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    ISO 13485 & MDR Knowledge base

    ISO 13485 continual improvement: Seven-step process for corrective and preventive actions

    Some organizations view corrective and preventive actions as nothing more than a formal exercise to make the registrar happy. When they fail to see the potential benefits, companies often struggle to implement an effective corrective action system. If this sounds like your organization, then keep reading to learn some useful tips for how to make your corrective and preventive actions work for you.

    Corrections and corrective actions – is there a difference?

    The first challenge is learning to differentiate between correction and corrective action. A correction occurs when you discover a problem, and implement an immediate fix to allow work to continue. A corrective action goes further, to discover the root cause and correct it to prevent the problem from occurring again in the future. Here’s an example: Say you find a defect in a batch of medical devices. The immediate correction might be rework, so that those devices are still usable. The corrective action would involve searching for the root cause, which might be incorrect calibration on a machine. So, you would fix that root cause by recalibrating, and implement a quality check to make sure that the next batch is free of defects.

    Every problem needs to be corrected, but not every problem requires corrective action. For large problems that seem to keep recurring, corrective action is your best bet, because this process will save significant money compared to correcting the problem over and over. But, if you have a small problem that has never happened before, then implementing and documenting the entire corrective action process would likely be cost-prohibitive.

    Keep in mind that the ISO 13485 standard doesn’t mandate that organizations use their corrective action process for every problem that pops up; rather, this system must be put into place to further the goal of continual improvement.

    The corrective action process

    In my experience, we all tend to go through the same few steps – whether consciously or not – when we work to solve a problem. These same steps work quite well when implemented as a corrective action system as part of an ISO 13485 Quality Management System (QMS), or in any other ISO management system, for that matter. The way you choose to document this process is up to you – custom software, Excel spreadsheets, and online or paper forms are all valid choices—but the steps you should follow are the same regardless of the format.

    1) Define the problem. First of all, you need to be sure that the “problem” in question is actually a problem, and not just someone’s perception that something is wrong. Try using a “Should be/Is” statement as a test, so that you can lay out the problem along with the requirement that should be met. An example might be: This part should be chrome-plated/This part is missing areas of chrome plating. If you can’t specifically define the “should be,” then you may not have an actual problem on your hands.

    2) Define the scope. Does this problem apply to only one individual part? Is it only found in today’s batch, or did the same problem happen yesterday, too? Is the defective part only found on one product, or are multiple products affected? You need to understand how big the problem is, how widespread, and – just as importantly – where the problem is not. If it only happens on one product line, or only on Tuesdays, you need to know this.

    3) Containment actions. You need to have some immediate measures or a temporary fix to stop the problem for now. Then, you can look for the root cause and know that if the problem arises again while you are implementing corrective action, you’ll be able to catch it.

    4) Find the root cause. Now for the hard(er) part: making sure you really did find the root cause of the problem. There are whole books and courses devoted to this subject, but you can find tools like “5-Whys” and the Fishbone Diagram online to help you make sure you have identified the underlying issue, and not just the surface problem. Once you’ve done this, you’ll need to make sure that your scope hasn’t grown, which would require additional containment actions.

    5) Plan a corrective action. Now it’s time to determine a plan for eliminating the underlying cause of your problem. You’ll also need to figure the costs involved, and the potential return on your investment. Where will the funding come from? Who needs to approve the budget?

    6) Implement the corrective action. And now for the easy part: follow the steps of your plan, and make it happen. Whether this involves recalibration of equipment like described above, or a complete overhaul of the assembly process, you know what needs to be done.

    7) Follow up to make sure the plan worked. Now that you’ve applied corrective action, after an appropriate amount of time, you’ll know whether it was effective. If the problem doesn’t resurface, then you likely solved the case. If it does, then you need to consider the possibility that you incorrectly determined the root cause. This is the most critical step in the whole process, and many organizations fail to complete it. Sometimes, a company just wants to close the books and move on, or they think that the certification body wants to see problems solved quickly, but rushing through this step can mean that all your hard work was for nothing.

    And, that’s the whole process!

    Under clauses 8.5.2 and 8.5.3 of the ISO 13485:2016 standard, corrective and preventive actions are required for existing nonconformities, as well as those that could happen in the future. To clarify, you’ll use corrective action on a problem that has already occurred; preventive action will follow the same seven steps, but applied to a “near-miss” or a potential problem. A corrective action might involve recalibrating a machine after product defects are noted, while a preventive action would be recalibrating because someone noticed it was off, before any defective parts are produced.

    Saving money through corrective and preventive actions

    This might seem obvious, but by properly solving your organization’s biggest problems, you’ll realize the biggest benefits. Using corrective action appropriately for the biggest, costliest problems is the best way to cut costs through continual improvement – and saving money by making improvements is the main reason you implemented your Quality Management System anyway, isn’t it?

    Download this free Checklist of Mandatory Documentation Required by ISO 13485:2016 to see the structure of documents necessary for ISO 13485:2016.