The AIAG Measurement System Analysis (MSA) identifies calibration, Gauge Repeatability and Reproducibility, along with bias, linearity, and stability studies as a way to ensure your metrology is in order. It is the job of the manufacturer to ensure gauges are calibrated at the appropriate frequencies.
When medical devices aren’t calibrated properly, inaccurate readings can have negative consequences. A medical scale that is off by a few pounds may lead to improper medication dosages. Blood pressure readings may be off, leading to a misdiagnosis. When gauges used in manufacturing medical devices are off, the effects may be even more insidious, leading to a device failure.
Using a gauge management application makes it easier for automotive and medical device manufacturers to meet gauge calibration standards by automating and tracking calibration schedules, as well as digitizing inspection and corrective action records.
Gauge Calibration Challenges
Gauges are like any other type of equipment. As they are used, wear or damage alters them, resulting in inaccuracies. When gauges are improperly calibrated, inaccuracies could put the products being manufactured outside of recommended tolerances and decrease their reliability without anyone even knowing there is a risk.
Compliance regulations and frameworks such as IATF 16949 and ISO 13485 require that manufacturing companies calibrate gauges on a regular basis. These frequent calibrations need to be recorded and tracked. For medical device manufacturers, the FDA sets the standards for gauge calibration and requires that every calibration be recorded and trackable.
When each department or team records its own calibrations, it is easy to miss deadlines or forget to calibrate. Many companies use spreadsheets to keep calibration records. These spreadsheets are error prone, hard to maintain and share, and lack follow-up.
The Consequences of Poor Gauge Calibration
Even small variances in calibration can lead to nonconformances in products. Nonconforming products may need to be pulled from the warehouse. If these products reach the consumers, they could trigger a costly and reputation-damaging recall.
Errors in calibration can have catastrophic consequences. For example, a component on an automobile could fail, resulting in an injury or even death. A medical device may not work properly, putting a patient’s health in jeopardy.
Typically, companies calibrate gauges once a year. A manufacturer could use a bad gauge for 9 months or so without noticing a problem — until they see a product defect.
By that point, going back to correct the problem and remake the product is expensive. Gauge management helps prevent nonconformances by catching calibration errors early.
The Key to Optimal Gauge Calibration
Gauge management ensures that gauges are being calibrated regularly so inaccuracies can be caught and corrected quickly. A gauge management application automates the inspection and record-keeping process.
With a gauge management application, inspections and calibrations can be scheduled regularly. Maintaining records and tracking calibration is digitized, increasing accuracy and giving every member of the team access to results and documentation related to corrective actions.
Gauge Calibration Made Easy
As leaders in operational excellence, QAD CEBOS has developed a new Gauge Management Application. Our Gauge Management Application can manage a gauge list for production and master gauges.
With the application, manufacturers can set gauge calibration schedules based on either the calendar or usage frequency. Both internally and externally calibrated gauges can be managed, and gauge ownership can be tracked. The application facilitates all AIAG-MSA gauge studies, keeping your company compliant.
Learn more about what a gauge management application can do for your company. Register for our latest webinar QAD CEBOS EQMS – Gauge Management Application Overview.