Effective CAPA: Focusing on Systemic Issues

CAPA stands for Corrective Action Preventive Action and is the heart of a strong quality system. It usually is the starting point for most FDA inspections and other quality system audits. There are numerous feeder systems into the CAPA system. A few examples include:

 ·      Complaint management system
 ·      Adverse Event reporting 
 ·      Acceptance test failures 
 ·      Raw material supply failures/issues
 ·      Nonconforming product
 ·      Field service reports 
 ·      Equipment calibration failures 
 ·      Manufacturing deviations
 ·      Preventive maintenance records
 ·      Environmental monitoring reports 
 ·      Validation or revalidation failures 
 ·      Process monitoring 
 ·      Internal audit programs
 ·      Supplier quality issues
 ·      Lean six sigma projects

This is not meant to be an all-inclusive list, but as you can see, almost every process can feed into the CAPA system. Therefore, it is critical to ensure all employees throughout the organization have a clear understanding of what the CAPA system is and how it works. 

The most effective CAPA system is one that focuses on systemic issues rather than every possible failure that occurs. Remember, the basic quality principle of significant few versus trivial many. CAPA systems that handle each quality system failure as unique can become overwhelming and cumbersome. In these cases, the volume of work is often more than an organization can manage. If this situation occurs, the CAPA system becomes a larger compliance risk, because the volume can’t be effectively managed in a timely manner.  

Each of the processes listed above are sub-systems within the quality system that should have defined processes for handling improvement opportunities and/or failures. This is where a strong failure investigation to root cause becomes critical and adds great value. Once root cause is identified, you can apply the basic principles of CAPA much more effectively.
 
There are three main decision points to be considered once root cause has
been determined:
 ·      Correction – what must be done (if anything) immediately to address the issue, satisfy the customer and keep
product moving.  This may be an interim fix or a final solution. It is possible that a failure does not require deeper corrective and/or preventive action.
 ·      Corrective action – action taken to prevent recurrence. Every corrective action does not necessarily need a
preventive action.
 ·      Preventive action – action taken to prevent occurrence. How can I prevent this from happening in similar situations or elsewhere in the quality system?

 It is possible to have an issue that only requires one of the actionsabove, or it could require all three levels of CAPA. This is best demonstrated through an example:

 EXAMPLE

Problem statement: Final QC test for release fails. Repeat OOS also fails. Potential scrap of $150K

 Investigation: Equipment used to perform test was out-of-calibration

 Correction: Equipment calibrated. Release test repeated. Results in specification

 Root Cause: Equipment for performing test was not on the equipment maintenance program

 Corrective Action: Equipment added to the maintenance and calibration program

 Preventive Action: All equipment used for Critical To Quality (CTQ) testing and/or release testing evaluated to assure they are part of calibration and maintenance program. Additionally, the process for procuring and installing
equipment was modified to require all new equipment is added to calibration maintenance program at time of installation. 

It is also helpful to implement a CAPA oversight and/or review board. The members of this board are usually senior management or leaders with authority to assign resources and prioritize CAPAs as appropriate. The CAPA review board assures progress is being made on the high priority open CAPAs and that the system is working effectively.

 Key lessons for CAPA:

 ·      Define the appropriate feeder systems to support CAPA processes
 ·      Use the formal CAPA system for systemic issues 
 ·      Subject matter experts should be assigned to lead CAPA investigations
 ·      Resource and prioritize properly to support CAPA processes

About the Author

B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large
corporations, as well as small startup companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com

Additional complimentary CAPA Content

http://www.enkap.com/page/capa-content-power-package-1