A CAPA Plan is a corrective and preventive action plan designed to identify and address issues in quality assurance and regulatory compliance processes. The goal of a CAPA Plan is to improve overall process performance by eliminating the root cause of any problems and preventing them from occurring again in the future. It is an important tool for Quality Assurance and Regulatory Compliance teams to ensure the highest levels of quality and compliance.
Each focus area has its own objectives, projects, and KPIs to ensure that the strategy is comprehensive and effective.
This CAPA Plan template is designed for Quality Assurance and Regulatory Compliance teams who are looking to create a plan that outlines corrective and preventive actions to address issues and improve processes. It provides a framework to define focus areas, set objectives, measure targets, and implement related projects.
A focus area is the broader category that your objectives and projects will fall under. Examples of strategic focus areas that could fall under a CAPA Plan could be: Improve CAPA Processes , Promote Quality Assurance, and Ensure Regulatory Compliance.
Objectives are the specific goals that you want to achieve within each focus area. Each objective should be measurable and achievable, and should relate to the overall goal of the CAPA Plan.
Examples of some objectives for the focus area of Improve CAPA Processes could be: Increase Efficiency of CAPA Process, and Increase CAPA Compliance.
KPIs, or Key Performance Indicators, are measurable targets that you set in order to track progress towards each objective. They should be defined in terms of an initial baseline, a target goal, and a unit of measurement.
An example of a KPI for the focus area of Improve CAPA Processes could be: Decrease Avg Time from CAPA Initiation to Completion.
Projects, or actions, are the specific initiatives that need to be completed in order to achieve each KPI. These should be clearly defined and tracked in order to ensure that they are completed in a timely manner.
An example of a project related to Improve CAPA Processes could be: Automate CAPA Tracking.
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