- The risk is not the overdue instrument, it is every result recorded with it since the last valid calibration.
- You need a register, a schedule that chases itself, and a documented impact assessment for lapses.
- Auditors test traceability and the lapse process, not whether you have a certificate somewhere.
If you cannot answer, the honest position is that every measurement taken with it since March is unverified. That is a recall conversation in some sectors, and it is why the register and the usage trail matter more than the certificates.
What belongs in the register
- A unique identifier physically marked on the instrument, not just recorded on a list.
- Location and the person or area responsible for it.
- Calibration interval, and the basis for that interval.
- Last calibration date, next due date, and current status.
- The certificate, with traceability to a recognised standard.
- Acceptance criteria: what tolerance makes it fit for the measurements you take with it.
Choosing intervals honestly
Most sites inherit intervals and never revisit them. The defensible basis is a combination of manufacturer recommendation, how critical the measurement is, how heavily the instrument is used, and its actual history. An instrument that has drifted at every one of its last four calibrations needs a shorter interval, and one that has never drifted may justify a longer one, provided you document the reasoning.
The lapse process, written before you need it
Instruments will go overdue. What distinguishes a controlled system is having decided in advance what happens next.
- Quarantine the instrument immediately so it cannot be used further.
- Establish the last date it was known good.
- Identify what was measured with it since, which requires knowing where it was used.
- Assess whether those results are still valid, given the drift found at re-calibration.
- Decide on notification, re-testing or recall, and record the reasoning.
- Review whether the interval or the reminder process caused the lapse.
Step three is where most sites fail, because nothing records which instrument was used for which check. If your inspection records capture the instrument identifier at the point of measurement, this becomes a query. If they do not, it becomes guesswork.
What auditors actually test
Rarely whether you own certificates. Usually: pick an instrument at random, show me its certificate and traceability; show me one overdue instrument and what you did about it; show me a measurement result and prove the instrument used was in calibration on that date. The third is the one that catches sites out.
Making the schedule chase itself
Calibration lapses are almost always a reminder failure rather than a decision. A schedule that generates the task ahead of the due date, assigns it to the person responsible for that instrument, and escalates when it passes, removes the failure mode. Recording the instrument identifier as a field on the inspection that uses it is the other half, and it is what makes the impact assessment answerable.