Posts Tagged ‘standard’
Metal Pressing Technology in Japan
The metal pressing technology in Japan is something that many other countries have adopted as their standard. It’s important to maintain 100% accuracy with metal pressing because once even one tiny part fails, the whole product collapses. Imagine if that product is a surgical tool used to operate on major organs and it fails while in the operating room? It would be catastrophic.
For this reason, many manufacturers of auto parts and medical devices which are intensely regulated turn to Japanese technology. There are more than 1.5 million medical tools today and every month, new tools are being introduced. This is a figure provided by the International Organization for Standardization or ISO. It is the group that certifies products and services as being accepted based on international standards. It’s why you often see companies proudly bearing their ISO certification as proof of quality. Not known to many, the standards used to critique consumer tools and specialized parts and equipment were partly borrowed from the standards of the top Japanese manufacturing companies including the metal press and stamping firms.
In the metal press technology of Japan, there is a set system known as DQ/IQ/OQ and PQ for medical devices. In a nutshell it identifies, tests the design (DQ or Design Qualification), installation (IQ or Installation Qualification), operation (OQ or Operational Qualification), and performance (PQ or Performance Qualification). If a medical device fails on one of these tests, it does not get certified which means medical companies, doctors, hospitals, and clinics will not buy the medical device.
Thus medical device makers turn to top-notch metal press companies to fulfill and help them pass the PQ and OP tests. It’s a long process which starts with studies, plan, parameters, testing, and determining consistency before even making it to the final stage of production. It’s a critical process with each component passing rigorous testing and analysis. In this arena, the famous remark in the movie, Apollo 13 holds true, “Failure is not an option. “