Corrective and Preventive Action (CAPA) is a structured approach to improving an organization’s processes to reduce or eliminate non-conformance. Stated simply, CAPA is all about solving and preventing problems. Read on to learn how CAPA can help you solve some of your most pressing problems today…
Elements of a Problem
In order to solve problems effectively, it is first essential to identify the three elements that are common among all problems:
Issue – is the symptom or pain experienced by the customer or the process owner.
Root Cause – is the ultimate cause of the issue. Root Cause is determined using cause and effect analyses and is essential in effective problem solving.
Solution – addresses the Issue and/or the Root Cause. Solutions may eliminate, reduce, or mitigate the occurrence of the problem.
Types of Issues
Before we introduce the CAPA process, being able to identify the type of issue will help in determining the problem-solving strategy. A variety of tools may be used within the CAPA process, and some are more suited to some issue types that others. Consider the three issue types:
Gradual Decline – characterized by a slow steady decrease in performance over time.
Sudden Drop Off – characterized by a sudden adverse change in performance.
Performance Gap – characterized by a pre-existing difference between performance and goal.
Types of Causes
While the root cause is the ultimate cause of the issue, it is not always sufficient or possible to identify the root cause. As such, other causes may be found to help ensure effective problem solving:
Potential Causes – is a listing of all factors that could have led to the issue and must be ruled in/out.
Contributing Causes – are factors that indirectly led to the issue and must be addressed.
Root Causes – are factors that directly led to the issue and must be addressed.
Types of Solutions
Once the issue type and cause(s) have been identified, a solution strategy must be considered. Again, understanding the types of solutions will be essential to effective problem solving:
Correction – is an action taken to reduce or eliminate the effects of the non-conformance.
Corrective Action – is an action taken to reduce or eliminate causes of non-conformances to prevent reoccurrence of an issue.
Preventive Action – is an action taken to reduce or eliminate causes of potential non-conformances to prevent occurrence of an issue.
The CAPA Process
High performance organizations rely on processes to accomplish a variety of activities, and CAPA is no exception. Processes are established to ensure a standard approach to producing predictable results time and time again. Here is an overview of a highly effective CAPA process:
Initiation – is the formal start of the CAPA. It begins with an initial problem statement, proposing the problem as “CAPA worthy”, approval to initiate the CAPA, and assigning a CAPA owner. Once assigned, the problem statement may be refined. It is essential to start off with a good problem statement to ensure that the right problem is being solved and the effectiveness of the solution may ultimately be objectively verified.
Investigation Plan – is the documented strategy of trying to determine the root cause of the issue. As mentioned earlier, there are a variety of tools available to determine root cause, and the issue type will aid in the investigation planning process.
Investigation – is the execution of the plan. Data is collected and root cause analysis tools are used to demonstrate cause and effect relationships. The investigation ends with the statement of causes and an implementation plan documenting the improvement plan.
Implementation – is the execution of the activities defined in the improvement plan. This is the implementation of the solution that seeks to reduce or eliminate the cause to prevent reoccurrence of the issue.
Verification – activities are twofold: verification of completion and verification of effectiveness. Verification of completion is a formal review of the solution to ensure everything was implemented per the plan. Verification of effectiveness (VoE) is a formal review and/or monitoring of outcomes to ensure that the solution has reliably addressed the issue with a high level of confidence. Statistical methods are commonly used, and the VoE will tie back to the problem statement.
Closure – the CAPA is formally closed upon a successful verification phase. Should the CAPA be deemed incomplete or ineffective, a subsequent investigation must be performed to understand why and additional measures must be implemented before the CAPA may be closed.
Implementing Your CAPA Process
Now that you have the basics, you may be asking, “How can I implement an effective CAPA process in my organization?” For any process implementation, a formal documentation of the process must be established. Standard Operating Procedures (SOPs) and Work Instructions (WIs) are common formats. In addition to the CAPA process itself, Work Instructions on root cause analysis tools are commonly established to provide how-to guidance on using the tools and methods deemed acceptable within the organization. Training, coaching, and standard operating mechanisms such as a CAPA Review Board meeting will help ensure full deployment and sustaining of the CAPA process for long-term effective problem solving and continuous improvement.