Quality assurance standards are essential. Ignoring them can lead to serious problems.
A few years ago, a company created ultrapure plastic packaging for semiconductors. Business was strong, but I became concerned about its engineering and manufacturing practices. The company declined over time, which made me wonder whether it still exists.
Like many firms, this one often paid lip service to strict manufacturing standards. ISO 9000 has a key principle: document each part only in its latest revision. Also, parts must meet the required specifications.
The company had many customers in the Pacific Rim. They had to move some manufacturing closer to those areas. This change would help them avoid shipping empty containers from the U.S. to Japan and Korea. One of their products was a large blow-molded plastic bottle with a capacity of 200 liters. To start, they made a prudent choice by selecting a smaller bottle for the initial overseas run. But, I learned that the first molds were being made from stainless steel. I know this manufacturing method, and stainless steel was a poor choice. It’s harder to machine and cuts at slower speeds than aluminum. Its thermal resistance is also worse than aluminum’s. This is important. The mold needs to reach the right temperature so that the product can expand as intended. If it doesn’t, the plastic cools immediately upon contact, leading to defects and longer cycle times.
We addressed this issue, but another problem soon emerged. The specified plastic resin had important properties for quality tests, like drop testing. The bottles must resist corrosive liquids. They also need to survive drops from great heights in freezing temperatures. Many plastics become brittle and crack in such conditions. I found out the manufacturer wasn’t using the right resin. They also wouldn’t say which resin they were using. This left the door open for anyone to use any resin. I sent several emails to the quality assurance team, but they took no action. This was a clear breach of ISO 9000 requirements and common sense. As a subcontractor, they should follow the contractor’s instructions. If they didn’t, we would find 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