Corrective Actions

When reviewing responses to audit nonconformities, you should look for correction, root cause analysis, and then corrective action. The ANSI-ASQ National Accreditation Board (ANAB) that accredits certification bodies (CBs) knows the proper corrective action process.

When ANAB was experiencing less than adequate responses to nonconformities they issued during audits of certification bodies, they issued a “Heads Up” to their auditors to provide guidance on evaluating corrective action responses.

Guidance:

ANAB said that nonconformity responses should be reviewed in three parts; correction, root cause analysis and corrective action. In reviewing the three parts, they look for a plan, and then evidence that the plan is being implemented. In some cases, the CB may take action and not provide a plan; that is acceptable as long as the following guidance is met.

Correction – To be fully accepted, the response must include the following components: 

1. The extent of the nonconformity has been determined and contained.

The nonconformity has been corrected and the response is written in the past tense, e.g., the missing record was found (not will be found). The CB has examined the system to see if there are other examples that need correction (extent of the issue) and have addressed the extent in their response. The response should include the evidence ANAB found and any other evidence the CB may have found.

2. If correction cannot be immediate, a plan to correct the NCR may be appropriate, and include identification of responsible parties for the actions and a schedule (dates) for implementation.

3. If applicable, all parties involved have been informed of the problem (identify internally affected parties, auditors, customers, etc).

4. Evidence that the correction was implemented or evidence that the plan is being implemented.

Root Cause Analysis – To be fully accepted, the response must follow the following guidance: 

5. The Root Cause refrains from simply repeating the finding or the direct cause.

6. The Root Cause is a brief expression of fact that attempts to neither explain the situation away nor rationalize the condition.

7. A well thought out Direct Cause has been determined along with a well thought out analysis to determine the true 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.

8. The root cause statement must focus on a single issue. If more than one cause is identified, for instance training and inadequate work instructions, then two Corrective Action plans must be submitted.

9. The Root Cause statement addresses a fundamental issue without any obvious “why” questions remaining. If a “why” question can reasonably be asked about the root cause analysis, this indicates that the analysis did not go far enough.

Corrective Action – To be fully accepted, the response must include the following components: 

10. The corrective action, or corrective action plan, addresses the root cause(s) determined in the root cause analysis.

11. In order to accept the plan, it shall include actions to address the root cause(s), identification of responsible parties for the actions, and a schedule (dates) for implementation.

12. In order to accept the evidence of implementation, enough evidence is provided to show the plan is being implemented as outlined in the response (and on schedule). Evidence in full is not required to close the nonconformity; some evidence may be reviewed during future assessment when verifying the corrective actions.

You can see the ANAB communication at Heads Up 137.