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  • Digg It - Chaos Theory: The Uncontrollable Factor in the Development of Management Systems

    Failures in project management systems can be superficially explained by anything from a lack of project detail to managerial conflicts. However, this failure often has deeper roots. Until we begin to recognize this uncontrollable factor it will be difficult to master the implementation of any management system. This factor is known as the “Chaos Theory” or simply “chaos”. Chaos Theory could be considered a core management theory fo
    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
    r the 21st century. According to Wheatley (1992) when management tries to control chaos by “shoehorning” it into a specific structure, an organization is bound to fail. Controlling chaos this rigidly is actually limiting information gathering (Stuart, 1995) and creating the illusion of management. According to McNamara (1999), Chaos Theory recognizes that events are rarely controlled. As systems such as those in management grow in c
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    mplexity, the more they become volatile or susceptible to cataclysmic events.

    One way to plan for such chaos is through “contingency management”. Contingency management is having an alternative plan to fall back on when chaos strikes, allowing for critical internal processes to continue and meet the desired outcome. Most managers do not see contingency management as a necessary step, because it takes time. In a world where efficienc
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    y and timeliness is key, this step is often the first to be overlooked. Until management recognizes the importance of contingency management and allows it to be fully implemented, chaos will continue to hinder the progress and efficiency of management systems.

    DEFINING AND ESTIMATING CHAOS

    The more general name for the field is complexity theory, where chaos is a particular mode of behavior (Rosenhead, 1998). Chaos theory explains
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    hat the behavior in turbulent systems quickly becomes disordered (Wikipedia, 2005). Chaos theory acknowledges that management systems break down. It recognizes that decisions need to be made even in the absence of all intended information (Herz, 2001). Complete order, while the ideal, will always be the one unaccounted for variable—part of our human nature. Similar to accidents, chaos is like a release of energy in an uncontrolled wa
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    y (Blockley, 1998).

    Project management systems are considered dynamic systems, similar to those in nature, which means they change over time and are hard to predict. Even though they are changing, there is usually an underlying predictability that can be identified. This is where chaotic behavior comes into play. Behavior in systems can be placed into two zones, one, the stable zone, where the system, if disturbed, returns to its in
    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
    tial state and two, the zone of instability where some small activity leads to further divergence (Rosenhead, 1998).

    CALCULATING CHAOS

    Chaos is immeasurable because of its level of randomness and unpredictability. Gabriel (1996) states that looking for sufficient equations to enable one to ‘manage’ such chaos is part of a futile and wish-fulfilling quest. However there are some researchers that believe calculating chaos is possible
    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
    . While chaos in the business world mimics that in nature, unlike chaos in nature, there are measurable ways for project managers to try and calculate the degree to which chaos will affect their project. The following formula can help to calculate project constraints:

    Dynamics = D + a*P + b*R + c*D*P + d*P*R + e*R*D + f*D*P*R

    Where D=directives, P=prerequisites, R=resources and a & f are constraints.

    However Bertelsen and Koskela
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    2003) postulate that aside from estimating the size of the chaos (small to extra large), a system is too complicated to predict its function and response to a given problem.

    WHY IS BUSINESS SO CHAOTIC?

    The pace of today’s businesses and technological innovations have quickened to an impossible pace. Sometimes project timelines need to be written before all tasks and resources have been completely identified, which puts a project be
    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
    hind schedule before it has begun. This increasingly fast-paced system is “a breeding ground” for a chaotic management system (Yoke, 2003).

    This breeding ground is creating a complexity explosion, which is affecting the way project managers need to manage. Undertaking a management system project is more than a weeklong project—many last for years or longer. As conditions are constantly changing, goals and objectives need to also be
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    lexible to change. Goals and objectives are necessary, however, flexibility is key in order to ensure positive long-term results of a project.

    HOW TO MANAGE CHAOS

    The first line of defense in order to manage chaos is a good management team and an even better project manager. According to Bertelsen & Koskela (2003) an organization can manage its chaos by seeking out the factors that are easiest to change. An organization should then
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    handle a projects dynamics and stress in the face of uncertainties. Finally, a manager should both always have a contingency plan and be able to keep track of critical factors and issue warnings. By turning an organization into a “learning organization” successful management of chaos is more likely (Bertelsen & Koskela, 2003).

    Systems are so dynamically complex and highly sensitive to conditions that any link between cause and effe
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t can set off a ripple effect rendering its future deliverable unpredictable. Technologies, timelines, scope, costs, personnel, are constantly changing within an organization and management must be adaptable. The same holds true for project managers. If they are not given the flexibility to adapt to chaos then management systems will fail. Project managers need to be seen as venture capitalists: always searching for new ideas.

    Most
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    management systems set forth a detailed plan and than proceed to follow it. According to McNamara the best way to do this is to work backwards through the system of an organization. This will help to show which processes will produce the right output and what inputs are required to conduct those processes (McNamara, 1999). A good project manager is one who realizes that plans often need to change in order to accommodate a changing si
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    uation. By following contingency plans, good managers can avoid such mishaps as scope creep and cost overruns. There are different tools that project managers can use to help manage the chaos and successfully manage complicated systems. According to the Numbers Group some such tools are:

    1. Work Breakdown Structure (WBS) – breaks the product to be developed or produced by hardware, software, support, or service element and relates
    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
    the scope to each. Example of WBS

    2. Program Evaluation and Review (PERT) – a model, which helps the project manager define the critical path using, randomized tasks Example of Pert Chart

    3. Implementation Schedule (GANTT) – graphical representation of the duration of tasks against the progression of time.

    Example of Gantt Chart

    4. Enneagram - originally a tool for personality mapping, can find order in chaos by identifying un
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    erlying patterns in an organization. The map allows project managers to predict certain outcomes, which results in more reliable management systems. The Enneagram provides a structured view with which to see the order in between chaos (Fowlke & Fowlke, 1997). Example of an Enneagram

    CONCLUSION

    A good project manager is one who can adapt to a changing environment as well as allow individuals to manage their own areas of expertise.
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    This business trend is seen in forward thinking companies in the 21st century, and is also known as “managing by objectives” or “empowering knowledge workers”. Unfortunately, in most companies this value paradigm is missed because management is focused on the financials rather than on renewing and developing knowledge (Stuart, 1995).

    The project manager’s main function is to recognize employees’ strengths and to empower his group 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
    work individually, both in a team and as individuals. The new project manager needs to be forward thinking and to have the ability to be flexible, creative, and able to respond to events quickly (Yolk 2003). Organizations need to embrace disorder and look to the edge of chaos (Stuart, 1995). Perhaps this empowerment of both individuals and teams as a whole, in conjunction with managements’ ability to stay nimble in the face of a dr
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    amatically changing environment, will allow organizations to better manage the challenge of chaos in the 21st century.

    REFERENCES

    Bertlesen, Sven; Koskela, Lauri. "Avoiding and Managing Chaos in Projects." .

    Blockley, David. "Managing Proneness to Failure." Journal of Contingencies & Crisis Management June 1998: 147-176.

    Freedman, David. "Chaos Theory." Inc. October 1998: 50-60


    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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