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Digg It - Performance Begins With an S
Performance and behaviour in many organisations are not managed well. The common missing ingredient in managing performance and behaviour is the absence of enforced standards.
We are confronted almost daily with stories of IT project overruns and outri
We are confronted almost daily with stories of IT project overruns and outri
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
ght failures, public service procedural errors with dire consequences to individuals or quality and service errors resulting in unhappy customers. We are also confronted with examples of poor behaviour from sports people struggling with fame to senior executives defraud
; 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
ing their staff or their shareholders.
The consequence to an organisation of poor performance of employees, at any level, is low productivity, high rework rates, higher risk and consequently, higher costs to achieve the outcomes required from any given role.
The conse
The consequence to an organisation of poor performance of employees, at any level, is low productivity, high rework rates, higher risk and consequently, higher costs to achieve the outcomes required from any given role.
The conse
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
quence of poorly behaving employees is increased risk with significant negative potential for an organisation's brand and its health safety, security and environment performance.
Most of the poor performance and poor behaviour occurs simply because it is tolerated.
Fr
Most of the poor performance and poor behaviour occurs simply because it is tolerated.
Fr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
om my observations, the tolerance comes about for the core reason that there are no enforced standards.
In the absence of formal enforced standards, people apply their own standards using their best efforts to complete a role. The standards used are formed from previou
In the absence of formal enforced standards, people apply their own standards using their best efforts to complete a role. The standards used are formed from previou
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s experience in the role or, a similar role, or if they are new to a role, from their personal values. These personal values are generated from their upbringing at home, their school, sporting teams and other social interactions.
The values are also generated from inte
The values are also generated from inte
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
ractions with opinions from the media.
Those interactions with the media are now likely to be with sources constructed to be popular rather than a well thought out editorial or journalistic piece. For example, tabloid newspapers, popular magazines, TV shows increasingl
Those interactions with the media are now likely to be with sources constructed to be popular rather than a well thought out editorial or journalistic piece. For example, tabloid newspapers, popular magazines, TV shows increasingl
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
y of the contrived reality type and web based interactions such as forums and blogs.
The impact of personal interactions on values, it seems to me, is increasingly being tilted to these popular sources. The norm for behaviour is more that of the subjective norm within
The impact of personal interactions on values, it seems to me, is increasingly being tilted to these popular sources. The norm for behaviour is more that of the subjective norm within
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
people's social groups rather than that of other formal standards.
Realigning people's standards away from the popular culture norms to those required by an organisation to execute their strategies and maintain their brand positioning is more necessary than ever.
The
Realigning people's standards away from the popular culture norms to those required by an organisation to execute their strategies and maintain their brand positioning is more necessary than ever.
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
realignment of standards can be accomplished in four steps.
Write standards
The first step, not surprisingly, is to write standards. Standards of performance should take the form of an action and an object of the action with accompanying measures that
Write standards
The first step, not surprisingly, is to write standards. Standards of performance should take the form of an action and an object of the action with accompanying measures that
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tell us whether the action has been completed satisfactorily.
For example, answer the telephone in three rings. Or attend a minimum of ten board meetings. Or unload a truck, without incident, within one hour, 80% of the time and with ninety minutes 100% of the time.
For example, answer the telephone in three rings. Or attend a minimum of ten board meetings. Or unload a truck, without incident, within one hour, 80% of the time and with ninety minutes 100% of the time.
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
Note in the last example, a qualifier "without incident" was given. One might also add conditions to standards. For example, "When the front office is fully staffed, check in will be completed, without complaint, within three minutes on 90% of occasions a
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
nd within five minutes on 100% of occasions." The condition is, "When the front office is fully staffed".
Standards of behaviour are more likely to be written into policies or codes of behaviour. For example, "Directors will declare all pecuniary in
Standards of behaviour are more likely to be written into policies or codes of behaviour. For example, "Directors will declare all pecuniary in
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
terests in the pecuniary interest register." Or "All employees will act in a safe manner at all times at work, travelling to and from work and when representing the company". Or "All employees will refrain from behaviour which causes offence to custo
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
mers, suppliers, the general public and colleagues at all times".
Communicate standards
The likelihood of anyone adhering to standards if they have not been communicated well is zero. The standards can best be communicated, at first, by involving
Communicate standards
The likelihood of anyone adhering to standards if they have not been communicated well is zero. The standards can best be communicated, at first, by involving
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
people in their construction.
When the standards are completed, communicate them repeatedly in different formats. Do not fall into the trap of using text only means of communication. A large majority of any organisation's employees will require visual or auditory mean
When the standards are completed, communicate them repeatedly in different formats. Do not fall into the trap of using text only means of communication. A large majority of any organisation's employees will require visual or auditory mean
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
s of communication to "get it".
Test people to make sure that the communication has got through and they understand the standards.
Enforce standards
Creating standards without enforcing them is a waste of time and effort. As soon as one per
Test people to make sure that the communication has got through and they understand the standards.
Enforce standards
Creating standards without enforcing them is a waste of time and effort. As soon as one per
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
son is seen to be not behaving or performing within the standards with no action taken, the subjective norm will turn to standards not mattering.
Integrate standards with your reward and recognition system, appraisal system and recruitment methods.
Ensure that standar
Integrate standards with your reward and recognition system, appraisal system and recruitment methods.
Ensure that standar
.
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
ds created for completing appraisals and managing performance are, in turn, enforced.
Review and update standards
Involve your people in reviewing the suitability of standards. Not all standards will withstand the scrutiny of application without modif
Review and update standards
Involve your people in reviewing the suitability of standards. Not all standards will withstand the scrutiny of application without modif
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 and all standards will need to change over time as the environment in which the organisation operates changes.
Demonstrating a willingness to adjust standards to make them work to execute the strategies of the organisation will generate buy-in from your people.
Demonstrating a willingness to adjust standards to make them work to execute the strategies of the organisation will generate buy-in from your people.
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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