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Digg It - Supplier Sees 53% Reduction in Out-of-Spec Orders Case Study
The goal of perfection is a challenge. It is often viewed as an expensive process requiring large investments. Yet one company has realized a 53% re
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
duction in orders that have to be set aside for additional Quality Control checks. How did they do it? They used communication techniques - not capit
; 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
l outlay!
The secret to there success revolved around team skills and communication. The company's Production Manager formed a focus group to discus
The secret to there success revolved around team skills and communication. The company's Production Manager formed a focus group to discus
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
comprised of members from each department that was affected in some way by the rejects. Using a proven "problem identification" process, the producti
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n manager was able to facilitate a brain-storming session separating symptoms from root causes. The team was quickly able to identify the main reason
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
for the rejections.
"Using this process lead us very quickly to a cause that we never would have even thought of otherwise," the Production Manager s
"Using this process lead us very quickly to a cause that we never would have even thought of otherwise," the Production Manager s
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
ated.
Parts were being rejected due to what Union members saw as an insignificant variation in the specifications. They did not understand management
Parts were being rejected due to what Union members saw as an insignificant variation in the specifications. They did not understand management
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
was rejecting the part because of one or two degree differential in the temperature during one phase of production. Union members had grown to view t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e rejections as a management scheme to pick on shifts or individuals. Management knew the impact of the temperature on the finished product and the ul
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
imate reliability of the part in the final product.
As the Quality Control Manager pointed out, "We had been working on what we thought the problem w
As the Quality Control Manager pointed out, "We had been working on what we thought the problem w
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
s for quite some time. We were addressing symptoms and never even got close to the root cause."
The success came after a Team Skills program was pre
The success came after a Team Skills program was pre
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
sented by Rochester Hills based Max Impact. During the program members of management learned through vivid examples and experiential learning how to
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
se individual talents to generate synergy as a team." We learned how to work together in a way that will have long-term rewards," according to the com
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
any's President.
"Using the team problem solving model we learned in the Team Skills program, and the tools we received from the program, we saw the
"Using the team problem solving model we learned in the Team Skills program, and the tools we received from the program, we saw the
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
ejection issue in a different light," added the Production Manager said, "The problem has been haunting us a long time and was getting worse. With jus
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
three meetings we were able to reverse the trend dramatically."
Although pleased with this success, the company's President says, "it is exciting to
Although pleased with this success, the company's President says, "it is exciting to
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
know that we can use this same process to handle even more problems." He has his eyes on nearly a quarter million dollar savings he hopes to see with
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n the next six months. "As good a success as it was, it is more rewarding to see that my manager now truly believe that things don't have to be the w
.
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
y they always have been. They know that even though we were good, we can do even better."
If you would like more information about the problem identi
If you would like more information about the problem identi
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
ication system used in this success, contact Max Impact at 248-802-6138 or via email: info@getmaximpact.com
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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