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Digg It - Six Sigma Audit
Six Sigma methodology is not a self-sustaining management tool perhaps unlike other technologies. It can only deliver the results subject to multiple varia
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
bles and inputs such as deployment intensity and culture. Nonetheless, the results take around 4-6 months to show, depending on the projects selected and ad
; 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
erence to the tenets of the methodology.
The Six Sigma audit process does not depart too much from the assessment process of the deployment, in order that
The Six Sigma audit process does not depart too much from the assessment process of the deployment, in order that
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
implementation status is checked for its effectiveness. The audit procedure dwells on questionnaires and checklists which help auditors evaluate the status
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
f respective processes on ‘as is’ condition which is later compared with ‘should be’ condition. The ‘should be’ condition is the reference standard clearly
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
defined at the beginning of the deployment in the goal setting stage.
The audit process in Six Sigma is pretty much comparable with a ISO 9000 audit. Many
The audit process in Six Sigma is pretty much comparable with a ISO 9000 audit. Many
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
ix Sigma companies have successfully developed Six Sigma audit procedures based on the ISO 9000 principles but goes a bit further in the sense that Six Sigm
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
a takes into consideration the Voice of Customer (VOC). However, while auditing customers it is the internal customers that are interviewed. Using of audit
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rocedures developed by Malcolm Baldrige Quality Awards is not new and unique in Six Sigma audit.
Use of Checklists and Charts for Six Sigma Audit
Using ch
Use of Checklists and Charts for Six Sigma Audit
Using ch
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
arts, made in the form of checklists, in audit ensures that nothing is left to chance. A checklist, which is exhaustive, is prepared during the launch of th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
project. There will be multiple checklists for each process and activity which can be used methodically to assess the processes involved in the project. Fo
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
r example, to check the leadership level and knowledge levels of Black Belts you can use the appropriate list.
The process audit checklists, like the rest,
The process audit checklists, like the rest,
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
are prepared based on the Standard Operating Procedure defined in the beginning. Each question critically examines as to whether a step is being followed an
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
d if yes, how well. The activities and sub activities, since they are measurable, can be rated on the fact sheet on a predetermined scale. The answers to th
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
se questionnaires are summarized on the sheet itself.
For example, take the case of a dispatch system. If the process variation had occurred, the deviation
For example, take the case of a dispatch system. If the process variation had occurred, the deviation
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
is recorded in the operator’s log which gets exposed during the audit. The variations are plotted against the standard deviation for exact picture.
The de
The de
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
iations from the mean represent process variation and with the help of these data, root causes of process variations are interpreted.
The Scope of the Six
The Scope of the Six
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Sigma Audit
All in all, the scope of the audit is only limited by the preset goals and the customer reactions to the changes. The measurable aspects, inclu
All in all, the scope of the audit is only limited by the preset goals and the customer reactions to the changes. The measurable aspects, inclu
.
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
ing the customer satisfaction level are recognized independently and critically examined, which throws light on the current status of that process. The corr
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
elation that exists between all processes put together gives the final picture of where the project is heading with respect to ROI and customer satisfaction
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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