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CAPA - Corrective and Preventive Action

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Compliancequest

CAPA or Corrective And Preventive Action is a methodological strategy for mitigating risks and improving processes, identifying the sources of actual or potential issues and their root causes, planning solutions for those problems, and documenting the solution so that similar issues don’t occur in the future. CAPA is a way to improve the company’s processes by taking a series of actions that eliminate the recurring events and causes of non-conformities. The major intent of a CAPA system is to focus on the root causes of particular problems and risks so that there won’t be a need for either corrective action or preventive action in the future.

Dealing with customer complaints and non-conformances is the backbone for rectifying problems but organizations can now reinforce the process throughout the digitally connected enterprise by managing CAPAs in real-time and ensuring stakeholders take impactful, proper actions.

A general Corrective and Preventive Action (CAPA) process follows the Plan-Do-Check-Act (PDCA) cycle to resolve unexpected events. The first process will be the identification phase where you will identify non-conformities in your processes and determine what kind of problem you are looking at. Non-conformities may be determined during an internal or external audit, through customer complaints, or if reported internally.

In case of systemic issues, Corrective Action is needed to eliminate a problem and prevent its recurrence while for non systemic issues, Preventive Action is required to reduce the risks of this adverse event occurring.

You can use numerous techniques to improve your Corrective Action, Preventive Action approach. Root Cause Analysis (RCA) is an analytical method that helps identify and rectify the sources of potential problems. Failure Mode and Effects Analysis (FMEA) is another effective element of a proactive approach, that provides input for your CAPA activities. APQP (Advanced Product Quality Planning) is generally used in the automotive industry to drive quality improvement in mobility end products. The 5 Whys-technique is also useful in detecting the cause-and-effect relationships inducing a particular problem.

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