for a particular part. Tere are three phases of qualifications that medical device manu- facturers must perform to prove their process is valid to the FDA, according to Nate Rose, Applications Engineer- ing Manager for Opti- cal Gaging Products (OGP; Rochester, NY). Installation Quali-
fication (IQ) is the first phase, Operational Qualification (OQ) is the second, and Per- formance Qualification (PQ) is the third and final phase. IQ verifies the system is installed and calibrated ac- cording to the manufacturer’s specifications. IQ also includes verification of the environment in which the equipment is installed, and other factors such as documentation, traceabil- ity, utilities, and contact materials. Operational Qualification (OQ) is a procedure to verify that
Scalable solutions for collecting, storing, and managing quality data are so stringent for the FDA, that Mitutoyo ensures its Measurlink software meets the agency’s requirements as its baseline.
the intended requirements. “It’s effective for them because they do not need to purchase the artifacts or redevelop de- tailed procedures and documentation,” Rose said. OGP developed a package of validation routines using its
a metrology device operates as intended and is effective and re- producible. Te OQ tests include standard operating conditions, verification of accuracy and repeatability (using NIST traceable standards other than those used for calibration) for all axes and sensors. OQ also verifies other aspects of the FDA requirements, including access control and tracking, data management and archiving, preventitive maintenance schedules and other factors. “Te results of an OQ are documented and maintained as a permanent record of the system’s performance.” Rose said. Te final phase, PQ, for measurement systems, typically
includes verification of gage repeatability and reproducibility using typical sample parts and their respective measurement fixtures, routines and procedures. Although OGP is primarily a supplier of metrology equip-
ment and soſtware, it developed its validation services to help small and medium-sized enterprises through their IQ, OQ, and PQ phases. “Our customers asked us to provide what we call the FDA Service, because many companies do not have the staff or artifacts to conduct the IQ and OQ on their own,” he said. For its FDA Service, OGP created procedures and specialized NIST traceable artifacts designed to verify the equipment, sensors and soſtware they offer. Tese might be chrome-on-glass line scale artifacts, or specialized gages for verifying specific geometric construction capabilities in the soſtware. Te resulting test procedures verify the system meets
SmartFeature soſtware. OGP specifically designed it for multi- sensor metrology programming and support. “We really could not provide the FDA Service without SmartFeature soſtware. It provides the user access control, logging, audit, and editing control of the measurement routines that FDA requires,” Rose said. “We need to log who inspected something, when, and track any modification of the inspection routines.” At a more fundamental level, medical device manufactur-
ers also need to control and evaluate machine tool perfor- mance to meet certain requirements of CFR Title 21, accord- ing to Clive Warren of Renishaw (Hoffman Estates, IL). “If a device manufacturer is machining parts, they are expected to know the capabilities of their machines prior to produc- ing those parts,” he said. “Te theory is they should not be producing any defective parts—even if they end up inspecting them 100% anyway.” Renishaw offers their QC20W device for ballbar analysis as a key tool for determining machining capa- bility. Te QC-20W measures to the standardized circularity test as defined in international standards such as ISO 230-4. “As an approved methodology for determining the contour-
ing performance of machine tools, it helps meet the report- ing requirements for CFR Title 21,” he said. Tis is critical on complex parts such as knee or hip replacements, with complex curved and contoured surfaces, according to Warren. “You need to know how all the different interrelated machine functions are performing and what their effect may be on workpiece quality.
Medical Manufacturing 2014 79
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