How to Close Non-Conformities: A 10-Point Checklist
When a Certification Body issues a nonconformity (or nc) during an audit, there is strict guidance they must follow to close out the nonconformity. In this article, we provide a comprehensive 10-point checklist to help you achieve complete nc closure during your next audit.
Correction: What the auditor is looking for…
- Identification and Containment: The non-conformity should be identified and contained promptly.
- Clear Plan: If immediate correction is not possible, there must be a clear plan with assigned responsibilities and deadlines. If required, communicate the issue internally to affected departments, customers, and suppliers as needed.
- Evidence of Implementation: There must be evidence that the correction has been implemented or is actively in progress.
Root Cause Analysis: What the auditor is looking for…
4. Direct and Root Causes: Distinguish between the direct cause of the nc (e.g., someone not following a process) and the root cause (the reason behind not following the process).
5.Originality of Root Cause: The root cause should not be a repeat of the nonconformity or the direct cause and should not attempt to explain or justify the direct cause.
6. Comprehensive Root Cause Statement: There should be a root cause statement to address fundamental issues without leaving any “why” questions unanswered. If a “why” question can be asked, the analysis did not go far enough. Consider using tools like the 5 Whys analysis for complex issues.
7. Multiple Root Causes: If multiple root causes are identified, there must be corrective action plans established for each. For instance, if training and inadequate work instructions are root causes, create separate corrective action plans.
Corrective Action: What the auditor is looking for…
- Addressing Root Causes: The corrective action must address the root cause(s) determined in the root cause analysis. This needs to include precise actions, responsibilities, and completion dates.
- Evidence of Implementation: In order to accept the evidence of implementation, there must be sufficient evidence demonstrating that the plan is in progress.
- Partial Evidence Acceptance: Remember that full evidence is not always required to close a non-conformity. Some aspects may be carried forward to future assessments in order to verify full effectiveness.
By following this 10-point checklist, you can enhance your readiness for certification audits and improve your chances of obtaining full closure on non-conformities. Properly managing non-conformities is essential for maintaining the integrity of your certification. Utilising these guidelines will not only help you close non-conformities in audits effectively, but also demonstrate your commitment to continuous improvement.