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The Corrective Actions and Preventive Actions (CAPA) process plays a significant role in achieving operational excellence. It increases customer satisfaction, improves product quality, and decreases risk, such as product recalls. Using the right CAPA program, you can improve quality and business processes. In addition, you can uncover and resolve process and quality issues and develop new preventative measures to avoid future problems.
In this blog, we will understand the need for an effective CAPA process, its components, and the resolution workflow you must design to handle quality problems effectively.
The highly regulated industries are prone to serious quality issues. When an investigation team has completed a thorough root cause analysis (RCA), it turns its attention to resolving the issue. The most common way to resolve quality issues – and prevent them from reoccurring – is through corrective and preventative action programs (CAPA). The plans outline specific steps to be taken to address each root cause that was identified.
Related Article: Explain the Five-Why Analysis to Determine Root Cause(s)
CAPAs must be verified as adequate and complete, following international standards and regulations, before you can consider the issue resolved. In addition, it is stated in ICH Q10 step 3.2.2: “CAPA should be utilized, and the effectiveness of the actions evaluated.” As a result, quality units need to measure and determine whether the corrective action has eliminated the problem.
You must evaluate CAPA plans for effectiveness due to the following three reasons:
It would be best to evaluate CAPAs for their effectiveness in closing the loop between the identification of a problem and resolution.
An effective CAPA system must:
However, you cannot get all these requirements as software features directly. Therefore, it is still essential to understand the significance of the CAPA process in quality management.
Qualityze CAPA Management covers it all for you, enabling your QA teams to handle quality issues proactively.
Related Topic - Is your Quality Management Team trained to Review CAPAs
Making your effectiveness checks successful requires using many highly effective tools and principles. Some common approaches include:
An analysis of trend data can help identify whether the corrective action has resolved reported issues. Check for recurrences of the problem or variation over a predetermined time after the corrective action has been taken. Data usually tells you whether a fix worked or a second corrective action is necessary.
A quality unit will review the remediated process at a scheduled time. When you continuously review your processes and data, you can quickly identify the gaps and inconsistencies before they result in expensive product recalls.
Conduct CAPA audits to verify that operators, processes, or equipment follow the corrective action described in the CAPA. Additionally, internal audits allow reviewers to observe the daily occurrences and how the solution works in the affected areas.
In monitoring and laboratory testing, sampling can prove helpful in verifying corrective actions.
Designing an effective CAPA resolution workflow is a rigorous process. Since the resolution is not just about implementing an action plan to resolve quality issues; it is about evaluating the solution’s effectiveness – so that similar problems do not recur. For this to happen, you must take a comprehensive approach, from understanding the CAPA to assessing the solutions implemented to make things right.
A CAPA Resolution Workflow typically includes;
Primarily, it is crucial to understand the CAPA. It requires you to record all the necessary details, including the issue, sites impacted, people impacted, reporters, and much more. So, CAPA initiation is about documenting the information you may need to develop the most appropriate and effective action plan.
Once the CAPA is initiated, the next step calls for investigating the root cause of the CAPA reported. One CAPA may have multiple root causes. You must identify all of them before proceeding further. Missing any root cause can lead to repetitive issues, which will only lead to product recalls. This is just a waste of time and efforts your teams put in to manage a CAPA.
Now you have a list of root causes with you. Next, it would be best to analyze the risk associated with each root cause so you can mitigate them without affecting the ongoing operations. Finally, you can also perform an impact assessment for the risks and root causes identified.
The impact assessment will help you plan the right action plan to manage CAPAs with minimum disturbance to other operations.
Notify the other team members of the successful action plan implementation within the specified timeframe.
Well, the process does not end with implementation alone. But, first, you must understand the aftereffects of whether the action plan you have implemented is effective. Are there any improvements?
The effectiveness review is one of the most critical steps that mark the success of the action plans implemented. Make sure you deploy the right people in charge of review activities.
Lastly, you can close the CAPA record with a justified statement of action plans implemented and their effectiveness review results. Again, it is important to document everything chronologically to trace the details as required in the future (maybe during audits or regulatory inspections).
The steps of an effective CAPA resolution workflow may make the task look really simple to you. But it is pretty challenging because of the details and documentation involved. Using outdated systems or paper-based mechanisms to manage CAPA will only complicate things.
So, it would be best to use next-generation CAPA Management Software, i.e., Qualityze. The software will make your CAPA process friction and error-free while reducing the overall cycle time.
With Qualityze, organizations can develop risk-based, compliance-driven processes to address systemic issues and prevent a recurrence. The software provides a comprehensive approach to mitigating quality issues while meeting compliance requirements and fostering continuous improvement.
Most importantly, you can design the CAPA resolution workflow in the desired manner using this cloud-based, configurable solution. It will take the CAPA process management to the next level without hassles.
Managing CAPAs is critical to quality management. However, using manual systems is an outdated approach. Instead, use the next-generation CAPA management software to maintain quality, safety, and reliability.
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.
