Quality assurance standards exist for good reasons. Not following them can be disastrous
Some years back, company that made ultrapure plastic packaging for the semiconductor manufacturing industry. At the time, business was very robust, but a close look at some of the ways they handled engineering and manufacturing gave me great pause to wonder. Eventually, the company began to backslide and now I wonder if it even exists.
As with many companies, adhering to strict manufacturing standards oftentimes is more lip service than reality. One of the basic tenets of ratings such as ISO 9000 is that documentation for any part exists in only the most current revision, and, of course, the parts must be manufactured to the specifications.
The company had many customers on the Pacific Rim, and there was a need to move some manufacturing closer to those locations in order to avoid shipping empty containers from the United States all the way to Japan, Korea etc. One of their products was a large, blow-molded plastic bottle, with a capacity of 200 liters. With the good sense of learning to walk before one learns to run, a much smaller bottle was picked for the initial overseas manufacturing run. Word came back that the first build of the molds were being made from stainless steel. I know the basics behind this manufacturing method, and knew that stainless steel was a poor choice – it was much harder to machine, cutting at much slower speeds than other materials such as aluminum, and its thermal resistance is poor in comparison to aluminum. This feature is particularly important because in order to achieve a properly expanded product from the mold, the mold must be up to a correct temperature, and be able to dissipate heat at a rate that allows a good production rate to be maintained without overheating the mold. Otherwise, as soon as the plastic hits the mold an inner wall it cools off too quickly and will not expand properly, or causes high cycle times to allow the plastic to cool enough to be ejected.
This was corrected but then another problem quickly asserted itself. The plastic resin specified for this bottle was picked for very good reasons, as it needed to have material properties that would pass specific quality tests such as drop testing. It sounds easy enough, but the bottles may contain highly corrosive liquids, and must tolerate being dropped from a considerable height at subfreezing temperatures. Many plastics will become brittle and crack like an egg under such conditions. It came to my attention that the manufacturer was not using the specified resin and refused to state what resin was being used, effectively allowing any resin to be used. I shot off several emails to those in charge of quality assurance but no action was taken. This was an obvious breach of ISO 9000 requirements, not to mention common sense. This company was a subcontractor! The contractor dictates what the subcontractor does-end of story! If the subcontractor does not follow instructions then we pull the plug and look elsewhere for a more competent supplier.
To this day, I shake my head and wonder at the liability the company exposed itself to when choosing to ignore this issue.
Norman T. Neher, P.E.
Analytical Engineering Services, Inc.
Elko New Market, MN
www.aesmn.org