QMSC Cloud-based Calibration Management
For organizations in regulated and non-regulated industries inspection equipment calibration is one of the most critical processes required for delivering conforming and acceptable products and services in manufacturing environments. Ensuring that inspection and verification equipment is in-tolerance and functioning properly is not an especially difficult process. But, for small and large organizations, tracking, recalling and overall calibration management can be a headache.
Small businesses such as machine shops commonly require machine operators to purchase and use their own inspection tools for in-process inspection. A dedicated inspector typically performs an independent verification for final acceptance. In these instances, it is customary for the organization to arrange and pay for the cost of calibration. This innovative approach ensures in-process work is monitored and measured during manufacturing while allowing the company to have a smaller inspection staff and defer some cost of overhead. But, problems become apparent when inspection equipment is due for calibration. As the quality manager makes the rounds to collect equipment for calibration, or if an outside service provider is onsite to complete the job, they often learn that some equipment has been removed from the shop by an employee to work on personal projects. Occasionally these tools are brought back onsite and used to inspect product without being calibrated. This leads to out of calibration equipment being used for inspection. Unnecessary time and effort are spent to locate the missing tools, collect and send for calibration then the re-inspect affected product.
Larger organizations are not immune to these issues. In fact, the problems often seem to be multiplied by scale. Which is why they tend to only allow company-owned equipment. But, company-owned equipment programs share similar challenges with organizations which allow or require employee-owned tools. Instead of employees taking the tools home for use on personal projects, they inexplicably go missing only to reappear later. When found, that equipment is sometimes mistakenly used to inspect product but now while out of calibration. At the root of both approaches to inspection equipment management is a common inspection related issue: mistaken use of out-of-calibration equipment.
While of some value, corrective action by employee training often fails to correct the issue. Preventing use of equipment with an out of calibration status is necessary.
What happens when out-of-tolerance inspection equipment is used for product or services acceptance?
Most of management standards such as AS9100, ISO 17025, ISO 9001, IATF 16949 and others, require that when calibrated equipment which used for acceptance of manufactured products or supplied services are identified to be out of tolerance when received at calibration, an assessment be performed to determine if products produced or services supplied were impacted by the equipment’s out-of-tolerance condition. This analysis tends to be a manual and resource consuming process.
Even for a small shop, a single inspection tool frequently used for product acceptance might take thousands of readings in a short time. If inspection equipment is determined to have been out of tolerance when some product was deemed to be acceptable, re-inspection of all affected product or services may be necessary to ensure compliance with applicable requirements. In severe cases, recall of product may be necessary.
Usually, this review requires skilled and knowledgeable personnel to dig through many reports, identify characteristics or dimensions which were inspected by the equipment, calculate a corrected value, and then report out to management and engineering. This can be an inaccurate method of analysis as the organization may not know when the equipment drifted out of tolerance. In some cases, customer notification is necessary to limit the severity of the impact. Even if determined that impact is a low severity or no impact at all, an out of tolerance analysis can be very costly due to the time and resources committed.
Managing internal calibration versus and external supplied calibration also has unique challenges. Some companies struggle with procedures which require where calibration be recorded on their internal documentation even when calibration was provided by an outside laboratory. Or they have a hybrid method of document retention where paper certificates are scanned and uploaded to the network. This redundancy can result in gaps due to the manual process.
Fortunately, QMSC has a solution for all these problems.
Here’s how our cloud-based calibration management delivers fundamental improvements to your calibration program: