving to achieve gradual, orderly, and continuous improvement throughout all the elements of a process. It is based on analyzing a process or system with a view to developing an understanding of how it works, and working out how it can be continually improved. Kaizen activities are aimed at adding value to every operating step in a process, and eliminating any waste from that process.
A Kaizen Event is a carefully planned, well structured team-based activity f
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ocused on solving problems in a process. The Event should be customer-driven, in that the improvements that it initiates and implements are aimed at getting a product or service of the highest quality to a customer in the least amount of time.
The Event is based on a Plan, Do, Check, Act approach to problem solving and achieving continuous improvement.
5S:
5S is a methodology aimed at removing waste from the workplace by means of improved workplace organization, visual communication, and overall cleanliness. The methodology is based around a number of
The Event is based on a Plan, Do, Check, Act approach to problem solving and achieving continuous improvement.
5S:
5S is a methodology aimed at removing waste from the workplace by means of improved workplace organization, visual communication, and overall cleanliness. The methodology is based around a number of
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
activities or stages that are focused on cleaning and organizing the workplace to enable employees to carry out their daily tasks in as safe and efficient a manner as possible.
The 5S stages or pillars and the order in which they should be implemented are as follows:
- Sort
- Set in
- Shine
- Standardise
- Sustain
Your management and staff need to be familiar with all aspects of the 5S methodology before you commit fully to the concept. All your relevant staff should receive appropriate training in the 5S aims, stages and implement
The 5S stages or pillars and the order in which they should be implemented are as follows:
- Sort
- Set in
- Shine
- Standardise
- Sustain
Your management and staff need to be familiar with all aspects of the 5S methodology before you commit fully to the concept. All your relevant staff should receive appropriate training in the 5S aims, stages and implement
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
ation methods before commencing any pilot program.
Example of 5S Visual Display Cabinet
Source : Stryker Orthopaedics, Limerick
Benefits of Lean
All types of organizations are discovering the advantages of educating their people on Lean and applying its principles within their own organization. Some of these organizations are trying to function effectively in the face of mounting challenges such as a high cost base relative to their competition; declining market share due to process or cost problems, and limited capacity. In all of these cases, Lean c
Example of 5S Visual Display Cabinet
Source : Stryker Orthopaedics, Limerick
Benefits of Lean
All types of organizations are discovering the advantages of educating their people on Lean and applying its principles within their own organization. Some of these organizations are trying to function effectively in the face of mounting challenges such as a high cost base relative to their competition; declining market share due to process or cost problems, and limited capacity. In all of these cases, Lean c
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
an have an immediate, positive impact on business. Through the process of implementing Lean, the organization can find ways to achieve a number of benefits. Results will vary, but here are some typical savings and improvements:
- More operational flexibility
- Increased turnover
- Consistent product or service delivery
- Reduced lead times
- Reduced space
- Improvement in quality
- Reduction in operating costs
SME Case Study
Founded in 1986 Reagecon manufactures and distributes a comprehensive range of reagents, standa
- More operational flexibility
- Increased turnover
- Consistent product or service delivery
- Reduced lead times
- Reduced space
- Improvement in quality
- Reduction in operating costs
SME Case Study
Founded in 1986 Reagecon manufactures and distributes a comprehensive range of reagents, standa
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
rds and laboratory equipment aimed at providing the correct result for analysts and technicians in all sectors. The company employs over 70 staff primarily in Shannon and reaches customers in some 30 countries through a network of European and Asian distributors. The business has grown strongly in recent years and expects to break the ?10m turnover this year.
Early in 2005 Reagecon was introduced to the concept of Lean by one of its key customers. To begin that process they sent a small team to their customer’s site to see how it was done and on their re
Early in 2005 Reagecon was introduced to the concept of Lean by one of its key customers. To begin that process they sent a small team to their customer’s site to see how it was done and on their re
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
turn one of their members went on to get formal accreditation in the principles of Lean.
The application of the Lean program began with the introduction of a 5S program in all areas of the business. This included the manufacturing floors, the distribution warehouses, the customer care function and the administration functions. This was followed with an initial Kaizen blitz to begin addressing wasted time. Those first two programs saved the company approximately 2,500hours. This additional time released from their processes was extremely valuable as the b
The application of the Lean program began with the introduction of a 5S program in all areas of the business. This included the manufacturing floors, the distribution warehouses, the customer care function and the administration functions. This was followed with an initial Kaizen blitz to begin addressing wasted time. Those first two programs saved the company approximately 2,500hours. This additional time released from their processes was extremely valuable as the b
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
usiness was growing and more needed to be done with the same resources.
So successful was the program that they have now invested in putting eight more Reagecon team members through formal accredited training on the principles of lean. That team has just now completed its studies and has been tasked with reviewing all business processes with a goal of using what they have learnt to drive more waste from the business.
The practical nature of the training coursework has meant that the team has already saved a further 500 man-hours as they completed the va
So successful was the program that they have now invested in putting eight more Reagecon team members through formal accredited training on the principles of lean. That team has just now completed its studies and has been tasked with reviewing all business processes with a goal of using what they have learnt to drive more waste from the business.
The practical nature of the training coursework has meant that the team has already saved a further 500 man-hours as they completed the va
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rious modules of the course. Experience to date has convinced Reagecon that Lean is not just for large organizations and they expect much more to come from the program in the coming months.
Conclusion
On their own, the individual Lean concepts and tools will provide certain measurable benefits, but it is the combination of them and their systematic implementation that will lead to more dramatic gains. Successful Lean implementation requires commitment and involvement across all levels as an organization-wide change initiative.
The first step to any Lea
Conclusion
On their own, the individual Lean concepts and tools will provide certain measurable benefits, but it is the combination of them and their systematic implementation that will lead to more dramatic gains. Successful Lean implementation requires commitment and involvement across all levels as an organization-wide change initiative.
The first step to any Lea
.
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
n initiative is to gain top management support. Effective communication of Lean Thinking throughout the organization is seen as a vital ingredient in its successful implementation. This has to begin at senior management level in any company. Management must appreciate and understand the financial opportunity and long-term business benefits of converting from traditional ways of doing business to a streamlined Lean approach. It is imperative to educate and train core staff in Lean Thinking, and to appoint a number of internal Lean Champions to drive impro
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
vements across the organisations core business processes.
Without significant change in how businesses organize and arrange the way that they work, any piecemeal change will do little more than maintain the status quo. The maxim should be that every process can be improved and, therefore, even if you think ‘it isn’t broke’, fix it anyway.
Finally, remember that Lean can be applied equally to all activities as diverse as manufacturing, logistics, financial services, construction, and government departments. Indeed anywhere where a business process exists
Without significant change in how businesses organize and arrange the way that they work, any piecemeal change will do little more than maintain the status quo. The maxim should be that every process can be improved and, therefore, even if you think ‘it isn’t broke’, fix it anyway.
Finally, remember that Lean can be applied equally to all activities as diverse as manufacturing, logistics, financial services, construction, and government departments. Indeed anywhere where a business process exists
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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