Pipette calibration is a small part of a quality system and a disproportionately common source of findings. The reason is consistent: the calibrations are usually being done, and the record connecting them is usually incomplete.
What an inspector will ask for
- The asset register: every instrument, serial number, location, assigned user, interval, last service date, next due date.
- Certificates for every listed instrument, current and traceable to national standards.
- The SOP stating your interval and the rationale behind it.
- Evidence of what happened the last time an instrument failed as-found.
- The calibration provider's ISO/IEC 17025 scope of accreditation.
The four gaps we find most often
Ghost instruments. Assets on the register that no longer exist, or instruments on the bench that were never added. Both are findings. Reconcile the register physically, not from memory, at every service visit.
Missing as-found data. A certificate showing only post-adjustment results cannot support an impact assessment. If your provider does not report as-found, you cannot answer the most important question an inspector will ask about a failure.
No documented failure response. An out-of-tolerance result is not itself a finding. Having no record of what you did about it is. There should be a written assessment of the affected work for every as-found failure.
Unjustified intervals. "Annually" with no rationale invites the next question. One paragraph tying the interval to use intensity, chemistry, and consequence closes it.
The strongest programs are not the ones with no failures. They are the ones that catch failures, document them, and can show what was done about the work performed in between.
Close the gaps in the right order
Start with the register, because everything else references it. Walk the benches, reconcile serial numbers, and mark instruments that are retired, missing, or unlisted. Then pull certificates against the reconciled list and identify what is overdue or absent. Then write the interval rationale. Then check that a failure response procedure exists and has actually been used.
That sequence takes most laboratories a day or two and removes the majority of the findings we see.
Where we can help
Send us your current asset register and your last set of certificates. We will reconcile the list, flag overdue and missing instruments, and lay out a schedule that closes the gaps without a break in the record. It is a normal first step when a laboratory moves its program to us, and it is the fastest way to find out what shape your program is actually in.
Next step
Want this reviewed against your own program?
Send your asset register and last certificates. We’ll reconcile the list, flag what’s overdue, and tell you what we would change.
Get started