Help: How to classify findings (Major / Minor / OFI) Click to expand
Conformity
Meets requirements (ISO + internal procedures). No action needed (optional: note good practice).
OFI (Opportunity for Improvement)
Not a nonconformance. You’re compliant, but there’s a risk or efficiency improvement. Corrective action is optional.
Minor Nonconformity
Isolated lapse. The system works overall, but this instance didn’t. Corrective action required (limited scope).
Major Nonconformity
Systemic failure or missing/broken control. Repeated minors can become a major. Immediate corrective action required.
Use this for Opportunities for Improvement (OFIs). If this is a Nonconformity, the NC Statement + CAP fields should be completed.
Quick decision guide
- Is there a requirement? If no → Conformity or OFI. If yes → continue.
- Is the process missing or failing system-wide? Yes → Major. No → continue.
- Is it isolated? Yes → Minor. If repeated/pattern → Major.
Plain language: Major = the system failed or doesn’t exist. Minor = the system works, but this instance didn’t. OFI = it works, but it could work better.