Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs.
In fact, one expert suggested the CAPA process is designed as an opportunity to respond to critical and systemic issues, investigate them, and resolve them to mitigate the risk of recurrence.
However, many companies are doing the process incorrectly, said Alexandre Alain, a lifescience product manager at VERSE Solutions during an FDAnews webinar.
Alain identified some of the reasons for repeat CAPAs, including poor investigations and root cause analysis. If a devicemaker can’t identify the correct cause of an issue, it will fix the wrong problem. Along those lines, companies don’t do the legwork to develop the right solution to correct a problem.
Don’t Forget Effectiveness Check
Not having an effectiveness check is another leading cause of a repeat CAPA, Alain said, adding that inadequate training of personnel, poor use of data, lack of a risk assessment also lands companies in hot water.
One way to help prevent these recurrences is the creation of a risk table that documents complaints, reports of nonconformance or other events. These tables can include information on severity, frequency or any preassigned risk elements.
Based on that risk table, “the event can either be immediately corrected within the process or put into a critical event and investigated more thoroughly to see, moving forward, if the CAPA is needed,” he added.
Training and qualification are also key factors to consider. “Do not think anyone can do a CAPA,” he said, adding that it is essential to have the correct personnel in place who understand what is going on. Don’t rely on one person doing everything — rather, ensure that there are people with the knowledge and skills to tackle the various steps of the CAPA process.
Deciding When a CAPA Is Needed
The next step is defining whether a CAPA and investigation are warranted. It is crucial at this stage to fully understand and define the problem so others may avoid it in the future. To that end, company personnel should write out the problem description thoroughly.
However, the people documenting the problem are not always the ones who will establish an action plan and conduct the investigation, “so a good problem description is crucial,” Alain said.
With that said, a problem description should not contain too much extraneous information — having a clear summary should be the goal.
Alain also urged that the description of the problem be truthful, as hiding issues from the management or auditors will prevent companies from effectively tackling the problem.
The next step is the investigation and root cause analysis. The investigation should involve team members from multiple departments to help document information and question personnel to demonstrate the company did its due diligence.
Companies also should become proficient at using root cause analysis techniques to address specific problems. Alain noted there are many techniques, such as the cause-and-effect diagram and Pareto charting, and it’s imperative to build internal expertise so personnel can identify root causes easily.
In addition, companies should be aware that there could be multiple root causes that go beyond “operator error” and “lack of training.”
Finally, create CAPAs that are deliverable, resisting the urge to rush just to finish them. “Do not focus on due date, but more on correcting the issue,” he advised.