Medical device manufacturers who sell their products in the United States must comply with the quality control guidelines outlined by the U.S. Food and Drug Administration in part 820 of Title 21 of the Code of Federal regulations. These guidelines lay out specific requirements for quality systems, covering production and process control, corrective and preventive…
In 2017, the International Organization for Standards (ISO) updated its guidelines for the accuracy and calibration of hand torque tools, previously modified in 2003. It was a comprehensive update that split the standard into two parts. The first part, ISO 6789-1:2017, lays out requirements for the design and testing of torque tools to ensure they…
You don’t want to be surprised by a torque tool that is out of calibration. After all, torque tools are precision instruments used to tighten critical, often safety-sensitive fasteners. When these tools are out of calibration, products can be made incorrectly, possibly even failing in the field. So, when a torque wrench is out of…
Devices that we depend on every day can be reduced to uselessness by something as small as a single speck of dust in the manufacturing plant. The satellites that orbit far above our heads, the hard drives in our computers, and the medical devices that keep hearts beating and administer life-saving drugs are all assembled…
As tunnel workers know, boring machines are anything but. Ranging from merely large to staggeringly huge, these complicated devices chew through loam, clay, and solid rock to excavate large and small tunnels across the world. What’s also enormous is the degree to which the success of a tunneling project rests on the proper maintenance of…
Little problems on a large scale become big problems. Let’s do some math: You figured it out! Or cheated….it doesn’t really matter. Because the next problem is the most important one: Congratulations! You figured this one out, too. Now the only thing you have to figure out is what you’re going to tell Congress when…
This article is about using rotary torque sensors to measure torque during the torque verification and auditing process. But first, let’s talk football. Recently, a professional field goal kicker blew an easy shot. It was his second in the game and his fifth in two weeks. You can call it coincidence or cause-and-effect, but his…
Designing an assembly line can be exciting. For in-house manufacturing engineers, it’s a chance to shape the future of your company by designing the physical space that makes your future business possible. For consulting or third-party manufacturing engineers, it’s a way to demonstrate your skills in an interesting new environment. In either case, designing an…
In “The Twits,” a short story by Roald Dahl, Mr. and Mrs. Twit, a disagreeable older married couple, play a series of nasty pranks on each other. One of these tricks is particularly illuminating for manufacturers and repair shops relying on torque tools to properly assemble products or handle maintenance jobs. To get back at…
If you know something’s broken, you can fix it. But if you know how something got broken, then you can prevent it—and anything like it—from breaking in the first place. Which would you rather be able to do? In the assembly world, ideally, pieces in production don’t break at all. But, inevitably, they will and…