In short: An effective nonconformity statement has three parts: the requirement, the objective evidence observed, and a clear statement of how the evidence fails to meet the requirement. It should be factual, concise and understandable without the auditor present.
What are the three parts of a nonconformity?
- Requirement — the clause, procedure or contract condition
- Evidence — what was seen, heard or reviewed, with references
- Statement — how the evidence does not meet the requirement
What is an example?
Requirement: Procedure QP-07 requires calibration of all measuring equipment every 12 months. Evidence: Micrometer M-114 in Cell 3 was last calibrated 18 months ago (record CAL-2021-044). Nonconformity: Measuring equipment was not calibrated at the defined interval.
What should auditors avoid?
- Opinions and vague words such as “poor” or “inadequate”
- Recommending solutions in the finding
- Findings without traceable evidence
Key takeaways
- Use requirement, evidence and statement.
- Be factual and specific.
- Let the auditee own the solution.
Frequently asked questions
What is the difference between a major and minor nonconformity?
A major nonconformity affects the system’s ability to achieve intended results; a minor one is an isolated lapse.
Should auditors suggest corrective actions?
Generally no; auditors identify the gap and the auditee determines the action.
What is an observation?
A potential issue or improvement opportunity that is not a nonconformity.