This is a ready-to-use calibration record. One is completed for each calibration event. The single most important feature is that as-found error is recorded before any adjustment, because that data is the only thing that tells you whether the measurements the instrument produced since its last calibration were trustworthy. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This content is general educational reference, not legal or regulatory advice.
Record header
| Field | Entry |
|---|---|
| Instrument ID | <<FILL: e.g. PI-3307>> |
| Description | <<FILL: e.g. pressure gauge, autoclave>> |
| Location | <<FILL: room / suite>> |
| Classification | Critical / Non-critical / Reference-only |
| Range / span | <<FILL: e.g. 0 to 60 psig>> |
| Tolerance (with basis) | <<FILL: e.g. ±1% of full scale>> |
| Calibration date | <<FILL: date>> |
| Next due date | <<FILL: date>> |
| Procedure reference | <<FILL: WI-ID>> |
| Environmental conditions | <<FILL: temperature, humidity if relevant>> |
Standard(s) used (the traceability link)
| Standard ID | Description | Certificate no. | Cal due date | Uncertainty |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
The standard must be in date at the time of use. If it is not, this calibration is invalid.
Test points: as-found (before any adjustment)
| Point | Nominal | Standard value | Instrument reading | Error | Tolerance | Pass/Fail |
|---|---|---|---|---|---|---|
| 1 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
| 2 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
| 3 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
As-found overall result: Pass / Fail (any point out of tolerance = Fail = raise OOT investigation)
Adjustment
| Field | Entry |
|---|---|
| Adjustment performed? | Yes / No |
| Reason | <<FILL: only if adjusted; as-found must already be recorded>> |
Test points: as-left (after any adjustment)
| Point | Nominal | Standard value | Instrument reading | Error | Tolerance | Pass/Fail |
|---|---|---|---|---|---|---|
| 1 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
| 2 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
| 3 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | P / F |
As-left overall result: Pass / Fail
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Technician | <<FILL>> | ||
| Reviewer / QA | <<FILL>> |
Field instructions
- Error = instrument reading minus standard value (state the sign; direction matters for impact).
- As-found first, always. If the instrument is off and you adjust it, the as-found table must already be complete. An as-left-only record cannot support an impact assessment.
- Record numeric values, not just “pass.” A device creeping toward its limit across three cycles is telling you the interval is too long before it ever goes out of tolerance; you can only see that from numeric as-found trending.
- Any as-found fail triggers the out-of-tolerance investigation and impact assessment; do not simply adjust and move on.
- Uncertainty statement is required for accredited work and where a guard-band decision rule applies.
Retention
Retain for not less than <<FILL: retention period>>, and in any case long enough to support impact assessment across the full life of any product the instrument’s data supported.
Filled specimen
The following shows the record completed for an autoclave pressure gauge that failed as-found and was adjusted back into tolerance. Numbers are illustrative.
Instrument: PI-3307, pressure gauge, autoclave, Sterile Prep. Range 0 to 60 psig. Tolerance ±1% FS (±0.6 psi). Standard: pressure module TS-204, cert PC-2026-118, due 2027-06-01, uncertainty ±0.15 psi.
As-found (before adjustment):
| Point | Nominal | Standard | Reading | Error | Tolerance | Pass/Fail |
|---|---|---|---|---|---|---|
| 1 | 15 psig | 15.00 | 15.4 | +0.4 | ±0.6 | Pass |
| 2 | 30 psig | 30.00 | 30.8 | +0.8 | ±0.6 | Fail |
| 3 | 45 psig | 45.00 | 45.9 | +0.9 | ±0.6 | Fail |
As-found overall: Fail. Out-of-tolerance investigation OOT-2026-0074 raised; affected window from last good calibration (2026-05-22) assessed. Gauge reads high, so recorded chamber pressures overstated actual, screened against the sterilization cycle pressure requirement with QA.
Adjustment performed: Yes, span adjusted.
As-left (after adjustment):
| Point | Nominal | Standard | Reading | Error | Tolerance | Pass/Fail |
|---|---|---|---|---|---|---|
| 1 | 15 psig | 15.00 | 15.1 | +0.1 | ±0.6 | Pass |
| 2 | 30 psig | 30.00 | 30.2 | +0.2 | ±0.6 | Pass |
| 3 | 45 psig | 45.00 | 45.2 | +0.2 | ±0.6 | Pass |
As-left overall: Pass. Technician A. Okafor, 12 July 2026; QA review R. Gomez, 13 July 2026.
Because as-found was captured before the span adjustment, the investigation could quantify that the gauge read up to 0.9 psi high and assess exactly which cycles in the affected window were at risk. Had the technician adjusted first, that assessment would have been impossible.
Common inspection findings this record prevents
- A record showing only post-adjustment (“as-left”) readings, so no impact assessment is possible.
- Only “pass” recorded, with no numeric error, so interval management and trending are blind.
- The standard used was out of date, invalidating the calibration, with nothing on the record to reveal it.
- An as-found failure that was quietly adjusted away with no deviation raised.
How to adapt this record
- Match the number of test points to your procedure (three shown; use as many as the instrument and range require).
- Where an electronic calibration tool generates the record, ensure it enforces as-found before adjustment and carries an audit trail; the ALCOA+ expectations apply to calibration data too.
- Point the out-of-tolerance path to your real deviation and impact-assessment forms.
- Confirm the tolerance and its basis match the calibration master list and the individual procedure exactly; a mismatch across documents is a frequently cited finding.