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Main Subject - Best Practices Plan: Dissemination of a Great Idea
Good news spreads quickly
News of the invention of the wheel must have traveled in every direction as quickly as horse or camel could run. Those who learned of its advantages over the litter and the sledge adopted it right away. And no sooner was it adopted than it began to be adapted: made lighter, stronger, faster. Wheels were soon attached to axles, then to axles with pivots.
The idea catches on
Then transportation lost its monopoly on the new technology, and wheels helped to make pottery, lift buckets out of wells, steer ships, grind grain, keep time. Even now, the process of adopting and adapting the wheel continues as new uses are modified, improved, and applied in ingenious ways. The observation is certainly true: “Without the wheel
News of the invention of the wheel must have traveled in every direction as quickly as horse or camel could run. Those who learned of its advantages over the litter and the sledge adopted it right away. And no sooner was it adopted than it began to be adapted: made lighter, stronger, faster. Wheels were soon attached to axles, then to axles with pivots.
The idea catches on
Then transportation lost its monopoly on the new technology, and wheels helped to make pottery, lift buckets out of wells, steer ships, grind grain, keep time. Even now, the process of adopting and adapting the wheel continues as new uses are modified, improved, and applied in ingenious ways. The observation is certainly true: “Without the wheel
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
, today’s civilization would be impossible.” [1]
No wheel, little progress
Meanwhile for hundreds and perhaps thousands of years, in islands of the South Pacific, the Americas, and other isolated places, cultures existed without any knowledge of the wheel. Their technology lagged behind because they still faced that first, high hurdle. Human beings have always been better modifiers than inventors. Why reinvent the wheel when someone has already done the hard work?
Best practices needed
Like civilization, your company is on a journey; yours is one of continuous quality improvement. It is “a journey with a definite a beginning but no end, and every one of your employees is a co-traveler.
No wheel, little progress
Meanwhile for hundreds and perhaps thousands of years, in islands of the South Pacific, the Americas, and other isolated places, cultures existed without any knowledge of the wheel. Their technology lagged behind because they still faced that first, high hurdle. Human beings have always been better modifiers than inventors. Why reinvent the wheel when someone has already done the hard work?
Best practices needed
Like civilization, your company is on a journey; yours is one of continuous quality improvement. It is “a journey with a definite a beginning but no end, and every one of your employees is a co-traveler.
; 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
The extent of your progress depends on how well you live your core values values: like company family, commitment to quality, customer focus, embracing technology, integrity and respect, and teamwork. These values overlap, merge, and blend into one another when it comes to the sharing, evaluating, and implementing of best practices.
Definition is important
What are best practices? Unless we have a clear idea of what they look like, we won’t recognize them when we see them. According to the American Productivity and Quality Centre, best practices are “those practices that have been shown to produce superior results; selected by a systematic process; and judged as exemplary, good, or successfully demonstrated.” [2]
Definition is important
What are best practices? Unless we have a clear idea of what they look like, we won’t recognize them when we see them. According to the American Productivity and Quality Centre, best practices are “those practices that have been shown to produce superior results; selected by a systematic process; and judged as exemplary, good, or successfully demonstrated.” [2]
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
>
Of course, this definition still leaves quite a bit of room for differences of opinion about what is “best” and what is not. According to C. Ashton in Managing Best Practices, “best” is always contextual, or situation-specific.” [3] A more sophisticated, multilevel approach to defining best practices comes from Chevron: [4]
Of course, this definition still leaves quite a bit of room for differences of opinion about what is “best” and what is not. According to C. Ashton in Managing Best Practices, “best” is always contextual, or situation-specific.” [3] A more sophisticated, multilevel approach to defining best practices comes from Chevron: [4]
- Good idea – unproven but makes sense intuitively; could have a positive impact on business performance; worth investigating further.
- Good practice – technique, methodology, procedure, or process already implemented that has improved business results for an organization in a measurable way.
- “Proven”
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
best practice – a good practice determined to be the best approach, based on analysis of process performance data.
For more than the past decade, businesses across the country and around the world have been developing, identifying, implementing, and adapting best practices as one means of achieving the excellence of efficiency and superior customer service that would set them apart from their competitors. No doubt your company is engaged in the same quest.
Process of best practices transfer
A recent study identified six steps involved in the transfer of best practices:” [5]
For more than the past decade, businesses across the country and around the world have been developing, identifying, implementing, and adapting best practices as one means of achieving the excellence of efficiency and superior customer service that would set them apart from their competitors. No doubt your company is engaged in the same quest.
