10 Calibration Concerns That Could Trigger Audit Failures in Regulated Industries
In regulated industries like life sciences, aerospace, and manufacturing, calibration is critical, but often misunderstood. Small oversights can lead to big risks: failed audits, downtime, and compliance gaps. Here are 10 lesser-known calibration facts every quality, compliance, and operations leader should know.
1. Calibration drift is silent but deadly.
Even the most advanced instruments drift out of spec over time. In critical industries, unnoticed drift can mean failed product batches, mission failure, or patient harm, without a single warning light.
2. “As Found” data matters more than you think.
Many audits hinge on whether a device was in-tolerance before adjustment. Missing “as found” data can trigger investigation, fines, or even product recalls.
3. Not all calibrations include traceable measurements.
Just because a device is 'calibrated' does not mean that its measurements are traceable. ISO/IEC 17025 accredited labs have been audited by third parties to have the technical capability to provide demonstrated uncertainties. This helps to ensure compliance with industry regulations such as those imposed by the FDA, FAA, and ISO.
4. One out-of-tolerance tool can invalidate an entire process.
In pharma or aerospace, if a single instrument used in production or inspection is found out-of-tolerance, all associated product may be subject to recall, reverification, or rework.
5. Electronic records aren’t always audit-safe.
Digital calibration records must be FDA 21 CFR Part 11 compliant in life sciences. A PDF isn’t enough, without secure, validated systems, data integrity is at risk.
6. Turnaround time is a hidden productivity killer.
If tool calibration takes too long and spare equipment isn’t available, entire manufacturing lines or field operations can grind to a halt, especially for Field Service Engineers and technicians in remote settings.
7. Environmental conditions affect calibration validity.
Calibrations performed in the wrong temperature or humidity range can be invalid. Auditors will look for evidence that these conditions are recorded and taken into account. That's why documentation of environmental controls is a requirement for certificates from an accredited lab.
8. Not all failure data gets reported.
Some non-accredited labs skip over or underreport “out-of-tolerance” results. That puts the customer at serious risk, especially if they assume everything passed.
9. Calibration frequency isn't fixed—it should be risk-based.
Regulations increasingly favor interval justification over rigid schedules. That means you should adjust your calibration frequency based on usage history, criticality, and past performance, not habit.
10. Field calibration ≠ lab calibration.
Onsite calibration is convenient, but not all measurements can be reliably verified outside controlled lab environments. High-accuracy instruments may require lab-grade conditions for valid results.