The Finding That Was Really an Observation
You are writing the report for an internal audit of a calibration system. You have three candidate items: (1) Two of 20 calibrated instruments were past their due date by 6 and 11 days, and both had been used on product in that window. (2) The calibration procedure does not define acceptance criteria for one instrument type, so technicians use judgment. (3) The calibration lab's turnaround time is 3 weeks, which the lab manager says 'makes it hard to stay current.' The audit criteria are the internal calibration procedure and ISO 9001 clause 7.1.5. Your draft report lists all three as nonconformities of equal weight. The auditee's manager objects that (2) and (3) are 'just opinions' and demands they be removed.
1. Classify each item and justify the classification against the criteria.
Read the worked answer
Item 1 - Nonconformity (major or minor depending on program definitions).
- Requirement: instruments must be calibrated before due date / within defined intervals; product measured with out-of-calibration equipment is a control failure.
- Evidence: two instruments, specific dates, specific product use.
- Why it matters: it is a direct failure to meet a requirement with product impact. This is the strongest item and should stand.
Item 2 - Nonconformity (documentation/control of criteria), not an opinion.
- Requirement: the procedure must define acceptance criteria so results are consistently judged; ISO 9001 requires documented information to the extent necessary for the effective operation of the process.
- Evidence: the procedure itself lacks criteria for one instrument type; technicians confirmed they use judgment.
- Why the manager is wrong: this is not an opinion - it is a gap in the documented information against a stated requirement, verified by reading the procedure and interviewing technicians. It should be written as a nonconformity with the specific clause and the specific instrument type.
Item 3 - Observation / opportunity for improvement, not a nonconformity.
- Requirement: no requirement sets a maximum calibration turnaround.
- Evidence: 3 weeks is a fact, but 'hard to stay current' is the manager's characterization, not a demonstrated breach. It is a contributing condition to Item 1.
- Treatment: report as an observation, linked to Item 1 as a root-cause input. Do not weight it equally.
2. The auditee demands items 2 and 3 be removed. How do you respond, and what does this test about report integrity?
Read the worked answer
Response:
- Item 2 stays. It is supported by the procedure text and interviews; it is not an opinion. I would make the wording precise: cite the clause, quote the missing criteria, name the instrument type, and state the consequence (inconsistent acceptance decisions). Precision is the antidote to 'that's just an opinion.'
- Item 3 is reclassified to an observation, because the auditee is partly right - as written it overstates. Reclassifying it is not capitulation; it is correcting the report to match the evidence.
What this tests - report integrity:
- The report must be accurate in both directions: not softened to appease, not inflated to look thorough. Equal-weighting all three was the original error.
- Classification must be defensible from the criteria and evidence, not from the auditee's comfort or the auditor's preference.
- The auditee has a right to respond; their response is recorded, but does not unilaterally change findings. Disagreements are resolved by evidence review through the defined process, with escalation if unresolved.
- A good report distinguishes nonconformity / observation / OFI clearly so the corrective-action process is not diluted by weak items - and so strong items are not weakened by association.