Competitive regulation

But globalization brings a whole new level of complexity to the enterprise. When an enterprise seeks to operate in a new environment, markets, competition, regulations, economies, and humem resources can be very different from what an enterprise has experienced. Accommodating such differences requires understanding them and how they will affect the strategies and processes of the enterprise. 

Institutional barriers to competition - regulations, patents, and licensing Social values - lifestyles, common norms, and ideals Sanctions, supports, and incentives to do business Customer goodwill, product quality, safety and corporate reputation Complementary products or services in the stakeholder system... 

Within companies there are likely to be cross-business effects of risk. There are varying areas of risk, such as business risk, market risk, operational risk, and reputational risk and there are likely to be multiple domains of compliance risk. For example, there may be environmental, health and safety, tax, consumer, planning, and competition regulations to meet. Moreover these may cut across each other and in so doing create more complex sources of risk. Indeed, regulatory authorities themselves may have individual requirements which create risk management problems in other domains. It is for reasons... 

There is an inherent economic penalty associated with producing Hquids from either natural gas or soHd coal feedstock. Synthetic Hquid fuels technologies are generally not economically competitive with cmde oil processing in the absence of extraneous influences such as price supports or regulations. 

Although ASTM specifies certain quaUty levels, there are a number of factors that contribute to other quaUty levels in the marketplace. At times, government regulations are more restrictive than ASTM specifications, especiaHy with respect to environmental issues. Secondly, competitive forces may encourage companies to provide fuel quaUty that is better than that defined by ASTM. Thirdly, ASTM specifications do not have the force of law, and certain companies may decide to exceed or not meet their recommended values. In response to this last factor, some states have adopted ASTM fuel quahty specifications as state regulations, thus forcing a minimum quaUty level in the field. 

Secondary sources of data are useful when they exist. Databases (qv) of pubUshed information have been assembled, and market researchers can tap them provided their company buys the service. These databases can save the market analyst many hours of work. The services also provide much of the general sociopolitical—economic background needed, such as petroleum (qv) prices, government regulations, foreign competition, etc. 

In the preparation of classical killed or toxoid vaccines, simple process technology was used. With the advance of new vaccines, far more sophisticated process technologies are needed. The desire to reduce side effects of vaccination requires processes which will yield antigens of extreme purity. The new regulation in cGMP requires consistent production procedures, and global competition also demands that the most efficient process technology be appHed. 

Sales and raw-materials prices may be affected by any of the following discounts and allowances, availabihty of substitutes, contract pricing, government regulations, quahty and form of the materials, and competition. Sales volume may be affected by any of the following new uses for the product, new markets, advertising, quahty, overcapacity, replacement by another product, competition, and timing of entry into the market. 

Transportation is often an important part of produc t cost. Bulk transportation may provide significant savings. When there is a choice between two or more forms of transportation, the competition may result in rate reduc tion. Transportation is subject to considerable regulation, which will be discussed in some detail under specific headings. 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

In addition to regulations, public, owner, and political pressures require ever-better safety and environmental performance. Yet, at the same time, every company needs to find ways to reduce till costs in order to stay competitive. In the face of these apparently conflicting pressures, companies are looking for new ways to manage PSM and ESH issues. 

---