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Corrective and preventive actions (CAPA) is a cornerstone to ensuring the quality of medical device manufacturing. Perhaps that’s the reason why improper CAPA procedures are consistently ranked as one of the top reasons for both of the FDA’s dreaded 483 Observation and Warning Letters.
In our recent 2022 State of Medical Device Report, approximately half of participants rated their company’s CAPA competency as being average or below.
But what’s causing these CAPA management shortcomings? Why do systemic issues persist, even for those who have a compliant complaint-handling procedure on file? To find the answer, we suggest looking within, specifically with a comprehensive breakdown of using root cause analysis.
Root cause analysis (RCA) is a method of identifying the factors, conditions, and precise cause of a particular problem. Rather than settling for reactive, quick fixes, root cause analysis investigations dig deep into the systematic issues below the surface to find permanent solutions.
Root cause investigations are typically triggered by an issue with the manufacturing, function, or safety of a medical device — typically in the form of nonconformance, such as:
Issue from the supplier
Internal manufacturing defect
Defect with a part of your QMS
Root cause analysis is an umbrella term, and can be executed in a variety of ways depending on team and industry needs. In general, though, the practice of root cause analysis requires its own dedicated team made up of those directly involved in the design and manufacturing process and any other stakeholders or subject matter experts whose input can help find solutions faster.
Root cause analysis can also be carried out with the use of different methodologies, such as:
Ishikawa Diagram (also known as Fishbone Diagram, or Cause And Effect Analysis)
Fault Tree Analysis
Scatter Plot (also known as Scatter Diagram, or Correlation Chart)
We explore these root cause analysis methodologies in greater detail in another blog, but from an overhead view all successful RCA investigations will generally follow these 6 steps:
Create a problem statement for the non-conformance based on data and relevant evidence.
Determine the causal factors that caused the problem.
Identify what led to those causal factors (the root cause).
Decide the corrective actions you need to take to eliminate the problem and prevent it from recurring.
Evaluate the RCA process and monitor the ongoing impact of the corrective actions through VOE (Verification of Effectiveness) checks.
Make improvements as necessary.
CAPA stands for Corrective and Preventive Action, a systematic approach to risk management in manufacturing in which incidents like nonconformities or other quality events are investigated to not only address what happened, but why it happened and how it can be prevented from happening again.
As the name suggests, CAPA is made up of two separate, yet equally important elements:
“Corrective action” to eliminate the cause of a detected nonconformity or other undesirable situation
“Preventive action” to eliminate the cause of a potential non-conformity or other undesirable situation
Regulatory bodies around the globe mandate that medical device companies have a CAPA system in place to immediately address nonconformances and other incidents. The CAPA process is one of the core processes that exist within the quality system of a medical device company.
A well-defined CAPA process begins by identifying a potential CAPA event, collecting the essential information as to what, where, and when it occurred, as well as determining whether the event should trigger a CAPA investigation. From there, the next steps involve assembling a cross-functional investigation team, as well as implementing any containment actions that may be needed.
Once these issues are addressed in the immediate sense, the CAPA investigation begins, as companies analyze quality audit reports, work operations, returned products, service records, concessions, processes, and other sources of quality data, and work to discover the root cause(s).
Upon identifying the root cause, companies will determine how to address the problem, verify or validate the solution, implement the necessary changes, and report changes along with other relevant changes for management review.
Root cause analysis empowers medical device teams to think proactively about a high risk quality event, why it occurred, and what can be done to prevent it from happening again. These objectives closely mirror those of corrective and preventive actions, so much so that they’re named as the fourth step of the RCA process.
But the similarities between root cause analysis and CAPA go even deeper, as they both:
Are triggered by a nonconformance
Encourage continuous improvement of quality processes
Maintain, collect, and analyze information
Identify and investigate product and quality problems
Document and communicate corrective and preventive actions to appropriate stakeholders
In a regulated industry like medical devices, CAPA is explicitly required as part of a quality management system (QMS) by standards like ISO 13485, as well as 21 CFR Part 820 and the EU Medical Device Regulation (EU MDR).
Technically, root cause analysis and CAPA practices are independent of one another — that is to say that organizations should be performing RCA whenever issues arise, and not only when a CAPA has been raised. However, every CAPA that is raised necessitates the use of RCA. And within the CAPA requirements, there are many similarities to the more generic RCA process.
If we look at the CAPA requirements in 21 CFR Part 820.100, we see seven needs for CAPA in a QMS:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
As we can see, root cause analysis functions best as a way to fulfill the corrective action portion, and to inform the preventive action portion of a CAPA system.
Root cause analysis is a fantastic tool for understanding and ultimately preventing the systemic issues which plague medical device manufacturers. However, there are some major potholes to avoid when integrating root cause analysis into your CAPA game plan.
In our 15 Steps to Creating a Risk-based CAPA Process infographic, you’ll see that the root cause analysis step is all the way down at number nine. But why? Wouldn’t it make more sense to start with the RCA process from the very beginning?
It’s understandable that you’ll want to get to the bottom of a systemic issue quickly. But by immediately jumping into a root cause determination, many medical device companies simply restate the problem in different languages, rather than finding the actual root cause of the issue.
All too often, medical device companies will skip straight to this step, ignoring the earlier process and documentation-oriented steps.
Without a well-documented and thorough investigation, you risk never finding and fixing the root cause of the problem that triggered your CAPA. And that means you’ll probably be opening another CAPA for the same issue in the near future.
When it comes to solving and communicating corrective and preventive actions, documentation is essential. When companies depend solely on emails, in-person meetings, or a paper-based system, it becomes too easy for messages or changes to the design or manufacturing procedures to get lost in the mix.
The best place to store all your root cause analysis and CAPA related documentation is in the risk management file which should have been created during the design validation phase of development.
The reason being, that if a complaint comes in, the investigation team will have something to refer back to. They can identify which, if any, issues came up during user testing or even the initial design and development process. This also reveals whether the complaint qualifies as new information or if this issue came up before the device was brought to market.
Tracking your root cause analysis as part of your CAPA system requires an eQMS solution that works the way you need it to.
That’s why we built a dedicated CAPA management software workflow into the Greenlight Guru QMS solution.
Our end-to-end QMS platform makes it as easy as possible for medical device companies to effectively manage their risk-based CAPA process in a connected ecosystem, where inputs and outputs tell the true story. We make it simple to define and follow your CAPA process to ensure it remains both effective and compliant.
So if you’re ready for unparalleled visibility into your CAPA process, then get your free demo of Greenlight Guru today!
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...