Quality Events (QEs) are a fact of life in clinical research. Documents go missing arbitrarily. Temperature excursions for investigational products happen more often than we’d like. People do, well, people-y things. However, what separates a mature, well-appointed quality organization from the perpetually frustrated quality organization is not that one organization has more or fewer events than the other; it’s how well the Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPAs) are executed.
Before we dive into the meat and potatoes of RCA and CAPA, let’s review the process for how QEs are reported because this sets the stage for how the RCA is performed (and who is included), what CAPAs are (and aren’t) needed, and whether or not and Effectiveness Check (EC) is required.
Below is the typical progression of activities when a QE occurs.
We are going to focus on the three activities in the dashed box: Root Cause Analysis, Corrective Action and Preventive Action, and the Effectiveness Check. When done well, the RCA, CAPA, and EC are powerful tools that strengthen your quality management system, protect patients, and prevent repeat issues which can lead to audit or inspection findings.
Clinical Quality Assurance exists to protect patient safety, preserve clinical data integrity, ensure compliance with regulatory requirements, and enable reliable decision-making. The first thing an auditor or inspector will ask for will be a list of your quality events, and they first thing they’re going to want to know will not be “who messed up?” but “how did this happen and how will you keep this from happening again?” A well-defined RCA and CAPA process demonstrates that you and your team truly understand why the issue happened, and that you have the correct tools to prevent the issue from happening again.
A RCA exercise is a structured process for understanding why a quality event occurred. Not just the very obvious failure of a process or system, but the true underlying cause of that failure. However, it should be noted that RCA activities are not: a blame game, a formality just to “get this whole thing over with faster,” or something that QA has devised to test just how strong your mental fortitude really is.
Some common pitfalls that exist in the RCA space.
A solid RCA should:
Taking your RCA game from “site staff failed to follow the SOP” to “the SOP lacked clear decision guidance, training did not include practical scenarios, and monitoring oversight did not detect early indicators of process drift”
This is what happens when your quality organization can effectively use the last bullet point.
Depending on the complexity of the issue, a variety of tools are available when conducting a RCA. This is not an exhaustive list, of course, but instead a compilation of the most used tools within the clinical research realm.
Once you have completed your root cause analysis using one of the nifty tools discussed in the last section, it’s time to develop how the root cause is going to be addressed. If not formulated thoughtfully, every good intention the team has can go straight down the drain if what is broken or ineffective isn’t fixed to prevent recurrence. As you work through your CAPA process, take care not to make these common mistakes.
Implementing ‘retraining only’ CAPAs
Not only is retraining not an effective CAPA and is like nails on a chalkboard to any quality assurance professional, but if every CAPA suggests that retraining is needed, it calls into question the robustness and effectiveness of your organization’s training program. Yes, it is an appealing CAPA: it’s fast, it’s familiar, and it feels safe. However, it screams “Here we don’t fix our systems, we just tell our folks to be careful.” Quality by design is no longer a buzz word in the ‘biz, it’s now an expectation.
Including vague action items
These include wish list items like “increase oversight” and “improve communication.” These are not measurable, lack accountability, and rarely address the root cause of the issue.
CAPAs that do not link directly back to the root cause
If the CAPA that you and the team developed doesn’t link directly and meaningfully back to the root cause, it cannot be effectively corrected and you will inevitably be stuck in the dreaded QE à CAPA à QE cycle.
Failing to utilize the Effectiveness Check (EC)
Implementing a CAPA without going back to verify that it actually worked and addressed the root cause is like making an empty promise to your significant other. A well-formulated EC is defined up front, uses objective, measurable evaluation criteria, and occurs after enough time has passed to be meaningfully assessed.
When CAPAs are strong, well-formulated, and effective, something magical happens. Well, maybe not truly “magical” in the “unicorn prancing over a rainbow” sort of way, but more in a “wow! That’s how this is supposed to work!” kind of way.
Things that strong, effective CAPAs do:
Strong and effective CAPAs also demonstrate to auditors and inspectors your organization understands your processes, the risks, and the impacts on quality when one or more factors in your process break. They also show that you were able to step seamlessly into “Sleuth Mode” and work thoughtfully to fix the system and not just the symptom. Finally, it makes evident that your organization is able to learn from your mistakes, work to prevent recurrence in a meaningful way, and that your quality culture is mature and robust.
Quality events are inevitable but repeating them doesn’t have to be. When root cause analysis is treated like an investigation instead of just a check box on a form, CAPA are designed to strengthen your organization’s systems rather than scold your personnel, and quality stops being reactive and starts being strategic. And that is a pretty “magical” place to be.
Author:
Emily Dickinson
Director Quality Assurance
Linical