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Just Other Articles - Lack of Operations Manuals Stunting Your Growth?
Lack of Operations Manuals stunting your growth?
CONTENTS:
1. Do you lack functional Operations Manuals?
2. Use a SYSTEM to write your Operations Manuals!
3. Yes, but my people just don't/won't write stuff down!
4. But people WILL write stuff down - if ...
5. Call to
CONTENTS:
1. Do you lack functional Operations Manuals?
2. Use a SYSTEM to write your Operations Manuals!
3. Yes, but my people just don't/won't write stuff down!
4. But people WILL write stuff down - if ...
5. Call to
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
Action.
1. Do you lack functional Operations Manuals?
Great businesses depend on systems, not people.
That's because you can duplicate systems, but not people.
If your business can't duplicate salable results, it won't survive. Duplication is Nature's Survival Law.
If your organization l
1. Do you lack functional Operations Manuals?
Great businesses depend on systems, not people.
That's because you can duplicate systems, but not people.
If your business can't duplicate salable results, it won't survive. Duplication is Nature's Survival Law.
If your organization l
; 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
cks Operations Manuals, your growth and success will be limited due to lack of a duplicable (documented) system.
2. You can use a SYSTEM to write your Operations Manuals!
Extraordinary people don't build great businesses. Ordinary people produce extraordinary results using a duplicable syste
2. You can use a SYSTEM to write your Operations Manuals!
Extraordinary people don't build great businesses. Ordinary people produce extraordinary results using a duplicable syste
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
m. That's how you build a great business.
The faster you develop good Operations Manuals the faster you will have a great business!
3. Yes, but my people just don't/won't write stuff down!
You will hear many excuses and attitudes for why people don't write Operations Manuals.
"We just don'
The faster you develop good Operations Manuals the faster you will have a great business!
3. Yes, but my people just don't/won't write stuff down!
You will hear many excuses and attitudes for why people don't write Operations Manuals.
"We just don'
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
have enough time."
"It's not my job man! You hired me to be a [manager, programmer, accountant, engineer, whatever]. I'm not a writer!"
"I hate to write. Who needs it!"
"Whenever I feel like writing, I lie down until the feeling goes away."
"It's different here. Things change too fast. Th
"It's not my job man! You hired me to be a [manager, programmer, accountant, engineer, whatever]. I'm not a writer!"
"I hate to write. Who needs it!"
"Whenever I feel like writing, I lie down until the feeling goes away."
"It's different here. Things change too fast. Th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e minute we write something down, it's obsolete..."
These are typical objections people express. But, one of the most UNexpressed fears is:
"If I document my job in an Operations Manual, I can be replaced! I'll lose my job!"
No wonder so few organizations have Operations Manuals!
4. But pe
These are typical objections people express. But, one of the most UNexpressed fears is:
"If I document my job in an Operations Manual, I can be replaced! I'll lose my job!"
No wonder so few organizations have Operations Manuals!
4. But pe
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
ple WILL write stuff down - if ... and only if they can realize a benefit!
Let's face it. You can grow your organization ONLY if you can promote and/or replace your employees. Thus, you and your team can MOVE UP only if you can replace yourselves.
And you can do this by documenting your posi
Let's face it. You can grow your organization ONLY if you can promote and/or replace your employees. Thus, you and your team can MOVE UP only if you can replace yourselves.
And you can do this by documenting your posi
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
tions in well-organized Operations Manuals.
"Mike! Are you saying that by writing stuff down in Operations Manuals we'll receive more raises, promotions, and vacations."
Absolutely!
These goodies are not available without your company's growth and prosperity!
Did you know most business sta
"Mike! Are you saying that by writing stuff down in Operations Manuals we'll receive more raises, promotions, and vacations."
Absolutely!
These goodies are not available without your company's growth and prosperity!
Did you know most business sta
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t-ups fail while most franchises succeed. Successful franchises use a documented management system ... in short ... Operations Manuals!
"But Mike, our company is not a 'franchise!'"
Neither is mine.
But SMS has a documented management system, including about 13,000 pages of Operations Manua
"But Mike, our company is not a 'franchise!'"
Neither is mine.
