Quality Assurance & Non Surgical Sterilants
THIS BLOG IS ABOUT QUALITY ASSURANCE, AND IF YOU THINK THAT HAS NOTHING TO DO WITH CHOCOLATE, MANOLO BLAHNIKS, RIDING IN AN ELEVATOR OR NONSURGICAL STERILANTS FOR PETS, YOU WOULD BE WRONG
By: Shirley D. Johnston, DVM, PhD, DACT
When you’re giving out a $25 million prize, it’s crucial to have all your ducks in a row.
In order to win the grand prize, a scientist must prove to the foundation that he or she has developed a single dose, non-surgical sterilant for male and female cats and dogs that is safe, “approvable” as a veterinary prescription drug by the FDA, and of relatively low cost so as to be affordable by animal shelters. Oh, and don’t forget, it must maintain sterility for the 10-20 year lifespan of the dog and cat after a single administration.
That’s a high bar, so how will we know when all the criteria have been met and we should hand over the cardboard check for $25 million dollars? How do we determine that the product will really work in cats and dogs for their whole lifetime? The key is quality assurance.
Quality assurance? What the heck is quality assurance?
The word quality means a distinctive characteristic or attribute. That characteristic can further be defined as being good or poor (good or poor quality).
The words quality assurance refer to systematic actions that are necessary in the production of goods or services to result in consistency and good quality of goods/products produced.
So, for example, the reason that every Hershey bar tastes the same, or that every size 6 shoe fits a size six foot, is because of quality assurance actions in their production. They reliably have the characteristics of a chocolate bar or a shoe. Manufacturers train employees to produce chocolate bars and shoes the same way every time, even when different employees do the work. Like ingredients for chocolate bars, ingredients for the manufacture of food, beverages, and medications must be acquired, handled, measured, mixed and stored the same way every time in order to obtain a standard product. When a product recall happens, the manufacturer must go back and review all of the procedures used to create the product, to see if quality assurance was maintained.
From lawn mowers to elevators to airplanes, the consistent and safe performance of machines depends on quality assurance practices in building and operating them. For airplanes, every pilot completes a standard pre-flight check list before every flight to assure crew and passenger safety. As many of us know, sometimes to our dismay, when even one element of the checklist (such as an indicator light) is not functioning properly, the plane does not fly until it is corrected. This is quality assurance.
So it follows that when we’re funding research to develop methods to non-surgically sterilize cats and dogs, we use quality assurance to ensure that the research findings are accurate, reproducible, and auditable. Found Animals Foundation requires that scientists utilize quality assurance measures when generating data to prove that they have won the $25 million Michelson Prize. To help them out, we put together a Quality Assurance Toolkit with a variety of forms to maintain records of when equipment needs to be calibrated, what trainings the scientific staff have received, how data was obtained, etc.
This way, when we receive the data that says we’ve found our winner, we know we really have.
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