Closure on non-conformities
When a Certification Body issues a non conformity during an audit there is strict guidance they must follow to close out the nonconformity. Here is a 10 point check list for you to follow to ensure you will get full closure during your next audit…
Correction…what the auditor is looking for…
- The nonconformity has been determined and contained?
- If correction cannot be immediate, there must be a clear plan in place with responsibilities, dates and if required the issue must have been communicated to all affected departments internally and to any customers and suppliers affected.
- There must be evidence that the correction was implemented or is being implemented.
Root Cause Analysis…what the auditor is looking for…
4. There should be a defined Direct Cause as well as a Root Cause… (e.g. someone did not follow a process would be direct cause; determining why someone did not follow a process would lead to the true root cause).
5. The Root Cause should not be a repeat of the non-conformity or the direct cause and should not attempt to explain or justify the direct cause.
6. There should be a Root Cause statement to addresses a fundamental issue without any obvious “why” questions remaining. If a “why” question can reasonably be asked, this indicates that the analysis did not go far enough. This hints at using 5 Why analysis as a tool for more complex issues.
7. There may be several ‘Root Causes’ but each cause must have a Corrective Action Identified…for instance if training and inadequate work instructions are identified as root causes, a Corrective Action plans must be identified for each.
Corrective Action…what the auditor is looking for…
8. The corrective action must address the root cause(s) determined in the root cause analysis. This needs to include specific actions, responsibilities and dates for completion.
9. In order to accept the evidence of implementation there must be enough evidence is provided to show the plan is being implemented.
10. Full evidence is not required to close a non-conformity and this may be carried forward to future assessments in order to verify full effectiveness.