But SMS has a documented management system, including about 13,000 pages of Operations Manua
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
ls.
When anyone or I want to know how to do something, all we need do is pull a manual off the shelf. What could be easier? There's near zero "tribal knowledge" here.
We can relocate on a moment's notice with minimum hassle.
I know of many companies that wanted to move from California.
Sud
When anyone or I want to know how to do something, all we need do is pull a manual off the shelf. What could be easier? There's near zero "tribal knowledge" here.
We can relocate on a moment's notice with minimum hassle.
I know of many companies that wanted to move from California.
Sud
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
enly, they were faced with hiring many new, inexperienced employees in another state.
Suddenly, they were faced with writing (insufficient) Operations Manuals literally as-they-packed!
Believe me, displaced employees were less than cooperative! And those who moved with the company inherited
Suddenly, they were faced with writing (insufficient) Operations Manuals literally as-they-packed!
Believe me, displaced employees were less than cooperative! And those who moved with the company inherited
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
normous problems due to poor - or no - documentation.
So, here's my advice. Start now!
Develop a set of Operations Manuals where you collect information that governs how your company's positions function.
At SMS, we have at least one 3-ring binder for every position on our Org Chart.
Devel
So, here's my advice. Start now!
Develop a set of Operations Manuals where you collect information that governs how your company's positions function.
At SMS, we have at least one 3-ring binder for every position on our Org Chart.
Devel
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
op your Operations Manuals in a standard format containing at least the following information for each position.
ACCOUNTABILITY - Specify the position's accountabilities.
STANDARDS - Specify the standards for the position. Include the policies that define / limit the position's authority and
ACCOUNTABILITY - Specify the position's accountabilities.
STANDARDS - Specify the standards for the position. Include the policies that define / limit the position's authority and
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
the position holder's general conduct.
WORK INSTRUCTIONS - Specify how the position's work will be performed.
GENERAL INFORMATION - Provide information about your organization, your products and services, your competition, etc. Include other material that enriches the position holder's unde
WORK INSTRUCTIONS - Specify how the position's work will be performed.
GENERAL INFORMATION - Provide information about your organization, your products and services, your competition, etc. Include other material that enriches the position holder's unde
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
rstanding of the working environment.
INTERFACE - Describe how the position interfaces with:
INTERFACE - Describe how the position interfaces with:
- Its superior position.
- Its subordinate positions.
- Peer position(s) with frequent contact.
- Non-peer staff positions with frequent contact.
- The "Outside World" (customers,
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
vendors, etc.).
You can design your manuals to have five sections each as follows.
You can design your manuals to have five sections each as follows.
- POSITION SECTION
- COMPANY/PRODUCTS SECTION
- POLICY SECTION Company-wide policies:
- SYSTEMS SECTION Action plans, sample forms, flowcharts, scripts, collateral materials, etc.
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
LOGIC SECTION Explain the principles behind the position's work.
5. Call to Action.
To review, your Operations Manuals are collection points for information that governs functioning of positions on your Org Chart.
I sent you this eZine to give you an outline to ease development of yo
5. Call to Action.
To review, your Operations Manuals are collection points for information that governs functioning of positions on your Org Chart.
I sent you this eZine to give you an outline to ease development of yo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r Operations Manuals.
As you've probably guessed, developing Operations Manuals is a big task. I've done it often for many clients. If I be of assistance, just send me an email.
Together, we can document what you want, how you want it, and when you want it. We will discuss various creative
As you've probably guessed, developing Operations Manuals is a big task. I've done it often for many clients. If I be of assistance, just send me an email.
Together, we can document what you want, how you want it, and when you want it. We will discuss various creative
.
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
approaches before the project begins.
Mike Hayden
Principal/Consultant
Your partner in streamlining business. For more information,
Email: mailto:info@seniormanagementservices.com
Website: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Mike Hayden
Principal/Consultant
Your partner in streamlining business. For more information,
Email: mailto:info@seniormanagementservices.com
Website: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
agementServices.com" target="_new">http://www.SeniorManagementServices.com
(c) 2003 Mike Hayden, All rights reserved. You may use material from the Profitable Venture Tactics eZine in whole or in part, as long as you include complete attribution, including live website link and email link
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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