Try to imagine a world without strict quality assurance and quality control guidelines - where packaged foods fail to list all ingredients, where medications contain substances that are harmful to human health. It may conjure up images of peddlers of yore, hawking their tinctures and miracle powders to an unsuspecting public, an image that ceased to be a reality in the 20th century, as such fields as food and pharmaceutical testing took great leaps forward, thanks, in part, to the emergence of three game-changing concepts: Cost of Quality, Zero Defects and Total Quality Management (TQM).
Quality Assurance and Quality Control Concept #1, Cost of Quality, 1950s
This quality assurance and quality control concept goes by several names, including "the price of nonconformance" and "the cost of poor quality." At the time of its emergence, it had one main advocate, Joseph Juran, a Romanian-born American who used statistics to study the human reasons behind organizational errors. Although he worked for a communications company, his theories and methods had far reaching effects, and continue to impact pharmaceutical testing and food quality training today.
Quality Assurance and Quality Control Concept #2, Zero Defects, 1960s
This concept emerged in the aerospace industry in the '60s, but has left an enduring mark on the quality assurance and quality control industry. Its influence can still be felt in pharmaceutical testing and food quality training programs around the world.
Championed by Philip Crosby, a quality control manager for an American missile program, Zero Defects is an approach to quality assurance and quality control that views defects as quite simply unacceptable. According to this principle, there is no excuse for mistakes of any kind. Critics have argued that a certain level of error is unavoidable in any endeavour, to which a proponent of Zero Defects might respond that it would be unacceptable for even one in a million bottles of over-the-counter painkillers to contain a harmful substance. To anticipate error is to set one's sights too low, according to the proponents of Zero Defects.
The intolerance for error makes this concept of particular interest to the pharmaceutical testing and food quality training world.
Quality Assurance and Quality Control Concept #3, Total Quality Management, 1980-
Total Quality Management takes an integrative approach to quality assurance and quality control whereby every person, at every level of an organization, who is involved in any way with bringing a product to market is ultimately responsible for the quality of that product.
This concept, which impacts pharmaceutical testing and food quality training today, is attributed to the combined work of multiple quality assurance and quality control leaders, including the aforementioned Joseph Juran.
How has the field evolved since the turn of the millennium? Some say that there has been a transition away from a focus on manufacturing towards a focus on service - a shift that perhaps reflects some larger changes in North America, where the manufacturing sector has famously fallen on hard times.