A corrective action is the improvement to the organization’s processes, which are taken to eliminate several causes of non-conformity or other undesirable situations. In fact, in today’s modern day business, this process has been evolved as Corrective Action and Preventive Action (CAPA) plan, and has become the key to management success. This action plan is essential to all the companies that are expected to meet the important CAPA requirements as outlined in 21 CFR 211.180 and 21 CFR 820.100 regulations and also in ISO 8402. Today, it is not just about correcting the problem that has occurred due to non-conformity, but also involves developing an action plan that prevents the occurrence of such situation in future.
Thus, a corrective action plan is the strategy that includes eliminating or correcting the problems that has already occurred, whereas the CAPA plan also includes the preventive action measures as well, which involves the steps that are taken to eliminate the root cause of the problem, thereby preventing it from reoccurrence. It is very important to establish corrective action plan all through the organization, because correcting the non-conformity problems at the earliest will generally be more cost-effective than fixing them at a later stage. To ensure that the actions implemented are effective, a systematic analysis of the root cause of failure is of utmost importance. In fact, corrective action is considered an important part of the overall Quality Management System of an organization.
Corrective action is established in the organization in response to unexpected levels of internal nonconformity, customer complaints, various nonconformities identified during internal audit, and unstable trends in monitoring the products and processes. However, preventive measures are generally implemented in response to identifying the potential causes of nonconformity. As such, it is important to understand that corrective action is a reactive response, because it is implemented on detection of a nonconformance. Any organization will first eliminate or correct the problem, and then determine the root cause of that problem to take preventive measures to avoid the reoccurrence.
A corrective action procedure must essentially explain how to:
- Review the nonconformance and other customer complaints
- Decide the root cause of the problem
- Decide the best course of action to prevent the problem from recurring
- Put the plan into necessary action
- Make sure that the course of action has actually solved the problem
Establishment of corrective action in an organization is the path towards the effectiveness and improvement of the Total Quality Management system. The non-conformance problems can be easily identified internally through management review, internal audits, document reviews, or staff suggestions. Customer complaints and rejection are also the external sources for implementing corrective action.
Some of the common examples of corrective action being practiced in the organizations are:
- Audible and visible alarms
- Error proofing
- Improvements in maintenance schedules
- Process Redesign
- Training and improving the existing training programs
- Improvements in storage and material handling
- Product Redesign
Thus, it is important to take the corrective action before it is too late.