Process of best practices transfer
A recent study identified six steps involved in the transfer of best practices:” [5]
- Searching
This step involves finding best-in-class solutions from a variety of sources, both internal and
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
xternal to your company. Your company's SOPs constitute a tremendous resource (hopefully available on your intranet) available to and from employees in all of your sites and regions. Success stories contained in newsletters and award presentations are another internal source. Good sources for external searches can involve newsletters and journals, business contacts, trade shows and workshops, new hires, “boomerang” employees.” [6] and outsourcing contacts.” [7] If you start looking for best practices, your search will certainly pay off.” [8]
Evaluating
This is a critical but essential step, though it is heavily dependent on the
This is a critical but essential step, though it is heavily dependent on the
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
specific situation and people involved. On the one hand is the tendency to assume “the way we’ve always done it is the best.” On the other hand is the equally questionable assumption, “it must be better because it’s new.” [9]
Validating
Measurements help to eliminate this kind of subjectivity. Does the department already engaged in the practice have higher productivity, less downtime, more rapid customer response, or fewer reworks than the same department at another site that has not adopted it? The evidence should be compelling that the payback of the change will be much greater than its costs. And once a practice is validated as “best” it needs to be publicized. This will encourage others not only
Measurements help to eliminate this kind of subjectivity. Does the department already engaged in the practice have higher productivity, less downtime, more rapid customer response, or fewer reworks than the same department at another site that has not adopted it? The evidence should be compelling that the payback of the change will be much greater than its costs. And once a practice is validated as “best” it needs to be publicized. This will encourage others not only
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
to adopt it, but to come forward with best practices of their own.
Implementing
The practice has to be documented (usually in an SOP), and usually someone already engaged in the practice should be involved in training others. During the implementation step, team members should be looking to adapt the practice to local needs and varying circumstances, as well as analyzing opportunities for improvements.
A note of caution: Although “Imitation is the sincerest form of flattery,” copying someone else’s success does not always work. As David Bracken, director of Mercer Delta Consulting, put it, “I have always been skeptical about taking tools designed in one setting and using them in another organization ... more often than not attempts at
The practice has to be documented (usually in an SOP), and usually someone already engaged in the practice should be involved in training others. During the implementation step, team members should be looking to adapt the practice to local needs and varying circumstances, as well as analyzing opportunities for improvements.
A note of caution: Although “Imitation is the sincerest form of flattery,” copying someone else’s success does not always work. As David Bracken, director of Mercer Delta Consulting, put it, “I have always been skeptical about taking tools designed in one setting and using them in another organization ... more often than not attempts at
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
‘copying’ are doomed to failure.” [10]
Not only might the copied practice suffer from “copy-of-a-copy” degradation, but the people on whom the practice is imposed might very well lack the motivation of the group that developed and implemented the practice in the first place.
Reviewing
Once a best practice has been plugged in, it should be reviewed from time to time. All processes—even the best ones—grow stale over time, and what is “best” now may not remain “best” for long. As one study noted, “‘best’ is a moving target in today’s world.” [11]
Routinizing
Making a best practice into a standard practice is what the transfer process is
Not only might the copied practice suffer from “copy-of-a-copy” degradation, but the people on whom the practice is imposed might very well lack the motivation of the group that developed and implemented the practice in the first place.
Once a best practice has been plugged in, it should be reviewed from time to time. All processes—even the best ones—grow stale over time, and what is “best” now may not remain “best” for long. As one study noted, “‘best’ is a moving target in today’s world.” [11]
Making a best practice into a standard practice is what the transfer process is
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
all about. Successful adoption means that a best practice has become incorporated into the culture of what it means to do business with your company. What was once above the ceiling now becomes the floor upon which we stand to reach even higher.
Beyond best practices
Identifying, evaluating, adopting or adapting, implementing, reviewing, and routinizing best practices can lead to marked improvements in the way you do business. This strategy can help you to be more efficient, improve your profitability, eliminate mistakes, and most importantly, raise the level of your service to the external customer even higher.
There is a proviso, however. Peter Skarzynski and Peter Williamson of Strategos warn that all of this adopting of best practices
Beyond best practices
Identifying, evaluating, adopting or adapting, implementing, reviewing, and routinizing best practices can lead to marked improvements in the way you do business. This strategy can help you to be more efficient, improve your profitability, eliminate mistakes, and most importantly, raise the level of your service to the external customer even higher.
There is a proviso, however. Peter Skarzynski and Peter Williamson of Strategos warn that all of this adopting of best practices
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
an lead to what they call “strategic convergence,” a phenomenon in which each competitor within an industry moves its practices and procedures closer and closer to those of its rivals. Their survey of more than 500 CEOs indicates that such convergence is actually taking place in many industries. Its eventual result would be the elimination of virtually everything that distinguishes one competitor from another. [12]
Their solution? Innovation! The company that devotes itself to innovation will always be able to differentiate itself from its competition. They offer ten rules on how to innovate successfully in their article, “Innovation as Revolution.” [13]
Another important cave
Their solution? Innovation! The company that devotes itself to innovation will always be able to differentiate itself from its competition. They offer ten rules on how to innovate successfully in their article, “Innovation as Revolution.” [13]
Another important cave
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
at is that sharing best practices is not the only tool you have to achieve excellence. Of even greater importance are your people. You must continue to hire people with great attitudes and then provide them with the training they need to be experts at their job. Then you need to re-recruit them so that they will stay with the company. This re-recruiting process involves making your company the “employer of choice” by having great managers, a great working environment, and great benefits. [14] The best people—your employees—will drive your best practices, speeding you ahead in your Quality Journey.
