Realizing the Demands of Instrument Calibration

In today’s heavily regulated environment, an increasing number of companies are required to comply with strict regulatory standards in order to provide goods and services to their customers. The FDA, ISO, OSHA and other governing bodies are becoming increasingly focused on how organizations manage the calibration of their equipment as part of their quality control systems. For instance, the FDA is responsible for the oversight of more than $2.4 trillion in consumption of medical products, food and tobacco (FDA Fact Sheet April 2017). These industries must comply to the Code of Federal Regulations governed by the FDA requiring them to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. These companies are frequently subjected to external audits by their governing bodies to ensure that the various aspects of their calibration program comply to specific standards. Some of the key details auditors will review is evidence that instruments were calibrated at specified intervals and following any change or event that might have affected accuracy or performance. Most organizations allocate the resources needed to complete scheduled calibration, but are often caught off-guard by “unscheduled” calibration requirements. With most company resources already stretched thin, additional personnel is simply not available to properly calibrate instruments as often as needed to ensure compliance with these strict demands.

As an example, infrared thermometers are especially prone to needing frequent calibration as they are extremely sensitive to environmental changes which can result from rapidly changing weather conditions. Infrared thermometers are also used for many safety related tasks and are therefore subject to OSHA compliance guidelines. It is critical that these instruments be calibrated whenever the need arises to ensure they are providing accurate readings.

“Even though infrared (IR) thermometers are relatively easy to use, proper calibration can be a very time consuming activity. To ensure the instrument is calibrated correctly, the calibration process should be carried out by trained technicians in a controlled laboratory environment. Various equipment including holding fixtures, black body sources and standard reference thermometers must be used to ensure the accuracy of calibration,” as revealed by Precision Calibration Systems.

It is important to know what factors trigger calibration and re-calibration of your equipment in order to avoid audit non-conformances and maintain the overall integrity of your quality assurance program.

6 Examples of When Calibration Should be Performed

• Upon the Arrival of New Equipment – All new equipment must be calibrated to ensure proper function and accuracy before placing into service. As part of calibration requirements, new equipment should also be assigned a unique identification number for record keeping, instrument tracking and recall.
• After Every Repair – Any repair work undertaken on devices or equipment can end up altering their basic configuration and affecting accuracy. It is therefore important to re-calibrate instruments before putting them back into use after any repair is made to be sure that they are providing accurate results.
• As per Manufacturer Recommendations – Every piece of measuring equipment has a manufacturers recommendation for the frequency of re-calibration. These recommendations should be followed diligently to ensure accuracy and functionality is maintained throughout the instrument’s life cycle.
• Following Product Quality Issues – Anytime the quality of a product or test is called into question, all equipment used to measure or verify any parameter of the process should be re-calibrated as part of a thorough investigation.

• Following Major Weather Events – Rapid changes in temperatures, humidity and barometric pressure often affect the performance and measuring accuracy of sensitive measuring equipment. Following any extreme weather events, you should review the data of the environmental conditions for the location where your equipment is stored. If conditions became unstable beyond acceptable limits, you should immediately request a re-calibration of all affected instruments.
• Compliance to Regulatory Guidelines – Proper maintenance and calibration of safety equipment is essential in maintaining accuracy and preventing accidents. For instance, there are stringent guidelines in place for specific types of instruments that ensure the safety of workers such as portable gas monitors, as prescribed by the Occupational Safety and Health Administration (OSHA). The importance of following calibration requirements cannot be understated!