ABSTRACT
Although quality assurance is a necessity in almost every industry, it is uniquely critical in the drug and medical device industries. This has always been due to the financial risks associated with healthcare-product liabilities. Unlike other industries, correcting a quality problem in the healthcare field may involve a product recall of many batches (lots) of manufactured product. This could entail thousands of units at significant cost. If someone buys a package labeled as a 90-watt light bulb and finds that the bulb in the package is 60 watts, he or she returns it for another. If you buy a drug or medical device product and it is mislabeled, the entire batch gets recalled.
