CAPA Case Study

This blog presents a CAPA training case study related to hundreds of open CAPAs, and how to effectively remediate this issue using a CAPA filter to avoid “death by CAPA.”

Years ago, when I took my first CAPA course, the student sitting next to me explained that he was taking the course as part of a consent decree with the US FDA. Evidently. his company had hundreds of open CAPAs that were not being closed promptly, and the CAPAs were ineffective when the records were finally closed.

Hundreds of open CAPAs?!

I was in total shock. You probably only have five to ten open CAPAs at your company. How could anyone have hundreds open?

He told me that every time a customer asked for technical support, a person was paged. If the page was not answered within three minutes, this was considered a customer complaint, and a new CAPA was opened automatically. The course instructor described the situation as “Death by CAPA.” His company did three things wrong    

1. Overreaction with Microscopic Focus

The company incorrectly identified failure to meet the three-minute target response time as a customer complaint. Also, several complaints related to the same issue should not result in a CAPA specific to each complaint.

2. Lack of Management Oversight

Nobody was tracking how long CAPAs remained open. There were no actions taken when target completion dates were missed. There were no reports to management on the status of CAPAs, and the only time CAPAs were discussed in a meeting was at the annual Management Review meeting.    

3. Failure to Check Effectiveness

Instead of verifying that corrective actions were effective, the company confirmed that corrective actions were implemented. Most of the corrective actions involved “retraining” or “revising the procedure.”

For any process to work correctly, you need to ensure that the process can handle the volume. If one person is responsible for managing hundreds of CAPAs each year, the CAPA process will be ineffective. You need more resources or fewer CAPAs. My recommendation is to use a CAPA filter.

 

A CAPA filter does two things. First, it sorts CAPAs into problem categories. For example, all the poor response times to pages should be one problem with one CAPA. Second, a CAPA filter sorts CAPAs according to risk. A response to a page within five minutes instead of three minutes results in a customer waiting longer. A customer receiving no response could have a more severe impact, especially if the customer has diabetes that cannot seem to get their glucose monitoring device to work correctly.

Trend Analysis

Therefore, response rates to pages should be a metric subject to monitoring and measuring—not necessarily a CAPA. You have a positive trend if the number of late responses is declining, and the average delay is steadily shrinking. In this case, there may be no need for a CAPA. You have a negative trend if the number of late responses is increasing, or the average delay is getting longer. In this case, one or two CAPAs may be needed—not one CAPA for each occurrence.

Depending upon the issue, there may be a safety issue associated with extreme limits. In this case, it is recommended to establish alert limits and action limits. Alert limits may increase the frequency of monitoring and measuring, and corrections may also be implemented. However, if the action limit is reached, then a CAPA may be required.

Quality Plan

When I audit a company, it is not uncommon to observe a problem and to quickly identify a root cause. This frequently happens when the issue is familiar to many companies, and the root cause is: 1) inadequate procedures, 2) insufficient training, or 3) inadequate management oversight. If the problem is limited to one area, a CAPA may be entirely appropriate. However, if I observe the same type of problems in several areas, then the root cause is systemic. This can happen in a company where the following problems exist at the same time:

1. The training procedure does not require demonstrating training effectiveness
2. Employees are only required to “read and understand” procedures
3. The top management has put a “freeze” on spending related to training

In a small company, this trifecta of doom is not uncommon. Therefore, in these cases, a CAPA does not address the root cause. Many companies will mistakenly identify the root cause as an “inadequate procedure.” The correction will be to fix the problem caused by the inadequate procedure. The corrective action will be to revise the procedure.

This is only a partial solution because it does not address the root cause. A stronger approach is to identify the root cause as an “ineffective training process.” The correction will be the same. The corrective action, however, will be expanded to include the initiation of a Quality Plan for changing the company training process.

The combined approach of a CAPA plan and a Quality Plan is a better solution because the process change will affect the entire Quality Management System and will require many months to implement fully. This is especially true if resources are constrained.

Here are a couple of upcoming webinars I am doing on CAPA and Complaint Handling:

• 5 Ways To Improve Your CAPA Process
• June 6, 2013
• Complaint Handling & FDA Reporting Requirements: Develop, Implement and Maintain Effective Processes
• Thursday, June 20, 2013