CAPA is an acronym for Corrective and Preventive Action that includes non-conformances, out of specification results, customer complaints, anomalous trends, validation excursions, audit results and responses, and other quality system outputs. FDA and ICH refer to CAPA as a “methodology” to be utilized as needed across the multiple quality systems. In nearly every FDA 483, Warning Letter, Consent Decree, and recall, you can read about failures related to CAPA. I believe that CAPA is more than just a tool; it’s a fundamental principle of Quality and spans across everything we do. In my opinion, CAPA is ultimately the Voice of the Customer (or Process) and we should be listening carefully to what is being said.
Understanding the common definition of CAPA isn’t as important as understanding the underlying concept. CAPA relates to nearly every single thing we do – both at work and at home – every day. Think about it. Inevitably, the battery on the smoke detector only hits critical low energy level when I’m asleep. The annoying and incessant beeping wakes me and I stumble around trying to find a new 9-volt battery and the source of the noise. What do I learn from this process? The next day, I change every battery in each smoke detector in the house. I also set a reminder six months in the future on my calendar. After that, I start researching the complexity and cost involved in installing electricity-powered smoke detectors.
Going back to my earlier comment about listening, what about CAPA in the workplace? Just like listening is so much more than hearing, so is information analysis considerably more involved than data collection and trending. For example, what does it mean to say that you had 100 customer complaints this month?
What does the data tell you generally and specifically? Is there any relationship with other reported non-conformances or out-of-specification events? For example, does a complaint trend mirror a non-conformance trend or internal audit findings? How do product, process, or supplier changes relate to this data? The point is are you looking at all the outputs from your processes as inputs to your overall quality system? In other words, are you performing a horizontal analysis of CAPA?
It’s common practice to perform trending within the various quality systems, but few businesses truly analyze the data across the systems and get a big picture view of the operation. A seasoned FDA field inspector was the keynote speaker at an industry conference I had the pleasure of attending earlier this year. Her presentation centered on various gaps in quality systems that a strong internal audit function should have previously identified. She gave an example of customer complaints that were closely related to changes made as a result of a manufacturing non-conformance. Thus linking various quality systems under one single umbrella. Had the company been performing an effective internal audit, the speaker believed this “common thread” would have been identified and remediated before the FDA inspection. This is exactly my point regarding the need for a broader view of CAPA and listening to the Voice of the Customer.
Returning to the CAPA at home analogy, let’s consider not only smoke detectors but other household systems. What about changing air or water filters, cleaning air purifiers, backing up the computer system, monitoring the pool water quality, changing oil and rotating car tires, cleaning out the gutters and clearing drains, and other routine maintenance activities? Each individual incident may create a unique CAPA but a review of them all would likely show that I need a better, more organized system for tracking repeated, periodic maintenance. Perhaps I also need to evaluate my raw material supply process (new batteries and filter available?) or component quality (chemical test kit within expiry?). By implementing a global CAPA, I can eliminate unexpected interruptions in my sleep schedule, unnecessary damage to equipment, lost information, and a variety of other painful and costly experiences. Taking a bigger picture view or performing a horizontal analysis can help identify real corrective and preventive actions that drive improvements across the entire organization and have true impact to the business.