Risk Management and Warehouse Building Project Essay

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

Product liability laws allow drug users to sue the manufacture, not the FDA, for any adverse drug reactions and side effects. While the FDA oversees drug safety, they do not ensure it. To avoid the costs associated with lawsuits and the risk of a bad name, drug companies do their best to fully, sometimes overly test products before release. “When product liability law attempts to ensure safety already assured by the FDA, prices may be inefficiently high due to liability costs that do not deter manufacturers from producing unsafe products” (Philipson & Sun, 2008, p. 86).

The FDA also looks at several products that have chemical implications to them, such as drugs. It looks at drug manufacturing standards, as well as the labels of each drug (both over-the-counter and prescription drugs) and must give its approval on new drugs before they can be sold to the public. The FDA also looks at cosmetics. It must ensure that, like food articles, each product is properly labeled as to what comprises each item. Biological products, such as the nation’s blood supply, are also regulated by the FDA. It does research to improve upon the testing methods of blood, to ensure that the supply in hazard free. It also is in charge of handing out licenses to product and manufacturing establishments.

Some other type of testing is required by the FDA when human subjects are need to prove the liability of a product. The FDA divides unapproved

that information and management of this is going to be critical in the future. The need to be informed is

Brief surveys are conducted on a regular basis by the customer service department to ensure quality is consistent throughout the organization. The Federal Drug Administration (FDA) conducts audits of all manufacturing sites to ensure the proper goods manufacturing practices are followed. The FDA also reviews all standard operating procedures (SOPs) relating to product manufacturing and handling.

The FDA formulates rules, regulation and standards for allowing and certification of processed nourishment, drugs, food and other related products

In addition, I would design a strategic transportation plan that coordinates inbound and outbound shipments to reduce transportation costs and improve service levels. The warehouse will be designed

Internet surfing might be at risk in this product as web commenced is in used.

3. The challenges involved in exporting are the same of any other international operation; there are commercial risks, political risks, cultural risks and currency risks. In order to be prepared to face these risks the company would indeed need to invest and create an export team, hiring and training employees in international operations. The team will require skills in areas such as product development, logistics, finance, currency management, foreign languages and cross-cultural skills.

develop a methodology for quantifying risks, or should each situation be addressed individually? Can we have both a quantitative and qualitative risk evaluation system in place at the same time?

The organization in this study, a multi-billion dollar warehousing and distribution company, has been housed in an old building and will be moved to a new state-of-the-art facility. This move involves the planning, organizing, staging and moving of products from one location to the other. Included in planning needs are signage, warehouse racking placement, warehouseman selector choosing routes, freezer, cooler and dry product placement. Incorporated into this move will be the necessity to deal with contractors who are completing the building as well as contacting all vendors and suppliers to inform them of the change of location and service changes during the two-day transition period. The actual moving of all products will require 16 hours, 30 employees on two shifts at two different locations.

Risk management is the term applied to a logical and systematic method of establishing the context, identifying, analyzing, evaluating, treating, monitoring and communicating risks associated with any activity, function or process in a way that will enable organizations to minimize losses and maximize opportunities. (Lecture notes)Risk Management is also described as 'all the things you need to do to make the future sufficiently certain'. (The NZ Society for Risk Management, 2001)

We are all aware about the importance of supply, manufacturing and operations chain for any business. It becomes even more important if we are crossing the borders and entering international marketplaces as we are