In today’s highly regulated environment, many organizations are required to comply with strict standards in order to deliver safe, reliable products and services. Regulatory bodies such as the FDA, ISO, and OSHA are placing increased emphasis on how companies manage the calibration of their equipment as part of a robust quality control system.
For example, the U.S. Food and Drug Administration oversees more than $2.4 trillion in medical products, food, and tobacco consumption. Industries under FDA jurisdiction must comply with the Code of Federal Regulations, which requires documented procedures to ensure equipment is routinely calibrated, inspected, checked, and properly maintained.
To verify compliance, organizations are regularly subjected to external audits. During these audits, reviewers look closely for evidence that instruments are calibrated at defined intervals and recalibrated after any change or event that could impact accuracy or performance. While most companies plan and allocate resources for scheduled calibration, many are caught off-guard by unscheduled calibration requirements. With internal resources already stretched thin, additional personnel are often unavailable to meet these unexpected demands — creating potential compliance risks.
Some instruments require more frequent calibration due to their sensitivity to environmental conditions. Infrared thermometers, for example, are highly susceptible to changes in temperature, humidity, and weather. Because they are often used for safety-critical applications, they are also subject to OSHA compliance requirements.
Ensuring these instruments provide accurate readings is essential. As noted by Precision Calibration Systems:
“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 process should be carried out by trained technicians in a controlled laboratory environment. Specialized equipment — including holding fixtures, blackbody sources, and reference thermometers — must be used to verify accuracy.”
Understanding what triggers calibration and recalibration is key to avoiding audit non-conformances and maintaining the integrity of your quality assurance program.
1. Upon Arrival of New Equipment
All new instruments should be calibrated before being placed into service to verify proper operation and accuracy. As part of this process, equipment should also be assigned a unique identification number for tracking, recordkeeping, and recall purposes.
2. After Every Repair
Any repair or adjustment can alter an instrument’s configuration and affect accuracy. Instruments must be recalibrated before returning to service to ensure reliable performance.
3. According to Manufacturer Recommendations
Manufacturers provide specific guidance on calibration intervals for each instrument. These recommendations should be followed closely to maintain accuracy and extend the instrument’s usable life.
4. Following Product Quality Concerns
If a product or test result is questioned, all equipment used to measure or verify the process should be recalibrated as part of a comprehensive investigation.
5. After Major Weather or Environmental Events
Significant changes in temperature, humidity, or barometric pressure can impact sensitive equipment. After extreme weather events, environmental conditions should be reviewed. If acceptable limits were exceeded, affected instruments should be recalibrated immediately.
6. To Meet Regulatory Compliance Requirements
Proper calibration of safety-related instruments is essential to protect workers and prevent accidents. Regulatory agencies such as OSHA mandate strict calibration requirements for equipment like portable gas monitors. Failure to comply can have serious safety and regulatory consequences.
Calibration is more than a routine maintenance task — it is a critical component of regulatory compliance, product quality, and workplace safety. Knowing when recalibration is required helps organizations stay audit-ready, minimize risk, and maintain confidence in their measurement systems.
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