5 Critical Factors in the CAPA Process


2020-bl-quality-excellence-02_715x320Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.

Ken Peterson is a widely recognized expert in CAPA, risk assessment, and quality management systems. Over the course of more than 30 years, Peterson has provided his expertise to numerous multi-national corporations including Abbott Laboratories, Kodak, and Pfizer. For a three-part webinar series, he brought his insights to MasterControl.

During the second installment, Peterson explains how to effectively respond to quality events to arrive at the best possible solution. A key to accomplishing this is understanding the four actions described below.

1. No Action

No action refers to monitoring low-impact quality events by doing the following:

  • Watching
  • Observing
  • Tracking

Based on what you and your team learn from these monitoring activities, you can take action if the impact of the situation calls for it.

2. Containment Action

Some issues call for immediate action. The aim of containment is to address the symptoms and bring them to a manageable level. In other words, the goal is to ensure the issue won’t disrupt day-to-day operations, cause safety or health problems, etc.

3. Corrective Action

When a quality event has a significant impact, you need a more permanent solution. It’s important you investigate the root cause and determine the appropriate corrective response, and your goal is to eliminate the root cause.

4. Preventative Action

In this case, you need to address quality issues that might occur and determine their likely cause. “Bear in mind that a corrective action is, oftentimes, a change and you’re going to need to consider how this change is going to affect other elements downstream in the process,” Peterson said. “If there’s a potential problem, it’s good to address it as a preventative action before the problem occurs and creates a new CAPA.”

Use a SMART Approach

When deciding on the most effective action, Peterson identified five factors based on the SMART method established by Peter Drucker. SMART is an acronym as well as an approach to setting goals that helps people or businesses home in on what needs to be accomplished, and how to do it efficiently. In Peterson’s example, SMART action is specific, measurable, aligned, realistic, and time bound.

Specific: Is the corrective action articulate? Will affected stakeholders and departments understand it?

Measurable: Can the corrective action be verified and validated? Can you easily confirm that the action is indeed solving the problem?

Alighted: The corrective action must have a one-to-one relationship with the cause of the problem. It must relate specifically to the cause and not something else.

Realistic: To be realistic with your corrective response, you have to ask certain things: Do we have the necessary resources? Will it involve other departments? Is the timeframe realistic?

Time Bound: You need to consider the speed and efficiency factor. When does the action need to be completed? You also have to consider the consequences of leaving CAPAs open too long, especially the possibility that it might bring about negative audit results.

For additional insights on the closed-loop CAPA process, watch the webinar series here.


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