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CAPA is often the most discussed topic among all the aspects of the closed-loop quality management system due to the critical role it plays. Still, companies face difficulty in implementing it right and feel frightened by the thoughts of regulatory audits. Such difficulties often come as a surprise in the highly advanced technological era when companies have access to cutting-edge CAPA management software.
In fact, the CAPA process is becoming one of the challenging aspects for the organizations as the time passes by and the regulatory standards getting stringent. This results in immense pressure on the companies to follow best practices, which further leads to certain mistakes that they don’t even realize.
Organizations tend to forget that “Quality is Everyone’s Responsibility” and designate quality teams to make decisions about CAPA – whether it should be issued or not – without the involvement of other teams and departments from where they can get better insights for decision-making. Will you call it informed decision-making? Absolutely not, right!
In previous years, CAPA is just considered as a regular job function. It should rather be treated like any other core business activity – all the functions involved in a particular issue should be considered with its CAPA as well. It is the only way to determine the actual cause of the problem, which many companies don’t do, leaving CAPA potential unleveraged.
Having cross-functional teams becomes important here so to have a comprehensive overview of all the on-going processes in the organization. If you will give the responsibility of handling a complex process like CAPA to just one department, they will work with their own speculations while missing on the critical information.
One of the best steps a company can take in such a scenario is to balance the knowledge across the organization. Additionally, there should be regular cross-functional meetings for management review. Such meetings give you better chances of flagging issues quickly that may lead to CAPA upon review.
The main objective of having an MRB is to review, evaluate, assess, correct, prevent, and control quality issues, which is definitely unattainable without the insights from the cross-functional team.
In every industry, corrective actions are more regularly practiced than that of preventive actions. But there is aggressive need of raising the bar little higher. At times, you might receive no complaints or identify any nonconformances. This doesn’t imply that there is no room of improvement. Being proactive requires you to be in action in the early stage of a project – this the point of time where you realize you can reduce a few more risks.
This can be a little challenging for the medical device industry due to dependency on insightful data for decision-making. A compliant or nonconformance is merely a sign that a problem has already occurred. The best step here is to take data through some customer feedback or survey data. It’s more like a proactive approach to work on the things before any issue pops up.
However, there are some companies that simply add disclaimers along with the label as an easy option for reducing risks. It is a very systematic and proactive approach that needs to be implemented for the CAPAs as well.
Every company is different, so is their product. And, it becomes difficult to expect that a recently published regulatory criterion are applicable to every device. Companies should make a proactive approach, considering the regulatory requirements, to create a criterion based on their understanding of the product. We can’t diagnose all the symptoms every time. So, we should take the necessary steps to prevent symptoms from occurring in the first place.
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Appropriate usage of CAPA matters for issue addressed on time and for avoiding delays in quality management processes. So, you must ask yourself a question before proceeding further.
The question is – Are you using CAPA too frequently or not regularly enough to meet your quality goals.
The most important thing to remember about CAPA is that it involves too many processes. You need to be careful, but also be considerate about what issue does or doesn’t require CAPA. Make this a note – every quality issue doesn’t qualify for CAPA.
When you should or shouldn’t mark an issue for CAPA? The simple solution is – you should use CAPA for the resolution of a systemic issue. If every single complaint will be categorized as CAPA – you will just feel overburdened and will likely to make costly mistakes as a result.
But that doesn’t mean you should wait for something bad to happen before warranting an issue as CAPA. Establish a criterion to classify issues as CAPA and non-CAPA to address the real issues before they become complex to manage. Also, the FDA wants you to act and follow on the real CAPA issues.
This is often one of the most significant steps to discuss as companies are spending very little time on identifying the root cause of a quality issue. The commonly observed mistake here is that people simply restate the problem, probably with different words and pass that as its root cause. Obviously, it isn’t the real issue; it’s merely a symptom reflected from the root cause.
As a result, you will continue to experience the same issue over time. You will have to face this as a recurring event since the actual root cause was never identified and resolved.
For determining the root cause of quality issues, you can use several methods like 5 Whys, Fishbone (Ishikawa) diagram, Scatter Diagram, Failure Mode and Effects Analysis (FMEA), Pareto Chart, etc.
As already discussed earlier every organization and their products are different, they may choose different methodologies for root cause analysis as per the processes and workflows they have. The main objective is to identify the root cause of the issue for appropriately resolving it and limiting its recurrence.
Managing CAPA comes later in the scenario. The first thing is defining it right. If your CAPA process is not defined appropriately, you might miss on tweaking real issue or resolving the problem completely. However, you have advanced CAPA management software to mitigate quality issues while meeting compliance requirements.
For those who are still managing CAPA process manually, it is quite significant to align the process with the organizational objectives such that no aspect is missed. Missing out even a single issue can call for an expensive recall.
Once you will have a comprehensive approach to manage CAPAs, you will tend to become more precise towards the patterns of occurrences and will start making a proactive approach to limit the issues way before they occur.
If you will start being proactive first, the need for corrective actions will be minimal.
Having discussed all the common mistakes that companies make in the CAPA processes, you can make a proactive approach towards these mistakes with a robust CAPA management solution like Qualityze.
Because manually management is not going to work in the long term since organizations have already started migrating towards advanced solutions and cloud for maintaining and managing their business-critical data in a safe and secure environment.
To know how Qualityze can help you improve CAPA processes, get in touch with our customer success team today!
Author
Qualityze Editorial is the unified voice of Qualityze, sharing expert insights on quality excellence, regulatory compliance, and enterprise digitalization. Backed by deep industry expertise, our content empowers life sciences and regulated organizations to navigate complex regulations, optimize quality systems, and achieve operational excellence.
