Pay Close Attention To Equipment Calibration Certificates, FDA Says

Article preview from "The Silver Sheet" - June, 2010

Devices manufactured with improperly calibrated equipment can pose a hidden risk for companies, FDA says. The agency urges firms to investigate if they discover that a product made with out-of-specification equipment has gone to market. Further, many device firms are not adequately reviewing the work of third-parties that calibrate their manufacturing equipment.

Pay Close Attention To Equipment Calibration Certificates, FDA Says

Article preview from "The Silver Sheet" - June, 2010

Too many device firms aren't double-checking the quality of finished products after determining that manufacturing equipment was out of calibration, an FDA official says.

"A large majority of manufacturers contract out their calibration activities. Because of this, what we typically see is that companies are blindly accepting calibration certificates from test houses," FDA/GMP expert Kim Trautman told "The Silver Sheet."

Test houses are third parties used by firms to ensure that equipment used in the manufacture or the inspection and testing of their devices is properly calibrated and maintained.

Calibration certificates are sent to firms describing the condition of the equipment as it was received by the test house, as well as its condition when it was returned to the manufacturer.

"I have seen situations where a test house has sent equipment back to a manufacturer and the certificate said, 'Yes, this piece of equipment was way out of calibration. It was XYZ, and we have now recalculated it,'" Trautman said.

"So my question to the manufacturer is, what did you do with that information? Because you now know that there is finished product that was sold during this period of time when the instrument [used to manufacture it] was way out of calibration," she said.

At that point, a firm should investigate to ensure that the equipment in question did not have an adverse effect on devices already manufactured, Trautman said.

In addition to equipment condition, test-house certificates also specify the calibration method that was used.

Those test methods typically tie to national and international standards from the International Organization for Standardization (ISO), the American National Standards Institute (ANSI), the American Association for Laboratory Accreditation (A2LA), or another accrediting body.

FDA requires equipment testing and calibration under Quality System Regulation Sec. 820.72, "Inspection, Measuring and Test Equipment," as well as Sec. 820.70(g), "Production and Process Controls; Equipment."

Manufacturing equipment, as well as instruments used for inspection and testing, can range from a simple ruler, to widely used voltage meters, to complex custom-built test equipment that contains software - all of which "require accuracy and precision," Trautman said.

"All equipment has to be appropriate for its purpose, and it has to be maintained, adjusted and cleaned," she said.

Companies may calibrate equipment themselves; however, most firms use a combination of in- and out-of-house testing.

Firms also may have test-house representatives calibrate equipment at their manufacturing facilities if the equipment is too large to move or if the firms don't have the expertise to conduct calibration activities on their own.

 

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