CAPA Problems Aren't Just Quality Problems - Did You Know?

Did You Know?

Does your company have a CAPA problem? CAPA problems aren't just a quality problem but a business problem that can reduce your ability to compete and innovate. Inside the organization they become everyone's problem and they often result from an "open-looped" CAPA system.

What is an "open-loop" system? An "open-loop" system is one that does not make use of CAPA outputs that occur within the CAPA system. In other words, many CAPA outputs such as a preventive actions, validation studies, etc. are not performed and remain as unfulfilled actions that just "sit around" and remain unresolved. This leads to disconnects and a lack of transfer between key activities that are either delayed or simply are not implemented. This is a common (and very serious) problem for all life science industries, including blood and biologics.

Thinking Closed-Loop

A closed-loop CAPA system does exactly the opposite of an open-loop system. A closed-loop CAPA system utilizes CAPA outputs by converting them into inputs that connect to specific tasks that are subsequently carried out (until resolution) and redirected back into the CAPA system for further review. Take for example a view of the key CAPA steps that every blood and biologics company should keep in mind:

  1. An issue is initiated, reviewed and input into the CAPA system;
  2. Based on the review and significance of that issue it will either be mitigated and contained and/or escalated for corrective action;
  3. If an issue is contained and impact is minimal it will be closed. If an issue is escalated to a further stage within the CAPA process, it will advance forward into the system and will then be investigated;
  4. After investigation a likely root cause will be determined and then that output will become an input within the CAPA system for a corrective action and an implementation plan. A verification of effectiveness will follow.

Without a closed-loop system, the CAPA process lacks effective communication. There is no logical flow from step to step; the bridges are missing from one action to the next. The opportunity for risk increases because of a lack of critical thinking and automated flow between steps. A regulated industry can’t afford to work in an environment where the loops are breached.

To learn more about closed-loop CAPA systems, please contact Ken Peterson at MasterControl, Inc.