CQA Practice Test 11
10 free CQA practice questions in the real exam format, covering the official content areas, with an explanation for every answer.
Question 1 of 10
Audit ProcessAudit File — Receiving Inspection
Auditor J. Mendes is conducting an internal audit of receiving inspection at a medical device component plant on 6 October 2026. The criteria are work instruction WI-RI-04 Rev C and the plant's calibration procedure. The receiving supervisor acts as guide. The scope covers day-shift and second-shift inspection.
WI-RI-04 Rev C — Receiving Inspection of Machined Housings (excerpt)
4.1 Measure the bore diameter of five parts from each lot with a bore gauge listed in the calibration log.
4.2 Use only gauges with a current calibration. Do not use a gauge past its calibration due date; tag it and return it to QA.
4.3 Record the lot number, gauge ID, readings and inspector initials on form RI-F2.
4.4 If any reading is out of tolerance, place the lot on HOLD and notify QA.
| Gauge ID | Description | Last calibrated | Due | Status |
|---|---|---|---|---|
| BG-07 | Bore gauge 0–25 mm | 10 Sep 2025 | 10 Sep 2026 | Active |
| BG-09 | Bore gauge 0–25 mm | 2 Mar 2026 | 2 Mar 2027 | Active |
| BG-11 | Bore gauge 25–50 mm | 18 Jan 2026 | 18 Jan 2027 | Out for repair since 30 Aug 2026 |
| MIC-03 | Micrometer 0–25 mm | 15 Jan 2026 | 15 Jan 2027 | Active |
Auditor notes — 6 October
09:40 Observed inspector measuring lot 26-1187 with bore gauge BG-07. Calibration label on BG-07 reads "Due 10 Sep 2026." Readings within tolerance; lot released to stock at 10:05.
09:55 Inspector stated: "QA told us last month that BG-07 was extended to December, so it's fine."
10:20 Reviewed RI-F2 forms for the 7 day-shift lots received since 10 Sep: BG-07 recorded on all 7. All 7 lots released.
10:35 Supervisor stated that second shift "always uses BG-09." Second-shift RI-F2 forms are kept in a separate binder; not yet reviewed.
11:10 Supervisor tagged BG-07 and returned it to QA.
Which item in the auditor's notes is objective evidence that can support a finding without further corroboration?