De Ce Contează Calibrarea: Păstrați Înregistratoarele Gata de Audit

You bought a quality temperature logger, deployed it across your cold chain, and passed your last audit. So why does your calibration certificate have an expiry date? And what happens if you ignore it?

This article explains the fundamentals of traceable calibration, why it matters for regulatory compliance, and how to keep your TERMOGRAF TG5 recorders perpetually audit-ready.

What Is Traceable Calibration?

Calibration is the process of comparing a measuring instrument's readings against a known reference standard. "Traceable" means that reference standard itself is linked to national or international measurement standards through an unbroken chain of comparisons — typically back to a National Metrology Institute (NMI) like PTB (Germany), NIST (USA), or INM (Romania).

A traceable calibration certificate tells an auditor: "This device reads within ±X°C of the true temperature, and we can prove it." Without that certificate, your temperature data has no verifiable accuracy — and auditors know it.

Why Does Calibration Expire?

All physical sensors drift over time due to:

• Thermal cycling — repeated exposure to temperature extremes gradually shifts sensor response
• Mechanical stress — handling, vibration during transport, accidental drops
• Chemical exposure — humidity, condensation, or chemical environments can degrade sensor elements
• Electronic aging — component tolerances change over months and years

A typical annual recalibration interval ensures drift is caught before it exceeds acceptable limits (usually ±0.5°C for cold chain applications). Some high-risk environments (e.g., ultra-low temperature storage at –70°C) may require more frequent calibration.

What Regulators Expect

Every major cold chain regulation addresses calibration:

• EU GDP (2013/C 343/01) §9.2 — monitoring equipment must be calibrated at suitable intervals
• WHO TRS 961 Annex 9 — calibration must be traceable to national standards
• EU Reg 852/2004 (HACCP) — measuring instruments must be calibrated regularly
• EN 12830 — specifies accuracy classes for temperature recorders

During an audit, inspectors will ask to see your calibration certificates, check the dates, and verify that out-of-tolerance events were handled with a documented impact assessment.

The Cost of Skipping Calibration

Failing to calibrate can lead to:

1. Audit non-conformity — a critical finding that can halt your distribution license
2. Product recalls — if temperature data is deemed unreliable, all products logged by that device may require recall investigation
3. Insurance claims denied — insurers may reject claims for temperature-damaged goods if calibration was overdue
4. Customer loss — pharmaceutical manufacturers increasingly audit their logistics partners' calibration programs

How TERMOGRAF Simplifies Calibration

Every TERMOGRAF TG5 ships with a traceable calibration certificate. When it's time for recalibration:

1. Send the device to a TERMOGRAF-authorized calibration laboratory
2. The lab performs a multi-point calibration (typically 3–5 temperature points across the operating range)
3. You receive a new certificate with measurement uncertainties and pass/fail results
4. The device is returned, ready for another year of compliant operation

For fleets of 10+ devices, TERMOGRAF offers calibration management support — including reminders, batch scheduling, and loaner devices to minimize downtime.

Best Practices

• Maintain a calibration schedule with clear next-due dates for every device
• Set calendar reminders 30 days before expiry to allow lead time
• Store certificates digitally (PDF) in a controlled document management system
• If a device fails calibration, perform an impact assessment on all data recorded since the last valid calibration
• Consider an "as found / as left" calibration protocol for maximum audit transparency