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A well-defined corrective and preventive action (CAPA) process is intended to identify problems, understand root causes, resolve issues, and take corrective action to prevent the recurrence of those problems. While the results are well worth the effort, designing and implementing a good CAPA process comes with some challenges. Here are some of the most common problems we see when companies are struggling with their CAPA processes. 

1. A Complex or Poorly Defined CAPA Process 

This first problem arises when a CAPA process becomes too much or too little of a good thing. Very often, organizations set out to account for every possible exception or incident, and to make every one of those factors part of a comprehensive CAPA process. Unfortunately, that kind of complexity can be counterproductive because it makes it difficult for stakeholders within the organization to understand and follow the process.  

Systems and processes need to be designed in such a way that they support the people responsible for fulfilling the mission of the organization. If they are too burdensome, stakeholders will fail to buy into the process and the process cannot ultimately serve its intended purpose.  

On the other end of the spectrum, CAPA processes are sometimes too lightweight, leading to uncertainty about which specific steps should be taken, and/or inconsistency in the way they are followed. A good CAPA process will incorporate an escalation process that can handle low-frequency incidents or unexpected conditions. 

2. Lack of Sufficient Documentation 

A good CAPA process promotes thorough documentation at every stage of the process. Ideally, employees should have access to technology tools that simplify documentation by streamlining the collection of information in a structured way. Mobile apps that support rapid input, with simple user interface design and minimal unnecessary fields, facilitate this process. The ability to add photos or other attachments to documentation is a strong plus. 

Again, simplicity is key. When the CAPA process is easy to follow, the likelihood of collecting clear and complete documentation increases dramatically. If it is hard to do, then it simply won’t get done.  

3. A Reactive CAPA Process, Instead of Proactive 

Many organizations focus too much on the “corrective action” part of CAPA. That’s understandable; after all, corrective action lends itself to the application of hard data. In other words, it deals with something that has already happened, as opposed to a speculative scenario about what could happen. 

In heavily regulated companies, so much is driven by hard data. It is easy to justify a “wait and see” approach in which quality issues are addressed after they occur, and when the facts have become clearer. A well-designed CAPA process will apply sufficient emphasis to the “preventative action” part of the equation. 

4. Lack of Cross Functional Buy-In 

Quality is everyone’s job. Unfortunately, in many organizations quality management is not fully understood across departmental boundaries. Internal political squabbles, conflicting priorities, and a lack of understanding drives many of the conflicts that stand in the way of CAPA processes being as effective as they should be. 

The solution is to assemble a team of stakeholder representatives to help design the CAPA process. The team should be large enough to adequately represent perspectives from the various departments that have a stake in the outcome, but not so large that consensus becomes difficult or impossible to achieve. 

5. Insufficient Process Training 

Stakeholder buy-in naturally leads us to the next issue; insufficient training in the CAPA process. Employees must not merely understand the process to be followed, – they must also understand why they are following it. When team members are expected to follow rote procedures, it creates uncertainty as to what is important and what is not.   

For many people, the training needs to include how to write a clear problem statement. As human beings, many of us are wired to jump directly to proposed solutions, without clearly stating the actual problem. Team members should also be well-versed in the language of the product and process in question. Clarity of communication is essential. 

Ultimately, quality management should be subject to the same kind of scrutiny that applies to other processes throughout the organization. In other words, it makes sense to periodically review quality management processes, including CAPA, to identify existing or potential problems, improve the processes, deploy technology tools, and re-align stakeholders around the commitment to making CAPA an asset for your organization.  

 

Paul Dionne

Written by Paul Dionne