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Advice You - Do Kaizen Events Help in Non-manufacturing Units?
The word Kaizen means continuous improvement. Implementation of a quality process does not mean that there is no need for any further improvements of changes. In fact, most quality processes are reviewed at frequent interv
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
als and findings are then implemented as changed processes. This review process which is geared to bring about a positive change in the total process, when done formally with all concerned personnel, is known as a Kaizen E
; 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
ent.
Kaizen events can be considered as a pro-active step in those organizations where the management aspired to become Six Sigma certified some day and can be considered as a reactive step in those which have a low Sigma
Kaizen events can be considered as a pro-active step in those organizations where the management aspired to become Six Sigma certified some day and can be considered as a reactive step in those which have a low Sigma
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
score. Just as Six Sigma is now moving into the non-manufacturing sector, Kaizen Events are also becoming part of the non-manufacturing sector.
Getting together business managers in a non-manufacturing unit at a Kaizen ev
Getting together business managers in a non-manufacturing unit at a Kaizen ev
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nt is useful for any company whether Six Sigma certified or not. In fact, some times its easier to get business managers in one location in a non-manufacturing unit as they might be physically located in the same premise.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
urthermore, the personnel in a non-manufacturing unit may be along the same socio-economic line and likely to think alike. Manufacturing unit personnel come from different walks of life and it takes a lot of patience to ge
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
everyone to agree to any new process change or development.
Kaizen events can be deemed very important in non-manufacturing process as many processes within a service organization affect the customer directly. Periodical
Kaizen events can be deemed very important in non-manufacturing process as many processes within a service organization affect the customer directly. Periodical
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
review and improvement of processes help improve the organization’s performance in an all-round fashion. Kaizen Events in non-manufacturing units not only help in review of specific processes and review from all business p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ocess owners, it also acts as an excellent platform to educate newcomers in the company about the organization’s commitment to quality.
Educating the team members on the processes and re-iterating the effectiveness of the
Educating the team members on the processes and re-iterating the effectiveness of the
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
process are excellent by products of Kaizen Events. However, Kaizen Events cannot be treated as regular meetings to discuss an agenda. These events need to be formulated to deliver maximum value to all attendees. Usually t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ere is a designated person with the organization who leads Kaizen Events. Non-manufacturing units may even decide to rotate the designated person as most business managers are similar in qualifications.
If you plan to lea
If you plan to lea
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
d a Kaizen Event in your non-manufacturing business, you should make the event follow a strong structure. Apart from that, all best practices for meetings should also be adhered to. The meeting should focus on the reviews
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
n hand and the leader’s effort should be not to let the topic deviate from the official agenda. Well timed breaks, discouraging side conversations and documentation of all discussions are some of the standard procedures to
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
be implemented in a Kaizen event.
Preparedness is one of the key ways to succeed in a Kaizen event and that is applicable to both manufacturing and non-manufacturing units. The leader has to be suitably prepared with docu
Preparedness is one of the key ways to succeed in a Kaizen event and that is applicable to both manufacturing and non-manufacturing units. The leader has to be suitably prepared with docu
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
ents, flow charts and displays to run the entire team over the process in a productive manner. A loosely thought out Kaizen Event can not only be counter-productive, it can also be de-motivating to the entire team.
Kaizen
Kaizen
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
events in non-manufacturing units may help in diagnosing a process but it would still need to be done frequently to be able to keep a tab on the improvements which happen in the process. One of the key differences in Kaize
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
events between manufacturing and non-manufacturing units is the location of the event. In manufacturing units, the events might be held on the shop floor itself whereas in the case of non-manufacturing events, the meeting
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
can be held in a conference room or board room. In manufacturing units, the leader of the meeting will need to attack the core issues right away whereas in a non-manufacturing unit, there can be some amount of educational
.
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
r interactive session as well.
Rapid progress in a quality compliance exercise can be achieved with Kaizen Events. In fact, Kaizen events can easily be followed in non-manufacturing units which do not have a major quality
Rapid progress in a quality compliance exercise can be achieved with Kaizen Events. In fact, Kaizen events can easily be followed in non-manufacturing units which do not have a major quality
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
and business process improvement exercise underway. The spirit of Kaizen can be implemented in the organization with Kaizen Events and can play a vital long term role in achieving the quality goals of the business managers
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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