Success or Death by CAPA

Success or Death by CAPA

A CAPA system is the main mechanism and data source that an efficient quality system uses to survey the quality of people, processes, products and problems. It is important for organizations to utilize CAPAs to its full potential without overwhelming the system. Especially in the pharmaceutical industry, there seems to be a misconception that having too many CAPAs is a sign of poor control over systems. There is a fine line between having too many vs. too few CAPAs and organizations should strive for the ideal number, aka. the Goldilocks model.

An organization must have clear processes to evaluate when a situation requires a CAPA investigation and understand that not every investigation will result in a CAPA. For example, for an investigation where the root cause is not yet determined, initiating a CAPA would only result in misallocation of resources and would not decrease failure rate. 

Timing is a crucial component of the CAPA process, but how long is too long? While each CAPA is expected to have varying processing times depending on the identified root cause, a CAPA should not remain open for a long period of time without any indication of activity. In the event of approaching a CAPA deadline with not enough progress, there should be extension protocols in place (with escalating level of approvals for extensions) and the system should reflect the status information and milestones as well as rationale for the extension and the risk of not closing as per the original date.


Do you have a robust CAPA system?

According to an article published by the National Science Foundation (NSF), unless organizations can answer ‘YES’ to the following questions, they might want to reevaluate their CAPA systems.

1. Do you use a scored risk assessment process to determine the need for an investigation and CAPA?

2. Do fewer than 10 percent of your investigations conclude human error as the root cause?

3. Do you maintain and use metrics on how your CAPA system is performing?

4. Do you perform effectiveness checks that include objective and measurable criteria?

5. Do fewer than 25 percent of your CAPAs need extensions?

6 Signs of An Ineffective CAPA System

1. Instead of focusing on applying a systemic process to resolve a problem to prevent a repeat, employees are more focused on closing the CAPA to continue production 

2. CAPA process identifies issues but does not find the root cause

3. The organization lacks expertise in developing a CAPA system that integrates compliance into business practices and quality systems

4. The employees lack the training to use CAPA systems to improve profitability by decreasing the cost of quality or choose not to use them

5. The CAPA system does not use effective checks, which result in ineffective consequences

6. The CAPA process adds unnecessary steps and complexity to production which ultimately results in failure to comply with local procedures

6 Ways Organizations Can Improve CAPA processes

1. Update CAPA systems to be simple, easy to follow and easily integrable across the entire organization 

2. Implement root cause analysis tools

3. Use additional data analysis tools within the CAPA process

4. Configure data so similar problems can be categorized to facilitate trending and further data analysis

5. Determine the frequency of data analysis and metric review

6. Recognise adverse trends in real time and step in before they are left to become non-conformances

Death by CAPA: What happens when organizations overwhelm the process

In an attempt to improve their CAPA systems, some organizations overdo things by adding unnecessary steps and elements to their CAPA systems. Over time, having too many CAPAs or over-complicating the system overwhelms and ultimately results in the death of their CAPA systems. Organizations can avoid this overkill, death by CAPA, cycle by taking the following precautions:

1. Use a risk-based filter to identify size, scope and severity of events and use this data to prioritize them

2. Develop a scoring system to measure CAPAs

3. Train and encourage employees to use CAPAs effectively

4. Stay current with industry and seek advice from experts

An organization’s CAPA system can be one of its most valuable assets or biggest challenges. It is crucial for organizations to systematically evaluate and update CAPAs to avoid underuse or overkill and maximize its efficient use for organization’s success.