correction vs corrective action
In Dr Simon, he talk briefly about correction vs corrective action. What I understood from the lecture Is that correction is any action that is taken to eliminate a non-conformity, and corrective action are steps that are taken to remove the causes of an existing nonconformity or undesirable situation. Do anyone have more understanding on this matter or do you have a real example about when this happen to you?
From my experience, I am actually working on a project that currently deals with both. Due to regulation change in Asia on how the packaging is labeled, we were able to create the new product to reflect the change. However, with the old product in stock that does not have that change, in the system it shows that I can be shipped but in reality the product would be a non-conformance. So the correction during the first phase of the project was to implement a checking point of the product being sent to Asia to my manually allocated and reduce the chance of sending the non-compliant product. With Phase II, we would work towards implementing corrective action within the system so that the products can be automatically identified and reduce the need of utilizing a resource for the manual allocation. After this is completed, then the CAPA can be closed and the project can be finalized.
As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. While CAPA's, are steps taken to find the root cause of the non-conformity, document it and the necessary change to prevent the non-conformity from occurring again. Essentially, correction addresses the short term need and gets immediate attention, whereas corrective action is a long-term solution. However, if a nonconformity is an isolated incident with low risk, sometimes the company would decide that it would not make sense to put resources and invest time on understanding the root cause or performing a CAPA and that only correction is necessary.
As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent it from happening again. During the CAPA execution, documentation may change such as SOP's and process specs, which leads to the correction action itself.
Correction is taken to rectify a known nonconformance; Corrective Action is taken to prevent recurrence of said nonconformance.. Correction will take very little investigation to find and is a quick fix for this one-time problem. However, it does not take action to preclude the problem from reoccurring.If the audit has identified that a problem is more serious than one simple non-conformance, the organization will need to implement corrective action to prevent the problem from happening againthe organization needs to look deeper into the cause of the problem to find the root cause so it can be eliminated. For example You find that a customer is unhappy with your delivery service because a package is late in arriving. You make a correction for this by finding the package and delivering it as soon as possible, and follow up by offering a partial refund to the customer to maintain customer satisfaction even with this error. This would be your correction; however, if during your investigation you find that this is happening to other customers and you decide to take action to prevent it from happening again, you will look further for the root cause of the problem. If during this root cause analysis you find that packages have been misidentified and sent to the wrong area of the city for delivery, which caused them to become lost and delayed, you might implement additional steps to verify that the identification on packages is correct before they are sent for delivery, potentially including updates to your computer tracking system to make this easier and error free. This would be your corrective action.
In layman terms, the biggest difference is that a Corrective is immediate fix and is more of a one time or a defect of a process. Whereas a corrective action is a method of solving a reoccurring issue that is meant to improve the processes of a company and find the root problem. A current Corrective action I am apart of is a CAPA in classifying vendors in terms of risk by a better and more in-depth classification standard. Previously, the company had a scale but it was not clearly defined and an audit helped identify the issue which leads to a large scale requalifying of all vendors that the company deals with. The proper execution of this CAPA will lead to a more streamlined process for qualifying vendors and a better documentation practice.
A CAPA process that I was a part of during my exposure in the IT industry. Although, the term CAPA wasn't used but the process was similar. There was a defect in running our energy scripts in the software called Powerplant. The scripts usually come from a vendor that would be software enhancements or adding employee data. As a contracting company, we were the customer to the vendor. In one instance upon running the script, it revealed lot of employee details to my team. Our job was only to run the script, we would not be generally aware of the data it contained. This called for a CAPA process where the defect had to be fixed on our machines and then a preventative wall was created to block the user from seeing the data/code for running the scripts in the future.
As mentioned by many above, correction is the actual action to eliminate the nonconformity, on the other hand the corrective action is the process to actively prevent the nonconformity from occurring; which is CAPA. In addition as mentioned, correction is an immediate action that receives full attention that is a short term solution while the corrective action is a long term solution, that would need further resources to find a solution. There are certain situations where there are nonconformities that the company will need to make an ultimate decision to see if they would like to initiate a CAPA, usually companies attempt to prevent a CAPA from being initiated because it involves the FDA to be notified and also resources are invested and possible rework. In my case, the company i worked for in regards vision testing systems, we attempt to rectify the problem in a way to prevent a CAPA from being initiated, we intiate a CAPA when there is a definite device failure, this would be discovered either by QC or by our customers.
I agree with previous comments about Correction being the short-term solution and Corrective action, on the other hand, is a long-term solution. Correction is taken to rectify a known nonconformance and Corrective Action is taken to prevent recurrence of said nonconformance.
I would like to illustrate this with simple examples of these 2 related concepts that are easy to remember: a crack pipe led to water leakage on the floor. Here correction would mean clean the water damage. corrective action means not only to fix the pipe but also find the cause for the broken pipe so that the pipe won't break in the future.
In my experience, a correction can also be called a rework in which the product is fixed for a nonconformity. In the medical device industry, this would mean fixing the medical device before it even leaves the production floor. For example, if there is a hole in the membrane it can be replaced if caught early on. This correction fixes something individually. In contrast, a corrective action fixes a problem at the source, hopefully ensuring that the nonconformity does not occur again in the future. If it turns out that many of the membranes have a hole in them, there could be a problem with the production process and it needs to undergo a corrective action to fix it.