Uh, oh, something bad happened; now what?  Time for some corrective actions.  Uh, oh, something bad is about to happen; now what?  Time for some preventive actions.

Corrective actions and preventive actions are very similar concepts.  In both cases, a person or group of people are trying to fix a problem. The main difference is when the problem occurs relative to the action. For a corrective action, you are responding to a problem and therefore “correcting” it whereas a preventive action takes place before a nonconformance actually happens. Preventive actions are usually triggered by reviewing product/process trends and identifying trending leading towards nonconformance.

In either case, a manufacturer needs to respond to what their scientists and engineers say is the cause; this is part of the Plan-Do-Check-Act components of the Deming-Shewhart Cycle[1].  It’s all well and good to know where a system goes wrong, be that system a medical device, a piece of software, or a sales business; if the information learned goes unused, then all the effort going into improvement is wasted. 

Corrective and Preventive Actions are a systematic method to improve processes, and not a collection of one-off events that can be knocked out over a long weekend.  If the surface of a particular component needs to be polished to a sheen in order for the component to play its role in a larger machine, it isn’t enough for management to make the statement to the labor force and be done with it.  The labor force needs to be given all the tools and training they need to perform their tasks, and their work must be continually compared to the needed standard.  As new fabricators are brought in, their work must be evaluated to the same standard; as existing workers continue, their work must be evaluated to the standard, in order to prevent complacency. In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market. If you need help in making sure you know how to prevent bad things from happening, and correcting when other bad things happen, contact the experts at EMMA International by calling 248-987-4497 or emailing info@EMMAinternational.com

[1] ASQ. (n.d.).  “What is the PDCA Cycle?”.  Retrieved from https://asq.org/quality-resources/pdca-cycle

Ethan Benedict

Ethan Benedict

Mr. Benedict has experience in FDA compliance for both medical devices and pharmaceuticals. He has experience with many different elements of quality and regulatory compliance. Mr. Benedict holds a Bachelor of Science in Mechanical Engineering from York College of Pennsylvania, and a Bachelor of Science in Physics from Ursinus College.

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