say the part is good, and then discard the metrology data. All of the data, good or bad, is being fed back into some kind of process-control loop,” said Nate Rose, Applications Engi- neering Manager at OGP. This often includes comparing the data to the part’s CAD model to determine how well the part complies with the design intent.
OGP offers more than equipment to help their medical device manufacturing customers, especially smaller operators for whom medical manufacturing is relatively new. For ex- ample, OGP offers tools and services to help companies meet regulatory requirements for installation qualification (IQ) and operational qualification (OQ), two of three phases required to make measurement systems compliant with FDA regulation. “We also offer workbooks to assist companies in preparing for the process qualification [PQ] phase, although they must do the actual qualification on their own,” explains Rose. “We are seeing an increase in the services that we do. I think that is because there are more manufacturers getting involved in the
medical device supply chain. A number of aerospace com- ponent manufacturers have added medical because, really, there is much similarity between the two.”
Establishing a foundation of accuracy is as important as in-process control. “The most challenging areas within the medical market are makers of implants, such as hip and knee replacements,” agrees Clive Warren of Renishaw (Hoffman Estates, IL). “These require complex machining processes to exacting standards.” Complying with medical manufac- turing quality standards means proving CNC machines are capable of cutting to stated tolerances. “Ballbar analysis is a proven method for determining machine tool capability, and is the most practical, convenient and comprehensive tool for assessing the performance and accuracy of CNC machines,” according to Warren. The QC-20W measures to ±0.1 µm. “The new QC-20 wireless ballbar means testing is much faster and safer, since you do not have to route the wire out of the machine or override the door interlock,” he says.
THE CUTTING EDGE
We use PremiumMicro grain solid carbide for longer tool life and increased feeds and speeds.
Tools are stocked uncoated and ALTiN coated.
Designs for threading, grooving, PCD, and CBN-tipped inserts
Set includes boring bar, 5 inserts, 5 screws, and a torx plus key
Available in coated AlTiN or uncoated sub micrograin carbide
Hardened steel head features proprietary mechanical attachment... no annealing from brazing heat
Pocket keeps chips away from machined surface Fits into SCI standard QHC coolant tool holders Inserts lapped and ground to fine finish for maximum chip flow Available in right-hand and left-hand versions Bars stocked with or without locating flat... Low profile screw keeps chips flowing