Your company's search for best practices
Your company should be pro-active in its search for best practices. The mai
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 points of the program should include:
- Internal search – Researching best practices should start with what is already being done internally, concentrating on improving perceived weaknesses.
- Sharing of information – News about best practices should be disseminated throughout your company by department managers’ meetings and senior managers’ meetings, the publishing of SOPs on your intranet, employee newsletter and e-mail announcements, employee meetings, and as many other methods as you can devise.
- Corporate and management support – The capture and transfer of best practices should be supported by your board of directors and senior managers by promoting the development of SOPs through
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
out the company, encouraging alignments, and proactively supporting all quality initiatives. Corporate support must also be strong to make improvements through identifying and implementing best practices.
An ongoing quest
Your search for best practices must be continual, as you strive to strengthen what is weak, make what is good even better, and plug in what is best. You should also seek ways to adapt practices regarded as “best-in-class” to new situations and circumstances. The overall direction of your improvement journey is away from isolation toward interconnectedness, away from the static toward the dynamic, and away from top-down management toward the empowerment of all employees. You should make measurable progress in all three of thes
An ongoing quest
Your search for best practices must be continual, as you strive to strengthen what is weak, make what is good even better, and plug in what is best. You should also seek ways to adapt practices regarded as “best-in-class” to new situations and circumstances. The overall direction of your improvement journey is away from isolation toward interconnectedness, away from the static toward the dynamic, and away from top-down management toward the empowerment of all employees. You should make measurable progress in all three of thes
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
e aspects; enlisting the cooperation of all employees will ensure that such progress accelerates.
Copyright ©2005 Steve Singleton, All rights reserved.
Notes
- World Book, s.v. “Wheel.” [BACK]
- Yasar F. Jarrar and Mohamed Zairi, “Best practice transfer for future competitiveness: a study of best practices,” Total Quality Management 11, 4-6 (July 2000):S734ff. [BACK]
- Ashton, Managing Best Practices (London: Business Intelligence, 1998), cited in Jarrar and Zairi. [BACK]
- A
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
cited in Jarrar and Zairi. [BACK]
“Identifying and transferring internal best practices,” published by American Productivity and Quality Centre in 1997. This white paper is summarized in Jarrar and Zairi. [BACK]
A “boomerang” employee is one who leaves to work for another company and then returns. The returning employee may prove to be a valuable resource for best practices from their previous company, since they were able to compare the practices they learned at the other company from the perspective of those they knew at your compoany. Karen Lee, “Tales of ‘boomerang’ employees on the rise,” Employee Benefit News 14, 6 (May 2000): 63; Tiffany Kjos, “Boomerang emplo
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
yees on the rise in tight market,” Inside Tuscon Business 9, 52 (March 20, 2000):14. [BACK]
For outsourcing as a source of best practices, see Peter Bendor-Samuel, “Leverage Best Practices,” Executive Excellence 18, 2 (February 2000):17. For a case study of an excellent external search for best practices, see Michelle M. Rodier, “A quest for best practices,” IIE Solutions 32, 2 (February 2000):36. [BACK]
Some organizations formalize this search process by demanding managers provide a timely decision for each proffered best practice: to investigate it; to adopt or adapt it and say when; or to reject it and explain why. They then track which departments ar
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e most active in adopting best practices and which are resisting change. Thomas A. Stewart, “Knowledge worth $1.25 billion,” Fortune 142, 13 (November 27, 2000):302. [BACK]
According to Ed Yager, a consultant and trainer on best practices implementation, we should evaluate the validity of so-called best practices according to three categories: 1) The known knowns – what we are aware that we know or think we know; 2) the known unknowns – our awareness of what we don’t know but wish we did; and 3) the unknown unknowns – what we are unaware of, but could really use if we knew it. “Adopting best practices,” Enterprise/Salt Lake City 30, 28 (January 15, 2001):11. Those most resistant to best practices tend t
.
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
o absolutize category 1, thinking their knowledge is broad and deep; minimize category 2, assuming what they don’t know is insignificant or irrelevant; and deny even the possibility of the existence of category 3. [BACK]
David Bracken, “Linkage Inc.’s Best Practices in Leadership Development Handbook [Book Review],” Personnel Psychology 53, 4 (Winter 2000):1026. [BACK]
Jarrar and Zairi. [BACK]
As cited by Daniel Jennings, “Benchmarking best practices may not be the best practice for your company,” EBN 1254 (March 19, 2001):47. [BACK]
Their ten rules are: 1) Seek
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
innovation at the level of the business model; 2) Listen to new voices; 3) Work from the future back; 4) Diverge, then converge; 5) Use multiple lenses to generate new learning and opportunities; 6) Create a portfolio of options on the future; 7) Evaluate new opportunities using different criteria; 8) Embed innovation through practice; 9) Instill a passion for creating the future; and 10) Break the rules. Peter Skarzynski and Dr. Peter Williamson, “Innovation as Revolution,” Economic Bulletin (April 2000). [BACK]
Kevin Freiberg and Jackie Freiberg, “Best Practices,” Business Credit 102, 3 (March 2000):52. [BACK]
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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