| If you’ve been following along with our blog discussion on the systems engineering approach to medical device design, you should by now be convinced that instructions are important. In fact, the meticulous instructions produced during the manufacturing, operating, and maintenance phases of the Development stage are also crucial to later stages, that of Production and Utilization. Let’s finish up our discussion on the Development stage by taking a look at its final aspect, Preproduction.
The Preproduction aspect is instrumental to nipping potential problems in the bud before the medical devices go into actual production. In the initial Preproduction stages, systems engineers coordinate with the manufacturing and purchasing departments within the company as well as outside suppliers. The goal is to acquire all parts and equipment necessary to build a limited number of medical devices on the assembly line. Subjects such as preference in molded plastic components, motors, gears, pumps, springs, electronic components, circuit boards, wire, and tubing are discussed and agreed upon. Vendors are assessed with regard to their ability to produce parts when they are needed and that meet design specifications, satisfy quality requirements, and have costs that fall within budgetary constraints. The assembly of Preproduction devices provides an opportunity for systems engineers to validate manufacturing and quality control instructions and assess the device design with regard to manufacturability, meaning, the extent to which devices can be manufactured with relative ease, at minimal cost, while maintaining maximum reliability. Devices manufactured during this aspect of the Development stage serve as a test. Are instructions clearly written? Do the device parts fit together as they should? Are parts strong enough to withstand the assembly process? Can the devices be assembled as quickly and easily as expected? If the answer is “no” to any of these questions, then the device design and instructions must be returned to the design engineers and technical writers. Heads come together to rehash things and work out the bugs. Next time we’ll continue with the Preproduction aspect of the Development stage to see how laboratory and field testing enables systems engineers to shake out any more bugs from the medical device design, operating instructions, and maintenance instructions. ___________________________________________
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Posts Tagged ‘maintenance’
Systems Engineering In Medical Device Design – Preproduction, Part I
Monday, February 4th, 2013
Food Manufacturing Challenges – Look and Taste
Sunday, September 25th, 2011| Ever wonder why the burger you get at your favorite fast food chain never looks like the one on TV? The bun isn’t fluffy, the beef patty doesn’t make it to the edges, and the lettuce is anything but crisp. Well, it’s because a professional known as a Food Stylist, working together with a professional marketing firm and production crew, has painstakingly created the beautiful, bright and balanced burger used to lure you in. The process can take days or even weeks to create and has nothing to do with reality. The burger you’re really going to get will look more like a gorilla sat on it.
Many of the same issues must be dealt with when mass producing food. Chances are human hands will never even touch the product, like they did when creating the prototype in the test kitchen. In the world of food manufacturing, the “look” part can be extremely challenging. How do you get machines and production lines to create visually appealing food that entices prospective buyers to make an investment in it? How do you get it to taste good, or at least acceptable to the palate? The “taste” part of food manufacturing can be even more challenging. For example, in the test kitchen of a pastry product manufacturer, a recipe will be developed using home pantry products like flour, butter, and eggs. Ever made bread or a pie crust? The stickiness factor is enough to drive many insane. Even nimble human fingers have a hard time dealing with it. Now enter food processing machinery and conveyor belts into the scenario. This brings the possibility of stickiness to a whole new level. Huge messes that gum up the machinery are common, and production line shutdowns are the result. When faced with these challenges, plant engineers have to work closely with chefs in the R&D kitchen to come up with some sort of compromise in the recipe or final form of the food product. The goal is to cost effectively produce food products acceptable to consumers for purchase, and it’s often an iterative process involving many successive changes to recipes and equipment designs, coupled with a lot of testing and retesting, before success is finally met. If testing ultimately proves that the product appeals to consumers’ tastes and flows nicely through production lines, then there’s a good chance it will be a commercial success. In any case, cost is the dictating factor as to whether the food product will successfully make it onto the shelves of your supermarket. A margin of profit must be made. But this success is only part of the design process. Before full commercial production can commence, processing equipment and production lines must be designed so that they:
Next time we’ll explore how cleanliness requirements factor into food manufacturing equipment design. ____________________________________________
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