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Digg It - Change Management - Adopting A Continuous Improvement Program
An Organizational Development (OD) professional may have a special challenge regarding change when a company decides to adopt a quality initiative program. These programs commonly referred to as Continuous Improvement (CI) or process improvement programs are popular and used by most Fortune 500 companies. They include but 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
re not limited to ISO, CMMI, Six Sigma, Lean Manufacturing, Lean Six Sigma and TQM. To understand the OD professional’s role in change management it is important to first understand CI programs in general.
All CI programs are designed to increase quality and revenue. Each program includes a set of analytical problem solvin
All CI programs are designed to increase quality and revenue. Each program includes a set of analytical problem solvin
; 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
g tools and statistics to guide employees through a particular quality model. ISO 9000 – The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards bodies. CMMI - Capability Maturity Model Integration - is a process improvemen
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t approach that provides organizations with the essential elements of effective processes. Both of these methodologies require certification from an outside organization. ISO is closely aligned with electrical equipment and CMMI was created by SEI (Software Engineering Institute) and Carnegie Mellon University with a core fo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cus on software development.
Both ISO and CMMI have expanded their methodology to include management programs and are often used as a marketing advantage. For example, if a company who is selling a product is ISO or CMMI certified, it may be considered a plus by a company who is interested in buying the service or product.
Both ISO and CMMI have expanded their methodology to include management programs and are often used as a marketing advantage. For example, if a company who is selling a product is ISO or CMMI certified, it may be considered a plus by a company who is interested in buying the service or product.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
This is especially if that company is certified in the same methodology. What is important for the OD professional to note is that the decision to adopt a particular methodology may be made purely as a marketing tool and the ability for the employees to adapt may be considered secondary.
For most employees the very thought
For most employees the very thought
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
of process improvement, which always involves some sort of gap analysis can be frightening. Process improvement can mean the elimination of jobs or departments. Key to CI programs is the ability to gain and act on current knowledge. Employee resistance, for all the obvious reasons, can hinder the success of the program.
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
If the purpose of the CI program is not properly communicated everyone loses.
Change management considerations with formal programs such as ISO and CMMI are straightforward with minimum flexibility. If the organization does not follow a set of prescribed steps the organization will not be certified or recertified.
With oth
Change management considerations with formal programs such as ISO and CMMI are straightforward with minimum flexibility. If the organization does not follow a set of prescribed steps the organization will not be certified or recertified.
With oth
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
er CI programs such as Six Sigma, Lean Manufacturing or Lean Six Sigma the need to change the culture is less structured. This presents its own set of issues for the OD Professional whose change agent skills have been enlisted. Establishing a clear understanding of the CI program, vocabulary, goals and expectation is necess
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
ary before any communication is released to the employee population. Although Six Sigma, Lean Manufacturing and Lean Six Sigma all have guidelines the review process is not standardized.
Six Sigma is a methodology developed by Motorola designed to eliminate defects. Early adopters include Bank of America, Caterpillar, Honey
Six Sigma is a methodology developed by Motorola designed to eliminate defects. Early adopters include Bank of America, Caterpillar, Honey
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
well International (previously known as Allied Signal), Raytheon and General Electric (introduced by Jack Welch). Most Six Sigma organizations rely heavily on the DMAIC model which is an acronym for Define, Measure, Analyze, Improve and Control. Six Sigma organizations also rely on martial arts designations to explain the v
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
arious levels of expertise: white belt, yellow belt, green belt, black belt and master black belt.
The martial arts designations are also true of Lean Six Sigma companies who incorporate Lean Manufacturing or Lean Thinking – a methodology focused on reducing waste - into the Six Sigma program. In some ways the martial arts
The martial arts designations are also true of Lean Six Sigma companies who incorporate Lean Manufacturing or Lean Thinking – a methodology focused on reducing waste - into the Six Sigma program. In some ways the martial arts
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
designation are helpful to the OD professional since they help identify who in the organization might be able to offer subject matter expertise. However, the martial arts designations have also not always been seen as a positive change factor. Some organizations, such as Raytheon, have elected not to use the terms at all a
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
nd call their employees experts.
The very idea of helping employees become better thinkers implies that they are not performing to the best of their ability. To be successful, quality initiative programs have to be repackaged as part of continuous improvement. When employees are approached with the ‘good to great’ message
The very idea of helping employees become better thinkers implies that they are not performing to the best of their ability. To be successful, quality initiative programs have to be repackaged as part of continuous improvement. When employees are approached with the ‘good to great’ message
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
it is easier to digest.
The CI movement has been around for a long time. Many site TQM or Total Quality Management as the program that made CI programs popular. TQM is a management strategy designed to heighten the awareness of quality. The original TQM strategy involved quality circles where all employees involved with
The CI movement has been around for a long time. Many site TQM or Total Quality Management as the program that made CI programs popular. TQM is a management strategy designed to heighten the awareness of quality. The original TQM strategy involved quality circles where all employees involved with
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
the process that was targeted for improvement had the opportunity to provide input. Unfortunately, in modern day CI programs this step is missed. Members of the project team involved in implementing the change are tasked with identifying the process owner but are not as concerned with the ‘everyone involved in the process’
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
foundation. This often causes communication problems that hinder the OD professional’s ability to be a successful change agent.
The good news is that OD professionals are rarely burdened with determining which functions to measure and which metrics to use when identifying the success of a CI program. Since metrics, benchma
The good news is that OD professionals are rarely burdened with determining which functions to measure and which metrics to use when identifying the success of a CI program. Since metrics, benchma
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rking, statistics and tools exist within each CI program it is more of a matter of scaling down the information. With most CI programs scorecards are used as well. The Balanced Scorecard is a popular template used by many companies regardless of the CI program adopted. This scorecard developed by Robert S. Kaplan and David
.
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
Norton in 1992 has been evolved and modified for a variety of industries and departments. The OD professional can be a more successful agent for change by studying the areas the organization has assessed as the most important and understanding how the CI program is intended to impact each area.
For the OD professional not f
For the OD professional not f
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
amiliar with CI programs reviewing TQM basics is a good place to start. TQM presents most of the analytical problem solving tools and logic that is the cornerstone of all CI programs. Since all CI programs promote ways of doing things better, faster and cheaper the opportunity to utilize change management skills is abundant
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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