After the end of September 2018, a certificate to ISO 9001:2008 will no longer be valid. One change in its replacement ISO 9001:2015 is a requirement to establish procedures for comprehensive risk management. Shops with medical ISO 13485 certification already manage this.
Failure mode and effects analysis (FMEA) is one common method of risk identification and mitigation, although it is sometimes referred to differently from company to company. Protomatic, a Dexter, Michigan, prototype machining and custom short-run production facility serving the medical, automotive, military and aerospace industries, refers to its as PFMEA—process failure mode and effects analysis.
By: Stephanie Hendrixson 13. April 2017
Natural cancellous bone (the spongy bone tissue found inside vertebrae and at the ends of large bones) grows in a random arrangement of bridges and cavities. Conventionally machined implants aim to imitate this with rough coatings to help anchor the devices and encourage the in-growth of bone tissue. The problem with this method is that the natural bone can only grow as deep as the coating, and there is a danger that the coating may eventually detach from the implant itself.
Metal additive manufacturing solves these problems with its ability to build hollow structures that are more similar to cancellous bone. Natural bone can grow deep into the interior of porous implants made with AM, making for an implant that is far more secure in the body. Medical manufacturer Stryker has developed a strategy for manufacturing spine implants that combines Tritanium, a proprietary titanium alloy, with the company’s Laser Rapid Manufacturing technique, a laser-driven additive manufacturing process.
Supplied by Glebar, the video above depicts a through-feed grinding, inspection and packaging cell that was the subject of this April-issue article. Such footage makes it easy, in my view, to get lost in watching the parts proceed through multiple feeders, conveyors and processing stations. It’s even easier to forget the amount of work that goes into manufacturing automation, which, as in this case, often resembles some kind of twisted Rube Goldberg machine.
For this particular cell, engineers from Glebar spent a significant amount of time working with their customer to figure out how to separate bulk-loaded parts for individual, pre-machining inspections. Although required to ensure zero defects, these inspections couldn't disrupt the two-part-per-second production rate. Problem was, the parts were too small and too brittle for traditional means of conveyance through the inspection stations, which consisted of a laser diameter check for ovality and a high-speed camera inspection for voids and defects.
ProCNC is a shop I’ve written about a couple of times. In “Creating A Machine Shop Franchise Template,” I describe how the shop applied basic franchising concepts to maximize efficiency in all aspects of its business. In “Committed to Kaizen,” I explain why the shop devoted 5 percent of company time to continuous improvement activities.
One interesting aspect of this shop is that it developed a web-based shop management system for its own internal use. But after agreeing to sell its system to a nearby shop called Sealth Aero Marine and seeing how Sealth benefitted from it, the decision was made to get out of the machine shop business and into the software business by forming Adion Systems.
By: Jedd Cole 10. April 2017
According to Brian Pfluger, EDM product line manager with Makino, while many EDM users understand how part probing speeds setups, many don’t realize the potential value for statistical process control (SPC) analysis and machining validation. Some of the probing options broken down by Derek Korn in his April cover feature enable feature measurement or validation to occur automatically after machining on wire, sinker or hole-making EDM equipment.