Nonconformity Reporting and Corrective Action
A nonconformity (NC) is a failure to meet a requirement. It must be written so it is clear, factual, evidence-based, and traceable to the requirement. Standard structure: requirement (clause/criteria), evidence (what was observed, where, when), and the gap (how the evidence fails the requirement). Avoid opinions, root-cause speculation, or prescribing the fix.
Distinguish severity: major (systemic failure, absence of a required process, or failure that materially affects product conformity) vs. minor (isolated lapse not indicating system breakdown). Understand observation/opportunity for improvement as distinct from an NC-no requirement breached.
Corrective action concepts: correction (fix the immediate instance) vs. corrective action (eliminate the cause to prevent recurrence); root cause analysis (5-Why, fishbone); containment; effectiveness verification; and closure criteria. A corrective action is not closed until evidence shows the cause was addressed and the problem has not recurred over a defined period.
Traps: (1) Writing an NC that names a person or blames rather than describing the condition. (2) Accepting "retrained the operator" as root cause when the system allowed the error. (3) Closing a CA on the strength of a revised procedure alone, without effectiveness evidence. (4) Confusing correction with corrective action. (5) Overstating severity.
Rule of thumb: if the NC cannot be understood and verified by someone who was not there, rewrite it.
Worked example: "Three of ten sampled purchase orders lacked supplier approval evidence (clause X)." Correction: obtain approvals. Corrective action: revise the approval workflow and verify over the next quarter that sampled POs are approved before release.