Why should calibration be scheduled and its records kept?

• A. To compete with other facilities.
• B. To ensure traceability and verification of measurements.
• C. To reduce production time.
• D. To comply with supplier audits.

Answer: (B)

Regular calibration and keeping records establish traceability and verify that measurements are accurate. In GMP settings, the readings from instruments like thermometers, scales, and pH meters directly influence critical decisions about safety and quality. Calibration compares instrument readings to known reference standards, so the results genuinely reflect the true values. Scheduling calibration prevents drift from going unchecked and keeps instrument performance within specified tolerances, reducing measurement uncertainty. Recording every calibration—what was tested, the standard used, who performed it, and the results—creates an auditable trail that proves measurements are reliable and defensible during audits or investigations. While it can help with audits, the core purpose is ensuring measurements are traceable and verified.