This is a ready-to-use worksheet for scoring a sample of equipment and instrument qualification packages side by side against the same completeness and quality criteria. A single-package review tells you whether one asset’s paperwork is in order. This worksheet is built to do something different: score several sampled packages against the same rubric at once so a pattern across the sample, such as every OQ in the sample skipping boundary testing, is visible as a pattern rather than getting buried in five separate narrative reviews. Replace every <<FILL: ...>> placeholder. A filled specimen follows. This is educational reference content, not legal or regulatory advice.
Feed the output of this worksheet into the findings register of a program-level audit report; see Equipment and Instrument Qualification Program Audit Checklist for the walkthrough this worksheet supports.
Header
| Field | Entry |
|---|---|
| Worksheet number | <<FILL: WS-ID>> |
| Audit reference | <<FILL: linked checklist or audit report number>> |
| Site / facility | <<FILL>> |
| Packages sampled (count) | <<FILL>> |
| Sampling technique | <<FILL: e.g. stratified random across risk classes>> |
| Scored by | <<FILL>> |
| Date | <<FILL>> |
Scoring key
| Score | Meaning |
|---|---|
| 2 | Present and inspection-ready: specific numeric criteria, actual recorded values, contemporaneous signatures |
| 1 | Present but weak: vague criteria, ticks without values, a contemporaneity or independence gap |
| 0 | Missing or absent |
| NA | Not applicable to this asset type or its assigned qualification depth |
Completeness and quality grid
List one column per sampled asset. Score every row for every asset; do not skip a row because the answer is inconvenient.
| Element | <<FILL: Asset 1 ID>> | <<FILL: Asset 2 ID>> | <<FILL: Asset 3 ID>> | <<FILL: Asset 4 ID>> | <<FILL: Asset 5 ID>> | Note (pattern across sample) |
|---|---|---|---|---|---|---|---|
| URS or equivalent requirements, approved | | | | | | |
| DQ (vendor or design review) documented | | | | | | |
| IQ protocol approved before execution | | | | | | |
| IQ execution shows actual values, not only ticks | | | | | | |
| IQ report approved | | | | | | |
| OQ protocol has specific numeric acceptance criteria | | | | | | |
| OQ tests edge/worst-case conditions, not one comfortable point | | | | | | |
| OQ software/data-integrity functions tested (Group C / computerized only) | | | | | | |
| OQ report approved | | | | | | |
| PQ protocol and report exist (direct-impact equipment) | | | | | | |
| Current calibration certificate on file, states uncertainty | | | | | | |
| Most recent periodic review documented and on schedule | | | | | | |
| Change log complete and current | | | | | | |
| Contemporaneity: execution dates match signature dates | | | | | | |
Scoring rollup
| Asset ID | Sum of scores | Applicable rows (excl. NA) | Completeness % | Flag (below <<FILL: threshold, e.g. 80%>>) |
|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> |
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Item | Entry |
|---|---|
| Population-level completeness (average across sample) | <<FILL>> |
| Row with the most 0/1 scores across the sample (systemic candidate) | <<FILL>> |
| Assets flagged below threshold | <<FILL: list, or "none">> |
Pattern-level findings
Use this section for observations that are about the sample as a whole, not a single asset. A row that scores 0 or 1 on most sampled packages is a program gap, not five separate findings.
| Element with a sample-wide pattern | Assets affected | Likely root cause | Route to |
|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL: CAPA ref / audit finding ref>> |
How this feeds the audit report
| Item | Entry |
|---|---|
| Individual asset scores below threshold | <<FILL: route each to its own finding in the audit findings register>> |
| Sample-wide patterns identified above | <<FILL: route as a single systemic finding, typically Major, not one finding per asset>> |
Filled specimen
Six packages sampled at a mid-sized site (threshold set at 80% completeness).
| Element | BRX-014 | HPLC-11 | STZ-04 | CHM-09 | BAL-0042 | DL-07 | Note |
|---|---|---|---|---|---|---|---|
| URS approved | 2 | 2 | 2 | 2 | 2 | 1 | DL-07 URS lacks specific location-envelope requirement |
| DQ documented | 2 | 2 | 2 | 1 | 2 | 1 | |
| IQ protocol approved before execution | 2 | 2 | 2 | 2 | 2 | 2 | |
| IQ execution shows actual values | 2 | 2 | 2 | 2 | 2 | 1 | |
| IQ report approved | 2 | 2 | 2 | 2 | 2 | 2 | |
| OQ criteria specific and numeric | 2 | 2 | 2 | 2 | 2 | 1 | |
| OQ tests edge/worst-case conditions | 1 | 2 | 2 | 2 | 0 | 0 | Systemic candidate; see pattern findings |
| OQ software/data-integrity functions tested | NA | 0 | NA | NA | NA | 1 | HPLC-11 Group C, audit trail never tested |
| OQ report approved | 2 | 2 | 2 | 2 | 2 | 1 | |
| PQ protocol/report exist | 2 | 2 | 2 | 2 | NA | NA | |
| Calibration certificate current, states uncertainty | 2 | 2 | 2 | 2 | 2 | 2 | |
| Periodic review current | 0 | 2 | 2 | 2 | 2 | 2 | BRX-014 overdue, drives audit finding F-02 |
| Change log complete | 0 | 2 | 2 | 2 | 2 | 2 | BRX-014 impeller repair missing, drives F-01 |
| Contemporaneity | 2 | 2 | 1 | 2 | 2 | 2 | STZ-04 one late-signed record |
Rollup: BRX-014 scores 19 of 26 applicable points (73%), flagged below threshold. DL-07 scores 16 of 24 applicable points (67%), flagged below threshold, driven by a portable-asset-specific gap (no location-envelope requirement, no relocation re-verification captured in IQ/OQ). The remaining four packages score above 90%.
Pattern-level finding: “OQ tests edge/worst-case conditions” scores 0 or 1 on three of six packages (BRX-014, BAL-0042, DL-07), spanning three different equipment families. That spread is the signal this worksheet exists to catch: boundary testing is a systemic weak point in this site’s OQ practice, not an isolated gap on one balance, and it should be routed as a single Major program-level finding with its own CAPA rather than three unrelated ones.
Common inspection findings this worksheet prevents
- A completeness review performed package by package that never compares results across the sample, missing a systemic gap hiding in plain sight.
- A single flagged asset treated as an isolated paperwork problem when the same gap recurs across the sample.
- A portable or single-use asset scored against the same rigid grid as fixed equipment with no room to note where the gap is category-specific.
- No numeric completeness threshold, so “mostly complete” substitutes for an actual score.
How to adapt this worksheet
- Set the applicable-row count and threshold to match your own risk-based expectations; a Group A instrument will legitimately score NA on several rows.
- Add or remove grid rows to match your own qualification package structure, but keep the same rows across every asset in a given scoring pass so the comparison stays valid.
- Route individual low scores to their own audit findings, and route any row with a sample-wide pattern to a single systemic finding instead of duplicating it per asset.
- Re-run this worksheet on a fresh sample at the next audit cycle and compare population-level completeness over time.