ISO 9001: How to verify the effectiveness of corrective actions?

 

Having completed my first ISO 9001 auditor training many years ago, I struggled with the responsibility placed on auditors to verify the effectiveness of corrective actions taken prior closing the non-conformity. How was I to guarantee that the non-conformity would not occur again? Can anyone? Having switched roles into that of an instructor now I am often faced with this question of the auditor’s dilemma on when the corrective action is deemed to be effective. Will it truly be able to prevent similar non-conformities from occurring?

ISO 9001 training takes students through an intensive 4-5-day journey into an often unknown world. Learning about ISO 9001 and the principles of auditing can appear to be quite daunting at the outset but with a well-structured course and a good instructor the takeaways are immense. ISO 9001 asks organization to ensure the audit is objective and impartial and this starts at the planning stage of the audit and continues right through until the non-conformity is closed out.

A non-conformity is the non-fulfillment of a requirement. Well written non-conformities identify the requirement not met, the factual objective evidence that demonstrates how the requirement was not met and a nature statement that identifies the issue that needs to be addressed. A well written no-conformity statement points the auditee in the right direction. ISO 9001 auditor training taught me the value of a well-written non-conformity statement and how often badly written non-conformities are the root case of poor corrective actions. This because the problem is not clearly identified for the auditee.

As part of the close out of non-conformities auditees need to determine the immediate correction to be implemented, deal with any consequences and to then determine the need for corrective action. In closing out the auditor needs to determine that correction, if needed, was taken. Observe the dates of completion. If corrective action is needed, it should clearly be evident to the auditor the approach taken to evaluate the root causes and what were the identified root causes. It is here that it is beneficial for auditors to also have undergone some form of root cause analysis training. This enables them to evaluate the root cause analysis process used by the organization. Most ISO 9001 auditortraining do not contain in-depth coverage of problem solving / root cause analysis training. Organizations should follow the path down to the root causes and not stop at the direct and indirect causes.

Lastly auditors are looking to verify that the corrective action taken has addressed the root causes. In effectively identifying the root causes organizations will be able to prevent the non-conformity from recurring and similar or potential non-conformities from occurring across the system. In essence, it is now a system corrective action and not a localized one. The best method to verify close out is by going back onsite however documentation may be accepted provided the integrity of the documentation being presented can be trusted.

ISO 9001auditor training addresses the importance of close out of the NCs properly. Auditors and organizations need to recognize that as the context and other factors change, the risk to the system also changes, and therefore the organization must continue to assess the effectiveness of action taken to close out the Non-conformity.