QIC Guru

As a third party auditor we see many common threads where organizations just don’t understand how to implement a particular element of the ISO 9001 standard. For instance, section 8.5.2f corrective action reviewing the effectiveness of the corrective action taken.  I have seen this particular requirement missed, more than any other requirement.   What does it mean to review the effectiveness of a corrective action? Does it mean complete the action and close it, I done? No, this requirement goes to the heart of continual improvement, because it makes you look at what you have done, and determine if it actually accomplished what you set out to accomplish.

THE TERM CONTINUAL IMPROVEMENT REFERS TO AN ONGOING PROCESS OF PERFORMANCE ENHANCEMENT. CONTINUAL IMPROVEMENTS CAN BE ACHIEVED BY CARRYING OUT INTERNAL AUDITS, PERFORMING MANAGEMENT REVIEWS, ANALYZING DATA, AND IMPLEMENTING CORRECTIVE AND PREVENTIVE ACTIONS.

Corrective action effectiveness should be verified/validated and reviewed by management; if specific actions are not timely and/or effective further or additional action should be assigned. A good practice is to conduct periodic audits of corrective actions to further verify effectiveness of corrective actions. You need to know that what you have done actually worked, and if it didn’t then you need to do something else. The whole purpose for writing a corrective action is to fix something that has caused a problem. If you never go back and look at the affect the change had on your system, how will you know that it worked?

It is so important to make sure all of the individuals involved with your quality management system receive some form of iso 9001 training, so that when the auditor gets to your door, this and other misinterpretations of the standard won’t cause you heartburn.